K Number
K032721
Device Name
MODIFICATION TO: STELLARTECH COAGULATION SYSTEM (MODELS 1100C-115 & 1100C-230)
Date Cleared
2003-10-06

(33 days)

Product Code
Regulation Number
878.4400
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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.
Device Description
The Stellartech Coagulation System consists of the following components. - Stellartech Coagulation Generator . - Stellartech Probe Connection Module . - Stellartech Coagulation Probe . - Optional Accessory Stellartech Sizing Probe . - . Optional Stellartech Footswitch. The proximal end of the Stellartech Coagulation Probe connects to the Stellartech Probe Connection Module. The proximal end of the Stellartech Probe Connection Module cable connects to the Stellartech Coagulation Generator.
More Information

Not Found

No
The document describes a standard electrosurgical coagulation system and does not mention any AI or ML components or functionalities.

Yes
The device is indicated for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract for various conditions, which directly addresses a medical condition or disease.

No

The device is indicated for use in the coagulation of bleeding and non-bleeding sites, which is a therapeutic function rather than a diagnostic one.

No

The device description explicitly lists multiple hardware components: a generator, a probe connection module, a coagulation probe, and optional accessories like a sizing probe and footswitch. This indicates it is a hardware-based medical device, not software-only.

Based on the provided information, the Stellartech Coagulation System is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states the device is for "coagulation of bleeding and non-bleeding sites in the gastrointestinal tract". This is a therapeutic procedure performed directly on the patient's tissue, not a test performed on a sample taken from the patient.
  • Device Description: The components described (generator, probes, footswitch) are consistent with a device used for direct tissue treatment, not for analyzing biological samples.
  • Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other elements typically associated with in vitro diagnostics.

IVD devices are used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening. The Stellartech Coagulation System is a therapeutic device used to treat conditions within the body.

N/A

Intended Use / 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.

Product codes

GEI

Device Description

The Stellartech Coagulation System consists of the following components.

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

gastrointestinal tract including but not limited to, the esophagus.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K013139, K023765, K032062, K032452

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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.

0

OCT-6 2003 K032721 (pg 1 of 1)

510(k) Safety Summary

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)

B. Predicate Devices

DevicePremarket Notification
Stellartech Coagulation SystemK013139, 12/18/01
Stellartech Coagulation SystemK023765, 11/29/02
Stellartech Coagulation SystemK032062, 7/29/03
Stellartech Coagulation SystemK032452, 8/21/03

Device Description: C.

The Stellartech Coagulation System consists of the following components.

  • Stellartech Coagulation Generator .
  • Stellartech Probe Connection Module .
  • Stellartech Coagulation Probe .
  • Optional Accessory Stellartech Sizing Probe .
  • . Optional Stellartech Footswitch.

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

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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird figure.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 6 2003

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

Re: K032721

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: September 2, 2003 Received: September 9, 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, 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

2

Page 2 - Mr. Gary A. 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. 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

3

K032721

510(k) NUMBER (IF KNOWN):

DEVICE NAME: INDICATIONS FOR USE:

Stellartech Coagulation System

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.

Miriam C. Provost

Division of General, Restorative and Neurological Devices

03270 510(k) Number

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

(Per 21 CFR 801.109)

OR

Over-The-Counter-Use