(90 days)
The Given® Diagnostic System is intended for visualization of the small bowel mucosa. It may be used as an adjunctive tool in the detection of abnormalities of the small bowel
The Given® Diagnostic System is comprised of three subsystems M2ATM Capsule, Data Recorder Set, and Rapid™ Workstation. The M2A™ Capsule is a wireless, disposable capsule designed to glide smoothly through the digestive system by the peristaltic activity of the intestinal muscles and is excreted naturally. During its passage, the capsule transmits digital data that is captured by receiving antennas attached to the patient's body. The images are stored in the Data Recorder that is connected to the receiving antennas and is worn on a belt around the waist of the patient. When the test is over, the antennas and recorder are removed from the patient's body. The images from the recorder are downloaded to the Rapid™ Workstation for processing and viewing by the physician.
The provided text is a 510(k) summary for the Given® Diagnostic System. It does not contain information about specific acceptance criteria, device performance, study details, or ground truth establishment. Therefore, I cannot generate the requested information based on the input provided.
This document mainly outlines:
- The applicant and contact information.
- Trade and classification names of the device.
- Intended use and contraindications.
- Device description.
- A statement of substantial equivalence to a predicate device.
- The FDA's decision letter for clearance.
To answer your request, a document detailing the performance study, clinical trials, or validation reports would be necessary.
{0}------------------------------------------------
MAY 0 2 2002
510(K) SUMMARY
Page 1 of 3
Given® Diagnostic System (with Localization Module) 510(k) Number KQ20341
Applicant's Name:
Given Imaging Ltd. 2 Carmel St. P.O. Box 258 New Industrial Zone Yokneam 20692, Israel Tel.: 011-972-4-9097730 Fax: 011-972-4-9592466
Contact Person:
Shoshana Friedman, RAC V.P. Regulatory & Medical Affairs Tel: 011-972-4- 9097784 Fax: 011-972-4-9592466 Email: shosh@givenimaging.com
Trade Name:
Given® Diagnostic System
Classification Name:
Ingestible Telemetric Gastrointestinal Capsule Imaging System
Classification:
FDA has classified Ingestible Telemetric Gastrointestinal Capsule Imaging System as class II devices (product code 78NZE) and they are reviewed by the Gastroenterology Panel.
7-3
{1}------------------------------------------------
Predicate Device:
- · Given® Diagnostic Imaging System (K010312)
Page 2 of 3
Performance Standards and Special Controls:
The Given® Diagnostic System (with the Localization Module) complies with the requirements presented in "Class II Special Controls Guidance Document; Ingestible Telemetric Gastrointestinal Capsule Imaging System; Final Guidance for Industry and FDA" issued on November 28,2001
Intended Use:
The Given® Diagnostic System is intended for visualization of the It may be used as an adjunctive tool in the small bowel mucosa. detection of abnormalities of the small bowel
The M2A® Capsule is contraindicated for use under the following conditions:
- In patients with known or suspected gastrointestinal obstruction, strictures, or fistulas based on the clinical picture or preprocedure testing and profile.
- In patients with cardiac pacemakers other implanted . or electromedical devices
- In patients with swallowing disorders. .
Device Description:
The Given® Diagnostic System is comprised of three subsystems M2ATM Capsule, Data Recorder Set, and Rapid™ Workstation.
The M2A™ Capsule is a wireless, disposable capsule designed to glide smoothly through the digestive system by the peristaltic activity of the intestinal muscles and is excreted naturally. During its passage, the capsule transmits digital data that is captured by receiving antennas attached to the patient's body. The images are stored in the Data Recorder that is connected to the receiving antennas and is worn on a belt around the waist of the patient. When the test is over, the antennas and recorder are removed from the patient's body. The
7-4
{2}------------------------------------------------
Page 3 of 3
images from the recorder are downloaded to the Rapid™ Workstation for processing and viewing by the physician.
Substantial Equivalence:
Given Imaging Ltd. believes that, based on the information provided Civen submission, the Given® Diagnostic System with the Localization Module is substantially equivalent to the Given® Diagnostic Imaging System cleared under K010312 without raising any new safety and/or efficacy issue.
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is a stylized image of an eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
MAY 2 2002
Ms. Shoshana Friedman Vice-President, Regulatory & Medical Affairs . Given® Imaging Limited New Industrial Park PO Box 258, Yogneam 20692 ISRAEL
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Re: K020341 Trade/Device Name: Given® Diagnostic System (with Localization Module) Regulation Number: 21 CFR 876.1300 Regulation Name: Small bowel mucosa visualization device Regulatory Class: II Product Code: 78 NEZ Dated: January 31, 2002 Received: February 1, 2002
Dear Ms. Friedman:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
{4}------------------------------------------------
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours.
Nancy C Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Page 2
{5}------------------------------------------------
INDICATIONS FOR USE STATEMENT
Ko20341 510(k) Number
Device Name:
Given® Diagnostic System
Indications for Use:
The Given® Diagnostic System is intended for visualization of the small bowel mucosa. It may be used as an adjunctive tool in the detection of abnormalities of the small bowel
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
510(k) Number K020341
Prescription Use (Per 21 CFR 801.109) OR
Over the Counter Use_
Nancy C Broadon 7-7
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K020341
§ 876.1300 Ingestible telemetric gastrointestinal capsule imaging system.
(a)
Identification. 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. The device captures images of the small bowel with a wireless camera contained in a capsule. This device includes an ingestible capsule (containing a light source, camera, transmitter, and battery), an antenna array, a receiving/recording unit, a data storage device, computer software to process the images, and accessories.(b)
Classification. Class II (special controls). The special control is FDA's guidance, “Class II Special Controls Guidance Document: Ingestible Telemetric Gastrointestinal Capsule Imaging Systems; Final Guidance for Industry and FDA.”