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.

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, the subject of this submission, 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

Here’s a breakdown of the requested information based on the provided text for the Given® Diagnostic System (Suspected Blood Indicator (SBI)):

Acceptance Criteria and Device Performance Study

The provided text focuses on the 510(k) summary and clearance letter for the Given® Diagnostic System with the Suspected Blood Indicator (SBI) feature. It states that "The verification activities demonstrated that the proposed modification does not raise any new safety and/or effectiveness issue." However, it does not explicitly detail specific quantitative acceptance criteria for the SBI feature or present a specific study that quantifies its performance against such criteria. The SBI feature is described as "intended to mark frames of the video suspected of containing blood or red areas."

Given this, the table below reflects what can be inferred or directly stated from the provided document regarding acceptance criteria and performance:

Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Inferred/Stated)	Reported Device Performance (Inferred/Stated)
Intended Functionality	The Suspected Blood Indicator (SBI) feature is intended to mark frames of the video suspected of containing blood or red areas.	The device was cleared by the FDA, implying that the verification activities demonstrated its functionality for its intended use and that it does not raise any new safety and/or effectiveness issues. No specific quantitative performance metrics (e.g., sensitivity, specificity for blood detection) are provided in this document.
Safety and Effectiveness	The modification (SBI feature) does not raise any new safety and/or effectiveness issues compared to the predicate devices.	"The verification activities demonstrated that the proposed modification does not raise any new safety and/or effectiveness issue."
Substantial Equivalence	Substantial equivalence to predicate devices (K010312, K020341, K022362) for the Given® Diagnostic System with the new SBI feature.	The FDA determined the device is substantially equivalent to legally marketed predicate devices.

Study Information (Based on provided text)

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective nature) for the verification activities related to the SBI feature.
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):
- The document does not provide details on the number or qualifications of experts used to establish ground truth for any test set or verification activity related to the SBI feature.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- The document does not describe any specific adjudication method used for a test set.
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:
- The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. No effect size for human reader improvement with/without AI assistance is provided. The SBI is presented as an "adjunctive tool" or an "optional feature" that "automatically marks images," suggesting it aids interpretation, but no formal comparative study with human readers is detailed here.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The document implies that standalone performance was assessed for the SBI feature to demonstrate that "the proposed modification does not raise any new safety and/or effectiveness issue." The SBI is described as an automated function: "The analysis is based on detection of colorimetric abnormalities...". However, no specific performance metrics (e.g., sensitivity, specificity, accuracy) from a standalone evaluation are provided.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The document does not explicitly state the type of ground truth used for evaluating the SBI feature. Given its function ("suspected blood or red areas"), it's likely based on visual identification by experts or possibly correlated with other diagnostic findings, but this is not specified.
The sample size for the training set:
- The document does not provide any information about the sample size used for a training set for the SBI algorithm.
How the ground truth for the training set was established:
- The document does not provide any information about how ground truth was established for a training set.

In summary, while the document confirms FDA clearance based on "verification activities" demonstrating no new safety/effectiveness issues and substantial equivalence, it lacks specific quantitative details about the performance of the SBI feature, the methodology of any studies conducted, or the characteristics of the data/experts involved in those studies. The information provided is typical for a 510(k) summary confirming substantial equivalence without extensive performance data for a new software feature on an already cleared device.

Summary

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510(K) SUMMARY

Given® Diagnostic System

510(k) Number K022980

FEB 2 7 2003

Applicant's Name:

Given Imaging Ltd. 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.

Predicate Device:

· Given® Diagnostic Imaging System (K010312)
· Given® Diagnostic System (K020341)
· Given® Diagnostic System (K022362)

Performance Standards and Special Controls:

The Given® Diagnostic System complies with the requirements presented in "Class II Special Controls Guidance Document;

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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.

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.

Substantial Equivalence:

The proposed modified Given® Diagnostic System is substantially equivalent to the Given® Diagnostic System cleared under K010312, K020341, and K022362. The verification activities demonstrated that the proposed modification does 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 logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 7 2003

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

Re: K022980

Trade/Device Name: Given® Diagnostic System (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: November 27, 2002 Received: December 3, 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

510(k) Number (if known): K022980

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.

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 `K022186

Prescription Use _ Lo (Per 21 CFR 801.109)

Over the Counter Use ________

	Nancy Brogdon
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number	K027980

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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.”