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 installation of 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, systemcontrolled 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 At the cecum, the balloon is inflated to engage the colon walls, and the colonoscope is then withdrawn by the endoscopist using standard withdrawal technique.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 describes a 510(k) premarket notification for the G-EYE® System, aiming to demonstrate its substantial equivalence to a previously cleared predicate device. The submission focuses on expanding the range of compatible endoscope models and affirms that this change does not raise new questions of safety or effectiveness.

While the document details various nonclinical tests conducted to support substantial equivalence (reprocessing validation, biocompatibility, software verification/validation, electrical safety, and verification bench testing), it does not provide a table of specific acceptance criteria or reported device performance for these tests in a quantifiable manner. It merely states that "Each of these tests met its acceptance criteria, supporting substantial equivalence to the predicate."

Furthermore, the document mentions the availability of clinical data from five studies involving approximately 4500 subjects, stating that these studies "demonstrated that the device functioned as intended, with no serious device-related adverse events" and "facilitates visualization of the colonic mucosa surface area." However, it does not present the specific acceptance criteria or the study results for these clinical studies in a way that directly addresses quantitative performance metrics or comparative effectiveness.

Given the information provided in the input, it is not possible to fully address all parts of your request. The response below will focus on what can be extracted from the text.

Acceptance Criteria and Device Performance Study for the G-EYE® System

The provided 510(k) summary focuses on demonstrating substantial equivalence of the G-EYE® System to its predicate (K202469), primarily for expanding the range of compatible endoscope models. The study details included are largely general statements confirming that various tests met their acceptance criteria, rather than specific quantitative performance figures.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, a detailed table with quantifiable acceptance criteria and reported device performance cannot be generated. The document states that various tests "met its acceptance criteria" but does not specify these criteria or the test results numerically.

Acceptance Criteria Category	Acceptance Criteria (as stated or inferred)	Reported Device Performance (as stated or inferred)
Reprocessing Validation	Consistent with FDA guidance.	"Met its acceptance criteria." (Specific data not provided)
Biocompatibility	Established in accordance with ISO 10993-1.	"Met its acceptance criteria." (Specific data not provided)
Software Verification & Validation	Software performs as intended.	"Demonstrated that the software performs as intended." (Specific data not provided)
Electrical Safety & EMC	Passing in accordance with IEC 60601-1 and IEC 60601-1-2.	"Results were passing." (Specific data not provided)
Verification Bench Testing (SPARKC & G-EYE® Colonoscope)	Operational and functional testing requirements met.	"Met its acceptance criteria." (Specific data not provided)
Clinical Performance (General)	Functions as intended, no serious device-related adverse events, facilitates visualization of colonic mucosa.	"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 colonic flexures provided by the G-EYE® System facilitates visualization of the colonic mucosa surface area." (No quantitative metrics provided)

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

Nonclinical Test Sets: The sample sizes for the specific nonclinical tests (reprocessing, biocompatibility, software, electrical safety, bench testing) are not specified in the document.
Clinical Data: "In total, the studies included approximately 4500 subjects."
Data Provenance: The document does not specify the country of origin for the clinical data or whether it was retrospective or prospective.

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

This information is not provided in the document. The document refers to "clinical studies" but does not detail how ground truth was established within those studies, nor does it mention the number or qualifications of experts involved in establishing ground truth for any test set (clinical or nonclinical).

4. Adjudication Method for the Test Set

The document does not provide details on any adjudication methods used for the test sets.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

The document does not explicitly state that an MRMC comparative effectiveness study was done regarding human readers improving with AI vs. without AI assistance. The focus is on the device's mechanical function (balloon) rather than an AI component assisting human readers. The text mentions "clinical studies" but does not describe them in the context of MRMC studies or effect sizes for human reader improvement.

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

The G-EYE® System, as described, is a mechanical device that enhances visualization during colonoscopy. It incorporates a balloon and inflation system. There is no mention of an AI algorithm or standalone algorithm performance in the provided text.

7. The Type of Ground Truth Used

For the nonclinical tests (reprocessing, biocompatibility, software, electrical safety, bench testing), the "ground truth" seems to be defined by adherence to established standards and company-defined acceptance criteria.
For the clinical data, the "ground truth" for reported outcomes appears to be clinical observation ("device functioned as intended," "no serious device-related adverse events," "facilitates visualization of the colonic mucosa surface area"). There is no explicit mention of pathology, expert consensus, or specific outcomes data as "ground truth" for quantitative performance metrics.

8. The Sample Size for the Training Set

The document describes a 510(k) submission for a medical device (colonoscope system) that has been previously cleared, and the current submission expands compatibility. It does not mention a "training set" in the context of machine learning or AI models. Therefore, a sample size for a training set is not applicable or provided.

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

As a "training set" for an AI/ML model is not mentioned, this question is not applicable based on the provided text.

Summary

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April 11, 2022

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

Re: K220158

Trade/Device Name: G-EYE System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FDF Dated: January 19, 2022 Received: January 19, 2022

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

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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 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 (QS) 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,

for 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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510(k) Number (if known)

K220158

Device Name

G-EYE® System Indications for Use (Describe)

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

ال Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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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: January 19, 2021

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 (Predicate Device K202469)

G-EYE® System (Reference Device 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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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, systemcontrolled 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

Technological Characteristics

The G-EYE® System is nearly identical to the previously cleared version of the device ("Predicate Device") (K202469). Both the subject device and Predicate Device have the same 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 models. 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 noted above. 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 conducted nonclinical 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 quidance in Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling.

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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.

Although not required to demonstrate substantial equivalence, clinical data is available from five clinical studies that further support the safety and performance of the device for its intended use. In total, the studies included approximately 4500 subjects. All five 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 colonic 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, same indications, same principles of operation, and similar technological characteristics. The minor technological differences do not present 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 (K202469).

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.