(34 days)
The V-Cath® Poly 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 4FR or larger catheter is recommended.
Not Found
I apologize, but the provided text from the FDA 510(k) clearance letter for the V-Cath® Poly PICC (K033853) does not contain the specific information required to answer your request regarding acceptance criteria and a study proving device performance.
The letter primarily:
- Identifies the device: V-Cath® Poly PICC
- States the clearance: Substantially equivalent to legally marketed predicate devices.
- Specifies the Regulation Number and Product Code: 880.5200, FOZ
- Lists the Indications for Use: "for the patient that requires repeated access for infusion or injection therapy. It can also be used for blood sampling although a 4FR or larger catheter is recommended."
- Outlines general regulatory compliance directives for the manufacturer.
It does not include:
- A table of acceptance criteria and reported device performance.
- Details about a specific study (sample size, data provenance, ground truth, adjudicated methods, MRMC study, standalone performance, training set details).
To obtain this information, you would typically need to consult the original 510(k) submission document itself, which would contain the preclinical and clinical data submitted to the FDA to demonstrate substantial equivalence. The clearance letter only summarizes the FDA's decision based on that submission.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 4 2004
HDC Corporation Mr. Earl P.A. Smart Quality Assurance Manager, and Management Representative 628 Gibraltar Court Milpitas, California 95035
Re: K033853
Trade/Device Name: V-Cath® Poly PICC Regulation Number: 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: December 9, 2003 Received: December 24, 2003
Dear Mr. Smart:
We have reviewed your Section 510(k) premarket notification of intent to market the device we navo roviewed your between ined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate dovices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Intersate conmisered prior with have been reclassified in accordance with the provisions of Amendmont, or to do rolland Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provisions is a a 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 (1 WIT), it may of our of the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device ear ov routlish further announcements concerning your device in the Federal Register.
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Page 2 -Mr. Smart
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be auvisou mat I Dri 5 ilsulition that your device complies with other requirements mean that I DA nas made a actes and regulations administered by other Federal agencies. of the Act of ally I ederal barates and sequirements, including, but not limited to: registration 1 ou thuse comply with an art art art 801); good manufacturing practice allu listing (21 CF R Futt 067), labelity 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.
21 CFR 1000-1000. This letter will anow you to begal finding of substantial equivalence of your device to a premitser notifieddion. The rise 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), IT you desire specific at 100 to: Joinese at (301) 594-4618. Also, please note the regulation entified, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may overn 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/dsma/dsmamain.html
Sincerely yours,
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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Appendix # 3
Indications for Use
| 510(k) Number | K 033853 |
|---|---|
| Device Name: | V-Cath® Poly PICC |
| Indications for Use: | The V-Cath® Poly 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 4FR or larger catheter is recommended. |
Prescription Use
(Per 21 CFR 801 Subpart D)
AND/OR
Over-the-Counter Use (Per 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Viola Hibbard; Interim Branch Chief, US
(Division Sign-Off) Division of Anesthesiology, General Hospita Infection Control, Dental Devices
510(k) Number:__ KO3 Page 1 of _
§ 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).