STELLARTECH COAGULATION SYSTEM, MODELS 1100C-115A & 1100C-230A

K042909 · Stellartech Research Corp. · GEI · Nov 12, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K042909
• Device Name: STELLARTECH COAGULATION SYSTEM, MODELS 1100C-115A & 1100C-230A
• Applicant: Stellartech Research Corp.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Nov 12, 2004
• Decision: SESE
• Submission Type: Special
• 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 device for GI tract coagulation. System components include a coagulation catheter, connection module, generator, sheath, and optional footswitch and sizing catheter/sheath. The catheter connects to the module, which interfaces with the generator. Operated by clinicians in a clinical setting, the system delivers electrosurgical energy to target tissue sites to achieve coagulation. The device is used to treat various GI lesions, including ulcers, tears, and vascular malformations, aiding in hemostasis or tissue treatment. Clinical benefit is derived from the controlled application of energy to manage bleeding or non-bleeding GI sites.

Clinical Evidence

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

Technological Characteristics

Electrosurgical cutting and coagulation system (21 CFR 878.4400). Components include catheter, connection module, generator, and sheath. Operates via electrosurgical energy delivery. Technical specifications and material standards are not detailed in the provided documentation.

Indications for Use

Indicated for patients requiring coagulation of bleeding or non-bleeding sites in the gastrointestinal tract, including the esophagus. Specific conditions include Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions, and Angiodysplasia.

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 Coagulation System (K013139)
• Stellartech Coagulation System (K023765)
• Stellartech Coagulation System (K032062)
• Stellartech Coagulation System (K032452)
• Stellartech Coagulation System (K032721)
• Stellartech Coagulation System (K040240)
• Stellartech Coagulation System (K041383)

Submission Summary (Full Text)

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K042909 1 of 2

#### A. Name of Device

- Stellartech Coagulation System Trade Name: �
- Electrosurgical Unit and Accessories Common Name: .
- . Classification Name: Device, Electrosurgical Cutting and Coagulation and Accessories (21 CFR 878.4400)

#### Predicate Devices B.

| Device | Premarket Notification |
|--------------------------------|------------------------|
| Stellartech Coagulation System | K013139, 12/18/01 |
| Stellartech Coagulation System | K023765, 11/29/02 |
| Stellartech Coagulation System | K032062, 07/29/03 |
| Stellartech Coagulation System | K032452, 08/21/03 |
| Stellartech Coagulation System | K032721, 10/06/03 |
| Stellartech Coagulation System | K040240, 04/01/04 |
| Stellartech Coagulation System | K041383, 06/14/04 |

#### ్. Device Description:

The Stellartech Coagulation System consists of the following components.

- Stellartech Coagulation Catheter .
- Stellartech Coagulation Catheter Connection Module .
- Stellartech Coagulation Generator .
- . Stellartech Sheath
- . Optional Stellartech Footswitch.
- . Optional Stellartech Sizing Catheter
- Optional Stellartech Sizing Sheath .

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

#### 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.

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### E. Technical characteristics

K0429109 2 of 2

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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DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 2 2004

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

Re: K042909

Trade/Device Name: Stellartech Coagulation System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: October 20, 2004 Received: October 21, 2004

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 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 - 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), 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/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

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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510(k) NUMBER (IF KNOWN):

DEVICE NAME: Stellartech Coagulation System

# INDICATIONS FOR USE:

The Stellartech Coagulation System is indicated for use in the coagulation of bleeding and nonbleeding 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.

Miriam C. Provost

Division of General. Restorative. and Neurological Devices

8042909 510(k) Number_

Prescription Use (Part 21 CFR 801.Subpart D)

AND'OR

Over-The-Counter-Use (21 CFR 807.Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)