(70 days)
No
The summary describes a radiofrequency catheter and its associated generator, focusing on its physical characteristics and intended use for endovascular coagulation. There is no mention of AI, ML, image processing, or any data-driven algorithms that would suggest the incorporation of such technologies. The performance studies described are standard device verification and validation tests, not AI/ML model performance evaluations.
Yes.
Explanation: The device is intended for "endovascular coagulation of blood vessels in patients with superficial vein reflux," which is a therapeutic intervention.
No.
The device description and intended use indicate that the ClosureFAST™ Radiofrequency Catheter is used for the treatment of superficial vein reflux through endovascular coagulation, not for diagnosing it.
No
The device description explicitly states it is a catheter with a physical heating element, flexible shaft, and cable, indicating it is a hardware device.
No, this device 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 therapeutic procedure performed on the patient's body, not a test performed on a sample taken from the patient.
- Device Description: The description details a catheter with a heating element, flexible shaft, and cable, designed for use with a generator. This is consistent with a device used for a medical procedure, not for analyzing a biological sample.
- Lack of IVD Characteristics: There is no mention of analyzing blood, tissue, or any other biological sample. The device's function is to apply radiofrequency energy directly to blood vessels within the body.
IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
The ClosureFAST™ Radiofrequency Catheter is intended for endovascular coagulation of blood vessels in patients with superficial vein reflux.
Product codes
GEI
Device Description
The ClosureFAST™ Radiofrequency Catheter is provided sterile, and is a single-use, disposable device. It has a 3cm radiofrequency heating element, a flexible shaft, and an integrated instrument cable. It is designed for use with the VNUS RFG2 Generator, cleared under 510(k) K040638.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
blood vessels
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
Testing was performed on the proposed ClosureFast to compare it to the predicate device. Testing included Design Verification and Validation on catheter compatibility, design specifications and performance. Results from the testing demonstrate that the modified device is substantially equivalent to the legally marketed predicate device.
Key Metrics
Not Found
Predicate Device(s)
ClosureFAST™ Catheter (K061373)
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
KII1887
A. Submitter
Covidien 15 Hampshire St. Mansfield, MA 02048 Phone: 508-452-4135
510(k) Summary
B. Contact Person
Daniel Campion Manager Regulatory Affairs
C. Date Prepared
June 30, 2011
D. Trade/Proprietary Name
ClosureFAST™ Radiofrequency Catheter
E. Common/Usual Name
Electrosurgical Device
F. Classification Name
Electrosurgical cutting and coagulation device and accessories
G. Predicate Device(s)
ClosureFAST™ Catheter (K061373)
H. Device Description
The ClosureFAST™ Radiofrequency Catheter is provided sterile, and is a single-use, disposable device. It has a 3cm radiofrequency heating element, a flexible shaft, and an integrated instrument cable. It is designed for use with the VNUS RFG2 Generator, cleared under 510(k) K040638.
-Intended Use
The ClosureFAST™ Radiofrequency Catheter is intended for endovascular coagulation of blood vessels in patients with superficial vein reflux.
J. Technology Characteristics
The ClosureFAST™ Radiofrequency Catheter is identical to the predicate device in terms of its intended use and fundamental scientific technology.
The function of the ClosureFAST™ catheter is to coagulate blood vessels by delivering radiofrequency energy to a heating element on the distal end of the catheter that is positioned at a desired treatment site. The device now will be offered with a 3cm heating element, therefore allowing physicians to treat refluxing vein segments less than 7cm in length.
Image /page/0/Picture/24 description: The image shows the text "SEP - 9 2011". The text appears to be a date, with "SEP" representing the month of September. The number 9 likely represents the day of the month. The year is 2011.
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K. Materials
The ClosureFAST™ Radiofrequency Catheter is composed of the same materials as the predicate device.
L. Performance Data
Testing was performed on the proposed ClosureFast to compare it to the predicate device. Testing included Design Verification and Validation on catheter compatibility, design specifications and performance. Results from the testing demonstrate that the modified device is substantially equivalent to the legally marketed predicate device.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus, a staff with two snakes entwined around it, which is a common symbol associated with medicine and healthcare.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Covidien % Mr. Daniel Campion Regulatory Affairs Vascular Therapies 15 Hampshire St. Mansfield, MA 02048
SEP - 9 2011
Re: KI11887
Trade/Device Name: ClosureFast Radiofrequency Catheter Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: August 10, 2011 Received: August 12, 2011
Dear Mr. Campion:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
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
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Page 2 - Mr. Daniel Campion
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/Reportal?roblem/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,
E. Keith
Fo Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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4. Indications for Use Statement
510(k) Number (if known): _KI | | 887
Device Name: ClosureFAST™ Radiofrequency Catheter
Indications for Use: The ClosureFAST™ Radiofrequency Catheter is intended for endovascular coagulation of blood vessels in patients with superficial vein reflux.
Prescription use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Part 21 CRF 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K111887