(20 days)
Not Found
There are no K/DEN numbers for reference devices listed in the text.
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on hardware components for coagulation.
Yes
Explanation: The device is indicated for use in the "coagulation of bleeding and nonbleeding sites in the gastrointestinal tract," which directly addresses and treats medical conditions such as Esophageal Ulcers and Mallory-Weiss tears. This therapeutic action makes it a therapeutic device.
No
The device is indicated for coagulation of bleeding and non-bleeding sites, which is a treatment/therapeutic function, not a diagnostic one.
No
The device description explicitly lists multiple hardware components (Catheter, Connection Module, Generator, Sheath, Footswitch, Sizing Catheter, Sizing Sheath) that are part of the system.
Based on the provided information, the Stellartech Coagulation System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the "coagulation of bleeding and nonbleeding sites in the gastrointestinal tract". This describes a therapeutic procedure performed directly on the patient's tissue, not a test performed on a sample taken from the patient.
- Device Description: The components listed (catheter, generator, sheath, footswitch, etc.) are typical of devices used for surgical or interventional procedures, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, tissue, or other biological samples, which is the core function of an IVD.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Stellartech Coagulation System directly treats tissue within the body.
N/A
Intended Use / 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.
Product codes
GEI
Device Description
The Stellartech Coagulation System consists of the following components.
- Stellartech Coagulation Catheter .
- Stellartech Coagulation Catheter Connection Module t
- . 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal tract including but not limited to, the
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
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.(b)
Classification. Class II.
0
510(k) Safety Summary
1 of 2
Name of Device A.
- 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 |
C. Device Description:
The Stellartech Coagulation System consists of the following components.
- Stellartech Coagulation Catheter .
- Stellartech Coagulation Catheter Connection Module t
- . 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.
D. Indicated 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.
1
K041383
2 of 2
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 Dy Tirac or design, principantially equivalent to devices currently marketed in the United States.
2
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 is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of an eagle or bird with three wing-like shapes above a wavy line.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 4 2004
Mr. Gary Seeger Mr. Gary Boogs. Stellartech Research Corporation 1346 Bordeaux Drive Sunnyvale, California 94089
Re: K041383
Trade/Device Name: Stellartech Coagulation System Regulation Number: 21 CFR 878.4400 Regulation Name: 21 CFTC 0701 cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: May 24, 2004 Received: May 25, 2004
Dear Mr. Seeger:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon - 10(t) pe device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enclosure) to regally management date of the Medical Device American's or to commerce price to May 20, 1978, the exactions of the Federal Food, Drug, devices martial nave been require approval of a premarket approval application (PMA). and Cosmetic Act (Act) that do not require approvise as esseral controls provisions of the Act. The I ou may, merciole, market the act received in the requirements for annual registration, listing of general controls provisions of use ice, 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 II your device is classified (500 a0010) this Existing major regulations affecting your device can
may be subject to such additional controls. Existing major may be subject to such additional controller Little 21, Parts 800 to 898. In addition, FDA may be found in the Oous acements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I Dri 3 losaanse or our device complies with other requirements of the Act that FDA has made a determination an administered by other Federal agencies. You must of any Federal statutes and regulations annualiter on your not limited to: registration and listing (21 comply with an the Act 3 requirements, mercessed ing practice requirements as set CrK Fart 807), adomig (21 CFR Part 820); govern 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Mr. Gary Seeger
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter witi anow you to begin maneting your antial equivalence of your device to a legally prematket notheation: The PDA mising of castion 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 advice for your ac 110 cm on one one one one one one one one of your Conider the Office of Computance and the results on (21CFR Part 807.97). You may obtain Misolanding by reference to premaintentibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 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
4
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 non-The Stellatteen Coagulation Cystem to including but not limited to, the esophagus. Indications blecaing sites in the gastromesting theirs tears, Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions, and Angiodysplasia.
Miriam C. Provost
Division of General, Restorative, and Neurological Devices
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 P.AGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)