MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM

K062786 · Given Imaging , Ltd. · NEZ · Oct 18, 2006 · Gastroenterology, Urology

Device Facts

• Record ID: K062786
• Device Name: MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM
• Applicant: Given Imaging , Ltd.
• Product Code: NEZ · Gastroenterology, Urology
• Decision Date: Oct 18, 2006
• 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™ SB 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

Given® Diagnostic System consists of PillCam™ SB capsule, data recorder, and RAPID® workstation. Capsule captures small bowel images; transmits data to wearable recorder; data transferred to workstation for physician review. Suspected Blood Indicator (SBI) feature automatically flags video frames containing potential blood or red areas. Used in clinical settings to assist physicians in identifying small bowel pathologies. System modifications include improved capsule hardware and labeling updates for RAPID® software automatic mode.

Clinical Evidence

No clinical data provided; substantial equivalence based on design modifications and performance testing.

Technological Characteristics

Ingestible telemetric capsule imaging system. Components: PillCam™ SB capsule, data recorder, RAPID® workstation. Features Suspected Blood Indicator (SBI) for automated frame marking. Class II device per 21 CFR 876.1300.

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)

Submission Summary (Full Text)

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

page 1 of 2

### ATTACHMENT 6-1

0C1 1 8 2006

GI EN
IMAGING

510(K) SUMMARY Given® Diagnostic System 510(k) Number KQ6 2786

Expanding the scope of

Applicant's Name:

Given Imaging Ltd. Hermon Building (Shaar Yoqneam) New Industrial Zone P.O. Box 258 Yogneam 20692, Israel Tel.: [phone] Fax: [phone]

#### Contact Person:

Shosh Friedman, RAC Senior V.P. Regulatory & Clinical Affairs 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 number CFR 876.1300) and they 21 are reviewed by the Gastroenterology Panel.

#### Predicate Device:

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

#### Performance Standards and Special Controls:

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

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

K062706 Page 2 of 2

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

The modifications to the Given® Diagnostic System, which are the subject of this Special 510(k), include (1) improved PillCam™ SB capsule; and (2) labeling change, which does not affect the intended use of the device, related to the Automatic Mode of the RAPID® Software Application.

#### 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.

Image /page/1/Picture/10 description: The image shows the logo for Given Imaging. The logo has the word "GI" in large, bold letters, followed by an image of what appears to be a capsule with waves emanating from the bottom. To the right of the capsule is the word "IMAGING" in smaller, bold letters. Below the logo is the phrase "Expanding the scope of GI" in a smaller, italicized font.

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

# OCT 1 8 2006

Shoshana Friedman, R.A.C. Senior V.P. Regulatory and Clinical Affairs Given® Imaging Ltd. Hermon Building (Shaar Yoqneam) New Industrial Park P.O. Box 258 Yoqneam 20692 ISRAEL

Re: K062786

Trade/Device Name: Given® Diagnostic System い
, , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , Regulation Number: 21 CFR §876.1300 Regulation Name: Ingestible telemetric gastrointestinal capsule imaging system Regulatory Class: II Product Code: NEZ Dated: September 15, 2006 Received: September 18, 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 a logo for the FDA Centennial, celebrating 100 years from 1906 to 2006. The logo is circular with the letters FDA in a stylized font at the center. Below the logo, the words "Promoting Public" are visible, suggesting a public service or health-related context.

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

Page 2 -

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.xxx | (Gastroenterology/Renal/Urology | 240-276-0115 |
|----------------|---------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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/cdrl/industry/support/index.html.

Sincerely yours,

Nancy C Hodgdon

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 (if known): KO6 2786

Device Name:

Given® Diagnostic System

Indications for Use:

The Given® Diagnostic System with the PillCam™ SB 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)

OR

510(k) Number ________________________________________________________________________________________________________________________________________________________________

Prescription Use (Per 21 CFR 801.109)

Over the Counter Use_

David b. Legum

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

6-6