The Irrigation Pump and Irrigation Biopsy Valve System is intended to provide a manual, foot-controlled delivery of fluid from commercially available sterile water bottles to flexible gastrointestinal endoscopes to facilitate the irrigation and lavage of debris within the gastrointestinal tract.

The Irrigation Pump is intended as a disposable, manual, foot-controlled, irrigation pump with a bottle cap and back-flow valve that delivers fluid from sterile water bottles.

The Irrigation Biopsy Valve is intended as a disposable, replaceable valve that connects the Irrigation Pump to the accessory channel of a flexible, endoscope.

Device Description

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "US Endoscopy Irrigation Pump and Valve System". This document details the regulatory submission and approval for a medical device, not a diagnostic algorithm or AI product. Therefore, many of the requested categories in your prompt are not applicable to this type of submission.

Here's an analysis based on the available information:

1. A table of acceptance criteria and the reported device performance

The submission does not explicitly list "acceptance criteria" in the way one would for a diagnostic algorithm with performance metrics like sensitivity, specificity, or AUC. Instead, the device's acceptable performance is demonstrated through its design characteristics, comparison to predicate devices, and functional bench testing.

Acceptance Criteria (Implied)	Reported Device Performance
Safety and Effectiveness for Intended Use	Substantially equivalent to predicate devices based on design, comparison, and performance testing.
Biocompatibility	All components that come into indirect contact with the patient have a long history of use in medical devices and are biocompatible.
Functional Bench Testing	Performance testing consisted of functional bench testing (details not provided in the summary).
No Direct Patient Contact	No components come into direct contact with the patient.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This device is an irrigation pump and valve system, not a diagnostic software that uses a "test set" of patient data. The "testing" referred to is functional bench testing of the physical device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. "Ground truth" in the context of diagnostic algorithms refers to a verified diagnosis or outcome. For this device, performance is evaluated through engineering and functional tests.

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

Not applicable. There is no expert adjudication for this type of device submission.

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 is not an AI or diagnostic imaging device that involves human readers.

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

Not applicable. This is a physical medical device, not a standalone algorithm.

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

Not applicable. For this device, "ground truth" would be related to its functional specifications (e.g., fluid delivery rate, pressure, leak integrity) which are assessed through engineering tests, not clinical "ground truth" data.

8. The sample size for the training set

Not applicable. No "training set" is used for this type of medical device submission.

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

Not applicable.

Summary

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CONFIDENTIAL United States Endoscopy Group, Inc. August 8, 2009

510(k) Premarket Notification: Traditional Irrigation Pump and Irrigation Biopsy Valve System

NR.V - 2 2009

K092461
Page 1 of 2

510(k) SUMMARY FOR THE US ENDOSCOPY IRRIGATION PUMP AND VALVE SYSTEM

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92

Applicant:

United States Endoscopy Group, Inc. 5976 Heisley Road Mentor, Ohio 44060

Contact Person:

Craig L. Moore General Counsel 5976 Heisley Road Mentor, Ohio 44060 Telephone No .: (440) 639-6470 Fax No .: (440) 639-6256

Device Common Name:

Classification Name:

Trade Name:

Endoscope and Accessories

None at this time.

Device Classification: Class II, per 21 CFR 876.1500

Product Code: 78 (OCX)

Predicate Devices:

EndoGator Endoscopy Irrigation Pump EGP 100, ਕ. manufactured by Byrne Medical, Inc. (K060962).

Irrigation Pump and Irrigation Biopsy Valve System

b. ERBE EIP2, (K# unknown)

EndoGator System, Byrne Medical, Inc. (K031773) C.
Irrigation Channel Tubing, Byrne Medical, Inc. d. (K033695)

FLOTM e. ERBE Endoscopy Pump Tubing, manufactured by Byrne Medical, Inc. (K031773, K033695)

193

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CONFIDENTIAL United States Endoscopy Group, Inc. August 8, 2009

Product Description:

Indication For Use:

The Irrigation Pump is intended as a disposable, manual, foot-controlled, irrigation pump with a bottle cap and back-flow valve that delivers fluid from sterile water bottles.

The Irrigation Biopsy Valve is intended as a disposable, replacement valve that connects the Irrigation Pump to the accessory channel of a flexible endoscope.

Safety and Performance:

Substantial equivalence for the new device was based on design characteristics, a comparison to legally marketed predicate devices, and performance testing. Performance testing consisted of functional bench testing. No components come into direct contact with the patient. All components that come into indirect contact with the patient have a long history of use in medical devices and are biocompatible.

Conclusion:

Based on the indications for use, technological characteristics, performance testing, and comparison to predicate devices, the proposed US Endoscopy Irrigation Pump and Valve i System has been shown to be safe and effective for its intended use.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The logo is simple and recognizable, conveying a sense of authority and trustworthiness.

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. Craig L. Moore General Counsel United States Endoscopy Group, Inc. 5976 Heisley Road Mentor OH 44060

NOV - 5 2009

Re: K092461

Trade/Device Name: Irrigation Pump and Irrigation Biopsy Valve System Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCX Dated: August 7, 2009 Received: August 11, 2009

Dear Mr. Moore:

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.

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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Page 2 –

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,

Lucia M. Miron

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

09246

510(k) Number (if known):

Device Name: Irrigation Pump and Irrigation Biopsy Valve System

Indications for Use:

The Irrigation Pump is intended as a disposable, manual, foot-controlled, irrigation pump with a bottle cap and back-flow valve that delivers fluid from sterile water bottles.

The Irrigation Biopsy Valve is intended as a disposable, replaceable valve that connects the Irrigation Pump to the accessory channel of a flexible, endoscope.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use × (Part 21 CFR 801 Subpart D)

Dan Lewis

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number

Over-The-Counter Use (21 CFR 807 Subpart C)

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.