The Stellartech Coagulation System 2 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 2 consists of the following components.

. Stellartech Coagulation Catheter 2
Stellartech Coagulation Generator 2 .
. Stellartech Catheter Connection Cable 2
Optional Stellartech Sheath ●
Optional Stellartech Footswitch 2. .
Optional Stellartech Sizing Catheter 2 .
The proximal end of the Stellartech Coagulation Catheter 2 connects through the Stellartech Catheter Connection Cable 2 to the Stellartech Coagulation Generator 2.

AI/ML Overview

The provided text is a 510(k) Safety Summary for a medical device called the "Stellartech Coagulation System 2." This document primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than presenting a performance study with detailed acceptance criteria and expert-adjudicated ground truth as would be typical for AI/ML device submissions.

Therefore, many of the requested categories cannot be filled as the information is not present in the provided text.

Here is an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The 510(k) summary focuses on substantial equivalence rather than explicit performance metrics against pre-defined acceptance criteria for a new clinical study.

2. Sample size used for the test set and the data provenance

This information is not provided. The document does not describe a new clinical study or test set for performance evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided. As no new test set is described, there's no mention of ground truth establishment by experts.

4. Adjudication method for the test set

This information is not provided.

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

This information is not provided. The Stellartech Coagulation System 2 is an electrosurgical unit, not an AI/ML diagnostic tool, so an MRMC study comparing human readers with and without AI assistance would not be applicable.

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

This information is not provided. Given the device type, 'standalone algorithm performance' is not relevant.

7. The type of ground truth used

This information is not provided.

8. The sample size for the training set

This information is not provided. The document refers to prior predicate devices, implying that the "training" for this device would be based on the established clinical use and safety of those equivalent devices, not a computational training set.

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

This information is not provided. Similar to point 8, the concept of "ground truth for a training set" as it applies to AI/ML is not relevant to this traditional medical device submission.

Summary of Device and Regulatory Context (from the provided text):

The Stellartech Coagulation System 2 is an electrosurgical unit and accessories used for the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract, including specific indications like Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, etc.

The device received 510(k) clearance by demonstrating substantial equivalence to a list of previously cleared Stellartech Coagulation System predicate devices (K013139, K023765, K032062, K0324552, K032721, K040240, K041383, K042909). The equivalence was based on its design, principles of operation, materials, and intended use. The 510(k) process in this context did not require a new clinical study with specific performance acceptance criteria or the establishment of ground truth as typically seen for novel diagnostic or AI-driven devices.

Summary

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APR 1 2 2005

510(k) Safety Summary

K050831 1 of 2

A. Name of Device

Trade Name: Stellartech Coagulation System 2
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
Stellartech Coagulation System	K041383, 06/14/04
Stellartech Coagulation System	K042909, 11/12/04

C. Device Description:

The Stellartech Coagulation System 2 consists of the following components.

. Stellartech Coagulation Catheter 2
Stellartech Coagulation Generator 2 .
. Stellartech Catheter Connection Cable 2
Optional Stellartech Sheath ●
Optional Stellartech Footswitch 2. .
Optional Stellartech Sizing Catheter 2 .

The proximal end of the Stellartech Coagulation Catheter 2 connects through the Stellartech Catheter Connection Cable 2 to the Stellartech Coagulation Generator 2.

Indicated Use D.

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E. Technical characteristics

K050831 2 of 2

The technological characteristics of the Stellartech Coagulation System 2 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 2 is substantially 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 is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the border of the circle. Inside the circle is a stylized image of an eagle with three lines representing the wings and body.

APR 1 2 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. James Santos Senior Quality Engineer Stellartech Research Corporation 1346 Bordeaux Drive Sunnyvale, California 94089

Re: K050831

Trade/Device Name: Stellartech Coagulation System 2 Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: March 31, 2005 Received: April 1, 2005

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 Santos

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin maneting of substantial equivalence of your device to a legally premarket nonifeddion: "The 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 If you desire specific acrite for your as (240) 276-0120 . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain Misoranumg by reference to premainters within the Act from the Division of Small other general information on Jour response Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) NUMBER (IF KNOWN):

K050831

1 of 1

DEVICE NAME: Stellartech Coagulation System 2

INDICATIONS FOR USE:

The Stellartech Coagulation System 2 is indicated for use in the coagulation of bleeding and nonbleeding sites in the gastrointestinal tract including but not limited to, the esophagus. Indiations include Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angromata, Barrett's Esophagus, Dieulafoy Lesions, and Angiodysplasia.

Image /page/4/Picture/6 description: The image shows the words "Prescription Use" followed by the text "(Part 21 CFR 801.Subpart D)". There is a large X above a horizontal line to the right of the text. The text is in a simple, sans-serif font and is left-aligned.

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)

Special 510(k) Device Modification Notification K023765, K013139, K032062, K032721, K040240, K041383, K0402909

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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.