MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM

K060805 · Given Imaging , Ltd. · NSI · May 24, 2006 · Gastroenterology, Urology

Device Facts

• Record ID: K060805
• Device Name: MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM
• Applicant: Given Imaging , Ltd.
• Product Code: NSI · Gastroenterology, Urology
• Decision Date: May 24, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1300
• Device Class: Class 2
• Attributes: Software as a Medical Device, 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 visualization 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. The Given® Diagnostic System with the PillCam™ ESO Capsule is intended for the visualization of esophageal mucosa.

Device Story

RAPIDAccess is an optional accessory for the Given® Diagnostic System, designed to facilitate capsule endoscopy procedures without requiring the full diagnostic workstation. It consists of two versions: RAPIDAccess RT (Real-Time), a standalone accessory for monitoring capsule advancement through the GI tract, and RAPIDAccess SW (software application). The system processes telemetric signals from the PillCam™ (ESO or SB) capsule, which captures images of the GI mucosa. The device is used in clinical settings by healthcare providers to visualize the GI tract. By providing real-time monitoring and access to capsule data, it assists clinicians in identifying mucosal abnormalities, thereby supporting diagnostic decision-making and patient management.

Clinical Evidence

No clinical data provided. The submission relies on the substantial equivalence of the accessory system to the previously cleared Given® Diagnostic System.

Technological Characteristics

The system comprises the PillCam™ capsule (ESO or SB), a data recorder set, and the RAPIDAccess accessory (RT hardware or SW software). It utilizes telemetric transmission for image data. The system complies with the 'Class II Special Controls Guidance Document; Telemetric Gastrointestinal Capsule Imaging System'.

Indications for Use

Indicated for visualization of small bowel mucosa in adults and children ≥10 years old, and visualization of esophageal mucosa. Includes Suspected Blood Indicator (SBI) feature to mark frames suspected of containing blood or 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, K052184)
• Given® Diagnostic System with PillCam™ ESO Capsule (K041149, K042960)

Submission Summary (Full Text)

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K608005 Page 1 of 2

### ATTACHMENT 6-1

#### 510(K) SUMMARY

MAY 2 4 2006

RAPID® 4 (for Given® Diagnostic System)

510(k) Number K_

#### 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:

RAPIDAccess (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, K040248 and K052184.
- Given® Diagnostic System with PillCam™ ESO Capsule cleared under K041149 and K042960

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K060805 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; Telemetric Gastrointestinal Capsule Imaging System; Ingestible Final Guidance for Industry and FDA" issued on November 28, 2001

#### Intended Use:

There is no change in the intended used of the Given® Diagnostic System as a result of including the RAPIDAccess optional accessory system

#### Device Description:

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

The RAPIDAccess optional accessory system, which is the subject of this Special 510(k) application, is designed to facilitate access to PillCam Capsule Endoscopy by allowing the performance of CE procedure without requiring the use of a full Given® Diagnostic System. It comes in two versions: RAPIDAccess RT (Real-Time), which is a standalone accessory that also allows monitoring the advancement of the capsule through the GI tract, and RAPID Access SW (software application).

#### Substantial Equivalence:

Given Imaging Ltd. believes that the Given® Diagnostic System with RAPIDAccess optional accessory system is substantially the equivalent to the market-cleared Given® Diagnostic System without raising any new safety and/or efficacy issue.

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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in bold, black font. The text is on a white background. The text is likely part of a document or sign.

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

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# MAY 2 4 2006

Shoshana Friedman, R.A.C. Senior Vice President Regulatory and Clinical Affairs Given® Imaging Limited New Industrial Park P.O. Box 258, Yoqneam ISRAEL 20692

K060805 Re:

Trade/Device Name: Given® Diagnostic System - RAPID Access Regulation Number: 21 CFR §876.1300 Regulation Name: Ingestible telemetric gastrointestinal capsule imaging system Regulatory Class: II Product Code: NEZ and NSI Dated: April 26, 2006 Received: April 28, 2006

Dear Ms. Friedman:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rove 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 prof to thay 20, 1976, and cordance 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 If your do rever to such additional controls. Existing major regulations affecting your I tppto rary, it ifely of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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**Protecting and Promoting Public Health**

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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 promation no licate 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.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 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/industry/support/index.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

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Enclosure

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# ATTACHMENT 6-3

# INDICATIONS FOR USE STATEMENT

510(k) Number (if known):_KO6 © OOOS

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 lor vivalies 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

0.
(Division Sign-Off))
Division of Reproductive, Abdominal,
and Radiological Devices

510(k) Numbe

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