← Product Code [FOZ](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FOZ) · K073241 # VASCULAR PATHWAYS RIVS RAPID INTRAVASCULAR CATHETER START SYSTEM (K073241) _Vascular Pathways · FOZ · Feb 8, 2008 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FOZ/K073241 ## Device Facts - **Applicant:** Vascular Pathways - **Product Code:** [FOZ](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FOZ.md) - **Decision Date:** Feb 8, 2008 - **Decision:** SESE - **Submission Type:** Abbreviated - **Regulation:** 21 CFR 880.5200 - **Device Class:** Class 2 - **Review Panel:** General Hospital - **Attributes:** Therapeutic ## Indications for Use The Vascular Pathways RIVS is intended 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. ## Device Story Single-use, sterile intravascular catheter; provides venous access. Features integrated needle-shielding mechanism for safety post-placement. Used by clinicians for blood sampling, pressure monitoring, or fluid administration. Device facilitates safe vascular access; minimizes needle-stick risk via shielding. ## Clinical Evidence Bench testing only. ## Technological Characteristics Sterile, single-use intravascular catheter. Conforms to ISO 10555-1 (catheters), ISO 594-1 (luer fittings), and ISO 7864 (needles). Sterilization via AAMI TIR 33 (25kGy VD max). ## Regulatory 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. ## Predicate Devices - Angiocath® Autoguard™ and Insyte® Autoguard™ Catheter ([K984059](/device/K984059.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ 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. | Common
Name/ Product | Intravascular Catheter | | | Code/Class | 80 FOZ | | | | Class II | | E. | Regulation
Number | 21 CFR 880.5200 | | F. | Device
Description | 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. | | G. | Statement of
Intended Use | The Vascular Pathways RIVS is intended 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. | | H. | Performance
Standards | The RIVS device does or will conform to the following recognized
standards:
ISO 10555-1: 1995 Sterile, Single Use Intravascular Catheters, ISO
594-1: 1986 Conical Fittings with 6% (luer) - Part 1, ISO 7864: 1993
Sterile Hypodermic needles for single use, and AAMI TIR 33 –
Sterilization of healthcare products - Substantiation of 25Kgy as a
sterilization dose - VD max | | I. | Substantial
Equivalence
Conclusion | The Vascular Pathways - intravascular catheter is substantially
equivalent to the Angiocath® Autoguard ™ and Insyte® Autoguard™
Catheter cleared by the FDA under K984059. The RIVS share the
same intended use; operation, access to anatomical sites, safety and
physical characteristics, and therefore is substantially equivalent to the
Angiocath® Autoguard ™ and Insyte® Autoguard™ Catheter. There
are no new issues raised regarding safety or effectiveness of the
device | {1}------------------------------------------------ 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. {2}------------------------------------------------ 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 {3}------------------------------------------------ ## 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 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------1000 (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices 510(k) Number: Kun 3291 --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FOZ/K073241](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FOZ/K073241) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com