[Federal Register Volume 79, Number 95 (Friday, May 16, 2014)]
[Rules and Regulations]
[Pages 28401-28404]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-11173]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 876
[Docket No. FDA-2014-N-0431]
Medical Devices; Gastroenterology-Urology Devices; Classification
of the Colon Capsule Imaging System
AGENCY: Food and Drug Administration, HHS.
ACTION: Final order.
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SUMMARY: The Food and Drug Administration (FDA) is classifying the
colon capsule imaging system into class II (special controls). The
special controls that will apply to the device are identified in this
order and will be part of the codified language for the colon capsule
imaging system's classification. The Agency is classifying the device
into class II (special controls) in order to provide a reasonable
assurance of safety and effectiveness of the device.
DATES: This order is effective June 16, 2014. The classification was
effective beginning January 29, 2014.
FOR FURTHER INFORMATION CONTACT: Irene Bacalocostantis, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm. G244, Silver Spring, MD 20993-0002,
301-796-6814.
SUPPLEMENTARY INFORMATION:
I. Background
In accordance with section 513(f)(1) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were
not in commercial distribution before May 28, 1976 (the date of
enactment of the Medical Device Amendments of 1976), generally referred
to as postamendments devices, are classified automatically by statute
into class III without any FDA rulemaking process. These devices remain
in class III and require premarket approval unless and until the device
is classified or reclassified into class I or II, or FDA issues an
order finding the device to be substantially equivalent, in accordance
with section 513(i) of the FD&C Act, to a predicate device that does
not require premarket approval. The Agency determines whether new
devices are substantially equivalent to predicate devices by means of
premarket notification procedures in section 510(k) of the FD&C Act (21
U.S.C. 360(k)) and part 807 (21 CFR part 807) of the regulations.
Section 513(f)(2) of the FD&C Act, as amended by section 607 of the
Food and Drug Administration Safety and Innovation Act (Pub. L. 112-
144, July 9, 2012), provides two procedures by which a person may
request FDA to classify a device under the criteria set forth in
section 513(a)(1). Under the first procedure, the person submits a
premarket notification under section 510(k) of the FD&C Act (21 U.S.C.
360) for a device that has not previously been classified and, within
30 days of receiving an order classifying the device into class III
under section 513(f)(1) of the FD&C Act, the person requests a
classification under section 513(f)(2). Under the second procedure,
rather than first submitting a premarket notification under section
510(k) and then a request for classification under the first procedure,
the person determines that there is no legally marketed device upon
which to base a determination of
[[Page 28402]]
substantial equivalence and requests a classification under section
513(f)(2) of the FD&C Act. If the person submits a request to classify
the device under this second procedure, FDA may decline to undertake
the classification request if FDA identifies a legally marketed device
that could provide a reasonable basis for review of substantial
equivalence with the device or if FDA determines that the device
submitted is not of ``low-moderate risk'' or that general controls
would be inadequate to control the risks and special controls to
mitigate the risks cannot be developed.
In response to a request to classify a device under either
procedure provided by section 513(f)(2) of the FD&C Act, FDA will
classify the device by written order within 120 days. This
classification will be the initial classification of the device.
Given Imaging Ltd. submitted a request on November 21, 2012, for
classification of the PillCam[supreg] COLON 2 capsule endoscopy system
under section 513(f)(2) of the FD&C Act. The manufacturer recommended
that the device be classified into class II (Ref. 1).
In accordance with section 513(f)(2) of the FD&C Act, 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. FDA
classifies 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 to provide reasonable assurance of the safety and
effectiveness of the device for its intended use. After review of the
information submitted in the de novo request, FDA determined that the
device can be classified into class II with the establishment of
special controls. FDA believes these special controls, in addition to
general controls, will provide reasonable assurance of the safety and
effectiveness of the device.
Therefore, on January 29, 2014, FDA issued an order to the
requestor classifying the device into class II. FDA is codifying the
classification of the device by adding Sec. 876.1330 (21 CFR
876.1330).
Following the effective date of this final classification
administrative order, any firm submitting a premarket notification
(510(k)) for a colon capsule imaging system will need to comply with
the special controls named in the final administrative order.
The device is assigned the generic name colon capsule imaging
system, and it is identified as a prescription, single-use ingestible
capsule designed to acquire video images during natural propulsion
through the digestive system. It is specifically designed to visualize
the colon for the detection of polyps. It is intended for use only in
patients who had an incomplete optical colonoscopy with adequate
preparation, and a complete evaluation of the colon was not technically
possible.
FDA has identified the following risks to health associated with
this type of device and the measures required to mitigate these risks
in Table 1:
Table 1--Colon Capsule Imaging System Risks and Mitigation Measures
----------------------------------------------------------------------------------------------------------------
Identified risk Mitigation measure
----------------------------------------------------------------------------------------------------------------
Adverse tissue reaction......... Biocompatibility.
Equipment, malfunction leading Electrical safety, thermal and mechanical safety.
to injury. Software validation, verification, and hazard analysis.
Non-clinical testing.
Labeling.
Interference with other devices Electromagnetic compatibility testing.
and with this device (e.g., Software validation, verification, and hazard analysis.
interference with image Non-clinical testing.
acquisition, patient
information compromised).
Poor image acquisitions......... Optical imaging performance testing
Non-clinical testing.
Labeling.
Failure to excrete.............. Labeling.
Misinterpretation of the Clinical performance data.
captured images. Non-clinical testing.
Labeling.
Possibility of missing a polyp, Clinical performance data.
or falsely identifying a polyp. Software validation, verification, and hazard analysis.
Labeling.
Abdominal pain, nausea, Clinical performance data.
vomiting, choking. Labeling.
----------------------------------------------------------------------------------------------------------------
FDA believes that the following special controls, in addition to
the general controls, address these risks to health and provide
reasonable assurance of safety and effectiveness:
The capsule must be demonstrated to be biocompatible.
Non-clinical testing data must demonstrate the mechanical
and functional integrity of the device under physically stressed
conditions. The following performance characteristics must be tested
and detailed protocols must be provided for each test:
[cir] Bite test to ensure that the capsule can withstand extreme
cases of biting.
[cir] pH resistance test to evaluate integrity of the capsule when
exposed to a range of pH values.
[cir] Battery life test to demonstrate that the capsule's operating
time is not constrained by the battery capacity.
[squ] Shelf-life testing to demonstrate that the device performs as
intended at the proposed shelf-life date.
[cir] Optical testing to evaluate fundamental image quality
characteristics such as resolution, field of view, depth of field,
distortion, signal-to-noise ratio, uniformity, and image artifacts. A
test must be performed to evaluate the potential of scratches, caused
by travelling through the gastrointestinal tract, on the transparent
window of the capsule and their impact on the optical and color
performance.
[cir] An optical safety analysis must be performed based on maximum
(worst-case) light exposure to internal gastrointestinal mucosa, and
covering ultraviolet, visible, and near-infrared ranges, as
appropriate. A mitigation analysis must be provided.
[cir] A color performance test must be provided to compare the
color differences between the input scene and output image.
[[Page 28403]]
[cir] The video viewer must clearly present the temporal or spatial
relationship between any two frames as a real-time lapse or a travel
distance. The video viewer must alert the user when the specific video
interval is captured at a frame rate lower than the nominal one due to
communication errors.
[cir] A performance test evaluating the latency caused by any
adaptive algorithm such as adjustable frame rate must be provided.
[cir] If the capsule includes a localization module, a localization
performance test must be performed to verify the accuracy and precision
of locating the capsule position within the colon.
[cir] A data transmission test must be performed to verify the
robustness of the data transmission between the capsule and the
recorder. Controlled signal attenuation should be included for
simulating a non-ideal environment.
[cir] Software validation, verification, and hazards analysis must
be provided.
[cir] Electrical equipment safety, including thermal and mechanical
safety and electromagnetic compatibility (EMC) testing must be
performed. If the environments of intended use include locations
outside of hospitals and clinics, appropriate higher immunity test
levels must be used. Labeling must include appropriate EMC information.
[cir] Information demonstrating immunity from wireless hazards.
The clinical performance characteristics of the device for
the detection of colon polyps must be established. Demonstration of the
performance characteristics must include assessment of positive percent
agreement and negative percent agreement compared to a clinically-
acceptable alternative structural imaging method.
Clinician labeling must include:
[cir] Specific instructions and the clinical and technical
expertise needed for the safe use of the device.
[cir] A detailed summary of the clinical testing pertinent to use
of the device, including the percentage of patients in which a polyp
was correctly identified by capsule endoscopy, but also the percent of
patients in which the capsule either missed or falsely identified a
polyp with respect to the clinically acceptable alternative structural
imaging method.
[cir] The colon cleansing procedure.
[cir] A detailed summary of the device technical parameters.
[cir] A detailed summary of the device- and procedure-related
complications pertinent to use of the device.
[cir] An expiration date/shelf life.
Patient labeling must include:
[cir] An explanation of the device and the mechanism of operation.
[cir] Patient preparation procedure.
[cir] A brief summary of the clinical study. The summary should not
only include the percentage of patients in which a polyp was correctly
identified by capsule endoscopy, but also the percent of patients in
which the capsule either missed or falsely identified a polyp with
respect to the clinically acceptable alternative structural imaging
method.
[cir] A summary of the device- and procedure-related complications
pertinent to use of the device.
Colon capsule imaging systems are prescription devices restricted
to patient use only upon the authorization of a practitioner licensed
by law to administer or use the device. (Proposed Sec. 876.1330(a);
see section 520(e) of the FD&C Act (21 U.S.C. 360j(e)) and Sec.
801.109 (21 CFR 801.109) (Prescription devices).) Prescription-use
restrictions are a type of general controls as defined in section
513(a)(1)(A)(i) of the FD&C Act.
Section 510(m) of the FD&C Act provides that FDA may exempt a class
II device from the premarket notification requirements under section
510(k) of the FD&C Act if FDA determines that premarket notification is
not necessary to provide reasonable assurance of the safety and
effectiveness of the device. For this type of device, FDA has
determined that premarket notification is necessary to provide
reasonable assurance of the safety and effectiveness of the device.
Therefore, this device type is not exempt from premarket notification
requirements. Persons who intend to market this type of device must
submit to FDA a premarket notification prior to marketing the device,
which contains information about the prostate lesion documentation
system they intend to market.
II. 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.
III. Paperwork Reduction Act of 1995
This final administrative 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 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.
IV. Reference
The following reference has been placed on display in the Division
of Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852, and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday,
and is available electronically at http://www.regulations.gov.
1. K123666: De Novo Request per 513(f)(2) of the Federal Food, Drug,
and Cosmetic Act from Given Imaging Ltd., dated November 21, 2012.
List of Subjects in 21 CFR Part 876
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
876 is amended as follows:
PART 876--GASTROENTEROLOGY-UROLOGY DEVICES
0
1. The authority citation for 21 CFR part 876 continues to read as
follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
0
2. Add Sec. 876.1330 to subpart B to read as follows:
Sec. 876.1330 Colon capsule endoscopy system.
(a) Identification. A prescription, single-use ingestible capsule
designed to acquire video images during natural propulsion through the
digestive system. It is specifically designed to visualize the colon
for the detection of polyps. It is intended for use only in patients
who had an incomplete optical colonoscopy with adequate preparation,
and a complete evaluation of the colon was not technically possible.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) The capsule must be demonstrated to be biocompatible.
(2) Non-clinical testing data must demonstrate the mechanical and
functional integrity of the device under physically stressed
conditions. The following performance characteristics
[[Page 28404]]
must be tested and detailed protocols must be provided for each test:
(i) Bite test to ensure that the capsule can withstand extreme
cases of biting.
(ii) pH resistance test to evaluate integrity of the capsule when
exposed to a range of pH values.
(iii) Battery life test to demonstrate that the capsule's operating
time is not constrained by the battery capacity.
(iv) Shelf-life testing to demonstrate that the device performs as
intended at the proposed shelf-life date.
(v) Optical testing to evaluate fundamental image quality
characteristics such as resolution, field of view, depth of field,
distortion, signal-to-noise ratio, uniformity, and image artifacts. A
test must be performed to evaluate the potential of scratches, caused
by travelling through the gastrointestinal tract, on the transparent
window of the capsule and their impact on the optical and color
performance.
(vi) An optical safety analysis must be performed based on maximum
(worst-case) light exposure to internal gastrointestinal mucosa, and
covering ultraviolet, visible, and near-infrared ranges, as
appropriate. A mitigation analysis must be provided.
(vii) A color performance test must be provided to compare the
color differences between the input scene and output image.
(viii) The video viewer must clearly present the temporal or
spatial relationship between any two frames as a real-time lapse or a
travel distance. The video viewer must alert the user when the specific
video interval is captured at a frame rate lower than the nominal one
due to communication errors.
(ix) A performance test evaluating the latency caused by any
adaptive algorithm such as adjustable frame rate must be provided.
(x) If the capsule includes a localization module, a localization
performance test must be performed to verify the accuracy and precision
of locating the capsule position within the colon.
(xi) A data transmission test must be performed to verify the
robustness of the data transmission between the capsule and the
recorder. Controlled signal attenuation should be included for
simulating a non-ideal environment.
(xii) Software validation, verification, and hazards analysis must
be provided.
(xiii) Electrical equipment safety, including thermal and
mechanical safety and electromagnetic compatibility (EMC) testing must
be performed. If the environments of intended use include locations
outside of hospitals and clinics, appropriate higher immunity test
levels must be used. Labeling must include appropriate EMC information.
(xiv) Information demonstrating immunity from wireless hazards.
(3) The clinical performance characteristics of the device for the
detection of colon polyps must be established. Demonstration of the
performance characteristics must include assessment of positive percent
agreement and negative percent agreement compared to a clinically
acceptable alternative structural imaging method.
(4) Clinician labeling must include:
(i) Specific instructions and the clinical and technical expertise
needed for the safe use of the device.
(ii) A detailed summary of the clinical testing pertinent to use of
the device, including the percentage of patients in which a polyp was
correctly identified by capsule endoscopy, but also the percent of
patients in which the capsule either missed or falsely identified a
polyp with respect to the clinically acceptable alternative structural
imaging method.
(iii) The colon cleansing procedure.
(iv) A detailed summary of the device technical parameters.
(v) A detailed summary of the device- and procedure-related
complications pertinent to use of the device.
(vi) An expiration date/shelf life.
(5) Patient labeling must include:
(i) An explanation of the device and the mechanism of operation.
(ii) Patient preparation procedure.
(iii) A brief summary of the clinical study. The summary should not
only include the percentage of patients in which a polyp was correctly
identified by capsule endoscopy, but also the percent of patients in
which the capsule either missed or falsely identified a polyp with
respect to the clinically acceptable alternative structural imaging
method.
(iv) A summary of the device- and procedure-related complications
pertinent to use of the device.
Dated: May 9, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-11173 Filed 5-15-14; 8:45 am]
BILLING CODE 4160-01-P