ENDOGATOR ENDOSCOPY IRRIGATION PUMP, MODEL EGP-100

K060962 · Byrne Medical, Inc. · OCX · Apr 19, 2006 · Gastroenterology, Urology

Device Facts

• Record ID: K060962
• Device Name: ENDOGATOR ENDOSCOPY IRRIGATION PUMP, MODEL EGP-100
• Applicant: Byrne Medical, Inc.
• Product Code: OCX · Gastroenterology, Urology
• Decision Date: Apr 19, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

Endoscopic irrigation for use with washing catheters integral endoscope water jet channels and endoscope working channels.

Device Story

EndoGator EGP-100 is an endoscopy irrigation pump used to deliver sterile water through endoscope channels. Device utilizes a peristaltic pump head driven by a motor with adjustable RPM (0-550 ml/min). Operation is controlled via a potentiometer/control dial and a foot-pedal-activated air switch. Used in clinical settings by healthcare professionals. Device facilitates irrigation during endoscopic procedures to improve visualization or clear debris. Peristaltic design ensures no contamination of sterile water during delivery.

Clinical Evidence

Bench testing only. No clinical data provided. Safety and efficacy established through comparison of technical specifications and performance parameters (flow rate, pressure) against the predicate device, supplemented by electromagnetic compatibility and safety testing.

Technological Characteristics

Peristaltic pump; adjustable flow rate 0-550 ml/min; pressure range 0-48 PSI; Class I, Type BF equipment; continuous operation; manual control via potentiometer and foot-pedal air switch; dimensions 3.5" x 6" x 8".

Indications for Use

Indicated for endoscopic irrigation in male and female patients, ranging from pediatric to adult, for use with washing catheters, integral endoscope water jet channels, and endoscope working channels.

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

• Meditron Endolav Model EL-100 (K882048)

Submission Summary (Full Text)

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K060962

# Attachment H Reply to deficiency

AFR 1 9 2006

Date: 3/28/06

510(k) Summary 21 CFR 807.92

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:

Byrne Medical, Inc. Company Name: 2021 Airport Road, Conroe, TX 77301 Address: Telephone: [phone] [phone] Fax Christopher Meador Contact: e-mail: [e-mail]

#### 2. Device:

| Proprietary Name: | EndoGator Endoscopy Irrigation Pump |
|----------------------|-------------------------------------|
| Common Name: | Endoscopy Irrigation Pump |
| Classification Name: | Endoscope and/or Accessories |

### 3. Predicate Devices:

Meditron Endolav Model EL-100, K882048, Xylog Corp., 83 Hobart St, Hackensack, NJ 07601

#### র্বা Classifications Names & Citations:

- 21 CFR 876.1500, Class II, KOG, Gastroenterology and Urology.
### 5. Description:

The Byrne Medical, Inc., EndoGator Endoscopy Irrigation Pump is used for Endoscopic irrigation for use with washing catheters integral endoscope water jet channels and endoscope working channels.

The EGP-100 pump will provide an adjustable flow-rate from 0-550ml/min, which is based on a variable motor RPM. The motor is controlled by the use of a potentiometer and control dial. A foot pedal activated air switch controls the running or stopping of the purnp motor and a peristaltic pump head. These parts will not cause contamination of sterile water during deliverance.

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## 6. Indications for Use:

Endoscopic irrigation for use with washing catheters integral endoscope water jet channels and endoscope working channels.

## 7. Contra-indications:

None noted at the time of this submission.

# 8. Comparison:

The general method of operation and construction between the predicate device and the Byrne Medical, Inc., EndoGator pump is simulator. Indications for use are the same for both devices.

The Byrne Medical, Inc., EndoGator pump is smaller and the weight is less.

Specifications comparison:

| Parameter | EndoGator EGP-100<br>This Submission | Meditron Endovav<br>EL-100<br>K882048 | Parameter<br>is the<br>same |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Indications for Use | Endoscopic irrigation for<br>use with washing<br>catheters, integral<br>endoscope water jet<br>channels, and<br>endoscope working<br>channels. | Endoscopic irrigation<br>for use with washing<br>catheters, integral<br>endoscope water jet<br>channels, and<br>endoscope working<br>channels. | Yes |
| Regulation # | 21 CFR 876.1500 | 21 CFR 876.1500 | Yes |
| Target Population | Male/Female pediatric to adult | Male/Female pediatric to adult | Yes |
| Prescription Device | Yes | Yes | Yes |
| Dimensions (H x W xD) | 3.5" x 6" x 8" | 4.5" x 5" x 8" | No |
| Classification | Class I, Type BF,<br>Ordinary Equipment for<br>Continuous operation | Class I, Type BF,<br>Ordinary Equipment for<br>Continuous operation | Yes |
| Min and Max flow rate | Min - 0 ml/min<br>Max - 550 ml/min | Min - 15 ml/min<br>Max - 650 ml/min | No |
| Pressure | Min - 0 PSI<br>Max - 48 PSI | Min - 2 PSI<br>Max - 40 PSI | No |
| Pump type | Peristaltic | Peristaltic | Yes |

#### ். Test Review:

The EMI and Safety Testing shall be conducted and meet spacified acceptance criteria before the device is marketed.

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## Conclusions:

The conclusion drawn trom this comparison, together with required passage of electromagnetic compatibility and safety testing, is that the Byrne Medical, Inc. EndoGator pump is equivalent in safety and efficacy to its predicated device.

T. Ricards

Christopher Meador Regulatory Affairs and Quality Control Manager

Date: 3/28/06

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or other bird-like figure. The symbol is composed of three curved lines that converge at the bottom.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Byrne Medical, Inc. c/o Mr. Daniel W. Lehtonen Staff Engineer - Medical Devices and Responsible Third Party Official Intertek Testing Services NA, Inc. 2307 East Aurora Road, Unit B7 TWINSBURG OH 44087

K060962 Rc:

> Trade/Device Name: EndoGator Model # EGP-100 Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: KOG Dated: April 6, 2006 Received: April 7, 2006

Dear Mr. Lehtonen:

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.

APR 19 2006

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.

Image /page/3/Picture/9 description: The image shows the FDA Centennial logo, which includes the years 1906-2006. Below the logo, the text "Protecting and Promoting Public Health" is written in a decorative font. The logo is circular and contains the letters FDA in a stylized font. The word "Centennial" is written below the letters FDA.

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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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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/cdrh/industry/support/index.html

Sincerely yours,

Nancy C. Brogdon

Nancv C. Brogdon Director. Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Attachment C Reply to deficiencies

# Indications for Use Statement

510(k) Number K060962

#### EndoGator Model # EGP-100 Device Name:

Indications for Use: Endoscopic irrigation for use with washing catheters integral endoscope water jet channels and endoscope working channels.

Prescription Use ત્ત્વન્ય (Part 21 CFR 801 Subpart D) ANDIOR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David R. Larson
Division Sign Off

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number. K060962