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 Catheter .
Stellartech Coagulation Catheter Connection Module .
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 document is a 510(k) premarket notification for the Stellartech Coagulation System. This type of FDA submission aims to demonstrate that a new medical device is substantially equivalent to a legally marketed predicate device, rather than proving its safety and effectiveness through extensive clinical trials as would be required for a PMA (Premarket Approval).

Therefore, the document does not contain the kind of detailed information about acceptance criteria, specific device performance metrics, sample sizes for test or training sets, expert qualifications, or adjudication methods that would be present in a study designed to prove a device meets specific performance criteria.

Here's why and what information is available:

Substantial Equivalence: The core of a 510(k) is to show that the new device has the same intended use and technological characteristics as a predicate device, or if there are differences, that those differences do not raise new questions of safety and effectiveness. This is typically done through comparisons of design, materials, performance specifications, and sometimes bench testing or limited clinical data demonstrating equivalency, not superiority or novel performance.

Based on the provided text, I cannot complete the table or answer most of the questions as the information is not present. The document states:

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."
E. Technical Characteristics: "The technological characteristics of the Stellartech Coagulation System are substantially equivalent to those of the above listed predicate devices."

This indicates that the "study" for this submission was a comparison to predicate devices, focusing on demonstrating equivalency rather than meeting specific quantifiable performance acceptance criteria in a standalone clinical or analytical study as you've outlined.

However, I can extract the following relevant information:

Device Name: Stellartech Coagulation System
Intended Use: Coagulation of bleeding and non-bleeding sites in the gastrointestinal tract (esophagus), including Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions, and Angiodysplasia.
Predicate Devices: Stellartech Coagulation System (K013139, K023765, K032062, K032452, K032721, K040240, K041383)

Therefore, the table and answers will reflect the absence of this detailed information in a 510(k) submission focused on substantial equivalence.

Acceptance Criteria and Device Performance (Based on available 510(k) information)

Acceptance Criteria Category	Specific Metric/Criterion (Not explicitly stated in a 510(k))	Reported Device Performance (Not explicitly stated as such in a 510(k))
Safety	Not explicitly defined as a numerical criterion in a 510(k).	Demonstrated to be substantially equivalent in safety to predicate devices through design comparison. Specific safety metrics (e.g., adverse event rates, tissue damage thresholds) are not provided in this document.
Effectiveness	Not explicitly defined as a numerical criterion in a 510(k).	Demonstrated to be substantially equivalent in effectiveness to predicate devices for the indicated uses. Specific effectiveness metrics (e.g., coagulation success rate, time to hemostasis) are not provided in this document.
Technical Characteristics	All technical characteristics are equivalent to the predicate devices.	The Stellartech Coagulation System's design, principles of operation, and materials are equivalent to the predicate devices.
Intended Use	Identical to the predicate devices.	The intended use for coagulation of bleeding/non-bleeding sites in the GI tract (esophagus) and specific conditions (Esophageal Ulcers, Mallory-Weiss tears, etc.) is identical to the predicate.

Study Information (Based on available 510(k) information)

Sample size used for the test set and the data provenance:
- Sample Size: Not applicable/Not provided. This 510(k) focuses on substantial equivalence through comparison of technological characteristics and intended use to predicate devices, not on a clinical "test set" in the context of an AI/diagnostic algorithm.
- Data Provenance: Not applicable/Not provided. The submission relies on design and functional comparisons to existing devices, not on a dataset of clinical cases.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. There was no "test set" requiring expert-established ground truth mentioned in this 510(k).
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/None. There was no "test set" requiring adjudication mentioned in this 510(k).
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. This device is an electrosurgical coagulation system, not an AI or diagnostic imaging device that would involve human readers or AI assistance in interpretation.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is an electrosurgical coagulation system, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable/Not explicitly stated as ground truth. The "ground truth" for a 510(k) is essentially the established safety and effectiveness profile of the predicate devices. The new device demonstrates equivalency to this established profile.
The sample size for the training set:
- Not applicable/Not provided. This type of submission does not involve a "training set" like an AI/machine learning model would.
How the ground truth for the training set was established:
- Not applicable/Not provided. There was no "training set" for this submission.

In summary, the provided document is a regulatory submission focused on demonstrating "substantial equivalence" of a medical device to existing predicate devices under 21 CFR 878.4400. It does not detail a study involving performance metrics, test sets, training sets, or expert consensus as would be common for diagnostic algorithms or novel devices undergoing more rigorous clinical evaluation.

Summary

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K042909 1 of 2

A. Name of Device

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
Stellartech Coagulation System	K041383, 06/14/04

్. Device Description:

The Stellartech Coagulation System consists of the following components.

Stellartech Coagulation Catheter .
Stellartech Coagulation Catheter Connection Module .
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.

Indicated Use D.

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E. Technical characteristics

K0429109 2 of 2

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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 2 2004

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

Re: K042909

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: October 20, 2004 Received: October 21, 2004

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 R. Santos

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 (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):

DEVICE NAME: Stellartech Coagulation System

INDICATIONS FOR USE:

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.

Miriam C. Provost

Division of General. Restorative. and Neurological Devices

8042909 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 PAGE 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.