(182 days)
Not Found
No
The device description and intended use focus on a simple heat-based cautery mechanism, and there are no mentions of AI, ML, or related concepts in the provided text.
Yes
The device is intended for "coagulating tissue or arresting bleeding from small vessels," which are therapeutic actions.
No
The device, cautery handles and tips, is intended for coagulating tissue and arresting bleeding, which are therapeutic functions. There is no mention of assessment, diagnosis, or detection of any medical condition using this device.
No
The device description explicitly states it is "Battery powered Cautery Handles and Cautery Tips," which are hardware components used to generate heat.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for coagulating tissue or arresting bleeding during surgical procedures using heat. This is a direct intervention on the patient's body.
- Device Description: The description confirms it's a battery-powered device that applies heat to tissue.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) in vitro (outside the body) to provide diagnostic information. IVDs are used to diagnose diseases or conditions based on the analysis of these samples.
Therefore, this device falls under the category of a surgical instrument used for therapeutic purposes, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
GEI, HQR
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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 Stiles |
| 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. |
| 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.
2
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:
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