(53 days)
The electrosurgical instruments are intended to remove tissue and control bleeding.
The various unipolar and bipolar Micro-France electrosurgical instruments consist of scissors, forceps, and probes, and are available in configurations for laparoscopic / endoscopic access and open field surgery. Accessories include unipolar and bipolar cables available in lengths up to 3 M.
The provided text is a 510(k) summary for electrosurgical instruments. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study on acceptance criteria and performance of the new device.
Therefore, the input does not contain the information necessary to describe:
- Acceptance criteria table and reported device performance.
- Sample size used for the test set or data provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for the test set.
- Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size.
- Whether a standalone (algorithm only) performance study was done.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document primarily states the device's intended use ("to remove tissue and control bleeding") and identifies predicate devices that it claims substantial equivalence to. It does not provide performance metrics, study designs, or data related to demonstrating the device meets specific acceptance criteria in the way a clinical or performance study report would.
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DEC 21 1999
510(k) Summary
1.0 Date Prepared
October 28, 1999
2.0 Submitter (Contact)
Martin D. Sargent Xomed Surgical Products Jacksonville, FL (904) 279-7586
3.0 Device Name
| Proprietary Name: | Micro-France electrosurgical instruments |
|---|---|
| Common Name(s): | Electrosurgical cutting and coagulation accessories |
| Classification Name(s): | Electrosurgical cutting and coagulation accessories |
5.0 Device Classification
Electrosurgical cutting and coagulation accessories: Procode JOS Class II 21 CFR 878.4400
6.0 Device Description
The various unipolar and bipolar Micro-France electrosurgical instruments consist of scissors, forceps, and probes, and are available in configurations for laparoscopic / endoscopic access and open field surgery. Accessories include unipolar and bipolar cables available in lengths up to 3 M.
7.0 Intended Use
The Electrosurgical instruments are used to remove tissue and control bleeding.
8.0 Substantial Equivalence
The Electrosurgical instruments are substantially equivalent to devices marketed by Richard Wolf Medical Instruments (K980129), Concept (K792365), Instrument Maker (K890972), Linvatec (K944992), Megadyne Medical Products (K903302), New England Surgical Instrument (K895331), and Kirwan Surgical Products (K913514).
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an emblem featuring a stylized depiction of an eagle or bird-like figure, composed of three curved lines that suggest wings or feathers.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 1 1999
Mr. Martin D. Sargent Senior Regulatory Affairs Specialist Xomed Surgical Products 6743 Southpoint Drive, North Jacksonville, Florida 32216-0980
K993655 Re:
Trade Name: Micro-France Electrosurgical Instruments, Various Regulatory Class: II Product Code: GEI Dated: October 28, 1999 Received: October 29, 1999
Dear Mr. Sargent:
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 Devices 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), it 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 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 devices 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 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.
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Page 2 - Mr. Martin D. Sargent
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,
Stephen Purden
James E. Dillard III
Aa Ja
Acting Director Division of General and Restorative Devices Office of Devices Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): Device Name: Electrosurgical Cutting and Coagulation Accessories Indications for Use:
The electrosurgical instruments are intended to remove tissue and control bleeding.
(Please do not write below this line - continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE)
Hupt Rhodes
(Division Sign-Off) Division of General Restorative Devices K993655 510(k) Number _
Prescription Use
(Per 21 CFR 801.109)
Or
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
§ 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.