[Federal Register Volume 82, Number 243 (Wednesday, December 20, 2017)]
[Rules and Regulations]
[Pages 60306-60308]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-27443]


=======================================================================
-----------------------------------------------------------------------

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