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JUti 14 2004510k Safety SummaryA Name of Device Trade Name Stellartech


LI T E Technical characteristicsThe technological characteristics of the Stellartech Coagulation System are substantiallyequivalent to those of the above listed predicate devicesF SummaryBy virtue of

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Document on Subject : "JUti 14 2004510k Safety SummaryA Name of Device Trade Name Stellartech"— Transcript:

1 JUti 14 2004510(k) Safety SummaryA. Name
JUti 14 2004510(k) Safety SummaryA. Name of Device* Trade Name: Stellartech Coagulation System* Common Name: Electrosurgical Unit and Accessories* Classification Name: Device, Electrosurgical Cutting and Coagulation and Accessories(21 CFR 878.4400)B. Predicate DevicesDevice Premarket NotificationStellartech Coagulation System K013139, 12/18/01Stellartech Coagulation System K023765, 11/29/02Stellartech Coagulation System K032062, 07/29/03Stellartech Coagulation System K032452, 08/21/03Stellartech Coagulation System K032721, 10/06/03Stellartech Coagulation System K040240, 04/01/04C. 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 SheathThe proximal end of the Stellartech Coagulation Catheter connects to the Stellartech CoagulationCatheter Connection Module. The Stellartech Coagulation Catheter Connection Module cableconnects to the Stellartech Coagulation Generator.D. Indicated UseThe Stellartech Coagulation System is indicated for use in the coagulation of bleeding and non-bleeding sites in the gastr

2 ointestinal tract including but not limi
ointestinal tract including but not limited to, the esophagus. Indicationsinclude Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata,Barrett's Esophagus, Dieulafoy Lesions, and Angiodysplasia.Special 510(k) Device Modification Notification K023765, K013139, K032062, K032452, K032721, K040240 Page 23 of 108 + LI T 'E. Technical characteristicsThe technological characteristics of the Stellartech Coagulation System are substantiallyequivalent to those of the above listed predicate devices.F. SummaryBy virtue of design, principles of operation, materials and intended use, the StellartechCoagulation System is substantially equivalent to devices currently marketed in the United States.Special 510(k) Device Modification Notification K023765, K013139, K032062, K032452, K032721, K040240 Page 24 of 108 fe P H hvDEPARTMENT OF HEALTH & HUMAN SERVICES Public Health ServiceFood and Drug Administration9200 Corporate BoulevardJUN 1 4 2004 Raockville MD 20850Mr. Gary SeegerVice President, Regulatory Affairs/Quality AssuranceStellartech Research Corporation1346 Bordeaux DriveSunnyvale, California 94089Re: K041383Trade/Device Name: Stellartech Coagulation SystemRegulation Number: 21 CFR 878.4400Regulation Name: Electrosurgical cutting and coagulation device and accessori

3 esRegulatory Class: IIProduct Code: GEID
esRegulatory Class: IIProduct Code: GEIDated: May 24, 2004Received: May 25, 2004Dear Mr. Seeger:We have reviewed your Section 510(k) premarket notification of intent to market the devicereferenced above and have determined the device is substantially equivalent (for the indicationsfor use stated in the enclosure) to legally marketed predicate devices marketed in interstatecommerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or todevices 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. Thegeneral controls provisions of the Act include requirements for annual registration, listing ofdevices, good manufacturing practice, labeling, and prohibitions against misbranding andadulteration.If your device is classified (see above) into either class II (Special Controls) or class III (PMA), itmay be subject to such additional controls. Existing major regulations affecting your device canbe found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA maypublish further announcements concerning your device in the

4 Federal Register.Please be advised that
Federal Register.Please be advised that FDA's issuance of a substantial equivalence determination does not meanthat FDA has made a determination that your device complies with other requirements of the Actor any Federal statutes and regulations administered by other Federal agencies. You mustcomply with all the Act's requirements, including, but not limited to: registration and listing (21CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as setforth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronicproduct radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Page 2 -Mr. Gary SeegerThis 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 legallymarketed predicate device results in a classification for your device and thus, permits your deviceto proceed to the market.If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), pleasecontact 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 obtainother general informa

5 tion on your responsibilities under the
tion on your responsibilities under the Act from the Division of SmallManufacturers, 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.htmlSincerely yours,Celia M. Witten, Ph.D., M.D.DirectorDivision of General, Restorativeand Neurological DevicesOffice of Device EvaluationCenter for Devices and Radiological HealthEnclosure 5 10(k) NUMBER (IF KNOWN):2DEVICE NAME: Stellartech Coagulation SystemINDICATIONS FOR 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. Indicationsinclude Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata,Barrett's Esophagus, Dieulafoy Lesions, and Angiodysplasia.(Division Sign-Off)Division of General, Restorative,and Neurological Devices510(k) Number K6Yq/3K3Prescription Use AND'OR Over-The-Counter-Use(Part 21 CFR 801 .Subpart D) (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, K032452, K032721, K040240 Page 17 of 10