(18 days)
The V-Cath® PICC is indicated for the patient that requires repeated access for infusion or injection therapy. It can also be used for blood sampling although a 3.8FR or larger catheter is recommended.
Not Found
I am sorry, but based on the provided text, there is no information available about acceptance criteria, device performance metrics, or any studies conducted to prove the device meets specific criteria.
The text is a 510(k) clearance letter from the FDA for the V-Cath® PICC. This letter confirms that the device is substantially equivalent to a predicate device and can be marketed. It discusses regulatory matters, product classification, and general controls, but it does not contain any data, results, or details of studies regarding the device's performance against specific acceptance criteria.
Therefore, I cannot populate the table or answer the specific questions you've posed as the necessary information is not present in the provided document. The document only states the "Indications for Use" of the device.
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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 & Human Services. The logo features a stylized abstract design resembling an eagle or bird in flight, composed of three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 16 1998
Mr. James S. Abilla Director of Quality Systems & Regulatory Affairs Management Representative HDC Corporation 2109 O'Toole Avenue San Jose, California 95131-1338
K983409 Re : V-Cath® PICC (Peripherally Inserted Central Trade Name: Catheter) Regulatory Class: II Product Code: FOZ September 21, 1998 Dated: Received: September 28, 1998
Dear Mr. Abilla:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Abilla
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Appendix 3
Indications for Use Statement
19996 14983409 510(k) Number Device Name V-Cath® PICC The V-Cath® PICC is indicated for the patient that requires Indications for Use repeated access for infusion or injection therapy. It can also be used for blood sampling although a 3.8FR or larger catheter is recommended.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Patrizia Cascenti
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 83409 510(k) Number_
Prescription Use (Per 21 CFR 801.109)
X
OR
Over-the-counter Use
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).