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Class II Special Controls Guidance Document: Ingestible Telemetric Gastrointestinal Capsule Imaging System; Final Guidance for Industry and FDA |
U.S. Department of Health and Human
Services |
|
Gastroenterology and Renal Devices Branch |
Comments and suggestions may be submitted at any time for Agency consideration to Dockets Management Branch, Division of Management Systems and Policy, Office of Human Resources and Management Services, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD, 20852. When submitting comments, please refer to the exact title of this guidance document. Comments may not be acted upon by the Agency until the document is next revised or updated.
For questions regarding the use or interpretation of this guidance contact Carolyn Y. Neuland Ph.D., at (240) 276-4151or by email carolyn.neuland@fda.hhs.gov.
Additional copies are available from the Internet at: http://www.fda.gov/cdrh/ode/guidance/1385.pdf or CDRH Facts-On-Demand. In order to receive this document via your fax machine, call the CDRH Facts-On-Demand system at 800-899-0381 or 301-827-0111 from a touch-tone telephone. Press 1 to enter the system. At the second voice prompt, press 1 to order a document. Enter the document number (1385) followed by the pound sign (#). Follow the remaining voice prompts to complete your request.
This document is intended to provide guidance. It represents the Agency's current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind the Food and Drug Administration (FDA) or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations. |
On August 1, 2001, FDA reclassified ingestible capsule wireless gastrointestinal imaging system from Class III designation to Class II. This guidance document describes a means by which ingestible capsule wireless gastrointestinal imaging system devices may comply with the requirements of class II special controls. Designation of this guidance document as a special control means that manufacturers of an ingestible telemetric gastrointestinal capsule imaging system, who follow the recommendations listed in this document before introducing their device into commercial distribution in the United States, will be able to market their device after they have submitted a premarket notification submission, referred to as a 510(k), and received a finding of "substantial equivalence" for their device. Manufacturers should comply with either the recommendations of this guidance or some alternate means that provide equivalent assurance of safety and effectiveness.
The issues identified in this guidance document represent those that we believe need to be addressed before your device can be marketed. In developing the guidance, we carefully considered the relevant statutory criteria for Agency decision-making. We also considered the burden that may be incurred in your attempt to comply with the guidance and address the issues we have identified. We believe that we have considered the least burdensome approach to resolving the issues presented in the guidance document. If, however, you believe that there is a less burdensome way to address the issues, you should follow the procedures outlined in the "A Suggested Approach to Resolving Least Burdensome Issues" document. It is available on our Center web page at: http://www.fda.gov/cdrh/modact/leastburdensome.html
FDA identifies this generic type of device as an gastroenterology and renal device under 21CFR §876.1300, product code NEZ. This generic type of device, an Ingestible Telemetric Gastrointestinal Capsule Imaging System, is used for visualization of the small bowel mucosa as an adjunctive tool in the detection of abnormalities of the small bowel.
FDA has identified risks to health associated with this type of device. These risks involve:
FDA believes the following controls, when combined with the general controls of the act, will provide reasonable assurance of the safety and effectiveness of this type device:
i. patients with cardiac pacemakers or other implanted electronic devices;
ii. patients with known intestinal obstruction or significant intestinal
strictures;
i. The physician should consider performing a contrasted x-ray series in patients with suspected strictures or fistulas prior to using this device;
ii. Variations in individual patient GI motility may decrease the length of the small bowel that is imaged;
- describe correct storage for the device prior to being used;
- address the issue of electromagnetic interference which may cause loss of images (e.g., from MRI, other in-band RF transmitters such as amateur radio);
- address the experience needed by the physician to correctly interpret the acquired images;
- address any ancillary diagnostic tests or examinations that should be performed prior to or in conjunction with this device;
- address the limits of the technology based on clinical studies and bench testing; and
- summarize the results of clinical studies.
- Evidence should be submitted to evaluate the mechanical and structural integrity of the device system when subjected to clinical use conditions. This testing should include the following:
i. evaluation of the device system when exposed to a range of pH levels for the period of time that the device will be used;
ii. mechanical integrity test, as needed, to evaluate the strength of the device system when subjected to mechanical forces that may be expected during clinical usage;
iii. battery life; and
iv. field of view and depth of focus.
Sufficient evidence of performance is needed for software-controlled medical devices. The degree of evidence needed is determined by the "level of concern" described in the FDA guidance document titled "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" http://www.fda.gov/cdrh/ode/57.html. The "level of concern" is related to the outcome of software failure and may be minor, moderate, or major. The software for this device is generally considered a "minor level of concern" as defined in the Software guidance.
Overall, the documentation related to the software contained in the medical device should provide sufficient evidence to describe the role of the software included in the device, and performance testing to demonstrate that the software functions as designed.
- ease of device ingestion;
- intestinal transit time (time between ingestion and excretion);
- documentation of excretion/recovery;
- diagnostic yield when compared to other standard mucosal imaging procedures (upper endoscopy, enteroscopy, colonoscopy);
- adverse events during and following the use of the device; and
- agreement between two or more reviewers with respect to interpretation of the images obtained.
FDA has determined that premarket notification is necessary to provide reasonable assurance of the safety and effectiveness of this generic type of device, and therefore, the device type is not exempt from the premarket notification requirements of the Federal Food, Drug, and Cosmetic Act. Thus, persons who intend to market a device of this type need to submit a premarket notification to FDA and receive agency clearance prior to marketing the device.
An Abbreviated 510(k) that relies on a Class II Special Controls Guidance Document should contain the following.
The following is a table of the controls that address the identified risks
to health:
Risk | Reference to Controls in This Document |
---|---|
(1) Biocompatibility; | 4. |
(2) Electrical and mechanical safety; | 5.a., b. |
(3) RF radiated power and EMC, including interference with other medical devices and with this device (e.g., interference with image acquisition); | 2.g., 2.h., 3.f., 5.b. |
(4) Functional reliability, | 3.a.b.c.d.e., 5.a.b., 6. |
(5) Intestinal obstruction or injury; and | 1., 2.a.b.c.d.e.f., 3.h., 7.a.b.c.d.e. |
(6) Misinterpretation of the captured images. | 3.g.i.j., 7.f. |
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