The EndoGator® Advantage CO2 Insufflator is designed to use CO2 as a distention media in the gastrointestinal tract when used in conjunction with a gastrointestinal endoscope.

Device Description

The EndoGator Advantage CO2 Insufflator EGA-501 is indicated to use CO2 as a distention media in the gastrointestinal tract when used in conjunction with a gastrointestinal endoscope. It is intended to be used for delivery of CO2 via an endoscope system to provide improved visualization during gastrointestinal endoscopic procedures.

The EndoGator Advantage CO2 Insufflator operates by receiving CO2 from a pressurized source and requlating it down to a lower pressure and flow rate by means of a two-stage pressure regulator and flow restrictor system. The device controls delivery of CO2 to an endoscope system for eventual use as a distention media in endoscopic procedures.

The output flow rate is user adjustable and can be set at low, medium or high settings. Flow is controlled by a system of electrical solenoid flow restrictors. The device contains a pressure relief safety valve as a redundant safety backup to the pressure regulator system.

The EndoGator Advantage CO2 Insufflator includes a CO2 warming feature that allows the clinician to modulate and control delivery of CO2 that has been warmed to a target temperature of 37°C. The insufflator warms CO2 using a flow-through heating element with built-in dual redundant resistance temperature detector sensors and an added safety thermostat.

The device design also contains an optional feature that allows for connection of an externally attachable water bottle warmer accessory. The water bottle warmer system design is identical to the design used in the related Endogator Advantage Irrigation Pump EGA-500 (K113119). The feature was included in the insufflator design to provide the user with the option for warm water irrigation in the event that they choose to use an alternative irrigation pump to the EGA-500.

AI/ML Overview

The provided text is a 510(k) summary for a medical device, the EndoGator Advantage CO2 Insufflator EGA-501. It details the device's description, indications for use, comparison to a predicate device, and a summary of non-clinical performance data. However, it does not describe acceptance criteria for specific performance metrics or the detailed study results that prove the device meets these criteria. It lists types of non-clinical tests performed, but not the quantitative outcomes or acceptance thresholds.

Given the information provided, I cannot fulfill all parts of your request. Specifically, the document is a regulatory submission summary, and typically these summaries do not include precise acceptance criteria tables or detailed study results with sample sizes, expert qualifications, or ground truth establishment methods for specific performance metrics. These details would be in the full submission, which is not provided.

Therefore, I can only provide information based on what is available in the text.

Here's what can be extracted and formatted, along with explanations for the missing information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a specific table of acceptance criteria with corresponding performance results. It states that "evaluation and testing has been performed to demonstrate that the differences do not impact device safety or performance, and any risks associated with the differences are acceptable." It also lists the types of tests conducted:

Test Type	Acceptance Criteria (Not explicitly stated in document)	Reported Device Performance (Not explicitly stated in document)
Simulated insufflation performance comparison	(Implicitly: performance similar to predicate)	(Implicitly: acceptable and safe)
CO2 flow and pressure comparison testing	(Implicitly: within safe and effective ranges)	(Implicitly: comparable to predicate)
CO2 heater performance	(Implicitly: warms CO2 to target 37°C safely)	(Implicitly: meets target temperature safely)
CO2 heater performance with flow shut-off	(Implicitly: safe response to flow shut-off)	(Implicitly: safe operation)
CO2 temperature and flow through endoscope system	(Implicitly: safe and effective delivery)	(Implicitly: safe and effective delivery)
CO2 pressure relief valve performance	(Implicitly: effective pressure relief)	(Implicitly: functions as safety backup)
Risk analysis	(Implicitly: risks are acceptable)	(Implicitly: identified risks are acceptable)
Electrical safety IEC 60601-1	Compliance with standard	(Implicitly: Compliant)
Electromagnetic compatibility IEC 60601-1-2	Compliance with standard	(Implicitly: Compliant)
Water bottle warmer performance	(Implicitly: identical to EGA-500 design, functions safely)	(Implicitly: acceptable and safe)

Explanation for Missing Details: This 510(k) summary focuses on demonstrating substantial equivalence to a predicate device ("E-Z-EM Endoscopic CO2 Regulator"). For such submissions, detailed quantitative performance thresholds and results are often contained in the full submission, not in the publicly available summary. The summary confirms that "testing has been performed to demonstrate that the differences do not impact device safety or performance, and any risks associated with the differences are acceptable," indicating that the device did meet unstated acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify sample sizes for any of the non-clinical tests performed. It also does not explicitly state the data provenance (e.g., country of origin, retrospective/prospective). Given that the tests are described as "bench testing," they would be performed in a laboratory setting, not with patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

This information is not applicable and therefore missing. The document describes "bench testing" of a physical device, not an algorithm that requires expert-established ground truth from images or clinical data.

4. Adjudication Method for the Test Set

This information is not applicable and therefore missing. The tests are for a physical device's performance, not an interpretative algorithm requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No. This is a 510(k) submission for a physical medical device (CO2 insufflator), not an AI algorithm that would typically undergo MRMC studies.

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

This question is not applicable. The device is a physical insufflator, not an algorithm. Therefore, "standalone" performance in this context refers to the device operating by itself, which is implicitly what the "bench testing" covers.

7. The Type of Ground Truth Used

For a physical device, "ground truth" typically refers to established engineering specifications, validated measurement techniques, and industry standards. The testing described (e.g., CO2 flow, pressure, temperature, electrical safety) would be validated against these objective physical measurements and standards (e.g., IEC 60601-1). It does not involve "expert consensus, pathology, or outcomes data" in the way an AI diagnostic tool would.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical insufflator, not an AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established

This information is not applicable for the same reason as above.

Summary

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Image /page/0/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, sans-serif font. Below the word "MEDIVATORS" is the text "A Cantel Medical Company" in a smaller, regular font. The logo is simple and professional, conveying a sense of reliability and expertise.

EndoGator Advantage CO2 Insufflator EGA-501

JUN 2 0 2012 .

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@medivators.com763-553-3345
Trade Name:	EndoGator Advantage CO2 Insufflator EGA-501
Common Name:	Endoscopic Insufflator
Classification Name:	Insufflator, automatic carbon-dioxide for endoscope
Product Code:	FCX, Gastroenterology/Urology
Device Class:	II
Regulation No.:	876.1500
Date Prepared:	June 8, 2012
Predicate Device:	E-Z-EM Endoscopic CO2 Regulator
510(k) Number:	K053008

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 CO2 Insufflator to the predicate E-Z-EM Endoscopic CO2 Regulator device 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 with several 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, regular font.

Indications for Use

The EndoGator Advantage CO2 Insufflator is designed to use CO2 as a distention media in the gastrointestinal tract when used in conjunction with a gastrointestinal endoscope.

The EndoGator Advantage CO2 Insufflator contains a CO2 warming feature that allows the clinician to modulate and control delivery of CO2 to the patient that has been warmed to a target temperature 37°C.

Comparison to Other Devices in Commercial Distribution in the United States

Both the subject and predicate devices have the same intended use and general performance as endoscopic CO2 insufflators. They are both intended to regulate and administer CO2 as a distention media in the gastrointestinal tract when used in conjunction with a qastrointestinal endoscope. The EndoGator Advantage CO2 Insufflator has the same basic indications for use as the predicate device, but the indications do differ in that the subject device contains a CO2 warming feature that allows the clinician to modulate and control delivery of CO2 to the patient that has been warmed to a target temperature of 37°C while the predicate does not. The added CO2 warming feature does not present additional risks as it is simply being used to introduce CO2 that is heated to approximately the same target temperature as the surrounding tissues in qastrointestinal (GI) tract.

Certain other performance and functional characteristics of the subject device such as user selectable modes of operation, unit displays/controls, output pressure, pressure relief setting and optional water warming capability do differ slightly from the predicate, however evaluation and testing has been performed to demonstrate that the differences do not impact device safety or performance, and any risks associated with the differences are acceptable.

Summary of Non-Clinical Performance Data

Medivators has performed bench testing to support the substantial equivalence of the EndoGator Advantage CO2 Insufflator to the predicate E-Z-EM Endoscopic CO2 Regulator cleared via K053008 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:

Simulated insufflation performance comparison .
CO2 flow and pressure comparison testing .
CO2 heater performance .
CO2 heater performance with flow shut-off ◆

K113310 Response Page 2 of 3

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Image /page/2/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 word "MEDIVATORS" is the text "A Cantel Medical Company" in a smaller font size. The logo is simple and professional, and it is likely used on the company's website, marketing materials, and products.

K113310
page 3 of 3

CO2 temperature and flow through endoscope system .
CO2 pressure relief valve performance .
Risk analysis .
Electrical safety IEC 60601-1 .
Electromagnetic compatibility IEC 60601-1-2 .
Water bottle warmer performance .

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 CO2 Insufflator EGA-501 is substantially equivalent to the E-Z-EM Endoscopic CO2 Regulator device.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized eagle emblem with three overlapping, curved shapes representing the eagle's head and wings.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Mr. Brent Geiger, MS, RAC International RA Manager Medivators (formerly Byrne Medical, A Minntech Corporation Business Group) 14605 28th Avenue North MINNEAPOLIS MN 55442

JUN 2 0 2012

Re: K113310

Trade/Device Name: EndoGator® Advantage CO2 Insufflator, Model EGA-501 Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FCX Dated: June 11, 2012 Received: June 12, 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.

Sincerély wours,

Daymond K-torko

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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Traditional 510(k) Submission Byrne Medical, Conroe, Texas 77303

Indications for Use

510(k) Number (if known) KII 3310

Device Name: EndoGator® Advantage CO2 Insufflator

Indications for Use:

The EndoGator® Advantage CO2 Insufflator is designed to use CO2 as a distention media in the gastrointestinal tract when used in conjunction with a gastrointestinal endoscope.

Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use 2.1 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)

Vogn. M. Whz
Division Sign-Off

Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K113310

Section 6

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.