(63 days)
No
The summary describes a standard bipolar forceps that uses electrical current for grasping, coagulating, and transecting tissue. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The performance is compared to a predicate device from 2002, further suggesting a lack of advanced computational technology.
No
Explanation: A therapeutic device is used to treat a disease or condition. This device is used for grasping, coagulating, and transecting tissue during surgical procedures, which are actions performed during treatment rather than being a treatment itself. It is a surgical tool, not a therapeutic device.
No
The device is described as Bipolar Forceps intended for grasping, coagulating, and transecting tissue during surgery. Its function is interventional (surgical), not diagnostic.
No
The device description clearly states it is a physical forceps that utilizes electrical current, indicating it is a hardware device.
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 "grasping, coagulating, and transecting of tissue" during surgical procedures. This is an in vivo (within a living organism) application, not an in vitro (outside of a living organism, typically in a lab) diagnostic test.
- Device Description: The description reinforces its function as a surgical tool that uses electrical current to interact directly with tissue.
- Lack of IVD Characteristics: There is no mention of analyzing samples (like blood, urine, or tissue) to diagnose a condition, monitor treatment, or screen for diseases, which are the hallmarks of an IVD.
Therefore, this device is a surgical instrument, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Bipolar Forceps is intended for use in open and laparoscopic surgeries where grasping, coagulating, and transecting of tissue is indicated.
The submitted Bipolar Forceps are indicated for both GYN and general laparoscopic procedures.
Product codes
GEI
Device Description
The submitted Bipolar forceps are forceps that grasps, coagulate, and transects tissue, utilizing electrical current. The Bipolar forceps are compatible with all standard bipolar generators that have a bipolar outlet.
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
The submitted devices perform the same as the devices cleared in 510(k) K012279, April 30, 2002 by Patton Medical Corporation.
No clinical tests performed.
Key Metrics
Not Found
Predicate Device(s)
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
Image /page/0/Picture/1 description: The image is a logo for Richard Wolf Medical Instruments Corporation. The logo features the words "RICHARD WOLF" in bold, sans-serif font, with "RICHARD" stacked above "WOLF". Below the name is the text "Medical Instruments Corporation" in a smaller, regular font. To the right of the name is a square containing a stylized image of a wolf.
K0238i3
353 Corporate Woods Parkway Vernon Hills, IL 60061 Phone: 847-913-1113 Customer Service: 800-323-WOLF www.richard-wolf.com
12.0 510 (k) Summary of Safety and Effectiveness
| Date of Preparation: | |||||
|---|---|---|---|---|---|
| November 11, 2002 | |||||
| Company / Institution name: | FDA establishment registration number: | ||||
| RICHARD WOLF MEDICAL INSTRUMENTS CORP. | 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: | State/Province: | Country: | ZIP / Postal Code: | ||
| Vernon Hills | Illinois | USA | IL 60061 | ||
| Contact name: | Mr. Robert L. Casarsa | ||||
| Contact title: | Quality Assurance Manager | ||||
| Product Information: | |||||
| Trade name: | |||||
| Bipolar Forceps | Model number: | ||||
| XXXX | |||||
| Common name: | |||||
| Bipolar Forceps | Classification name: | ||||
| DEVICE, ELECTROSURGICAL, CUTTING & | |||||
| COAGULATION & ASSESSORIES | |||||
| Information on devices to which substantial equivalence is claimed: same devices as cleared devices | |||||
| 510(k) Number | Trade or proprietary or model name | Manufacturer | |||
| 1 K012279 | 1 Patton Tripol Bipolar Forceps | 1 | |||
| 2 | 2 | 2 | |||
| 3 | 3 | 3 | |||
| 4 | 4 | 4 | |||
| 5 | 5 | 5 |
1
1.0 Description
The submitted Bipolar forceps are forceps that grasps, coagulate, and transects tissue, utilizing electrical current. The Bipolar forceps are compatible with all standard bipolar generators that have a bipolar outlet.
2.0 Intended Use
The submitted device is intended for use in open and laparoscopic surgery where grasping, coagulating, and transecting is indicated.
3.0 Technological Characteristics
The submitted devices are the same devices cleared in 510(k) K012279, April 30, 2002.
4.0 Substantial Equivalence
The submitted devices pose the same type of questions about safety or effectiveness as the existing devices. The submitted devices are the same devices cleared in 510(k) K012279, April 30, 2002.
5.0 Performance Data
The submitted devices perform the same as the devices cleared in 510(k) K012279, April 30, 2002 by Patton Medical Corporation.
6.0 Clinical Tests
No clinical tests performed.
7.0 Conclusions Drawn
These devices are designed and tested to quarantee the safety and effectiveness, when used according to the instructions manual.
By:
Robert L. Casassa
Robert L. Casarsa Quality Assurance Manager
Date: Nov 11, 2002
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its wings and head. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the eagle.
JAN 1 7 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Robert L. Casarsa Quality Assurance Manager Richard Wolf Medical Instruments Corporation 353 Corporate Woods Parkway Vernon Hills, Illinois 60061
Re: K023813
Trade Name: Bipolar Forceps Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: II Product Code: GEI Dated: November 11, 2002 Received: November 15, 2002
Dear Mr. Casarsa:
We have reviewed your Section 510(k) premarket 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) 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.
3
Page 2 - Mr. Casarsa
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. 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 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 vours.
Miriam 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
4
5.0 INDICATIONS FOR USE
510(k) Number (if known): —
Device Name: Bipolar Forceps
Indications For Use:
The Bipolar Forceps is intended for use in open and laparoscopic surgeries where grasping, coagulating, and transecting of tissue is indicated.
Indications and Application:
The submitted Bipolar Forceps are indicated for both GYN and general laparoscopic procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Mesiam C. Provost
I, Restorative
2(k) Number K023813
OR
Prescrintion Use Per 21 CFR 801.109
Over-The Counter