The G-EYE® colonoscope is intended to be used with a compatible video processor (including light source), documentation equipment, monitor, endotherapy device such as a biopsy forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the lower gastrointestinal tract including the anus, rectum, sigmoid colon, colon and ileocecal valve. It incorporates a balloon at the colonoscope to maintain central positioning within the lumen and help control the endoscope's view field and/or endoscope positioning.

Device Description

The G-EYE® System comprises the G-EYE® Colonoscope and the NaviAid™ SPARKC ("SPARKC") inflation pump. The G-EYE® Colonoscope includes a reprocessable, reusable balloon (the G-EYE® balloon) that is attached to a standard, commercially available colonoscope which is remanufactured by Smart Medical to include the balloon at its bending section. The balloon onto the standard colonoscope is considered remanufacturing of the standard colonoscope by Smart Medical, which assumes responsibility for the final device including the G-EYE® balloon and the remanufactured colonoscope. The G-EYE® balloon is inflated by the dedicated SPARKC inflation system, which enables automatic control of the required balloon pressure in one of several user-selected, system-controlled pressure levels such that the balloon conforms to the colonic lumen diameter. The G-EYE® Colonoscope is advanced by the endoscopist with the balloon deflated, which essentially preserves the standard colonoscope's diameter and insertion technique. At the cecum, the balloon is inflated to engage the colonoscope is then withdrawn by the endoscopist using standard withdrawal technique. Withdrawal of the inflated balloon mechanically straightens the colonic folds and anatomic flexures, centers the colonoscope optics within the colonic lumen, and minimizes uncontrolled bowel slippage during withdrawal, therefore maintaining the endoscope's field of view

AI/ML Overview

The provided text is a 510(k) summary for the G-EYE® System, specifically K202469, which is primarily a submission to expand the range of compatible colonoscope manufacturers. The document repeatedly states that the new device (K202469) is "nearly identical" or "substantially similar" to its predicate device (K192588), and that the differences "do not raise different questions of safety or effectiveness."

Therefore, the document does not describe a new study designed to prove the device meets new acceptance criteria for an AI/ML-based device. Instead, it refers to prior performance testing and clinical studies on the predicate device (K192588) to support the substantial equivalence of the new G-EYE® System (K202469). The "Performance Data" section lists several types of tests, but these are primarily engineering and reprocessing validations, not performance against clinical endpoints that would typically require expert ground truth or MRMC studies.

Based on the provided text, it is not possible to answer the detailed questions regarding acceptance criteria, study design for AI/ML performance, ground truth establishment, or sample sizes for AI/ML model training/testing, as the document focuses on the mechanical and reprocessing aspects of a colonoscopy assist device, and its substantial equivalence to a prior cleared version.

Here's a breakdown of what can be extracted and what cannot:

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

The document states that "Each of these tests met its acceptance criteria, supporting substantial equivalence to the predicate." However, the specific acceptance criteria (e.g., numerical targets for performance metrics) are not detailed within this 510(k) summary. The performance reported is qualitative: the tests "met its acceptance criteria" and "demonstrated that the software performs as intended."
The clinical performance is described as "the device functioned as intended, with no serious device-related adverse events. In addition, the studies demonstrated that the device served its intended function, and that the mechanical straightening of the and anatomic flexures provided by the G-EYE® System facilitates visualization of the colonic mucosa surface area." No specific metrics like sensitivity, specificity, or ADR improvement are provided.

2. Sample sizes used for the test set and the data provenance:

The document states: "clinical data is available from four clinical studies that further support the safety and performance of the device for its intended use. In total, the studies included approximately 4000 subjects."
Sample size for test set: The "4000 subjects" refers to participants in prior clinical studies that support the predicate device, not a specific test set for an AI/ML model. It's unclear how many of these were used as a "test set" in the AI/ML sense, or if a separate, dedicated "test set" was used for the current submission's minor changes.
Data provenance: Not specified (e.g., country of origin, retrospective/prospective). These studies were likely conducted for the predicate device's clearance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not specified. The clinical studies mentioned focused on the device's mechanical function and safety, not on AI/ML performance requiring expert ground truth in the context of diagnostic accuracy.

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

Not applicable/Not specified, as this is not an AI/ML diagnostic device being evaluated for standalone or assisted performance against expert ground truth.

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:

Not mentioned. This device assists withdrawal by straightening folds, not primarily by providing AI-assisted detection or diagnosis. Therefore, an MRMC study comparing human readers with and without AI assistance is not described or relevant for this specific device's function as presented. The product description emphasizes mechanical straightening and improved visualization, not AI-driven lesion detection.

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

Not applicable. This device is a mechanical aid to colonoscopy, not a standalone diagnostic algorithm.

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

For the clinical studies, "ground truth" would likely be based on standard colonoscopy findings (e.g., visual identification of polyps, histopathology of removed tissues) and patient outcomes. The text primarily focuses on the device's ability to "facilitate visualization" and its safety, rather than providing diagnostic outputs that require "ground truth" in the AI/ML sense.

8. The sample size for the training set:

Not specified. There is no indication that this device uses machine learning that requires a "training set" in the conventional sense. The "software verification and validation" mentioned likely pertains to the control software for the balloon inflation, not an AI/ML detection algorithm.

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

Not applicable, as no training set for an AI/ML model is indicated.

In summary, the provided 510(k) summary is for a mechanical colonoscopy assist device seeking clearance for expanded compatibility, not an AI/ML diagnostic or detection device requiring the specific types of performance studies listed in the prompt. The "Performance Data" section discusses engineering verification, validation (reprocessing, biocompatibility, software, electrical safety), and references prior clinical studies on the predicate device for overall safety and performance (i.e., its ability to mechanically aid visualization), rather than AI/ML specific metrics.

Summary

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October 26, 2020

SMART Medical Systems Ltd. % Janice Hogan Regulatory Counsel Hogan Lovells US LLP 1735 Market Street, Floor 23 Philadelphia, PA 19103

Re: K202469

Trade/Device Name: G-EYE System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FDF Dated: August 27, 2020 Received: August 27, 2020

Dear Janice Hogan:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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

510(k) Number (if known)

K202469

Device Name

G-EYE® System Indications for Use (Describe)

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

区 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 A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) SUMMARY

SMART Medical Systems Ltd.'s G-EYE® System

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Adva Yoselzon VP of Regulatory & Clinical Affairs Smart Medical Systems Ltd. 5 Hanofar, Raanana 4366404 Tel: +972-9-7444321 Fax: +972-9-7444543 Mobile: +972-52-8911112 Email: ayoselzon@smartmedsys.com

Date Prepared: August 27, 2020

Name of Device

G-EYE® System

Common or Usual Name

Endoscope and accessories, Gastroenterology-Urology

Classification

21 CFR 876.1500, Class II, product code FDF

Predicate Devices

G-EYE® System (K192588)

Intended Use / Indications for Use

The G-EYE® Colonoscope is intended to be used with a compatible video processor (including light source), documentation equipment, monitor, endotherapy device such as a biopsy forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the lower gastrointestinal tract including the anus, rectum, sigmoid colon, colon and ileocecal valve. It incorporates a balloon at the distal end of the colonoscope to maintain central positioning within the lumen and help control the endoscope's view field and/or endoscope's positioning.

Device Description

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endoscopist using standard withdrawal technique. Withdrawal of the inflated balloon mechanically straightens the colonic folds and anatomic flexures, centers the colonoscope optics within the colonic lumen, and minimizes uncontrolled bowel slippage during withdrawal, therefore maintaining the endoscope's field of view

Technological Characteristics

The G-EYE® System is nearly identical to the previously cleared version of the device ("Predicate Device") (K192588). Both the subject device and Predicate Device have indications for use and principles of operation and substantially similar technological characteristics and materials.

The subject device and Predicate Device are both multi-use and intended to be reprocessed. Similar to the predicate, the G-EYE® Colonoscope is reprocessed in accordance with the reprocessing instructions of the original endoscope manufacturer with supplemental instructions related to the G-EYE® balloon. The current submission solely expands the range of endoscope manufacturers. This difference does not raise different questions of safety and effectiveness, as confirmed by the company's reprocessing validation testing.

The materials of the G-EYE® Colonoscope are substantially similar to those of the Predicate Device, and any differences in the materials of the G-EYE® Colonoscope and the predicate device do not raise different questions of safety or effectiveness. This was confirmed through the company's biocompatibility testing and performance testing.

Both the G-EYE® System and the Predicate Device feature a standard colonoscope. All compatible colonoscopes are 510(k) cleared and have an insertion tube diameter of 11.0mm - 13.2mm. The primary difference between the G-EYE® Colonoscope of the G-EYE® System and the G-EYE® colonoscope of the Predicate Device is the underlying standard colonoscope model, as all standard colonoscopes underlying the G-EYE® Colonoscopes are 510(k) cleared colonoscopes, the minor differences among the standard colonoscopes included in the G-EYE® System and in the Predicate Device do not raise new questions of safety and effectiveness, and the difference does not adversely impact performance, as confirmed by the company's performance testing.

Performance Data

In support of this 510(k) premarket notification, Smart Medical conclinical testing to evaluate the performance of the G-EYE® System for its intended use. The performance testing conducted includes the following:

Reprocessing validation testing consistent with FDA's guidance in Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling.
Biocompatibility of patient-contacting components has been established in accordance with ISO 10993-1.
. Software verification and validation was performed, and demonstrated that the software performs as intended.
Electrical safety and electromagnetic compatibility testing was conducted and results were passing in accordance with IEC 60601-1 and IEC 60601-1-2.
. Verification bench testing of the SPARKC and G-EYE® Colonoscope which included operational and functional testing.

Each of these tests met its acceptance criteria, supporting substantial equivalence to the predicate.

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Although not required to demonstrate substantial equivalence, clinical data is available from four clinical studies that further support the safety and performance of the device for its intended use. In total, the studies included approximately 4000 subjects. All four studies demonstrated that the device functioned as intended, with no serious device-related adverse events. In addition, the studies demonstrated that the device served its intended function, and that the mechanical straightening of the and anatomic flexures provided by the G-EYE® System facilitates visualization of the colonic mucosa surface area.

Substantial Equivalence

The G-EYE® System and its Predicate Device have the same intended use and indications, technological characteristics and principles of operation. The minor technological different questions of safety or effectiveness than the Predicate Device, and accepted scientific methods exist to evaluate the performance of the G-EYE® System compared to its Predicate Device. Performance data has demonstrated that the G-EYE® System is as safe and effective as its predicate. Thus, the G-EYE® System is substantially equivalent to the previously cleared G-EYE® System (K192588).

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.