ELECTROSURGICAL ELECTRODE FAMILY by GENESIS MEDICAL, INC.

This document is a 510(k) clearance letter from the FDA for a family of electrosurgical electrodes. It confirms that the device is "substantially equivalent" to predicate devices already on the market, subject to general controls.

However, this document does not contain the detailed information necessary to describe the acceptance criteria and the study that proves the device meets those criteria.

Here's why and what information is missing:

Acceptance Criteria and Reported Device Performance: This letter states that the device is "substantially equivalent" to existing devices. It does not provide specific performance metrics (e.g., accuracy, precision, impedance, coagulation depth) or a table of acceptance criteria that the device was tested against.
Study Details (Sample Size, Data Provenance, Ground Truth, etc.): The letter itself is part of the regulatory approval process, not the study report itself. It references an underlying 510(k) submission (K992045) which would contain the study data. None of the following are present in this document:
- Sample size for the test set or training set.
- Data provenance (country of origin, retrospective/prospective).
- Number or qualifications of experts.
- Adjudication method.
- Information on MRMC comparative effectiveness studies or standalone algorithm studies.
- Type of ground truth used.
- How ground truth for the training set was established.

Conclusion:

Based only on the provided document, I cannot fulfill your request for:

A table of acceptance criteria and reported device performance.
Sample sizes or data provenance.
Details about expert involvement.
Adjudication method.
MRMC study information.
Standalone study information.
Type of ground truth.
Training set details.
Ground truth establishment for the training set.

This document is a high-level regulatory clearance and does not delve into the detailed technical and clinical study aspects of the device's validation. You would need to consult the actual 510(k) submission (K992045) for that information, which is typically much more extensive.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle's head facing left, with three parallel lines extending from the back of the head to represent feathers or wings.

JAN 2 7 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Thomas C. Wehman, Ph.D. Regulatory Affairs Genesis Medical, Inc. 524 Weddell Drive, Suite 4 Sunnyvale, California 94089

Re: K992045

Trade Name: Genesis Medical, Inc. Electrosurgical Electrode Family:

Model 4400 - Four Needle Electrode Single Balloon, Irrigation and Aspiration with Sponge option Model 4400 - Four Needle Electrode Single Balloon, Irrigation and Aspiration without Sponge option

Model 4110 - Four Needle Electrode Dual Balloons, Irrigation and Aspiration with Sponge option

Model 4110 - Four Needle Electrode Dual Balloons, Irrigation and Aspiration without Sponge option

Model 4002 - Four Needle Electrode, Guidewire, Irrigation and Aspiration with Sponge option

Model 4002 - Four Needle Electrode, Guidewire, Irrigation and Aspiration without Sponge option

Regulatory Class: II Product Code: GEI Dated: November 8, 1999 Received: November 17, 1999

Dear Dr. Wehman:

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

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Page 2 - Thomas C. Wehman, Ph.D.

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. 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.

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 vours.

Stpt. Riverda

James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):	Unknown K992045
Device Name:	Genesis Medical, Inc. Electrosurgical Electrode Family
Indications for Use:	Indicated for coagulation of tissue
	These devices are intended for use by qualified medical personn-trained in the use of electrosurgery.
Contraindications:	The use of electrosurgery is contraindicated when, in thejudgment of the physician, electrosurgical procedures wouldbe contrary to the best interest of the patient.

Indications For Use

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE, IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Stigh Ploder

(Division Sign-Off)

Division of General Restorative Devices 5 : 0(k) Number ______________________________________________________________________________________________________________________________________________________________

Over-the-Counter Use (Optional format 1-2-96)

Prescription Use
(per 21 CFR 801.109)

Regulation Number and Section

§ 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.