GIVEN DIAGNOSTIC SYSTEM

K031033 · Given Imaging , Ltd. · NEZ · Jul 1, 2003 · Gastroenterology, Urology

Device Facts

• Record ID: K031033
• Device Name: GIVEN DIAGNOSTIC SYSTEM
• Applicant: Given Imaging , Ltd.
• Product Code: NEZ · Gastroenterology, Urology
• Decision Date: Jul 1, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1300
• Device Class: Class 2

Intended Use

The Given® Diagnostic System is intended for visualization of the small bowel mucosa. It may be used as a tool in the detection of abnormalities of the small bowel. The Suspected Blood Indicator (SBI) feature is intended to mark frames of the video suspected of containing blood or red areas.

Device Story

Given® Diagnostic System consists of M2A® capsule, data recorder, and RAPID® workstation. Disposable wireless capsule travels via peristalsis through digestive tract; captures and transmits digital images to external antennas worn by patient. Data stored on belt-worn recorder. Post-procedure, data downloaded to RAPID® workstation for physician review. RAPID 2.0 software includes Suspected Blood Indicator (SBI) feature; automatically identifies and marks video frames containing suspected blood or red areas based on colorimetric analysis. Physician reviews marked frames to assist in identifying small bowel abnormalities. System facilitates non-invasive visualization of small bowel mucosa.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and compliance with Class II Special Controls Guidance Document for Ingestible Telemetric Gastrointestinal Capsule Imaging Systems.

Technological Characteristics

System comprises M2A® capsule, data recorder, and RAPID® workstation. Capsule utilizes wireless transmission of digital image data. Software-based Suspected Blood Indicator (SBI) performs colorimetric analysis to detect red areas. Complies with Class II Special Controls Guidance Document (Nov 28, 2001).

Indications for Use

Indicated for visualization of small bowel mucosa and detection of small bowel abnormalities in patients requiring diagnostic imaging of the small bowel.

Regulatory Classification

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.

Special Controls

*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.”

Predicate Devices

• Given® Diagnostic System (K010312)
• Given® Diagnostic System (K020341)
• Given® Diagnostic System (K022362)
• Given® Diagnostic System (K022980)

Submission Summary (Full Text)

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JUL 1 2003 510(K) SUMMARY Given® Diagnostic System (with revised indications) 510(k) Number K_03 / 0 33

Applicant's Name:

Given Imaging Ltd. 13 HaYetzira St. P.O. Box 258 New Industrial Zone Yokneam 20692, Israel Tel.: [phone] Fax: [phone]

Contact Person:

Shoshana Friedman, RAC V.P. Regulatory & Medical Affairs Tel: [phone] Fax: [phone] Email: [e-mail]

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.

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K031033 Page 2 of 3

Predicate Device:

· Given® Diagnostic System (K010312, K020341, K022362, K022980)

## Performance Standards and Special Controls:

The Given® Diagnostic System complies with the requirements "Class II Special Controls Guidance Document; presented in 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 small bowel mucosa. It may be used as a tool in the detection of abnormalities of the small bowel

The Suspected Blood Indicator (SBI) feature is intended to mark frames of the video suspected of containing blood or red areas.

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 DataRecorder 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 RAPID 2.0 software, contains an optional feature called Suspected Blood Indicator (SBI), which automatically marks images that correlate with the existence of suspected blood or red areas. The analysis is based on detection of colorimetric abnormalities, or deviations from an expected spectrum, corresponding to normal tissue.

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## Substantial Equivalence:

Given Imaging Ltd. believes that, based on the information provided in this submission, the Given® Diagnostic System with revised indications is substantially equivalent to the Given® Diagnostic System cleared under K010312, K020341, K022362, and K022980 without raising any new safety and/or efficacy issue.

KO3 1033

3

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - U.S.A." arranged around the perimeter. Inside the circle is a stylized symbol featuring three curved lines that resemble a human figure or abstract design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 2003

2003

Ms. Shoshana Friedman, RAC V. P. Regulatory & Medical Affairs Given® Imaging Limited New Industrial Park P.O. Box 258, Yoqneam 20692 ISRAEL

Re: K031033

Trade/Device Name: Given® Diagnostic System with Suspected Blood Indicator (SBI) Regulation Number: 21 CFR §876.1300 Regulation Name: Ingestible telemetric gastrointestinal capsule imaging system Regulatory Class: II Product Code: 78 NEZ Dated: March 31, 2003 Received: April 15, 2003

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.

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This letter will allow you to begin marketing your device as described in your Section 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 the letter:

| 8xx. 1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. 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 [phone] or [phone] 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

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510(k) Number (if known): Ko3 10 33

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 a tool in the detection of abnormalities of the small bowel.

The Suspected Blood Indicator (SBI) feature is intended to mark frames of the video suspected of containing blood or red areas

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510(k) Number K031023

Prescription Use (Per 21 CFR 801.109)

OR

Over the Counter Use__________________________________________________________________________________________________________________________________________________________

David A. Lymm