STELLARTECH COAGULATION SYSTEM

K013139 · Stellartech Research Corp. · GEI · Dec 18, 2001 · General, Plastic Surgery

Device Facts

• Record ID: K013139
• Device Name: STELLARTECH COAGULATION SYSTEM
• Applicant: Stellartech Research Corp.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Dec 18, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Stellartech Coagulation System is indicated for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to, the esophagus. Indications include Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions, and Angiodysplasia.

Device Story

Stellartech Coagulation System is an electrosurgical unit for GI tract coagulation. System components include a generator, probe connection module, coagulation probe, and optional footswitch. The probe connects to the module, which connects to the generator. The device delivers radiofrequency energy to coagulate bleeding or non-bleeding tissue sites. Used in clinical settings by physicians to treat conditions like esophageal ulcers, Mallory-Weiss tears, and angiodysplasia. The output allows for controlled tissue coagulation, potentially reducing bleeding and managing specific GI lesions.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and technological characteristics compared to legally marketed predicate devices.

Technological Characteristics

Electrosurgical cutting and coagulation device (21 CFR 878.4400). System comprises a generator, probe connection module, and coagulation probe. Operates via radiofrequency energy delivery. Class II device.

Indications for Use

Indicated for coagulation of bleeding and non-bleeding GI tract sites, including esophagus. Patient population includes those with Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions, and Angiodysplasia. Prescription use only.

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 Radiofrequency Generator Model 1025A-115 and Model 1025A-230 (K994173)
• ArthroCare Electrosurgery System Generator (K971532)
• RadioTherapeutics RF-2000 Radiofrequency Generator (K981672)
• ArthroCare Electrosurgery System Probe (K971532)
• Ximed Balloon Electrosurgical Probe/Device (K943014)
• Boston Scientific Microvasive Gold Probe (K970278)
• Bronchus Bronchial Catheter (K980046)
• C.R. Bard Eliminator Balloon Dilator (K940965)
• Hobbs Medical Dilation Balloon Catheter (K834413)
• Boston Scientific Microvasive Rigiflex ABD Achalasia Balloon Dilator (K number unknown)

Submission Summary (Full Text)

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### 510(k) Safety Summary 16.

DEC 1 82001

#### Name of Device A.

| Name of Device | |
|----------------------|--------------------------------------------------------------------------------------|
| Trade Name: | Stellartech Coagulation System |
| Common Name: | Electrosurgical Unit and Accessories |
| Classification Name: | Device, Electrosurgical Cutting and Coagulation and Accessories<br>(21 CFR 878.4400) |

Kol 3139

#### Predicate Devices B.

| Device | Premarket Notification |
|-----------------------------------------------------------------------------|------------------------|
| Stellartech Radiofrequency Generator Model<br>1025A-115 and Model 1025A-230 | K994173, 01/20/00 |
| ArthroCare Electrosurgery System Generator | K971532, 07/23/99 |
| RadioTherapeutics RF-2000 Radiofrequency<br>Generator | K981672, 07/17/98 |
| ArthroCare Electrosurgery System Probe | K971532, 07/23/99 |
| Ximed Balloon Electrosurgical Probe/Device | K943014, 03/11/96 |
| Boston Scientific Microvasive Gold Probe | K970278, 04/11/97 |
| Bronchus Bronchial Catheter | K980046, 05/01/98 |
| C.R. Bard Eliminator Balloon Dilator | K940965, 05/20/94 |
| Hobbs Medical Dilation Balloon Catheter | K834413, 05/22/84 |
| Boston Scientific Microvasive Rigiflex ABD<br>Achalasia Balloon Dilator | K number unknown |

#### Device Description: C.

The Stellartech Coagulation System consists of the following components.

- Stellartech Coagulation Generator ●
- Stellartech Coagulation Probe Connection Module .
- Stellartech Coagulation Probe .
- Optional Stellartech Footswitch. ●

The proximal end of the Stellartech Coagulation Probe connects to the Stellartech Coagulation Probe Connection Module. The proximal end of the Stellartech Coagulation Probe Connection Module cable connects to the Stellartech Coagulation Generator.

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#### Indicated Use D.

The Stellartech Coagulation System is indicated for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to, the esophagus. Indications include Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions, and Angiodysplasia.

#### Technical characteristics E.

The technological characteristics of the Stellartech 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 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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, facing to the right. The eagle is enclosed within a circle of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged around the upper and lower portions of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# DEC 1 8 2001

Mr. James R. Santos Senior Quality Engineer Stellartech Research Corporation 1346 Bordeaux Drive Sunnyvale, California 94089

Re: K013139

Trade/Device Name: Stellartech Coagulation System Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: September 17, 2001 Received: September 19, 2001

Dear Mr. Santos:

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 for too based in 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 - Mr. James R. Santos

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,

Stupt Elwode
Celia M. Witten, Ph.D., M.D.

Celia Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K 013139

## DEVICE NAME:

Stellartech Coagulation System

INDICATIONS FOR USE:

The Stellartech Coagulation System is indicated for use in the coagulation of bleeding and The blomation over coughters by sittestinal tract including but not limited to, the esophagus. Indications include Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions, and Angiodysplasia.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
✓
(Per 21 CFR 801.109)

OR

Over-The-Counter-Use

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

Stellartech Coagulation System 510(k) Number K0/3/39 Page 20 of 174