(31 days)
K943776, pre-enactment
Not Found
No
The device description and intended use are purely focused on the electrical connection function of the cables, with no mention of data processing, analysis, or any AI/ML related terms. The performance studies also focus on electrical safety standards.
No
Explanation: The device is described as cables used to connect HF instruments to HF devices, directing a high frequency electrical current. It does not exert any direct therapeutic effect on a patient.
No.
The device is described as a cable used to connect high-frequency instruments and devices, directing electrical current. It does not perform any diagnostic function itself, such as detecting, identifying, or analyzing diseases or conditions.
No
The device description explicitly states it is a cable used to direct electrical current, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to connect surgical instruments to HF devices for directing electrical current. This is a function performed in vivo (within the body) during surgical procedures, not in vitro (outside the body) for diagnostic purposes.
- Device Description: The description reinforces the use of the cables to direct electrical current to an instrument, which is consistent with surgical applications.
- Lack of IVD Indicators: There is no mention of analyzing samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic information. The focus is purely on the electrical connection for surgical intervention.
Therefore, the Uni/Monopolar High Frequency Cables are considered a surgical accessory, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Uni/Monopolar HF Cables are used to connect adequately equipped R. Wolf HF instruments to the corresponding HF devices.
The Uni/Monopolar High Frequency Cables are used to connect adequately equipped R. Wolf HF instruments to the corresponding HF devices.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The Uni/Monopolar 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.
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)
No known FDA performance standard exists.
The Monopolar HF Cables were tested to comply with the appropriate sections of ANSI/AAMI standard on high frequency devices, HF18 and IEC601-2-18.
No clinical tests performed.
The devices are designed and tested to guarantee the safety and effectiveness when used according to the instruction manuals.
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.
K943776, pre-enactment
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
353 Cerporate Woods Parkway Vernon Hills, Illinois 6006 1 Phone: $47.913.1143 Fax: 847.913.1488
AUG 3 1 1998
Image /page/0/Picture/2 description: The image shows the logo for Richard Wolf Medical Instruments Corporation. The text "RICHARD WOLF" is in large, bold, black letters. Below that, in smaller letters, is the text "MEDICAL INSTRUMENTS CORPORATION". The text is left-aligned.
Image /page/0/Picture/3 description: The image contains a series of handwritten digits and a letter. The characters are 'k', '9', '8', '2', '6', and '77'. The characters are written in a dark ink on a white background. The handwriting appears somewhat messy and uneven.
ਸਿੰ
통
510(k) Summary of Safety and Effectiveness
| Submitter: | Date of Preparation: | July 31, 1998 | |
|---|---|---|---|
| Company / Institution name: | Richard Wolf Medical Instruments Corp. | FDA establishment regulation number: | 14 184 79 |
| Division name (if applicable): | N.A. | Phone number (include area code): | (847) 913-1113 |
| Street address: | 353 Corporate Woods Parkway | FAX number (include area code): | (847) 913-0924 |
| City: | Vernon Hills | State/Province: | Illinois |
| Country: | USA | ZIP/Postal Code: | 60061 |
| Contact name: | Mr. Robert L. Casarsa | ||
| Contact title: | Quality Assurance Manager |
Product Information:
| Trade name: | Unipolar/Monopolar HF Cable | Model number: | 815.xxx, 8106.xxx |
|---|---|---|---|
| Common name: | Unipolar/Monopolar HF Cable | Classification Name: | Uni/Monopolar HF Cable |
Information on devices to which substantial equivalence is claimed:
| 510(k) Number | Trade or proprietary or model name | Manufacturer | |
|---|---|---|---|
| 1 | K943776 | Bipolar Cables 8108 | Richard Wolf GmbH |
| 2 | pre-enactment | Monopolar Cables 8106, 815 | Richard Wolf GmbH |
| 3 | |||
| 4 |
1.0 Description
The Uni/Monopolar 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.
1
2.0 Intended Use
The Uni/Monopolar HF Cables are used to connect adequately equipped R. Wolf HF instruments to the corresponding HF devices.
Technological Characteristics 3.0
TheUni/Monopolar HF Cables may be operated at a maximum recurrent peak voltage of 4000 Vp.
The cables can be sterilized by steam at 134℃.
4.0 Substantial Equivalence
Uni/Monopolar HF Cables 815 and 8106 are substantially equivalent to existing pre-amendment Uni/Monopolar HF Cables 815 and 8106. The material changes have not reduced safety or effectiveness.
5.0 Performance Data
No known FDA performance standard exists.
The Monopolar 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. Casasa
Robert L. Casarsa Quality Assurance Manager
Date: July 29 98
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services-USA. The seal is circular and contains the department's name around the perimeter. Inside the circle is a stylized image of three human figures.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 3 1 1998
Mr. Robert L. Casarsa Quality Assurance Manager Richard Wolf Medical Instruments Corporation 353 Corporate Woods Parkway Vernon Hills, Illinois 60061
Re: K982677
Trade Name: Uni/Monopolar HF Cable Regulatory Class: II Product Code: GEI Dated: July 31, 1998 Received: July 31, 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 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). 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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 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/dsma/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
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510(k) Number (if known):
Device Name:
Uni/Monopolar HF Cable
Intended Use:
The Uni/Monopolar High Frequency Cables are used to connect adequately equipped R. Wolf HF instruments to the corresponding HF devices.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH Office of Device Evaluation (ODE)
coll
ative Devices eneral Re
Prescription Use
Per 21 CFR 801.109