(345 days)
The Trans Catheter Extractor is a catheter accessory device intended for minimally invasive removal of tunneled long term catheters. The Trans Catheter Extractor is indicated for use with tunneled, double lumen Permcath catheters with cuff sizes ranging from 10.8 french to 14.5 french.
The Trans Catheter Extractor is a catheter accessory device intended for minimally invasive removal of tunneled long term catheters.
There is no information in the provided document about acceptance criteria, device performance details, or any study conducted to prove the device meets acceptance criteria.
The document is an FDA 510(k) clearance letter for the "Trans Catheter Extractor" (K063048). This letter indicates that the device has been found substantially equivalent to a predicate device already on the market, allowing the applicant to market the device.
The letter explicitly states: "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 (QS) regulation (21 CFR Part 820)..."
Therefore, based solely on the provided text, I cannot answer the specific questions regarding acceptance criteria and study details. This document is a regulatory approval letter, not a scientific study report.
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Public Health Service
SEP 1 4 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Tom Tran President/CEO TRAN PA-C. Incorporated 3348 Herringridge Drive Orlando, Florida 32812
Re: K063048
Trade/Device Name: Trans Catheter Extractor Regulation Number: 880.5970 Regulation Name: Percutaneous, Implanted Long-Term Intravascular Catheter Regulatory Class: II Product Code: ODY Dated: August 29, 2007 Received: September 6, 2007
Dear Mr. Tran:
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.
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Page 2 - Mr. Tran
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 (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 (240) 276-0115. 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/industry/support/index.html.
Sincerely yours.
Clare
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
of __ 1 ______________________________________________________________________________________________________________________________________________________________________ Page 1 -----------------------------------------------------------------------------------------------------------------------------------------------------------------------
510(k) Number (if known):
Device Name:
Trans Catheter Extractor
The Trans Catheter Extractor is a catheter accessory device intended for minimally invasive removal of tunneled long term catheters. The Trans Catheter Extractor is indicated for use with tunneled, double lumen Permcath catheters with cuff sizes ranging from 10.8 french to 14.5 french.
Prescription Use X (Per 21 CFR 801 Subpart D)
OR
Over-The Counter Use (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)
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§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.
(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”