(58 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 esophaqus. 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 Catheter .
- Stellartech Coagulation Catheter Connection Module ●
- Stellartech Coagulation Generator .
- Stellartech Sheath .
- Optional Stellartech Footswitch. ◆
- Optional Stellartech Pressure Gauge
- Optional Stellartech Sizing Catheter .
- 후 Optional Stellartech Sizing Sheath
The proximal end of the Stellartech Coagulation Catheter connects to the Stellartech Coagulation Catheter Connection Module. The proximal end of the Stellartech Coagulation Catheter Connection Module cable connects to the Stellartech Coagulation Generator.
The provided document is a 510(k) safety summary for the Stellartech Coagulation System. It focuses on demonstrating substantial equivalence to predicate devices and does NOT contain information about acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/ML device.
Therefore, I cannot provide the requested information. The document pertains to a traditional medical device (electrosurgical unit), not an AI/ML device, and thus does not involve the types of studies and criteria typically associated with AI/ML performance evaluation.
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APR = 1 2004
510(k) Safety Summary
Name of Device
- Stellartech Coagulation System Trade Name: .
- Electrosurgical Unit and Accessories Common Name: ●
- Device, Electrosurgical Cutting and Coagulation and Accessories Classification Name: ◆ (21 CFR 878.4400)
B. Predicate Devices
A.
| 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 |
C. Device Description:
The Stellartech Coagulation System consists of the following components.
- Stellartech Coagulation Catheter .
- Stellartech Coagulation Catheter Connection Module ●
- Stellartech Coagulation Generator .
- Stellartech Sheath .
- Optional Stellartech Footswitch. ◆
- Optional Stellartech Pressure Gauge
- Optional Stellartech Sizing Catheter .
- 후 Optional Stellartech Sizing Sheath
The proximal end of the Stellartech Coagulation Catheter connects to the Stellartech Coagulation Catheter Connection Module. The proximal end of 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.
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E. Technical characteristics
The technological characteristics of the Stellartech Coagulation System are substantially cquivalent to those of the above listed predicate devices.
Summary F.
By virtue of design, principles of operation, matcrials 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 seal for the Department of Health & Human Services - USA. The seal is circular and contains the department's logo. The logo is a stylized representation of a human figure, with three lines forming the body and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 1 2004
Mr. James R. Santos Senior Quality Engineer Stellartech Research Corporation 1346 Bordeaux Drive Sunnyvale, California 94089
Rc: K040240
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: March 23, 2004 Received: March 24, 2004
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 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 yours.
Muriam 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
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K040240/AI
Indications for Use
510(k) Number (if known): K040240
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 esophaqus. Indications include Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions, and Angiodysplasia.
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 PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Page 1 of
510(k) Number_ KO40240
§ 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.