(88 days)
1 pre-enact.
Not Found
No
The summary describes a mechanical bipolar forceps set for coagulation and grasping, with no mention of AI/ML, image processing, or data-driven performance metrics.
Yes
The "Intended Use / Indications for Use" states "For therapy in connection with endoscopic accessories used in medical specialties..." and describes its use for "coagulation of tubes, tissue coagulation and vascular coagulation to stop bleedings." These are therapeutic actions.
No
The device is used for therapeutic purposes (coagulation to stop bleeding) rather than for diagnosing conditions.
No
The device description explicitly mentions "modular hipolar forcep set" and describes physical actions like "precise grasping and axial holding placement of the jaws," indicating a hardware component. The performance studies also refer to testing "bipolar forceps" and "device materials," further confirming it is 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 clearly describes a device used for coagulation of tissues and vessels under endoscopic vision to stop bleeding. This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The description details a bipolar forceps set used for grasping, holding, and performing coagulation. This is a surgical instrument.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body to provide diagnostic information. This device is used for direct surgical intervention.
N/A
Intended Use / Indications for Use
For the coagulation of tubes, tissue coagulation and vascular coagulation to stop bleedings under endoscopic vision.
Indication and field of application:
For therapy in connection with endoscopic accessories used in medical specialies such as urology, gynecology, surgery.
Contraindications:
Not to be used for female sterilization (coagulation of fallopian tubes).
Contraindications are inflammations or bacterial contamination of wounds in the operation site. Contraindications directly related to the product are currently unknown. The attending physician must determine if the intended use is appropriate based on the yeneral condition of the patient. For further instructions, refer to the latest medical literature.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The modular hipolar forcep set provides precise grasping and axial holding placement of the jaws. performs thorough hygiene, and site irrigation can be achieved without using additional instruments
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
endoscopic vision
Anatomical Site
tubes, tissue, vascular (coagulation to stop bleedings)
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)
The bipolar forceps were tested to meet the appropriate sections of the ANSI/ AAMI standard on high frequency devices 11518 and IEC 601-1/ 1EC 601-2-2. Device materials tests were performed to assure biocompatibility of the new material. The tests indicated that no irrigation would occur.
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.
1 pre-enact.
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
7 1998 JUL
8
RICHARD WOLF
MEDICAL INSTRUMENTS CORPORATION
981321
510(k) Summary of Safety and Effectiveness
| Submitter: | |
|---|---|
| Company / Institution name: | RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
| Division name (if applicable): | N.A. |
| Street address: | 353 Corporate Woods Parkway |
| City: | Vernon Hills |
| State/Province: | Illinois |
| Country: | USA |
| ZIP / Postal Code: | 60061 |
| Contact name: | Mr. Robert L. Casarsa |
| Contact title: | Quality Assurance Manager |
| Date of Preparation: | April 8, 1998 |
|---|---|
| FDA establishment registration number: | 1418479 |
| Phone number (include area code): | (847) 913-1113 |
| FAX number (include area code): | (847) 913-0924 |
Product Information:
| Trade name: | Bipolar forceps set (modular) |
|---|---|
| Model number: | 8390.xxx, 8391.xxx, 8393.xxx, 8394.xxx |
| Common name: | Modular Bipolar forceps |
| Classification name: | Bipolar forceps |
Information on devices to which substantial equivalence is claimed:
| 510(k) Number | Trade or proprietary or model name | Manufacturer |
|---|---|---|
| 1 pre-enact. | Kleppinger bipolar forceps 8383.21, 8384.21 | Richard Wolf GmbH |
| 2 | 2 | 2 |
1.0 Description
The modular hipolar forcep set provides precise grasping and axial holding placement of the jaws. performs thorough hygiene, and site irrigation can be achieved without using additional instruments
Revised 6/19/98
1
Image /page/1/Picture/3 description: The image shows a black square with a white symbol inside. The symbol appears to be a stylized letter or character, possibly from a non-Latin alphabet or a unique design. The symbol is composed of lines and curves, creating an abstract and somewhat angular shape. The overall impression is that of a logo or icon.
2.0 Intended Use
The bipolar forceps are used for coagulation of tubes, tissue coagulation, and vascular coagulation to stop bleedings under endoscopic vision.
Not to be used for female sterilization (coagulation of fallopian tubes).
3.0 Technological Characteristics
There are no significant technological characteristic changes to the new devices compared to the pre-enactment devices. The insulation of the electrodes is changed to a more durable coared material. An irrigation port is added.
Substantial Equivalence 4.0
The submitted devices pose the same type of questions about safety or effectiveness as the compared devices. The new technological characteristics have not diminished safety or effectiveness. The submitted devices are substantially equivalent to existing pre-enactment devices sold by Richard Wolf. In addition, the submitted devices are substantially equivalent to devices sold by various competitors.
ડ.0 Performance Data
No known FDA performance standard exists.
The bipolar forceps were tested to meet the appropriate sections of the ANSI/ AAMI standard on high frequency devices 11518 and IEC 601-1/ 1EC 601-2-2. Device materials tests were performed to assure biocompatibility of the new material. The tests indicated that no irrigation would occur.
6.0 Clinical Tests
No special clinical tests performed.
7.0 Conclusions Drawn
These devices are designed and tested to guarantee the safety and effectiveness, when used according to the instructions manual.
By: Robert L. Casassa
Robert L. Casarsa Quality Assurance Manager
Date: 6/1/98
Revised 6/19/98
2
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Image /page/2/Picture/11 description: The image shows a partial view of the Department of Health & Human Services logo. The text "DEPARTMENT OF HEALTH &" is visible vertically along the left side of the image. To the right of the text is the symbol of the Department of Health & Human Services, which is a stylized representation of people.
7 1998 JUL
Mr. Robert L. Casarsa ·Richard Wolf Medical Instruments Corporation 353 Corporate Woods Parkway Vernon Hills, Illinois 60061
Re: K981321 Trade Name: Modular Bipolar Forceps Regulatory Class: II Product Code: GEI Dated: April 8.1998 Received: April 10, 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 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 requirement, 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.
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.
3
Page 2 - Mr. Robert Casarsa
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
13:29 9661-67-471
RICHARD MULL
1 2 2 2 2 2 2 2 2 2 2 2 2 4 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 1 : 813
510(k) Number (if known): ______ K981321
Binolar Forceps Set (modular) Device Name:__________________________________________________________________________________________________________________________________________________________________
Intended Use:
For the coagulation of tubes, tissue coagulation and vascular coagulation to stop bleedings under endoscopic vision.
Indication and field of application:
For therapy in connection with endoscopic accessories used in medical specialies such as urology, gynecology, surgery.
Contraindications:
Not to be used for female sterilization (coagulation of fallopian tubes).
Contraindications are inflammations or bacterial contamination of wounds in the operation site. Contraindications directly related to the product are currently unknown. The attending physician must determine if the intended use is appropriate based on the yeneral condition of the patient. For further instructions, refer to the latest medical literature.
(17),EASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDHED)
Daodd
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K981321
Prescription Use
Per 21 CFR 801.109
( ))ર
Over-The-Counter__
Revised 6/19/98