(203 days)
Not Found
None
No
The summary describes a standard electrosurgical hook electrode and does not mention any AI or ML components or functionalities.
No
The device is used for surgical procedures (coagulation and cutting of tissue), not for treating a disease or condition in a therapeutic manner. It is a surgical tool.
No
Explanation: The device description states its purpose is for "coagulation and cutting of tissue," which are therapeutic actions, not diagnostic ones. There is no mention of it being used to identify or analyze medical conditions.
No
The device description clearly states it is a "unipolar electrosurgical device" and is "attached via cable to an electrosurgical generator," indicating it is a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "coagulation and cutting of tissue." This describes a surgical procedure performed directly on a patient's body, not a test performed on a sample taken from the body.
- Device Description: The description confirms it's an "electrosurgical device used primarily for cutting, but also usable for coagulation." This is consistent with a surgical tool.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue samples, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
IVDs are used to perform tests in vitro (outside the body) on samples to provide information about a patient's health status. This device is used in vivo (inside the body) to perform a surgical action.
N/A
Intended Use / Indications for Use
The electrosurgical unipolar hook electrode is intended to be used for coagulation and cutting of tissue.
Product codes
GEI
Device Description
The Hook Electrode is a unipolar electrosurgical device used primarily for cutting, but also usable for coagulation. The device is attached via cable to an electrosurgical generator.
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
Tested to assure 3000 volt isolation and validation to recommended sterilization processes. No clinical tests performed.
Key Metrics
Not Found
Predicate Device(s)
1 pre-enactment, 2 existing device
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
MAY 2 | 1997
| 510(k) Summary of Safety and Effectiveness | ||
|---|---|---|
| Submitter: | ||
| Company / Institution name: | RICHARD WOLF MEDICAL INSTRUMENTS CORP. | |
| Date of Preparation | October 25, 1996 | |
| Division name (if applicable): | N.A. | |
| FDA establishment registration number: | 14 184 79 | |
| Street address: | 353 Corporate Woods Parkway | |
| Phone number (include area code): | (847) 913-1113 | |
| City: | Vernon Hills | |
| State/Province: | Illinois | |
| Country: | USA | |
| ZIP / Postal Code: | 60061 | |
| FAX number (include area code): | (847) 913-0924 | |
| Contact name: | Mr. Robert L. Casarsa | |
| Contact title: | Quality Assurance Manager | |
| Product Information: | ||
| Trade name: | Unipolar Electrosurgical Hook Electrode | |
| Model number: | 8383.423, 8384.423 | |
| Common name: | Hook Electrode | |
| Classification name: | Electrosurgical cutting and coagulation device and accessories | |
| Information on devices to which substantial equivalence is claimed: | ||
| 510(k) Number | Trade or proprietary or model name | Manufacturer |
| 1 pre-enactment | 1 Hook Electrode 8383.42 | 1 Richard Wolf Medical Instruments |
| 2 existing device | 2 Hook Electrodes 8383.423, 8384.423 | 2 Richard Wolf Medical Instruments |
| 3 | 3 | 3 |
1.0 Description
The Hook Electrode is a unipolar electrosurgical device used primarily for cutting, but also usable for coagulation. The device is attached via cable to an electrosurgical generator.
2.0 Intended Use
The electrosurgical unipolar hook electrode is intended to be used for coagulation and cutting of tissue.
Technological Characteristics 3.0
- · durable powder coating
- · 3000 Volt isolation
- gas and steam sterilizable .
1
Substantial Equivalence 4.0
The basic design of the hook electrode is equivalent to pre enactment devices from R.Wolf and equivalent to existing competitive devices.
5.0 Performance Data
Tested to assure 3000 volt isolation and validation to recommended sterilization processes.
Clinical Tests 6.0
No clinical tests performed.
Conclusions Drawn 7.0
These devices are designed and tested to guarantee the safety and effectiveness, when used according to the instruction manual.
By:
Robert J. Casanova
Robert L. Casarsa Quality Assurance Manager
Date: Oct 25, 1996
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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, with its wings spread and head facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 1 1997
Mr. Robert L. Casarsa Manager of Quality Assurance Richard Wolf Medical Instruments Corporation 353 Corporate Woods Parkway Vernon Hills, Illinois 60061
Re: K964329 Trade Name: Electrosurgical Hook Electrodes Regulatory Class: II Product Code: GEI Dated: April 18, 1997 Received: April 22, 1997
Dear Mr. Casarsa:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Mr. Robert L. Casarsa
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K 964329 510(k) Number (if-known):
ELECTOSURGICAL HOOK ELECTRODES Device Name: __
Indications For Use:
(PER 21 CFR 601.109)
The electrosurgical unipolar hook electrode is used for coagulation and cutting of tissue.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | K964329 |
| 510(k) Number |
| PRESCRIPTION USE | OR | OVER-THE-COUNTER USE_ |
|---|---|---|
| ------------------ | ---- | ----------------------- |