WILSON-COOK BIPOLAR PROBE

K990145 · Wilson-Cook Medical, Inc. · KNS · Mar 25, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K990145
• Device Name: WILSON-COOK BIPOLAR PROBE
• Applicant: Wilson-Cook Medical, Inc.
• Product Code: KNS · Gastroenterology, Urology
• Decision Date: Mar 25, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Used in conjunction with single or dual plug bipolar electrosurgical generators to endoscopically provide hemostasis throughout the gastrointestinal tract.

Device Story

The Wilson-Cook Bipolar Probe is an endoscopic electrosurgical accessory designed for hemostasis. The device consists of a catheter shaft with a proximal mono or dual plug for connection to a bipolar electrosurgical generator, a flush port for irrigation, and a distal probe tip. During an endoscopic procedure, the physician passes the probe through the endoscope's working channel to the site of bleeding. The device delivers electrical current from the generator to the tissue at the distal tip to achieve coagulation. The probe is sterile and disposable. By providing controlled hemostasis, the device assists in managing gastrointestinal bleeding, potentially reducing the need for more invasive surgical interventions.

Clinical Evidence

No clinical data. Evidence consists of design verification testing, including visual, dimensional, and functional testing, which met predetermined acceptance criteria. Biocompatibility was established based on the history of use of the predicate device.

Technological Characteristics

Bipolar electrosurgical probe; catheter-based form factor with proximal plug and flush port. Energy source: external bipolar electrosurgical generator. Sterile, single-use disposable. Materials of construction are consistent with the predicate device.

Indications for Use

Indicated for patients requiring endoscopic hemostasis throughout the gastrointestinal tract via bipolar electrosurgical coagulation.

Regulatory Classification

Identification

An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.

Predicate Devices

• Dobbhoff Bipolar Hemostatic Probe (K912129)

Submission Summary (Full Text)

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3/25/99

#### PREMARKET NOTIFICATION FOR THE WILSON-COOK BIPOLAR RE: PROBE

#### 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS I.

### Submitted By:

Wilson-Cook Medical Inc. 4900 Bethania Station Road Winston-Salem, NC 27105

### Device Description:

The Wilson-Cook Bipolar Probe is comprised of a mono or dual plug, flush port, catheter shaft and probe. The dual or single plug is located at the proximal end of the catheter shaft and is used for connection to the appropriate bipolar generator. The flush port is also located at the proximal end of the catheter and is used as necessary for irrigation. The distal tip of the device is the probe component used for hemostasis.

| Trade Name: | Wilson-Cook Bipolar Probe |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Bipolar Probe |
| Classification Name/Code: | Unit, Electrosurgical, Endoscopic (with or without accessories)/78 KNS |
| Classification: | FDA has classified similar devices as Class II, as per 21 CFR § 876.4300. This device falls within the purview of the Gastroenterology and Urology Device Panel. |
| Performance Standards: | To the best of our knowledge, performance standards for this device do not exist. |
| Intended Use: | Used in conjunction with single or dual plug bipolar electrosurgical generators to endoscopically provide hemostasis throughout the gastrointestinal tract. |

# Predicate Device:

| PREDICATE DEVICE | MANUFACTURER | DOCUMENT CONTROL<br>NUMBER |
|--------------------------------------|-------------------------------------|----------------------------|
| Dobbhoff Bipolar<br>Hemostatic Probe | Biosearch Medical<br>Products, Inc. | K912129 |

# Substantial Equivalence:

The Wilson-Cook Bipolar Probe is substantially equivalent to the referenced predicate device with respect to design, materials of construction and intended use.

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#### PREMARKET NOTIFICATION FOR THE WILSON-COOK BIPOLAR RE: PROBE

| DEVICE<br>CHARACTERISTIC | Wilson-Cook Bipolar<br>Probe<br>[Subject of 510(K)] | Biosearch Hydromer<br>grafted Bipolar<br>Hemostatic Probe<br>(K912129) |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Used in conjunction with<br>single or dual plug bipolar<br>electrosurgical generators<br>to endoscopically provide<br>hemostasis throughout the<br>gastrointestinal tract. | The probe is designed to<br>function as a conventional<br>electro-coagulation device<br>when supplied with current<br>from a standard bipolar<br>electro-surgical generator.<br>The device is intended to<br>be passed through an<br>endoscope's working<br>channel to provide<br>hemostasis throughout the<br>GI tract. |
| Sterility | Sterile Disposable | Non-Sterile Disposable |

#### I. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS (continued)

Testing: Biocompatibility has been established for the patient contacting materials through a history of use in the Biosearch Bipolar Probe. This product line has been subjected to Design Verification. During Design Verification, visual, dimensional and functional testing to ensure the performance, design integrity for this product line was conducted. All results obtained during our Design Verification met our predetermined acceptance criteria for this product line.

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Public Health Service

Rockville MD 20850

Food and Drug Administration 9200 Corporate Boulevard

MAR 2 5 1999

Ms. Paula Joyce QA/RA Manager Wilson-Cook® Medical, Inc. 4900 Bethania Station Road Winston-Salem, NC 27105

Re: K990145

Wilson-Cook® Bipolar Probe Dated: January 15, 1999 Received: January 19, 1999 Regulatory Class: II 21 CFR 876.4300/Procode: 78 KNS

Dear Ms. Joyce:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Dan Petit

APT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page __ 13_ of __ 13

510(k) Number (if known): _K99 Ol 45

Wilson-Cook Bipolar Probe Device Name:

Indications for Use:

Used in conjunction with a single or dual plug bipolar electrosurgical generators to endoscopically provide hemostasis throughout the gastrointestinal tract.

t

# (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter (Optional Format 1-2-96)

Elarid le. Heyman

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