82 FR 60306 - Medical Devices; General Hospital and Personal Use Devices; Classification of the Image Processing Device for Estimation of External Blood Loss

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 243 (December 20, 2017)

Page Range		60306-60308
FR Document		2017-27443

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.

Federal Register, Volume 82 Issue 243 (Wednesday, December 20, 2017)

[Federal Register Volume 82, Number 243 (Wednesday, December 20, 2017)]
[Rules and Regulations]
[Pages 60306-60308]
From the Federal Register Online  [www.thefederalregister.org]
[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.

-----------------------------------------------------------------------

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

[[Page 60307]]

``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
------------------------------------------------------------------------
         Identified risks                    Mitigation measures
------------------------------------------------------------------------
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.
------------------------------------------------------------------------

    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.

[[Page 60308]]

    (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

60306 Federal Register / Vol. 82, No. 243 / Wednesday, December 20, 2017 / Rules and Regulations

Country Entity License requirement License review policy Federal Register citation

Joint Stock Company Federal Scientific For all items subject to Presumption of denial ...... 82 FR [INSERT FR PAGE
and Production Center Titan- the EAR. (See § 744.11 NUMBER], 12/20/17.
Barrikady, a.k.a., the following three of the EAR).
aliases:
—Federal Research and Production
Center Titan Barrikady JSC;
—Titan Design Bureau; and
—JSC FNPTS Titan-Barrikady.
Prospekt Imeni V.I. Lenina, b/n 400071,
Volgograd, Russia.

* * * * * * *

Dated: December 15, 2017. MD 20993–0002, 301–796–6398, authorized under section 513(f)(2) of the
Richard E. Ashooh, Jitendra.Virani@fda.hhs.gov. FD&C Act. Section 207 of the Food and
Assistant Secretary for Export SUPPLEMENTARY INFORMATION: Drug Administration Modernization Act
Administration. of 1997 established the first procedure
I. Background for De Novo classification (Pub. L. 105–
[FR Doc. 2017–27388 Filed 12–19–17; 8:45 am]
BILLING CODE 3510–33–P Upon request, FDA has classified the 115). Section 607 of the Food and Drug
image processing device for estimation Administration Safety and Innovation
of external blood loss as class II (special Act modified the De Novo application
DEPARTMENT OF HEALTH AND controls), which we have determined process by adding a second procedure
HUMAN SERVICES will provide a reasonable assurance of (Pub. L. 112–144). A device sponsor
safety and effectiveness. In addition, we may utilize either procedure for De
Food and Drug Administration believe this action will enhance Novo classification.
patients’ access to beneficial innovation, Under the first procedure, the person
21 CFR Part 880 in part by reducing regulatory burdens submits a 510(k) for a device that has
by placing the device into a lower not previously been classified. After
[Docket No. FDA–2017–N–6570] device class than the automatic class III receiving an order from FDA classifying
assignment. the device into class III under section
Medical Devices; General Hospital and The automatic assignment of class III 513(f)(1) of the FD&C Act, the person
Personal Use Devices; Classification occurs by operation of law and without then requests a classification under
of the Image Processing Device for any action by FDA, regardless of the section 513(f)(2).
Estimation of External Blood Loss level of risk posed by the new device. Under the second procedure, rather
AGENCY: Food and Drug Administration, Any device that was not in commercial than first submitting a 510(k) and then
HHS. distribution before May 28, 1976, is a request for classification, if the person
automatically classified as, and remains determines that there is no legally
ACTION: Final order.
within, class III and requires premarket marketed device upon which to base a
SUMMARY: The Food and Drug approval unless and until FDA takes an determination of substantial
Administration (FDA or we) is action to classify or reclassify the device equivalence, that person requests a
classifying the image processing device (see 21 U.S.C. 360c(f)(1)). We refer to classification under section 513(f)(2) of
for estimation of external blood loss into these devices as ‘‘postamendments the FD&C Act.
class II (special controls). The special devices’’ because they were not in Under either procedure for De Novo
controls that apply to the device type commercial distribution prior to the classification, FDA shall classify the
are identified in this order and will be date of enactment of the Medical Device device by written order within 120 days.
part of the codified language for the Amendments of 1976, which amended The classification will be according to
image processing device for estimation the Federal Food, Drug, and Cosmetic the criteria under section 513(a)(1) of
of external blood loss’ classification. We Act (FD&C Act). the FD&C Act. Although the device was
are taking this action because we have FDA may take a variety of actions in automatically placed within class III,
determined that classifying the device appropriate circumstances to classify or the De Novo classification is considered
into class II (special controls) will reclassify a device into class I or II. We to be the initial classification of the
provide a reasonable assurance of safety may issue an order finding a new device device.
to be substantially equivalent under We believe this De Novo classification
and effectiveness of the device. We
section 513(i) of the FD&C Act (21 will enhance patients’ access to
believe this action will also enhance
U.S.C. 360c(i)) to a predicate device that beneficial innovation, in part by
patients’ access to beneficial innovative
does not require premarket approval. reducing regulatory burdens. When FDA
devices, in part by reducing regulatory
We determine whether a new device is classifies a device into class I or II via
burdens. the De Novo process, the device can
substantially equivalent to a predicate
DATES: This order is effective December by means of the procedures for serve as a predicate for future devices of
20, 2017. The classification was
ethrower on DSK3G9T082PROD with RULES

premarket notification under section that type, including for 510(k)s (see 21
applicable on May 9, 2014. 510(k) of the FD&C Act and part 807 (21 U.S.C. 360c(f)(2)(B)(i)). As a result, other
FOR FURTHER INFORMATION CONTACT: U.S.C. 360(k) and 21 CFR part 807, device sponsors do not have to submit
Jitendra Virani, Center for Devices and respectively). a De Novo request or premarket
Radiological Health, Food and Drug FDA may also classify a device approval application (PMA) in order to
Administration, 10903 New Hampshire through ‘‘De Novo’’ classification, a market a substantially equivalent device
Ave., Bldg. 66, Rm. G459, Silver Spring, common name for the process (see 21 U.S.C. 360c(i), defining

VerDate Sep<11>2014 16:19 Dec 19, 2017 Jkt 244001 PO 00000 Frm 00026 Fmt 4700 Sfmt 4700 E:\FR\FM\20DER1.SGM 20DER1

Document Created: 2018-10-25 10:54:50
Document Modified: 2018-10-25 10:54:50

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Rules and Regulations
Action		Final order.
Dates		This order is effective December 20, 2017. The classification was applicable on May 9, 2014.
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]
FR Citation		82 FR 60306

82 FR 60306 - Medical Devices; General Hospital and Personal Use Devices; Classification of the Image Processing Device for Estimation of External Blood Loss

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 243 (December 20, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration