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

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.

AI/ML Overview

Please note that the provided text is a 510(k) summary for the Given® Diagnostic System and primarily focuses on regulatory approval and substantial equivalence to predicate devices, rather than detailed performance studies with acceptance criteria, sample sizes, and ground truth methodologies.

Therefore, many of the requested details about specific study design, acceptance criteria, multi-reader studies, and detailed ground truth establishment are not explicitly present in the provided document. I will extract what is available and note when information is missing.

Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state quantitative acceptance criteria for device performance. Instead, it relies on demonstrating compliance with "Special Controls Guidance Document" and "substantial equivalence" to predicate devices. The "reported device performance" is implicitly that it functions similarly to the predicate devices for its intended use.

Acceptance Criteria (Quantitative)	Reported Device Performance (Quantitative)
Not explicitly stated in the document. The key acceptance criterion appears to be "substantial equivalence" to predicate devices and compliance with regulatory guidance.	The device was cleared by the FDA, implying it met the regulatory standard of substantial equivalence and safety/effectiveness. This means it is considered to perform acceptably for its intended use as an "adjunctive tool in the detection of abnormalities of the small bowel" for "visualization of the small bowel mucosa."

Detailed Study Information:

Due to the nature of a 510(k) summary, which often focuses on demonstrating substantial equivalence rather than presenting a detailed de novo clinical trial, much of the requested information about a specific performance study is not available in the provided text.

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not explicitly stated in the provided document. The document mentions "verification activities" but does not detail the size or nature of a clinical test set.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not explicitly stated in the provided document.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not explicitly stated in the provided document.
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 explicitly stated in the provided document. The device is a diagnostic visualizer, and the summary focuses on its function rather than human-in-the-loop performance improvements. It is not an AI-assisted device in the contemporary sense.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not explicitly stated in the provided document. The device is described as providing images for viewing by a physician, implying a human-in-the-loop system.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly stated in the provided document. Given the "visualization of the small bowel mucosa" and "detection of abnormalities," it is highly probable that ground truth would involve expert endoscopist review, surgical findings, or pathology, but this is not mentioned.
The sample size for the training set:
- Not applicable/Not explicitly stated in the provided document. The Given® Diagnostic System (M2A™ Capsule, Data Recorder Set, and RAPID® Workstation) described in this 510(k) appears to be a hardware-software system for image acquisition and viewing, not a machine learning or AI-driven diagnostic algorithm that would typically require a distinct "training set" in the modern sense. Its "training" would be more related to engineering and calibration.
How the ground truth for the training set was established:
- Not applicable/Not explicitly stated in the provided document. (See above point for training set relevance).

Summary of Device Performance (from the document):

The 510(k) filing for the Given® Diagnostic System (K022362) was reviewed by the FDA and determined to be "substantially equivalent" to its predicate devices (K010312 and K020341). This determination means the FDA found the device to be as safe and effective as a legally marketed device. The document states: "The verification activities demonstrated that the proposed modifications do not raise any new safety and/or effectiveness issue."

The "intended use" and implicit performance are:

"visualization of the small bowel mucosa"
"adjunctive tool in the detection of abnormalities of the small bowel"

The study supporting this approval, as described in the 510(k) summary, primarily focused on demonstrating substantial equivalence to existing predicate devices and compliance with relevant special controls guidance, rather than presenting a standalone clinical trial with explicit quantitative performance metrics against defined acceptance criteria. The document does not provide details on specific clinical study designs, patient cohorts, reader evaluations, or ground truth methodologies that would typically be found in a detailed study report.

Summary

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510(K) SUMMARY Given® Diagnostic System 510(k) Number K 022362

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.

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Predicate Device:

· Given® Diagnostic Imaging System (K010312)
· Given® Diagnostic System (K020341)

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 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

Device Description:

The Given® Diagnostic System is comprised of three subsystems: M2A™ Capsule, Data Recorder Set, and RAPID® Workstation.

Substantial Equivalence:

The proposed modified Given® Diagnostic System is substantially equivalent to the Given® Diagnostic System cleared under K010312 and K020341. The verification activities demonstrated that the proposed modifications do not raise any new safety and/or effectiveness issue.

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Image /page/2/Picture/1 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized image of an eagle with its wings spread, facing to the left. The eagle's body is formed by three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 0 9 2002

Shoshana (Shosh) Friedman, RAC V.P. Regulatory & Medical Affairs Given Imaging Limited New Industrial Park PO Box 258 Yogneam 20692 ISRAEL

Re: K022362

Trade/Device Name: Given Diagnostic System Regulation Number: 21 CFR 876.1300 Regulation Name: Ingestible telemetric gastrointestinal capsule imaging system Regulatory Class: II Product Code: 78 NEZ

Dated: July 18, 2002 Received: July 22, 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.

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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

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INDICATIONS FOR USE STATEMENT

0223402 510(k) Number (if known):_

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 _

L Prescription Use (Per 21 CFR 801.109)

Over the Counter Use__________________________________________________________________________________________________________________________________________________________

Nancy C Brandon
Division Sign Off

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number 6-6 K022362

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.”