GIVEN PILLCAM UGI CAPSULE ENDOSCOPY SYSTEM
Device Facts
| Record ID | K140284 |
|---|---|
| Device Name | GIVEN PILLCAM UGI CAPSULE ENDOSCOPY SYSTEM |
| Applicant | Given Imaging , Ltd. |
| Product Code | NEZ · Gastroenterology, Urology |
| Decision Date | Dec 17, 2014 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.1300 |
| Device Class | Class 2 |
Indications for Use
The PillCam UGI capsule endoscopy system is intended for visualization of the upper gastrointestinal tract (esophagus, stomach, duodenum). It may be used for visualization of blood in the upper gastrointestinal tract (esophagus, stomach, duodenum) in patients who are hemodynamically stable and at least18 years of age.
Device Story
System consists of ingestible PillCam capsule, DR 3 recorder, RAPID software, and workstation. Capsule acquires video images during GI transit; transmits via RF to external recorder. Recorder stores data; transferred to workstation for processing via RAPID software. Software creates video for physician review; generates clinical reports. Used in clinical settings by physicians to visualize upper GI tract; aids in identifying blood. Benefits include non-invasive visualization of esophagus, stomach, and duodenum.
Clinical Evidence
Bench testing only. Optical resolution tests confirmed pH environments do not affect image quality. Biting and pH resistance tests from predicate COLON 2 capsule were leveraged. Device complies with FDA guidance for Telemetric Gastrointestinal Capsule Imaging Systems.
Technological Characteristics
Ingestible capsule with 4 white LEDs per optical head. Field of view: 172° (ISO 9600-3). Visibility distance: 0-30mm. Adaptive frame rate: 35 fps (first 10 mins), 18 fps (remaining 80 mins). Connectivity: RF transmission to external DR 3 recorder. Workstation: modified PC running RAPID 8.0 software. Disposable capsule.
Indications for Use
Indicated for visualization of the upper GI tract (esophagus, stomach, duodenum) and detection of blood in the upper GI tract in hemodynamically stable patients aged 18 years or 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 ESO 2 capsule (K071153)
- Given PillCam Platform System with RAPID 6.5 and Given PillCam Platform with ESO 3 capsule (K103025)
- Given PillCam SB 3 capsule endoscopy system (K123864)
- Given PillCam COLON 2 capsule endoscopy system (K123666)
Submission Summary (Full Text)
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 16, 2014
Given Imaging, Ltd. Hila Debby Director, Clinical & Regulatory 2 Hacarmel Street New Industrial Park, PO Box 258 Yogneam 20692 Israel
Re: K140284
> Trade/Device Name: Given PillCam UGI capsule endoscopy system Regulation Number: 21 CFR§ 876.1300 Regulation Name: Ingestible telemetric gastrointestinal capsule imaging system Regulatory Class: II Product Code: NEZ Dated: November 11, 2014 Received: December 15, 2014
Dear Hila Debby,
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.
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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 device-related 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Benjamin R. Fisher -A
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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## INDICATIONS FOR USE
K140284 510(k) Number (if known):
Device Name: Given PillCam UGI capsule endoscopy system
Indications for Use:
The PillCam UGI capsule endoscopy system is intended for visualization of the upper gastrointestinal tract (esophagus, stomach, duodenum). It may be used for visualization of blood in the upper gastrointestinal tract (esophagus, stomach, duodenum) in patients who are hemodynamically stable and at least18 years of age.
Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
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AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Image /page/3/Picture/0 description: The image shows the logo for Given Imaging. The logo is in a blue box with the word "GIVEN" in white, with the "I" in "GIVEN" being a stylized image of a pill. Below the word "GIVEN" is the word "IMAGING" in white. To the right of the logo are several blue squares.
Given Imaging, LTD. 2 Hacarmel St. New Industrial Park Yoqneam 20692 Israel
## 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<br>and Address: | Given Imaging Ltd.<br>2 Hacarmel Street<br>New Industrial Park<br>PO Box 258<br>Yokneam 20692<br>Israel<br>Tel.: 011-972-4-9097774<br>Fax: 011-972-73-2501533 |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Hila Debby<br>Director, Clinical & Regulatory<br>Email: Hila.Debby@givenimaging.com |
| Phone Number: | 972 (4) 909-7774 |
| Fax Number: | (972) 73-2501533 |
| Establishment<br>Registration<br>Number: | 9710107 |
| Date Prepared: | January 30, 2014 |
| Device Trade<br>Name(s): | Given® PillCam® UGI capsule endoscopy system |
| Device Common<br>Name: | Ingestible telemetric gastrointestinal capsule imaging system |
| Classification: | Regulation No: 876.1300, Class: II<br>Panel: Gastroenterology/Urology<br>NSI- System, Imaging, Esophageal, Wireless, Capsule<br>NEZ - System, Imaging, Gastrointestinal, Wireless, Capsule |
| Predicate<br>Device(s): | · Given Diagnostic System with PillCam ESO 2 capsule<br>(K071153)<br>● Given PillCam Platform System with RAPID 6.5 and Given<br>PillCam Platform with ESO 3 capsule (K103025)<br>· Given PillCam® SB 3 capsule endoscopy system (K123864)<br>• Given PillCam® COLON 2 capsule endoscopy system<br>(K123666) |
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Image /page/4/Picture/0 description: The image contains the logo for Given Imaging. The logo is in a blue box and contains the text "Given" in white, with a green triangle below the text. Below the triangle is the text "Imaging" in white. To the right of the logo are several blue squares of varying shades.
Given Imaging, LTD. 2 Hacarmel St. New Industrial Park Yoqneam 20692 Israel
General Device Description:
The Given PillCam Endoscopy system is comprised of four main subsystems; (1) the ingestible PillCam capsule, (2) the DR 3 PillCam Recorder, (3) the RAPID software, and (4) the Given Workstation and Accessories.
- 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 PillCam Recorder located outside the body.
- 2. DR 3 PillCam Recorder
DR 3 PillCam Recorder is an external The receiving/recording unit that receives and stores the acquired images from the capsule.
- 3. RAPID Software
The RAPID Software is a software application that is utilized to process, analyze, store, and view the acquired images collected from the PillCam Recorder to create a RAPID video of the images. The software also includes a reporting function to create detailed clinical reports, inservice training videos, and patient instruction forms. RAPID 8.0 supports PillCam capsule endoscopy of the GI
tract with all PillCam video capsules. In addition, RAPID 8.0 supports PillCam Recorder DR 2C and PillCam Recorder DR 3.
- 4. Given Workstation and Accessories
The Workstation is a modified standard personal computer that is the operational platform for the RAPID software. The PillCam Recorder is an external receiving/recording unit that receives acquired images from the capsule. The Sensor Array receives data from the PillCam capsule and transfers the data to the PillCam Recorder. Other accessories include a flat panel LCD monitor, a highcapacity mass storage device, and a high-capacity USB portable storage device.
- Indication for use: The PillCam UGI capsule endoscopy system is intended for visualization of the upper gastrointestinal tract (esophagus, stomach, duodenum). It may be used for visualization of blood the upper gastrointestinal tract (esophagus, stomach, in duodenum) in patients who are hemodynamically stable and at least18 years of age.
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Image /page/5/Picture/0 description: The image shows the logo for Given Imaging. The logo is in a blue box with the words "Given" and "Imaging" in white. The "i" in Given is replaced with a green triangle. To the right of the logo are several blue squares in different shades.
Given Imaging, LTD. 2 Hacarmel St. New Industrial Park Yoqneam 20692 Israel
The technological characteristics are similar to the predicate Technological Characteristics: devices (ESO 2, ESO 3 and COLON 2 capsules). There are two modifications compared to the ESO 2 and ESO 3 capsules that are listed in Section 12 of this submission. However, it may be concluded from the Substantial Equivalence Summary that none of the presented changes raise any new safety issues. These two modifications have been made in order to achieve better coverage of the upper GI tissue. The first modification is the prolonged operation time. The second modification is the adaptive frame rate [35 frames per second (fps) in the first 10 minutes and 18 frames per second (fps) in the remaining 80 minutes]. No new safety issues were raised due to the proposed design. Optical Features 4 white LEDs per optical head are used as the UGI capsule illumination source. The Field of view is 172° (ISO 9600-3) and the Effective Visibility distance is set to 0-30mm. Bench testing: Since PillCam UGI capsule and the COLON 2 capsule predicate device are identical in terms of external components and technology, the biting test and pH resistance test for the predicate device are applicable for PillCam UGI capsules as well. In addition optical resolution test results demonstrate that different pH environments do not affect the optical performance of the PillCam capsule, specifically the image quality.
The device meets the guidance entitled "Class II Special Performance Data: Controls Guidance 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.
Conclusion: Based on the technological characteristics of the devices, Given Imaging Ltd. believes that the PillCam UGI capsule endoscopy system and the predicate devices selected are substantially equivalent and do not raise new issues of safety or effectiveness.
