KIRWAN DISPOSABLE BATTERY-POWERED CAUTERY, MODEL 41-61XX SERIES

K062659 · Kirwan Surgical Products, Inc. · HQP · Mar 9, 2007 · Ophthalmic

Device Facts

• Record ID: K062659
• Device Name: KIRWAN DISPOSABLE BATTERY-POWERED CAUTERY, MODEL 41-61XX SERIES
• Applicant: Kirwan Surgical Products, Inc.
• Product Code: HQP · Ophthalmic
• Decision Date: Mar 9, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4115
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Kirwan battery-powered cautery units are intended for general surgical use to cauterize small blood vessels in order to help reduce blood loss and keep the site clear of excess blood.

Device Story

Disposable battery-powered thermal cautery unit; used in general surgery to cauterize small blood vessels. Device operates via internal battery power to heat a tip for thermal coagulation. Used by clinicians in surgical settings to minimize blood loss and maintain clear operative fields. Simple mechanical design; no complex electronics or software. Benefit includes improved visualization and hemorrhage control during surgical procedures.

Clinical Evidence

Bench testing only. No clinical data provided. Safety and effectiveness established through adherence to prevailing standards and guidelines, including ISO 11137 for radiation sterilization and ISO 10993-1 for biological evaluation.

Technological Characteristics

Thermal cautery unit; battery-powered. Disposable form factor. Sterilization via radiation per ISO 11137. Biocompatibility evaluated per ISO 10993-1. Low-to-moderate hazard profile.

Indications for Use

Indicated for general surgical use to cauterize small blood vessels to reduce blood loss and maintain site visibility. Intended for prescription use.

Regulatory Classification

Identification

A thermal cautery unit is an AC-powered or battery-powered device intended for use during ocular surgery to coagulate tissue or arrest bleeding by heat conducted through a wire tip.

Predicate Devices

• AAXXX Series, Bovie/Aaron Cautery units
• 844XXXX Series, Medtronic/Solan Cautery units
• 23X Series, Bovie Medical Corp., Perfectemp Cautery units

Submission Summary (Full Text)

{0}------------------------------------------------

K062659

Image /page/0/Picture/1 description: The image shows the logo for Kirwan Surgical Products. The logo features a caduceus symbol inside of a square on the left. To the right of the symbol is the name "Kirwan" in large block letters, followed by the registered trademark symbol. Below and to the right of the name is the text "Surgical Products" in a smaller font.

MAR 0 9 2007

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

{as required by 21 CFR, section 807.92( c )}

FOR

### KIRWAN DISPOSABLE BATTERY-POWERED CAUTERY

# MODELS: 45-61XX, SERIES of DISPOSABLE BATTERY-POWERED CAUTERY

Common name: Thermal Cautery Units.

Classification name: Thermal Cautery Unit (§886.4115)

Product code: GEI.

Devices Class: Class II

Kirwan battery-powered cautery units are intended for general surgical use to cauterize small blood vessels in order to help reduce blood loss and keep the site clear of excess blood.

Technological safety and effectiveness is established by the fact that these cautery units do not contain any new technological risks or characteristics when compared to the legally marketed devices offered here as predicates. They are manufactured according to prevailing standards and represent a technology that has existed in clinical settings for over 25-years.

There are no applicable performance standards listed for these devices under Section 514 of the Food, drug and Cosmetic Act. Nonetheless, Kirwan 41-61XX series devices have been tested and manufactured in accordance with prevailing standards and guidelines in order to assure safety and efficacy. Kirwan cauteries

Kirwan Surgical Products, Inc. 180 Enterprise Drive Marshfield, MA 02050 Phone: [phone] Fax: [phone] Contact: Kevin P. Prario, Regulatory Affairs Manager Date prepared: 9/6/2006

Page 1 of 2

{1}------------------------------------------------

have been found to comply with the requirements of the applicable sections within the following standards and quidelines;

- ISO 11137, Sterilization of health care products Requirements for I validation and routine control-radiation sterilization.
- I ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing.

### Safety and hazard analysis has determined that the hazard conditions for the 41-61XX Disposable Battery-Powered Cautery range in the low-to-moderate level and for this reason are acceptable.

Therefore, the 41-61XX Disposable Battery-Powered Cautery devices are substantially equivalent in intended use, technological safety and effectiveness and performance to the following predicates;

- AAXXX Series, Bovie/Aaron Cautery units. .
- 트 844XXXX Series, Medtronic/Solan Cautery units.
- 부 23X Series, Bovie Medical Corp., Perfectemp Cautery units.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with flowing lines, representing the department's mission of health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 0 9 2007

Kirwan Surgical Products % Mr. Kevin Prario Regulatory Affairs Manager 180 Enterprise Drive Marshfield, Massachusetts 02050

Re: K062659

Trade/Device Name: Kirwan Disposable Battery-Powered Cautery, Model 41-61XX S Regulation Number: 21 CFR 886.4115 Regulation Name: Thermal cautery unit Regulatory Class: II Product Code: HOP Dated: February 2, 2007 Received: March 1, 2007

Dear Mr. Prario:

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

{3}------------------------------------------------

Page 2 - Mr. Kevin Prario

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 [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 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 vours.

foo

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

# Indications for Use

510(k) Number (if known): ___

Device Name:

#### Models: 41-61XX, Series of Kirwan Disposable Battery-Powered Cautery.

Indications for Use:

Kirwan battery-powered cautery units are intended for general surgical use to cauterize small blood vessels in order to help reduce blood loss and keep the site clear of excess blood.

Prescription Use _ X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)


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

11062657 510(k) Number

Page 1 of 1