(83 days)
Not Found
No
The summary describes a mechanical surgical instrument with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is used for grasping, manipulating, cutting, dissection, and biopsy of soft tissue/organs, and can perform coagulation of hemorrhages, all of which are direct interventions for medical conditions or parts of medical procedures.
No
The device is described as being used for "grasping, manipulating and cutting as well as the dissection and biopsy of soft tissue/ organs." While biopsy can contribute to a diagnostic process, the device itself performs mechanical actions (cutting, grasping) rather than providing diagnostic information directly or interpreting data to generate a diagnosis. The "Device Description" also mentions it's "particularly suitable for diagnostic, smaller interventions," suggesting it's used during such interventions, not primarily as a diagnostic tool itself.
No
The device description clearly details physical components like forceps, scissors, handles, jaws, and a Luer connector, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for grasping, manipulating, cutting, dissection, and biopsy of soft tissue/organs under endoscopic control. It also mentions cutting suture material and coagulating minor hemorrhages using HF current. These are all procedures performed directly on the patient's body during a surgical or diagnostic procedure.
- Device Description: The description reinforces its use in laparoscopic microsurgery and its physical interaction with the patient's anatomy.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnostic purposes. This device does not perform any such analysis of specimens outside the body.
The device is a surgical instrument used in vivo (within the body) during endoscopic procedures.
N/A
Intended Use / Indications for 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.
Product codes
GEI
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue/ organs
Indicated Patient Age Range
pediatric
Intended User / Care Setting
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.
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
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.
1
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
2
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
4
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