TRABECTOME HIGH FREQUENCY GENERATOR/LP

K061258 · Neomedix Corp. · GEI · May 18, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K061258
• Device Name: TRABECTOME HIGH FREQUENCY GENERATOR/LP
• Applicant: Neomedix Corp.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: May 18, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The Trabectome™ High Frequency Generator/LP is for use with compatible electrosurgical instruments in low power microsurgical applications for the removal, destruction and coagulation of tissue.

Device Story

The Trabectome™ High Frequency Generator/LP is a non-sterile, reusable electrosurgical generator used in low-power microsurgical applications. It generates high-frequency (RF) high-voltage, low-amperage current. The device operates in either monopolar or bipolar mode at a frequency of approximately 500 kHz. It is activated via a footswitch or other single-pole closure device connected to an input jack on the front panel. Available in 110 VAC or 220 VAC models, the generator provides power to compatible electrosurgical instruments to facilitate tissue removal, destruction, and coagulation. It is intended for use by clinicians in a surgical setting.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Electrosurgical generator; RF energy source; operating frequency ~500 kHz; maximum power output 6 watts; monopolar and bipolar modes; 110 VAC or 220 VAC input; footswitch activation; reusable, non-sterile.

Indications for Use

Indicated for use with compatible electrosurgical instruments in low power microsurgical applications for the removal, destruction, and coagulation of tissue.

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.

Predicate Devices

• Aaron Medical Model 800 High Frequency Desiccator (K955681)

Submission Summary (Full Text)

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NeoMedix Corporation 510(k) Premarket Notification April 12, 2006

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### 510 (k) SUMMARY

K 061258

#### Applicant

NeoMedix Corporation 15042 Parkway Loop, Ste. A Tustin, CA 92780

Contact Person

Thomas Schroeder VP, RAIQA Phone [phone] FAX: [phone] e-mail: [e-mail]

#### Common, Classification and Proprietary Names

| Common Names: | Electrosurgical Generator |
|----------------------|---------------------------------------------------------------------------------------|
| Classification Name: | Electrosurgical cutting and coagulation device, 21 CFR<br>878.4400, Product Code GEI. |
| Proprietary name: | Trabectome™ High Frequency Generator/LP |

#### Predicate Device

The NeoMedix Corporation Trabectome™ High Frequency Generator/LP is substantially equivalent in design, construction and features to the Aaron Medical Model 800 High Frequency Desiccator cleared under K955681. Both devices operate in either the monopolar or bipolar mode at an operating frequency of ~ 500 kHz. There are no technological differences between the two devices other than the maximum power output. The Aaron 800 generator has a maximum power output of 30 watts while the Trabectome™ High Frequency Generator/LP has a maximum power output of 6 watts.

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<061258

NeoMedix Corporation 510(k) Premarket Notification April 12, 2006

#### Indications for Use

Page 2 of (2)

The Trabectome™ High Frequency Generator/LP is for use with compatible electrosurgical instruments in low power microsurgical applications for the removal, destruction and coagulation of tissue.

#### Device Description

The Trabectome™ High Frequency Generator/LP is a non-sterile, reusable electrosurgical generator. The device is designed to generate high frequency (radiofrequency "RF") high voltage and low amperage current. The device operates in either the monopolar or the bipolar mode. The device is available in two voltage models: 110 VAC or 220 VAC (for international use). The generator is activated through an input jack on the front panel. The activation can be via a footswitch or other single pole closure device with a compatible plug.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 18 2006

NeoMedix Corporation c/o Ms. Michelle S. Lee Underwriters Laboratories Inc. 2600 NW Lake Road Camas, Washington 98607

Re: K061258

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Trade/Device Name: Trabectome™ High Frequency Generator/LP Regulation Name: Electrosurgical cutting and coagulation device Regulatory Class: II Product Code: GEI Dated: May 1, 2006 Received: May 5, 2006

Dear Ms. Lee:

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 - Ms. Michelle S. Lee

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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely yours,

Hulbert Leiner

f

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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NeoMedix Corporation 510(k) Premarket Notification April 12, 2006

## INDICATIONS FOR USE STATEMENT

510(k) Number (if known): __

K061258

Trabectome™ High Frequency Generator/LP Device Name:

Indications for use: The Trabectome™ High Frequency Generator/LP is for use with compatible electrosurgical instruments in low power microsurgical applications for the removal, destruction and coagulation of tissue.

Prescription Use: × (Part 21 CFR 801 Subpart D) AND/OR

Over-the-counter Use: (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hake Steiner as

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

**510(k) Number** K061258

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