ARIEL RADIO FREQUENCY (RF) ELECTROSURGICAL CONTROL MODULE AND ACCESSORIES

K013730 · Novasys Medical, Inc. · GEI · Feb 6, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K013730
• Device Name: ARIEL RADIO FREQUENCY (RF) ELECTROSURGICAL CONTROL MODULE AND ACCESSORIES
• Applicant: Novasys Medical, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Feb 6, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Ariel RF Electrosurgical Control Module provides radiofrequency energy to Novasys coagulating electrodes for soft tissue coagulation. Operated by trained medical personnel in clinical settings. Device transforms electrical power into RF energy delivered via electrodes to target tissue. Output allows physicians to achieve hemostasis or tissue coagulation during surgical procedures. Benefits include controlled thermal effect on soft tissue.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Electrosurgical generator providing RF energy for tissue coagulation. System includes control module and compatible coagulating electrodes. Operates under 21 CFR 878.4400 (Product Code GEI).

Indications for Use

Indicated for coagulation of soft tissue. Intended for use by qualified medical personnel trained in electrosurgery. Contraindicated when, in the physician's judgment, electrosurgical procedures are contrary to the patient's best interests.

Regulatory Classification

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.

Submission Summary (Full Text)

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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: [phone]

#### Date Summary Prepared:

11-2-01

#### Name of the Device:

| Proprietary Name: | Novasys "Ariel" RF Electrosurgical<br>Control Module and Accessories |
|----------------------|----------------------------------------------------------------------|
| Common/Usual Name: | Electrosurgical Generator and<br>Accessories |
| Classification Name: | Electrosurgical Device (per 21 CFR<br>878 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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 Assigned<br>K013730 |
| Device Name: | NOVASYS "ARIEL" RF ELECTROSURGICAL<br>CONTROL MODULE AND ACCESSORIES |
| Indications For Use: | The Novasys "Ariel" RF Electrosurgical Control<br>Module and Accessories, in combination with<br>various Novasys electrodes, is indicated for the<br>coagulation of tissue. |
| | This device is intended for use by qualified medical<br>personnel trained in the use of electrosurgery. |
| Contraindications for Use: | The use of the Novasys "Ariel" RF<br>Electrosurgical Control Module and Accessories is<br>contraindicated when, in the judgment of the<br>physician, electrosurgical procedures would be<br>contrary to the best interests of the patient. |

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use (Per 21 CFR 801.109) | <div>✓</div> |
|---------------------------------------|--------------|
|---------------------------------------|--------------|

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.