(85 days)
Not Found
No
The 510(k) summary describes a simple electrosurgical device for coagulation and smoke evacuation, with no mention of AI, ML, image processing, or data-driven performance metrics.
No
The device is used to coagulate small blood vessels and evacuate smoke during surgery, which are operational functions rather than therapeutic interventions to treat or prevent a disease.
No
The device is described as an electrode with a suction applicator used for coagulating blood vessels and evacuating smoke during plastic and reconstructive surgery. Its function is interventional (coagulation) and assistive (smoke evacuation), not diagnostic.
No
The device description clearly outlines physical components (suction applicator, button electrode, bipolar connector) and its intended use involves physical interaction with tissue (coagulating blood vessels, suctioning smoke). This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "coagulating small blood vessels that bleed as a result of blunt dissection of tissue subcutaneously" in "plastic and reconstructive surgery." This is a surgical procedure performed on the patient's body, not a test performed on a sample taken from the patient's body.
- Device Description: The description details a surgical instrument with an electrode and suction, designed for direct interaction with tissue during surgery.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Richard Wolf Bipolar Button Electrode with Suction Applicator is designed for use in plastic and reconstructive surgery. The device provides a method of coagulating small blood vessels that bleed as a result of blunt dissection of tissue subcutaneously. When used in conjunction with the suction applicator. smoke caused by the cauterization of tissue is evacuated from the operative site.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The Richard Wolf Bipolar Button Electrode with Suction Applicator consists of the suction applicator with a suction channel, a button electrode, and the bipolar connector.
Electrical current is confined to between the two prongs at the distal tip of the instrument which prevents the electrical current to migrate to critical anatomy in the facial area.
Working length of 150 mm and 280 mm
Suction applicator diameter is 3 mm
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)
Abrasion/Flaking testing was performed to assure the integrity and bonding of the insulation material to the instruments.
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
1 F47 913 0924 Vernon I tills, Illinois 80084 Phone: 847,943,4445 Fax: 847.913.1488
973295
L
MEDICAL INSTRUMENTS CORPORATION
| Submitter: | Date of Preparation: August 27, 1997 |
|---|---|
| Company / Institution Name: | Richard Wolf Medical Instruments Corp. |
| FDA establishment registration 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: | Bipolar Button Electrode w/ Suction Applicator |
|---|---|
| Model number: | 8801.551. 8801,451 |
| Common name: | Bipolar Electrode |
| Classification name: | General and Plastic Surgery |
Information on devices to which substantial equivalence is claimed:
| 510(k) Number | Trade or proprietary or model name | Manufacturer |
|---|---|---|
| 1 K945805 | 1 Monopolar/Frazier Suction Probe | 1 Wells Endoscopic |
| 2 | 2 | 2 |
| 3 | 3 | 3 |
| 4 | 4 | 4 |
1.0 Description
The Richard Wolf Bipolar Button Electrode with Suction Applicator consists of the suction applicator with a suction channel, a button electrode, and the bipolar connector.
2.0 Intended Use
Richard Wolf Bipolar Button Electrode with Suction Applicator is designed for use in plastic and reconstructive surgery. The device provides a method of coagulating small blood vessels that bleed as a result of blunt dissue subcutaneously. When used in conjunction with the suction applicator, smoke caused by the cauterization of issue is evacuated from the operative site,
Rrvised 11/12/97 3. 3. 4
1
evacuated from the operative site.
3.0 Technological Characteristics
- · Electrical current is confined to between the two prongs at the distal tip of the instrument which prevents the electrical current to migrate to critical anatomy in the facial area.
- · Working length of 150 mm and 280 mm
- . Suction applicator diameter is 3 mm
4.0 Substantial Equivalence
The Richard Wolf Bipolar Cautery and Suction Tube has the same intended use as the Wells Endoscopic Company's Monopolar/Frazier Suction Probe.
5.0 Performance Data
Abrasion/Flaking testing was performed to assure the integrity and bonding of the insulation material to the instruments.
6.0 Clinical Tests
None
}
ﻤﺴﺎ
7.0 Conclusions Drawn
These devices are designed and tested to guarantee the safety and effectiveness, when used according to the instruction manual.
By: Robert L. Larson
Robert L. Casarsa Quality Assurance Manager
Date: Aug 22, 92
2
Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 26 1997
Mr. Robert L. Casarsa Quality Assurance Manager Richard Wolf Medical Instruments Corporation 353 Corporate Woods Parkway Vernon Hills, Illinois 60061
Re: K973295
Trade Name: Bipolar Button Electrode w/Suction Applicator Regulatory Class: II Product Code: GEI Dated: August 27, 1997 Received: September 2, 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 current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (OS) 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.
3
Page 2 - Mr. 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,
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
5 10(k) Number (if known): ___K973295
Device Name:__________________________________________________________________________________________________________________________________________________________________ Bipolar Button Electrode with Suction Applicator
comments marked the first and in which the such and the more the more has
Indications for Use:
of National Comments of the more of the country of the
Indications for Use:
Richard Wolf Bipolar Button Electrode with Suction Applicator is designed for use in plastic and reconstructive surgery. The device provides a method of coagulating small blood vessels that bleed as a result of blunt dissection of tissue subcutaneously. When used in conjunction with the suction applicator. smoke caused by the cauterization of tissue is evacuated from the operative site.
Cla Watts
Prescription Use (Per 21 CFR 801.109)
Revised 11/12/97