MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM

K022980 · Given Imaging , Ltd. · NEZ · Feb 27, 2003 · Gastroenterology, Urology

Device Facts

• Record ID: K022980
• Device Name: MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM
• Applicant: Given Imaging , Ltd.
• Product Code: NEZ · Gastroenterology, Urology
• Decision Date: Feb 27, 2003
• Decision: SESE
• Submission Type: Traditional
• 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. 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 M2A™ ingestible capsule, data recorder, and RAPID® workstation. Capsule travels via peristalsis, capturing and transmitting digital images to external antennas worn by patient. Data recorder stores images; post-procedure, data is downloaded to workstation for physician review. RAPID 2.0 software includes Suspected Blood Indicator (SBI) feature; automatically identifies and marks video frames containing suspected blood or red areas based on colorimetric analysis. Physician reviews marked images to assist in detecting small bowel abnormalities. System provides non-invasive visualization, potentially aiding diagnosis of small bowel pathology.

Clinical Evidence

No clinical data provided; substantial equivalence supported by verification activities and performance testing of the SBI feature.

Technological Characteristics

System comprises ingestible wireless capsule, wearable data recorder, and workstation. Capsule utilizes peristalsis for transit. Software-based colorimetric analysis detects red/blood-like spectrum deviations. Complies with Class II Special Controls Guidance for Ingestible Telemetric Gastrointestinal Capsule Imaging Systems.

Indications for Use

Indicated for visualization of small bowel mucosa and as an adjunctive tool for detecting small bowel abnormalities in patients requiring diagnostic imaging of the small intestine.

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)
• Given® Diagnostic System (K022362)

Submission Summary (Full Text)

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# 510(K) SUMMARY

# Given® Diagnostic System

# 510(k) Number K022980

FEB 2 7 2003

# Applicant's Name:

Given Imaging Ltd. 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.

#### Predicate Device:

- · Given® Diagnostic Imaging System (K010312)
- · Given® Diagnostic System (K020341)
- · Given® Diagnostic System (K022362)

#### Performance Standards and Special Controls:

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

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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.

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: 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.

The RAPID 2.0 software, the subject of this submission, contains an optional feature called Suspected Blood Indicator (SBI), which automatically marks images that correlate with the existence of suspected blood or red areas. The analysis is based on detection of colorimetric abnormalities, or deviations from an expected spectrum, corresponding to normal tissue.

# Substantial Equivalence:

The proposed modified Given® Diagnostic System is substantially equivalent to the Given® Diagnostic System cleared under K010312, K020341, and K022362. The verification activities demonstrated that the proposed modification does 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 logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 7 2003

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

Re: K022980

Trade/Device Name: Given® Diagnostic System (Suspected Blood Indicator (SBI)) Regulation Number: 21 CFR §876.1300 Regulation Name: Ingestible telemetric gastrointestinal capsule imaging system Regulatory Class: II Product Code: 78 NEZ Dated: November 27, 2002 Received: December 3, 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

### 510(k) Number (if known): K022980

# 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.

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 `K022186

Prescription Use _ Lo (Per 21 CFR 801.109)

OR

Over the Counter Use ________

| | Nancy Brogdon |
|-----------------------------------------------------------------------------------|---------------|
| (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K027980 |

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