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.

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.

AI/ML Overview

This document is a 510(k) premarket notification for the Stellartech 100 Coagulation System. It focuses on establishing substantial equivalence to predicate devices rather than presenting a study demonstrating the device meets specific acceptance criteria based on performance data.

Therefore, many of the requested categories related to performance studies, sample sizes, ground truth establishment, and expert involvement cannot be extracted from the provided text because these types of studies were not included or required for this type of submission.

Here's what can be extracted based on the information provided:

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Implicit Acceptance Criteria for 510(k) Equivalence:The device's design, principles of operation, materials, and intended use are substantially equivalent to legally marketed predicate devices.Specific Performance Criteria (Not explicitly stated):The document does not detail specific quantitative performance acceptance criteria (e.g., coagulation efficacy, power output ranges, safety limits) against which the device was tested. The focus is on substantial equivalence to predicate devices.	The Stellartech 100 Coagulation System is substantially equivalent to the listed predicate devices by virtue of its design, principles of operation, materials, and intended use.

Acceptance Criteria

Reported Device Performance

Implicit Acceptance Criteria for 510(k) Equivalence:The device's design, principles of operation, materials, and intended use are substantially equivalent to legally marketed predicate devices.Specific Performance Criteria (Not explicitly stated):The document does not detail specific quantitative performance acceptance criteria (e.g., coagulation efficacy, power output ranges, safety limits) against which the device was tested. The focus is on substantial equivalence to predicate devices.

The Stellartech 100 Coagulation System is substantially equivalent to the listed predicate devices by virtue of its design, principles of operation, materials, and intended use.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Information Not Provided: The submission is a 510(k) for substantial equivalence and does not describe a clinical study with a "test set" in the context of performance metrics. It references comparison to predicate devices.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Information Not Provided: The submission does not detail any expert-driven ground truth establishment for a performance test set. The "ground truth" for a 510(k) substantial equivalence determination generally relies on the established safety and efficacy of the predicate devices and the manufacturer's engineering assessment of their device's equivalence.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Information Not Provided: As no performance study with a "test set" requiring adjudication is described, this information is not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable / Information Not Provided: This device is an electrosurgical unit, not an AI-assisted diagnostic or imaging device used by "readers." Therefore, an MRMC study is not relevant to this submission.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable / Information Not Provided: This device is a physical electrosurgical system, not an algorithm. Standalone algorithm performance is not relevant.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Implicit Ground Truth for Substantial Equivalence: The ground truth for this 510(k) submission is the legally marketed predicate devices and their established safety and effectiveness. The manufacturer asserts that the Stellartech 100 Coagulation System's characteristics are "substantially equivalent" to these known devices. There is no mention of specific clinical outcomes data or pathology reviews presented in this summary to establish "ground truth" for a novel performance claim beyond equivalence.
The sample size for the training set:
- Not Applicable / Information Not Provided: This device is an electrosurgical unit, not a machine learning model, so there is no "training set" in the context of AI.
How the ground truth for the training set was established:
- Not Applicable / Information Not Provided: As there is no training set, this question is not applicable.

Summary

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1. 510(k) Safety Summary

A. Name of Device

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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 SystemCobra Surgical Probe	K981981, 09/03/1999
Boston Scientific Corp. Microvasive GoldProbe	K970278, 04/11/1997
Model VIO 300 D, Erbe VIO ElectrosurgicalUnit	K060484, 03/16/2006
Medtronic Cardioblate System	K060400, 02/28/2006
Aura 70 Watt Bipolar ElectrosurgicalCoagulator	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.

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D. Indicated Use

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.

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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

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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

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Indications for Use

K061544

510(k) Number (if known):

Device Name:

Indications For Use:

Stellartech 100 Coagulation System

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)
signature
(Division Sign-Off)
Division of General, Restora
and Neurological Devices

Page	1 of 1
510(k) Number	K061544

Regulation Number and Section

§ 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.