(130 days)
Not Found
No
The summary describes a standard electrosurgical coagulation system and does not mention any AI or ML components or capabilities.
Yes
The device is intended for coagulating soft tissue during general surgical procedures and to produce hemostasis, which are therapeutic interventions.
No
The device is described as a "Coagulation System" used for coagulating soft tissue and blood to produce hemostasis during surgical procedures. Its function is therapeutic (coagulation and hemostasis), not diagnostic (identifying or characterizing a disease or condition).
No
The device description explicitly lists hardware components: a coagulation generator, a probe, and an optional footswitch. This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, the Stellartech 100 Coagulation System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "coagulating soft tissue during open (non-laparoscopic or non-endoscopic) general surgical procedures" and "to coagulate blood and soft tissue to produce hemostasis." This describes a device used directly on the patient's body during surgery.
- Device Description: The components are a generator, a probe, and an optional footswitch. These are typical components of an electrosurgical or coagulation system used in surgery.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue samples) outside the body to provide information about a patient's health. The description of the Stellartech 100 Coagulation System does not involve the analysis of any specimens.
Therefore, the Stellartech 100 Coagulation System is a surgical device used for therapeutic purposes (coagulation and hemostasis) directly on the patient, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Stellartech 100 Coagulation System is intended for coagulating soft tissue during open (non-laparoscopic or non-endoscopic) general surgical procedures. The System may also be used to coagulate blood and soft tissue to produce hemostasis.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The Stellartech 100 Coagulation System consists of the following components.
- Stellartech 100 Coagulation Generator Models #1050B-115 & 1050B-230 .
- . Stellartech 101 Probe
- Optional Stellartech Footswitch. .
The proximal end of the Stellartech 101 Probe connects to the Stellartech 100 Coagulation Generator Models #1050B-115 & 1050B-230.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K994173, K023765, K974521, K032062, K981981, K970278, K060484, K060400, K052203, K051749, K011722
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
1. 510(k) Safety Summary
A. Name of Device
Page 1 of 2
| Trade Name: | Stellartech 100 Coagulation System | 001 1 3 2006 |
|---|---|---|
| Common Name: | Electrosurgical Unit and Accessories | |
| Classification Name: | Device, Electrosurgical Cutting and Coagulation and Accessories (21 CFR 878.4400) |
Kol 1544
Predicate Devices B.
| Device | Premarket Notification |
|---|---|
| Stellartech RF Generator, | |
| Models #1025A-115 & 1025A-230 | K994173, 01/20/2000 |
| Stellartech Coagulation Generator, | |
| Models # 1100C-115 & 1100C-230 | K023765, 11/29/2002 |
| VNUS Closure System | K974521, 02/20/1998 |
| Stellartech Coagulation Probe | K032062, 07/29/2003 |
| Boston Scientific Tissue Coagulation System | |
| Cobra Surgical Probe | K981981, 09/03/1999 |
| Boston Scientific Corp. Microvasive Gold | |
| Probe | K970278, 04/11/1997 |
| Model VIO 300 D, Erbe VIO Electrosurgical | |
| Unit | K060484, 03/16/2006 |
| Medtronic Cardioblate System | K060400, 02/28/2006 |
| Aura 70 Watt Bipolar Electrosurgical | |
| Coagulator | K052203, 10/20/2005 |
| Estech Cobra Surgical System | K051749, 09/13/2005 |
| AtriCure Bipolar Coagulation System | K011722, 08/30/2001 |
| Subject Device, | |
| Stellartech 100 Coagulation System | K061544, N/A |
C. Device Description:
The Stellartech 100 Coagulation System consists of the following components.
- Stellartech 100 Coagulation Generator Models #1050B-115 & 1050B-230 .
- . Stellartech 101 Probe
- Optional Stellartech Footswitch. .
The proximal end of the Stellartech 101 Probe connects to the Stellartech 100 Coagulation Generator Models #1050B-115 & 1050B-230.
1
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D. Indicated Use
The Stellartech 100 Coagulation System is intended for coagulating soft tissue during open (non-laparoscopic or non-endoscopic) general surgical procedures. The System may also be used to coagulate blood and soft tissue to produce hemostasis.
Technical characteristics E.
The technological characteristics of the Stellartech 100 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 100 Coagulation System is substantially equivalent to devices currently marketed in the United States.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle-like symbol with three curved lines representing human profiles. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 3 2006
Stellartech Research Corp. % Mr. Gary A. Seeger Vice President, Quality Assurance and Regulatory Affairs 1350 Bordeaux Drive Sunnyvale, California 94089
Re: K061544
Trade/Device Name: Stellartech 100 Coagulation System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: September 27, 2006 Received: September 29, 2006
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, 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. U.D.A.max 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
3
Page 2 - Mr. Gary A. Seeger
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.
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 (240) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Meller
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name:
Indications For Use:
Stellartech 100 Coagulation System
The Stellartech 100 Coagulation System is intended for coagulating soft tissue during open (non-laparoscopic or non-endoscopic) general surgical procedures. The System may also be used to coagulate blood and soft tissue to produce hemostasis.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restora
and Neurological Devices
| Page | 1 of 1 |
|---|---|
| 510(k) Number | K061544 |