GIVEN PILLCAM PLATFORM WITH RAPID 6.5 / GIVEN PILLCAM PLATFORM WITH PILLCAM ESO 3 CAPSULES

K103025 · Given Imaging , Ltd. · NEZ · May 13, 2011 · Gastroenterology, Urology

Device Facts

• Record ID: K103025
• Device Name: GIVEN PILLCAM PLATFORM WITH RAPID 6.5 / GIVEN PILLCAM PLATFORM WITH PILLCAM ESO 3 CAPSULES
• Applicant: Given Imaging , Ltd.
• Product Code: NEZ · Gastroenterology, Urology
• Decision Date: May 13, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1300
• Device Class: Class 2
• Attributes: Software as a Medical Device, Pediatric

Intended Use

The PillCam Platform with a PillCam SB capsules is intended for visualization of the small bowel mucosa. The PillCam Platform with PillCam SB capsules may be used in the visualization and monitoring of lesions that may indicate Crohn's disease not detected by upper and lower endoscopy. The PillCam Platform with PillCam SB capsules may be used in the visualization of lesions that may be a source of obscure bleeding (either overt or occult) not detected by upper and lower endoscopy. The PillCam Platform with PillCam SB capsules may be used in the visualization of lesions that may be potential causes of iron deficiency anemia (IDA) not detected by upper and lower endoscopy. The Suspected Blood Indicator (SBI) feature is intended to mark frames of the video suspected of containing blood or red areas. The PillCam Platform with PillCam SB capsules may be used as a tool in the detection of abnormalities of the small bowel and is intended for use in adults and children from two years of age. The PillCam Platform with a PillCam ESO capsule is intended for the visualization of esophageal mucosa in adults and children from 18 years of age. The PillCam Platform with a PillCam ESO 3 capsule is intended for the visualization of esophageal mucosa in adults and children from 18 years of age.

Device Story

System comprises ingestible video capsule, external DataRecorder, and RAPID software on workstation. Capsule acquires GI tract images, transmitting via RF to DataRecorder worn by patient. RAPID software processes, analyzes, and stores images, creating video for clinician review. Includes Suspected Blood Indicator (SBI) to flag potential blood/red areas. Used in clinical settings by healthcare providers to detect GI abnormalities. Output assists clinical decision-making by identifying lesions or bleeding sources. Benefits include non-invasive visualization of GI mucosa.

Clinical Evidence

Bench testing and human volunteer study. Safety of ESO 3 capsule size change validated in 55 volunteers using SIP procedure. 53/55 (96.4%) ingested capsule without difficulty; 2/55 (3.6%) required sitting up to ingest. Ingestion difficulty rate (3.6%) compared favorably to 7% rate observed in clinical study of ESO 2 predicate. No adverse events reported.

Technological Characteristics

Ingestible telemetric capsule imaging system. Components: disposable video capsule, RF DataRecorder, SensorArray/SensorBelt, and workstation. Connectivity: RF transmission from capsule to recorder, USB/mass storage for data transfer. Software: RAPID 6.5 for image processing/analysis. Dimensions: ESO 3 capsule modified from ESO 2. Sterilization: Not specified.

Indications for Use

Indicated for visualization of small bowel mucosa (adults/children ≥2 years) for Crohn's disease, obscure GI bleeding, or iron deficiency anemia not detected by endoscopy. Also indicated for visualization of esophageal mucosa (adults/children ≥18 years).

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 - RAPID Access (K060805)
• Given Diagnostic System with PillCam SB2 Capsules (K070475)
• Given Diagnostic System with PillCam ESO2 Capsules (K071153)
• Given PillCam Platform with PillCam SB2 Capsules (K090557)
• Given PillCam Platform with PillCam SB Capsules with PillCam SensorBelt (K091405)

Submission Summary (Full Text)

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K103025 Page 1 of

Image /page/0/Picture/1 description: The image shows the logo for Glen Imaging. The logo features the word "Glen" in large, blocky letters, with a stylized image of a glass or beaker in between the "l" and the "E". Below the word "Glen" is the word "Imaging" in smaller letters. The logo is simple and professional, and it is likely used by a company that provides medical imaging services.

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

MAY 1 3 2011

## 510(k) Summary

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<br>Address: | Given Imaging Ltd.<br>Hermon Building<br>New Industrial Park<br>PO Box 258<br>Yokneam 20692<br>Israel<br>Tel.: [phone]<br>Fax: [phone] |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Tim Thomas<br>Vice President,<br>Regulatory Affairs and 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 7, 2010 |
| Device Trade<br>Name(s): | Given PillCam® Platform with RAPID 6.5<br>Given PillCam® Platform with PillCam® ESO 3 Capsules |
| Device Common<br>Name: | Ingestible telemetric gastrointestinal capsule imaging system |
| Classification: | Regulation No: 876.1300, Class: II<br>Panel: Gastroenterology<br>NEZ - System, Imaging, Gastrointestinal, Wireless, Capsule<br>NSI - System, Imaging, Esophageal, Wireless, Capsule |
| Predicate Device(s): | Given® Diagnostic System - RAPID Access (K060805)<br>Given® Diagnostic System with PillCam® SB2 Capsules (K070475)<br>Given® Diagnostic System with PillCam® ESO2 Capsules (K071153)<br>Given PillCam® Platform with PillCam® SB2 Capsules (K090557)<br>Given PillCam® Platform with PillCam® SB Capsules with<br>PillCam® SensorBelt (K091405) |

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K103025

Image /page/1/Picture/1 description: The image shows the logo for Given Imaging. The logo is in black and white and features the company name in a stylized font. The "I" in Given is replaced by an image of a capsule endoscopy device. The word "Imaging" is written below "Given".

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

## 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.

#### 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. RAPID 6.5 supports PillCam capsule endoscopy of the GI tract with all PillCam video capsules.

### 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 SensorArray or 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.

Indication for use:

### 1. Given PillCam® Platform with RAPID 6.5

### With PillCam® SB Capsule

The PillCam Platform with a PillCam SB capsules is intended for visualization of the small bowel mucosa.

- The PillCam Platform with PillCam SB capsules may be used ● in the visualization and monitoring of lesions that may indicate Crohn's disease not detected by upper and lower endoscopy.
- . The PillCam Platform with PillCam SB capsules may be used in the visualization of lesions that may be a source of obscure bleeding (either overt or occult) not detected by upper and lower endoscopy.
- . The PillCam Platform with PillCam SB capsules may be used in the visualization of lesions that may be potential causes of iron deficiency anemia (IDA) not detected by upper and lower endoscopy.

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

1. GE

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K103025

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Image /page/2/Picture/2 description: The image shows the logo for GI-EN Imaging. The logo is in black and white and features the company name in a stylized font. The letters "GI" are on the left, followed by an image of a medical device, and then the letters "EN" and the word "IMAGING" on the right. The logo is simple and modern, and it is likely used to represent the company's brand.

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

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

The PillCam Platform with PillCam SB capsules may be used as a tool in the detection of abnormalities of the small bowel and is intended for use in adults and children from two years of age.

#### With PillCam® ESO Capsule

The PillCam® Platform with a PillCam® ESO capsule is intended for the visualization of esophageal mucosa in adults and children from 18 years of age.

# 2. Given PillCam® Platform with PillCam® ESO 3 Capsule

The PillCam® Platform with a PillCam® ESO 3 capsule is intended for the visualization of esophageal mucosa in adults and children from 18 years of age.

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Image /page/3/Picture/2 description: The image shows the logo for Glen Imaging. The logo consists of the word "Glen" in large, stylized letters, with a graphic of a lightbulb underneath the "l". Below the word "Glen" is the word "Imaging" in smaller letters. The logo is simple and modern, and the use of the lightbulb suggests that the company is involved in some kind of imaging technology.

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

| Technological Characteristics: | The technological characteristics are similar to the predicate devices, except for the differences that are listed in Section 13 of this submission. However, it may be concluded from the Substantial Equivalence Summary that none of the presented differences raise any new safety or efficacy issues. PillCam ^® ESO 3 capsule dimensions are different than the predicate device (ESO 2 capsules) and therefore the safety of PillCam ^® ESO 3 capsules in SIP procedure was validated. The results are presented in section 20 of this submission. It may be concluded based on the test results that the changes in the capsule's dimension do not raise new safety issues. |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Bench testing: | Since PillCam ^® ESO 3 capsule and the predicate device are same capsules in terms of external components and technology. The biting test and pH resistance test for the predicate device are applicable for PillCam ^® ESO 3 capsules as well. |
| Performance Data: | 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. The proposed changes in this submission do not raise new performance or safety issues. Since the capsule size was changed (ESO 3 capsule is longer and has larger diameter than the predicate device), the safety of size difference of PillCam ^® ESO 3 Capsules was validated using SIP procedure. The results are summarized in section 20 of this submission: The objective of the test was to evaluate the safety of the new PillCam ^® ESO 3 Capsules compared to the cleared PillCam ^® ESO 2 capsule. The test includes a report of 55 volunteers that underwent PillCam ^® ESO 3 capsules endoscopy. 53 volunteer ingested the PillCam ^® ESO3 capsule using SIP procedure with no reported adverse event or ingesting difficulties. Two volunteers (3.6%) faced difficulties to ingest the capsule in flat position. Once they sit up, they were able to ingest the capsule smoothly with no additional complication. The rate of difficulties is comparable with clinical study that was conducted with PillCam ^® ESO 2 capsules. 7% of the patients (total of 100 subjects) in the study had ingestions difficulties. It May be concluded that ingesting difficulties rate was not increased due to size change of the capsule, therefore no new safety issues were raised. |
| Conclusion: | Based on the technological characteristics and clinical safety of the devices, Given Imaging Ltd. believes that the Given PillCam ^® Platform with RAPID 6.5 and the Given PillCam ^® Platform with PillCam ^® ESO 3 Capsules and the predicate devices selected are substantially equivalent and do not raise new issues of safety or effectiveness. |

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

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

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

MAY 1 3 2011

Re: K103025

Trade/Device Name: Given PillCam® Platform with RAPID 6.5 and Given PillCam® Platform with PillCam® ESO 3 Capsule Regulation Number: 21 CFR §876.1300 Regulation Name: Ingestible telemetric gastrointestinal capsule imaging system Regulatory Class: II Product Codes: NEZ and NSI Dated: May 11, 2011 Received: May 12, 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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## Page 2

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/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/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 toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Huckel Lemmer 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 Dornier MedTech America, Inc.

## INDICATIONS FOR USE

510(k) Number (if known):

Device Name: Given PillCam® Platform with RAPID 6.5

### Indications for Use:

## With PillCam® SB Capsule

The PillCam Platform with a PillCam SB capsules is intended for visualization of the small bowel mucosa.

- The PillCam Platform with PillCam SB capsules may be used in the visualization and . monitoring of lesions that may indicate Crohn's disease not detected by upper and lower endoscopy.
- The PillCam Platform with PillCam SB capsules may be used in the visualization of . lesions that may be a source of obscure bleeding (either overt or occult) not detected by upper and lower endoscopy.
- The PillCam Platform with PillCam SB capsules may be used in the visualization of . lesions that may be potential causes of iron deficiency anemia (IDA) not detected by upper and lower endoscopy.

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

The PillCam Platform with PillCam SB capsules may be used as a tool in the detection of abnormalities of the small bowel and is intended for use in adults and children from two years of age.

## With PillCam® ESO Capsule

The PillCam® Platform with a PillCam® ESO capsule is intended for the visualization of esophageal mucosa in adults and children from 18 years of age.

Prescription Use _ X (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)

Amy McWhirry

Given Imaging Ltd. 510(k) Submission Given PillCam® Platform with RAPID 6,5 Given PillCam® Platform with PillCam® ESO 3 Capsules May 11, 2011

(Division Sign-om)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K103025

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Proprietary to Dornier MedTech America, Inc.

Concurrence of CDRH, Office of Device Evaluation (ODE)

### INDICATIONS FOR USE

510(k) Number (if known):

K103025

Device Name: Given PillCam® Platform with. PillCam® ESO 3 Capsules

Indications for Use:

The PillCam® Platform with a PillCam® ESO 3 capsule is intended for the visualization of esophageal mucosa in adults and children from 18 years of age.

Helent Reiner

Gastro-Rena

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

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 RAPID 6.5 Given PillCam® Platform with PillCam® ESO 3 Capsules May 11, 2011