The EndoGator Advantage Irrigation Pump is indicated for endoscopic irrigation for use with washing catheters, integral endoscope water jet channels and endoscope working channels.

Device Description

The EndoGator Advantage Irrigation Pump EGA-500 is the second generation development of the current Byrne Medical EGP-100 Irrigation Pump. The EndoGator Advantage provides for a slightly higher flow rate of endoscope irrigation water and contains an attached water bottle heater to afford the clinician the option of performing water irrigation with warmed water as compared to room temperature.

The EndoGator Advantage Irrigation Pump works by turning a peristaltic roller pump head to move liquid through a tube set and into an endoscope system. The pump head will not operate if the pump head is open, and will cease to operate if the pump head is opened while the motor is activated. The unit incorporates a "Prime" feature which allows the unit to operate for a predetermined period of time.

The device includes a water bottle warming cradle that is intended to maintain a bottle of sterile water for irrigation at a target temperature of 37°C with a tolerance of ±3°C. The water bottle heating element is attached to the underside of the aluminum cradle which then conducts heat through the bottle to warm the water. The heating element is controlled by dual temperature sensors for redundancy and safety.

AI/ML Overview

This document describes the EndoGator Advantage Irrigation Pump EGA-500, a medical device. The information provided is primarily for a 510(k) submission, focusing on establishing substantial equivalence to predicate devices, rather than a study proving the device meets explicit acceptance criteria in the context of AI/algorithm performance.

Therefore, many of the requested items related to AI/algorithm performance, such as test set sample size, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, are not applicable or cannot be extracted from the provided text.

However, based on the non-clinical performance data and device description, we can infer some aspects related to acceptance criteria and how they were addressed.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is not an AI/algorithm-based device and the document describes a 510(k) submission for an irrigation pump, the "acceptance criteria" are derived from the performance claims and testing conducted to demonstrate substantial equivalence to predicate devices. The "reported device performance" reflects the successful outcomes of these tests.

Acceptance Criteria Category	Specific Criteria (Inferred from testing)	Reported Device Performance/Conclusion
Flow and Pressure	Equivalent or acceptable flow and pressure characteristics compared to predicate devices.	"Flow and pressure comparison" was performed, implying that the EGA-500 demonstrated comparable or acceptable performance to the predicate EndoGator EGP-100 and Olympus AFU-100.
Water Temperature	Maintain target temperature of 37°C ±3°C for sterile water for irrigation.	"Water temperature consistency and distribution" and "Heater performance" testing were conducted. The device aims to maintain water at a target temperature of 37°C ±3°C, and the testing supports this capability. The added water warming feature is deemed acceptable as it introduces water heated to approximately the same temperature as surrounding GI tissues.
Pump Performance	Reliable and consistent operation of the peristaltic roller pump head.	"Pump performance" testing was conducted to ensure the pump operates consistently and reliably. The description notes safety features like the pump head not operating when open and ceasing operation if opened during activation, and a "Prime" feature.
Safety - Electrical	Compliance with IEC 60601-1 (Electrical safety).	The device meets "Electrical safety IEC 60601-1" standards, indicating it passed relevant electrical safety tests.
Safety - EMC	Compliance with IEC 60601-1-2 (Electromagnetic compatibility).	The device meets "Electromagnetic compatibility IEC 60601-1-2" standards, indicating it passed relevant EMC tests.
Simulated Use	Safe and effective operation in simulated clinical settings.	"Simulated-use" testing was performed, suggesting the device functioned as intended under conditions mimicking its intended use.
Risk Analysis	Identification and mitigation of potential risks.	"Risk analysis" was conducted. The document states that "Any additional risks presented by the added water warming feature on the subject device are acceptable because it is simply being used to introduce water that is heated to approximately the same temperature as the surrounding tissues in gastrointestinal (GI) tract," implying that identified risks were assessed and deemed acceptable or mitigated.
Indications for Use	Equivalent indications for use as predicate devices.	The device has "equivalent indications for use as the predicate devices." All devices share the same intended performance and method of sterile water irrigation during GI endoscopy.

Study Information (Based on the provided text):

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified in the provided text. Bench testing was performed on the device itself.
- Data Provenance: Not specified. Testing was conducted by Medivators, a US-based company, likely implying testing occurred in the USA. The data would be prospective as it was generated specifically for this 510(k) submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is a non-AI medical device; "ground truth" in the context of expert consensus on images or outcomes is not relevant here. Device performance criteria were likely established by engineering and regulatory standards.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This concept is typically relevant for studies involving human interpretation or subjective assessments, not for bench testing of device performance against engineering specifications.
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 is not an AI-assisted device, nor does the document describe a human reader study.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device (irrigation pump), not an algorithm. The "standalone" performance here refers to the device operating on its own as designed, which is inherent in the "bench testing" mentioned.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable in the conventional sense. For this device, the "ground truth" or reference for assessment would be:
  - Engineering specifications and design requirements: For pump performance, flow rates, and pressure.
  - Regulatory standards: Such as IEC 60601-1 and IEC 60601-1-2 for electrical safety and EMC.
  - Predicate device performance: For comparative equivalence of function.
  - Thermodynamic principles/specifications: For temperature control (37°C ±3°C).
The sample size for the training set:
- Not applicable. This is not an AI/machine learning device; there is no "training set."
How the ground truth for the training set was established:
- Not applicable. There is no training set for this type of device.

Summary

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APR 2 7 2012

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EndoGator Advantage Irrigation Pump EGA-500

510(k) Summary

Manufacturer:	Medivators(formerly Byrne Medical, A Minntech Corporation Business Group)
Address:	3150 Pollok Dr.Conroe, TX 77303USA
Official Contact:	Brent Geiger, MS, RACInternational RA Managerbgeiger@minntech.com763-553-3345
Trade Name:	EndoGator Advantage Irrigation Pump EGA-500
Common Name:	Endoscopic Irrigation Pump
Classification Name:	Endoscopic Irrigation/Suction System
Product Code:	OCX, Gastroenterology/Urology
Device Class:	II
Regulation No.:	876.1500
Date Prepared:	April 23, 2012
Predicate Devices:	Byrne Medical EndoGator Pump Model EGP-100 K060962Olympus AFU-100 Irrigation Pump K073207

Medivators has provided the following information to the U.S. Food and Drug Administration to support the substantial equivalence determination of the subject EndoGator Advantage Irrigation Pump EGA-500 to the predicate EndoGator EGP-100 and Olympus AFU-100 irrigation pumps currently cleared for commercial distribution in the United States.

Device Description

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Image /page/1/Picture/0 description: The image shows the logo for MEDIVATORS, a Cantel Medical Company. The logo consists of a circular graphic on the left, followed by the word "MEDIVATORS" in bold, uppercase letters. Below the company name is the text "A Cantel Medical Company" in a smaller font size. The logo is simple and professional, conveying a sense of trust and reliability.

K113119
PG. 2 of 2

Indications for Use

The EndoGator Advantage Irrigation Pump EGA-500 is indicated for endoscopic irrigation for use with washing catheters, integral endoscope water jet channels and endoscope working channels.

Comparison to Other Devices in Commercial Distribution in the United States

The EndoGator Advantage Irrigation Pump has equivalent indications for use as the predicate devices. All devices have the same intended performance and use the same method of sterile water irrigation during GI endoscopy procedures. The primary difference between the subject and predicate devices is that the subject device contains a water bottle warming cradle that is intended to maintain a sterile water bottle for endoscopic irrigation at a target temperature of 37°C with a tolerance of ±3°C. Any additional risks presented by the added water warming feature on the subject device are acceptable because it is simply being used to introduce water that is heated to approximately the same temperature as the surrounding tissues in gastrointestinal (GI) tract.

Summary of Non-Clinical Performance Data

Medivators has performed bench testing to support the substantial equivalence of the EndoGator Advantage Irrigation Pump to the predicate EndoGator EGP-100 and Olympus AFU-100 irrigation pumps currently cleared for commercial distribution in the United States. The following types of data were provided to FDA to support substantial equivalence and demonstrate that the device performs consistently, reliably and safely as intended:

Flow and pressure comparison .
Water temperature consistency and distribution .
. Pump performance
Heater performance .
Simulated-use .
Risk analysis .
Electrical safety IEC 60601-1 .
Electromagnetic compatibility IEC 60601-1-2 .

Conclusion

Medivators has provided the appropriate premarket notification and supporting safety and performance information in the form of a 510(k) submission. Based on the information provided. we believe that the EndoGator Advantage Irrigation Pump EGA-500 is substantially equivalent to the Byrne Medical EndoGator Pump Model EGP-100 and Olympus AFU-100 Irrigation Pump.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Brent Geiger, MS, RAC International RA Manager Minntech Corporation 14605 28th Avenue North MINNEAPOLIS MN 55442

APR 2 7 2012

Re: K113119

Trade/Device Name: EndoGator Advantage Irrigation Pump Model EGA-500 Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: OCX Dated: March 21, 2012 Received: March 22, 2012

Dear Mr. Geiger:

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

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Benjamin K. Evans

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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Premarket Notification 510(k) EndoGator Advantage Irrigation Pump

Indications for Use

K113119 510(k) number (if known):

Device Name:

EndoGator Advantage Irrigation Pump EGA-500

Indications for Use:

The EndoGator Advantage Irrigation Pump is indicated for endoscopic irrigation for use with washing catheters, integral endoscope water jet channels and endoscope working channels.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-the-Counter Use (Part 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and Urological Devices
510(k) Number	K113119

K113119 Response

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.