(34 days)
I am sorry, but the input you provided is "Not Found". Therefore, I cannot identify any Predicate Device(s) or K/DEN numbers. Please provide the relevant text.
I am sorry, but the input "Not Found" does not contain any K/DEN numbers. Please provide the text from which I can identify the reference devices.
No
The summary describes a standard medical catheter and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No.
The device description indicates it is used for "access for infusion or injection therapy" and "blood sampling," classifying it as a medical device for delivery or collection, not for treating a disease or condition itself.
No
The V-Cath® Poly PICC is described as a device for repeated access for infusion, injection therapy, and blood sampling. These functions are therapeutic or for obtaining samples, not for diagnosing a medical condition.
No
The 510(k) summary describes a physical medical device (a PICC catheter) and does not mention any software component.
Based on the provided information, the V-Cath® Poly PICC is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as being used for infusion, injection therapy, and blood sampling directly from the patient. This involves accessing the patient's circulatory system.
- IVD Definition: In vitro diagnostics are medical devices used to examine specimens taken from the body, such as blood, urine, or tissue, outside of the body to detect diseases, conditions, or infections.
The V-Cath® Poly PICC is a device used in vivo (within the living body) for accessing the vascular system, not for testing samples in vitro.
N/A
Not Found
§ 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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized wing segments and a wavy base, representing human services.
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.
1
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
2
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 _