MAGNATEK ELECTROSURGICAL UNITS MODELS, ESU-10, ESU-15 by MAGNA ADVANCED TECHNOLOGIES, INC.

This document is a 510(k) clearance letter from the FDA for an electrosurgical unit. It confirms that the device is substantially equivalent to a previously marketed device. However, it does not contain the detailed information needed to answer your request about acceptance criteria and study data.

Here's a breakdown of why and what kind of information is missing:

Why the requested information is not present in this document:

This is a clearance letter, not a study report. The FDA 510(k) clearance letter primarily states that a device is substantially equivalent to a predicate device and can be marketed. It does not typically include the specifics of performance studies, acceptance criteria, or detailed ground truth methodologies.
The device is an Electrosurgical Unit. For this type of device, the "performance" is often related to electrical safety, power output accuracy, tissue effect (cutting/coagulation effectiveness), and biocompatibility, rather than diagnostic accuracy metrics like sensitivity, specificity, or AUC, which are common for AI/ML-driven diagnostic devices.
The clearance date is June 24, 1998. AI/ML-driven medical device evaluations, with their specific metrics and study designs, were not common or required in 1998 in the way they are today.

Therefore, I cannot provide the requested information from this document. It does not describe a study involving algorithms, test sets, experts, or ground truth for diagnostic performance.

Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 4 1998

Ms. Annie Velez ·Magna Advanced Technologies, Inc. 7200 N.W. Seventh Street Miami, Florida 33126

K981416 Trade Name: Magnatek Electrosurgical Unit Models, ESU-10, ESU-15 Regulatory Class: II Product Code: GEI Dated: April 14,1998 Received: April 20, 1998

Dear Ms. Velez

Re:

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 (OS) 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.

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.

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Page 2 - Ms. Annie Velez

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,

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

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INDICATION FOR USE STATEMENT

510(k) Number:

Not yet available 5981/4/6

Device Name: Electrosurgical Units

Device Model: ESU-10 / ESU-15

Indications for Use:

The ESU-10 / ESU-15 units is to be used in order to cut and coagulate (burn) the skin in surgical procedures.

Federal Law restricts the use of this device by or on the order of a qualified physician only.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over the Counter Use

to oeez

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number

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.