GIVEN PILLCAM PLATFORM WILL PILLCAM SB CAPSULES, ESO CAPSULES, GIVEN AGILE PATENCY SYSTEM

K090557 · Given Imaging , Ltd. · NSI · Sep 28, 2009 · Gastroenterology, Urology

Device Facts

• Record ID: K090557
• Device Name: GIVEN PILLCAM PLATFORM WILL PILLCAM SB CAPSULES, ESO CAPSULES, GIVEN AGILE PATENCY SYSTEM
• Applicant: Given Imaging , Ltd.
• Product Code: NSI · Gastroenterology, Urology
• Decision Date: Sep 28, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1300
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Given PillCam® Platform with the PillCam® SB Capsules 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 two years of age. The Suspected Blood Indicator (SBI) feature is intended to mark frames of the video suspected of containing blood or red areas. 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 in adults and children from two years of age.

Device Story

Given PillCam Platform consists of ingestible video capsule, RAPID software, and workstation hardware. Capsule acquires GI tract images during natural propulsion, transmitting via RF to external DataRecorder/SensorArray. RAPID software processes, analyzes, and stores images, creating video and clinical reports. AGILE Patency System includes dissolvable capsule and external scanner to verify GI patency before PillCam administration. Used in clinical settings by healthcare providers to visualize small bowel mucosa and detect abnormalities. Suspected Blood Indicator (SBI) feature automatically marks video frames containing potential blood/red areas. Output assists clinicians in diagnosing GI conditions; benefits include non-invasive visualization of small bowel.

Clinical Evidence

Clinical data summarized to demonstrate safety and effectiveness for proposed indications. No specific study metrics (e.g., sensitivity/specificity) provided in summary; compliance with FDA Class II Special Controls Guidance Document cited as evidence basis.

Technological Characteristics

Ingestible telemetric capsule imaging system. Components: disposable ingestible capsule, RF transmitter, external SensorArray, DataRecorder, and workstation (modified PC). Software-based image processing and reporting. Complies with Class II Special Controls Guidance Document for Ingestible Telemetric Gastrointestinal Capsule Imaging System (2001).

Indications for Use

Indicated for visualization of small bowel mucosa and detection of abnormalities in adults and children (≥2 years). AGILE system indicated to verify GI tract patency in patients with known/suspected strictures (adults and children ≥2 years) prior to capsule endoscopy.

Regulatory Classification

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.

Special Controls

*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.”

Predicate Devices

• Given® Diagnostic System with PillCam® SB2 Capsule (K070475)
• Given® AGILE Patency System (K053639)

Submission Summary (Full Text)

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K090557 Page 1 of 3

Given Imaging Limited New Industrial Park PG Box 258. Yogneam

# 510(k) Summary

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR 807.92.

Submitter Name and Address:

Contact Person:

Fax Number:

Date Prepared:

Given Imaging Ltd. Hermon Building New Industrial Park PO Box 258 Yogneam 20692 Israel Tel.: [phone] Fax: [phone] Tim Thomas Global Director, Regulatory and Quality

Email: tim [e-mail]

Phone Number:

770-662-0510

9710107

770-662-0870 ext. 1006

Given® AGILE Patency System

Establishment Registration Number:

February 23, 2009

Device Trade Name(s):

Device Common Name:

Classification:

Regulation No: 876.1300 Class: II Panel: Gastroenterology NEZ - System, Imaging, Gastrointestinal, Wireless, Capsule NSI - System, Imaging, Esophageal, Wireless, Capsule

Ingestible telemetric gastrointestinal capsule imaging system

Given PillCam® Platform with PillCam® SB Capsules

Predicate Device(s):

Given® Diagnostic System with PillCam® SB2 Capsule (K070475) Given® AGILE Patency System (K053639)

Given Imaging Ltd. Now Industrial Park, PO Box 258, Yoqueam 20692, Isract

Image /page/0/Picture/19 description: The image shows the logo for Given Imaging. The logo consists of the text "Given" in a large font, with a stylized image of a capsule endoscopy device between the words. Below the word "Given" is the word "Imaging" in a smaller font.

SEP 2 8 2009

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K090557 Page 2 of 3

Given Imaging Limited New Industrial Park PO Box 258, Yogneam 20602 Israel Voice 972 4 909 77.77 Fax [phone]

Image /page/1/Picture/1 description: The image shows the logo for Given Imaging. The logo is in black and white and features the words "Given" and "Imaging" in a sans-serif font. There is an image of a capsule between the two words. The logo is simple and modern.

General Device Description:

The Given PillCam® Platform is comprised of three main subsystems; (1) the ingestible PillCam capsule, (2) the RAPID® software, and (3) the Given® Workstation and Hardware.

1. Ingestible PillCam Capsule

The disposable, ingestible PillCam Capsule is designed to acquire video images during the natural propulsion through the GI tract. The capsule transmits the acquired images via a RF communication channel to the DataRecorder located outside the body.

RAPID Software

2

The RAPID Software is a software application that is utilized to process, analyze, store, and view the acquired images collected from the DataRecorder to create a RAPID video of the images. The software also includes a reporting function to create detailed clinical reports, in-service training videos, and patient instruction forms.

ਤੇ Given Workstation and Hardware

The Workstation is a modified standard personal computer that is the operational platform for the RAPID software. The DataRecorder is an external receiving/recording unit that receives acquired images from the capsule. The SensorArray receives data from the PillCam capsule and transfers the data to the DataRecorder. The RAPID Real Time is a handheld device that allows for real-time viewing of acquired images through the GI tract. Other accessories include a flat panel LCD monitor, a high-capacity mass storage device, and a high-capacity USB portable storage device.

The Given Agile Patency System is designed to determine which patients with known or suspected intestinal strictures can safely ingest a PillCam video capsule. The system consists of an ingestible and dissolvable capsule that is the same size as the PillCam SB capsule, and an external scanner.

Given Imaging Ltd. New Industrial Park, PO Box 258, Yoqueam 20692. Israel

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K090557 Page 3 of 3

Given Imaging Limited New Industrial Park PD Box 258, Yogneam 20602 Israel Voice 972 4 909 7777 Fax 972 ± 950 2466

Image /page/2/Picture/1 description: The image shows the logo for Given Imaging. The logo consists of the word "Given" in large, block letters, followed by a stylized image of a capsule. Below the word "Given" is the word "Imaging" in smaller letters. The logo is simple and professional, and it is likely used to represent the company's brand.

#### Intended Use:

SB Indications for Use:

The Given PillCam® Platform with the PillCam® SB Capsules 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 two years of age.

The Suspected Blood Indicator (SBI) feature is intended to mark frames of the video suspected of containing blood or red areas.

### AGILE Indications for Use:

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 in adults and children from two years of age.

The technology characteristics are exactly the same as the predicate devices.

The devices meet the guidance entitled "Class II Special Controls Guidance Document: Ingestible Telemetric Gastrointestinal Capsule Imaging System; Final Guidance for Industry and FDA dated November 28, 2001. Clinical data has been summarized to show safety and effectiveness for the proposed indications for use.

Based on the technological characteristics and clinical. performance of the devices, Given Imaging Ltd. believes that the Given PillCam® Platform with PillCam® SB Capsules, the Given® AGILE Patency System and the predicate devices selected are substantially equivalent and do not raise new issues of safety or effectiveness.

Technological Characteristics:

Performance Data:

Conclusion:

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Mr. Tim Thomas Global Director, Regulatory and Quality Given Imaging Limited New Industrial Park, PO Box 258 Yogneam, 20692 ISRAEL

SEP 2 8 2009

Re: K090557

Trade/Device Name: Given® AGILE Patency System and Given PillCam® Platform with PillCam® SB Capsules

Regulation Number: 21 CFR 876.1300

Regulation Name: Ingestible telemetric gastrointestinal capsule imaging system Regulatory Class: II Product Code: NEZ, NSI Dated: September 13, 2009

Received: September 15, 2009

Dear Mr. Thomas:

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); medical device reporting (reporting of medical

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device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Device Name: Given® AGILE Patency System

Indications for Use:

AGILE Indications for Use:

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 in adults and children from two years of age.

Prescription Use _ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
`K090557`
510(k) Number
Given Imaging Ltd. 510(k) Submission
Given PillCam® Platform with PillCam® SB Capsules
Given® AGILE Patency System
September 22, 2009

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Proprietary to Given Imaging Ltd.

### INDICATIONS FOR USE

**510(k) Number (if known):**

510(k) Number (if known):

Device Name: Given PillCam® Platform with PillCam® SB Capsules

Indications for Use:

SB Indications for Use:

The Given PillCam® Platform with the PillCam® SB Capsules 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 two years of age.

The Suspected Blood Indicator (SBI) feature is intended to mark frames of the video suspected of containing blood or red areas.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

510(k) Number (if known):

Given Imaging Ltd. 510(k) Submission Given PillCam® Platform with PillCam® SB Capsules Given® AGILE Patency System September 22, 2009

(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devic

510(k) Number