V-CATH PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) SEE APPENDIX 1

K983409 · Hdc Corp. · FOZ · Oct 16, 1998 · General Hospital

Device Facts

• Record ID: K983409
• Device Name: V-CATH PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) SEE APPENDIX 1
• Applicant: Hdc Corp.
• Product Code: FOZ · General Hospital
• Decision Date: Oct 16, 1998
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

V-Cath® PICC is a peripherally inserted central catheter used for repeated vascular access. Device facilitates infusion, injection therapy, and blood sampling. Used in clinical settings by healthcare professionals. Provides central venous access to deliver medications or fluids and withdraw blood samples. Benefits include reduced need for repeated peripheral venipuncture.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Peripherally inserted central catheter (PICC). Available in various French sizes (e.g., 3.8FR or larger for blood sampling).

Indications for Use

Indicated for patients requiring repeated access for infusion or injection therapy, or blood sampling (3.8FR or larger recommended).

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 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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