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 document is a 510(k) Safety Summary for a medical device called the "Stellartech Coagulation System." This type of document is submitted to the FDA to demonstrate that a new device is substantially equivalent to a legally marketed predicate device.

It's important to understand that a 510(k) submission primarily focuses on demonstrating "substantial equivalence" of a new device to existing predicate devices, rather than establishing acceptance criteria through new clinical studies measuring performance against specific metrics.

Therefore, the document does not contain information about:

A table of acceptance criteria and reported device performance directly derived from a new study specific to this submission.
Sample sizes used for a test set, data provenance, or the number/qualifications of experts for ground truth establishment.
Adjudication methods, MRMC comparative effectiveness studies, or standalone algorithm performance studies.
Training set sample sizes or how their ground truth was established.

Instead, the document asserts substantial equivalence based on prior predicate devices and their established safety and effectiveness.

Here's what the document does provide and why the requested information is not present:

A table of acceptance criteria and the reported device performance:
- N/A. The document does not present specific acceptance criteria in the form of performance metrics (like sensitivity, specificity, accuracy, etc.) and then report the device's measured performance against those criteria. The acceptance criterion for a 510(k) is "substantial equivalence" to a predicate device. The "performance" demonstrated is that its technical characteristics, principles of operation, materials, and intended use are comparable to legally marketed predicate devices.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- N/A. No new clinical or test set data is presented in this 510(k) summary for performance evaluation against specific metrics. The substantial equivalence argument relies on the inherent safety and effectiveness of the 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):
- N/A. As no new test set is described, there's no mention of experts for establishing ground truth.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. No test set described.
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:
- N/A. This device (Electrosurgical Unit) is not an AI/imaging diagnostic device, and no MRMC study or AI assistance is mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This is not an algorithmic device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- N/A. As no new performance study is detailed, no ground truth types are described. The "ground truth" in a 510(k) for substantial equivalence is the safety and effectiveness of the legally marketed predicate devices.
The sample size for the training set:
- N/A. This is not an AI/machine learning device that requires a training set.
How the ground truth for the training set was established:
- N/A. Not applicable, as it's not an AI/machine learning device.

In summary: The provided document is a 510(k) submission, which aims to demonstrate "substantial equivalence" to existing devices, not to present novel clinical study data with specific acceptance criteria and performance metrics. The information requested (acceptance criteria, study details, sample sizes, ground truth methods, MRMC studies, etc.) is typically found in PMA (Premarket Approval) applications or clinical studies for novel devices, not generally in 510(k) summaries like this one.

Summary

{0}------------------------------------------------

A. Name of Device

510(k) Safety Summary

KO23765
Trade Name: Stellartech Coagulation System .

NOV 2 9 2002

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
Stellartech Radiofrequency Generator Model1025A-115 and Model 1025A-230	K994173, 01/20/00
ArthroCare Electrosurgery System Generator	K971532, 07/23/99
Valleylab Force 2 Electrosurgical Generator	K921884, 12/15/92
RadioTherapeutics RF-2000 RadiofrequencyGenerator	K981672, 07/17/98
ArthroCare Electrosurgery System Probe	K971532, 07/23/99
Ximed Balloon Electrosurgical Probe/Device	K943014, 03/11/96
Boston Scientific Microvasive Gold Probe	K970278, 04/11/97
Bronchus Bronchial Catheter	K980046, 05/01/98
C.R. Bard Eliminator Balloon Dilator	K940965, 05/20/94
Hobbs Medical Dilation Balloon Catheter	K834413, 05/22/84
Boston Scientific Microvasive Rigiflex ABDAchalasia Balloon Dilator	K number unknown

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.

{1}------------------------------------------------

Indicated Use D.

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.

{2}------------------------------------------------

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 features a stylized eagle with three stripes forming its body and wings. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K023765

Trade/Device Name: Stellartech Coagulation System Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: November 11, 2002 Received: November 12, 2002

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

{3}------------------------------------------------

Page 2 - Mr. James R. Santos

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 (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). 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,

Muriam C. Provost

for Celia M. Witten, Ph.D., MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

510(k) NUMBER (IF KNOWN):

DEVICE NAME:

Stellartech Coagulation System

INDICATIONS FOR USE:

K02376

Muriam C. Parrott

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

510(k) Number K623765

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.