GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO2 CAPSULE

K071153 · Given Imaging , Ltd. · NSI · Jun 11, 2007 · Gastroenterology, Urology

Device Facts

• Record ID: K071153
• Device Name: GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO2 CAPSULE
• Applicant: Given Imaging , Ltd.
• Product Code: NSI · Gastroenterology, Urology
• Decision Date: Jun 11, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1300
• Device Class: Class 2

Intended Use

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

Device Story

Given® Diagnostic System consists of PillCam™ ESO2 ingestible capsule, data recorder set, and RAPID® workstation/software. Capsule captures esophageal images as it traverses the esophagus; transmits data wirelessly to external recorder worn by patient. Physician uses RAPID® software on workstation to review images; facilitates visualization of esophageal mucosa. System supports simplified ingestion procedure (SIP). Enables non-invasive esophageal assessment; assists clinical decision-making regarding esophageal health.

Clinical Evidence

No clinical data provided in the summary; substantial equivalence based on technological characteristics and design modifications.

Technological Characteristics

Ingestible telemetric capsule imaging system (21 CFR 876.1300). Comprised of ingestible capsule, data recorder, and workstation software. Complies with 'Class II Special Controls Guidance Document; Ingestible Telemetric Gastrointestinal Capsule Imaging System'.

Indications for Use

Indicated for visualization of the esophageal mucosa in patients requiring esophageal examination.

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™ ESO Capsule (K041149)
• Given® Diagnostic System with PillCam™ ESO Capsule (K042960)

Submission Summary (Full Text)

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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.: [phone] Fax: [phone]

## Contact Person:

Shosh Friedman, RAC Senior Consultant Tel: [phone] Fax: [phone] Email: [e-mail]

#### 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.

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.

#### 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 [phone] or [phone] 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)

OR

Over the Counter Use__________________________________________________________________________________________________________________________________________________________

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

510(k) Number

6-6