(83 days)
The forceps are used for grasping, manipulating and cutting as well as the dissection and biopsy of soft tissue/ organs under endoscopic control. The modular scissors can also be used for cutting of suture material. Minor hemorrhages can be coagulated using HF current, provided that products are marked accordingly. The modular forceps can be disassembled for easy cleaning and replacement.
The forceps with HF are part of the MICRO and MINI instrument set for laparoscopic microsurgery, particularly suitable for diagnostic, smaller interventions, outpatient, and pediatric laparoscopy. The instruments smaller diameter is less invasive and allows better cosmetic effects than bigger diameters. The forceps and scissors have comparable device materials as former R. Wolf devices. The dimensions are smaller for very minimal invasive laparoscopy. The design of the same, but miniaturized. The design of the handles is the same, but adapted to the smaller forceps. The modular forceps and scissors with 3.5 mm diameter can be disassembled into jaws with shaft and handle for easy cleaning and replacement. They have a Luer connector to rinse cavities and channels of the forceps with a cleaning gun while reprocessing. The jaws are rotatable with an adjustment knob at the handle.
Acceptance Criteria and Study for RICHARD WOLF MEDICAL INSTRUMENTS CORP. MINI and MICRO Forceps with HF
This document describes the acceptance criteria and the study conducted to demonstrate that the RICHARD WOLF MEDICAL INSTRUMENTS CORP. MINI and MICRO Forceps with HF devices meet these criteria, based on the provided 510(k) Summary.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No breakage of jaws or other instrument parts during use | "The Instruments have been tested to assure that there is no breakage of the jaws or other parts of the instrument." |
| No permanent deformation of forceps under normal use | "Mechanical load tests show that there is no permanent deformation of the forceps if used normally." |
| Functional performance maintained after steam sterilization | "The steam sterilization tests performed by Richard Wolf show that steam sterilization has no influence on the functional performance of the submitted devices when using the fractional method." |
| Safety and effectiveness when used according to instructions | "These devices are designed and tested to guarantee the safety and effectiveness when used according to the instructions manual." |
Note: The 510(k) summary does not explicitly state numerical acceptance limits for "no breakage," "no permanent deformation," or "no influence on functional performance." The statements indicate that these conditions were met qualitatively through testing.
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not specify the exact sample sizes (number of instruments tested) for the mechanical load tests or steam sterilization tests. It uses general phrasing like "The Instruments have been tested" and "Mechanical load tests show."
The data provenance is not explicitly stated in terms of country of origin, but the testing was "performed by Richard Wolf," implying internal testing by the manufacturer. The tests were likely retrospective laboratory tests on manufactured devices, rather than prospective clinical trials.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not Applicable. The described tests are engineering and laboratory performance tests, not clinical evaluations requiring expert interpretation of ground truth in a diagnostic or clinical context. The "ground truth" here is the objective measurement of mechanical integrity and functional performance against defined engineering standards or internal specifications.
4. Adjudication Method for the Test Set
Not Applicable. As the tests are objective engineering assessments, there is no need for an adjudication method by experts. The results are based on direct measurement and observation of physical characteristics and functional outcomes.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The provided 510(k) summary explicitly states under Section 6.0, "Clinical Tests: No clinical tests performed." Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance was not conducted.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not Applicable. This device is a surgical instrument (forceps), not an AI algorithm or a software-only device. Therefore, a standalone performance study for an algorithm is irrelevant. The performance evaluated relates to the physical and functional integrity of the instrument itself.
7. Type of Ground Truth Used
For the mechanical load tests, the "ground truth" would be the engineering specifications for acceptable deformation and breakage limits. For steam sterilization, the "ground truth" would be the pre-sterilization functional performance for comparison. These are objective engineering and performance standards, not expert consensus, pathology, or outcomes data in a clinical sense.
8. Sample Size for the Training Set
Not Applicable. This device is a physical surgical instrument. There is no AI algorithm involved, and therefore, no "training set" in the context of machine learning. The design and validation of this device do not involve machine learning models.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. As mentioned above, there is no AI algorithm or training set for this device.
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353 Corporate Woods Parkway - DEC 17 1997 Vernon Hills, Illinois 60064 Phone: 847-913.1113 Fax: 847.913.1488
K 97 3648
RICHARD W MEDICAL INSTRUMENTS COR
510(k) Summary of Safety and Effectiveness
| Submitter: | Date of Preparation: | September 22, 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: | MINI and MICRO Forceps with HF | Model number: | 8390.xxx, 8391.xxx, 8393.96x, 8394.96x, 8756.xxx | ||||
| Common name: | Forceps, biopsy, electric | Classification name: | Endoscopic electrosurgical unit and accessories | ||||
| Information on devices to which substantial equivalence is claimed: |
| 510(k) Number | Trade or proprietary or model name | Manufacturer | |||
|---|---|---|---|---|---|
| 1 | pre-enact. | 1 forceps/ scissors with H.F. 8383.03, .12, 930L, 930S | 1 Richard Wolf | ||
| 2 | K935270 | 2 Modular Forceps and Scissors System | 2 Richard Wolf | ||
| 3 | K935070 | 3 Dissecting and Grasping Forceps 3.5/ 5 mm | 3 Karl Storz | ||
| 4 | 4 Biopsy Instruments, Endoscopic Instrumentation 3.5/ 5 mm | 4 Jarit |
1.0 Description
.
(१);:
The forceps with HF are part of the MICRO and MINI instrument set for laparoscopic microsurgery, particularly suitable for diagnostic, smaller interventions, outpatient, and pediatric laparoscopy.
The instruments smaller diameter is less invasive and allows better cosmetic effects than bigger diameters.
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2.0 Intended Use
The forceps are used for grasping, manipulating and cutting as well as the dissection and biopsy of soft tissue/ organs under endoscopic control.
The modular scissors can also be used for cutting of suture material.
Minor hemorrhages can be coagulated using HF current, provided that products are marked accordingly.
Technological Characteristics 3.0
The forceps and scissors have comparable device materials as former R. Wolf devices. The dimensions are smaller for very minimal invasive laparoscopy. The design of the same, but miniaturized. The design of the handles is the same, but adapted to the smaller forceps.
The modular forceps and scissors with 3.5 mm diameter can be disassembled into jaws with shaft and handle for easy cleaning and replacement. They have a Luer connector to rinse cavities and channels of the forceps with a cleaning gun while reprocessing. The jaws are rotatable with an adjustment knob at the handle.
4.0 Substantial Equivalence
These devices are substantially equivalent to existing pre-enactment devices and 510(k) devices sold by Richard Wolf and 510(k) devices sold by Karl Storz and Jarit.
5.0 Performance Data
The Instruments have been tested to assure that there is no breakage of the jaws or other parts of the instrument.
Mechanical load tests show that there is no permanent deformation of the forceps if used normally.
The steam sterilization tests performed by Richard Wolf show that steam sterilization has no influence on the functional performance of the submitted devices when using the fractional method.
6.0 Clinical Tests
No 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. Casarcia
Robert L. Casarsa Quality Assurance Manager
Date: Sept 22, 97
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 17 1997
Mr. Robert L. Casarsa Quality Assurance Manager Richard Wolf Medical Instruments Corporation 353 Corporate Woods Parkway Vernon Hills, Illinois 60061
Re: K973648
Trade Name: MINI Forceps with HF, 3.5mm and MICRO Forceps with HF, 2mm Regulatory Class: II Product Code: GEI Dated: September 22, 1997 Received: September 25, 1997
Dear Mr. Casarsa:
We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices 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 devices in the Federal Register. Please note: this response to your premarket notification submissions does not affect any obligation you might have under sections 531 through 542 of the Act for
Image /page/2/Picture/10 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing right, stacked on top of each other. The profiles are simple and abstract, with only the basic outline of a head and neck visible.
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Page 2 - Mr. Robert L. Casarsa
devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices 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 devices, 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,
[signature]
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
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INDICATIONS FOR USE
510(k) Number (if known):
Device Name:
MINI Forceps with HF, 3.5 mm and MICRO Forceps with HF, 2 mm
Intended use:
The forceps are used for grasping, manipulating and cutting as well as the dissection and biopsy of soft tissue/ organs under endoscopic control.
The modular scissors can also be used for cutting of suture material.
Minor hemorrhages can be coagulated using HF current, provided that products are marked accordingly.
The modular forceps can be disassembled for easy cleaning and replacement.
Indication and Applications:
For examination, diagnostics and/or therapy by qualified, suitably trained personnel in connection with endoscopically used accessories in different medical disciplines, such as surgery, urology and gynecology, particularly suitable for outpatient and pediatric laparoscopy.
Contraindications:
There are no known contraindications directly relating to the product. The physician in charge must decide whether the intended application is possible taking into account the general condition of the patient. For further instructions please see the current technical literature.
Combinations:
The forceps have a HF connection for the use with monopolar HF units.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANQTHER PAGE IF NEEDED) Concurrence of CDRH Office of Device Evaluation (OD
Office of Device Evaluation (ODE)
neral Restorative De
Prescription Use
Per CRF 801.109
/ 3w
OR
Over-The Counter
§ 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.