The PeerScope System is intended for diagnostic visualization of the digestive tract. The system also provides access for therapeutic interventions using standard endoscopy tools. The PeerScope System is indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum).

Device Description

The PeerScope System Model HG is a G1 platform for diagnostic visualization and therapeutic intervention of the digestive tract for use in healthcare facility/hospital. The system consists of the Main Control Unit (MCU) Videoprocessor that provides the device controls, user interfaces, image processing, pneumatic controls and interfaces with various external accessories, and of the PeerScope GS flexible video Gastroscope labeled for repeatable clinical usage within the upper digestive tract. The operation principles of the PeerScope System are similar to those of other legally marketed standard Gastroscopic systems. The system also provides the physicians with two viewing capabilities: Standard 160° front field of view, and 210° wide field of view.

AI/ML Overview

The provided document describes the PeerScope System (Model HG), a gastroscope used for diagnostic visualization and therapeutic interventions in the upper digestive tract. The submission to the FDA focuses on establishing substantial equivalence to a predicate device, the EVIS EXERA II 180 System (K100584), rather than a standalone clinical study demonstrating specific performance metrics against pre-defined acceptance criteria for a new AI-powered diagnostic device.

Therefore, many of the requested elements for an AI device study are not applicable to this submission, as it concerns a medical device with similar technological characteristics to existing devices, seeking clearance under the 510(k) pathway.

However, I can extract information related to the device's performance, testing, and basis for demonstrating safety and effectiveness as presented in the document.

Summary of Acceptance Criteria and Device Performance (as inferable from the 510(k) submission):

The submission does not present a table of explicit acceptance criteria for a novel AI algorithm's performance. Instead, the "acceptance criteria" are implied by demonstrating that the PeerScope System Model HG performs equivalently to, and is as safe and effective as, its legally marketed predicate devices. The performance data presented focuses on design verification, software validation, reprocessing validation, and usability, all of which met their respective internal and regulatory acceptance criteria.

Category	Acceptance Criteria (Implied by Predicate Equivalence & Regulatory Standards)	Reported Device Performance (PeerScope GS Gastroscope)
Functional Equivalence	Must have the same intended use and indications for use as the predicate device (diagnostic visualization and therapeutic interventions in the upper digestive tract).	The PeerScope System Model HG has the same intended use and indications for use in the upper digestive tract. It provides diagnostic visualization and access for therapeutic interventions using standard endoscopy tools.
Technological Characteristics	Must utilize similar technologies to its predicate device(s) or demonstrate that differences do not raise new questions of safety and effectiveness.	The PeerScope System Model HG uses similar technologies. Key differences like having a side view, a wider field of view (210° vs. 140° for predicate's standard view), and integral LED illumination were assessed and deemed to have insignificant impact on device safety and effectiveness. Conversely, features present in the predicate but not the PeerScope (e.g., narrow band illumination) were noted as not impacting the PeerScope's safety/effectiveness for its intended use.
Risk Management	Risk analysis must be conducted in accordance with ISO 14971, identifying and mitigating unacceptable risks.	Risk analysis was conducted in accordance with ISO 14971.
Design Verification	Design verification tests must be identified, performed, and meet their acceptance criteria to ensure the device performs as intended and meets specifications.	Design verification tests were identified, performed, and met.
Software Validation	Must be carried out in accordance with FDA Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 2005)".	Software validation was carried out and met the requirements.
Reprocessing Validation	Must be carried out in accordance with FDA Guidance Document "Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Draft Guidance (May 2011)".	Reprocessing validation was carried out and met the requirements.
Usability	Must demonstrate safe and effective use in a clinical environment by experienced physicians.	Device usability was carried out by five experienced GI physicians in a US medical center, demonstrating that the device meets its specifications.
Compliance with Standards	Must comply with relevant international and national standards for medical devices, electrical safety, biocompatibility, and sterilization (e.g., AAMI / ANSI ES 60601-1, IEC 60601-1-2, IEC 60601-2-18, IEC 62304, ISO 10993, ISO 8600, ASTM E 1837).	The device was tested against and relies upon a comprehensive list of standards, including AAMI / ANSI ES 60601-1, IEC 60601-1-2, IEC 60601-2-18, IEC 62304, ISO 10993 (Parts #1, #5, #10, #12), ISO 8600 (Parts 1, 3, 4, 6), and ASTM E 1837-96.

Detailed Responses to Specific Questions:

A table of acceptance criteria and the reported device performance:
- Please refer to the table above. The acceptance criteria are largely implied by demonstrating substantial equivalence to the predicate device and compliance with applicable standards.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Usability Study: Five experienced GI physicians participated in the usability testing.
- Data Provenance: The usability testing was conducted in a U.S. medical center. The nature of this testing (observational use in a clinical environment) makes it prospective rather than retrospective.
- For other tests (Risk Analysis, Design Verification, Software Validation, Reprocessing Validation, Bench Data), the sample sizes are not explicitly stated, as these typically refer to engineering verification and validation activities rather than clinical study cohorts. The "device safety and performance were verified by EndoChoice Innovation Center Ltd. and accredited third party laboratories" (Israel and likely other locations for third-party labs).
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):
- For the usability study, five experienced GI physicians were used. Their specific years of experience are not detailed, but "experienced" implies sufficient expertise for evaluating a gastroscope.
- For other technical verification tests, "ground truth" is established by engineering specifications, regulatory standards, and validated test methods, rather than expert consensus on diagnostic interpretations.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- The document does not describe an adjudication method for the usability study. It states that device usability was "carried out by means of testing within a clinical environment ... by five experienced GI physicians." It implies a consensus or individual assessment by these physicians that the device meets its specifications for usability. Given the nature of a 510(k) for an endoscope, a formal adjudication process for diagnostic accuracy (like in an AI study) is not typically required.
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:
- No, an MRMC comparative effectiveness study was not done. This submission is for a medical device (gastroscope) and not an AI-powered diagnostic tool. The focus is on demonstrating substantial equivalence to a predicate device, not on improving human reader performance with AI assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This submission is for an endoscope system, not an AI algorithm. There is no standalone algorithm performance to report.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the usability study, the "ground truth" was the device's adherence to its specifications and satisfactory performance in a clinical environment, as assessed by experienced GI physicians.
- For bench testing and design verification, the "ground truth" comprises engineering specifications, performance standards (e.g., scope angulation, field of view, depth of field), and regulatory compliance requirements.
The sample size for the training set:
- Not applicable. As this is not an AI device, there is no training set mentioned or required.
How the ground truth for the training set was established:
- Not applicable. As there is no training set, there is no ground truth establishment for it.

In conclusion, this 510(k) submission for the PeerScope System (Model HG) demonstrates its safety and effectiveness primarily through bench testing, adherence to recognized standards, and a small-scale usability study, all aimed at proving substantial equivalence to a previously cleared predicate device. It does not involve the type of clinical performance study with acceptance criteria and ground truth validation that would be typical for a novel AI-driven diagnostic device.

Summary

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EndoChoice, Inc., 11810 Wills Road Alpharetta, GA 30009

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 Details

EndoChoice Inc. 11810 Wills Road OCT 1 0 2013 Alpharetta, GA 30009 Phone: 678-534-6012 866-567-8218 Fax: Date prepared: June 18, 2013 Submission Contact: Tamar Fuerst EndoChoice Innovation Center Ltd. Caesarea, 38900, Israel. Phone: +972-46327731, Fax: +972-46327743

Device Details

Proprietary Name: Classification Name Product Code: Committee/Panel: Device Class:

PeerScope System (Model HG) Endoscope and Accessories, 21 CFR 876.1500 FDS Gastroenterology/Urology II

Reason for 510(k) Submission: New Device

Identification of Legally Marketed Predicates Devices:

EVIS EXERA II 180 System (K100584) by Olympus. PeerScope System Model H (K130718) - by PeerMedical Ltd.

Device Description

PeerScope System Model HG Submission Section 5_ 510(k) Summary

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Intended use and indications for Use

The PeerScope System consists of camera heads, endoscopes, video system, light source and other ancillary equipment. ·

Technological characteristics

The PeerScope GS video Gastroscope incorporates the following additional features compared to the predicate device:

Category	Subject Device:PeerScope GSGastroscope	Predicate DeviceGastrointestinalVideoscope GIFType H180-(K100584)	Impact of the differenceson device performance
Direction of Views	Front and left (side)	Front only	Both designs utilizestandard front view.
Standard Field OfView [degrees]	160	140	Both designs utilizeindustry accepted standardfor Field Of View.
Wide Field Of View[degrees]	210	Not included	The Presentation of thewide view option is aunique feature of thePeerScope System featureof the PeerScope System,which is not includedEVIS EXERA II 180System specifications.
Depth Of Field [mm]	3-100	2-100	Both designs utilizeindustry accepted standardfor Depth Of Field.
Working Length [mm]	1050	1030	Both designs utilizeindustry accepted standardfor Working Length
Distal tip OuterDiameter [mm]	10.5	9.8	Both designs utilizeindustry accepted standardfor Distal tip OuterDiameter
Illumination Type	Integral LEDillumination	Examination lamp	Both systems utilizeaccepted industry standardfor illumination

PeerScope System Model HG Submission Section 5 - 510(k) Summary

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Category	Subject Device:PeerScope GSGastroscope	Predicate Device:GastrointestinalVideoscope GIFType H180(K100584)	Impact of the differenceson device performance
Narrow bandillumination	Not Included	Included	The narrow bandillumination is a uniquefeature of The EVISEXERA II 180 System,which is not included inthe PeerScope Systemspecifications.
Water Flow rate - lensirrigation	1.25 cc/sec	0.9 cc/sec	Both systems utilizeaccepted industry standardfor lens irrigation
Angulation Range[degrees]	Up 210, Down 120Left 120, Right 120	Up 210, Down 90Left 100, Right 100	Both systems utilizeaccepted industry standardfor Angulation Range

Based on the results of verification and performance testing, the impact of the above differences is insignificant in terms of the device safety and effectiveness for the device intended use.

Performance data

Bench data:

Risk analysis was conducted in accordance with ISO 14971. Design verification tests and their acceptance criteria were identified, preformed and met.

Software validation was carried out in accordance with FDA Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 2005)".

Reprocessing validation was carried out in accordance with FDA Guidance Document "Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Draft Guidance (May 2011)".

Device safety and performance were verified by EndoChoice Innovation Center Ltd. and accredited third party laboratories.

The following standards were used / relied upon for testing:

AAMI / ANSI ES 60601-1:2005/(R) 2012 and C1:2009/(R) 2012 AAMI / ANSI ES60601-1:2005/A1:2012 IEC 60601-1-2:2007 IEC 60601-2-18 Edition 3.0 2009-08 IEC 62304:2006 ISO 10993:2009 Part #1 ISO 10993:2009 Part #5 ISO 10993:2010 Part #10 ISO 10993:2007 Part #12 ISO 8600-1 Second edition 2005-05-01

PeerScope System Model HG Submission Page 3 of 4 Section 5 - 510(k) Summary

Rev 02

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ISO 8600-3 First edition 1997-07-01 ISO 8600-4 First edition 1997-07-01 ISO 8600-6 First edition 2005-03-15 ASTM E 1837- 96 (reapproved 2007)

Usubility Data:

Device Usability was carried out by means of testing within a clinical environment in a US medical center by five experienced GI physicians.

The conclusions drawn from the bench and usability tests demonstrate that the device meets its specifications, and supports a determination that the device is at least as safe and effective for its intended use as the predicate device.

Substantial Equivalence

The above presented data demonstrate that:

The PeerScope System Model HG and the predicate device, EVIS EXERA II 180 હો. System have the same intended use and indications for use in upper digestive tract.
The PeerScope System Model HG uses the same technologies used by the predicate b. PeerScope System Model H.
The PeerScope System Model HG does not raise different questions of safety and C. effectiveness.
The data provided collected by scientific acceptable methods, thus demonstrating d. equivalence and support the indications.

Conclusion: It is the opinion of EndoChoice Innovation Center Ltd. that the PeerScope system Model HG is substantially equivalent to the predicate devices, in terms of safety and effectiveness.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-Giff Silver Spring, MI) 20993-0002

October 10, 2013

EndoChoice, Inc. % Tamar Fuerst RA Manager EndoChoice Innovation Center Ltd. 2 Hatochen Street, Business and Industrial Park (North), POB 3161 Caesarea Israel 38900

Re: K131422

Trade/Device Name: PeerScope System (Model HG) Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: 11 Product Code: FDS Dated: August 29, 2013 Received: September 9. 2013

Dear Tamar Fuerst.

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 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Glenn BiBell -S

Acting 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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Indications for Use

510(k) Number (if known): K l 31422

Device Name: PeerScope System (Model HG)

Indications for Use:

The PeerScope System consists of camera heads, endoscopes, video system, light source and other ancillary equipment.

Prescription Use _ X (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)

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PeerScope System Model HG Submission Section 4_Indication for Use Statement

Confidential Page I of I

Rev 01

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.