The GCE Focus Cap has the shape of a short transparent tube which is attached to the distal end of the colonoscope. The Focus Cap is designed to facilitate the scope's view during colonoscopy procedures.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Focus Cap" device. This document does not describe a study that uses acceptance criteria for algorithm performance in the way typically seen for AI/ML devices. Instead, it focuses on demonstrating substantial equivalence to a predicate device through performance testing related to mechanical and biocompatibility aspects of the physical device.

Therefore, many of the requested categories are not applicable to the information contained in this document.

Here's a breakdown based on the provided text:

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

Acceptance Criteria	Reported Device Performance
Mechanical Testing: All test requirements as specified by test protocols and pre-determined acceptance criteria.	All test requirements were met.
Biocompatibility Testing: All test requirements as specified by test protocols and pre-determined acceptance criteria.	All test requirements were met.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document refers to "test protocols," but does not detail the sample sizes or provenance for the mechanical and biocompatibility testing.

3. 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)

Not applicable. This document is for a physical medical device (a cap for a colonoscope), not an AI/ML device that requires expert-established ground truth for its performance in a clinical task.

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

Not applicable. This document is for a physical medical device and does not involve adjudication of interpretations.

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 applicable. This document is for a physical medical device and does not involve AI assistance or human reader performance.

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

Not applicable. This is a physical device, not an algorithm.

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

For mechanical and biocompatibility testing, the "ground truth" would be established by standardized testing methods and material specifications, not expert clinical consensus or pathology. The document states "All test requirements were met as specified by test protocols and pre-determined acceptance criteria."

8. The sample size for the training set

Not applicable. This document is for a physical device, not an AI/ML model with a training set.

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

Not applicable. This document is for a physical device, not an AI/ML model with a training set.

Summary

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January 19, 2018

GCE Medical Corporation % Stephen M. Page President MedReg Associates Inc. 228 Hull Cove Farm Road Jamestown, Rhode Island 02835

Re: K171673 Trade/Device Name: Focus Cap Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FDF Dated: January 10, 2018 Received: January 16, 2018

Dear Stephen M. Page:

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 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.

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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

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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)

K171673

Device Name Focus Cap

Indications for Use (Describe)

The Focus Cap has been designed to be attached to the distal end of a colonoscope. The Focus Cap is intended for the following:

For use in keeping the suitable depth of the colonoscope's field of view.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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K171653

510(k) Summary

Submitter Information

A. Company Name: GCE Medical Corporation
B. Company Address: 2723 West Tenaya, Fresno CA 93711
Company Phone: 559-439-5757 C.
Contact Person: Dr. Stanley Chang D.
E. Summary Prepared on: January 10, 2018

Device Identification

Device Trade Name: Focus Cap A.
B. Device Common Name: Transparent Cap
Classification Name: Endoscope and accessories C.
Classification Number: 21 CFR Part 876.1500 D.
Product Code: FDF D.
E. Device Class: II

Identification of Predicate Device

Trade Name	Manufacturer	510(k)
Distal Distal Attachment	Olympus	K984358

Indications for Use

The GCE Medical Focus Cap has been designed to be attached to the distal end of a colonoscope. The Focus Cap is intended for the following:

For use in keeping the suitable depth of the colonoscope's field of view.

Device Description

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The Focus Cap will be offered in two sizes:

11mm (Catalog #11 FC 1701)
13.5mm (Catalog #13 FC 1702)

The 11mm Focus Cap will fit 11.6mm and 12.8mm scopes. The 13.5mm Focus Cap will fit 13.2mm and 13.9mm scopes.

Comparison to Predicate Device:

Characteristic	Comparison to PredicateOlympus DistalAttachment (K984358)	Differences
Intended Use	Identical	N/A
Indications for Use	Identical	N/A
Fundamentalscientifictechnology	Identical	N/A
Operatingprinciples	Similar	The operating principle for bothdevices is that they attach to a scopeby compression. Although there areslight differences in their relativeadhesion strengths, those differencesare minimal and have no impact onsafety or effectivenss.
Mechanism ofaction	Similar	Both the predicate and proposeddevices act as simple spacers. Theyestablish a space between the end ofthe scope and patient's anatomy,thereby preventing the camera imagefrom being blocked. Although the twodevices have slightly differentdimensional characteristics, thosedifferences are minimal and have noimpact on safety or effectiveness.
Technologicalaspects	Similar	The Olympus Distal Attachmentincorporates a side hole which is notpresent on the Focus Cap. In addition,the Focus Cap incorporates a slantdesign while the Olympus design isflat The slant design of the Focus

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Cap, which essentially takes the place
of the side hole, allows for a wide
open surface for the exit of fluid which
is many times larger than the side hole
on the predicate device. Therefore.
these differences have no impact on
safety or effectiveness.

Performance Testing

Performance testing has been completed for the GCE Focus Cap to demonstrate substantial equivalence to the predicate Olympus Distal Attachment (K984358). The Focus Cap has been subjected to the following verification and validation testing: Mechanical and biocompatibility. All test requirements were met as specified by test protocols and pre-determined acceptance criteria.

Conclusions

The subject Focus Cap and predicate Olympus Distal Attachment (K984358) share the same intended use and indications for use. Furthermore, the subject and predicate devices share the same fundamental technology and key device characteristics. Differences in design and technological characteristics between the subject and predicate devices do not raise any new questions of safety and effectiveness. The results of verification and validation support the safety and effectiveness of the Focus Cap for its intended use and provide reasonable assurance of the substantial equivalence of the subject device to the predicate Olympus Distal Attachment (K984358).

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.