PILLCAM PLATFORM WITH PILLCAM SB CAPSULES WITH PILLCAM SENSORBELT

K091405 · Given Imaging , Ltd. · NEZ · Jul 29, 2009 · Gastroenterology, Urology

Device Facts

• Record ID: K091405
• Device Name: PILLCAM PLATFORM WITH PILLCAM SB CAPSULES WITH PILLCAM SENSORBELT
• Applicant: Given Imaging , Ltd.
• Product Code: NEZ · Gastroenterology, Urology
• Decision Date: Jul 29, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1300
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Given PillCam® Platform with the PillCam® SB Capsules 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.

Device Story

System comprises ingestible PillCam capsule, RAPID software, and workstation/hardware. Capsule acquires GI tract video images during natural propulsion; transmits via RF to external DataRecorder/SensorBelt. RAPID software processes, analyzes, stores, and displays video; generates clinical reports. Physician uses workstation to review RAPID video; Suspected Blood Indicator (SBI) feature automatically marks frames containing potential blood/red areas. System aids clinicians in identifying small bowel abnormalities; facilitates diagnostic decision-making; provides non-invasive visualization alternative.

Clinical Evidence

Bench testing only. Device meets requirements of 'Class II Special Controls Guidance Document: Ingestible Telemetric Gastrointestinal Capsule Imaging System'.

Technological Characteristics

Ingestible telemetric capsule imaging system. Components: disposable capsule, RF DataRecorder, SensorBelt, RAPID software, workstation. Operates via RF transmission of video data from capsule to external recorder. Software-based image processing and analysis.

Indications for Use

Indicated for visualization of small bowel mucosa and detection of small bowel abnormalities in adults and children aged 10 years and older.

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 PillCam® SB2 Capsule (K070475)
• Given® Diagnostic System (K062786)

Submission Summary (Full Text)

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K091405 Page 1 of 3

Image /page/0/Picture/1 description: The image shows the logo for Given Imaging. The logo is black and white and features the company name in a bold, sans-serif font. The word "GIVEN" is on the top line, and the word "IMAGING" is on the bottom line. There is a graphic of a capsule between the two words.

Given Imaging Limited New Industrial Park PO Box 258, Yogneam 20602 Israel Voice 972 4 909 7777 Fax [phone]

## 510(k) Summary

JUL 2 9 2009

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR 807.92.

Submitter Name and Address:

Given Imaging Ltd. Hermon Building New Industrial Park PO Box 258 Yogneam 20692 Israel Tel .: [phone] Fax: [phone] Tim Thomas

Contact Person:

Phone Number:

Date Prepared:

Contact Person.

Email: [e-mail]

Global Director, Regulatory and Quality

770-662-0870 ext. 1006

770-662-0510

Fax Number:

Establishment Registration Number:

9710107

May 7, 2009

Device Trade Name(s):

Device Common Name:

Classification:

May 7, 2009

Given PillCam® Platform with PillCam® SB Capsules with PillCam® SensorBelt

Ingestible telemetric gastrointestinal capsule imaging system

Regulation No: 876.1300 Class: II Panel: Gastroenterology NEZ - System, Imaging, Gastrointestinal, Wireless, Capsule

Predicate Device(s):

Given® Diagnostic System with PillCam® SB2 Capsule (K070475) Given® Diagnostic System (K062786)

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K091405 Page 2 of 3

Given Imaging Limited New Industrial Park PO Box 258, Yogneam 20692 Israel Voice 972 4 909 7777 Fax [phone]

General Device Description:

The Given PillCam® Platform is comprised of three main subsystems; (1) the ingestible PillCam capsule, (2) the RAPID® software, and (3) the Given® Workstation and Hardware.

l. Ingestible PillCam Capsule

The disposable, ingestible PillCam Capsule is designed to acquire video images during the natural propulsion through the GI tract. The capsule transmits the acquired images via a RF communication channel to the DataRecorder located outside the body.

### 2 RAPID Software

The RAPID Software is a software application that is utilized to process, analyze, store, and view the acquired images collected from the DataRecorder to create a RAPID video of the images. The software also includes a reporting function to create detailed clinical reports, in-service training videos, and patient instruction forms.

3 Given Workstation and Hardware

The Workstation is a modified standard personal computer that is the operational platform for the RAPID software. The DataRecorder is an external receiving/recording unit that receives acquired images from the capsule. The PillCam® SensorBelt receives data from the PillCam capsule and transfers the data to the DataRecorder. The RAPID Real Time is a handheld device that allows for real-time viewing of acquired images through the GI tract. Other accessories include a flat panel LCD monitor, a high-capacity mass storage device, and a high-capacity USB portable storage device.

## Intended Use:

## SB Indications for Use:

The Given PillCam® Platform with the PillCam® SB Capsules 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.

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K091405 Page-353

Image /page/2/Picture/1 description: The image shows the logo for Given Imaging. The logo consists of the word "GIVEN" in large, bold letters, with a stylized image of a capsule or pill below the letters. To the right of the word "GIVEN" is the word "IMAGING" in smaller letters. The logo is simple and modern, and it is likely used to promote the company's products or services in the medical imaging field.

Given Imaging Limited New Industrial Park PO Box 258, Yogneam 20692 Israel Volce 972 4 909 777 Fax [phone]

Technological Characteristics:

Performance Data:

Conclusion:

The technology characteristics are exactly the same as the predicate device.

The devices meet the guidance entitled "Class II Special Controls Guidance Document: Ingestible Telemetric Gastrointestinal Capsule Imaging System; Final Guidance for Industry and FDA dated November 28, 2001.

Based on the design control (verification and validation) activities, Given Imaging Ltd. believes that the Given PillCam® Platform with PillCam® SB Capsules with PillCam® SensorBelt and the predicate device selected are substantially equivalent and do not change the fundamental scientific technology and intended use of the market-cleared device.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three overlapping wing shapes, symbolizing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle emblem.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Tim Thomas Global Director Regulatory and Quality Given Imaging Limited New Industrial Park P.O. Box 258, Yoqneam 20692 ISRAEL

1111 9 8 2009

Re: K091405

Trade/Device Name: Given PillCam® Platform with PillCam® SB Capsules with PillCam® SensorBelt

Regulation Number: 21 CFR §876.1300

Regulation Name: Ingestible telemetric gastrointestinal capsule imaging system Regulatory Class: II Product Code: NEZ

Dated: June 26, 2009

Received: July 1, 2009

Dear Mr. Thomas:

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); medical device reporting (reporting of medical

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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

Janine M. Morris Acting 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

510(k) Number (if known):

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Given PillCam® Platform with PillCam® SB Capsules with PillCam® SensorBelt

Indications for Use:

SB Indications for Use:

The Given PillCam® Platform with the PillCam® SB Capsules 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.

| Prescription Use<br>(Part 21 CFR 801 Subpart D). | ✓ |
|--------------------------------------------------|------------------------------------------------|
| AND/OR | Over-The-Counter Use<br>(21 CFR 801 Subpart C) |

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

| (Division Sign Off) | Concurrence of CDRH, Office of Device Evaluation (ODE) |
|------------------------------------------------------------------|--------------------------------------------------------|
| Division of Reproductive, Abdominal,<br>and Radiological Devices | |
| 510(k) Number | K091405 |

Given Imaging Ltd. Special 510(k) Submission
Given PillCam^® Platform with PillCam^® SB Capsules with PillCam^® SensorBelt
May 7, 2009