ENDO GATOR SYSTEM

K031773 · Byrne Medical, Inc. · OCX · Jun 24, 2003 · Gastroenterology, Urology

Device Facts

• Record ID: K031773
• Device Name: ENDO GATOR SYSTEM
• Applicant: Byrne Medical, Inc.
• Product Code: OCX · Gastroenterology, Urology
• Decision Date: Jun 24, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Indications for Use

The Endo Gator Irrigation Tubing is intended as sterile, disposable water bottle tubing with cap and back-flow device that supplies sterile water to irrigation pumps and cauterizing units. The Endo Gator Cartridge is intended as a replacement cartidge for irrigation pumps or cauterizing units for use with the Endo Gator disposable water bottle tubing and cap. The Auxiliary Water-port tubing for the Olympus Endoscopes is intended as a replacement for the existing water-port tubing make by Olympus for the 160 Series of Endoscopes.

Device Story

Endo Gator System comprises sterile, disposable irrigation tubing with cap/back-flow device, a reusable cartridge, and auxiliary water-port tubing for Olympus 160 Series endoscopes. Device connects water bottles to irrigation pumps or cauterizing units to supply sterile water during endoscopic procedures. System replaces existing manufacturer-specific cartridges and tubing. Used in clinical settings by medical professionals. Provides consistent water flow for lavage and irrigation; helps mitigate infection risks associated with improperly maintained reusable water containers. Output is controlled water delivery to the endoscope or cautery unit.

Clinical Evidence

Bench testing only. Testing included flow rate measurements (155-650 ml/min) and pressure testing (up to 10 PSI) to ensure performance within pump specifications (max 4.4 PSI). No clinical data provided.

Technological Characteristics

System includes disposable sterile tubing sets and a reusable cartridge. Materials are appropriate for medical application. Designed for compatibility with ERBE Endo 100, Pentax EI-400C/CGI-4000B, Meditron EI-100C/UGI-3000B, and Fujinon JW pumps. Mechanical fluid delivery system; no electronic or software components.

Indications for Use

Indicated for use as a sterile, disposable water delivery system for irrigation pumps and cauterizing units during endoscopic procedures, and as replacement tubing for Olympus 160 Series endoscopes. Prescription use only.

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.

In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls: 1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following: 1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures. 2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use. 3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use. 2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes. 3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches 4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error. 5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program. (6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms. (7) Labeling must include: (i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified; (ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA; (iii) Identification of compatible devices; (iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification; (v) Reprocessing instructions for reusable components; (vi) A shelf life for any sterile components; (vii) A description of the device-specific use training program; (viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and (ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance. (8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include: (i) Device motion accuracy and repeatability; (ii) System testing; (iii) Instrument reliability; (iv) Crosstalk; (v) Table motion control; (vi) Thermal effects on tissue; (vii) User-device interface performance; (viii) Workspace access testing; and (ix) Performance testing with compatible devices. (9) Software verification, validation, and hazard analysis must be performed. (10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed. (11) Performance data must demonstrate the sterility of all patient-contacting device components. (12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life. (13) Performance data must validate the reprocessing instructions for the reusable components of the device. (14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible. (15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic. (16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information: (i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and (ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.

Predicate Devices

• Endo SmartCap™ (K971125)
• UGI-3000B (K884836)

Submission Summary (Full Text)

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

Byrne Medical, Inc. % Mr. Ned Devine Responsible Third Party Entela, Inc. 3033 Madison Avenue SE Grand Rapids, MI 49548

JUL 2 7 2015

Re: K031773

Trade/Device Name: Endo Gator System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCX Dated (Date on orig SE ltr): June 6, 2003 Received (Date on orig SE ltr): June 9, 2003

Dear Mr. Devine,

This letter corrects our substantially equivalent letter of June 24, 2003.

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

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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 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 contact 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/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Benjamin R. Fisher -S

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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510(k) Number K_031773

Device Name: Endo Gator System

Indications for use:

The Endo Gator Irrigation Tubing is intended as sterile, disposable water bottle tubing with cap and back-flow device that supplies sterile water to irrigation pumps and cauterizing units.

The Endo Gator Cartridge is intended as a replacement cartidge for irrigation pumps or cauterizing units for use with the Endo Gator disposable water bottle tubing and cap.

The Auxiliary Water-port tubing for the Olympus Endoscopes is intended as a replacement for the existing water-port tubing make by Olympus for the 160 Series of Endoscopes.

Prescription Device:

Federal Law (US) restricts this device to sale by or on the order of a physician.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-The-Counter Use _

ivision Sign-Off)
Ivision of Reproductive, Abdominal,
ad Radiological Devices
K031773

§10(k) Number **__**

OR

(Optional Format 1-2-96)

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## Summary

Assigned 510(k) “K” Number K031773

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

- 1. Company making the submission:

| | Company | Or | Correspondent (contact) |
|--------------------|----------------------------------------------------------------------------|----|------------------------------------------------------------------------|
| Name:<br>Address: | Byrne Medical, Inc.<br>13843 Hwy 105 West<br>Suite 317<br>Conroe, TX 77304 | | Delphi Consulting Group<br>11874 South Evelyn Cr.<br>Houston, TX 77071 |
| Telephone:<br>Fax: | 800-490-9869<br>936-588-0392 | | 832-285-9423<br>775-429-9524 |
| Contact: | Don Byrne<br>President<br>[e-mail] | | Harvey Knauss<br>Consultant<br>[e-mail] |

#### 2. Device:

| Proprietary Name: | Endo Gator System |
|----------------------|----------------------------|
| Common Name: | Water Bottle Adapter |
| Classification Name: | Endoscopes and Accessories |

#### 3. Predicate Devices:

| Device Name | Manufacturer | "K" # |
|----------------|---------------|----------|
| Endo SmartCap™ | Byrne Medical | K971125* |
| UGI-3000B | Meditron | K884836 |

· Note: Company name changed from Endo Smart Cap Co to Byrne Medical.

- 4. Classification and Product Code: 21 CFR § 876.1500, Class II, 78 KOG and others.
- 5. Description:

The Byrne Medical Endo Gator System consists of the following assemblies:

- 100125 Endo Gator Irrigation Tubing A sterile, disposable water bottle A tubing with cap and back-flow device which supplies sterile water to irrigation pump or cauterizing units. Works only with the Endo Gator Cartridge.
- 100110 Endo Gator Cartridge Replacement cartridge for imgation pump(s) A or cauterizing units. The cartridge hub is designed to seat the Endo Gator

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Tubing and replace the existing cartridge from the pump manufacturer.

- 2 100115 Auxiliary Water-port Tubing for Olympus Scopes A sterile, disposable water irrigation tubing that replaces the existing water-port tubing made by Olympus for the 160 Series of scopes.
The Endo Gator System tubing sets are sold as a sterile, single patient use devices. It is packaged in a Chevron-style sterile barrier pouch with product label affixed to the clear side of the package. The Endo Gator Cartridge is reusable and is sold not sterile.

- 6. Indications for Use Statement:
The Endo Gator Irrigation Tubing is intended as sterile, disposable water bottle tubing with cap and back-flow device that supplies sterile water to irrigation pumps and cauterizing units.

The Endo Gator Cartridge is intended as a replacement cartridge for irrigation pumps or cauterizing units for use with the Endo Gator disposable water bottle tubing and cap.

The Auxiliary Water-port tubing for the Olympus Endoscopes is intended as a replacement for the existing water-port tubing make by Olympus for the 160 Series of Endoscopes.

- 6. Summary of Technological Characteristics and Differences:
The Endo Gator System tubing set consists of a bottle cap/tube set/connector are made of materials that are appropriate for the application, provided sterile for single patient use only. The Endo Gator Cartridge will mount on the irrigator pumps sold by ERBE Endo 100, Pentax El-400C, Pentax CGI-4000B, Meditron El-100C, Meditron UGI-3000B and Fujinon JW. The Endo Gator Cartridge is reusable. The use of the Endo Gator Cartridge becomes a replacement for some predicate device water systems.

Water container(s), which are reused and not maintained properly, may present an infection control risk.

The Endo Gator System and all predicate devices provide water to irrigator pumps or cauterizing units.

- 7. Contraindications:
The Endo Gator System is not designed, sold or intended for use except as indicated.

No other contraindications are known for this device.

- 8. Comparison:
The Byrne Medical Endo Gator System has the same device characteristics and the predicate devices. Difference between some systems is providing tubing sets sterile for single patient use.

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#### 9. Test Data:

The Byrne Medical Endo Gator System has been subjected to extensive safety, performance, and validations prior to release.

Bench testing was conducted utilizing Meditron UGI-3000B™GI Endoscopy Benon cooling was consected @ Endoscopic Lavage Pumps and EndoGator™ Cartridge and tubing sets.

Flow testing was completed at the minimum and maximum settings of the pump systems. Water flow was measured as a function of total volume over time. In each test the minimum pump setting produced 155 ml/min and maximum produced 650 ml/min with a measurement error of +/- 4%.

Pressure testing – EndoGator™ system was tested to 10 PSI without leaking or any other failure. The pump manufacturer's stated maximum pressure is 4.4 PSI.

#### 10. Conclusions:

The conclusion drawn from these tests is that the Byrne Medical Endo Gator System is equivalent in safety and efficacy to its predicate devices.

APRIL 2003 DATE: 30