The subject device is a sterile, single use, disposable medical device. It is designed to be placed on the distal end of an endoscope during endoscopic procedures to improve the physician's ability to visualize and examine the mucosa. AmplifEYE is made of injection molded polymer and consists of a main body tube with flexible wings arranged in a single row around one end of the main body tube. In a standard colonoscopy procedure, the endoscope is intubated through the rectum and advanced forward through the length of the colon. The endoscope is then retracted while the physician visually examines the colon mucosa for polyps or other abnormalities. The AmplifEYE wings fold down during intubation and movements that advance the endoscope forward so that forward movement is not hindered. During endoscope withdrawal, the wings open and fold outward to keep the depth of the endoscope's view field by manipulating the colonic folds and stabilizing the position of the endoscope within the intestinal lumen, thus aiding in the physician's ability to visualize and examine the mucosa.

AI/ML Overview

The Medivators AmplifEYE device, an endoscope accessory, does not present Acceptance Criteria in the provided text. Instead, the document focuses on demonstrating substantial equivalence to predicate devices (Arc EndoCuff and Arc Endocuff Vision) rather than defining specific performance thresholds as acceptance criteria for a new clinical indication or outcome.

The study presented is a non-clinical performance evaluation comparing the AmplifEYE with its predicate devices.

Here's an analysis based on the provided text, addressing your points where possible:

1. Table of Acceptance Criteria and Reported Device Performance:

As no explicit acceptance criteria are provided in the document for the AmplifEYE's primary function of "keeping the suitable depth of endoscope's view field" or "helping the endoscope with being inserted into the gastrointestinal tract," a table of acceptance criteria and reported device performance cannot be created as requested. The document primarily focuses on demonstrating equivalence through design and non-clinical testing.

The document highlights:

Parameter	Acceptance Criteria (Not explicitly stated, but implied by equivalence)	Reported Device Performance (AmplifEYE)
Intended Use	Equivalent to predicate devices (facilitate endoscopic therapy, maintain suitable depth of view, aid insertion).	Claimed equivalent by Medivators.
Principle of Operation	Equivalent to predicate devices.	Claimed equivalent by Medivators.
Scientific Technology	Equivalent to predicate devices.	Claimed equivalent by Medivators.
Sterilization Method	Demonstrate equivalent sterility assurance to predicate devices' irradiation method, even if different.	Ethylene Oxide sterilization validated to provide equivalent sterility assurance.
Open Wings Diameter	Equivalent performance, no questions of safety or efficacy despite slight size difference.	Slight greater open wings diameter than predicates, but bench testing and animal testing demonstrated equivalent performance and no safety/efficacy concerns.
Force to Remove	(Implied to be within acceptable limits for safe use and equivalent to predicates)	Tested as part of Design Verification. Specific values not reported.
Force to Deflect	(Implied to be within acceptable limits for safe use and equivalent to predicates)	Tested as part of Design Verification. Specific values not reported.
Shelf-life	(Implied to meet required duration and maintain functionality/sterility)	Validated (Functional Testing, Sterile Barrier Integrity Testing). Specific duration not reported.
Biocompatibility	Conformance to ISO 10993-1.	Polymer conforming to ISO 10993-1.

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

Sample Size for Test Set: Not explicitly stated for specific tests.
- Bench Testing: Indicated for "open wing diameter difference" and "Design Verification (Force to Remove Testing, Force to Deflect Testing)". The exact number of units or repetitions used for these tests is not provided.
- Animal Testing: Performed. The number and type of animals used are not specified.
Data Provenance: Not specified, but likely internal company testing (Medivators Inc.). The document does not indicate external or multi-center trial data. The data is non-clinical, related to device characteristics and animal studies, not human patient data.

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

Not Applicable. This study is a non-clinical evaluation for substantial equivalence, primarily focusing on engineering and material performance, and animal testing. It does not involve human subjects or the establishment of a medical 'ground truth' by experts in a diagnostic or clinical efficacy context.

4. Adjudication Method for the Test Set:

Not Applicable. As no 'ground truth' from human data or expert consensus is established for a diagnostic or efficacy claim, no adjudication method would be relevant or discussed in this context.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No. An MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI or other tools on human reader performance with medical images, which is not the scope of this device or its evaluation. The AmplifEYE is a physical accessory to an endoscope, not a diagnostic AI tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Yes, in spirit, as a non-clinical standalone device evaluation. The testing performed (Design Verification, Shelf-life, Sterilization Validation, Animal Testing) evaluates the device's inherent characteristics and performance without human interaction in a diagnostic or interpretive loop. However, it's important to note this is not an "algorithm-only" performance as the device is mechanical/physical, not software. The performance demonstrated in these tests is for the device itself.

7. The Type of Ground Truth Used:

Engineering specifications, industry standards, and biological response.
- For Design Verification (Force to Remove, Force to Deflect): Ground truth would be defined by engineering design requirements and acceptable ranges for mechanical properties.
- For Sterilization Validation: Ground truth involves demonstrating a Sterility Assurance Level (SAL), often 10^-6, through established microbiological testing methods.
- For Biocompatibility: Ground truth is adherence to standards like ISO 10993-1.
- For Animal Testing: Ground truth would be observed physiological responses, safety, and functionality in a living system.

8. The Sample Size for the Training Set:

Not Applicable. As described, this is not an AI/machine learning device; therefore, there is no "training set." The device is a physical medical accessory.

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

Not Applicable. See point 8.

Summary

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

July 14, 2016

Medivators, Inc. Kristin Bergeson Padilla Regulatory Affairs Associate 14605 28th Ave. North Minneapolis, MN 55447

K160846 Re: Trade/Device Name: AmplifEYE Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FED Dated: June 10, 2016 Received: June 13, 2016

Dear Kristin Bergeson Padilla:

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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements

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as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Joyce M. Whang -S

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) K160846

Device Name

AmpliEYE

Indications for Use (Describe)

To be attached to the distal end of the endoscope to facilitate endoscopic therapy, to be used for the following:

Keeping the suitable depth of endoscope's view field
Helping the endoscope with being inserted into the gastrointestinal tract

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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Image /page/3/Picture/0 description: The image shows the logo for Medivators, a Cantel Medical Company. The logo consists of a blue circular graphic on the left, followed by the word "MEDIVATORS" in blue capital letters. Below the company name is the text "A Cantel Medical Company" in a smaller blue font. The logo is simple and professional, with a focus on the company name.

Section 05 - 510(k) Summary

Manufacturer:	Medivators Inc., a Cantel Medical Company
Address:	3150 Pollok DriveConroe, TX 77303(800) 328-3345
Official Contact:	Kristin Bergeson PadillaRegulatory Affairs Associate, Medivators Inc.
Trade Name:	AmplifEYE
Common Name:	Endoscopic Access Overtube, Gastroenterology-Urology
Classification Name:	Endoscope and accessories
Product Code:	FED
Device Class:	II
Regulation No:	876.1500

Medivators Inc. has supplied the following information to the US Food and Drug Administration to support substantial equivalence of AmplifEYE to other endoscopic overtube visualization devices currently cleared for sale in the United States of America.

1. Intended Use

AmplifEYE is intended to be used to facilitate endoscopic therapy by keeping the suitable depth of the endoscope's view field and by helping the endoscope with being inserted into the gastrointestinal tract.

2. Device Description

3. Comparison to Other Devices in Commercial Distribution Within the United States

AmplifEYE is equivalent in function, intended use and scientific technology to its predicate devices, Arc EndoCuff cleared under 510(k) K122565 and Arc Endocuff Vision cleared under 510(k) K151801.

CONFIDENTIAL

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Image /page/4/Picture/0 description: The image contains the logo for Medivators, a Cantel Medical Company. The logo consists of a blue circular graphic with curved lines inside, followed by the word "MEDIVATORS" in a bold, sans-serif font, also in blue. Below the company name, there is a smaller line of text that reads "A Cantel Medical Company".

Similarities Between Subject and Predicate Devices

AmplifEYE and the predicate devices, Arc EndoCuff and Arc Endocuff Vision, have the same intended use, principle of operation and scientific technology. They are provided sterile and must be disposed of after a single use.

Differences Between Subject and Predicate Devices

The only notable differences between the subject device and the predicate devices are the method of sterilization and the open wings diameter. AmplifEYE is sterilized by ethylene oxide and the predicate devices, Arc EndoCuff and Arc Endocuff Vision, are sterilized by irradiation. The sterilization validation of AmplifEYE has demonstrated that the method of sterilization difference provides equivalent sterility assurance. AmplifEYE has an open wing diameter slightly greater than both of the predicate devices; however, bench testing and animal testing have demonstrated the open wing diameter difference results in equivalent performance and raises no questions of safety or efficacy.

A device comparison table which supports substantial equivalence of the subject device to the predicate device is provided below:

Device	Subject Device -	Predicate Device - Arc	Predicate Device – Arc
Parameters	AmplifEYE	EndoCuff (K122565)	Endocuff Vision (K151801)
Trade Name	AmplifEYE	Arc EndoCuff AEC 110;AEC 120; AEC 140	Arc Endocuff Vision
RegulationNumber	876.1500	876.1500	876.1500
Device Class	Class II	Class II	Class II
CertificationPanel	Gastroenterology/Urology	Gastroenterology/Urology	Gastroenterology/Urology
Product Code	FED	FED	FED
Indications for	To be attached to the distal	To be attached to the distal	To be attached to the distal
Use	end of the endoscope tofacilitate endoscopic therapy,to be used for the following:●Keeping the suitabledepth of endoscope'sview fieldHelping the endoscope●with being inserted intothe gastrointestinal tract	end of the endoscope tofacilitate endoscopic therapy,to be used for the following:Keeping the suitable●depth of endoscope'sview fieldHelping the endoscope●with being inserted intothe gastrointestinal tract	end of the endoscope tofacilitate endoscopic therapy,to be used for the following:Keeping the suitable●depth of endoscope'sview fieldHelping the endoscope●with being inserted intothe gastrointestinal tract
Single Use	Yes	Yes	Yes
Suppliedsterile	Yes	Yes	Yes
Method ofSterilization	Ethylene Oxide	Irradiation	Irradiation

Table 1 - Device Comparison Table

CONFIDENTIAL

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Image /page/5/Picture/0 description: The image shows the logo for Medivators, a Cantel Medical Company. The logo consists of a blue circular graphic on the left, which is made up of several curved lines. To the right of the graphic is the word "MEDIVATORS" in a large, blue, sans-serif font. Below the company name is the text "A Cantel Medical Company" in a smaller, sans-serif font, also in blue.

Direct/Indirect Patient Contact	Yes	Yes	Yes
Material	Polymer conforming to ISO 10993-1 for biocompatibility	Polymers conforming to USP class VI	Polymers
Dimensions	Length: 0.97"Open wings diameter: 1.6"Folded wings diameter: 0.7"-0.74"	Length: 0.94"Open wings diameter: 1.27"Folded wings diameter: 0.63"-0.74"	Length: 0.98"Open wings diameter: 1.38"Folded wings diameter: 0.59"

4. Summary of Non-Clinical Performance Data

Medivators has conducted the following testing to demonstrate the safety and effectiveness of AmplifEYE:

. Design Verification
- o Force to Remove Testing
- o Force to Deflect Testing
Animal Testing ●
Shelf-life Validation .
- Functional Testing o
- Sterile Barrier Integrity Testing O
Sterilization Validation .

5. Conclusion

AmplifEYE is substantially equivalent to predicate devices Arc EndoCuff cleared under 510(k) K122565 and Arc Endocuff Vision cleared under 510(k) K151801. Based on the intended use, technological characteristics, performance data and nonclinical tests performed, the subject device AmplifEYE is substantially equivalent to and as effective as the legally marketed predicate devices.

CONFIDENTIAL

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.