(87 days)
1 pre-enact.
No
The summary describes a bipolar forcep set for coagulation and does not mention any AI or ML capabilities, image processing, or data-driven performance metrics.
Yes
The device is described as performing 'coagulation of tubes, tissue coagulation and vascular coagulation, and to stop bleedings', which are therapeutic interventions. Additionally, it is used for 'coagulation of the fallopian tube and the mesoalpinx for female sterilization', which is also a therapeutic procedure.
No
Explanation: The device is used for coagulation and stopping bleeding, which are therapeutic functions, not diagnostic ones. It performs physical actions (grasping, holding, coagulation) rather than analyzing patient data to identify a condition or disease.
No
The device description clearly describes a physical, modular bipolar forcep set, which is a hardware device used for surgical procedures. The performance studies also focus on testing the hardware components and materials.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the device is a modular bipolar forcep set used for coagulation and stopping bleeding during endoscopic procedures. This is a therapeutic and surgical function performed directly on the patient's tissues, not on specimens outside the body.
- Intended Use: The intended use describes procedures like tissue coagulation, vascular coagulation, and fallopian tube coagulation, all of which are direct interventions on the patient.
Therefore, this device falls under the category of a surgical or therapeutic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The coagulation of tubes, tissue coagulation and vascular coagulation, and to stop bleedings under endoscopic vision, including coagulation of the fallopian tube and the mesoalpinx for female sterilization.
Product codes (comma separated list FDA assigned to the subject device)
85 HIN
Device Description
The modular bipolar 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
Not Found
Anatomical Site
fallopian tube, mesoalpinx
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 ANSV AAMI standard on high frequency devices HF18 and IEC601-2-2, 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.
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
§ 884.4150 Bipolar endoscopic coagulator-cutter and accessories.
(a)
Identification. A bipolar endoscopic coagulator-cutter is a device used to perform female sterilization and other operative procedures under endoscopic observation. It destroys tissue with high temperatures by directing a high frequency electrical current through tissue between two electrical contacts of a probe. This generic type of device may include the following accessories: an electrical generator, probes, and electrical cables.(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance 2/12/90 (K-90),” and
(iii) “Guidance (‘Guidelines’) for Evaluation of Laproscopic Bipolar and Thermal Coagulators (and Accessories),”
(2) International Electrotechnical Commission's IEC 60601-1-AM2 (1995-03), Amendment 2, “Medical Electrical Equipment—Part 1: General Requirements for Safety,”
(3) American National Standards Institute/American Association for Medical Instrumentation's HF-18, 1993, “Electrosurgical Devices,”
(4) Labeling:
(i) Indication: For female tubal sterilization, and
(ii) Instructions for use:
(A) Destroy at least 2 centimeters of the fallopian tubes,
(B) Use a cut or undampened sinusoidal waveform,
(C) Use a minimum power of 25 watts, and
(D) For devices with ammeters: continue electrode activation for 5 seconds after the visual endpoint (tissue blanching) is reached or current flow ceases indicating adequate tissue destruction.
0
4/16/99
1
■
353 Corporate Woods Vernon I lills, Illinois 6006 I Phone: 847.913.4143 Fax: $47.943.4488
RICHARD W MEDICAL INSTRUMENTS CORPORA
Image /page/0/Picture/9 description: The image shows a black square with a white drawing inside. The drawing appears to be a stylized representation of an animal, possibly a dog or wolf, standing on its hind legs. The animal has a long neck and a pointed head, and it is wearing some sort of garment or harness around its body.
510(k) Summary of Safety and Effectiveness
| Submitter: | Date of Preparation: | ||
|---|---|---|---|
| Company / Institution name: | January 13, 1999 | ||
| RICHARD WOLF MEDICAL INSTRUMENTS CORP. | FDA establishment registration number: | ||
| Division name (if applicable): | 1418479 | ||
| N.A. | Phone number (include area code): | ||
| (847) 913-1113 | |||
| Street address: | FAX number (include area code): | ||
| 353 Corporate Woods Parkway | (847) 913-0924 | ||
| City: | State/Province: | Country: | ZIP / Postal Code: |
| Vernon Hills | Illinois | USA | 60061 |
| Contact name: | |||
| Mr. Robert L. Casarsa | |||
| Contact title: | |||
| Quality Assurance Manager | |||
| Product Information: | |||
| Trade name: | Model number: | ||
| Bipolar forcep set (modular) | 8393.741, 8393.771, 8394.741, 8394.771 | ||
| Common name: | Classification name: | ||
| Modular Bipolar forceps | Coagulator-Cutter, Endoscopic, | ||
| Bipolar Accessories |
Information on devices to which substantial equivalence is claimed:
| 510(k) Number | Trade or proprietary or model name | Manufacturer |
|---|---|---|
| 1 pre-enact. | 1 Kleppinger bipolar forceps 8383.21, 8384.21 | 1 Richard Wolf GmbH |
| 2 K981321 | 2 Modular Bipolar Forcep Sets 8390/91/93/94 | 2 Richard Wolf Medical Instruments |
1.0 Description
The modular bipolar 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.
1
Image /page/1/Picture/3 description: The image contains a single Chinese character, '得', in a bold, sans-serif font. The character is black against a white background. The character appears to be centered in the image.
2.0 Intended Use
The coagulation of tubes, tissue coagulation and vascular coagulation, and to stop bleedings under endoscopic vision, including coagulation of the fallopian tube and the mesoalpinx for female sterilization.
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 coated material. A cleaning port is added. The instruments are identical to those cleared by K981321.
4.0 Substantial Equivalence
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.
5.0 Performance Data
No known FDA performance standard exists.
The bipolar forceps were tested to meet the appropriate sections of the ANSV AAMI standard on high frequency devices HF18 and IEC601-2-2, 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. Pearson
Date: Apr 16, 99
Robert L. Casarsa Quality Assurance Manager
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 lines forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 16 1999
Mr. Robert L. Casarsa Quality Assurance Manager RICHARD WOLF MEDICAL INSTRUMENTS CORP. 353 Corporate Woods Parkway Vernon Hills, IL 60061
Re: K990147 Modular Bipolar Forcep Set, Kleppinger Principle Dated: January 13, 1999 Received: January 19, 1999 Regulatory Class: III 21 CFR 884.4150/Procode: 85 HIN
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.
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) 594-4613. 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.
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
* (*) : 10) :
510(k) Number (if known):
Modular Bipolar Forcep Set. Kleppinger Principle Device Name:__________________________________________________________________________________________________________________________________________________________________
Intended Use:
The coagulation of tubes, tissue coagulation and vasculation, and to stop bleedings under endoscopic vision, including coagulation of the fallopian tube and the mesoalpinx for female sterilization.
(IT EASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOXITIER PAGE IF NEEDED)
Prescription Use
Per 21 CFR 801.109
(Division Sign-Off)
and Radiological Devices
510(k) Number_
Division of Reproductive, Abdominal, ENT,
()R
Over-The Counter_
5 - 1