The Gyrus ENT Somnoplasty® Model 2420 Tissue Coagulating Electrode is intended for use in the coagulation of tissues in the head and neck by qualified medical personnel trained in the use of electrosurgery. Indications for use for the Gyrus ENT Model 2420 Tissue Coagulating Electrode include the coagulation and reduction of enlarged tonsils for patients 13 years of age and older.

Device Description

The Model 2420 Tissue Coagulating Electrode is used to deliver RF energy for selective thermal coagulation of tissue. The electrode is provided as a dual needle that is deployed from a guide sleeve. The angle of deployment is fixed at approximately 45°. The needle is covered proximally by insulation to protect the mucosa during coagulation. A beveled penetrator plate is located at the tip of the guide sleeve and serves to penetrate the tonsil mucosal surface prior to electrode deployment. Temperature sensors located at the tip of the needle and the tip of the insulation monitor lesion temperature.

Like the previously cleared Model 1420 electrode, the Model 2420 provides a slide actuator on the handle used to extend or retract the needle electrodes through attached dual guide lumens. The proximal end of the handle accepts the detachable and reusable power cable. The distal end of the handle is attached to the guide lumens containing the needle electrodes. The entire device is disposable.

AI/ML Overview

This document is a 510(k) Summary for a medical device (Gyrus ENT Somnoplasty® Model 2420 Tissue Coagulating Electrode) seeking market clearance. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in terms of performance metrics.

Therefore, much of the requested information regarding acceptance criteria and performance evaluation through a study is not available in the provided text. The document is an FDA submission for market clearance, which relies on demonstrating equivalence to existing products rather than a novel clinical effectiveness study with defined acceptance criteria and performance outcomes.

Here is an attempt to address your request based only on the provided text, highlighting what is missing or not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not available in the provided 510(k) summary. Acceptance criteria for device performance (e.g., success rates, percentage reduction in tonsil size, complication rates) and corresponding reported performance metrics from a study are not included. The document emphasizes substantial equivalence to a predicate device, not a new performance evaluation against predefined criteria.

2. Sample Size Used for the Test Set and Data Provenance

This information is not available. The document does not describe a new clinical study with a defined test set for performance evaluation. It references previously cleared devices and states the current device "is substantially the same."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not available, as no new clinical study with a test set requiring expert ground truth establishment is described.

4. Adjudication Method

This information is not available, as no new clinical study with a test set requiring adjudication is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This information is not available. No MRMC comparative effectiveness study is mentioned, nor is any human-in-the-loop performance evaluation or an effect size for human readers improving with/without AI assistance. The device is a surgical electrode, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only) Performance

This information is not available. The device is a physical electrosurgical electrode and does not involve an algorithm for standalone performance evaluation.

7. Type of Ground Truth Used

This information is not available, as no new clinical study requiring ground truth establishment is described.

8. Sample Size for the Training Set

This information is not available. The device is an electrosurgical electrode, not an AI model, and therefore does not have a "training set" in the context of machine learning. The submission relies on the established safety and effectiveness of predicate devices.

9. How the Ground Truth for the Training Set Was Established

This information is not available (see point 8).

Summary of Device and its Basis for Clearance (Extracted Information):

Intended Use/Indications: Coagulation and reduction of enlarged tonsils for patients 13 years and older in the head and neck by qualified medical personnel trained in electrosurgery.
Device Description: The Somnoplasty® Model 2420 Tissue Coagulating Electrode is part of the Somnoplasty® System. It's a dual-needle electrode that deploys at approximately 45°, with insulation to protect mucosa and temperature sensors to monitor lesion temperature. It has a slide actuator on the handle and is disposable.
Basis for Clearance: Substantial Equivalence to previously cleared devices:
- Previous Somnoplasty® Systems cleared for uvula/soft palate coagulation (K971450), chronic turbinate hypertrophy (K973618), and UARS/OSAS airway obstruction reduction (K982717).
- Current Model S2 Generator cleared in K001438.
- RC-20 Cable cleared in K000720.
- Model 2420 Tissue Coagulating Electrode is "substantially the same" as the Model 1420 Electrode cleared in K000720.
Conclusion of FDA: The FDA determined the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market.

The 510(k) process is primarily a regulatory pathway to demonstrate that a new device is as safe and effective as a legally marketed predicate device, not to prove clinical efficacy and safety through new, extensive clinical trials with defined acceptance criteria for performance (unless the device is significantly different or intended for a new use not covered by predicates).

Summary

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MAY 2 8 2002

K020778

510(k) Summary of Safety and Effectiveness

Gyrus ENT

Somnoplasty® Model 2420 Tissue Coagulating Electrode

Intended Use/Indications

Submitted by

Jeffrey W. Cobb Vice President, Regulatory/Clinical Affairs & Quality Gyrus ENT L.L.C. 2925 Appling Road Bartlett, TN 38133 Telephone: (901) 373-0251 Facsimile: (901)-373-0242

Contact Person

Jeffrey W. Cobb Vice President, Regulatory/Clinical Affairs & Quality Telephone: (901) 373-2673 Facsimile: (901) 373-0242

Date Summary Prepared: March 7, 2002

Name of the Device

Classification Name: Electrosurgical Cutting and Coagulating Device and Accessories Common/Usual Name: Electrosurgical Generator and Tissue Coagulating Electrode Proprietary Name: Gyrus ENT Somnoplasty® Model 2420 Tissue Coagulating Electrode

P37

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Description and Substantial Equivalence

The Somnoplasty® System is comprised of three principal elements: (1) the Model 2420 Disposable Tissue Coagulating Electrode; (2) the Model RC-20 Reusable Cable*; and (3) the Modified Model S2 Electrosurgical Generator*, or another two-channel Gyrus electrosurgical generator. Previous versions of the Somnoplasty® System have been cleared for use in soft tissue coagulation in the uvula/soft palate (K971450), treatment of nasal obstruction due to chronic turbinate hypertrophy (K973618), and reduction of the incidence of airway obstructions in patients suffering from UARS or OSAS (K982717). *In addition, the current Model S2 Generator was cleared for use in conjunction with disposable soft tissue coagulation electrodes in K001438, and the RC-20 Cable was cleared in K000720.

The Model 2420 Tissue Coagulating Electrode also is substantially the same as the Model 1420 Electrode that was cleared in K000720. Thus, there are no significant differences in design or technological features between the current Somnoplasty® System and the company's previously cleared products. A brief description of each of the components of the current System is provided below.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/2 description: The image shows the address of the Food and Drug Administration. The address is 9200 Corporate Boulevard, Rockville MD 20850. The text is black and the background is white.

MAY 2 8 2002

Mr. Jeffrey W. Cobb Vice President, Regulatory/Clinical Affairs and Quality Gyrus ENT L.L.C. 2925 Appling Road Bartlett, TN 38133

Re: K020778

Trade/Device Name: Gyrus ENT Somnoplasty® Model 2420 Tissue Coagulating Electrode

Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: March 8, 2002 Received: March 11, 2002

Dear Mr. Cobb:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Jeffrey W. Cobb

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Gyrus ENT L.L.C. Bartlett, TN

Indications for Use

K 020778 510(k) Number (if known): Not Yet Assigned

Device Name:

Gyrus ENT Somnoplasty® Model 2420 Tissue Coagulating Electrode

Intended Use / Indications For Use:

Contraindications for Use: The use of the Somnoplasty System is contraindicated when, in the judgment of the physician, electrosurgical procedures would be contrary to the best interests of the patient.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Per 21 CFR 801.109) -

Over-The-Counter Use (Optional Format 1-2-96)

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K020778

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.