The EndoGator Endoscopy Irrigation Tubing (tubing and accessories to accommodate various endoscopes and irrigation pumps) is intended to provide irrigation via sterile water supply during GI endoscopic procedures when used in conjunction with an irrigation pump (or cautery unit).

Device Description

The ENDOGATOR Endoscopy Irrigation Tubing is composed of the following: 1) EndoGator™ Irrigation Tubing, and 2) EndoGator™ Irrigation Accessories. The ENDOGATOR Endoscopy Irrigation Tubing is indicated for irrigation during endoscopic procedures by using it in conjunction with an irrigation pump or cautery units, irrigation accessory, endoscope and disposable sterile water bottle. All tubing sets contain a back flow valve at the distal tip that allows irrigation water to travel in one direction, and therefore the risk of cross contamination is significantly reduced. The irrigation tubing sets are for twenty-four hour use and are to be discarded daily. The accessories are single-use devices and are to be discarded between patients. Tubing sets do not come into direct contact with patient tissue.

AI/ML Overview

The provided text describes the 510(k) Summary for the ENDOGATOR Endoscopy Irrigation Tubing. This document details a medical device and its comparison to a predicate device for substantial equivalence with the FDA. It does not contain information about the acceptance criteria and study design for an AI/ML powered device.

Therefore, I cannot provide the requested information about acceptance criteria for an AI/ML powered medical device, nor can I describe a study proving the device meets said criteria from this document. The document pertains to non-clinical performance testing of irrigation tubing, not an AI/ML diagnostic or therapeutic device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains 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.

March 11, 2022

STERIS Corporation Carroll Martin Regulatory Affairs Director 5960 Heislev Road Mentor, OH 44060

Re: K220395

Trade/Device Name: Endogator Endoscopy Irrigation Tubing Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FEQ Dated: February 11, 2022 Received: February 11, 2022

Dear Carroll Martin:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

{1}------------------------------------------------

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. 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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K220395

Device Name EndoGator Endoscopy Irrigation Tubing

Indications for Use (Describe)

The EndoGator Endoscopy Irrigation Tubing and accessories to accommodate various endoscopes and irrigation pumps) is intended to provide irrigation via sterile water supply during GI endoscopic procedures when used in conjunction with an irrigation pump (or cautery unit).

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the STERIS logo with a wavy line design underneath. The text "K220395 Page 1 of 5" is located in the upper right corner of the image. The STERIS logo is large and bold, making it the focal point of the image.

510(k) Summary for the ENDOGATOR Endoscopy Irrigation Tubing

STERIS Corporation 5960 Heisley Road Mentor, OH 44060

Contact: Carroll Martin Regulatory Affairs Director Tel: 440-358-6259 Email: Carroll_Martin@steris.com

February 11, 2022 Submission Date:

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

{4}------------------------------------------------

1. Device Name

Trade Name:	ENDOGATOR Endoscopy Irrigation Tubing
Device Class:	Class II
Regulation Name:	Endoscope and Accessories
Common/usual Name:	Irrigation Tubing
Regulation Number:	21 CFR 876.1500
Product Code:	FEQ

2. Predicate Device

EndoGator System, K092429

3. Device Description

The ENDOGATOR Endoscopy Irrigation Tubing is composed of the following: 1) EndoGator™ Irrigation Tubing, and 2) EndoGator™ Irrigation Accessories

The ENDOGATOR Endoscopy Irrigation Tubing is indicated for irrigation during endoscopic procedures by using it in coniunction with an irrigation pump or cauterv units, irrigation accessory, endoscope and disposable sterile water bottle. All tubing sets contain a back flow valve at the distal tip that allows irrigation water to travel in one direction, and therefore the risk of cross contamination is significantly reduced. The irrigation tubing sets are for twenty-four hour use and are to be discarded daily. The accessories are single-use devices and are to be discarded between patients. Tubing sets do not come into direct contact with patient tissue.

4. Indications for Use

The ENDOGATOR Endoscopy Irrigation Tubing (tubing and accessories to accommodate various endoscopes and irrigation pumps) is intended to provide irrigation via sterile water supply during GI endoscopic procedures when used in conjunction with an irrigation pump (or cautery unit).

Technological Characteristics Comparison Table 5.

A comparison of technical characteristics between the proposed and predicate devices is summarized in Table 1.

{5}------------------------------------------------

Features	Endogator SystemPredicate Device K092429	Modified Device	Comparison
Intended Use	The EndoGatorTM system (tubingand accessories to accommodatevarious endoscopes andirrigation pumps) is intended toprovide irrigation via sterilewater supply during GIendoscopic procedures whenused in conjunction with anirrigation pump (or cautery unit).	The EndoGator EndoscopyIrrigation Tubing (tubing andaccessories to accommodate variousendoscopes and irrigation pumps) isintended to provide irrigation viasterile water supply during GIendoscopic procedures when used inconjunction with an irrigation pump(or cautery unit).	Identical
Construction	The EndoGator TM Systemconsists of a bottle cap, tubing setand connector	The EndoGator EndoscopyIrrigation Tubing consists of a bottlecap, tubing set and connector	Identical
Sterile/Non-sterile	Sterile	Sterile	Identical
SterilizationMethod	Ethylene Oxide	Ethylene Oxide	Identical
SterilizationAssurance Level	10-6	10-6	Identical
Accessories	• Single Use Auxiliary Water JetConnector for Olympus®Endoscopes• Single Use Auxiliary Water JetConnector for Pentax®Endoscopes• Endogator Channel Adapter• Endogator Backflow Valve• Endogator Y-Connector• Endogator Pump Cartridge• Endogator Extension Tubing• SpyGlass Tube Set	• Single Use Auxiliary Water JetConnector for Olympus®Endoscopes• Single Use Auxiliary Water JetConnector for Pentax®Endoscopes• Endogator Channel Adaptor• Endogator Backflow Valve	SimilarAll of theapplicable listedaccessories for themodified deviceare identical to thepredicate.
Usage	Single Use:• Single Use Auxiliary Water JetConnector for OlympusEndoscopes• Single Use Auxiliary Water JetConnector for PentaxEndoscopes• Endogator Backflow Valve• Endogator Channel Adaptor• Endogator Y-Connector• SpyGlass Tube Set24 Hour/Multi-patient Use• Endogator Extension Tubing	Single Use:• Single Use Auxiliary Water JetConnector for Olympus®Endoscopes• Single Use Auxiliary Water JetConnector for Pentax®Endoscopes• Endogator Backflow Valve• Endogator Channel Adaptor24 Hour/Multi-patient Use• Endogator for Endostat II,Olympus OFP or Endo Stratus	IdenticalThe usage of theapplicableaccessories withmodified device isidentical as theusage for theaccessories fromthe predicatedevice.IdenticalThe usage of theirrigation tubing
Features	Endogator SystemPredicate Device K092429for Olympus Endoscopes	Modified Device	Comparison
	• Auxiliary Water jet Connectorfor Pentax Endoscopes	Pumps• Endogator for EGP-100,Olympus OFP, TorrentIrrigation Pumps and thegi4000 ElectrosurgicalGenerator (irrigation pumpcomponent)	for the modifieddevice is identicalto the usage for thepredicate device.
	• Endogator for Pentax/MeditronPumps
	• Endogator for Pentax/MeditronPumps with Fujinon EndoscopeConnectors
	• Endogator for Endostat II/IIIUnit or Olympus OFP Unit
	• Endogator for EGP-100Irrigation Unit
	• Endogator for EGP-100Irrigation Units with FujinonEndoscope Connectors
	Reusable:• Endogator Pump Cartridge	Reusable:• None	SimilarThere are noreusableaccessories beingused with themodified device.
Materials	Acrylonitrile Butadiene (Buna-N)Acrylonitrile Butadiene Styrene(ABS)CyclohexanoneHigh Impact Polystyrene (HIPS)Isopropyl AlcoholNickel-plated BrassPolycarbonatePolypropylenePolyvinyl Chloride (PVC)SiliconeUV cured Glue	Acrylonitrile Butadiene (Buna-N)Acrylonitrile Butadiene Styrene(ABS)Thermoplastic elastomerIsopropyl AlcoholNickel-plated BrassPolycarbonatePolypropylenePolyvinyl Chloride (PVC)SiliconeUV cured Glue	SimilarCyclohexane andhigh impactpolystyrene wereused incomponents forpart numbers thathave beendiscontinued. Theacrylonitrilebutadiene (Buna-N) in the o-ring ofthe check valve forthe irrigationtubing wasreplaced bythermoplasticelastomer (Buna-Nstill exists in othercomponents of thedevice).Thermoplasticelastomer is a well-known material inthe medical deviceindustry.Identical
Target Population	Patients undergoing anendoscopic procedure	Patients undergoing anendoscopic procedure	Identical
Features	Endogator SystemPredicate Device K092429	Modified Device	Comparison
Used/Delivered
Method ofApplication	Manual	Manual	Identical
CompatibleEndoscopes	Olympus, Pentax, Fujinon	Olympus, Pentax, Fujinon	Identical
CompatibleIrrigation Pumps	Pentax, Meditron, Endostat II,Endostat III, Olympus OFP	Endostat II, EGP-100, OlympusOFP, Endo Stratus, TorrentIrrigation Pump, gi4000Electrosurgical Generator(irrigation pump component)	Similar. Allcompatible pumpsare peristalticpumps.

Table 1. Technological Characteristics Comparison Table

{6}------------------------------------------------

{7}------------------------------------------------

K220395 Page 5 of 5

Summary of Non-Clinical Performance Testing 6.

The following testing was conducted to verify the changes:

Test	Purpose	Acceptance Criteria	Results
Tensile Testing	Ensure themodification to thechange in connectionmethod between thepump tubing andirrigation tubingsections meetspecifications.	Tensile values are tomeet designspecifications	Pass
Flow Rate Testing	Verify that flowratewas not impactedwhen using theirrigation tubing withthe Torrent Irrigationpump and the gi4000Electrical SurgicalGenerator.	Flowrate values areto meet designspecifications	Pass
Durability Testing	Verify that theirrigation tubingstructural integritywas not impactedwhen used with theTorrent Irrigationpump and the gi4000Electrical SurgicalGenerator	Device structuralintegrity must not becompromised whenused with theTorrent IrrigationPump and the gi4000ElectrosurgicalGenerator	Pass

7. Conclusion

Based on the intended use, technological characteristics and non-clinical performance data, the subject device is as safe, as effective and performs as well or better than the legally marketed predicate device (K092429).

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.