(90 days)
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.
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.
The provided text is a 510(k) Safety Summary for a medical device called the "Stellartech Coagulation System." This type of document is submitted to the FDA to demonstrate substantial equivalence to a legally marketed predicate device, rather than to establish acceptance criteria and prove a device meets them through a clinical study in the way a new, high-risk device might.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, specifically:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set or data provenance.
- Number of experts or their qualifications for establishing ground truth.
- Adjudication method for the test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study results.
- Standalone (algorithm only) performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
Explanation of the provided document's purpose:
The document focuses on demonstrating substantial equivalence to existing predicate devices (e.g., Stellartech Radiofrequency Generator, ArthroCare Electrosurgery System Generator, etc.). This means the manufacturer is asserting that their new device is as safe and effective as devices already on the market, rather than proving a novel claim against specific performance criteria derived from a new clinical study. The FDA's review (as indicated in the letter from Celia M. Witten, Ph.D., M.D.) confirms this substantial equivalence based on design, principles of operation, materials, and intended use.
The document lists:
- Trade Name: Stellartech Coagulation System
- Common Name: Electrosurgical Unit and Accessories
- Classification Name: Device, Electrosurgical Cutting and Coagulation and Accessories (21 CFR 878.4400)
- Indicated Use: Coagulation of bleeding and non-bleeding sites in the gastrointestinal tract, including specific conditions like Esophageal Ulcers, Mallory-Weiss tears, etc.
- Predicate Devices: A list of previously cleared electrosurgical devices.
- Device Description: Components of the Stellartech Coagulation System.
- Conclusion: The device is substantially equivalent to currently marketed devices.
In summary, this 510(k) submission is not a clinical study report designed to show an AI/device meets specific performance metrics against an established ground truth with quantified acceptance criteria. It's a regulatory document demonstrating that a new device is "like" an old, already-approved device.
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510(k) Safety Summary 16.
DEC 1 82001
Name of Device A.
| Name of Device | |
|---|---|
| Trade Name: | Stellartech Coagulation System |
| Common Name: | Electrosurgical Unit and Accessories |
| Classification Name: | Device, Electrosurgical Cutting and Coagulation and Accessories(21 CFR 878.4400) |
Kol 3139
Predicate Devices B.
| Device | Premarket Notification |
|---|---|
| Stellartech Radiofrequency Generator Model1025A-115 and Model 1025A-230 | K994173, 01/20/00 |
| ArthroCare Electrosurgery System Generator | K971532, 07/23/99 |
| RadioTherapeutics RF-2000 RadiofrequencyGenerator | K981672, 07/17/98 |
| ArthroCare Electrosurgery System Probe | K971532, 07/23/99 |
| Ximed Balloon Electrosurgical Probe/Device | K943014, 03/11/96 |
| Boston Scientific Microvasive Gold Probe | K970278, 04/11/97 |
| Bronchus Bronchial Catheter | K980046, 05/01/98 |
| C.R. Bard Eliminator Balloon Dilator | K940965, 05/20/94 |
| Hobbs Medical Dilation Balloon Catheter | K834413, 05/22/84 |
| Boston Scientific Microvasive Rigiflex ABDAchalasia Balloon Dilator | K number unknown |
Device Description: C.
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.
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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.
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 Coagulation System is substantially equivalent to devices currently marketed in the United States.
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Image /page/2/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 an eagle with its wings spread, facing to the right. The eagle is enclosed within a circle of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged around the upper and lower portions of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 8 2001
Mr. James R. Santos Senior Quality Engineer Stellartech Research Corporation 1346 Bordeaux Drive Sunnyvale, California 94089
Re: K013139
Trade/Device Name: Stellartech Coagulation System Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: September 17, 2001 Received: September 19, 2001
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 for too based in 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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). 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,
Stupt Elwode
Celia M. Witten, Ph.D., M.D.
Celia Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K 013139
DEVICE NAME:
Stellartech Coagulation System
INDICATIONS FOR USE:
The Stellartech Coagulation System is indicated for use in the coagulation of bleeding and The blomation over coughters by sittestinal 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.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
✓
(Per 21 CFR 801.109)
OR
Over-The-Counter-Use
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
Stellartech Coagulation System 510(k) Number K0/3/39 Page 20 of 174
§ 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.