(15 days)
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Not Found
No
The provided text does not contain any keywords or descriptions related to AI or ML technology.
Yes
The device is intended for "endovascular coagulation," which is a treatment to address "superficial vein reflux." This indicates a therapeutic (treatment) purpose rather than a diagnostic one.
No
The device is used for "endovascular coagulation of blood vessels," which is a treatment, not a diagnosis.
No
The 510(k) summary describes a "ClosureFAST™ Catheter," which is a physical medical device used for endovascular procedures. It does not mention any software component as the primary or sole function of the device.
Based on the provided information, the ClosureFAST™ Catheter is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "endovascular coagulation of blood vessels in patients with superficial vein reflux." This describes a procedure performed within the body (in vivo) to treat a condition.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (such as blood, urine, or tissue) to detect diseases, conditions, or infections.
The ClosureFAST™ Catheter is a therapeutic device used for a surgical procedure, not a diagnostic test performed on a sample outside the body.
N/A
Intended Use / Indications for Use
The ClosureFAST™ Catheter is intended for endovascular coagulation of blood vessels in patients with superficial vein reflux.
Product codes
GEI
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
blood vessels, superficial vein
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is simple and recognizable, representing the department's role in providing health and human services to the people of the United States.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
VNUS Medical Technologies, Inc. % Ms. Elizabeth Trujillo Manager, Regulatory Affairs 5799 Fontanoso Way San Jose, California 95138
APR 2 3 2010
Re: K082890
Trade/Device Name: ClosureFAST™ Intravascular Catheter Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: October 15, 2008 Received: October 15, 2008
Dear Ms. Trujillo:
This letter corrects our substantially equivalent letter of October 15, 2008
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 (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 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.
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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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance,
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark A. Millman
Mark N. Melkerson. M.S. Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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ClosureFAST™ Intravascular Catheter Special 510(k) Premarket Notification
Section 3
Indications-for-Use
KO82890 510(k) Number (if known):
Device Name: ClosureFAST™ Intravascular Catheter
Indications for Use: The ClosureFAST™ Catheter is intended for endovascular coagulation of blood vessels in patients with superficial vein reflux.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Milliken
(Division & gn-Oft) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K082890