GIVEN DIAGNOSTICS SYSTEM

K022362 · Given Imaging , Ltd. · NEZ · Aug 9, 2002 · Gastroenterology, Urology

Device Facts

• Record ID: K022362
• Device Name: GIVEN DIAGNOSTICS SYSTEM
• Applicant: Given Imaging , Ltd.
• Product Code: NEZ · Gastroenterology, Urology
• Decision Date: Aug 9, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1300
• Device Class: Class 2

Intended Use

The Given® Diagnostic System is intended for visualization of the small bowel mucosa. It may be used as an adjunctive tool in the detection of abnormalities of the small bowel

Device Story

System consists of M2A™ disposable wireless capsule, data recorder set, and RAPID® workstation. Capsule travels via peristalsis through digestive tract; transmits digital images to external receiving antennas worn on patient belt. Data recorder stores images; downloaded to workstation post-test. Physician reviews images on workstation to identify small bowel abnormalities. Adjunctive tool for clinical decision-making; aids in visualization of mucosa. Benefits include non-invasive small bowel assessment.

Clinical Evidence

No clinical data provided; substantial equivalence based on verification activities and compliance with FDA special controls guidance.

Technological Characteristics

System includes ingestible wireless capsule, external antenna array, data recorder, and workstation. Capsule utilizes wireless transmission of digital image data. Operates via peristaltic movement. Complies with Class II Special Controls Guidance Document for Ingestible Telemetric Gastrointestinal Capsule Imaging Systems.

Indications for Use

Indicated for visualization of small bowel mucosa as an adjunctive tool in the detection of small bowel abnormalities.

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 Imaging System (K010312)
• Given® Diagnostic System (K020341)

Submission Summary (Full Text)

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# 510(K) SUMMARY Given® Diagnostic System 510(k) Number K 022362

### Applicant's Name:

Given Imaging Ltd. 2 Carmel St. P.O. Box 258 New Industrial Zone Yokneam 20692, Israel Tel.: [phone] Fax: [phone]

## Contact Person:

Shoshana Friedman, RAC V.P. Regulatory & Medical 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) and they are reviewed by the Gastroenterology Panel.

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#### Predicate Device:

- · Given® Diagnostic Imaging System (K010312)
- · Given® Diagnostic System (K020341)

### 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 is intended for visualization of the small bowel mucosa. It may be used as an adjunctive tool in the detection of abnormalities of the small bowel

### Device Description:

The Given® Diagnostic System is comprised of three subsystems: M2A™ Capsule, Data Recorder Set, and RAPID® Workstation.

The M2A® Capsule is a wireless, disposable capsule designed to glide smoothly through the digestive system by the peristaltic activity of the intestinal muscles and is excreted naturally. During its passage, the capsule transmits digital data that is captured by receiving antennas attached to the patient's body. The images are stored in the DataRecorder that is connected to the receiving antennas and is worn on a belt around the waist of the patient. When the test is over, the antennas and recorder are removed from the patient's body. The images from the recorder are downloaded to the RAPID® Workstation for processing and viewing by the physician.

### Substantial Equivalence:

The proposed modified Given® Diagnostic System is substantially equivalent to the Given® Diagnostic System cleared under K010312 and K020341. The verification activities demonstrated that the proposed modifications do not raise any new safety and/or effectiveness issue.

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Image /page/2/Picture/1 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized image of an eagle with its wings spread, facing to the left. The eagle's body is formed by three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 0 9 2002

Shoshana (Shosh) Friedman, RAC V.P. Regulatory & Medical Affairs Given Imaging Limited New Industrial Park PO Box 258 Yogneam 20692 ISRAEL

#### Re: K022362

Trade/Device Name: Given Diagnostic System Regulation Number: 21 CFR 876.1300 Regulation Name: Ingestible telemetric gastrointestinal capsule imaging system Regulatory Class: II Product Code: 78 NEZ

Dated: July 18, 2002 Received: July 22, 2002

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 (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); 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.

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This letter will allow you to begin marketing your device as described in your 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:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.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

0223402 510(k) Number (if known):_

Device Name:

Given® Diagnostic System

## Indications for Use:

The Given® Diagnostic System is intended for visualization of the small bowel mucosa. It may be used as an adjunctive tool in the detection of abnormalities of the small bowel

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

510(k) Number _

L Prescription Use (Per 21 CFR 801.109)

OR

Over the Counter Use__________________________________________________________________________________________________________________________________________________________

Nancy C Brandon
Division Sign Off

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number 6-6 K022362