DEFENDO Y-OPSY IRRIGATOR

K110088 · Byrne Medical Incorporated · ODC · Jun 10, 2011 · Gastroenterology, Urology

Device Facts

• Record ID: K110088
• Device Name: DEFENDO Y-OPSY IRRIGATOR
• Applicant: Byrne Medical Incorporated
• Product Code: ODC · Gastroenterology, Urology
• Decision Date: Jun 10, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

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

Device Story

DEFENDO™ Y-Opsy Irrigator is a sterile, disposable, single-patient-use biopsy valve with a side port for irrigation. It attaches directly to the endoscope biopsy port; provides access for endoscopic device passage (e.g., biopsy forceps) through a slit diaphragm; enables simultaneous irrigation; maintains insufflation; minimizes biomaterial leakage; reduces healthcare professional exposure to biomaterials. Used in hospitals and clinics by medical professionals during endoscopic procedures. Device functions as a mechanical interface; no electronic or software components.

Clinical Evidence

Bench testing only. Comparison of flow rates against EndoGator® System Y-Connector showed equivalent or greater flow. Comparison against DEFENDO™ Biopsy Valve using five functional criteria demonstrated equivalent performance. Leak testing confirmed 100% of units maintained at least 10 psi without leakage during simulated biopsy sample withdrawal, bowel irrigation, and bowel insufflation.

Technological Characteristics

Injection-molded, sterile, disposable biopsy valve. Features a slit diaphragm for instrument passage and a side port for irrigation. Compatible with Olympus and Fujinon endoscopes. Mechanical device; no energy source, software, or connectivity.

Indications for Use

Indicated for patients undergoing endoscopy requiring simultaneous irrigation and instrumentation via the endoscope biopsy channel.

Regulatory Classification

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.

Predicate Devices

• Byrne Medical EndoGator® System Y-Connector (K092429)
• Byrne Medical DEFENDO™ Biopsy Valve (K090851)

Submission Summary (Full Text)

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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:

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.

### 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 Medical<br>DEFENDO™<br>Y-Opsy Irrigator | Byrne Medical<br>EndoGator® System<br>with Y-Connector | Byrne Medical<br>Defendo™ Biopsy<br>Valve | Same? |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------|
| Trade Name | DEFENDO™ Y-Opsy<br>Irrigator | EndoGator® System | DEFENDO™ Biopsy<br>Valve | N/A |
| 510(k) Doc.<br>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 |
| Review<br>Advisory<br>Committee | Gastroenterology/Urology | Gastroenterology/Urology | Gastroenterology/Urology | Yes |
| Indications for<br>use | The DEFENDO™ Y-<br>Opsy Irrigator is intended<br>to enable simultaneous<br>irrigation and<br>instrumentation in the<br>endoscope's biopsy<br>channel. | The EndoGator System®<br>(tubing and accessories<br>to accommodate various<br>endoscopes and<br>irrigation pumps) is<br>intended to provide<br>irrigation via sterile water<br>supply during GI<br>endoscopic procedures<br>when used in conjunction<br>with an irrigation pump<br>(or cautery unit). | The DEFENDO™ Biopsy<br>Valve is indicated for<br>covering the endoscope<br>biopsy port during an<br>endoscopy procedure. In<br>addition, the valve<br>provides access for<br>endoscopic device<br>passage and exchange,<br>helps maintain sufflation<br>and minimizes leakage of<br>biomaterial from the<br>biopsy port throughout<br>the endoscopic<br>procedure. | Yes |
| Compatible<br>Endoscope(s) | Olympus & Fujinon<br>endoscopes | Olympus & Fujinon<br>endoscopes | Olympus & Fujinon<br>endoscopes | Yes |
| Patient<br>Population | Patients who are<br>undergoing an endoscopy | Patients who are<br>undergoing an endoscopy | Patients who are<br>undergoing an<br>endoscopy | Yes |
| Environment<br>of Use | Hospital and/or Clinic | Hospital and/or Clinic | Hospital and/or Clinic | Yes |
| Manufacturing<br>method | Injection molded | Injection molded | Injection molded | Yes |
| Opening for<br>Instruments | Slit in diaphragm | Y-Connector | Slit in diaphragm | No |
| Reusable or<br>disposable | 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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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 [phone] or [phone] 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