GIVEN PILLCAM UGI CAPSULE ENDOSCOPY SYSTEM by GIVEN IMAGING LTD.

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 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.

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.
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.
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.
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.

AI/ML Overview

This document describes the Given PillCam UGI capsule endoscopy system. The provided text outlines the device's indications for use, general description, technological characteristics, and a brief statement on how it meets guidance. However, it does not contain specific details from a study proving the device meets acceptance criteria, nor does it provide a table of acceptance criteria with reported device performance.

Therefore, I cannot fulfill your request for:

A table of acceptance criteria and the reported device performance.
Sample size used for the test set and data provenance.
Number of experts used to establish ground truth for the test set and their qualifications.
Adjudication method for the test set.
Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size.
Whether a standalone performance study was done.
The type of ground truth used.
The sample size for the training set.
How the ground truth for the training set was established.

The document primarily focuses on establishing substantial equivalence to predicate devices, discussing:

Device Name: Given PillCam UGI capsule endoscopy system
Intended Use: Visualization of the upper gastrointestinal tract (esophagus, stomach, duodenum), including visualization of blood, in hemodynamically stable patients at least 18 years of age.
Components: Ingestible PillCam capsule, DR 3 PillCam Recorder, RAPID software, and Given Workstation and Accessories.
Technological Characteristics: Similar to predicate devices (ESO 2, ESO 3, COLON 2 capsules). Modifications include prolonged operation time and adaptive frame rate (35 fps for 10 minutes, then 18 fps for 80 minutes) to achieve better upper GI tissue coverage. optical features include 4 white LEDs, 172° field of view, and 0-30mm effective visibility distance.
Bench Testing: Biting test and pH resistance test from the COLON 2 capsule (predicate) are applicable due to identical external components and technology. Optical resolution testing showed pH environments do not affect optical performance.
Compliance: The device meets the "Class II Special Controls Guidance Telemetric Gastrointestinal Capsule Imaging System; Final Guidance for Industry and FDA dated November 28, 2001."

The document concludes that the modifications "do not raise new performance or safety issues" and that the system is substantially equivalent to predicate devices. This implies that the performance is considered acceptable based on its similarity to previously approved devices, rather than through a dedicated performance study with specific acceptance criteria detailed in this summary.

Summary

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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:

Prescription Use (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) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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 Nameand Address:	Given Imaging Ltd.2 Hacarmel StreetNew Industrial ParkPO Box 258Yokneam 20692IsraelTel.: 011-972-4-9097774Fax: 011-972-73-2501533
Contact Person:	Hila DebbyDirector, Clinical & RegulatoryEmail: Hila.Debby@givenimaging.com
Phone Number:	972 (4) 909-7774
Fax Number:	(972) 73-2501533
EstablishmentRegistrationNumber:	9710107
Date Prepared:	January 30, 2014
Device TradeName(s):	Given® PillCam® UGI capsule endoscopy system
Device CommonName:	Ingestible telemetric gastrointestinal capsule imaging system
Classification:	Regulation No: 876.1300, Class: IIPanel: Gastroenterology/UrologyNSI- System, Imaging, Esophageal, Wireless, CapsuleNEZ - System, Imaging, Gastrointestinal, Wireless, Capsule
PredicateDevice(s):	· Given Diagnostic System with PillCam ESO 2 capsule(K071153)● Given PillCam Platform System with RAPID 6.5 and GivenPillCam Platform with ESO 3 capsule (K103025)· Given PillCam® SB 3 capsule endoscopy system (K123864)• Given PillCam® COLON 2 capsule endoscopy system(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:

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.
1. 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.
1. 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.

1. 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.

Regulation Number and Section

§ 876.1300 Ingestible telemetric gastrointestinal capsule imaging system.

(a)
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.(b)
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.”