o PillCam Capsule Endoscopy System with PillCam SB 2 and SB 3 capsules may be used in the visualization and monitoring of lesions that may indicate Crohn's disease not detected by upper and lower endoscopy.
PillCam Capsule Endoscopy System with PillCam SB 2 and SB 3 capsules ● 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.
PillCam Capsule Endoscopy System with PillCam SB 2 and SB 3 capsules 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 Capsule Endoscopy System with PillCam SB 2 and SB 3 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 3 Capsule

The PillCam Capsule Endoscopy System with PillCam ESO 3 capsules is intended for the visualization of esophageal mucosa in adults and children from 18 years of age..

With PillCam UGI Capsule

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 least 18 years of age.

With PillCam COLON Capsule

The PillCam COLON 2 capsule endoscopy system is intended to provide visualization of the colon. It may be used for detection of colon polyps in patients after an incomplete optical colonoscopy with adequate preparation, and a complete evaluation of the colon was not technically possible. In addition, it is intended for detection of colon polyps in patients with evidence of gastrointestinal bleeding of lower GI origin. This applies only to patients with major risks for colonoscopy or moderate sedation, but who could tolerate colonoscopy and moderate sedation in the event a clinically significant colon abnormality was identified on capsule endoscopy.

Device Description

The RAPID Web is a client server based version of the RAPID video review and report creation components of the cleared RAPID 8 software. The RAPID Web is designed to allow users to review and analyze videos created using the cleared RAPID software, and to create reports over a private intranet network or over a secure internet connection. The PillCam capsule studies are created at workflow-relevant locations and stored at a central repository. The RAPID Web server is installed on a central server in an intranet or internet environment with access to the study repository. After the capsule endoscopy procedure was conducted using the cleared RAPID software, Given Workstation/User PC, PillCam capsule, and DR 3 PillCam recorder, end users will use an internet browser with authorization login to access, review, and manage the studies in the repository using workstation, user PC, a laptop or an Apple™ (screen size > 9.7").

AI/ML Overview

The provided text describes the 510(k) submission for RAPID Web, comparing it to its predicate device, RAPID 8.0. The core of the submission revolves around demonstrating that RAPID Web is substantially equivalent to RAPID 8.0, and thus, RAPID Web's "performance" is implicitly tied to how well it replicates the established performance of RAPID 8.0.

Here's an analysis of the acceptance criteria and study as presented in the document:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state numerical acceptance criteria in a table format for RAPID Web's diagnostic performance. Instead, it states the acceptance criterion informally as "RAPID 8.0 met the pre-specified sensitivity" in the context of a comparative performance study. The reported performance is that the analysis of "matched and un-matched pathologies" showed this criterion was met.

Acceptance Criteria (Stated or Implied)	Reported Device Performance
RAPID Web must perform equivalently to RAPID 8.0 in identifying pathologies. (Implied: RAPID 8.0's established diagnostic sensitivity for pathology identification, including "blood or red areas" marked by SBI, is maintained.)	A comparative performance study showed that "RAPID 8.0 met the pre-specified sensitivity" when RAPID Web and RAPID 8.0 were used to identify pathologies in the same video and video segments.
Software validation performed per FDA guidance.	"the software was validated and documented per FDA's software guidance document."
No new issues of safety or effectiveness introduced by technological differences.	"The minor differences in indications do not alter the intended diagnostic use of the device and do not affect its safety and effectiveness when used as labeled." "In addition, the minor technological differences between the RAPID Web and its predicate devices raise no new issues of safety or effectiveness."

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample Size for Test Set: The document states that a "comparative performance study wherein trained professionals identified pathologies in the same video and video segments that we displayed using RAPID Web and RAPID 8.0 was performed." However, it does not specify the number of cases (videos or video segments) used in this test set.
Data Provenance: The document does not specify the country of origin of the data or whether the data was collected retrospectively or prospectively.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

The document implies that "trained professionals" were involved in identifying pathologies. However, it does not specify the number of experts used to establish the ground truth or their specific qualifications (e.g., years of experience, medical specialty). The study design appears to be a comparison of user performance with two different software versions, rather than a separate ground truth establishment phase by independent experts for the test set itself. The "ground truth" for this comparative study seems to be derived from the consensus or established interpretations of "trained professionals" using the predicate device.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

The document does not describe an explicit adjudication method (like 2+1 or 3+1) for the test set. The study compares "matched and un-matched pathologies," suggesting a direct comparison of findings between the two software versions, likely relying on individual assessments by the trained professionals.

5. 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

The study described is a "comparative performance study" where "trained professionals identified pathologies in the same video and video segments that we displayed using RAPID Web and RAPID 8.0." This sounds like a multi-reader, multi-case study (MRMC) in the sense that multiple readers would use the two different software versions on the same cases.
However, this is not a study on human readers improving with AI vs. without AI assistance. RAPID Web and RAPID 8.0 are video review and analysis software. The "Suspected Blood Indicator (SBI) feature" is mentioned as "intended to mark frames of the video suspected of containing blood or red areas," which is an algorithmic assistance feature. The study assessed if this feature, within the new web-based context, maintained its performance from the predicate.
The document does not report any effect size demonstrating improvement of human readers with either RAPID Web or RAPID 8.0 over a non-assisted reading scenario. The study aims to demonstrate substantial equivalence between the two software versions.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

The document does not describe a standalone algorithm-only performance study. The performance evaluation is explicitly framed as a "comparative performance study wherein trained professionals identified pathologies," indicating human-in-the-loop performance. The SBI feature is an algorithm, but its performance is assessed within the context of human review.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the "pathologies" identified in the comparative study appears to be based on the interpretations of "trained professionals" themselves, as they "identified pathologies." The comparison is between the findings obtained using RAPID Web and those obtained using RAPID 8.0, with RAPID 8.0's established performance serving as the reference. There is no mention of an independent, higher-standard ground truth like biopsy/pathology reports or long-term clinical outcomes data being used to validate the accuracy of these identified pathologies in this particular comparative study. The study's goal is equivalence, not re-proving clinical accuracy against an external gold standard for the new platform.

8. The sample size for the training set

The document does not provide any information about a training set or its sample size. This submission is for a new version of existing software (RAPID Web being a client-server version of RAPID 8.0), not necessarily a new AI model that would require a distinct training phase described in the submission. The "Suspected Blood Indicator (SBI) feature" is part of the established functionality from the predicate device, not a new AI algorithm being introduced or trained for RAPID Web.

9. How the ground truth for the training set was established

As no training set is described in the document, there is no information on how ground truth for a training set was established.

Summary

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

May 26, 2017

Given Imaging Ltd. Hilla Debby Director Clinical & Regulatory 2 Hacarmel St. New Industrial Park POB 258 Yoqneam, 20692 Israel

Re: K170839 Trade/Device Name: RAPID Web Regulation Number: 21 CFR§ 876.1300 Regulation Name: Ingestible Telemetric Gastrointestinal Capsule Imaging System Regulatory Class: II Product Code: NEZ, NSI, PGD Dated: March 16, 2017 Received: March 21, 2017

Dear Hilla 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.

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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 (reporting of medical devicerelated 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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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,

Joyce M. Whang -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

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RAPID Web

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page

510(k) Number (if known)

K170839

Device Name

RAPID Web

Indications for Use (Describe)

With PillCam SB 2 and SB 3 Capsules

The PillCam Capsule Endoscopy System with a PillCam SB 2 and SB 3 capsules is intended for visualization of the small bowel mucosa.

o PillCam Capsule Endoscopy System with PillCam SB 2 and SB 3 capsules may be used in the visualization and monitoring of lesions that may indicate Crohn's disease not detected by upper and lower endoscopy.
PillCam Capsule Endoscopy System with PillCam SB 2 and SB 3 capsules ● 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.
PillCam Capsule Endoscopy System with PillCam SB 2 and SB 3 capsules 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.

With PillCam ESO 3 Capsule

The PillCam Capsule Endoscopy System with PillCam ESO 3 capsules is intended for the visualization of esophageal mucosa in adults and children from 18 years of age..

With PillCam UGI Capsule

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With PillCam COLON Capsule

Type of Use (Select one or both, as applicable)

区 Prescription Use (Part 21 CFR 801 Subpart D) CFR 801 Subpart C)

_ Over-The-Counter Use (21

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response. including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(k) SUMMARY

I. SUBMITTER

Submitter Name and Address:	Given Imaging Ltd.(GI Solutions,Medtronic)
2 Hacarmel Street
New Industrial Park
PO Box 258
Yokneam 20692
Israel
Contact Person:	Hilla Debby
Director, Clinical & Regulatory
Email: Hilla.Debby@medtronic.com
Phone Number:	972 (4) 909-7774
Fax Number:	972 (73) 2501533
Date Prepared:	March 16, 2017

II. DEVICE

Device Trade Name: RAPID Web

Common or Usual Name, Classification Name, Regulatory Class, and Product Code:

21 CFR 876.1300 Ingestible telemetric gastrointestinal capsule imaging system 21 CFR 876.1330 Colon capsule endoscopy system NEZ - System, imaging, gastrointestinal, wireless, capsule, class II

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NSI - System, imaging, esophageal, wireless, capsule, class II

PGD - colon capsule imaging system, class II

III. PREDICATE DEVICES

RAPID 8.0 Software (K123864)

Reference Devices: UGI Capsule (K140284) and COLON 2 Capsule (K153466)

DEVICE DESCRIPTION IV.

INTENDED USE / INDICATIONS FOR USE V.

With PillCam SB 2 and SB 3Capsules

The PillCam Capsule Endoscopy System with a PillCam SB 2 and SB 3 capsules is intended for visualization of the small bowel mucosa.

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· PillCam Capsule Endoscopy System with PillCam SB 2 and SB 3 capsules may be used in the visualization and monitoring of lesions that may indicate Crohn's disease not detected by upper and lower endoscopy.
· PillCam Capsule Endoscopy System with PillCam SB 2 and SB 3 capsules 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.
PillCam Capsule Endoscopy System with PillCam SB 2 and SB 3 capsule 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.

With PillCam ESO 3 Capsule

The PillCam Capsule Endoscopy System with PillCam ESO 3 capsules is intended for the visualization of esophageal mucosa in adults and children from 18 years of age.

With PillCam UGI Capsule

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With PillCam COLON Capsule

SUMMARY OF TECHNOLOGICAL CHARACTERISTICS VI.

The RAPID Web and RAPID 8.0 have the same intended use and indications, and similar technological characteristics and principles of operation. The only technological differences between the RAPID Web and its predicates are: relocation of software from local hard drive to web-based server, increased range of viewing platforms, removal of features intended for use on mainframes and PCs, removal of viewing modes and features not critical to diagnosis, and the addition of several user friendly features. These differences do not present any new issues of safety or effectiveness because they are not critical to diagnosis and primarily affect convenience. Thus, the RAPID Web is substantially equivalent to the RAPID 8.0.

Intended Use	RAPID Web(subject)	RAPID 8.0(K123864)
Viewing of capsuleendoscopy studies	Viewing of capsuleendoscopy studies	Viewing ofcapsule endoscopystudies
Capsule endoscopy procedure(Check-in, initialization, videocreation)	Not supported	Supported
Capsule endoscopy post-proceduresteps (Video review and reportcreation)	Supported	Supported
Installation	Installed on a server	Installed on awork station

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Hardware	Workstation, PC,laptops, Apple iPads >9.7" screen	Workstation, PC
Main video reading features (Open,play, viewing modes, FICE & Blue	Supported	Supported
Workstation related features(keyboard, CD, etc.)	Not supported	Supported
Optional viewing aids (mosaic view,image enhancement control options,Lewis score, atlas, comparethumbnails etc.)	Not supported	Supported
Additional features (dynamic playercontrol, findings preview)	Supported	Not Supported

Minimum Requirements

Minimum Display Requirements for Workstations Monitors

	MinimumRequirement
Diagonal	20"
Response time	8 ms
Advanced contrast	15,000:1
Resolution max	1600x900

Minimum Display Requirements for Laptops

	Minimum Requirement
Diagonal	12.5"
Static contrast	300:1
Brightness	200 nits
PPI	107 PPI
Resolution max	1366 x 7681280 x 800
Refresh rate	60 Hz

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Minimum Display Requirements for iPads

	MinimumRequirement
Diagonal	9.7"
Resolution max	264 PPI
Diagonal	2048 x 1536

Compatible operating systems and browsers:

1. For Windows 7 SP1, and Windows 8 or win 8.1:
- 1.1. Chrome v38.
- 1.2. Firefox v33.
- 1.3. Internet Explorer 11.0.4.

Hardware specifications: All Windows related tests were performed on Intel x86-based computer hardware that meets the operating system minimum requirements.

1. For MacOS v10.10 "Yosemite":
- 2.1. Safari 8.0
1. For MacOS v10.8 "Mountain Lion" and v10.9 "Mavericks": 3.1. Safari 7.1

MAC Hardware specifications:

-MacBook Pro 13", 2.4GHz dual-core Intel Core i5 processor, 4GB RAM
Macbook air 13", 1.8HGZ dual-core Intel Core i7, 4GB RAM -
1. For iPad with iOS 8.1:
- 4.1. Safari 8.0

iPad Hardware specifications:

iPad 4: Dual-core A6X with quad-core graphics and 16GB storage
iPad air: A7 chip with 64-bit architecture and 16GB storage -
1. Color depth: 24 bit

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VII. PERFORMANCE DATA

A comparative performance study wherein trained professionals identified pathologies in the same video and video segments that we displayed using RAPID Web and RAPID 8.0 was performed. RAPID 8.0 performance was assessed on multiple platforms, including workstations, laptops, and iPads. An analysis assessing the matched and un-matched pathologies showed that RAPID 8.0 met the pre-specified sensitivity.

In addition, the software was validated and documented per FDA's software guidance document.

VIII. CONCLUSIONS

The RAPID Web is as safe and effective as the RAPID 8.0. The RAPID Web has the same intended uses and indications, and similar technological characteristics, and principles of operation as its predicate device. The minor differences in indications do not alter the intended diagnostic use of the device and do not affect its safety and effectiveness when used as labeled. In addition, the minor technological differences between the RAPID Web and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the RAPID Web is as safe and effective as the RAPID 8.0. Thus, the RAPID Web is substantially equivalent.

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.”