(80 days)
The Bipolar HF Cables are used to connect adequately equipped R. Wolf HF instruments to the corresponding HF devices.
The Bipolar HF Cables are used to direct a high frequency electrical current from an electrical generator made by unspecified manufacturers to a R. Wolf HF instrument.
This document describes a 510(k) submission for a Bipolar HF Cable. There is no mention of an AI device in the provided text. Therefore, I cannot generate the requested information about acceptance criteria and studies for an AI device.
The provided text pertains to a medical device, specifically a "Bipolar HF Cable," which is a physical cable used to connect medical instruments. The 510(k) summary focuses on demonstrating "substantial equivalence" to a previously cleared device, not on evaluating the performance of an AI algorithm.
Therefore, the categories listed in your request (such as sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set, etc.) are not applicable to this document as it does not describe an AI device or a study involving an AI algorithm.
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353 Corporate Woods Parkway Vernon Hills, Illinois 60061 Phone: 847.913.1113 Fax: 847.913.1488
ਿੱਚ
RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION
510(k) Summary of Safety and Effectiveness
| Submitter: | Date of Preparation: |
|---|---|
| Company / Institution name: | September 15, 1998 |
| Richard Wolf Medical Instruments Corp. | FDA establishment regulation number: |
| Division name (if applicable): | 14 184 79 |
| N.A. | Phone number (include area code): |
| Street address: | (847) 913-1113 |
| 353 Corporate Woods Parkway | FAX number (include area code): |
| City: | (847) 913-0924 |
| Vernon Hills | |
| State/Province: | Country: |
| Illinois | USA |
| Contact name: | ZIP/Postal Code: |
| Mr. Robert L. Casarsa | 60061 |
| Contact title: | |
| Quality Assurance Manager |
Product Information:
| Trade name: | Model number: |
|---|---|
| Bipolar HF Cable | 8108.xxx |
| Common name: | Classification Name: |
| Bipolar HF Cable | Bipolar HF Cable |
Information on devices to which substantial equivalence is claimed:
| 510(k) Number | Trade or proprietary or model name | Manufacturer |
|---|---|---|
| 1 K943776 | 1 Bipolar Cables 8108 | 1 Richard Wolf GmbH |
| 2 pre-enactment | 2 Bipolar Cables 8108 | 2 Richard Wolf GmbH |
| 3 | 3 | 3 |
| 4 | 4 | 4 |
1.0 Description
The Bipolar HF Cables are used to direct a high frequency electrical current from an electrical generator made by unspecified manufacturers to a R. Wolf HF instrument.
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2.0 Intended Use
The Bipolar HF Cables are used to connect adequately equipped R.Wolf HF instruments to the corresponding HF devices.
Technological Characteristics 3.0
The bipolar HF Cables may be operated at a maximum recurrent peak voltage of 4000 Vp and the bipolar cables at a maximum 1000 Vp.
The cables can be sterilized by steam at 134℃.
4.0 Substantial Equivalence
Bipolar HF Cables 8108 are substantially equivalent to Bipolar HF Cables cleared on K943776. The material changes have not reduced safety or effectiveness.
5.0 Performance Data
No known FDA performance standard exists.
The Bipolar HF Cables were tested to comply with the appropriate sections of ANSI/AAMI standard on high frequency devices, HF18 and IEC601-2-18.
6.0 Clinical Tests
No clinical tests performed.
7.0 Conclusions Drawn
The devices are designed and tested to guarantee the safety and effectiveness when used according to the instruction manuals.
By: Robert J. Casassa
Robert L. Casarsa Quality Assurance Manager
Date: Sept 9, 98
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 4 1998
Mr. Robert L. Casarsa Quality Assurance Manager Richard Wolf Medical Instruments Corporation 353 Corporate Woods Parkway Vernon Hills, Illinois 60061
Re: K983236 Trade Name: Bipolar HF Cable Regulatory Class: II Product Code: GEI Dated: September 15, 1998 Received: September 15, 1998
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 vour 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 current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) 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.
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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 vour 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,
ia M. Witten, Ph.D., M.D. Cel Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Us
510(k) Number (if known):
Device Name:
Bipolar HF Cable
Intended Use:
The Bipolar HF Cables are used to connect adequately equipped R. Wolf HF instruments to the corresponding HF devices.
Contraindications:
Contraindications directly related to the product are currently unknown. For further information refer to the latest medical literature.
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Concurrence of CDRH Office of Device Evaluation (ODE)
(Division Sign-Off) Division of General Res 510(k) Number
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§ 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.