The Endoscope Tip Protector is intended to be used on the distal tip of an endoscope for the purpose of protecting the endoscope's delicate lens and the endoscope's bending rubber during transport and storage. It may also be used on the distal tip of medical/surgical instruments to protect delicate components/mechanisms.

Device Description

The Endoscope Tip Protector is a single-use molded protective cover to be used to protect endoscopes and medical/surgical instruments. The design of the Endoscope Tip Protector:

Is composed on non-porous plastic material that allows for air flow
Has minimal contact points with the endoscope or medical/surgical instruments
Fits a wide variety of devices: 4.9mm -15mm outer diameter
Protects the distal tip of the endoscope or medical/surgical instrument during transport or storage.
The Endoscope Tip Protector is available both non-sterile and sterile.

AI/ML Overview

Based on the provided text, the Acceptance Criteria and Device Performance for the Endoscope Tip Protector are as follows:

1. Table of Acceptance Criteria and Reported Device Performance:

Testing	Acceptance Criteria	Reported Device Performance
Attachment and Detachment Force	The Endoscope Tip Protector must be able to be attached and detached with minimal force.	PASS
Scope Protection	The Endoscope Tip Protector must reduce the impact force to the endoscope compared to without protection.	PASS
Transport Protection	The Endoscope Tip Protector must remain on the endoscope during transport.	PASS
Longevity of Hold on Endoscope	The Endoscope Tip Protector must remain on the endoscope for at least 7 days.	PASS
Irritation and Skin Sensitization	Must meet ISO 10993-10: 2010.	PASS
Cytotoxicity	Must meet ISO 10993-5:2009.	PASS
Sterility	The Endoscope Tip Protector must have a sterile version.	PASS
Packaging Validation	Sterile Packaging must meet ASTM F88/F88M-15, ASTM F2096-11, and ASTM F1886/F1886M-16.	PASS

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

The document does not specify the exact sample sizes used for each test (e.g., number of endoscope tip protectors tested, number of cycles for transport or attachment/detachment). The data provenance is also not explicitly stated in terms of country of origin or whether the studies were retrospective or prospective. It summarily states "Proposed Endoscope Tip Protector" and "PASS" for each criterion.

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

The document does not mention the use of experts to establish ground truth for this device's testing. The tests appear to be physical and biological performance tests rather than subjective evaluations requiring expert consensus.

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

There is no mention of an adjudication method, as the tests outlined are objective performance metrics (e.g., force, time, compliance with standards) rather than 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:

This is not applicable. The device is a physical endoscope tip protector, not an AI-assisted diagnostic tool or system that would involve human readers or comparative effectiveness studies of AI assistance.

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

This is not applicable. As noted above, the device is a physical product, not an algorithm.

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

The "ground truth" for the tests appears to be defined by industry standards (ISO 10993-10, ISO 10993-5, ASTM standards) and defined physical/mechanical performance requirements (e.g., "minimal force," "reduce impact force," "remain on the endoscope for at least 7 days"). These are objective, measurable criteria rather than subjective interpretations requiring expert consensus or clinical outcomes data in the traditional sense.

8. The sample size for the training set:

This is not applicable. The device is a physical product, not a machine learning model that requires a training set.

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

This is not applicable, as there is no training set for this type of device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 27, 2020

STERIS Corporation Jennifer Nalepka Lead Regulatory Affairs Specialist 5960 Heisley Road Mentor, OH 44060

Re: K191715

Trade/Device Name: Endoscope Tip Protector - Sterile Endoscope Tip Protector - Non-sterile Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: OCU Dated: January 9, 2020 Received: January 10, 2020

Dear Jennifer Nalepka:

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 medical devices and radiation-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. Acting 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) K191715

Device Name

Endoscope Tip Protector - Sterile, Endoscope Tip Protector - Non-sterile

Indications for Use (Describe)

The Endoscope Tip Protector is intended to be used on the distal tip of an endoscope for the endoscope's delicate lens and the endoscope's bending transport and storage. It may also be used on the distal tip of medical/surgical instruments to protect delicate components/mechanisms.

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

X | Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary For Endoscope Tip Protector - Sterile, Endoscope Tip Protector - Nonsterile

STERIS Corporation 5960 Heisley Road Mentor, OH 44060

Contact: Jennifer Nalepka Lead Regulatory Affairs Specialist Tel: 440-392-7458 Fax: 440-357-9198 Email: jennifer_nalepka@steris.com

July 30, 2019 Summary Date:

STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600

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STERIS Traditional 510(k) PREMARKET NOTIFICATION Endoscope Tip Protector

1. Device Name

Trade Name:	Endoscope Tip Protector - Sterile, Endoscope Tip Protector - Non-sterile
Device Classification:	Class II
Common/usual Name:	Endoscopic Storage Cover
Classification Name:	Endoscope and accessories
Classification Number:	21 CFR 876.1500
Product Code:	OCU

2. Predicate Device

K951104 Endo-boot - endoscope tip protector

3. Description of Device

The Endoscope Tip Protector is a single-use molded protective cover to be used to protect endoscopes and medical/surgical instruments. The design of the Endoscope Tip Protector:

Is composed on non-porous plastic material that allows for air flow
. Has minimal contact points with the endoscope or medical/surgical instruments
Fits a wide variety of devices: 4.9mm -15mm outer diameter ●
Protects the distal tip of the endoscope or medical/surgical instrument during transport or storage.

The Endoscope Tip Protector is available both non-sterile and sterile.

4. Intended Use

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5. Technological Characteristic Comparison Table

The Endoscope Tip Protector is very similar to the Endo-Boot in intended use. The differences between the proposed and predicate devices are the design and material of construction. The design is different in the predicate compared to proposed because the predicate has a sponge-like configuration whereas the proposed has an open cage-like configuration. These differences do not raise any new concerns of safety and effectiveness when compared to the predicate device.

Table 1 summarizes the difference between the proposed device and the predicate.

Feature	Endoscope Tip Protector(Proposed)	Endo-Boot - endoscopetip protector(Predicate K951104)	Comparison
Intended use	The Endoscope TipProtector is intended to beused on the distal tip of anendoscope for the purposeof protecting theendoscope's delicate lensthe endoscope's bendingrubber during transportand storage. It may alsobe used on the distal tip ofmedical/surgicalinstruments to protectdelicatecomponents/mechanisms.	The Endo-Boot is used asa protective cover for thetip of the endoscope orother surgical instruments(i.e. rigid laparoscope,laparoscopic instruments)during storage andtransport. The Endo-Bootwill aid in protecting thelens and other delicatecomponents from damage.	Similar
Length	10.2 cm	14 cm	Similar
EndoscopeCompatible Outerdiameter (OD)	4.9 mm - 15 mm	Small: 3.0 mm – 8.8 mmLarge: 8.8 mm - 15.0 mm	The EndoscopeTip Protector is"one size fits all"and covers a widevariety ofendoscope ODswithin the range ofthe predicatedevice
Biocompatible	Yes	Not performed	The predicateEndo-boot -endoscope tipprotector was notevaluated forbiocompatibilitybecause it initiallywas determined tobe non-patient
Feature	Endoscope Tip Protector(Proposed)	Endo-Boot - endoscopetip protector(Predicate K951104)	Comparison
Supplied Sterile	Yes, also supplied non-sterile	No	New sterile optionfor users.
Packaging	Sterile version:individually packaged in aTyvek pouch, 15 per boxNon-Sterile version:individually packaged in apoly bag, 50 per box	25 per dispenser box, 2dispenser boxes per case	All Endoscope TipProtectors arepackagedindividually.
Single Use	Yes	Yes	Identical
Disposable	Yes	Yes	Identical
Surface Contactwith Endoscope	Minimal; internaldiaphragm holds device inplace	Along entire Endo-Boot	Bumps ondiaphragm reducessurface contactwith endoscope
Accessories	None	None	Identical

Table 1. Predicate Device Comparison Table

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STERIS Traditional 510(k) PREMARKET NOTIFICATION Endoscope Tip Protector

6. Description of Safety and Substantial Equivalence

Table 2 summarizes the verification activity that was performed with its respective acceptance criteria to ensure that this modification does not affect the safety or effectiveness of the endoscope or medical/surgical instrument.

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STERIS Traditional 510(k) PREMARKET NOTIFICATION Endoscope Tip Protector

Testing	Acceptance Criteria	ProposedEndoscope TipProtector
Attachment andDetachment Force	The Endoscope Tip Protector must be ableto be attached and detached with minimalforce	PASS
Scope Protection	The Endoscope Tip Protector must reducethe impact force to the endoscopecompared to without protection	PASS
Transport Protection	The Endoscope Tip Protector mustremain on the endoscope duringtransport	PASS
Longevity of Hold onEndoscope	The Endoscope Tip Protector mustremain on the endoscope for at least 7days	PASS
Irritation and SkinSensitization	Must meet ISO 10993-10: 2010	PASS
Cytotoxicity	Must meet ISO 10993-5:2009	PASS
Sterility	The Endoscope Tip Protector must havea sterile version.	PASS
Packaging Validation	Sterile Packaging must meet ASTM F88/F88M-15, ASTMF2096-11, and ASTM F1886/F1886M-16	PASS

Table 2. Summary of Verification Activities

7. Conclusion

Based on the intended use, technological characteristics and non-clinical performance data, the subject device is as safe, as effective and performs at least as well as or better than the legally marketed predicate device (K951104), Class II (21 CFR 876.1500), product code OCU.

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.