GIVEN DIAGNOSTIC SYSTEM by GIVEN IMAGING LTD.

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.

AI/ML Overview

The provided text is a 510(k) summary for the Given® Diagnostic System with the Suspected Blood Indicator (SBI) feature. It describes the device, its intended use, and states that it meets performance standards and special controls. However, this document does not contain the specific details of a study that proves the device meets acceptance criteria, nor does it define explicit acceptance criteria in a quantifiable manner.

The document only states that the system "complies with the requirements presented in Ingestible Telemetric Gastrointestinal Capsule Imaging System: Final Guidance for Industry and FDA issued on November 28, 2001." It also asserts substantial equivalence to predicate devices "without raising any new safety and/or efficacy issue."

Therefore, I cannot fulfill your request for the following sections based on the provided text:

A table of acceptance criteria and the reported device performance
Sample size used for the test set and the data provenance
Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Adjudication method for the test set
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size
If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The sample size for the training set
How the ground truth for the training set was established

The document is a regulatory submission summary stating compliance and substantial equivalence, not a detailed clinical study report. Such details would typically be found in the actual studies conducted to support the 510(k) submission, which are not part of this summary document.

Summary

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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.: 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.

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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.

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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

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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	(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" (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 (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

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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

(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)

510(k) Number K031023

Prescription Use (Per 21 CFR 801.109)

Over the Counter Use__________________________________________________________________________________________________________________________________________________________

David A. Lymm

Regulation Number and Section

§ 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.”