The Given® Diagnostic System is comprised of three subsystems: PillCam™ Capsule (SB, ESO), Data Recorder Set, and RAPID® Workstation or RAPID® Software.

The modifications to the Given® Diagnostic System, which are subject of this Special 510(k) is the addition of a new model of esophageal capsule, the PillCam™ ESO2 Capsule, and the addition of an alternative ingestion procedure, the simplified ingestion procedure (SIP) for the esophageal capsules.

AI/ML Overview

The provided text describes a 510(k) submission for the Given® Diagnostic System with PillCam™ ESO2 Capsule, focusing on its substantial equivalence to a predicate device. However, the document does not contain explicit acceptance criteria or a study that directly proves the device meets specific performance criteria beyond the general statement of substantial equivalence.

The 510(k) summary explains that the submission is for a modification to an existing device, specifically the addition of a new esophageal capsule model (PillCam™ ESO2) and an alternative ingestion procedure. The core of the submission is to demonstrate that these modifications do not introduce new safety or efficacy issues and that the modified device is "substantially equivalent" to already cleared devices.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert qualifications, and adjudication methods are not present in the provided document. The 510(k) process primarily relies on demonstrating equivalence rather than on de novo performance studies against pre-defined acceptance criteria (unless a special controls guidance document specifies them, which is mentioned as being complied with in a general sense, but no specific performance endpoints are given).

Here's an analysis of the information that can be extracted or inferred based on the provided text, and where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
NOT PROVIDED	NOT PROVIDED
(Specific quantitative criteria like sensitivity, specificity, accuracy, or image metrics are not detailed in this document. The primary "performance" demonstrated is substantial equivalence to a predicate device for visualization of esophageal mucosa.)	(No specific performance metrics are reported in this document beyond the device being cleared based on substantial equivalence for its stated intended use.)

2. Sample size used for the test set and the data provenance

Sample size for test set: NOT PROVIDED. The document doesn't detail a specific clinical study for performance testing of the PillCam™ ESO2 capsule against a ground truth. The submission likely relies on previous studies for the predicate device and potentially bridging studies that confirm the new capsule's similar performance.
Data provenance: NOT PROVIDED. No information on country of origin of data or whether it was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of experts: NOT PROVIDED. Since no specific performance study with a test set is detailed, information on experts used to establish ground truth is absent.
Qualifications of experts: NOT PROVIDED.

4. Adjudication method for the test set

Adjudication method: NOT PROVIDED. No test set or corresponding adjudication method is mentioned in this document.

5. 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

MRMC study: NOT APPLICABLE / NOT PROVIDED. The device is an "Ingestible Telemetric Esophageal Capsule Imaging System" which typically functions as a diagnostic tool for visualization, not an AI-assisted diagnostic. There is no mention of AI integrated into the system described in this document, nor any MRMC study comparing human readers with and without AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone algorithm performance: NOT APPLICABLE / NOT PROVIDED. The device is a capsule imaging system, not an algorithm, and the document does not describe any standalone algorithmic performance evaluation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Type of ground truth: NOT PROVIDED. The document does not describe a specific study with a defined ground truth for the PillCam™ ESO2 capsule's performance. The basis for equivalence is likely derived from the predicate device's demonstrated ability to visualize the esophageal mucosa, which would have implicitly relied on a comparison to standard clinical evaluations (e.g., endoscopy findings by expert clinicians, or possibly biopsy results for pathology).

8. The sample size for the training set

Sample size for training set: NOT APPLICABLE / NOT PROVIDED. As this is an imaging device and not an AI/ML algorithm that requires a training set in the typical sense, this information is not relevant or provided in the document.

9. How the ground truth for the training set was established

Ground truth for training set: NOT APPLICABLE / NOT PROVIDED. Same as above, not relevant for this type of device and submission.

Summary of what IS provided:

Device Name: Given® Diagnostic System with PillCam™ ESO2 Capsule
Intended Use: Visualization of the esophageal mucosa.
Predicate Device: Given® Diagnostic System with PillCam™ ESO Capsule (cleared under K041149 and K042960).
Basis for Clearance: Substantial equivalence to the predicate device.
Modifications: Addition of the PillCam™ ESO2 Capsule and an alternative ingestion procedure (simplified ingestion procedure - SIP).
Regulatory Compliance: Complies with "Class II Special Controls Guidance in Document; Ingestible Telemetric Gastrointestinal Capsule Imaging System; Final Guidance for Industry and FDA" issued on November 28, 2001. (However, the specific performance requirements from this guidance are not detailed in this 510(k) summary).

In essence, this document is a summary of the 510(k) submission, not a detailed clinical study report. It focuses on the regulatory argument for substantial equivalence rather than reporting explicit performance metrics from a specific new clinical study with the ESO2 capsule.

Summary

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K07 //53

Page 1 of 2

JUN 1 1 2007

ATTACHMENT 6-1

510(K) SUMMARY

Given® Diagnostic System with PillCam™ ESO2 Capsule

510(k) Number K

Applicant's Name:

Given Imaging Ltd. Hermon Building (Shaar Yoqneam) New Industrial Zone P.O. Box 258 Yoqneam 20692, Israel Tel.: 011-972-4-9097730 Fax: 011-972-4-9592466

Contact Person:

Shosh Friedman, RAC Senior Consultant Tel: (403) 208-4916 Fax: (403) 208-4953 Email: Shosh.Friedman@givenimaging.com

Trade Name:

Given® Diagnostic System

Classification Name:

Ingestible Telemetric Esophageal Capsule Imaging System

Classification:

FDA has classified Ingestible Telemetric Esophageal Capsule Imaging System as class II devices (product code 78NSI, regulation number 21 CFR 876.1300) and they are reviewed by the Gastroenterology Panel.

Predicate Device:

Given® Diagnostic System with PillCam™ ESO Capsule cleared for marketing under K041149 and K042960

Performance Standards and Special Controls:

The Given® Diagnostic System complies with the requirements presented "Class II Special Controls Guidance in Document; Ingestible Telemetric Gastrointestinal Capsule Imaging System; Final Guidance for Industry and FDA" issued on November 28, 2001

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K071153 Page 2 of 2

Intended Use:

The Given® Diagnostic System with the PillCam™ ESO2 Capsule is intended for visualization of the esophageal mucosa.

Device Description:

The Given® Diagnostic System is comprised of three subsystems: PillCam™ Capsule (SB, ESO), Data Recorder Set, and RAPID® Workstation or RAPID® Software.

Substantial Equivalence:

Given Imaging Ltd. believes that the modified Given® Diagnostic System with the PillCam™ ESO Capsule is substantially equivalent to the market cleared Given® Diagnostic System with the PillCam™ ESO2 Capsule without raising any new safety and/or efficacy issue.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

JUN 1 1 2007

Shoshana Friedman, RAC Senior Consultant Given® Imaging Ltd. 91 Rockyspring Cir. NW Calgary, Alberta T3G 6A1 CANADA

Re: K071153

Trade/Device Name: Given® Diagnostic System with PillCam™ ESO2 Capsule Regulation Number: 21 CFR §876.1300 Regulation Name: Ingestible telemetric gastrointestinal capsule imaging system Regulatory Class: II Product Code: NSI Dated: May 30, 2007 Received: June 4, 2007

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 costi. 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 (Premarket Approval), it may be subject to such 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 F PA may publish further announcements concerning your device in the Federal Register.

Image /page/2/Picture/10 description: The image is a circular logo or emblem. The central element is the acronym "FDA" in a bold, stylized font, with the word "Centennial" written below it. The years "1906-2006" are positioned above the acronym. The entire design is encircled by text, which appears to be part of the organization's name or a related slogan, and is adorned with star symbols.

Protecting and Promoting Public Health

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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.

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 this letter:

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html

Sincerely vours.

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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ATTACHMENT 6-3

INDICATIONS FOR USE STATEMENT

510(k) Number:________________________________________________________________________________________________________________________________________________________________

Device Name:

Given® Diagnostic System (with PillCam™ ESO2 Capsule)

Indications for Use:

The Given® Diagnostic System with the PillCam™ ESO2 Capsule is intended for visualization of the esophageal mucosa

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

510(k) Number K071153

Prescription Use
(Per 21 CFR 801.109)

Over the Counter Use__________________________________________________________________________________________________________________________________________________________

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices	K071153

510(k) Number

6-6

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.”