(89 days)
The Novasys "Ariel" RF Electrosurgical Control Module and Accessories, in combination with various Novasys electrodes, is indicated for the coagulation of tissue. This device is intended for use by qualified medical personnel trained in the use of electrosurgery.
Novasys "Ariel" RF Electrosurgical Control Module and Accessories
This 510(k) premarket notification for the Novasys "Ariel" RF Electrosurgical Control Module and Accessories does not contain the requested information regarding acceptance criteria, device performance studies, or ground truth establishment.
The provided document is a summary of safety and effectiveness, a 510(k) clearance letter from the FDA, and an Indications for Use statement. These documents primarily confirm the device's classification, intended use, and substantial equivalence to legally marketed predicate devices, allowing it to proceed to market. They do not detail the specific performance studies, acceptance criteria, or experimental methodologies that would be found in a more comprehensive technical report or clinical study summary.
Therefore, I cannot provide the requested information.
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Novasys Medical, Inc.
510(k) Premarket Notification "Ariel" RF Electrosurgical Control Module and Accessories
FEB 0 6 2002
K 01 37 3 O
510(k) Summary of Safety and Effectiveness Novasys Medical, Inc.
"Ariel" RF Electrosurgical Control Module and Accessories
Intended Use:
The Novasys "Ariel" RF Electrosurgical Control Module and The Novasys Timended for use with Novasys Coagulating Electrodes for the coagulation of soft tissue. The system is intended for use by qualified medical personnel trained in the use of electrosurgical equipment.
Submitted by:
Novasys Medical, Inc. 39684 Eureka Drive Newark, CA 94560-4805 Telephone: +1.510.226-4060 Fax: +.510.353-0524
Contact Person:
Thomas C. Wehman, Ph. D. Head Quality and Regulatory Affairs Telephone: (510)226-4068
Date Summary Prepared:
11-2-01
Name of the Device:
| Proprietary Name: | Novasys "Ariel" RF ElectrosurgicalControl Module and Accessories |
|---|---|
| Common/Usual Name: | Electrosurgical Generator andAccessories |
| Classification Name: | Electrosurgical Device (per 21 CFR878 4400) |
:
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Image /page/1/Picture/1 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right. The eagle is composed of three thick, curved lines that suggest movement or flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 0 6 2002
Thomas C. Wehman, Ph.D. Head, Quality and Reliability Novasys Medical, Inc. 39684 Eureka Drive Newark, California 94560-4805
Re: K013730
Trade Name: Novasys "Ariel" RF Electrosurgical Control Module and Accessories Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories; Regulatory Class: II Product Code: GEI Dated: November 7, 2001 Received: November 9, 2001
Dear Dr. Wehman:
We have reviewed your Section 510(k) premarket 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) 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 - Dr. Thomas Wehman
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
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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Novasys Medical, Inc.
| Indications for Use | |
|---|---|
| 510(k) Number (if known): | Not Yet AssignedK013730 |
| Device Name: | NOVASYS "ARIEL" RF ELECTROSURGICALCONTROL MODULE AND ACCESSORIES |
| Indications For Use: | The Novasys "Ariel" RF Electrosurgical ControlModule and Accessories, in combination withvarious Novasys electrodes, is indicated for thecoagulation of tissue. |
| This device is intended for use by qualified medicalpersonnel trained in the use of electrosurgery. | |
| Contraindications for Use: | The use of the Novasys "Ariel" RFElectrosurgical Control Module and Accessories iscontraindicated when, in the judgment of thephysician, electrosurgical procedures would becontrary 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 (Per 21 CFR 801.109) | ✓ |
|---|---|
| --------------------------------------- | -------------- |
OR
| 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 | K013730 |
|---|---|
| --------------- | --------- |
Proprietary Data: This document and the information herein may not be reproduced, used or disclosedProprietary Data: This document and the information herein may not be reproduced, used or disclose ed without prior written consent of Novasys Medical, Inc.
§ 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.