The ENDOGATOR™ Hybrid Irrigation Tubing (tubing and accessories to accommodate various endoscopes and irrigation pumps) is intended to provide irrigation via sterile water and to supply air (via an air pump) or CO2 (via a CO2 supply) along with sterile water during GI endoscopic procedures when used in conjunction with an irrigation pump or cautery unit.

Device Description

The ENDOGATOR™ HYBRID Irrigation Tubing device contains a threaded cap and tubeset designed to be attached to sterile water bottles. The proximal end of the irrigation tubing includes the threaded bottle cap for attachment to a sterile water bottle. The bottle cap has three tubes attached, one for receiving CO2 (and air in the case of Pentax SKU's), one coaxial tube which has an inner lens rinsing uptake tube surrounded by an air/CO2 delivery tube, and one for delivering water for irrigation which interfaces with an irrigation pump. The water delivery tubes, both irrigation as well as lens rinsing include backflow check valves.

AI/ML Overview

The provided text describes the ENDOGATOR™ Hybrid Irrigation Tubing, a device for providing irrigation and supplying air/CO2 during GI endoscopic procedures. It compares this device to a predicate device (Universal Irrigation Solution Hybrid, K102855).

Here's a breakdown of the acceptance criteria and study information provided:

1. Table of acceptance criteria and the reported device performance

Testing	Requirements	Reported Device Performance
Water Flow Rate	Lensing Flow Rate must be no lower than 10% of Predicate after calling for water for 20 seconds	Pass
Insufflation Air & CO2 Flow	Air & CO2 Flow Rate must be no lower than 10% of the predicate	Pass
Backflow Test	The backflow valve must withstand at least 10 PSI	Pass
Lens Rinsing Flow Rate	Lensing Flow Rate must be no lower than 10% of predicate after calling for water for 20 seconds	Pass
Durability of glue bonded connections	The bonded connections must meet or exceed 10 lbs of axial pull force and must maintain strength and durability requirements after being subjected to 2X EtO sterilization.	Pass

Biocompatibility Testing:

Requirements: Evaluated in accordance with ISO 10993-1:2018 for "Surface - Mucosal Membrane" with a contact duration of "Limited (< 24 hours)".
Tests Performed: Cytotoxicity, Irritation, and Sensitization.
Reported Device Performance: All evaluation acceptance criteria were met.

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

The document does not explicitly state the sample size for the test set for any of the performance tests. It only lists the tests performed and their outcomes ("Pass").

The data provenance is presented as "Non-clinical testing", which implies lab or bench testing rather than clinical data from human subjects. The document does not specify the country of origin of the data; however, Medivators Inc. is located in Minneapolis, Minnesota, USA, which suggests the testing was likely conducted in the US or under US regulatory standards. The data is retrospective in nature, as it was provided to support a 510(k) premarket notification.

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

Not applicable. This is a medical device (tubing and accessories) that does not involve algorithmic or diagnostic assessment requiring expert ground truth for its performance evaluation (e.g., image interpretation). The performance data cited are objective engineering and material testing results (e.g., flow rates, pressure resistance, pull force, biocompatibility).

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

Not applicable. As described above, the performance tests for this device are objective physical and chemical evaluations, not subjective assessments requiring expert adjudication.

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 device is a piece of medical tubing and accessories, not an AI or diagnostic imaging system. Therefore, an MRMC comparative effectiveness study is not relevant.

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

Not applicable. This device is not an algorithm or AI system.

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

For the performance tests:

Water Flow Rate, Insufflation Air & CO2 Flow, Lens Rinsing Flow Rate: Measured values against predefined thresholds relative to the predicate device.
Backflow Test: Pressure resistance measurement (withstanding at least 10 PSI).
Durability of glue bonded connections: Axial pull force measurement (meeting or exceeding 10 lbs) and strength/durability requirements after sterilization.
Biocompatibility: Conformance to ISO 10993-1:2018 standards, evaluated via specific laboratory tests (Cytotoxicity, Irritation, Sensitization).

The "ground truth" here is the objective measurement against established physical and biological standards and performance relative to the predicate device.

8. The sample size for the training set

Not applicable. This device is not an AI or machine learning model, so there is no concept of a "training set."

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

Not applicable, as there is no training set for this device.

Summary

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August 14, 2023

Medivators Disha Kabrawala Senior Regulatory Affairs Specialist 14605 28th Avenue North Minneapolis, Minnesota 55447

Re: K231418

Trade/Device Name: ENDOGATOR™ Hybrid Irrigation Tubing Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: OCX Dated: May 11, 2023 Received: May 16, 2023

Dear Disha Kabrawala:

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

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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 (OS) 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,

Shanil P. Haugen -S

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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Indications for Use

510(k) Number (if known) K231418

Device Name ENDOGATOR™ Hybrid Irrigation Tubing

Indications for Use (Describe)

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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510(k) Summary For ENDOGATOR™ Hybrid Irrigation Tubing

Medivators Inc 14605 28th Ave N, Minneapolis, MN 55447 Fax No: 844-348-5637

Contact Person: Disha Kabrawala Senior Regulatory Affairs Specialist Phone: 732-319-7766 Email: disha kabrawala@steris.com
May 11, 2023 Summary Date:

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CANTEL MEDICAL TRADITIONAL PREMARKET NOTIFICATION [510(k)] ENDOGATOR™ Hybrid Irrigation Tubing

1. Device Name

Trade Name:	ENDOGATOR™ Hybrid Irrigation Tubing
Device Class:	II
Common/usual Name:	ENDOGATOR™ Hybrid Irrigation Tubing
Classification Name:	Endoscope and Accessories
Classification Number:	876.1500
Product Code:	OCX (endoscopic irrigation/suction system)

2. Predicate Devices

The Universal Irrigation Solution Hybrid, K102855

3. Description of Devices

Air/CO2 and Lens Rinse Line Description

The threaded cap uses a coaxial tube to partition water and air/CO2 which is connected to the endoscope-interfacing connector. Pressurized air or CO2 provided by the endoscope's processor/light source or a CO2 insufflator is fed into the endoscope (either directly or first through the device & bottle system via luer connection.) The Endogator Hybrid enables the air/CO2 to pressurize the bottle and flow through the endoscope to the air/water valve. The Endogator Hybrid serves as a passive element in the system, allowing the delivery of pressurized air/CO2 to endoscopes.

Irrigation Line Description

The irrigation tubing pump section is installed into peristaltic-roller-type irrigation pumps, which transfer water through means of applying force to the external surface of the tubeset via revolving rollers, actuated by a user-controlled foot pedal, causing water to be siphoned from the sterile water bottle and transferred

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CANTEL MEDICAL TRADITIONAL PREMARKET NOTIFICATION [510(k)] ENDOGATOR™ Hybrid Irrigation Tubing

downstream to the endoscope. The flow rate can be manipulated by userinteraction with the pump interface. The distal end of the irrigation tubing includes a backflow valve which allows water to travel only in one direction to mitigate cross-contamination. The irrigation check valve has a luer connection that enables the irrigation tubing to be connected to the ENDOGATOR™ auxiliary port or biopsy accessory adapters that interface with endoscopes (separate devices).

4. Intended Use / Indications for Use

ડ. Comparison of Technological Characteristics with the Predicate Device

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

Feature	ProposedENDOGATOR HybridIrrigation tubing	Predicate (K102855)The Universal IrrigationSolution Hybrid	Comparison
Intended Use	The ENDOGATOR™ HybridIrrigation Tubing (tubing andaccessories to accommodatevarious endoscopes andirrigation pumps) is intended toprovide irrigation via sterilewater and to supply air (via anair pump) or CO2 (via a CO2supply) along with sterile waterduring GI endoscopicprocedures when used inconjunction with an irrigationpump or cautery unit.	The Universal IrrigationHybrid™ solution (tubing andaccessories to accommodatevarious endoscopes andirrigation pumps) is intendedto provide irrigation via sterilewater and to supply air (via anair pump) or CO2 (via a CO2supply) along with sterilewater during GI endoscopicprocedures when used inconjunction with an irrigationpump or cautery unit.	Identical
Sterile	Sterile	Sterile	Identical
SterilizationMethod	Ethylene Oxide	Ethylene Oxide	Identical
SterilizationAssuranceLevel	10-6	10-6	Identical
Feature	ProposedENDOGATOR HybridIrrigation tubing	Predicate (K102855)The Universal IrrigationSolution Hybrid	Comparison
Intended Use	24hr/ Multi-patient use	24hr/ Multi-patient use	Identical
Reprocessing	None; Daily disposal	None; Daily disposal	Identical
CompatibleEndoscope(s)	Olympus® 140/160/180/190series GI endoscopesPENTAX™ GI Endoscopes,FUJI 500 series GI EndoscopesFUJI 700 series GI Endoscopes	Olympus®140/160/180/240/260 series GIendoscopes	DifferentAdditionalpartnumbersimplemented to forPentax, Fujiendoscopes
PatientContact	No direct contact	No direct contact	Identical
TargetPatientPopulation	Male/Female, Pediatric toAdult- Patients populationundergoing GI endoscopicprocedure	Male/Female, Pediatric toAdult- Patients populationundergoing GI endoscopicprocedure	Identical
Materials	Nitrile Butadiene (Buna-N)acrylonitrile-butadiene-styreneAcrylonitrile Butadiene Styrene(ABS)BLACK PEARL CThermoplastic ElastomerPolycarbonateNon-Phthalate PolyvinylChloride (PVC)PolypropyleneBuna-N NitrileNickel-Plated BrassSiliconeMabs TerfluxUV cured Glue	Nitrile Butadiene (Buna-N)acrylonitrile-butadiene-styreneAcrylonitrile Butadiene Styrene(ABS)BLACK PEARL CThermoplastic ElastomerPolycarbonatePhthalate Polyvinyl Chloride(PVC)PolypropyleneBuna-N NitrileNickel-Plated BrassSiliconeMabs Terflux	SimilarUse of non-phthalatepolyvinylChloridematerial fortubing
Usage	Single Use	Single Use	Identical
Feature	ProposedENDOGATOR HybridIrrigation tubing	Predicate (K102855)The Universal IrrigationSolution Hybrid	Comparison
Construction	Threaded Cap,Irrigation Tube set,Coaxial Tube,Backflow Check Valve	Threaded Cap,Irrigation Tube set,Coaxial Tube	DifferentBackflowcheck valveis added toprevent theflow inreversedirection.Thesuccessfulresults oftestingprove thatdevice issafe andeffective
Energy Used/ Delivered	None	None	Identical

Table 1: Physical Description and Technological Properties vs the Predicate Device

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ENDOC ATORIN Uybrid Friisotion Tubing ENDOGATOR™ Hybrid Irrigation Tubing

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CANTEL MEDICAL TRADITIONAL PREMARKET NOTIFICATION [510(k)] ENDOGATOR™ Hybrid Irrigation Tubing

6. Performance Data

The following performance data were provided in support of the substantial equivalence determination.

Testing	Requirements	Results
Water Flow Rate	Lensing Flow Rate must be no lowerthan 10% of Predicate after calling forwater for 20 seconds	Pass
Insufflation Air & CO2 Flow	Air & CO2 Flow Rate must be nolower than 10% of the predicate	Pass
Backflow Test	The backflow valve must withstand atleast 10 PSI	Pass
Lens Rinsing Flow Rate	Lensing Flow Rate must be no lowerthan 10% of predicate after calling forwater for 20 seconds	Pass
Durability of glue bondedconnections	The bonded connections must meet orexceed 10 lbs of axial pull force andmust maintain strength and durabilityrequirements after being subjected to2X EtO sterilization.	Pass

Table 2: Non-clinical testing

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Biocompatibility testing

Biocompatibility of the ENDOGATOR Hybrid™ Irrigation Tubing was evaluated in accordance with ISO 10993-1:2018 for the body contact category of "Surface -Mucosal Membrane" with a contact duration of "Limited (< 24 hours)". The following tests were performed: Cytotoxicity, Irritation, and Sensitization. All evaluation acceptance criteria were met.

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 (K102855), Class II (21 CFR 876.1500), product code OCX.

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.