MODIFICATON TO: GIVEN DIAGNOSTIC IMAGING SYSTEM

K070475 · Given Imaging , Ltd. · NEZ · May 7, 2007 · Gastroenterology, Urology

Device Facts

• Record ID: K070475
• Device Name: MODIFICATON TO: GIVEN DIAGNOSTIC IMAGING SYSTEM
• Applicant: Given Imaging , Ltd.
• Product Code: NEZ · Gastroenterology, Urology
• Decision Date: May 7, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1300
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Given® Diagnostic System with the PillCam™ SB2 Capsule 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 10 years of age and up The Suspected Blood Indicator (SBI) feature is intended to mark frames of the video suspected of containing blood or red areas

Device Story

System consists of ingestible PillCam SB2 capsule, data recorder, and RAPID workstation/software. Capsule captures small bowel images; transmits data to external recorder worn by patient. Physician reviews video on RAPID workstation. Suspected Blood Indicator (SBI) feature automatically marks video frames containing potential blood or red areas to assist clinician review. Used in clinical settings to detect small bowel abnormalities; aids diagnostic decision-making; provides non-invasive visualization of small bowel mucosa.

Clinical Evidence

No clinical data provided in this summary; substantial equivalence based on technological characteristics and compliance with special controls guidance.

Technological Characteristics

Ingestible telemetric capsule imaging system. Components: PillCam SB2 capsule, data recorder, RAPID workstation/software. Complies with 'Class II Special Controls Guidance Document; Ingestible Telemetric Gastrointestinal Capsule Imaging System'.

Indications for Use

Indicated for visualization of small bowel mucosa and detection of small bowel abnormalities in adults and children aged 10 years and older.

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 (K010312)
• Given® Diagnostic System (K020341)
• Given® Diagnostic System (K022362)
• Given® Diagnostic System (K022980)
• Given® Diagnostic System (K031033)
• Given® Diagnostic System (K032405)
• Given® Diagnostic System (K040248)
• Given® Diagnostic System (K052184)
• Given® Diagnostic System (K060805)
• Given® Diagnostic System (K062786)

Submission Summary (Full Text)

{0}------------------------------------------------

Page 1 of 2

## ATTACHMENT 6-1

510(K) SUMMARY

MAY -- 7 2007

Expanding the scope of C++

Given® Diagnostic System with PillCam™ SB2 Capsule

# 510(k) Number K070475

### 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 91 Rokyspring Cir. NW Calgary, AB T3G 6A1, Canada Tel: [phone] Fax: [phone] Email: [e-mail]

### 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, regulation CFR 876.1300) and they are reviewed number 21 bv the Gastroenterology Panel.

#### Predicate Device:

Given® Diagnostic System cleared for marketing under K010312, K020341, K022362, K022980, K031033, K032405, K040248, K052184, K060805 and K062786

{1}------------------------------------------------

K070475 Page 2 of 2

# 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 with the PillCam™ SB2 Capsule 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 10 years of age and up

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 PillCam™ Capsule (SB, ESO), Data Recorder Set, and RAPID® Workstation or RAPID® Software.

The modifications to the Given® Diagnostic System, which are the subject of this Special 510(k), include:

- Addition of a new model of small bowel capsule, the PillCam™ (1) SB2 capsule.
- (2) Addition of three new features to the RAPID Software
- Lewis Score (optional) .
- t Study Management
- Installation for End-User Computers (optional) .

### Substantial Equivalence:

Given Imaging Ltd. believes that the modified Given® Diagnostic System is substantially equivalent to the market cleared Given® Diagnostic System without raising any new safety and/or efficacy issue.

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows a logo with a stylized bird-like figure composed of three curved lines, suggesting movement or flight. To the left of the bird, there is text arranged vertically along a curved path, likely the name of an organization or department. The text is somewhat blurry, making it difficult to read the exact words.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Shoshana Friedman, RAC V.P. Regulatory and Medical Affairs Given® Imaging Ltd. 91 Rockyspring Cir. N.W. Calgary, Alberta T3G6A1 CANADA

- 7 2007 MAY

Re: K070475

KU/0475
Trade/Device Name: Given® Diagnostic System with PillCam™ SB2 Capsule Regulation Number: 21 CFR §876.1300 Regulation Name: Ingestible telemetric gastrointestinal capsule imaging system Regulatory Class: II Product Code: NEZ Dated: April 3, 2007 Received: April 6, 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 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 a circular stamp with the text "1906-2006" at the top. Inside the circle, the letters "FDA" are prominently displayed in a stylized font. Below the letters, the word "Centennial" is written in a cursive font. At the bottom of the circle, there are three stars.

{3}------------------------------------------------

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that I least of advisou mail 1221 i issumines 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) I this lotter will and in your finding of substantial equivalence of your device to a legally promation from the 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 11 you done if compliance at one of the following numbers, based on the regulation number at the top of this letter:

> 21 CFR 876.xxxx 21 CFR 884.xxxx 21 CFR 892.xxxx Other

(Gastroenterology/Renal/Urology) (Obstetrics/Gynecology) (Radiology);

240-276-0115 240-276-0115 240-276-0120 240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 Also, picase note the regulation 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 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

{4}------------------------------------------------

## ATTACHMENT 6-3

## INDICATIONS FOR USE STATEMENT

510(k) Number: K0 70475

Device Name:

Given® Diagnostic System

# Indications for Use:

The Given® Diagnostic System with the PillCam™ SB2 Capsule 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 10 years of age and up

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 K070475

Prescription Use (Per 21 CFR 801.109)

OR

Over the Counter Use_

Ruta Phillips
Division Sign Off

Division Sign-Off Division of Reproductive, Abdominal, and Radiological Device 510(k) Number