(85 days)
The Gyrus ENT Somnoplasty Generator, in combination with Gyrus ENT Somnoplasty Electrodes, is intended for use in the coagulation of soft tissue. This device is intended for use by qualified medical personnel trained in the use of electrosurgery.
The Gyrus ENT Somnoplasty Generator with the Gyrus ENT Soft Tissue Coagulating Electrodes is indicated for the coagulation of soft tissue. The system is intended for use by qualified medical personnel trained in the use of electrosurgical equipment.
The Gyrus ENT Somnoplasty Generator has controls for maximum temperature, energy delivered and time of energy delivery. The unit readouts for total energy delivered, has temperature for two impedance. and thermocouples. Connectors on the front panel include connector for active electrode and dispersive electrode. The foot pedal is connected on the back panel. Accessories included with the generator are a power cable and a footswitch.
The provided documents are a 510(k) summary for the Gyrus ENT Somnoplasty Generator. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing a full clinical trial to prove safety and efficacy against pre-defined acceptance criteria. Therefore, the documents do not contain information regarding detailed acceptance criteria, a specific study proving the device meets those criteria, or the other specific details requested (such as sample sizes for test/training sets, ground truth establishment, expert qualifications, MRMC studies, or standalone performance).
The 510(k) process relies on performance validation testing to show substantial equivalence. The summary states:
"Performance validation testing has been done to validate the performance of the device. The comparison and validation results presented in this 510(k) notification to the FDA show that the device is substantially equivalent to predicate devices and is safe and effective in its intended use."
However, the specific details of this "performance validation testing" are not included in the provided summary. This validation would typically involve bench testing to ensure the device performs as intended and comparably to the predicate device, but not a clinical study with detailed acceptance criteria as one might find for a novel device or a PMA submission.
Therefore, I cannot provide the requested table and information based on the given text.
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Gyrus ENT, Memphis, TN January 8, 2002
APR = 4 2002
KO20067 510(k) Summary of Safety and Effectiveness
Gyrus ENT Somnoplasty Generator
Submitted by:
Contact Person:
Gyrus ENT 2925 Appling Rd. Bartlett, TN 38133
Jeffrev W. Cobb Vice President Regulatory Affairs
901-373-2673 Telephone: 901-373-0220 Facsimile:
Date Summary Prepared:
January 7, 2002
Name of the Device:
Proprietary Name:
Proprietary Name:
Common/Usual Name:
Classification Name:
Predicate Device:
Description:
Gyrus ENT Somnoplasty Generator
COGENT 1
Electrosurgical Generator and Accessories
Electrosurgical Device (per 21 CFR 878.4400)
Somnus Model S1 (K000501)
The Gyrus ENT Somnoplasty Generator has controls for maximum temperature, energy delivered and time of energy delivery. The unit readouts for total energy delivered, has temperature for two impedance. and thermocouples. Connectors on the front panel include connector for active electrode and dispersive electrode. The foot pedal is connected on the back panel.
Accessories included with the generator are a power cable and a footswitch.
P51
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Gyrus ENT, Memphis, TN January 8, 2002
Statement of Intended Use:
The Gyrus ENT Somnoplasty Generator, in combination with Gyrus ENT Somnoplasty Electrodes, is intended for use in the coagulation of soft tissue.
This device is intended for use by qualified medical personnel trained in the use of electrosurgery.
Comparison to Predicate Devices:
The Gyrus ENT Somnoplasty Generator has been carefully compared to legally marketed devices with respect to intended use and technological characteristics. In addition, performance validation testing has been done to validate the performance of the device. The comparison and validation results presented in this 510(k) notification to the FDA show that the device is substantially equivalent to predicate devices and is safe and effective in its intended use.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Jeffrey W. Cobb Vice President Regulatory Affairs Gyrus ENT 2925 Appling Road Bartlett, TN 38133
Re: K020067
Trade/Device Name: Gyrus ENT Somnoplasty Generator Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: January 8, 2002 Received: January 9, 2002
Dear Mr. Cobb:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications ferenced above and harrsure) to legally marketed predicate devices marketed in interstate for use stated in the encrosale) to 10gary to 10gaily of the Medical Device American by D conninered phor to they 2019 103 103 103 100 100 100 100 100 100 100 1000 1000 1000 de necs that have been require approval of a premarket approval application (PMA). allu Cosmetic Treef, that to hevice, subject to the general controls provisions of the Act. The r ou may, diereleve, mains of the Act include requirements for annual registration, listing of general controls provision 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 If your device is classined controls. Existing major regulations affecting your device can may or buyer to back as assist as a submit ons, 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 I toase of actives and I Drivision that your device complies with other requirements of the Act that I Dri has intatutes and regulations administered by other Federal agencies. You must or any I vatha bathe 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 Of R Part 807); accems (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 premaince nevice 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,
Muriam C. Provost
for 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, Memphis, TN January 8, 2002
510(k) Premarket Notification Gyrus ENT Somnoplasty Generator
Indications for Use
510(k) Number (if known):
Device Name:
Indications For Use:
Not Yet Assigned
K02 0067
Gyrus ENT Somnoplasty Generator ELECTROSURGICAL GENERATOR
The Gyrus ENT Somnoplasty Generator with the Gyrus ENT Soft Tissue Coagulating Electrodes is indicated for the coagulation of soft tissue.
The system is intended for use by qualified medical personnel trained in the use of electrosurgical equipment.
Contraindications for Use:
The use of the Gyrus ENT Somnoplasty Generator is contraindicated when, in the judgment of the physician, electrosurgical procedures would be contrary to the best interests of the patient.
Somnoplasty may be contraindicated in patients with a compromised immune system.
(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) 1-2-96)
Over-The-Counter Use (Optional Format
uriam C. Provost
OR
Division Sign-Off) Division of General, Restorative and Neurological Devices
X020067 510(k) Number.
§ 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.