(84 days)
The Vascular Pathways RIVS system is indicated for use to sample blood, monitor blood pressure, or administer fluids intravenously. This device may be used with consideration given to patient size, appropriateness of the solution being infused, and duration of therapy.
The device is a single use, sterile intravascular catheter designed to provide access to veins. The device is provided with a mechanism which allows the needle to be shielded following placement of the catheter.
This document is a 510(k) summary for a medical device (Rapid Intravascular Catheter Start System) and does not contain information about acceptance criteria or a study proving device performance against such criteria.
The 510(k) summary focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than providing detailed performance data from a specific study against acceptance criteria. The information provided is primarily administrative and descriptive of the device and its intended use.
Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving the device meets them based on the provided text. The document refers to conformance with recognized standards (ISO 10555-1, ISO 594-1, ISO 7864, AAMI TIR 33), but does not specify the acceptance criteria or results from a study conducted by the manufacturer against these standards to demonstrate device performance.
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K07324/
Vascular Pathways Inc. K07-3241
FEB - g
Appendix A: 510 (K) Summary of Safety and Effectiveness for the Rapid Intravascular Catheter Start System ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
| A. | Submitter: | Vascular Pathways, Inc. |
|---|---|---|
| 713 Sandoval Way | ||
| Hayward, Ca 94544 | ||
| B. | Contact: | Mary Pascual Gallup |
| VP of Regulatory Affairs | ||
| Vascular Pathways | ||
| Phone: 510-487-1561 X17 | ||
| Fax : 510-487-1569 | ||
| C. | Trade name | RIVS - Rapid Intravascular Catheter Start system |
| D. | CommonName/ Product | Intravascular Catheter |
| Code/Class | 80 FOZ | |
| Class II | ||
| E. | RegulationNumber | 21 CFR 880.5200 |
| F. | DeviceDescription | The device is a single use, sterile intravascular catheter designed toprovide access to veins. The device is provided with a mechanismwhich allows the needle to be shielded following placement of thecatheter. |
| G. | Statement ofIntended Use | The Vascular Pathways RIVS is intended to sample blood, monitor bloodpressure or administer fluids intravenously. This device may be usedwith consideration given to patient size, appropriateness of the solutionbeing infused, and duration of therapy. |
| H. | PerformanceStandards | The RIVS device does or will conform to the following recognizedstandards:ISO 10555-1: 1995 Sterile, Single Use Intravascular Catheters, ISO594-1: 1986 Conical Fittings with 6% (luer) - Part 1, ISO 7864: 1993Sterile Hypodermic needles for single use, and AAMI TIR 33 –Sterilization of healthcare products - Substantiation of 25Kgy as asterilization dose - VD max |
| I. | SubstantialEquivalenceConclusion | The Vascular Pathways - intravascular catheter is substantiallyequivalent to the Angiocath® Autoguard ™ and Insyte® Autoguard™Catheter cleared by the FDA under K984059. The RIVS share thesame intended use; operation, access to anatomical sites, safety andphysical characteristics, and therefore is substantially equivalent to theAngiocath® Autoguard ™ and Insyte® Autoguard™ Catheter. Thereare no new issues raised regarding safety or effectiveness of thedevice |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Public Health Service
FEB - 8 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Mary Pascual Gallup Vice President of Regulatory Affairs Vascular Pathways, Incorporated 713 Sandoval Way Hayward, California 94544
Re: K073241
Trade/Device Name: Vascular Pathways RIVS Rapid Intravascular Catheter Stat System Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: November 14, 2007 Received: November 16, 2007
Dear Ms. Gallup:
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. Mary Pascual Gallup
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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu-Lin, Ph.D.
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 B: Indications for Use 510(K) Number: _______________________________________________________________________________________________________________________________________________________________
Device Name: Vascular Pathways RIVS Rapid Intravascular Catheter Start System
Indications For Use:
The Vascular Pathways RIVS system is indicated for use to sample blood, monitor blood pressure, or administer fluids intravenously. This device may be used with consideration given to patient size, appropriateness of the solution being infused, and duration of therapy.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use:_____________________________________________________________________________________________________________________________________________________________ Counter (Per 21 CFR 801.109
or
Over the
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(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: Kun 3291
§ 880.5200 Intravascular catheter.
(a)
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.(b)
Classification. Class II (performance standards).