(189 days)
Not Found
No
The description focuses on mechanical and thermal control mechanisms (peristaltic pump, heater, temperature sensors) and does not mention any AI/ML components or functionalities.
No.
The device is an irrigation pump used for endoscopic irrigation, which aids in flushing and cleaning the site during a procedure rather than directly treating or mitigating a disease or condition.
No
The device is an irrigation pump for endoscopic procedures, designed to deliver water for washing. It does not collect, analyze, or interpret data about a patient's health condition to aid in diagnosis.
No
The device description clearly details hardware components such as a peristaltic roller pump head, a motor, a water bottle warming cradle, a heating element, and temperature sensors.
Based on the provided information, the EndoGator Advantage Irrigation Pump is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "endoscopic irrigation for use with washing catheters, integral endoscope water jet channels and endoscope working channels." This describes a device used during an endoscopic procedure to irrigate the anatomical site (GI tract).
- Device Description: The description details a pump that moves liquid into an endoscope system. It also includes a water bottle heater. These are all components and functions related to delivering fluid for irrigation in vivo.
- Lack of In Vitro Activity: There is no mention of the device being used to test samples (blood, tissue, etc.) outside of the body to diagnose a condition. IVD devices are specifically designed for testing samples in vitro.
Therefore, the EndoGator Advantage Irrigation Pump is a medical device used for irrigation during endoscopic procedures, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
OCX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 .
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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
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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