VAXCEL PICC WITH PASV VALVE TECHNOLOGY

K021704 · Catheter Innovations, Inc. · LJS · Jun 6, 2002 · General Hospital

Device Facts

• Record ID: K021704
• Device Name: VAXCEL PICC WITH PASV VALVE TECHNOLOGY
• Applicant: Catheter Innovations, Inc.
• Product Code: LJS · General Hospital
• Decision Date: Jun 6, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5970
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Vaxcel™ PICC with PASV® Valve Technology is indicated for use in establishing peripheral access to the central venous system for administration of fluids including, but not limited to, hydration agents, antibiotics, chemotherapy, analgesics, nutritional therapy and blood products. It is also indicated for blood specimen withdrawal. This product is effective for central venous access in adults, children and infants who require intravenous (IV) therapy.

Device Story

Vaxcel™ PICC with PASV® Valve Technology is a peripherally inserted central catheter (PICC) designed for central venous access. Device features integrated PASV® valve technology to manage fluid flow and blood withdrawal. Used in clinical settings by healthcare professionals to establish access to central venous system for administration of various IV fluids and blood sampling. Benefits include reliable venous access for patients requiring long-term or frequent IV therapy. Device functions as a conduit for fluid delivery and blood aspiration; valve mechanism regulates flow. Healthcare providers utilize the catheter to facilitate patient treatment plans requiring central venous administration.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per USP Class VI and ISO 10993. Chemical compatibility testing performed against common medical chemicals. No clinical data provided.

Technological Characteristics

PICC catheter with integrated PASV® valve technology. Materials tested for biocompatibility per ISO 10993 and USP Class VI. Chemical compatibility verified against routine medical chemicals. Device is a percutaneous, implanted long-term intravascular catheter (Product Code LJS).

Indications for Use

Indicated for adults, children, and infants requiring central venous access for IV therapy, including fluid administration (hydration, antibiotics, chemotherapy, analgesics, nutrition, blood products) and blood specimen withdrawal.

Regulatory Classification

Identification

A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.

Special Controls

*Classification.* Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”

Predicate Devices

• PLACEMENT-plus™ (K003642)

Submission Summary (Full Text)

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## Catheter Innovations®

ﺍﻟﻤﺴﺎﻋﺪﺓ

Vaxcel™ PICC with PASV® Valve Technology

6 2002 Jun

Ko21704

Telephone:

Attachment 5

## Summary of Safety and Effectiveness

Catheter Innovations, Inc. Salt Lake City, Utah - 84.04

| General Provisions | Trade Name: Vaxcel™ PICC Catheter with PASV® Technology. |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name of Predicate<br>Device | PLACEMENT-plus™ [K003642] |
| Classification | Class II |
| Performance<br>Standards | Performance Standards have not been established by FDA under Section 514 of the<br>Food, Drug and Cosmetic Act. |
| Intended Use and<br>Device Description | The Vaxcel™ PICC with PASV® Valve Technology is indicated for use in establishing<br>peripheral access to the central venous system for administration of fluids including,<br>but not limited to, hydration agents, antibiotics, chemotherapy, analgesics, nutritional<br>therapy and blood products. It is also indicated for blood specimen withdrawal.<br>This product is effective for central venous access in adults, children and infants who<br>require intravenous (IV) therapy. |
| Biocompatibility | Vaxcel™ PICC with PASV® Valve Technology have been tested and compared to the<br>predicate device as per USP (Class VI) and ISO10993. All data demonstrate this<br>device is biocompatible for its intended use. |
| Chemical<br>Compatibility | All of the materials of the Vaxcel™ PICC with PASV® Valve Technology have been<br>tested against numerous chemicals routinely used in medical applications. All data<br>demonstrate this device is chemically compatible for its intended use. |
| Summary of<br>Substantial<br>Equivalence | The Vaxcel™ PICC with PASV® Valve Technology has been tested and compared to<br>the predicate device. All data gathered demonstrate this device is substantially<br>equivalent. No new issues of safety or efficacy have been raised. |

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Image /page/1/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 image of three human profiles facing right, stacked on top of each other. The profiles are simple and abstract, with no facial details. The profiles are enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle.

## Public Health Service

JUN 6 2002 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Rogers L. Richins Vice President, Technology & Regulatory Affairs Catheter Innovations, Incorporated 3598 West 1820 South Salt Lake City, Utah 84104

Re: K021704

Trade/Device Name: Vaxcel™ PICC with PASV® Value Technology Regulation Number: 880.5970 Regulation Name: Percutaneous, Implanted Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: May 21, 2002 Received: May 23, 2002

Dear Mr. Richins:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.

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Page 2 - Mr. Richins

You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality 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.

This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Gilchrist

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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510(k) Number (if known):

K021704

Vaxcel ™ PICC with PASV®Valve Technology Device Name:

Indications For Use:

Vaxcel ™ PICC with PASV®Valve Technology is indicated for use in establishing peripheral access to the central venous system for administration of fluids including, but not limited to, hydration agents, and piotics, chemotherapy, analgesics, nutitional therapy, and blood products, and blood indicated for blood specimen withdrawal.

The product is intended for central venous access in adults, children, and infants who require intravenous (IV) therapy.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF MEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V (Per 21 CFR 801.109)

OR

ਦੱਖ

Over-The-Caustor Use

(Optional Formal 1-2-96)

Patricia Cusciente
(Division Sign-Off)

Division of Dental, Infection Control, and General Hospital Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________