← Product Code [OCX](/productcode/OCX) · K113119 # ENDOGATOR ADVANTAGE IRRIGATION PUMP (K113119) _Byrne Medical, Inc. · OCX · Apr 27, 2012 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K113119 ## Device Facts - **Applicant:** Byrne Medical, Inc. - **Product Code:** [OCX](/productcode/OCX.md) - **Decision Date:** Apr 27, 2012 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.1500 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology ## 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. ## Device Story EndoGator Advantage Irrigation Pump EGA-500 is a peristaltic roller pump for GI endoscopy. Device moves sterile water through tube sets into endoscope channels for irrigation. Features include a water bottle warming cradle to maintain water at 37°C (±3°C) via an aluminum heating element controlled by dual redundant sensors. Pump operation is safety-interlocked; motor stops if pump head is opened. Clinicians operate the device in clinical settings to provide warmed irrigation, potentially improving patient comfort by matching tissue temperature. Output is controlled flow of irrigation fluid. ## Clinical Evidence Bench testing only. Data provided includes flow and pressure comparisons, water temperature consistency/distribution, pump and heater performance, simulated-use testing, risk analysis, and electrical safety/EMC testing per IEC 60601-1 and IEC 60601-1. No clinical data. ## Technological Characteristics Peristaltic roller pump; aluminum water bottle warming cradle; dual temperature sensors for redundancy. Electrical safety per IEC 60601-1; electromagnetic compatibility per IEC 60601-1-2. Operates via motor-driven tube set. ## Regulatory 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. ## Special Controls *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. In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls: 1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following: 1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures. 2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use. 3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use. 2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes. 3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches 4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error. 5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program. (6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms. (7) Labeling must include: (i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified; (ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA; (iii) Identification of compatible devices; (iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification; (v) Reprocessing instructions for reusable components; (vi) A shelf life for any sterile components; (vii) A description of the device-specific use training program; (viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and (ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance. (8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include: (i) Device motion accuracy and repeatability; (ii) System testing; (iii) Instrument reliability; (iv) Crosstalk; (v) Table motion control; (vi) Thermal effects on tissue; (vii) User-device interface performance; (viii) Workspace access testing; and (ix) Performance testing with compatible devices. (9) Software verification, validation, and hazard analysis must be performed. (10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed. (11) Performance data must demonstrate the sterility of all patient-contacting device components. (12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life. (13) Performance data must validate the reprocessing instructions for the reusable components of the device. (14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible. (15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic. (16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information: (i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and (ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period. ## Predicate Devices - Byrne Medical EndoGator Pump Model EGP-100 ([K060962](/device/K060962.md)) - Olympus AFU-100 Irrigation Pump ([K073207](/device/K073207.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ APR 2 7 2012 Image /page/0/Picture/1 description: The image shows the logo for Medivators, a Cantel Medical Company. The logo consists of a circular graphic on the left, composed of several horizontal lines. To the right of the graphic is the word "MEDIVATORS" in a bold, sans-serif font, with the tagline "A Cantel Medical Company" underneath in a smaller font. # 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 77303
USA | | Official Contact: | Brent Geiger, MS, RAC
International RA Manager
bgeiger@minntech.com
763-553-3345 | | 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 K060962
Olympus 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 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. {1}------------------------------------------------ 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 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. ## 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. {2}------------------------------------------------ # DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. 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 {3}------------------------------------------------ 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, 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 {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Medivators, a Cantel Medical Company. The logo consists of a circular graphic with horizontal lines on the left, followed by the word "MEDIVATORS" in bold, sans-serif font. Below the word "MEDIVATORS" is the text "A Cantel Medical Company" in a smaller font size. 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 --- **Source:** [https://fda.innolitics.com/device/K113119](https://fda.innolitics.com/device/K113119) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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