The Xomed ENT RF system is for use by qualified surgeons familiar with radiofrequency electrosurgery techniques. The system produces monopolar and bipolar cutting and coagulation, and may provide fluid irrigation.

Indications in general surgery are for cutting, removal, and coagulation of tissues.

Indications in otorhinolaryngology (ENT) are for cutting, removal, and coagulation of tissues and for the destruction of tissue by thermal ablation in ENT procedures including, but not limited to snoring procedures, submucosal palatal and turbinate shrinkage, and traditional uvulopalatoplasty.

Device Description

The Xomed ENT RF System consists of a radio frequency electrosurgical generator with a footswitch and/or fingerswitch to activate the generator RF output, various scissors, forceps, and probe electrosurgical instruments, and accessories including electrical cables to attach various electrosurgical instruments.

The system may be provided with an RF output current indicator, and a built-in peristaltic pump and associated footswitch for fluid irrigation.

AI/ML Overview

This submission is a 510(k) premarket notification for a medical device, not an AI/ML device. Therefore clinical performance studies, acceptance criteria, multi-reader multi-case studies, and ground truth information are not applicable.

The submission focuses on establishing substantial equivalence to a predicate device already on the market, rather than proving performance against specific acceptance criteria through a study as would be done for novel or AI/ML-driven devices.

Here's why the requested information isn't present in the document and what the document does provide:

Acceptance Criteria and Reported Device Performance: Not applicable. The submission does not define specific performance metrics like sensitivity, specificity, accuracy, or report on clinical study results against such criteria.
Sample Size, Data Provenance, Number of Experts, Adjudication Method: Not applicable. These details are relevant for clinical trials or studies assessing device performance (especially AI/ML models), which are not required for a 510(k) submission seeking substantial equivalence for this type of device.
MRMC Comparative Effectiveness Study: Not applicable. This type of study is typically done for diagnostic devices or AI algorithms where human reader performance is compared with and without AI assistance. This device is a surgical tool.
Standalone Performance: Not applicable. "Standalone performance" usually refers to the performance of an algorithm without human intervention, which is not relevant for an electrosurgical system.
Type of Ground Truth: Not applicable. Ground truth, such as pathology or outcomes data, is used to validate the output of diagnostic or predictive algorithms. This device is a surgical instrument.
Sample Size for Training Set, How Ground Truth for Training Set was Established: Not applicable. This device is not an AI/ML algorithm that requires training data and ground truth establishment.

What the document does provide regarding "proof" of the device:

The "study" for this type of device is the demonstration of Substantial Equivalence to a legally marketed predicate device.

Section 8.0 Substantial Equivalence: States that "The Xomed ENT RF system is substantially equivalent to the Surgitron IEC marketed by Ellman (K990146 and K980177) in its intended use, materials, and overall design."
The FDA's decision letter (starting on page 2) confirms this: "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..."

In summary, for this 510(k) submission, the "proof" is the demonstration and FDA's acceptance of substantial equivalence to a predicate device, based on comparable intended use, technology, and safety/effectiveness profiles, rather than a clinical study with specific acceptance criteria.

Summary

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DEC - 9 1999

510(k) Summary

K99 3112

1.0 Date Prepared

September 16, 1999

2.0 Submitter (Contact)

Martin D. Sargent Xomed Surgical Products Jacksonville, FL (904) 279-7586

3.0 Device Name

Proprietary Name: Common Name(s): Classification Name(s): Xomed ENT RF System Electrosurgical system Device, Electrosurgical, Cutting & Coagulation & Accessories

5.0 Device Classification

Device, Electrosurgical, Cutting & Coagulation & Accessories: 21 CFR 878.4400 Procode 97GEI Class II

6.0 Device Description

The system may be provided with an RF output current indicator, and a built-in peristaltic pump and associated footswitch for fluid irrigation.

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Intended Use 7.0

Indications in general surgery are for cutting, removal, and coagulation of tissues.

8.0 Substantial Equivalence

The Xomed ENT RF system is substantially equivalent to the Surgitron IEC marketed by Ellman (K990146 and K980177) in its intended use, materials, and overall design.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a symbol of three stylized human figures, representing health and well-being.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 9 1999

Mr. Martin D. Sargent Senior Regulatory Affairs Specialist Xomed Surgical Products 6743 Southpoint Drive North Jacksonville, Florida 32216

Re: K993112 Trade Name: Xomed ENT RF System Regulatory Class: II Product Code: GEI Dated: September 16, 1999 Received: September 17, 1999

Dear Mr. Sargent:

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.

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Page 2 - Mr. Martin D. Sargent

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.

Sincerely, yours,

Stpt Rhodes

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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12993112 510(k) Number (if known):_ Device Name: _________________________________________________________________________________________________________________________________________________________________ Indications for Use:

The Xomed ENT RF system is for use by qualified surgeons familiar with radiofrequency electrosurgery techniques. The system produces monopolar and bipolar cutting and coagulation, and may provide fluid irrigation.

Indications in general surgery are for cutting, removal, and coagulation of tissues.

(Please do not write below this line - continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE)

A.S. Rurch
(Division Sign-Off)

Division of General Restorative Devices
510(k) Number K953112

Prescription Use
(Per 21 CFR 801.109)

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

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.