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 in adults and children from 10 years of age and up.

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: M2A™ 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. It describes the device, its intended use, and its substantial equivalence to previously cleared devices. However, it does not contain any information about specific acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment.

The document primarily focuses on regulatory approval, stating compliance with special controls guidance and asserting substantial equivalence. There is no mention of a clinical study, performance metrics, or the methods used to validate the Suspected Blood Indicator (SBI) feature's accuracy.

Therefore, I cannot fulfill your request for:

A table of acceptance criteria and the reported device performance: This information is not present in the provided text.
Sample sized used for the test set and the data provenance: Not available.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
Adjudication method for the test set: Not available.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not available.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not available.
The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not available.
The sample size for the training set: Not available.
How the ground truth for the training set was established: Not available.

The document only states the intended use of the SBI feature: "The Suspected Blood Indicator (SBI) feature is intended to mark frames of the video suspected of containing blood or red areas." and mentions that "The analysis is based on detection of colorimetric abnormalities, or deviations from an expected spectrum, corresponding to normal tissue." This describes what the feature does, but not how well it does it or how that performance was verified.

Summary

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510(K) SUMMARY Given® Diagnostic System (with pediatric indication) 510(k) Number K_032405

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:

Shosh Friedman, RAC Corporate V.P. Regulatory & Medical Affairs Tel: 011-972-4- 9097784 Fax: 011-972-4-9938060 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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K03 2405 Page 2 of 3

Predicate Device:

· Given® Diagnostic System (K010312, K020341, K022362, K022980, K031033)

Performance Standards and Special Controls:

The Given® Diagnostic System 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 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: M2A™ 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 pediatric indication is substantially equivalent to the Given® Diagnostic System cleared under K010312, K020341, K022362, K022980, and K031033 without raising any new safety and/or efficacy issue.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features an eagle-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 9 2003

Shosh Friedman, RAC Corporate Vice President Regulatory and Medical Affairs Given Imaging Ltd. 13 Hayetzira St. New Industrial Park P.O. Box 258 Yogneam 20692 ISRAEL

Re: K032405

Trade/Device Name: Given® Diagnostic System (with pediatric indication) Regulation Number: 21 CFR §876.1300 Regulation Name: Ingestible telemetric gastrointestinal capsule imaging system Regulatory Class: II Product Code: 78 NEZ Dated: July 31, 2003 Received: August 7, 2003

Dear Mr. 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. F rogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name:

Given® Diagnostic System

Indications for Use:

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 K032405

Prescription Use
(Per 21 CFR 801.109)

Over the Counter Use_

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices

510(k) Number

6-7

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.”