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.

Device Description

The Stellartech Coagulation System consists of the following components.

Stellartech Coagulation Catheter .
Stellartech Coagulation Catheter Connection Module t
. Stellartech Coagulation Generator
Stellartech Sheath .
Optional Stellartech Footswitch. .
Optional Stellartech Sizing Catheter .
Optional Stellartech Sizing Sheath .
The proximal end of the Stellartech Coagulation Catheter connects to the Stellartech Coagulation Catheter Connection Module. The Stellartech Coagulation Catheter Connection Module cable connects to the Stellartech Coagulation Generator.

AI/ML Overview

The provided text is a 510(k) premarket notification for the Stellartech Coagulation System. It focuses on establishing substantial equivalence to previously marketed predicate devices rather than providing a detailed study proving performance against specific acceptance criteria.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not available in the provided document. This type of information is typically found in design validation studies, clinical trials, or performance testing reports, which are not included in this summary.

Here's a breakdown of what can and cannot be extracted from the provided text, following your requested format:

1. A table of acceptance criteria and the reported device performance

Not Available: The document does not specify quantitative acceptance criteria (e.g., specific thresholds for coagulation effectiveness, safety metrics, or device longevity) nor does it report specific performance data from a study that would demonstrate meeting such criteria. The submission is based on substantial equivalence, implying that its performance is assumed to be similar to legally marketed predicate devices without explicitly stating and measuring against specific acceptance targets.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Available: No test set or data provenance is mentioned. This submission is a regulatory filing for substantial equivalence, not a clinical study report.

3. 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)

Not Available: The concept of a "ground truth" and expert adjudication is not present in this type of regulatory submission focusing on substantial equivalence for a medical device like a coagulation system. Ground truth is usually relevant for AI/ML device assessments that rely on image or data interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Available: Not applicable, as no test set or ground truth adjudication process is described in this document.

5. 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 Available: This device is a medical instrument (electrosurgical unit), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or described.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Available: This device is a physical electrosurgical system, not an algorithm. Standalone performance as typically described for AI/ML devices is not applicable or discussed.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Available: Ground truth is not a concept discussed in this 510(k) summary. The device's safety and effectiveness are established by demonstrating substantial equivalence to predicate devices, implying that their previously established safety and effectiveness apply to this new device due to similar design and intended use.

8. The sample size for the training set

Not Available: There is no mention of a training set. This is a medical device, not an AI/ML product developed using training data.

9. How the ground truth for the training set was established

Not Available: Not applicable, as there is no training set described.

Summary of Device and Regulatory Context (based on provided text):

The Stellartech Coagulation System is an electrosurgical unit and accessories intended for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract, including specific indications such as Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions, and Angiodysplasia.

The 510(k) premarket notification (K041383) establishes substantial equivalence to several predicate Stellartech Coagulation Systems (K013139, K023765, K032062, K032452, K032721, K040240). The basis for FDA clearance is that the technological characteristics, design, principles of operation, materials, and intended use are substantially equivalent to these already marketed predicate devices. This means that extensive de novo studies with explicit acceptance criteria and performance reporting, as requested in your prompt regarding AI/ML devices, are typically not required for a 510(k) submission based on substantial equivalence to well-established technology.

Summary

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K041383

510(k) Safety Summary

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Name of Device A.

Stellartech Coagulation System . Trade Name:
Electrosurgical Unit and Accessories Common Name: .
Classification Name: Device, Electrosurgical Cutting and Coagulation and Accessories � (21 CFR 878.4400)

Predicate Devices B.

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
Stellartech Coagulation System	K040240, 04/01/04

C. Device Description:

The Stellartech Coagulation System consists of the following components.

Stellartech Coagulation Catheter .
Stellartech Coagulation Catheter Connection Module t
. Stellartech Coagulation Generator
Stellartech Sheath .
Optional Stellartech Footswitch. .
Optional Stellartech Sizing Catheter .
Optional Stellartech Sizing Sheath .

The proximal end of the Stellartech Coagulation Catheter connects to the Stellartech Coagulation Catheter Connection Module. The Stellartech Coagulation Catheter Connection Module cable connects to the Stellartech Coagulation Generator.

D. Indicated Use

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K041383
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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 Dy Tirac or design, principantially equivalent to devices currently marketed in the United States.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of an eagle or bird with three wing-like shapes above a wavy line.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 4 2004

Mr. Gary Seeger Mr. Gary Boogs. Stellartech Research Corporation 1346 Bordeaux Drive Sunnyvale, California 94089

Re: K041383

Trade/Device Name: Stellartech Coagulation System Regulation Number: 21 CFR 878.4400 Regulation Name: 21 CFTC 0701 cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: May 24, 2004 Received: May 25, 2004

Dear Mr. Seeger:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon - 10(t) pe device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enclosure) to regally management date of the Medical Device American's or to commerce price to May 20, 1978, the exactions of the Federal Food, Drug, devices martial nave been require approval of a premarket approval application (PMA). and Cosmetic Act (Act) that do not require approvise as esseral controls provisions of the Act. The I ou may, merciole, market the act received in the requirements for annual registration, listing of general controls provisions of use ice, 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 II your device is classified (500 a0010) this Existing major regulations affecting your device can
may be subject to such additional controls. Existing major may be subject to such additional controller Little 21, Parts 800 to 898. In addition, FDA may be found in the Oous acements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I Dri 3 losaanse or our device complies with other requirements of the Act that FDA has made a determination an administered by other Federal agencies. You must of any Federal statutes and regulations annualiter on your not limited to: registration and listing (21 comply with an the Act 3 requirements, mercessed ing practice requirements as set CrK Fart 807), adomig (21 CFR Part 820); govern 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Gary Seeger

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter witi anow you to begin maneting your antial equivalence of your device to a legally prematket notheation: The PDA mising of castion 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 If you desire specific advice for your ac 110 cm on one one one one one one one one of your Conider the Office of Computance and the results on (21CFR Part 807.97). You may obtain Misolanding by reference to premaintentibilities under the Act from the Division of Small other general 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

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K041383

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-The Stellatteen Coagulation Cystem to including but not limited to, the esophagus. Indications blecaing sites in the gastromesting theirs tears, Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions, and Angiodysplasia.

Miriam C. Provost

Division of General, Restorative, and Neurological Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________

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 P.AGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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.