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 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 Generator ●
Stellartech Coagulation Probe Connection Module ●
Stellartech Coagulation Probe .
Optional Stellartech Footswitch. .
The proximal end of the Stellartech Coagulation Probe connects to the Stellartech Coagulation Probe Connection Module. The proximal end of the Stellartech Coagulation Probe Connection Module cable connects to the Stellartech Coagulation Generator.

AI/ML Overview

The provided text is related to a 510(k) clearance for the Stellartech Coagulation System. It focuses on regulatory approval based on substantial equivalence to predicate devices, rather than a study demonstrating specific performance metrics against acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment is not present in the provided document.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

This information is not provided in the document. The 510(k) summary focuses on demonstrating "substantial equivalence" of the Stellartech Coagulation System to existing predicate devices (Hobbs Medical Dilation Balloon Catheter, Stellartech Coagulation System K013139, Stellartech Coagulation System K023765) based on design, principles of operation, materials, and intended use. It does not provide specific acceptance criteria or performance metrics for the device itself.

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

This information is not provided in the document. The submission is a regulatory premarket notification based on equivalence, not a clinical study with a test set.

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)

This information is not provided in the document. No test set or ground truth establishment is described.

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

This information is not provided in the document. No test set or adjudication method is described.

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 in the document. The device is an electrosurgical unit, not an AI-assisted diagnostic tool, so an MRMC study related to human reader improvement with AI 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 in the document. The device is a physical electrosurgical system, not an algorithm.

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

This information is not provided in the document. No ground truth is mentioned as it's not a study requiring such data.

8. The sample size for the training set

This information is not provided in the document. No training set is mentioned.

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

This information is not provided in the document. No training set or ground truth establishment is described.

Summary

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K032062 1

JUL 2 9 2003 510(k) Safety Summary

Name of Device A.

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

B. Predicate Devices

Device	Premarket Notification
Hobbs Medical Dilation Balloon Catheter	K834413, 05/22/84
Stellartech Coagulation System	K013139, 12/18/01
Stellartech Coagulation System	K023765, 11/29/02

C. Device Description:

The Stellartech Coagulation System consists of the following components.

Stellartech Coagulation Generator ●
Stellartech Coagulation Probe Connection Module ●
Stellartech Coagulation Probe .
Optional Stellartech Footswitch. .

The proximal end of the Stellartech Coagulation Probe connects to the Stellartech Coagulation Probe Connection Module. The proximal end of the Stellartech Coagulation Probe 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 non-bleeding 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.

E. Technical characteristics

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 Coagulation System is substantially equivalent to devices currently marketed in the United States.

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle head facing left with three curved lines above it, representing feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 9 2003

Mr. Gary Seeger Vice President Quality Assurance and Regulatory Affairs Stellartech Research Corporation 1346 Bordeaux Drive Sunnyvale, California 94089

Re: K032062

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: July 2, 2003 Received: July 8, 2003

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. Iisting 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. Gary Seeger

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. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained 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,

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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510(k) NUMBER (IF KNOWN):

K032062

DEVICE NAME:

Stellartech Coagulation System

INDICATIONS FOR USE:

Miriam C. Provost

(Division of General, Restorative and Neurological Devices

510(k) Number K032062

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

(Per 21 CFR 801.109)

Over-The-Counter-Use

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.