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 At the cecum, the balloon is inflated to engage the colon walls, and the colonoscope is then withdrawn by the endoscopist using standard withdrawal technique.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 (FDA 510(k) summary for the G-EYE® System) does not contain detailed information about acceptance criteria and a study proving the device meets these criteria in the format requested. Specifically, it lacks:

A table of acceptance criteria and reported device performance.
Sample sizes used for a test set specifically for evaluating the AI component (as the device described is not an AI/software as a medical device in the typical sense but rather a physical colonoscope system with a balloon).
Data provenance for a test set.
Details on expert involvement, ground truth establishment, or adjudication methods for a test set.
Information on MRMC studies or effect sizes of human reader improvement with AI assistance.
Standalone algorithm performance.
Type of ground truth used.
Sample size for a training set or how its ground truth was established.

The document discusses performance data in the context of demonstrating substantial equivalence to a predicate device, focusing on verification bench testing, reprocessing validation, biocompatibility, software verification/validation, and electrical safety/EMC. It also mentions three clinical studies conducted outside the United States that further support safety and performance, but these are noted as "not required to demonstrate substantial equivalence" and are presented at a high level.

Therefore, many of the requested points cannot be answered from the provided text because the device is a hardware system, not an AI software, and the document focuses on regulatory clearance via substantial equivalence rather than a detailed AI performance study.

However, I can extract the information that is present regarding performance and its acceptance:

Acceptance Criteria and Device Performance (as inferred from the text)

The document doesn't explicitly list quantitative "acceptance criteria" for a study in a table, but it states that various tests "met its acceptance criteria, supporting substantial equivalence to the predicate."

Here's a summary of the performance "studies" and what they aimed to achieve in terms of acceptance:

Category of Performance Test	Acceptance Criteria (Implied)	Reported Device Performance
Reprocessing Validation	Consistent with FDA guidance, proving safe and effective reprocessing.	Performed; results met acceptance criteria, demonstrating reprocessing validity.
Biocompatibility	In accordance with ISO 10993-1, assuring patient safety from materials.	Established; results met acceptance criteria, confirming material safety.
Software Verification & Validation	Software performs as intended.	Performed; demonstrated software performs as intended and met acceptance criteria.
Electrical Safety & Electromagnetic Compatibility (EMC)	Passing in accordance with IEC 60601-1 and IEC 60601-1-2.	Conducted; results were passing and met acceptance criteria.
Verification Bench Testing (SPARKC & G-EYE® Colonoscope)	Operational and functional performance as designed. (Specific metrics not detailed).	Included operational and functional testing; results met acceptance criteria.
Clinical Studies (Outside US)	Device functions as intended; no serious device-related adverse events; facilitates visualization of colonic mucosa.	Three studies, over 1000 subjects; demonstrated device functioned as intended with no serious device-related adverse events, and facilitated visualization.

Other Requested Information:

Since this is a filing for a physical medical device (colonoscope system) and not an AI/software device, much of the requested information (especially points 2-5, 8-9) is not applicable or not provided in the context of an AI performance study.

Sample size used for the test set and the data provenance: Not applicable in the context of an "AI test set." For the clinical studies (which were supplementary and not primary for 510(k) clearance): "over 1000 subjects" combined across three studies. Data provenance is "outside the United States." It's not specified if they were retrospective or prospective, but clinical studies are typically prospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as this is not an AI/diagnostic imaging device requiring expert ground truth in this manner for its 510(k). The clinical studies involved medical professionals using the device.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for this type of device and regulatory submission.
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 applicable. This device is not an AI assistance tool for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the clinical studies, the "ground truth" was essentially the observed performance of the device in facilitating procedures, absence of adverse events, and aiding visualization. These are clinical outcomes rather than a "ground truth" for an AI diagnostic task.
The sample size for the training set: Not applicable. This is not an AI device trained on data.
How the ground truth for the training set was established: Not applicable.

Summary

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April 15, 2020

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

Re: K192588

Trade/Device Name: G-EYE System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FDF Dated: March 17, 2020 Received: March 17, 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)

K192588

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 Requlatory & 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: March 16, 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

Pentax EC Video Colonoscopes (K181084) (predicate)

EndoRings (K133359) (reference device)

NaviAid™ BGC Device (K111760) (reference device)

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 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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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 colon walls, and 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

Technological Characteristics

The G-EYE® System is very similar to the previously cleared Pentax EC Video Colonoscopes series (K180285). Both the subject device and predicate device have the same intended use and substantially similar materials and principles of operation.

The subject device and predicate device are both multi-use and intended to be reprocessed. Similar to the predicate colonoscope, the G-EYE® Colonoscope is reprocessed in accordance with the reprocessing instructions of the original endoscope manufacturer with supplemental instructions for reprocessing of the G-EYE® balloon. 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 Pentax EC Video Colonoscopes 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 and its predicate is the installation of the G-EYE® balloon at the bending section of the G-EYE® Colonoscope. As all standard colonoscopes underlying the G-EYE® Colonoscopes (namely remanufactured by balloon installation, to become G-EYE® Colonoscopes) are identical to existing, 510(k) cleared colonoscopes, except for the G-EYE® balloon at the bending section, the minor differences among the various models of G-EYE® Colonoscopes included in the G-EYE® System do not raise new or different questions of safety or effectiveness compared to the cleared predicate device.

The G-EYE® balloon, the EndoRings reference device and the BGC reference device are designed to increase/decrease in diameter to help control the endoscopes view field and/or endoscope positioning, Specifically, the method of engaging the colon tissue to manipulate the colonic folds and conform to the lumen size is similar between the G-EYE® balloon and the EndoRings reference device. The EndoRings reference device achieves this sizing through three layers of "wings" that fold back (contract radially) upon insertion, and come forward (expand radially) upon withdrawal. The G-EYE® balloon and the EndoRings device share similar properties in this respect. The G-EYE® balloon is deflated (contracted radially) during insertion of the colonoscope into the colon, and subsequently inflated (expands radially) upon withdrawal. By manipulating the colonic folds, maintaining central position in the lumen, and avoiding sudden slippage, the "wings" of the EndoRings and the G-EYE® balloon both allow the user to maintain the endoscope's field of view during endoscopic procedure and therapy. Both devices help stabilize and view the mucosa without interfering with the endoscope's field of view, as both the wings and balloon are designed to engage the colon rearwardly of the distal tip of the endoscope and to not interfere with the endoscopic image.

The principle of operation of the G-EYE® System is substantially similar to that of its predicate device. The G-EYE® Colonoscope functions equivalent to its predicate colonoscope, with the exception of the added function of the G-EYE® balloon. Specifically, the functionality and operation of the standard colonoscope underlying the G-EYE® Colonoscope, do not change following its remanufacturing by installing the G-EYE® balloon.

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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.
2 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.
Σ Electrical safety and electromagnetic compatibility testing was conducted and results were passing in accordance with IEC 60601-1 and IEC 60601-1-2.
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.

Although not required to demonstrate substantial equivalence, clinical data is available from three clinical studies outside the United States that further support the safety and performance of the device for its intended In total, the studies included over 1000 subjects. All three studies demonstrated that the device use. 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 colonic folds 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 similar indications, technological characteristics and principles of operation. 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 and reference devices. 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 Pentax EC Video Colonoscopes (K181084).

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.