The Given® AGILE Patency System is an accessory to the PillCam video capsule and is intended to verify adequate patency of the gastrointestinal tract prior to administration of the PillCam video capsule in patients with known or suspected strictures.

Device Description

The Given® AGILE Patency System is a simple and easy to use device for verifying the patency of the GI tract. It consists of the following components:

· Given AGILE Patency capsule
· Given AGILE Patency Scanner
· TesTag (interference tester)
Once the patient ingests the Given AGILE Patency capsule it is propelled through the GI tract by normal peristalsis. If the AGILE Patency capsule is excreted structurally whole, then this indicates patency of the GI tract of the patient and a PillCam capsule can be administered. The capsule is designed to dissolve starting 30 hours following ingestion, during a period of approximately 12 hours. If anytime before 30 hours after capsule ingestion the AGILE Patency capsule cannot be detected in the patient's body by the Given AGILE Patency Scanner, it indicates that the GI tract is patent and that the capsule was excreted naturally.
The Given AGILE Patency Scanner is used to detect the presence of the Given AGILE Patency capsule in the patient's body. If a scanner is not available, or if localization of a retained capsule is desired, fluoroscopy can be used.
If the Given AGILE Patency Scanner detects the Given AGILE Patency capsule in the GI tract 30 hours post-ingestion, then patency of the GI tract is not indicated. Eventually, the capsule dissolves into small fragments and is naturally excreted.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the Given AGILE Patency System, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state numerical acceptance criteria in a table format. However, the core function and intended outcome of the device serve as the de facto "acceptance criteria." The device's performance is reported in relation to its ability to confirm or deny GI tract patency.

Acceptance Criteria (Implied)	Reported Device Performance
Criterion 1: Accurate indication of GI tract patency if the capsule is excreted structurally whole.	"If the AGILE Patency capsule is excreted structurally whole, then this indicates patency of the GI tract of the patient and a PillCam capsule can be administered."
Criterion 2: Accurate indication of GI tract patency if the capsule cannot be detected by the scanner before 30 hours post-ingestion.	"If anytime before 30 hours after capsule ingestion the AGILE Patency capsule cannot be detected in the patient's body by the Given AGILE Patency Scanner, it indicates that the GI tract is patent and that the capsule was excreted naturally."
Criterion 3: Accurate indication of non-patency if the capsule is detected in the GI tract 30 hours post-ingestion or later.	"If the Given AGILE Patency Scanner detects the Given AGILE Patency capsule in the GI tract 30 hours post-ingestion, then patency of the GI tract is not indicated." The capsule "eventually... dissolves into small fragments and is naturally excreted."

Study Information:

The provided 510(k) summary does not contain details of a clinical study that provides specific data on the device's performance, such as sensitivity, specificity, accuracy, or a breakdown of results from a test set. The document focuses on describing the device, its intended use, and its substantial equivalence to predicate devices. It states that "Given Imaging Ltd. believes that, based on the information provided in the submission, the Given® AGILE Patency System is substantially equivalent to its predicate devices without raising any new safety and/or efficacy issue." This implies that the justification for clearance is primarily based on equivalence to existing cleared devices rather than a de novo clinical performance study demonstrating specific metrics against a test set.

Therefore, for the following points, the answer is "Not provided in the document" as the requested details would typically be found in a clinical study report, which is not part of this 510(k) summary.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Not provided in the document.

3. 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 provided in the document.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not provided in the 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

Not applicable / Not provided in the document. This device is a patency system, not an imaging analysis system that would involve human readers interpreting images with or without AI assistance.

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

While the device operates somewhat "stand-alone" in determining retention (scanner detects presence), the overall system relies on human interpretation of the scanner results (and potentially fluoroscopy) to make a clinical decision. However, no specific "standalone performance study" data is presented.

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

Not provided in the document. Given the nature of the device, the ground truth for patency would likely be established by direct observation of capsule passage, subsequent passage of a PillCam, or alternative diagnostic procedures (e.g., endoscopy, imaging).

8. The sample size for the training set

Not applicable / Not provided in the document. This device does not appear to be an AI/machine learning system that requires a "training set" in the conventional sense. Its function is based on physical dissolution and a scanner detection mechanism.

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

Not applicable / Not provided in the document. (See point 8).

Summary

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Page 1 of 2

MAY - 8 2003

510(K) SUMMARY Given® AGILE Patency System 510(k) Number K_ K053639

Applicant's Name:

Given Imaging Ltd. Hermon Building (Shaar Yoqneam) 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 Senior V.P. Regulatory & Clinical Affairs Tel: 011-972-4- 909 7784 Fax: 011-972-4-993 8060 Email: shosh@givenimaging.com

Trade Name:

Given® AGILE Patency System (an optional accessory to the Given® Diagnostic System with PillCam Capsules)

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 78NSI) and they are reviewed by the Gastroenterology Panel.

Predicate Device:

The Given AGILE Patency System is an accessory for the Given® Diagnostic System with PillCam™ Capsules (Given Imaging Ltd.) cleared under K010312, K020341, K022362, K022980, K031033, K032405, K040248, K041149, K042960, and K052184.

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Ko:53639 Page 2 of

Intended Use:

Device Description:

The Given® AGILE Patency System is a simple and easy to use device for verifying the patency of the GI tract. It consists of the following components:

· Given AGILE Patency capsule
· Given AGILE Patency Scanner
· TesTag (interference tester)

Once the patient ingests the Given AGILE Patency capsule it is propelled through the GI tract by normal peristalsis. If the AGILE Patency capsule is excreted structurally whole, then this indicates patency of the GI tract of the patient and a PillCam capsule can be administered. The capsule is designed to dissolve starting 30 hours following ingestion, during a period of approximately 12 hours. If anytime before 30 hours after capsule ingestion the AGILE Patency capsule cannot be detected in the patient's body by the Given AGILE Patency Scanner, it indicates that the GI tract is patent and that the capsule was excreted naturally.

The Given AGILE Patency Scanner is used to detect the presence of the Given AGILE Patency capsule in the patient's body. If a scanner is not available, or if localization of a retained capsule is desired, fluoroscopy can be used.

If the Given AGILE Patency Scanner detects the Given AGILE Patency capsule in the GI tract 30 hours post-ingestion, then patency of the GI tract is not indicated. Eventually, the capsule dissolves into small fragments and is naturally excreted.

Substantial Equivalence:

Given Imaging Ltd. believes that, based on the information provided in the submission, the Given® AGILE Patency System is substantially equivalent to its predicate devices without raising any new safety and/or efficacy issue.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, with its wings spread and head facing to the right.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

MAY -8 2006

Shoshana Friedman, RAC Senior VP, Regulatory and Clinical Affairs Given Imaging Ltd. Hermon Building (Shaar Yoqneam) PO Box 258 New Industrial Zone Yokneam 20692 ISRAEL

Re: K053639

Trade/Device Name: Given® AGILE Patency System Regulation Number: 21 CFR §876.1300 Regulation Name: Ingestible telemetric gastrointestinal capsule imaging system Regulatory Class: II Product Code: NSI and NEZ Dated: April 26, 2006 Received: May 1, 2006

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 (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, FDA may publish further announcements concerning your device in the Federal Register.

Image /page/2/Picture/10 description: The image shows the FDA Centennial logo. The logo is circular with the words "1906-2006" at the top and "For the science of food" at the bottom. In the center of the logo is the acronym "FDA" in large, bold letters. Below the acronym is the word "Centennial" in a smaller font. There are three stars below the word "Centennial". The image also contains the words "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 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): _K053639 .

Device Name:

Given® AGILE Patency System

Indications for Use:

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

510(k) Number_K053639

Prescription Use (Per 21 CFR 801.109)

Over the Counter Use_

David A. Seymann
(Division Sign-Off)

Division of Reproductive, and Radiological Devices

510(k) Number.

7-6

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.”