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 Description

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.

AI/ML Overview

This 510(k) submission (K062659) for Kirwan Disposable Battery-Powered Cautery relies on a different approach to demonstrate substantial equivalence than clinical studies with explicit acceptance criteria. Instead, it leverages the device's adherence to existing standards and its analogous nature to legally marketed predicate devices.

Here's an analysis based on the provided text:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance	Study to Prove Performance
Safety	Compliance with ISO 10993-1 (Biological evaluation of medical devices - Part 1: Evaluation and testing)	Device found to comply with applicable sections of ISO 10993-1.	Not explicitly described as a discrete "study" in the provided text. Likely involved testing and documentation demonstrating conformity to the standard's requirements for biocompatibility.
Safety	Hazard analysis determined low-to-moderate hazard level.	For the 41-61XX Disposable Battery-Powered Cautery, hazard conditions range in the low-to-moderate level and are deemed acceptable.	Hazard analysis conducted, but details of methodology and specific results are not provided.
Sterilization	Compliance with ISO 11137 (Sterilization of health care products - Requirements for validation and routine control - radiation sterilization)	Device found to comply with applicable sections of ISO 11137.	Not explicitly described as a discrete "study." Likely involved validation and routine control procedures in accordance with the standard for radiation sterilization.
Effectiveness (Technological Equivalence)	Does not contain any new technological risks or characteristics compared to legally marketed predicate devices.	"These cautery units do not contain any new technological risks or characteristics when compared to the legally marketed devices offered here as predicates." Also, "They are manufactured according to prevailing standards and represent a technology that has existed in clinical settings for over 25-years."	This is a declarative statement based on a comparison of the device's design and operating principles to its predicates. No specific study is detailed for this comparison beyond the general statement of technological equivalence.
Performance (Substantial Equivalence)	Substantially equivalent in intended use, technological safety and effectiveness, and performance to predicate devices.	The 41-61XX Disposable Battery-Powered Cautery devices are substantially equivalent in intended use, technological safety and effectiveness and performance to the listed predicates: AAXXX Series Bovie/Aaron Cautery units, E844XXXX Series Medtronic/Solan Cautery units, and 23X Series Bovie Medical Corp., Perfectemp Cautery units.	This is the overarching conclusion of the 510(k) submission, supported by the compliance with standards and the lack of new technological risks or characteristics as assessed by the manufacturer and accepted by the FDA. No specific performance study (e.g., in vivo or in vitro efficacy trials) is described.

Study Details (as applicable to this type of submission):

Given the nature of this 510(k) for a well-established device technology, the "study" demonstrating adherence to acceptance criteria is not a traditional clinical trial or performance study with a test set of data, but rather a demonstration of compliance with recognized standards and a comparison to predicate devices.

Sample size used for the test set and the data provenance: Not applicable in the context of a traditional performance study. The "test set" here refers to the device itself being evaluated against standards and predicates. The data provenance would be internal manufacturing and testing records in compliance with ISO standards.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for device safety and sterilization is established by adherence to recognized international standards (ISO). For technological equivalence, the manufacturer's engineering and regulatory teams would assess the device against predicate designs.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Device compliance with standards and technological equivalence is typically a direct assessment, not an adjudicated review of clinical data.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a surgical instrument, not an AI-powered diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a manual surgical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Safety and Sterilization: Ground truth is established by international standards (ISO 10993-1 for biological evaluation, ISO 11137 for sterilization) and internal hazard analysis.
- Technological Equivalence/Performance: Ground truth for this aspect is based on the characteristics of legally marketed predicate devices (AAXXX Series, E844XXXX Series, 23X Series Cautery units) and the determination that the new device does not introduce new technological risks.
The sample size for the training set: Not applicable. This is not a machine learning or AI device that would require a "training set."
How the ground truth for the training set was established: Not applicable.

Summary

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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: (781) 834-9500 Fax: (781) 834-0022 Contact: Kevin P. Prario, Regulatory Affairs Manager Date prepared: 9/6/2006

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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.

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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

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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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

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

Enclosure

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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)

Imgur

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

11062657 510(k) Number

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Regulation Number and Section

§ 886.4115 Thermal cautery unit.

(a)
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.(b)
Classification. Class II.