STELLARTECH 100 COAGULATION SYSTEM

K061544 · Stellartech Research Corp. · GEI · Oct 13, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K061544
• Device Name: STELLARTECH 100 COAGULATION SYSTEM
• Applicant: Stellartech Research Corp.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Oct 13, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Stellartech 100 Coagulation System is intended for coagulating soft tissue during open (non-laparoscopic or non-endoscopic) general surgical procedures. The System may also be used to coagulate blood and soft tissue to produce hemostasis.

Device Story

Stellartech 100 Coagulation System comprises a generator (Models 1050B-115/230), a 101 probe, and an optional footswitch. Device functions as an electrosurgical unit for soft tissue coagulation and hemostasis. Operated by surgeons in open surgical settings. Generator delivers energy to the probe to achieve tissue effect. System design, principles of operation, and materials are substantially equivalent to existing electrosurgical coagulation systems.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, materials, and principles of operation.

Technological Characteristics

Electrosurgical coagulation system consisting of a generator and probe. Operates via electrosurgical cutting/coagulation principles (21 CFR 878.4400).

Indications for Use

Indicated for soft tissue coagulation and hemostasis during open, non-laparoscopic, and non-endoscopic general surgical procedures.

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

• Stellartech RF Generator, Models #1025A-115 & 1025A-230 (K994173)
• Stellartech Coagulation Generator, Models # 1100C-115 & 1100C-230 (K023765)
• VNUS Closure System (K974521)
• Stellartech Coagulation Probe (K032062)
• Boston Scientific Tissue Coagulation System Cobra Surgical Probe (K981981)
• Boston Scientific Corp. Microvasive Gold Probe (K970278)
• Model VIO 300 D, Erbe VIO Electrosurgical Unit (K060484)
• Medtronic Cardioblate System (K060400)
• Aura 70 Watt Bipolar Electrosurgical Coagulator (K052203)
• Estech Cobra Surgical System (K051749)
• AtriCure Bipolar Coagulation System (K011722)

Submission Summary (Full Text)

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# 1. 510(k) Safety Summary

## A. Name of Device

Page 1 of 2

| Trade Name: | Stellartech 100 Coagulation System | 001 1 3 2006 |
|----------------------|-----------------------------------------------------------------------------------|--------------|
| Common Name: | Electrosurgical Unit and Accessories | |
| Classification Name: | Device, Electrosurgical Cutting and Coagulation and Accessories (21 CFR 878.4400) | |

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# Predicate Devices B.

| Device | Premarket Notification |
|----------------------------------------------------------------------|------------------------|
| Stellartech RF Generator,<br>Models #1025A-115 & 1025A-230 | K994173, 01/20/2000 |
| Stellartech Coagulation Generator,<br>Models # 1100C-115 & 1100C-230 | K023765, 11/29/2002 |
| VNUS Closure System | K974521, 02/20/1998 |
| Stellartech Coagulation Probe | K032062, 07/29/2003 |
| Boston Scientific Tissue Coagulation System<br>Cobra Surgical Probe | K981981, 09/03/1999 |
| Boston Scientific Corp. Microvasive Gold<br>Probe | K970278, 04/11/1997 |
| Model VIO 300 D, Erbe VIO Electrosurgical<br>Unit | K060484, 03/16/2006 |
| Medtronic Cardioblate System | K060400, 02/28/2006 |
| Aura 70 Watt Bipolar Electrosurgical<br>Coagulator | K052203, 10/20/2005 |
| Estech Cobra Surgical System | K051749, 09/13/2005 |
| AtriCure Bipolar Coagulation System | K011722, 08/30/2001 |
| Subject Device,<br>Stellartech 100 Coagulation System | K061544, N/A |

# C. Device Description:

The Stellartech 100 Coagulation System consists of the following components.

- Stellartech 100 Coagulation Generator Models #1050B-115 & 1050B-230 .
- . Stellartech 101 Probe
- Optional Stellartech Footswitch. .

The proximal end of the Stellartech 101 Probe connects to the Stellartech 100 Coagulation Generator Models #1050B-115 & 1050B-230.

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# D. Indicated Use

The Stellartech 100 Coagulation System is intended for coagulating soft tissue during open (non-laparoscopic or non-endoscopic) general surgical procedures. The System may also be used to coagulate blood and soft tissue to produce hemostasis.

### Technical characteristics E.

The technological characteristics of the Stellartech 100 Coagulation System are substantially equivalent to those of the above listed predicate devices.

# F. Summary

By virtue of design, principles of operation, materials and intended use, the Stellartech 100 Coagulation System is substantially equivalent to devices currently marketed in the United States.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle-like symbol with three curved lines representing human profiles. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 3 2006

Stellartech Research Corp. % Mr. Gary A. Seeger Vice President, Quality Assurance and Regulatory Affairs 1350 Bordeaux Drive Sunnyvale, California 94089

Re: K061544

Trade/Device Name: Stellartech 100 Coagulation System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: September 27, 2006 Received: September 29, 2006

Dear Mr. Seeger:

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. U.D.A.max 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

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Page 2 - Mr. Gary A. Seeger

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.

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" (21CFR 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,

Mark N. Meller

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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# Indications for Use

K061544

510(k) Number (if known):

Device Name:

Indications For Use:

Stellartech 100 Coagulation System

The Stellartech 100 Coagulation System is intended for coagulating soft tissue during open (non-laparoscopic or non-endoscopic) general surgical procedures. The System may also be used to coagulate blood and soft tissue to produce hemostasis.

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

| Page | 1 of 1 |
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| 510(k) Number | K061544 |