FLOWPICC CATHETER

K082481 · Vasonova, Inc. · LJS · Dec 17, 2008 · General Hospital

Device Facts

• Record ID: K082481
• Device Name: FLOWPICC CATHETER
• Applicant: Vasonova, Inc.
• Product Code: LJS · General Hospital
• Decision Date: Dec 17, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5970
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The FlowPICC Catheter is indicated for short or long-term peripheral access to the central venous system for intravenous therapy and injection of contrast media. For blood sampling, infusions, or therapies, use a 5F or larger catheter. The maximum recommended infusion rate is 5cc/sec. The FlowPICC Catheter is indicated for use by itself or with the FlowPICC System (Stylet and Console) sold separately.

Device Story

FlowPICC Catheter is a double-lumen, open-ended peripherally inserted central catheter (PICC) designed for intravenous therapy, blood sampling, and power injection of contrast media. Fabricated from soft, radiopaque, biocompatible polyurethane; 50 cm length with 5 cm markings. Packaged with accessories for Seldinger or modified Seldinger insertion technique, including a stylet and adaptor. Used in clinical settings for central venous access. Can be used independently or with the FlowPICC System (Stylet and Console). Provides clinicians with a reliable conduit for fluid delivery and diagnostic imaging contrast administration.

Clinical Evidence

Bench testing and in vivo testing performed; device met all acceptance criteria. No clinical trial data reported.

Technological Characteristics

Double-lumen, open-ended PICC; material: biocompatible polyurethane; radiopaque; 50 cm length; 5 cm markings; includes stylet and adaptor; manual insertion via Seldinger/modified Seldinger technique.

Indications for Use

Indicated for patients requiring short or long-term peripheral access to the central venous system for intravenous therapy, contrast media injection, and blood sampling (5F or larger).

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

• Bard PowerPICC Catheter
• Cook Turbo-Ject Catheter

Submission Summary (Full Text)

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# 1082481

#### 5. 510(k) Summary

Sponsor:

VasoNova Inc. 1368 Bordeaux Drive Sunnyvale, CA 94089

Tina Cheng

510.589.6084 650 644.2456

August 27, 2008

## DEC 1 7 2008

Contact Person: Phone Number: Fax Number: Prepared:

Trade Name: Common Name: Classification: Product Code: Advisory Panel:

VasoNova FlowPICC Catheter, name subject to change Percutaneous, implanted, long-term intravascular catheter II LJS 21 CFR 880.5970 General and Plastic Surgery

Predicate Device:

Bard PowerPICC Catheter Cook Turbo-Ject Catheter

#### Device Description

The FlowPICC Catheter is a double lumen open-ended PICC designed for power injection through one designated lumen. The FlowPICC Catheter is fabricated from a soft, radiopaque, biocompatible polyurethane material with a working length of 50 cm with markings in 5 cm increments. The catheter is packaged with accessories necessary for implantation of a PICC catheter using a Seldinger or modified Seldinger technique. A stylet and adaptor sidenort are provided to assist in catheter insertion.

#### Intended Use

The FlowPICC catheter is indicated for short or long-term access to the central venous system for intravenous therapy, power injection of contrast media and blood sampling.

#### Performance Data

In vitro and in vivo testing demonstrates that the VasoNova FlowPICC Catheter meets all acceptance criteria.

#### Substantial Equivalence

The VasoNova FlowPICC catheter has the same intended use, technological characteristics and principles of operation as its predicate devices. Performance data demonstrate that the VasoNova FlowPICC is as safe and effective as the predicate devices.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services, USA. The seal features the department's name in a circular arrangement around the perimeter. In the center is a stylized symbol, possibly representing a human figure or abstract design, composed of three curved lines.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## DEC 1 7 2008

Ms. Tina Cheng Director, Product Development Vasonova, Incorporated 1368 Bordeaux Drive, Suite 100 Sunnyvale, California 94089

Re: K082481

Trade/Device Name: VasoNova FlowPICC Catheter Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: December 5, 2008 Received: December 8, 2008

Dear Ms. Cheng:

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.

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### Page 2 - Ms. Cheng

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. 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regardingpostmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act 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.gov/cdrh/industry/support/index.html.

Sincerely yours,

Clive
Shih, S., Liu, Ph.D.

Chiu S. Lin. Ph. D Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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## 510(k) Indications for Use

K082481 510(k) Number (if known):

Device Name:

## VasoNova FlowPICC Catheter

Indications for use:

The FlowPICC Catheter is indicated for short or long-term peripheral access to the central venous system for intravenous therapy and injection of contrast media. For blood sampling, infusions, or therapies, use a 5F or larger catheter. The maximum recommended infusion rate is 5cc/sec.

The FlowPICC Catheter is indicated for use by itself or with the FlowPICC System (Stylet and Console) sold separately.

signature

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K082481