(78 days)
No
The document describes a standard electrosurgical tool with a proprietary coating and does not mention any AI/ML components or functionalities.
No
This device is for surgical procedures to facilitate grasping and manipulation of soft tissue and blood vessels and provide electrocautery, which are not therapeutic actions.
No
Explanation: The device description and intended use state that the forceps are an electrosurgical tool designed for grasping, manipulating, and providing electrocautery during surgical procedures. There is no mention of it being used to diagnose conditions or gather diagnostic information.
No
The device description clearly states it is a physical electrosurgical tool constructed with stainless steel and coated with an electrical insulator, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "facilitate grasping and manipulation of soft tissue and blood vessels and provide electrocautery in surgical procedures." This describes a surgical tool used directly on the patient's body during a procedure.
- Device Description: The description details a surgical instrument (forceps) used for physical manipulation and electrocautery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVDs are devices used to perform tests on samples taken from the human body to provide information about a person's health. This device is a surgical instrument used on the body during a procedure.
N/A
Intended Use / Indications for Use
This product is intended to facilitate grasping and manipulation of soft tissue and blood vessels and provide electrocautery in surgical procedures.
Product codes
GEI
Device Description
The Link Technology Non-Stick Bipolar Forceps electrosurgical tool in the typical tweezers configuration. The forceps are constructed with stainless steel and coated with an electrical insulator. The uninsulated forceps tip is plated with a proprietary metallurgical alloy. The forceps are compatible with standard OEM (original equipment manufacturer) electrosurgical generators and bipolar electrode cables.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
The biological safety of the Non-Stick Bipolar Forceps has been defined through the selection of materials which demonstrate the appropriate levels of biocompatibility for its clinical use. This demonstration is based upon choosing materials that have an established history of safe use in similar medical devices, literature research, and biocompatibility studies that meet the standards outlined in ISO 10993-1.
Key Metrics
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
NOV 17 1999
K99 2931
510(k) Summary Link Technology, Inc. Non-Stick Bipolar Forceps
Submitter (Consultant) Name and Address
Morningstar Consulting Group, Inc. P. O. Box 219 Indian Hills, CO 80454
Submitter (Consultant) Contact Person
Kevin Morningstar, Senior Consultant (303) 697-8198 phone: (303) 697-7907 fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax:
Manufacturer Name and Address
Link Technology, Inc. 4001 Discovery Drive, Suite 390 Boulder, CO 80303
Manufacturer Contact Person
Jonathan Thorne, CEO phone: (303) 444-1949 (303) 4446237 fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax:
Common, Classification & Proprietary Names
Common Name: electrosurgical electrode electrosurgical cutting and coagulation device and Classification Name: accessories Proprietary Name: non-stick bipolar forceps
Predicate Devices
Ball Tip Electrode, Fusion Technologies, Inc., K970987 Midas Touch Bipolar Electrodes, ITI Medical Technologies, Inc., K982705
Device Description
The Link Technology Non-Stick Bipolar Forceps electrosurgical tool in the typical tweezers configuration. The forceps are constructed with stainless steel and coated with an electrical insulator. The uninsulated forceps tip is plated with a proprietary metallurgical alloy. The forceps are compatible with standard OEM (original equipment manufacturer) electrosurgical generators and bipolar electrode cables.
Indications for Use
This product is intended to facilitate grasping and manipulation of soft tissue and blood vessels and provide electrocautery in surgical procedures.
1
Technological Characteristics Comparison
This claim of substantial equivalence to the Fusion Ball Tip electrode is specifically in relation to the proprietary non-stick metal, and the claim of substantial equivalence to the ITI Midas Touch Bipolar Forceps is in relation to non-stick bipolar forceps in general.
The proprietary non-stick metal used in the Fusion Ball Tip Electrode is the same as that plated onto the tip of the Link Technology Non-Stick Bipolar Forceps Electrode. Therefore, the characteristics of the material which comes into contact with tissue during surgical use, such as non-stick properties, biocompatibility, and thermal and electrical conductivity, are identical.
In general design, configuration and intended use, the Link Technology Non-Stick Bipolar Forceps Electrode is substantially equivalent to the ITI Midas Touch Bipolar Forceps, except as explained above regarding the choice of surface material. The two forceps designs utilize different surface materials in order to achieve the desired nonstick performance. Otherwise they are interchangeable.
Performance and Safety
The biological safety of the Non-Stick Bipolar Forceps has been defined through the selection of materials which demonstrate the appropriate levels of biocompatibility for its clinical use. This demonstration is based upon choosing materials that have an established history of safe use in similar medical devices, literature research, and biocompatibility studies that meet the standards outlined in ISO 10993-1.
The Non-Stick Bipolar Forceps are re-usable surgical devices, provided non-sterile to the user. The Instructions for Use provide instructions for the cleaning, decontamination, and sterilization of the device before each use. The instructions for reprocessing of the device will be validated before the device is marketed.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a symbol that resembles three stylized human figures or waves, stacked on top of each other.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 7 1999
Link Technology, Inc. c/o Mr. Kevin Morningstar President and Senior Consultant Morningstar Consulting Group, Inc. P.O. Box 219 Indian Hills, Colorado 80454
K992931 Re: Trade Name: Non-Stick Bipolar Forceps Regulatory Class: II Product Code: GEI Dated: August 28, 1999 Received: August 31, 1999
Dear Mr. Morningstar:
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.
3
Page 2 - Mr. Kevin Morningstar
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) 594-4595. 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,
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James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K 992931 510(k) Number (if known): __
Device Name Link Technology Non-Stick Bipolar Forceps
Indications for Use:
The Link Technology Non-Stick Bipolar Forceps product is intended to facilitate grasping and The Life Technology Non Odok Biped. Perssport provide electrocautery in surgical procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division | |
|---|---|
| Division of | Restorative Devices |
| 510(k) Number | K992931 |
| Prescription Use
| (Per 21 CFR 801.109) | OR | Over-The-Counter Use __________ |
|---|---|---|
| ------------------------------------------ | ---- | --------------------------------- |
(Optional Format 1-2-96