GIVEN DIAGNOSTIC SYSTEM

K052184 · Given Imaging , Ltd. · NSI · Dec 1, 2005 · Gastroenterology, Urology

Device Facts

• Record ID: K052184
• Device Name: GIVEN DIAGNOSTIC SYSTEM
• Applicant: Given Imaging , Ltd.
• Product Code: NSI · Gastroenterology, Urology
• Decision Date: Dec 1, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1300
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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

Device Story

Given® Diagnostic System comprises wireless PillCam™ (SB or ESO), data recorder, and RAPID® 4 workstation. Capsule glides through GI tract, transmitting digital images to body-worn antennas and recorder. Post-procedure, data downloaded to RAPID® 4 workstation. Physician reviews video on workstation to identify mucosal abnormalities. RAPID® 4 software facilitates processing and viewing. Suspected Blood Indicator (SBI) feature automatically marks frames potentially containing blood/red areas to assist physician review. System aids clinical decision-making by providing visual evidence of GI tract pathology, potentially improving diagnostic yield for small bowel and esophageal conditions.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

System includes wireless ingestible capsule, external antenna array, data recorder, and workstation software. Connectivity via wireless transmission from capsule to body-worn recorder. Software-based image processing and review platform. Complies with Class II Special Controls Guidance for Ingestible Telemetric Gastrointestinal Capsule Imaging Systems.

Indications for Use

Indicated for visualization of small bowel mucosa in adults and children ≥10 years for detection of abnormalities; visualization of esophageal mucosa. Includes Suspected Blood Indicator (SBI) feature to mark frames suspected of containing blood/red areas.

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 (with M2A®/PillCam™ SB Capsule) (K010312, K020341, K022362, K022980, K031033, K032405, K040248)
• Given® Diagnostic System with PillCam™ ESO Capsule (K041149, K042960)

Submission Summary (Full Text)

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Page 1 of 2

#### DEC I 2005

## ATTACHMENT 6-1

#### 510(K) SUMMARY

# RAPID® 4 (for Given® Diagnostic System) 510(k) Number K_052184

#### 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 Corporate V.P. Regulatory & Medical Affairs Tel: [phone] Fax: [phone] Email: [e-mail]

### Trade Name:

RAPID® 4 (for Given® Diagnostic System)

#### Classification Name:

Ingestible Telemetric Gastrointestinal/Esophageal Capsule Imaging System

#### Classification:

FDA has classified Ingestible Telemetric Gastrointestinal/Esophageal Capsule Imaging System as class II devices (product code 78NZE for small bowel and 78 NSI for esophageal capsule, regulation no. 876.1300 ) and they are reviewed by the Gastroenterology Panel.

#### Predicate Device:

- Given® Diagnostic System (with M2A®/PillCam™ SB Capsule) cleared for marketing under K010312, K020341, K022362, K022980, K031033, K032405, and K040248.
- Given® Diagnostic System with PillCam™ ESO Capsule cleared under K041149 and K042960

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K052184 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:

With PillCam™ SB Capsule: 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

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

### Device Description:

The Given® Diagnostic System is comprised of three subsystems: PillCam™ Capsule (ESO or SB), Data Recorder Set, and RAPID® Workstation.

The PillCam™ Capsules are wireless, disposable capsules designed to glide smoothly through the GI tract. 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. A new RAPID® software application, RAPID® 4, for the RAPID® Workstation is the subject of this submission.

#### Substantial Equivalence:

Given Imaging Ltd. believes that, based on the information provided in this submission, the Given® Diagnostic System with RAPID® 4 is substantially equivalent to the market cleared Given® Diagnostic System with previous versions of the RAPID® software application without raising any new safety and/or efficacy issue.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with outstretched wings, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

#### DEC 1 2005

Shosh Friedman, RAC Corporate V.P. Regulatory & Medical Affairs Given Imaging Limited Herman Building (Shaar Yokneam) New Industrial Park P.O. Box 258 Yogneam 20692 ISRAEL

Re: K052184

KUS2184
Trade/Device Name: RAPID® 4 for the Given® Diagnostic System with PillCam™ ESO and SB Regulation Number: 21 CFR §876.1300 Regulation Name: Ingestible telemetric gastrointestinal capsule imaging system Regulatory Class: II Product Code: NSI and NEZ Dated: October 7, 2005 Received: October 11, 2005

Dear Ms. Friedman:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have reviewed your becared by equivalent (for the indications for use stated in above and nave occerimined the as redicate devices marketed in interstate commerce prior to the enclosure) to regally marketse predicate deal Device Amendments, or to devices that have been May 26, 1770, the clacultions dato of the Federal Food, Drug, and Cosmetic Act (Act) that reclassified in accordation with the proval application (PMA). You may, therefore, market the do not require approval or a premation approvisions of the Act. The general controls provisions of the Act device, subject to the general oomons priors, 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 If your device is classified (386 able) into major regulations affecting major regulations affecting your Approval), It may oc subject to subject to successions, Title 21, Parts 800 to 898. In addition, FDA device can be round in nouncements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that Please be advised that 1 DA 3 issualled of a vith other requirements of the Act or any FDA has made a decemination and Joan BS House Federal agencies. You must comply with all the Federal statues and regulations administed to registration and listing (21 CFR Part 807); labeling ACC STEQuirements, medium, but hot mixted to requirements as set forth in the quality systems (QS) (21 CFR 1 at 801); good manufacturing prades 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 his letter will anow you to begin manusing of substantial equivalence of your device to a legally premarket notheation: "The I DA midmig of backnown
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 11 you desire specific advice tor your ac restled to 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 notifications" (21 CFR Also, please note the regulation entitled, "Thisoration on your responsibilities under the Act from the 807.97). I ou may outer genoral missal 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. Hogdon

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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## ATTACHMENT 6-3

## INDICATIONS FOR USE STATEMENT

510(k) Number (if known): ____K052184__

## Device Name:

Given® Diagnostic System

#### Indications for Use:

## with PillCam™ SB Capsule

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

#### with PillCam™ ESO Capsule

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

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

510(k) Number _________________________

Prescription Use ___________ (Per 21 CFR 801.109)

OR

Over the Counter Use______

Nancy C. Brogdon
K05-2184

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

510(k) Number _

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