MODIFICATION TO V-CATH POLY PICC

K033853 · Hdc Corp. · FOZ · Jan 14, 2004 · General Hospital

Device Facts

• Record ID: K033853
• Device Name: MODIFICATION TO V-CATH POLY PICC
• Applicant: Hdc Corp.
• Product Code: FOZ · General Hospital
• Decision Date: Jan 14, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5200
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

V-Cath® Poly PICC is an intravascular catheter designed for repeated vascular access. It facilitates infusion, injection therapy, and blood sampling. Used in clinical settings by healthcare professionals for patients requiring long-term or frequent venous access. Device provides a conduit for fluid delivery or blood withdrawal; helps minimize repeated venipuncture for patients. Operation involves standard catheter insertion techniques.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Intravascular catheter; Class II; Product Code FOZ; Regulation 880.5200. Material composition and specific dimensions not detailed in provided text.

Indications for Use

Indicated for patients requiring repeated vascular access for infusion or injection therapy, or blood sampling (recommended 4FR or larger).

Regulatory Classification

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.

Submission Summary (Full Text)

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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.

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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 [phone]. 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 [phone] or [phone] 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 _