(63 days)
8283.12, 8283.13, 8660A, 8593, 50-6858
Not Found
No
The summary describes a surgical instrument (forceps) for grasping and coagulating tissue, with no mention of AI or ML capabilities.
Yes
The device is used to grasp, hold, dissect, vaporize, and coagulate tissue, which are all therapeutic actions.
No
This device is described as grasping forceps used to hold tissue for dissection, vaporization, or coagulation, which are therapeutic and surgical functions, not diagnostic ones.
No
The device description explicitly states the forceps are made of physical materials (stainless steel, plastic, etc.) and are used for physical manipulation and coagulation, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue samples) to provide information about a person's health. This testing is done outside of the body.
- Device Function: The description clearly states the instruments are used on the laryngeal anatomy to grasp, hold, dissect, vaporize, and coagulate tissue within the body. This is an in vivo procedure, not an in vitro diagnostic test.
The device is a surgical instrument used directly on the patient's anatomy.
N/A
Intended Use / Indications for Use
The instruments are for use on the laryngeal anatomy, e.g., the vocal cords, false cords, surpraglottis, glottis, epiglottis, tongue base, oral pharynx, and uvula. The instruments are used to grasp and hold tissue for dissection or vaporization. The forceps may be used to coagulate blood vessels within the tissue when it is connected to a unipolar high frequency generator. Depending on where the bleeding vessel is located, coagulate by applying a low dose of HF current. The intensity depends on the severity of the bleeding and on the vessel. Always start with a low dosage and increase the power if necessary.
Contraindications:
Do not use in the presence of flammable anesthetics.
Product codes
79 GEI
Device Description
The forceps are made of medical grade stainless steel, teflon coated medical grade stainless steel, black chrome plating, and plastic.
The grasping forceps have been insulated and now allow the application of high frequency current.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
laryngeal anatomy, e.g., the vocal cords, false cords, surpraglottis, glottis, epiglottis, tongue base, oral pharynx, and uvula.
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
No clinical tests performed.
Key Metrics
Not Found
Predicate Device(s)
Pre-amend. Grasping forceps, 8283.12/.13, Grasping Forceps, 8660A, Miniature Grasping Forceps. 8593, Grasping Forceps, 50-6858
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
555 Cerperite a ceas numer Vernon I fills, Illiners (2006) Phone: 847 915.1113 Fax: 847.913.1488
Stir
| RICHARD WOLF | ||||
|---|---|---|---|---|
| MEDICAL INSTRUMENTS CORPORATION | ||||
| 510(k) Summary of Safety and Effectiveness |
| Submitter: | Date of Preparation: | |
|---|---|---|
| Company / Institution name: | RICHARD WOLF MEDICAL INSTRUMENTS CORP. | July 7, 1997 |
| Division name (if applicable): | N.A. | FDA establishment registration number: |
| 14 184 79 | ||
| Street address: | 353 Corporate Woods Parkway | Phone number (include area code): |
| (847) 913-1113 | ||
| City: | Vernon Hills | FAX number (include area code): |
| State/Province: | Illinois | (847) 913-0924 |
| Country: | USA | ZIP / Postal Code: |
| 60061 | ||
| Contact name: | Mr. Robert L. Casarsa | |
| Contact title: | Quality Assurance Manager |
| Product Information: | |
|---|---|
| Trade name: | Model number: |
| Unipolar HF Grasping Forceps | 8254.601/.602 |
| Common name: | Classification name: |
| Forceps | Forceps, ENT |
| Information on devices to which substantial equivalence is claimed: | ||
|---|---|---|
| -- | --------------------------------------------------------------------- | -- |
| 510(k) Number | Trade or proprietary or model name | Manufacturer |
|---|---|---|
| 1 Pre-amend. | 1 Grasping forceps, 8283.12/.13 | 1 Richard Wolf |
| 2 | 2 Grasping Forceps, 8660A | 2 Karl Storz |
| 3 | 3 Miniature Grasping Forceps. 8593 | 3 Karl Storz |
| 4 | 4 Grasping Forceps, 50-6858 | 4 Pilling-Weck |
1.0 Description
The forceps are made of medical grade stainless steel, teflon coated medical grade stainless steel, black chrome plating, and plastic.
2.0 Intended Use
The instruments are for use on the laryngeal anatomy, e.g., the vocal cords, false cords, surpraglottis, glottis, epgilottis, tongue base, oral pharynx, and uvula. The instruments are used to grasp and hold tissue for dissection or vaporization. The forceps may be used to coagulate blood vessels within the tissue when it is connected to a unipolar high frequency generator. Depending on where the bleeding vessel is located, coagulate by applying a low dose of HF current. The intensity depends on the severity of the bleeding and on the vessel. Always start with a low dosage and increase the power if necessary.
1
Technological Characteristics 3.0
The grasping forceps have been insulated and now allow the application of high frequency current.
Substantial Equivalence 4.0
The submitted devices are substantially equivalent to existing pre-enactment devices sold by Richard Wolf , Karl Storz, and Pilling Weck.
5.0 Performance Data None
Clinical Tests 6.0 No clinical tests performed.
7.0 Conclusions Drawn
The forceps are substantially equivalent to other non-cautery capable forceps available on the market.
By: Robert H. Lawson
Date:
Robert L. Casarsa Quality Assurance Manager
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure embracing or protecting another person, represented by abstract lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 8 1997
Robert L. Casarsa Quality Assurance Manager Richard Wolf Medical Instruments Corp. 353 Corporate Woods Parkway Vernon Hills, Illinois 60064
Re:
K972519 Unipolar HF Micro Grasping Forceps Dated: July 7, 1997 Received: July 7, 1997 Regulatory class: II 21 CFR 878.4400/Procode: 79 GEI
Dear Mr. Casarsa:
We have reviewed your Section 510(k) notification of intent to market the device 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 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 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 (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. 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 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 marketd 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 question 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 vours
William Yiu, Ph.D.
Lillian Yin, Ph.D. Director. Division of Reproductive. Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
text
.
INDICATIONS FOR USE
| 510(k) Number (if known): | K972519 |
|---|---|
| --------------------------- | --------- |
Device Name: _________________________________________________________________________________________________________________________________________________________________
Intended Use:
The instruments are for use on the laryngeal anatomy, e.g., the vocal cords, false cords, surpraglottis, glottis, epiglottis, tongue base, oral pharynx, and uvula. The instruments are used to grasp and hold tissue for dissection or vaporization. The forceps may be used to coagulate blood vessels within the tissue when it is connected to a unipolar high frequency generator. Depending on where the bleeding vessel is located, coagulate by applying a low dose of HF current. The intensity depends on the severity of the bleeding and on the vessel. Always start with a low dosage and increase the power if necessary.
Contraindications:
Do not use in the presence of flammable anesthetics.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
David A. Ingram
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT and Radiological Devices
510(k) Number K972519
Prescription Use Pcr 21 CFR 801.109
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Over-The Counter