STELLARTECH COAGULATION SYSTEM 2, MODELS 1100C-115A AND 1100C-230A

K050831 · Stellartech Research Corp. · GEI · Apr 12, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K050831
• Device Name: STELLARTECH COAGULATION SYSTEM 2, MODELS 1100C-115A AND 1100C-230A
• Applicant: Stellartech Research Corp.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Apr 12, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Stellartech Coagulation System 2 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.

Device Story

Stellartech Coagulation System 2 is an electrosurgical device for GI tract coagulation. System components include a coagulation catheter, generator, connection cable, and optional sheath, footswitch, and sizing catheter. The catheter connects to the generator via cable; the generator delivers energy to the catheter tip to coagulate tissue at bleeding or nonbleeding sites. Used in clinical settings by physicians. Output allows for targeted tissue coagulation to treat lesions like ulcers, tears, and malformations. Benefits include effective hemostasis and treatment of esophageal conditions.

Clinical Evidence

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

Technological Characteristics

Electrosurgical cutting and coagulation device (21 CFR 878.4400). System comprises a generator, catheter, connection cable, and optional accessories (sheath, footswitch, sizing catheter). Operates via electrosurgical energy delivery to tissue.

Indications for Use

Indicated for patients requiring coagulation of bleeding or nonbleeding gastrointestinal tract sites, including esophagus. 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)
• Stellartech Coagulation System (K042909)

Submission Summary (Full Text)

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APR 1 2 2005

510(k) Safety Summary

# K050831 1 of 2

#### A. Name of Device

- Trade Name: Stellartech Coagulation System 2
- 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 |
| Stellartech Coagulation System | K042909, 11/12/04 |

## C. Device Description:

The Stellartech Coagulation System 2 consists of the following components.

- . Stellartech Coagulation Catheter 2
- Stellartech Coagulation Generator 2 .
- . Stellartech Catheter Connection Cable 2
- Optional Stellartech Sheath ●
- Optional Stellartech Footswitch 2. .
- Optional Stellartech Sizing Catheter 2 .

The proximal end of the Stellartech Coagulation Catheter 2 connects through the Stellartech Catheter Connection Cable 2 to the Stellartech Coagulation Generator 2.

## Indicated Use D.

The Stellartech Coagulation System 2 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.

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#### E. Technical characteristics

K050831 2 of 2

The technological characteristics of the Stellartech Coagulation System 2 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 2 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 is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the border of the circle. Inside the circle is a stylized image of an eagle with three lines representing the wings and body.

APR 1 2 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K050831

Trade/Device Name: Stellartech Coagulation System 2 Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: March 31, 2005 Received: April 1, 2005

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 Santos

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin maneting of substantial equivalence of your device to a legally premarket nonifeddion: "The 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 If you desire specific acrite for your as [phone] . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain Misoranumg by reference to premainters within the Act from the Division of Small other general information on Jour response 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,

# #

Miriam C. Provost, Ph.D. Acting 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):

K050831

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DEVICE NAME: Stellartech Coagulation System 2

INDICATIONS FOR USE:

The Stellartech Coagulation System 2 is indicated for use in the coagulation of bleeding and nonbleeding sites in the gastrointestinal tract including but not limited to, the esophagus. Indiations include Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angromata, Barrett's Esophagus, Dieulafoy Lesions, and Angiodysplasia.

Image /page/4/Picture/6 description: The image shows the words "Prescription Use" followed by the text "(Part 21 CFR 801.Subpart D)". There is a large X above a horizontal line to the right of the text. The text is in a simple, sans-serif font and is left-aligned.

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)

Special 510(k) Device Modification Notification K023765, K013139, K032062, K032721, K040240, K041383, K0402909

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