(10 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on hardware components for coagulation.
Yes.
The device is used for "coagulation of bleeding and non-bleeding sites" and treats various gastrointestinal conditions, indicating a direct therapeutic action.
No
The Stellartech Coagulation System is indicated for the coagulation of bleeding and non-bleeding sites; it is a treatment device, not a diagnostic one.
No
The device description explicitly lists multiple hardware components (Generator, Probe Connection Module, Probe, Sizing Probe, Footswitch) that are integral to the system's function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "coagulation of bleeding and non-bleeding sites in the gastrointestinal tract". This describes a therapeutic intervention performed directly on the patient's tissue, not a test performed on a sample taken from the patient.
- Device Description: The components listed (generator, probes, footswitch) are consistent with a device used for electrosurgical or thermal coagulation, which is a direct treatment method.
- Lack of IVD characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), performing diagnostic tests, or providing information for diagnosis.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is to directly treat a condition within the body.
N/A
Intended Use / Indications for 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.
Product codes
GEI
Device Description
The Stellartech Coagulation System consists of the following components.
- Stellartech Coagulation Generator
- Stellartech Coagulation Probe Connection Module
- Stellartech Coagulation Probe
- Optional Stellartech Sizing 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.
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 esophagus.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
'AUG 2 1 2003
KO32452
510(k) Safety Summary
Name of Device A.
- Trade Name: Stellartech Coagulation System .
- Common Name: Electrosurgical Unit and Accessories .
- Classification Name: Device, Electrosurgical Cutting and Coagulation and Accessories . (21 CFR 878.4400)
B. Predicate Devices
| Device | Premarket Notification |
|---|---|
| Stellartech Coagulation System | K013139, 12/18/01 |
| Stellartech Coagulation System | K023765, 11/29/02 |
| Stellartech Coagulation System | K032062, 07/29/03 |
C. Device Description:
The Stellartech Coagulation System consists of the following components.
- Stellartech Coagulation Generator ●
- Stellartech Coagulation Probe Connection Module ●
- Stellartech Coagulation Probe ●
- Optional Stellartech Sizing 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.
D. Indicated 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.
E. Technical characteristics
The technological characteristics of the Stellattech 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.
1
Image /page/1/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 three human profiles facing right, stacked on top of each other. The profiles are connected by a flowing line that forms the shape of a bird. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 1 2003
Mr. James R. Santos Senior Quality Engineer Stellartech Research Corporation 1346 Bordeaux Drive Sunnyvale, California 94089
Re: K032452
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: August 9, 2003 Received: August 11, 2003
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
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 (301) 594-4659. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Sincerely yours,
Mark A. Millman
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
3
510(k) NUMBER (IF KNOWN):
KO32452
DEVICE NAME:
Stellartech Coagulation System
INDICATIONS FOR 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.
Mark N Milken
(Division Sign-Off Division of General storative and Neurological L . nees
J(K) Number K03)452
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
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Over-The-Counter-Use __