(26 days)
No
The document describes a standard coagulation system with a generator, probe, and connection module. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The predicate devices are also standard coagulation systems.
Yes
The device is used for the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract, addressing conditions like ulcers and malformations, which falls under therapeutic intervention.
No
Explanation: The device is indicated for the coagulation of bleeding and non-bleeding sites, functioning as a therapeutic tool rather than a diagnostic one.
No
The device description explicitly lists multiple hardware components: a generator, a probe connection module, a probe, and an optional footswitch.
Based on the provided information, the Stellartech Coagulation System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states the device is for "coagulation of bleeding and non-bleeding sites in the gastrointestinal tract". This is a therapeutic procedure performed directly on the patient's tissue.
- Device Description: The components described (generator, probe, connection module, footswitch) are consistent with a device used for delivering energy (likely thermal or electrical) to tissue for coagulation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. The Stellartech Coagulation System is used in vivo (inside the body) for treatment.
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 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
K032062 1
JUL 2 9 2003 510(k) Safety Summary
Name of Device A.
- Stellartech Coagulation System Trade Name: .
- 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 |
|---|---|
| Hobbs Medical Dilation Balloon Catheter | K834413, 05/22/84 |
| Stellartech Coagulation System | K013139, 12/18/01 |
| Stellartech Coagulation System | K023765, 11/29/02 |
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 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 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.
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle head facing left with three curved lines above it, representing feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 9 2003
Mr. Gary Seeger Vice President Quality Assurance and Regulatory Affairs Stellartech Research Corporation 1346 Bordeaux Drive Sunnyvale, California 94089
Re: K032062
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: July 2, 2003 Received: July 8, 2003
Dear Mr. Seeger:
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. Iisting 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.
2
Page 2 - Mr. Gary Seeger
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. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained 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 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
3
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-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.
Miriam C. Provost
(Division of General, Restorative and Neurological Devices
OR
510(k) Number K032062
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
Over-The-Counter-Use