GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULESWITH PILLCAM R SENSORBELT

K103088 · Given Imaging , Ltd. · NEZ · Jan 14, 2011 · Gastroenterology, Urology

Device Facts

• Record ID: K103088
• Device Name: GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULESWITH PILLCAM R SENSORBELT
• Applicant: Given Imaging , Ltd.
• Product Code: NEZ · Gastroenterology, Urology
• Decision Date: Jan 14, 2011
• Decision: SESE
• Submission Type: Traditional
• 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 two years of age. 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 images; generates clinical reports. Used in clinical settings by healthcare providers. Suspected Blood Indicator (SBI) feature automatically marks video frames containing potential blood/red areas. Output assists clinicians in identifying small bowel abnormalities. Benefits include non-invasive visualization of small bowel mucosa.

Clinical Evidence

Clinical validation study conducted to support use in overweight patients (BMI ≥ 30 kg/m2). Study included 25 healthy volunteers who underwent SB procedure using PillCam SB2 capsule, DR2 DataRecorder, and PillCam SensorBelt. No multiple ingestions occurred. Data demonstrated substantial equivalence to predicate devices; performance of SensorBelt not studied in patients with BMI > 43.3.

Technological Characteristics

Ingestible telemetric capsule imaging system. Components: disposable capsule, RF-linked DataRecorder, SensorBelt, and PC-based workstation. Software-driven image processing and reporting. Complies with Class II Special Controls Guidance Document (Nov 28, 2001).

Indications for Use

Indicated for visualization of small bowel mucosa and detection of small bowel abnormalities in adults and children aged 2 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 PillCam Platform with PillCam SB Capsules with PillCam SensorBelt (K091405)
• Given PillCam Platform with PillCam SB Capsules and Given AGILE Patency System (K090557)

Submission Summary (Full Text)

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K103088 Pgz 1 of 3

Image /page/0/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 between the "I" and "E". Below the word "GIVEN" is the word "IMAGING" in smaller, bold letters.

Given Imaging Limited New Industrial Park PO Box 258, Yoqneam 20692 Israel Voice 972 4 909 77777 Fax [phone]

# 510(k) Summary

JAN 1 4 2011

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.

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| Submitter Name and<br>Address: | Given Imaging Ltd.<br>Hermon Building<br>New Industrial Park<br>PO Box 258<br>Yoqneam 20692<br>Israel<br>Tel.: [phone]<br>Fax: [phone] |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Tim Thomas<br>Vice President<br>Regulatory Affairs & Quality Assurance<br>Email: [e-mail] |
| Phone Number: | 770-662-0870 ext. 1006 |
| Fax Number: | 770-662-0510 |
| Establishment<br>Registration Number: | 9710107 |
| Date Prepared: | October 14, 2010 |
| Device Trade Name(s): | Given PillCam® Platform with PillCam® SB Capsules with<br>PillCam® SensorBelt |
| Device Common Name: | Ingestible telemetric gastrointestinal capsule imaging system |
| Classification: | Regulation No: 876.1300<br>Class: II<br>Panel: Gastroenterology<br>NEZ - System, Imaging, Gastrointestinal, Wireless, Capsule |
| Predicate Device(s): | Given PillCam® Platform with PillCam® SB Capsules with<br>PillCam® SensorBelt ,(K091405)<br>Given PillCam Platform with PillCam SB Capsules and Given<br>AGILE Patency System (K090557) |
| | |

Given Imaging Ltd. New Industrial Park, PO Box 258, Yoqneam 20692, Israel

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K103088

Image /page/1/Picture/1 description: The image shows the logo for Given Imaging. The logo consists of the word "GI-EN" in large, bold letters, with a stylized image of a capsule between the "I" and "E". Below the capsule image is the word "IMAGING" in smaller, bold letters. The logo is simple and modern, and it is likely used to represent a medical imaging company.

Given Imaging Limited New Industrial Park PO Box 258, Yogneam 20692 Israel

General Device Description:

Intended Use:

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

1. 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.

#### RAPID Software ನ

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.

Given Workstation and Hardware 3

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.

#### 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 two years of age.

The Suspected Blood Indicator (SBI) feature is intended to mark frames of the video suspected of containing blood or red areas.

Given Imaging Ltd. New Industrial Park, PO Box 258, Yogneam 20692, Israel

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K103088

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 between the "I" and the "E". Below the word "GIVEN" is the word "IMAGING" in smaller, bold letters. The logo is black and white.

Given Imaging Limited New Industrial Park PO Box 258, Yogneam 972 6 000 7777

Technological The technology characteristics are exactly the same as the Characteristics: predicate device. Performance Data: The device meets 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. Clinical validation test has been conducted in order to utilize PillCam® SensorBelt in overweight population with BMI greater than 30 kg/m2, and supporting exclusion of overweight population warning statement in Given PillCam® Platform with PillCam® SB Capsules with PillCam® SensorBelt labeling. The validation clinical test was conducted with twenty five healthy volunteers who underwent the SB procedure using PillCam®SB2 capsule, a DR2 DataRecorder, and a PillCam® SensorBelt. There had no multiple ingestions, and each of the twenty five healthy volunteers ingested a separate PillCam® SB2 capsule There are no new risks raised by utilizing PillCam® SensorBelt in overweight population of BMI ≥ 30kg/m2. The performance of the SensorBelt has not been studied in patients with BMI greater than 43.3.The clinical validation data presented in details in Section 20 -Performance Testing Clinical of this Traditional 510(k) Notification has shown substantial equivalence to the predicate device.

Conclusion:

Based on the clinical validation data Given Imaging believes that Given PillCam® Platform with PillCam® SB Capsules with PillCam® SensorBelt and the predicate devices selected are substantially equivalent and do not change the fundamental scientific technology and intended use of the market-cleared devices.

Given Imaging Ltd. New Industrial Park, PO Box 258, Yoqneam 20692, Israel

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The logo is in black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Mr. Tim Thomas Vice President, Regulatory Affairs & Quality Assurance Given® Imaging Limited New Industrial Park P.O. Box 258, Yoqneam 20692 ISRAEL

JAN 1 4 201

Re: K103088

> 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: January 4, 2011

Received: January 7, 2011

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 of medical device-related

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adverse events) (21 CFR 803); 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.

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/CDRH0fffices/ucm11 1 1 800 1, plass 1 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 Para 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 tollofire number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Richard Lemon MD

Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health.

Enclosure

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Proprietary to Given Imaging Ltd.

### INDICATIONS FOR USE

510(k) Number (if known):

K103088

Device Name: Given PillCam® Platform with PillCem® 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 two years of age.

The Suspected Blood Indicator (SBI) feature is intended to mark frames of the video suspected of containing blood or red areas.

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Given Imaging Ltd. 510(k) Submission

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

October 14, 2010

(Division Sign-Off)

Division of Reproductive, Gastro-Renal, and

Urological Devices

| 510(k) Number | K103088 |
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