The DEFENDO™Y-Opsy Irrigator is a sterile, disposable, single patient use, biopsy valve with a side port backflow valve for irrigation. It provides access for endoscopic device passage, helps maintain sufflation, and minimizes leakage of biomaterial from the biopsy channel during endoscopic procedures. The backflow valve prevents the potential of cross contamination between patients the device's diaphragm (slit) minimizes leakage from the biopsv channel while reducing the healthcare professional's exposure to biomaterials as endoscopy instruments are withdrawn.

AI/ML Overview

Here's an analysis of the acceptance criteria and supporting studies for the DEFENDO™ Y-Opsy Irrigator, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to predicate devices through comparative bench testing rather than defining explicit acceptance criteria for novel performance claims. The "acceptance criteria" are implied by the performance of the predicate devices.

Acceptance Criteria (Implied)	Reported Device Performance (DEFENDO™ Y-Opsy Irrigator)
Flow Rate: Equivalent or greater than the Endogator® System Y-Connector (K092429) (for irrigation functionality).	Demonstrated equivalent or greater flow rate than the predicate Endogator System Y-Connector (K092429) when tested with two separate manufacturers' endoscopes.
Functional Equivalence: Equivalent performance to the DEFENDO™ Biopsy Valve (K090851) across five functional criteria.	Demonstrated equivalent performance to the DEFENDO™ Biopsy Valve (K090851) across five functional criteria.
Leakage during biopsy sample withdrawal/bowel irrigation: No evidence of fluid leakage.	100% of tested DEFENDO™ Y-Opsy Irrigators showed no evidence of fluid leakage during sample biopsy or bowel irrigation.
Pressure maintenance during bowel insufflation: Maintain at least 10 psi with no leakage.	100% of tested DEFENDO™ Y-Opsy Irrigators maintained a pressure of at least 10 psi with no leakage.

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

Flow Rate Study: The sample size for the devices tested in the flow rate study is not explicitly stated, only that it utilized "two separate manufacturers' endoscopes." The provenance of this data is retrospective (bench testing results conducted by the manufacturer).
Functional Criteria Study: The sample size for the devices tested in the functional criteria study is not explicitly stated. The provenance of this data is retrospective (bench testing results conducted by the manufacturer).
Leak Testing: The sample size for the leak testing is described as "100% of the DEFENDO™ Y-Opsy Irrigators tested." The exact number (e.g., N=X) is not provided, but implies a comprehensive test of a batch. The provenance of this data is retrospective (bench testing results conducted by the manufacturer).
Country of Origin: Not specified but implicitly conducted by Byrne Medical Inc. in Conroe, Texas, USA.

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

Not applicable. This device is a medical accessory, and the "ground truth" for its performance is established through measurable physical properties (flow rate, leakage, functional criteria) through bench testing, not by expert interpretation of images or clinical data.

4. Adjudication Method for the Test Set:

Not applicable. As noted above, the evaluation is based on objective bench testing measurements, not expert review or adjudication of subjective data.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. This is not a diagnostic imaging device or an AI-assisted device that would involve human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. This is a physical medical device, not an algorithm or software. The performance studies are standalone to the device itself.

7. The Type of Ground Truth Used:

The ground truth used for these studies is based on:

Predicate Device Performance: The established performance characteristics of the legally marketed predicate devices (Byrne Medical Endogator® System Y-Connector and Byrne Medical DEFENDO™ Biopsy Valve).
Objective Bench Test Measurements: Quantifiable measurements such as flow rate (volume over time) and pressure capabilities, as well as qualitative assessments of functional equivalence during simulated use.

8. The Sample Size for the Training Set:

Not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."

9. 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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Summary of Safety and Effectiveness Data (As required by 21 CFR 807.92)

JUN 1 0 2011

January 10, 2011 Date Prepared: Revised: June 8, 2011
Byrne Medical Inc. Submitted by: 3150 Pollok Dr. Conroe, Texas 77303

936-521-4240

Company contact: John Willis Director of Requlatory Affairs 3150 Pollok Dr. Conroe, Texas 77303

936-521-4240

Indications for Use:

The DEFENDO™ Y-Opsy Irrigator is intended to enable simultaneous irrigation and instrumentation in the endoscope's biopsy channel.

Description:

Substantial Equivalence:

The DEFENDO™ Y-Opsy Irrigator is substantially equivalent to the Byrne Medical Endoqator® System Y-Connector and the Byrne Medical DEFENDO™ Biopsy Valve.

The Byrne Medical, Inc., DEFENDO™ Y-Opsy Irrigator and predicate device's (Byrne Medical Endogator® System Y-Connector, K092429 and Byrne Medical DEFENDO™ Biopsy Valve, K090851) are in Class II, 21 CFR 876.1500.

The predicate devices' are manufactured by Byrne Medical Inc., Conroe, Texas. The Byrne Medical, Inc., DEFENDO™ Y-Opsy Irrigator has been determined to meet the equivalence decision making process as detailed by the "510(k) Substantial Equivalence Decision-Making Process Flowchart" (updated July 30, 2007).

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Table 14-1: Comparison of features and principles of operation between the DEFENDO™ Y-Opsy Irrigator and Predicate Devices' (Byrne Medical Endogator® System Y-Connector and Byrne Medical DEFENDO™ Biopsy Valve)

Characteristic	Byrne MedicalDEFENDO™Y-Opsy Irrigator	Byrne MedicalEndoGator® Systemwith Y-Connector	Byrne MedicalDefendo™ BiopsyValve	Same?
Trade Name	DEFENDO™ Y-OpsyIrrigator	EndoGator® System	DEFENDO™ BiopsyValve	N/A
510(k) Doc.No	K110088	K092429	K090851	N/A
Product Code	ODC	FEQ	ODC	No
Regulation#	876.1500	876.1500	876.1500	Yes
Class	II	II	II	Yes
ReviewAdvisoryCommittee	Gastroenterology/Urology	Gastroenterology/Urology	Gastroenterology/Urology	Yes
Indications foruse	The DEFENDO™ Y-Opsy Irrigator is intendedto enable simultaneousirrigation andinstrumentation in theendoscope's biopsychannel.	The EndoGator System®(tubing and accessoriesto accommodate variousendoscopes andirrigation pumps) isintended to provideirrigation via sterile watersupply during GIendoscopic procedureswhen used in conjunctionwith an irrigation pump(or cautery unit).	The DEFENDO™ BiopsyValve is indicated forcovering the endoscopebiopsy port during anendoscopy procedure. Inaddition, the valveprovides access forendoscopic devicepassage and exchange,helps maintain sufflationand minimizes leakage ofbiomaterial from thebiopsy port throughoutthe endoscopicprocedure.	Yes
CompatibleEndoscope(s)	Olympus & Fujinonendoscopes	Olympus & Fujinonendoscopes	Olympus & Fujinonendoscopes	Yes
PatientPopulation	Patients who areundergoing an endoscopy	Patients who areundergoing an endoscopy	Patients who areundergoing anendoscopy	Yes
Environmentof Use	Hospital and/or Clinic	Hospital and/or Clinic	Hospital and/or Clinic	Yes
Manufacturingmethod	Injection molded	Injection molded	Injection molded	Yes
Opening forInstruments	Slit in diaphragm	Y-Connector	Slit in diaphragm	No
Reusable ordisposable	Disposable	Disposable	Disposable	Yes
Sterile	Yes	Yes	Yes	Yes

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Similarities and Differences:

Similarities: Indications for Use

All three products cover a biopsy port, provide access for endoscopic device passage and exchange, and help maintain sufflation, minimize leakage of biomaterial from the biopsy port throughout the endoscopic procedure and provide access for irrigation.

All three devices are suitable for use with both the Olympus and Fujinon endoscopes.

All three devices have the same Regulation number (876.1500) and all are Class II medical devices. All three are intended for the same patient population and environment of use.

Differences:

The Endogator® System is comprised of a peristaltic pump, tubing, and accessories, one of which is a Y-Connector. All these components are connected to the endoscope and work in unison, to provide for irrigation and allow for instrument passage into the colon. The DEFENDO™ Y-Opsy and DEFENDO™ Biopsy Valve are more of a "stand alone" product. The DEFENDO™ Y-Opsy connects directly to the biopsy port of the endoscope and allows for the passage of instrumentation such as biopsy forceps through the slit in the valve while also allowing for irrigation through a separate channel.

The DEFENDO™ Biopsy Valve also connects directly on to the endoscope biopsy port and only allows for passage of instrumentation such as Biopsy forceps through the slit in the valve.

Comparative Studies: Bench Testing

In a comparison of flow rates between the DEFENDO™ Y-Opsy Irrigator and the predicate. Endogator System Y-Connector utilizing two separate manufacturers' endoscopes, the DEFENDO™ Y-Opsy demonstrated equivalent or greater flow rate than that of the predicate.

In a comparison study between the DEFENDO™ Y-Opsy Irrigator and the predicate, the DEFENDO™ Biopsy Valve utilizing five functional criteria, the DEFENDO™ Y-Opsy Irrigator demonstrated equivalent performance to the DEFENDO™ Biopsy Valve.

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Leak Testing:

Leak testing was performed with the DEFENDO™ Y-Opsy Irrigator to simulate the withdrawal of biopsy samples, bowel irrigation and bowel insufflations. 100% of the DEFENDO™ Y-Opsy Irrigators tested showed no evidence of fluid leakage during sample biopsy or bowel irrigation.

Additionally, tests were performed simulating bowel insufflations, 100% of the DEFENDO™ Y-Opsy Irrigators tested maintained a pressure of at least 10 psi with no leakage.

Based on the above findings we have determined that the DEFENDO™ Y-Opsy Irrigator is substantially equivalent to its predicates, the Endogator® System Y-Connector (K092429) and the DEFENDO™ Biopsy Valve (K090851).

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.

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

JUN 1 0 2011

Mr. John Willis Director of Regulatory Affairs Byrne Medical, Inc. 3150 Pollok Drive CONROE TX 77303

Re: K110088

Trade/Device Name: DEFENDO™ Y-Opsy Irrigator Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: ODC Dated: May 4, 2011 Received: May 5, 2011

Dear Mr. Willis:

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 of medical device-related

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Page 2

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,

Hubert Lenoir MD

Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

11088

Device Name: DEFENDO™ Y-Opsy Irrigator.

Indications for Use:

The DEFENDO™ Y-Opsy Irrigator is intended to enable simultaneous irrigation and instrumentation in the endoscope's biopsy channel.

Over-The-Counter Use Prescription Use _ × Prescription Use
(Part 21 CFR 801 Subpart D) AND/OR (Part 21 CFFR 801 Subpart D) (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)

Aom M. Whig

tive. Gastro-Re

Y-Opsy

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.