GIVEN DIAGNOSTIC SYSTEM WITH M2A ESO CAPSULE

K041149 · Given Imaging , Ltd. · NSI · Oct 25, 2004 · Gastroenterology, Urology

Device Facts

• Record ID: K041149
• Device Name: GIVEN DIAGNOSTIC SYSTEM WITH M2A ESO CAPSULE
• Applicant: Given Imaging , Ltd.
• Product Code: NSI · Gastroenterology, Urology
• Decision Date: Oct 25, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1300
• Device Class: Class 2

Intended Use

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

Device Story

System comprises wireless disposable PillCam ESO capsule, data recorder set, and RAPID workstation. Capsule glides through esophagus, capturing and transmitting digital images to receiving antennas worn on patient's body. Data stored in waist-worn recorder. Post-procedure, data downloaded to RAPID workstation for physician processing and viewing. Enables visualization of esophageal mucosa; assists physician in clinical assessment of esophageal condition.

Clinical Evidence

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

Technological Characteristics

Wireless ingestible capsule; telemetric data transmission; receiving antennas; waist-worn data recorder; RAPID workstation for image processing. Class II device (21 CFR 876.1300). Complies with Class II Special Controls Guidance Document for Ingestible Telemetric Gastrointestinal Capsule Imaging System.

Indications for Use

Indicated for visualization of the esophagus. Patient population not specified.

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, K020341, K022362, K022980, K031033, K032405, and K040248)

Submission Summary (Full Text)

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#### 510(K) SUMMARY

# Given® Diagnostic System with PillCam™ ESO Capsule

#### 510(k) Number K041149

#### Applicant's Name:

Given Imaging Ltd. 13 Ha Yetzira St. P.O. Box 258 New Industrial Zone Yokneam 20692, Israel Tel.: [phone] Fax: [phone]

# Contact Person:

Shosh Friedman, RAC Corporate 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 System (K010312, K020341, K022362, K022980, K031033, K032405, and K040248.)

## Performance Standards and Special Controls:

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X041149

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™ ESO Capsule is intended for the visualization of esophageal mucosa.

# Device Description:

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

The PillCam™ ESO Capsule is a wireless, disposable capsule designed to glide smoothly through the esophagus. 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:

Given Imaging Ltd. believes that, based on the information provided in this submission, the Given® Diagnostic System with PillCam™ ESO Capsule is substantially equivalent to the market-cleared Given® Diagnostic System (with the M2A® SB Capsule) without raising any new safety and/or efficacy issue.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The seal is black and white and appears to be a scanned image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 25 2004

Shosh Friedman, RAC Corporate Vice President Regulatory & Medical Affairs Given Imaging Ltd. New Industrial Park P.O. Box 258, Yoqneam 20692 ISRAEL

Re: K041149

Trade/Device Name: Given® Diagnostic System with PillCam™ ESO Capsule Regulation Number: 21 CFR §876.1300 Regulation Name: Ingestible telemetric gastrointestinal capsule imaging system Regulatory Class: II Product Code: 78 NSI Dated: September 12, 2004 Received: September 22, 2004

Dear Ms. Friedman:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we nave reviewed your evenest 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 the chelosate) to tegans mant date of the Medical Device Amendments, or to devices that have been May 20, 1770, the chavinential of the Federal Food, Drug, and Cosmetic Act (Act) that recreasined in avoroval of a premarket approval application (PMA). You may, therefore, market the do not require approval or a provisions of the Act. The general controls provisions of the Act de not, subjor to the general 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 n your ab rise a subject to such additional controls. Existing major regulations affecting your Apple ral), It ifely of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA a vice ball of of arther announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that r case or as 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 I carar states and regarding, but not limited to registration and listing (21 CFR Part 807); labeling Act 3 requirements, moractice requirements as set forth in the quality systems (QS) (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 Section 510(k) I mis lotter will and in your e FDA finding of substantial equivalence of your device to a legally promated noticate 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 11 you don't 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 00 : 7 / 1 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): K041149

# Device Name:

Given® Diagnostic System with PillCam™ ESO Capsule

# Indications for Use:

The Given® Diagnostic System with the PillCam™ ESO Capsule is intended for the visualization of the esophagus.

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

510(k) Number K041149

and Radiological Device

510(k) Number .

Prescription Use (Per 21 CFR 801.109)

OR

Over the Counter Use__________________________________________________________________________________________________________________________________________________________

Nancy C. Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,