[Federal Register Volume 82, Number 243 (Wednesday, December 20, 2017)]
[Rules and Regulations]
[Pages 60306-60308]
[FR Doc No: 2017-27443]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 880

[Docket No. FDA-2017-N-6570]

Medical Devices; General Hospital and Personal Use Devices;
Classification of the Image Processing Device for Estimation of
External Blood Loss

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA or we) is classifying
the image processing device for estimation of external blood loss into
class II (special controls). The special controls that apply to the
device type are identified in this order and will be part of the
codified language for the image processing device for estimation of
external blood loss' classification. We are taking this action because
we have determined that classifying the device into class II (special
controls) will provide a reasonable assurance of safety and
effectiveness of the device. We believe this action will also enhance
patients' access to beneficial innovative devices, in part by reducing
regulatory burdens.

DATES: This order is effective December 20, 2017. The classification
was applicable on May 9, 2014.

FOR FURTHER INFORMATION CONTACT: Jitendra Virani, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. G459, Silver Spring, MD 20993-0002, 301-
796-6398, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the image processing device for
estimation of external blood loss as class II (special controls), which
we have determined will provide a reasonable assurance of safety and
effectiveness. In addition, we believe this action will enhance
patients' access to beneficial innovation, in part by reducing
regulatory burdens by placing the device into a lower device class than
the automatic class III assignment.
    The automatic assignment of class III occurs by operation of law
and without any action by FDA, regardless of the level of risk posed by
the new device. Any device that was not in commercial distribution
before May 28, 1976, is automatically classified as, and remains
within, class III and requires premarket approval unless and until FDA
takes an action to classify or reclassify the device (see 21 U.S.C.
360c(f)(1)). We refer to these devices as ``postamendments devices''
because they were not in commercial distribution prior to the date of
enactment of the Medical Device Amendments of 1976, which amended the
Federal Food, Drug, and Cosmetic Act (FD&C Act).
    FDA may take a variety of actions in appropriate circumstances to
classify or reclassify a device into class I or II. We may issue an
order finding a new device to be substantially equivalent under section
513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that
does not require premarket approval. We determine whether a new device
is substantially equivalent to a predicate by means of the procedures
for premarket notification under section 510(k) of the FD&C Act and
part 807 (21 U.S.C. 360(k) and 21 CFR part 807, respectively).
    FDA may also classify a device through ``De Novo'' classification,
a common name for the process authorized under section 513(f)(2) of the
FD&C Act. Section 207 of the Food and Drug Administration Modernization
Act of 1997 established the first procedure for De Novo classification
(Pub. L. 105-115). Section 607 of the Food and Drug Administration
Safety and Innovation Act modified the De Novo application process by
adding a second procedure (Pub. L. 112-144). A device sponsor may
utilize either procedure for De Novo classification.
    Under the first procedure, the person submits a 510(k) for a device
that has not previously been classified. After receiving an order from
FDA classifying the device into class III under section 513(f)(1) of
the FD&C Act, the person then requests a classification under section
513(f)(2).
    Under the second procedure, rather than first submitting a 510(k)
and then a request for classification, if the person determines that
there is no legally marketed device upon which to base a determination
of substantial equivalence, that person requests a classification under
section 513(f)(2) of the FD&C Act.
    Under either procedure for De Novo classification, FDA shall
classify the device by written order within 120 days. The
classification will be according to the criteria under section
513(a)(1) of the FD&C Act. Although the device was automatically placed
within class III, the De Novo classification is considered to be the
initial classification of the device.
    We believe this De Novo classification will enhance patients'
access to beneficial innovation, in part by reducing regulatory
burdens. When FDA classifies a device into class I or II via the De
Novo process, the device can serve as a predicate for future devices of
that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a
result, other device sponsors do not have to submit a De Novo request
or premarket approval application (PMA) in order to market a
substantially equivalent device (see 21 U.S.C. 360c(i), defining

``substantial equivalence''). Instead, sponsors can use the less-
burdensome 510(k) process, when necessary, to market their device.

II. De Novo Classification

    For this device, FDA issued an order on November 13, 2012, finding
the Gauss Surgical Pixel 3 Application not substantially equivalent to
a predicate not subject to PMA. Thus, the device remained in class III
in accordance with section 513(f)(1) of the FD&C Act when we issued the
order.
    On February 4, 2013, Gauss Surgical, Inc., submitted a request for
De Novo classification of the PIXEL 3 SYSTEM. FDA reviewed the request
in order to classify the device under the criteria for classification
set forth in section 513(a)(1) of the FD&C Act.
    We classify devices into class II if general controls by themselves
are insufficient to provide reasonable assurance of safety and
effectiveness, but there is sufficient information to establish special
controls that, in combination with the general controls, provide
reasonable assurance of the safety and effectiveness of the device for
its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the
information submitted in the request, we determined that the device can
be classified into class II with the establishment of special controls.
FDA has determined that these special controls, in addition to the
general controls, will provide reasonable assurance of the safety and
effectiveness of the device.
    Therefore, on May 9, 2014, FDA issued an order to the requester
classifying the device into class II. FDA is codifying the
classification of the device by adding 21 CFR 880.2750. We have named
the generic type of device image processing device for estimation of
external blood loss, and it is identified as a device to be used as an
aid in estimation of patient external blood loss. The device may
include software and/or hardware that is used to process images
capturing externally lost blood to estimate the hemoglobin mass and/or
the blood volume present in the images.
    FDA has identified the following risks to health associated
specifically with this type of device and the measures required to
mitigate these risks in table 1.

 Table 1--Image Processing Device for Estimation of External Blood Loss
                      Risks and Mitigation Measures
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         Identified risks                    Mitigation measures
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Failure to provide accurate or      Non-clinical performance testing;
 precise device output.              Software display of estimated
                                     cumulative error; Software
                                     verification, validation, and
                                     hazard analysis; Human factors
                                     testing; and Labeling.
Use error.........................  Human factors testing; and Labeling.
Electromagnetic incompatibility...  Electromagnetic compatibility
                                     testing; Wireless testing; and
                                     Labeling.
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    FDA has determined that special controls, in combination with the
general controls, address these risks to health and provide reasonable
assurance of safety and effectiveness. For a device to fall within this
classification, and thus avoid automatic classification in class III,
it would have to comply with the special controls named in this final
order. The necessary special controls appear in the regulation codified
by this order. This device is subject to premarket notification
requirements under section 510(k) of the FD&C Act.

III. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

IV. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to
previously approved collections of information found in other FDA
regulations. These collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501-3520). The collections of information in
the guidance document ``De Novo Classification Process (Evaluation of
Automatic Class III Designation)'' have been approved under OMB control
number 0910-0844; the collections of information in part 814, subparts
A through E, regarding premarket approval, have been approved under OMB
control number 0910-0231; the collections of information in part 807,
subpart E, regarding premarket notification submissions, have been
approved under OMB control number 0910-0120; and the collections of
information in 21 CFR part 801, regarding labeling, have been approved
under OMB control number 0910-0485.

List of Subjects in 21 CFR Part 880

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
880 is amended as follows:

PART 880--GENERAL HOSPITAL AND PERSONAL USE DEVICES

0
1. The authority citation for part 880 is revised to read as follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
2. Add Sec.  880.2750 to subpart C to read as follows:

Sec.  880.2750   Image processing device for estimation of external
blood loss.

    (a) Identification. An image processing device for estimation of
external blood loss is a device to be used as an aid in estimation of
patient external blood loss. The device may include software and/or
hardware that is used to process images capturing externally lost blood
to estimate the hemoglobin mass and/or the blood volume present in the
images.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) Non-clinical performance data must demonstrate that the device
performs as intended under anticipated conditions of use. Demonstration
of the performance characteristics must include a comparison to a
scientifically valid alternative method for measuring deposited
hemoglobin mass. The following use conditions must be tested:
    (i) Lighting conditions;
    (ii) Range of expected hemoglobin concentrations;
    (iii) Range of expected blood volume absorption; and
    (iv) Presence of other non-sanguineous fluids (e.g., saline
irrigation fluid).
    (2) Human factors testing and analysis must validate that the
device design and labeling are sufficient for appropriate use by
intended users of the device.

    (3) Appropriate analysis and non-clinical testing must validate the
electromagnetic compatibility (EMC) and wireless performance of the
device.
    (4) Appropriate software verification, validation, and hazard
analysis must be performed.
    (5) Software display must include an estimate of the cumulative
error associated with estimated blood loss values.
    (6) Labeling must include:
    (i) Warnings, cautions, and limitations needed for safe use of the
device;
    (ii) A detailed summary of the performance testing pertinent to use
of the device, including a description of the bias and variance the
device exhibited during testing;
    (iii) The validated surgical materials, range of hemoglobin mass,
software, hardware, and accessories that the device is intended to be
used with; and
    (iv) EMC and wireless technology instructions and information.

    Dated: December 15, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-27443 Filed 12-19-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: August 26, 2009 (Volume 74, Number 164)]
[Notices]
[Page 43221-43223]
[DOCID:fr26au09-147]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-1998-4334; FMCSA-1999-5578; FMCSA-2000-7363; FMCSA-
2001-9561; FMCSA-2001-9258; FMCSA-2003-14504; FMCSA-2003-15268; FMCSA-
2005-20027; FMCSA-2005-21254; FMCSA-2007-27897]

Qualification of Drivers; Exemption Applications; Vision

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of renewal of exemptions; request for comments.

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SUMMARY: FMCSA announces its decision to renew the exemptions from the
vision requirement in the Federal Motor Carrier Safety Regulations for
23 individuals. FMCSA has statutory authority to exempt individuals
from the vision requirement if the exemptions granted will not
compromise safety. The Agency has concluded that granting these
exemption renewals will provide a level of safety that is equivalent
to, or greater than, the level of safety maintained without the
exemptions for these commercial motor vehicle (CMV) drivers.

DATES: This decision is effective September 23, 2009. Comments must be
received on or before September 25, 2009.

ADDRESSES: You may submit comments bearing the Federal Docket
Management System (FDMS) Docket ID FMCSA-1998-4334; FMCSA-1999-5578;
FMCSA-2000-7363; FMCSA-2001-9561; FMCSA-2001-9258; FMCSA-2003-14504;
FMCSA-2003-15268; FMCSA-2005-20027; FMCSA-2005-21254; FMCSA-2007-27897,
using any of the following methods.
     Federal eRulemaking Portal: Go to http://
www.regulations.gov. Follow the on-line instructions for submitting
comments.
     Mail: Docket Management Facility; U.S. Department of
Transportation, 1200 New Jersey Avenue, SE., West Building Ground
Floor, Room W12-140, Washington, DC 20590-0001.
     Hand Delivery or Courier: West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue, SE., Washington, DC, between 9 a.m.
and 5 p.m., Monday through Friday, except Federal Holidays.
     Fax: 1-202-493-2251.
    Each submission must include the Agency name and the docket number
for this Notice. Note that DOT posts all comments received without
change to http://www.regulations.gov, including any personal
information included in a comment. Please see the Privacy Act heading
below.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov at any time or Room W12-140
on the ground level of the West Building, 1200 New Jersey Avenue, SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The FDMS is available 24 hours each day, 365
days each year. If you want acknowledgment that we received your
comments, please include a self-addressed, stamped envelope or postcard
or print the acknowledgement page that appears after submitting
comments on-line.
    Privacy Act: Anyone may search the electronic form of all comments
received into any of our dockets by the name of the individual
submitting the comment (or of the person signing the comment, if
submitted on behalf of an association, business, labor union, etc.).
You may review the DOT's complete Privacy Act Statement in the Federal
Register published on April 11, 2000 (65 FR 19476). This information is
also available at http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Dr. Mary D. Gunnels, Director, Medical
Programs,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA, Department of
Transportation, 1200 New Jersey Avenue, SE., Room W64-224, Washington,
DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m. Monday through
Friday, except Federal holidays.

SUPPLEMENTARY INFORMATION:

Background

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may renew an exemption
from the vision requirements in 49 CFR 391.41(b)(10), which applies to
drivers of CMVs in interstate commerce, for a two-year period if it
finds ``such exemption would likely achieve a level of safety that is
equivalent to, or greater than, the level that would be achieved absent
such exemption.'' The procedures for requesting an exemption (including
renewals) are set out in 49 CFR part 381.

Exemption Decision

    This notice addresses 23 individuals who have requested a renewal
of their exemption in accordance with FMCSA procedures. FMCSA has
evaluated these 23 applications for renewal on their merits and decided
to extend each exemption for a renewable two-year period. They are:
Linda L. Billings, John A. Chizmar, Weldon R. Evans, Richard L.
Gagnebin, Orasio Garcia, Leslie W. Good, Chester L. Gray, James P.
Guth, Britt D. Hazelwood, William W. Hodgins, Gregory K. Lilly, Michael
S. Maki, Larry T. Morrison, Kenneth A. Reddick, Leonard Rice, Jr., Juan
M. Rosas, Francis L. Savell, James T. Sullivan, Steven C. Thomas,
Edward A. Vanderhei, Larry J. Waldner, Karl A. Weinert, Kevin L.
Wickard.
    These exemptions are extended subject to the following conditions:
(1) That each individual have a physical examination every year (a) by
an ophthalmologist or optometrist who attests that the vision in the
better eye continues to meet the standard in 49 CFR 391.41(b)(10), and
(b) by a medical examiner who attests that the individual is otherwise
physically qualified under 49 CFR 391.41; (2) that each individual
provide a copy of the ophthalmologist's or optometrist's report to the
medical examiner at the time of the annual medical examination; and (3)
that each individual provide a copy of the annual medical certification
to the employer for retention in the driver's qualification file and
retain a copy of the certification on his/her person while driving for
presentation to a duly authorized Federal, State, or local enforcement
official. Each exemption will be valid for two years unless rescinded
earlier by FMCSA. The exemption will be rescinded if: (1) The person
fails to comply with the terms and conditions of the exemption; (2) the
exemption has resulted in a lower level of safety than was maintained
before it was granted; or (3) continuation of the exemption would not
be consistent with the goals and objectives of 49 U.S.C. 31136(e) and
31315.

Basis for Renewing Exemptions

    Under 49 U.S.C. 31315(b)(1), an exemption may be granted for no
longer than two years from its approval date and may be renewed upon
application for additional two year periods. In accordance with 49
U.S.C. 31136(e) and 31315, each of the 23 applicants has satisfied the
entry conditions for obtaining an exemption from the vision
requirements (63 FR 66226; 64 FR 16517; 66 FR 41656; 68 FR 44837; 70 FR
41811; 72 FR 62896; 68 FR 54775; 70-53412; 64 FR 27027; 64 FR 51568; 66
FR 48504; 65 FR 45817; 65 FR 77066; 66 FR 17743; 66 FR 33990; 68 FR
35772; 72 FR 52421; 66 FR 30502; 66 FR 41654; 68 FR 19598; 68 FR 33570;
68 FR 37197; 68 FR 48989; 70 FR 42615; 70 FR 2701; 70 FR 16887; 72 FR
27624; 70 FR 30999; 70 FR 46567; 72 FR 52422; 72 FR 39879; 72 FR
52419). Each of these 23 applicants has requested renewal of the
exemption and has submitted evidence showing that the vision in the
better eye continues to meet the standard specified at 49 CFR
391.41(b)(10) and that the vision impairment is stable. In addition, a
review of each record of safety while driving with the respective
vision deficiencies over the past two years indicates each applicant
continues to meet the vision exemption standards. These factors provide
an adequate basis for predicting each driver's ability to continue to
drive safely in interstate commerce. Therefore, FMCSA concludes that
extending the exemption for each renewal applicant for a period of two
years is likely to achieve a level of safety equal to that existing
without the exemption.

Request for Comments

    FMCSA will review comments received at any time concerning a
particular driver's safety record and determine if the continuation of
the exemption is consistent with the requirements at 49 U.S.C. 31136(e)
and 31315. However, FMCSA requests that interested parties with
specific data concerning the safety records of these drivers submit
comments by September 25, 2009.
    FMCSA believes that the requirements for a renewal of an exemption
under 49 U.S.C. 31136(e) and 31315 can be satisfied by initially
granting the renewal and then requesting and evaluating, if needed,

subsequent comments submitted by interested parties. As indicated
above, the Agency previously published notices of final disposition
announcing its decision to exempt these 23 individuals from the vision
requirement in 49 CFR 391.41(b)(10). The final decision to grant an
exemption to each of these individuals was based on the merits of each
case and only after careful consideration of the comments received to
its notices of applications. The notices of applications stated in
detail the qualifications, experience, and medical condition of each
applicant for an exemption from the vision requirements. That
information is available by consulting the above cited Federal Register
publications.
    Interested parties or organizations possessing information that
would otherwise show that any, or all of these drivers, are not
currently achieving the statutory level of safety should immediately
notify FMCSA.
    The Agency will evaluate any adverse evidence submitted and, if
safety is being compromised or if continuation of the exemption would
not be consistent with the goals and objectives of 49 U.S.C. 31136(e)
and 31315, FMCSA will take immediate steps to revoke the exemption of a
driver.

    Issued on: August 19, 2009.
Larry W. Minor,
Associate Administrator, Policy and Program Development.
[FR Doc. E9-20621 Filed 8-25-09; 8:45 am]

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