With PillCam SB Capsule: The PillCam SB capsule is intended for visualization of the small bowel mucosa. It may be used in the visualization and monitoring of lesions that may indicate Crohn's disease not detected by upper and lower endoscopy. It may be used in the visualization and monitoring of lesions that may be a source of obscure bleeding (either overt or occult) not detected by upper and lower endoscopy. It may be used in the visualization and monitoring 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 SB capsule 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 capsule endoscopy system with PillCam ESO capsules is intended for the visualization of esophageal mucosa.

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.

AI/ML Overview

This document is a 510(k) summary for the Given PillCam endoscopy system with RAPID 8.0 and Given PillCam SB 3 capsule endoscopy system. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, the provided text does not contain details about acceptance criteria, a specific study proving device performance against these criteria, or most of the other requested information.

The document states: "The Given PillCam endoscopy system with RAPID 8.0 was validated with clinical data. The Advanced A-Mode software feature was also validated with clinical data. The proposed changes in this submission do not raise new performance or safety issues." This is a general statement and not a detailed study description.

Therefore, most of the requested information cannot be extracted from the provided text.

Here is what can be inferred or explicitly stated from the provided document, recognizing the significant limitations:

Acceptance Criteria and Device Performance (Based on provided text, this information is not explicitly detailed)

The document primarily focuses on establishing substantial equivalence to predicate devices rather than demonstrating performance against specific quantitative acceptance criteria for a new clinical study. It mentions improved features, but not specific performance metrics.

Acceptance Criterion	Reported Device Performance
(Not explicitly stated in the document)	(Not explicitly stated in the document)

Study Information (Inferred/Not Available)

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Available. The document states "The Given PillCam endoscopy system with RAPID 8.0 was validated with clinical data," but does not provide details on the sample size, data origin, or study design (retrospective/prospective).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Available. The document mentions "clinical data" for validation but does not detail how ground truth was established or by whom.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Available.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Available. The document does not describe an MRMC study or AI assistance. The "RAPID software" processes and views images, and the "Suspected Blood Indicator (SBI) feature" marks suspected frames, which might be considered an assistive feature, but no comparative effectiveness study with human readers is detailed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Available. The document describes the system as a tool for visualization, implying human review. While the SBI feature marks frames, there's no standalone performance data for the algorithm itself beyond this marking function.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Available. While "clinical data" is mentioned, the method of establishing ground truth (e.g., pathology correlation for lesions) is not specified.
The sample size for the training set:
- Not Available. The document does not refer to a "training set" as it would for a machine learning model. The study described is for validation of performance, likely with a clinical dataset.
How the ground truth for the training set was established:
- Not Applicable/Not Available. As no "training set" or specific machine learning model training is described for this submission (which focuses on substantial equivalence for hardware and software updates), this information is not present. The validation focuses on the overall system performance.

Summary of what the document does describe regarding validation:

Bench Testing:
- The document states that since the PillCam SB 3 capsule and predicate device are identical in external components and technology, existing biting and pH resistance tests for the predicate apply.
- Additional bench testing included: Field of View (FOV), battery life, wireless communication, color reproduction, image quality, frame rate verification, and optical resolution.
- Conclusion from Bench Testing: The devices meet the guidance entitled "Class II Special Performance Data: Guidance Document: Ingestible Telemetric Controls Gastrointestinal Capsule Imaging System; Final Guidance for Industry and FDA dated November 28, 2001."
Clinical Data Validation:
- "The Given PillCam endoscopy system with RAPID 8.0 was validated with clinical data."
- "The Advanced A-Mode software feature was also validated with clinical data."
- The overall conclusion is that the new features (improved optical spatial resolution, higher effective and adaptive frame rate, real-time SB detection, bi-directional communication, and AFR activation) "do not raise new safety issues" and the devices are "substantially equivalent" to predicate devices.

Key Missing Information: The document is a 510(k) summary, which generally focuses on demonstrating substantial equivalence to pre-existing legally marketed devices rather than providing detailed, quantitative performance studies against specific acceptance criteria for a novel AI device. The general statement about "validated with clinical data" lacks the specifics requested in your prompt.

Summary

{0}------------------------------------------------

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 7777 Fax 972 4 959 2466

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.Hermon BuildingNew Industrial ParkPO Box 258Yokneam 20692IsraelTel.: 011-972-4-9097936Fax: 011-972-4-9938060
Contact Person:	Tim ThomasSVP, Regulatory, Clinical, and QualityEmail: tim.thomas@givenimaging.com
Phone Number:	770-662-0870 ext. 1006
Fax Number:	770-662-0510
EstablishmentRegistrationNumber:	9710107
Date Prepared:	August 9, 2013
Device TradeName(s):	Given® PillCam® SB 3 capsule endoscopy systemGiven® PillCam® endoscopy system with RAPID® 8.0
Device CommonName:	Ingestible telemetric gastrointestinal capsule imaging system
Classification:	Regulation No: 876.1300, Class: IIPanel: Gastroenterology/UrologyNEZ -- System, Imaging, Gastrointestinal, Wireless, Capsule
PredicateDevice(s):	• Given PillCam Platform with PillCam RAPID 6.5 (K103025)• Given PillCam Platform System with PillCam SB Capsules(K101250)

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for Given Imaging. The logo consists of the text "GI-EN" in a stylized font, with a small registered trademark symbol next to the "N". Below the text is an image of a medical device, followed by the word "IMAGING" in block letters. The logo is simple and professional, and it is likely used to represent a medical imaging company.

Given Imaging Limited New Industrial Park PO Box 258, Yoqneam 0692 Israel ice 972 4 909 777 Fax 972 4 959 2466

General Device Description:

Ingestible PillCam Capsule 1.
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
  The DR 3 PillCam Recorder is and external 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 or Sensor Belt receives data from the PillCam capsule and transfers the data to the PillCam Recorder. 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 highcapacity mass storage device, and a high-capacity USB portable storage device.

{2}------------------------------------------------

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 "E". Below the word "GIVEN" is the word "IMAGING" in smaller, bolder 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 20602 Israel Voice 972 4 909 7777 Fax 972 4 959 2466

Indication for use:

1. Given PillCam endoscopy system with RAPID 8.0

With PillCam SB Capsule

The PillCam SB capsule is intended for visualization of the small bowel mucosa.

· It may be used in the visualization and monitoring of lesions that may indicate Crohn's disease not detected by upper and lower endoscopy.
It may be used in the visualization and monitoring of . lesions that may be a source of obscure bleeding (either overt or occult) not detected by upper and lower endoscopy.
It may be used in the visualization and monitoring 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 SB capsule 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 ESO capsule is intended for the visualization of esophageal mucosa.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for Given Imaging. The logo consists of the word "GIVEN" in large, stylized letters, with a graphic of a capsule endoscopy device between the "I" and "E". Below the word "GIVEN" is the word "IMAGING" in smaller letters.

Given Imaging Limited New Industrial Park PO Box 258, Yoqneam 0602 Israe Voice 972 4 909 777 Fax 972 4 959 2466

The technological characteristics are similar to the predicate Technological devices, except for the differences that are listed in Section 12 of Characteristics: 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.

The primary improved features of PillCam SB 3 capsules are the capsule optical spatial resolution, to achieve better image quality, and higher effective and adaptive frame rate (AFR), to achieve better coverage of small bowel tissue in segments at which the capsule moves fast such as in the duodenum. The main new features implemented in PillCam recorder DR 3, are support of the new introduced SB 3 capsule and support of its functionalities such as: Real-time SB detection, Bi-directional communication and Adaptive Frame Rate (AFR) activation. The safety of PillCam SB 3 capsules was validated and no safety or efficacy issues have been raised. It may be concluded that the new features do not raise new safety issues.

Since PillCam SB 3 capsule and the predicate device are same Bench testing: capsules in terms of external components and technology. The biting test and pH resistance test for the predicate device are applicable for PillCam SB 3 capsules as well. Additional bench testing included field of view (FOV), battery life, wireless communication, color reproduction, image quality, frame rate verification, and optical resolution.
The devices meet the guidance entitled "Class II Special Performance Data: Guidance Document: Ingestible Telemetric Controls Gastrointestinal Capsule Imaging System; Final Guidance for Industry and FDA dated November 28, 2001.

The Given PillCam endoscopy system with RAPID 8.0 was validated with clinical data. The Advanced A-Mode software feature was also validated with clinical data. 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 Given PillCam endoscopy system with RAPID 8.0 and Given PillCam SB 3 capsule endoscopy system and the predicate devices selected are substantially equivalent and do not raise new issues of safety or effectiveness.

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized emblem with three curved lines, resembling a person with outstretched arms. The emblem is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WQ66-G609 Silver Spring, MD 20993-0002

August 12, 2013

Given Imaging, Ltd. % Tim Thomas Senior Vice President Hermon Building New Industrial Park, P.O. Box 258 Yokneam 20692 Israel

Re: K123864

Trade/Device Name: Given PillCam endoscopy system with RAPID 8.0 Regulation Number: 21 CFR§ 876.1300 Regulation Name: Ingestible telemetric gastrointestinal capsule imaging system Regulatory Class: II Product Code: NEZ Dated: July 11, 2013 Received: July 15, 2013

Dear Tim 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.

{5}------------------------------------------------

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 (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/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,

Herbert P. Lerner -S

for

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

{6}------------------------------------------------

INDICATIONS FOR USE

510(k) Number : K123864

Device Name: Given PillCam endoscopy system with RAPID 8.0

Indications for Use:

With PillCam SB Capsule

The PillCam SB capsule is intended for visualization of the small bowel mucosa.

It may be used in the visualization and monitoring of lesions that may indicate . Crohn's disease not detected by upper and lower endoscopy.
It may be used in the visualization and monitoring of lesions that may be a source of ● obscure bleeding (either overt or occult) not detected by upper and lower endoscopy.
It may be used in the visualization and monitoring 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 SB capsule 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 capsule endoscopy system with PillCam ESO capsules is intended for the visualization of esophageal mucosa.

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)

Herbert P. Lerner -S

(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices K123864 510(k) Number_

Given Imaging Ltd. K123864 - Response Letter PillCam® SB 3 capsule endoscopy system Supplement #1 April 28, 2013

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.”