K091924 · Vasonova, Inc. · LJS · Nov 18, 2009 · General Hospital
Device Facts
Record ID
K091924
Device Name
VPS CATHETER
Applicant
Vasonova, Inc.
Product Code
LJS · General Hospital
Decision Date
Nov 18, 2009
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 880.5970
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
VPS catheters are indicated for short or long-term central or peripheral access to the central venous system for intravenous fluid and blood infusions, contrast studies with and without a power injector, central venous pressure monitoring, and blood sampling.
Device Story
VPS Catheter is a single or dual lumen (3F, 4F, 5F) intravascular catheter for central or peripheral venous access. Fabricated from radiopaque polyurethane with reverse-taper design. Used for fluid/blood infusion, contrast studies, CVP monitoring, and blood sampling. Supplied sterile, single-use, with VPS Stylet for percutaneous placement via Seldinger or Modified Seldinger technique. Can be used independently or with VPS Console. Provides venous access for clinicians in hospital settings.
Clinical Evidence
Bench testing only. Testing included static, burst, and dynamic pressure; physical characteristics; flexural fatigue and flexibility; flow rate; tensile and torque strength; air leakage; priming volume; mechanical hemolysis; and collapsibility/elongation.
Technological Characteristics
Single (3F, 4F) or dual (5F) lumen open-ended central venous access catheter. Material: radiopaque, biocompatible polyurethane. Lengths: 50 or 55 cm. Features: reverse-taper design, 1 cm interval markings, 5 cm increments. Sterile, single-use. Mechanical device; no energy source or software algorithm.
Indications for Use
Indicated for short or long-term central access to the central venous system for intravenous therapy, central venous pressure monitoring, and contrast studies. 4F or larger catheters required for blood or hyperalimentation delivery. Maximum injection rates: 2cc/sec (3F), 5cc/sec (4F/5F). For use by itself or with VPS System (Stylet and Console). Prescription use only.
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
VasoNova VPS Catheter
Bard Catheter
Medcomp Catheter
Submission Summary (Full Text)
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#### 5. 510(k) Summary
| Sponsor: | VasoNova Inc.<br>1368 Bordeaux Drive<br>Sunnyvale, CA 94089 | NOV 1 8 2009 |
|--------------------|-------------------------------------------------------------|--------------|
| Contact Person: | Kim Tompkins | |
| Phone Number: | 408.738.7006 | |
| Fax Number: | 650.644.2456 | |
| Prepared: | June 26, 2009 | |
| Trade Name: | VPS Catheter, name subject to change | |
| Common Name: | Percutaneous, implanted, long-term intravascular catheter | |
| Classification: | II | |
| Product Code: | LJS 21 CFR 880.5970 | |
| Advisory Panel: | General Hospital | |
| Predicate Devices: | VasoNova VPS Catheter | |
| | Bard Catheter | |
| | Medcomp Catheter | |
### Device Description
The VPS Catheter is designed for use with or without the VPS Console. When sold together, the VPS Catheter is preloaded with the Stylet and supplied in a tray. The VPS Catheter is sterile, single use, non-pyrogenic and non-toxic.
VPS Catheters are single lumen (3F and 4F) or dual lumen (5F) open-ended central venous access catheters fabricated from a soft, radiopaque, biocompatible polyurethane material with a working length of 50 or 55 cm and catheter markings at 1 cm intervals and 5 cm increments. VPS Catheters are packaged sterile with the VPS Stylet in a tray with accessories necessary for a percutaneous micro-introducer placement (Modified Seldinger or Seldinger technique). The VPS Catheters feature a reverse-taper design.
## Intended Use
VPS catheters are indicated for short or long-term central or peripheral access to the central venous system for intravenous fluid and blood infusions, contrast studies with and without a power injector, central venous pressure monitoring, and blood sampling.
## Performance Data
Previously provided in vivo and in vivo testing demonstrated that the subject device meces all acceptance criteria. Completed testing included:
- Static, burst and dynamic pressure .
- Physical characteristics .
- . Flexural fatigue and flexibility
- . Flow rate
- . Flexural fatigue and flexibility
- Tensile and torque strength .
- Freedom from air leakage .
- . Priming volume
- Mechanical hemolysis .
- Collapsibility and elongation .
### Substantial Equivalence
VasoNova VPS Catheters have the same intended use, technological characteristics and principles of operation as its predicate devices. The subject and predicate catheters are similar in that they are labeled for central or peripheral access, deliver fluid and blood infusions, can be used for contrast studies, are appropriate for CVP monitoring and blood sampling. Previously provided performance data demonstrate that the subject device is as safe and effective as the predicate devices.
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# DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Ms. Kim Tompkins, RN, MBA Vice President, Regulatory/Quality/Clinical VasoNova Incorporated 1368 Bordeaux Drive, Suite 100 Sunnyvale, California 94089
NOV 1 8 2009
Re: K091924
Trade/Device Name: VasoNova VPS Catheter Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: October 29, 2009 Received: October 30, 2009
Dear Ms. Tompkins:
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 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 - Ms. Tompkins
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Susan Tanner
Susan Runner, D.D.S., M.A. Acting 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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#### 4. 510(k) Indications for Use
Page _1_ of _1
510(k) Number (if known):
Device Name:
VasoNova VPS Catheter
Indications for use:
VPS Catheters are indicated for short or long-term central access to the central venous system for intravenous therapy, central venous pressure monitoring and contrast studies. For blood or hyperalimentation delivery, use a 4F or larger catheter. The maximum recommended injection rate is 2cc/sec for the 3F catheter and 5cc/sec for the 4F and 5F catheters. Each VPS Catheter is indicated for use by itself or with the VPS System (Stylet and Console).
X Prescription Use (per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Antren D. Owen
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Kag 1934 510(k) Number:
