UNIT, CAUTERY, TEHRMAL,BATTERY-POWERED

K030158 · Walsh Medical Devices, Inc. · GEI · Jul 17, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K030158
• Device Name: UNIT, CAUTERY, TEHRMAL,BATTERY-POWERED
• Applicant: Walsh Medical Devices, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jul 17, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

CAUTERY HANDLES AND CAUTERY TIPS ARE INTENDED FOR COAGULATING TISSUE OR ARRESTING BLEEDING FROM SMALL VESSELS USING HEAT CREATED BY THE WIRE TIP. INDICATIONS INCLUDE OPHTHALMIC AND GENERAL AND PLASTIC SURGERY PROCEDURES.

Device Story

Battery-powered cautery handles and wire tips; used to coagulate tissue or arrest bleeding from small vessels via heat generated at wire tip. Used in ophthalmic, general, and plastic surgery, and vasectomy procedures. Operated by surgeons/clinicians in clinical settings. Device consists of handle (medium or low temp) and various tip geometries (short, medium, vasectomy, heavy-duty long).

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Battery-powered (AA) cautery handles with wire tips. Energy source: electrical resistance heating. Form factor: handheld device with interchangeable tips. No software or connectivity.

Indications for Use

Indicated for patients undergoing ophthalmic, general, and plastic surgery procedures, including vasectomies, requiring tissue coagulation or hemostasis of small vessels.

Regulatory Classification

Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

Predicate Devices

• Aaron Medical Industries (K945761)
• Aaron Medical Industries (K945762)
• Aaron Medical Industries (K945763)

Submission Summary (Full Text)

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# 510(k) Summary 10.0

Image /page/0/Picture/2 description: The image shows a sequence of alphanumeric characters, specifically 'K030158'. The characters are handwritten and appear to be on a white background. A horizontal line is present beneath the last digit, '8', possibly indicating an underline or a separation mark.

### Submitter Information a.

Walsh Medical Devices Inc. 1200 South Service Road, W, Unit 3 Oakville ON L6L. 5T7

| Telephone: | [phone] |
|-----------------|---------------------------------------------|
| Fax: | [phone] |
| Contact Person: | David Stiles<br>Director of Quality Systems |
| Date Prepared: | November 20, 2002 |

#### b. Device Identification

| Common/Usual Names: | Cautery Handles & Cautery Tips |
|------------------------|--------------------------------------------------------------|
| Proprietary Name: | Walsh Medical Devices Inc.<br>Cautery Handles & Cautery Tips |
| Device Classification: | CLASS II |

### Identification of Predicate Device(s) C.

The Walsh Medical Devices Inc. Cautery Handles and Cautery Tips are substantially equivalent to those offered by Aaron Medical Industries (K945761, k945762 & k945763) previously cleared and currently marketed.

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### Device Description d.

Battery powered Cautery Handles and Cautery Tips to

coagulate tissue or arrest bleeding from small vessels using

heat created by the wire tip during Ophthalmic, General and

Plastic Surgery and Vasectomy procedures.

# DESCRIPTION PRODUCT CODE #

| 9671 | Cautery Handle (MEDIUM TEMP) – 2 “AA”<br>batteries |
|------|----------------------------------------------------|
| 9672 | Cautery Handle (LOW TEMP) – 1 "AA" battery |
| 9675 | Cautery Tip (Short) |
| 9676 | Cautery Tip (Medium) |
| 9677 | Cautery Tip (Vasectomy) |
| 9678 | Heavy Duty Cautery Tip (Long) |

# Substantial Equivalence e.

The Walsh Medical Devices Inc. Cautery Handles and Cautery Tips Units are substantially equivalent to the Cautery Handles and Tips offered by Aaron Medical Industries (k945761, k945762 & k945763), differences exist between these devices relating to technical specifications, materials, and physical appearance do not affect the relative safety or effectiveness of the Walsh Cautery Handles and Cautery Tips relative to the predicates.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. 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 with its wings spread.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 17 2003

Mr. David Stiles Director of Quality Systems Walsh Medical Devices, Inc. 1200 South Service Road, W, Unit 3 Oakville, Ontario L6L 5T7

Re: K030158

Trade/Device Name: Walsh Medical Devices, Inc. Cautery Handles & Cautery Tips Regulation Number: 21 CFR 878.4400, 886.4100 Regulation Name: Electrosurgical cutting and coagulation device and accessories, Radiofrequency electrosurgical cautery apparatus Regulatory Class: II Product Code: GEI, HQR Dated: May 13, 2003 Received: May 14, 2003

Dear Mr. Stiles:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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.

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.

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Page 2 - Mr. David Stiles

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 [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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Miriàm C. Provost

(0) Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510 (k) NUMBER (IF KNOWN) : K030158

DEVICE NAME : WALSH MEDICAL DEVICES INC. CAUTERY HANDLES & CAUTERY TIPS

INDICATIONS FOR USE:

CAUTERY HANDLES AND CAUTERY TIPS ARE INTENDED FOR COAGULATING TISSUE OR ARRESTING BLEEDING FROM SMALL VESSELS USING HEAT CREATED BY THE WIRE TIP. INDICATIONS INCLUDE OPHTHALMIC AND GENERAL AND PLASTIC SURGERY PROCEDURES.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Per 21 CFR 801.109)

OR

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

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K030158