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 Description

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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Walsh Medical Devices Inc. Cautery Handles & Cautery Tips:

The provided 510(k) summary does NOT contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

Instead, this document is a 510(k) premarket notification for a medical device. A 510(k) is a submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed predicate device. This is primarily done by demonstrating "substantial equivalence," not by conducting new clinical studies or establishing novel performance acceptance criteria.

Therefore, many of the requested sections regarding acceptance criteria, sample sizes, expert qualifications, adjudication, and specific study types (MRMC, standalone) cannot be addressed from this document because such detailed studies are typically not required for a 510(k) submission seeking substantial equivalence.

Here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not provided	Not provided
(No specific performance criteria or tests results are present in this 510(k) summary.)	(The submission focuses on substantial equivalence to predicate devices rather than independent performance metrics or acceptance criteria.)

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not applicable / Not provided. This document does not describe a performance study with a test set.
Data Provenance: Not applicable / Not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Number of Experts: Not applicable / Not provided.
Qualifications of Experts: Not applicable / Not provided. This document does not mention the use of experts to establish a ground truth for a test set.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Adjudication Method: Not applicable / Not provided.

5. 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

MRMC Study: No. This document describes basic cautery devices, not an AI-assisted diagnostic or interpretive device. No MRMC study was performed or is relevant to this submission.
Effect Size of Human Readers with AI: Not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone Study: No. This device is a physical cautery handle and tips, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Type of Ground Truth: Not applicable / Not provided. The submission focuses on substantial equivalence to predicate devices. The "ground truth" in this context would be the safety and effectiveness of the predicate devices, which are assumed to be safe and effective based on their prior clearance and marketing.

8. The sample size for the training set

Sample Size for Training Set: Not applicable / Not provided. This is not an AI or machine learning device requiring a training set.

9. How the ground truth for the training set was established

How Ground Truth for Training Set was Established: Not applicable / Not provided.

Summary of Device and 510(k) Process:

The Walsh Medical Devices Inc. Cautery Handles & Cautery Tips are Class II medical devices (Electrosurgical cutting and coagulation device and accessories, Radiofrequency electrosurgical cautery apparatus). The submission (K030158) sought to demonstrate substantial equivalence to previously cleared and marketed predicate devices from Aaron Medical Industries (K945761, K945762 & K945763).

The device description indicates basic battery-powered cautery handles and various tips used for coagulating tissue or arresting bleeding in ophthalmic, general, plastic surgery, and vasectomy procedures.

The FDA's letter explicitly states that they "have determined the device is substantially equivalent... to legally marketed predicate devices." This determination is based on the information provided by the applicant, typically including comparisons of indications for use, technological characteristics, materials, and safety standards, rather than new extensive performance studies for a device type like this. The differences mentioned ("relating to technical specifications, materials, and physical appearance do not affect the relative safety or effectiveness") further support the substantial equivalence claim, meaning the device's performance is assumed to be equivalent to the already cleared predicate.

Summary

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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:	(905) 844-8344
Fax:	(905) 338-0488
Contact Person:	David StilesDirector of Quality Systems
Date Prepared:	November 20, 2002

b. Device Identification

Common/Usual Names:	Cautery Handles & Cautery Tips
Proprietary Name:	Walsh Medical Devices Inc.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”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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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:

(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)

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

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

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