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 lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve) for adult patients.

Device Description

The PeerScope system consists of endoscopic Main Control Unit (MCU), and of the PeerScope CS colonoscope. The MCU controls the endoscope. As other endoscopic legally marketed systems, it includes video system, light source, and interface to other ancillary equipment. The device labeled for use in healthcare facility/hospital for endoscopy and endoscopic treatment within the lower digestive tract. The operation principles of the PeerScope System are similar to those of other legally marketed standard colonoscopy systems. The PeerScope system model provides 160° standard front field of view and a 300° wide field of view.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the PeerScope System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Although explicit "acceptance criteria" and "reported device performance" in a quantitative table are not provided in this 510(k) summary, the document states that the device "passed the experiment criteria" and "met its intended use and specifications" in both bench and clinical validations. The criteria are implicit in meeting the device's intended use and specifications, with a focus on safety and effectiveness comparable to the predicate device.

Acceptance Criteria (Implicit)	Reported Device Performance
Device meets its intended use and specifications for diagnostic visualization and therapeutic interventions within the lower digestive tract for adult patients.	Clinical Data: "The results of the clinical validation passed the experiment criteria. No adverse events were observed." "The conclusions drawn from the bench and clinical tests demonstrate that the device meets its specifications, intended use and indication for use." "The device met its intended use and specifications."
Device demonstrates safety and effectiveness without raising new questions compared to the predicate device.	"Based on the results of verification, validation and performance testing, the impact of the above differences [from predicate] is insignificant in terms of the device safety and effectiveness for its intended use." "No adverse events were observed." "The PeerScope System does not raise different questions of safety and effectiveness."
Device's wide 300° field of view feature is efficient and effective.	Bench Data (Simulated Clinical Conditions): "The results of the bench validation passed the experiment criteria. The device met its intended use and specifications. Hazardous conditions were not observed." (This specifically mentions the wide 300° field of view evaluation).
Reprocessing validation in accordance with relevant draft guidance.	"Reprocessing validation was carried out in accordance with 'Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Draft Guidance / May 2011'."
Jet irrigation for auxiliary jet water supply is efficient despite reduced flow rate compared to predicate.	"The design of the reduced jet water flow has been verified & validated. The results demonstrated that the jet irrigation is efficient."
Compliance with relevant medical device safety, performance, and biocompatibility standards.	"The device safety and performance were verified by tests by PeerMedical and accredited third party laboratories. List of standards was used / relied upon for testing: [lists various IEC, ISO, ASTM standards]."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set:
- Clinical Data: Fifty (50) patients.
- Bench Data (Simulated Clinical Conditions): Not explicitly stated, but implies multiple trials or evaluations of "a final production unit."
Data Provenance:
- Clinical Data: Prospective, conducted at Elisha Medical Center, Haifa, Israel.
- Bench Data (Simulated Clinical Conditions): Prospective, performed by physicians at three US medical centers.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Clinical Data: The procedure was performed by "US, European and Israeli physicians." The exact number of physicians (experts) is not specified. Their qualifications are implied as being practicing physicians performing endoscopic procedures, but specific experience levels (e.g., "radiologist with 10 years of experience") are not provided.
Bench Data (Simulated Clinical Conditions): "The procedure was performed by physicians at three US medical centers." The exact number of physicians is not specified, nor are their specific qualifications beyond being "physicians."

4. Adjudication Method for the Test Set

The document does not specify an adjudication method (e.g., 2+1, 3+1, none) for the test set. It simply states that physicians performed the procedures and the results "passed the experiment criteria."

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or performed. This device is a colonoscope, not an AI-assisted diagnostic tool designed to improve human reader performance. The focus is on the safety and effectiveness of the endoscope itself.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable. The PeerScope System is an endoscope controlled by a human operator, not an AI algorithm. Therefore, no standalone algorithm performance was assessed.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth for the clinical data is implicitly based on the expert judgment/observations of the performing physicians during the endoscopic procedures, combined with the successful completion of the procedures without adverse events and meeting intended use. There is no mention of independent pathology or specific outcomes data beyond the successful completion of the procedure itself.

8. The Sample Size for the Training Set

The document describes validation and verification testing of a "final production unit" and clinical data from "50 patients." It does not mention any "training set" in the context of machine learning or AI. This is a conventional medical device submission, not an AI/ML device.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable as there is no mention of a training set for machine learning.

Summary

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SEP
2 8 2012

510(k) Summary of Safety and Effectiveness (in accordance to 21 CFR 807.92)

Submitter Details

PeerMedical Ltd. 2 Hatochen St., PO 3161 Business and Industrial Park (North), Caesarea, 38900, Israel Tel: +972 4 6327731, Fax: +972 4 6327734 Date summary prepared: June 2012 Submission Contact: Dan Laor, 6 Sireni St., Haifa, 32972, Israel.

Device Details

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

PeerScope System Colonoscope and accessories, flexible / rigid Endoscope accessories, 21 CFR 876.1500 FDF KOG Gastroenterology/Urology II

Reason for 510(k) Submission: New Device

Identification of Legally Marketed Predicate Devices

ProtectiScope CS -K081004 - Manufactured by Stryker GI

Device Description

Intended use and indications for Use

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Technological characteristics

The technological characteristics of PeerScope system were compared to the characteristics of the predicate device and were found very similar, in terms of: endoscope geometry, illumination type, energy source, lens irrigation, air flow and air pressure. Several differences were observed and are listed below:

K1202

Category	ProtectiScopeCS K081004	PeerScope System	Impact of the differences ondevice performance
Brightness Control	Automatic orManual	Factory Adjusted	Factory Adjusted method providesreliable design withoutcompromising performance.
Output Videosignals	VBS 2 channelsY/C 2 channelsDVI 2 channels	Composite 3channelsY/C 3 channels	Both devices utilized industryaccepted standard Output Videosignals.
Foot Switch	Included	Not Included	The foot switch is used to operatethe ProtectiScope CS uniquefeature which is not included in thePeerScope System specifications.
Water Flow rate forAuxiliary Jet watersupply	20 cc/sec	4.0 cc/sec	The design of the reduced jet waterflow has been verified & validated.The results demonstrated that the jetirrigation is efficient.
Disposable Sleeve	Included	Not Included	The disposable sleeve is a uniquefeature which is not included inthe PeerScope Systemspecifications.

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

Performance data

Bench data:

The device safety and performance were verified by tests by PeerMedical and accredited third party laboratories. List of standards was used / relied upon for testing:

IEC 60601-1: 1988 + Am. #1 (1991), #2 (1995) IEC 60601-2-18:1996 /EN 60601-2-18:1996 2nd Ed. +Am.1 (2000) IEC 60601-1-2:2007 ISO 10993:2009 Part #1 ISO 10993:2009 Part #5 ISO 10993:2010 Part #10 ISO 10993:2007 Part #12 ISO 8600-4 First edition 1997-07-01 ISO 8600-1 Second edition 2005-05-01 ISO 8600-3 First edition 1997-07-01 Am 1 ISO 8600-6 First edition 2005-03-15 ASTM E 1837- 96 (reapproved 2007)

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K120289 page 3 of 3

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

The device performance was validated by testing of a final production unit in simulated clinical conditions focusing on evaluation of the device wide 300° field of view. The procedure was performed by physicians at three US medical centers. Methods and procedures were identical to those used in clinical conditions. The results of the bench validation passed the experiment criteria. The device met its intended use and specifications. Hazardous conditions were not observed.

Clinical Data:

The device performance was validated by testing of a final production unit in clinical conditions. The procedure was performed at Elisha Medical Center, Haifa, Israel on a diverse adult population in terms of gender, ethnicity and age. The procedure was performed by US, European and Israeli physicians. Methods and procedures were identical to those used in USbased studies. Fifty (50) patients were enrolled in conformance with the device labeling. The results of the clinical validation passed the experiment criteria. No adverse events were observed.

The conclusions drawn from the bench and clinical tests demonstrate that the device meets its specifications, intended use and indication for use.

Substantial Equivalence

The above presented data demonstrate that:

The predicate device ProtectiScope CS -K081004 is legally marketed. a.
The PeerScope System and the predicate device have the same intended use. b.
The PeerScope System does not raise different questions of safety and C. effectiveness.
The data provided demonstrate equivalence and support the indications. d.

Conclusion: It is the opinion of PeerMedical that the PeerScope system is substantially equivalent to the predicate device, in terms of safety and effectiveness.

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Image /page/3/Picture/0 description: The image is a circular seal or logo. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the circumference of the circle. In the center of the seal is a stylized image of an eagle or other bird with its wings spread, with the body and wings formed by thick, curved lines. The image is black and white.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

2 8 2012

PeerMedical Ltd.
% Mr. Dan Laor
Quality & Regulatory Advisory
6 Sireni
HAIFA 32972
ISRAEL

Re: K120289

Trade/Device Name: PeerScope System Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FDF Dated: August 14, 2012 Received: August 15, 2012

Dear Mr. Laor:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bootion 310(t) presidentially equivalent (for the indications ferenced above and nave colorizes ally marketed predicate devices marketed in interstate for the stated in the encrosule) to regars mannent date of the Medical Device American Cruze commerce prior to May 20, 1976, the excordance with the provisions of the Federal Food, Drug, devices that have been rochasinou in accessariou of a premarket approval application (PMA). alla Cosmetic Hot (110) market the device, subject to the general controls provisions of the Act. The I ou may, merciolo, market the device, books of the requirements for annual registration, listing of general controls provisions of the fisc labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract lability adulteration. Trease note. CDICT does inst bevice labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (500 above) and in the major regulations affecting your device can be It may be subject to additional consols. Entrally - 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 Please be advised that I DA 3 issuation of a brander complies with other requirements of the Act
that FDA has made a determination that your device complies . You must that FDA has made a decornmance and regulations administered by other Federal agencies. You must or ally Federal statutes and regulations , including, but not limited to: registration and listing comply with an the Act 3 requirements, moradaily, strenging (reporting (reporting of medical

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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set device-related adverse evones) (21 OFF 003), good many and 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and 1000 10 forth in the quality by brounds (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 11 you desire specific actives for your actives/CDRH/CDRHOffices/ucm115809.htm for go to mp.nww.ida.gov/rtbound2123.cal Health's (CDRH's) Office of Compliance. Also, please the comer for DOY.cos and "Misbranding by reference to premarket notification" (21CFR Part note the regulations 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 I ou may obtain other general incomment one 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,

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

K120289 510(k) Number (if known):

Device Name: PeerScope System

Indications For Use:

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

× 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)

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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.