RAPID INTRAVASCULAR CATHETER START SYSTEM 22 GAUGE / 20 GAUGE / 18 GAUGE

K112347 · Vascular Pathways, Inc. · FOZ · Sep 22, 2011 · General Hospital

Device Facts

• Record ID: K112347
• Device Name: RAPID INTRAVASCULAR CATHETER START SYSTEM 22 GAUGE / 20 GAUGE / 18 GAUGE
• Applicant: Vascular Pathways, Inc.
• Product Code: FOZ · General Hospital
• Decision Date: Sep 22, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5200
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Single-use, sterile intravascular catheter system; provides venous access. Components: protective cover, catheter with luer lock, needle with flashback chamber, safety container, guide wire, slider, spring, and release button. Mechanism: needle shielded post-placement via safety mechanism. Used by clinicians for blood sampling, pressure monitoring, or fluid administration. Benefits: facilitates secure venous access while protecting user from needle sticks.

Clinical Evidence

Bench testing only. Verification and validation testing confirmed design specifications and user needs were met. Biocompatibility testing confirmed no changes to safety profile.

Technological Characteristics

Single-use, sterile intravascular catheter. Components: protective cover, luer lock, needle, flashback chamber, safety container, guide wire, slider, spring, release button. Materials: not specified. Energy source: manual/mechanical. Connectivity: none. Sterilization: sterile.

Indications for Use

Indicated for patients requiring intravenous access for blood sampling, blood pressure monitoring, or fluid administration. Use depends on patient size, infusion solution appropriateness, and therapy duration.

Regulatory Classification

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

• Rapid Intravascular Catheter Start System (K073241)

Submission Summary (Full Text)

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Special 510(k): Device Modification Rapid Intravascular Catheter Start System

#### SECTION 13. 510(K) SUMMARY

SEP 2 2 2011

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

510(k) Number: _ ___

## Applicant Information:

| Date Prepared: | July 15, 2011 |
|-------------------|-------------------------------------------|
| Name: | Vascular Pathways, Inc. |
| Address: | 1847 Trade Center Way<br>Naples, FL 34109 |
| Phone: | [phone] |
| Fax: | [phone] |
| Contact Person: | Michael A Daniel / Steven J Hoffman |
| Phone Number: | [phone] |
| Office: | [phone] |
| Facsimile Number: | [phone] |

## Device Information:

| Classification: | Class II |
|---------------------------|-------------------------------------------|
| Trade Name: | Rapid Intravascular Catheter Start System |
| Common Name: | Intravascular Catheter |
| Classification Name: | Intravascular Catheter |
| Product Code/ Regulation: | FOZ / 21CFR 880.5200 |

### Predicate Device:

The RIVS 18, 20 and 22 gauge devices are substantially equivalent in intended use and method of operation to the following predicate device:

K073241 - Vascular Pathways, Inc., Rapid Intravascular Catheter Start System

### Device Description:

The RIVS 18, 20 and 22 Gauge devices are single use, sterile intravascular catheters designed to provide access to veins. The devices are provided with a safety mechanism which allows the needle to be shielded following placement of the catheter.

All devices have the basic structure of a protective cover, a catheter with a luer lock fitting, a needle connected to a flashback chamber, a safety container, a guide wire within the lumen of the needle which is connected to a slider and a spring and release button.

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# 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.

# Comparison to Predicate Device:

The design of the three RIVS devices is essentially the same device as the predicate RIVS with moderate design modifications to reduce cost of goods and improve manufacturability. The products share common features such as identical operating principles, basic design, performance characteristics, anatomical site for venous access, safety, and physical characteristics.

The devices are packaged sterile and are for single patient use. Further, the modified RIVS, two new gauge devices and the predicate device have the same intended use, which is to provide access to veins. Verification and validation testing provided proof the modifications met the design specifications and user needs and biocompatibility testing provided evidence there were no changes to that safety aspect of the device.

# Summary:

Based upon the intended use, product technical information, performance testing and biocompatibility information provided in this pre-market notification, the modified RIVS 22 gauge and the additional 18 and 20 gauge devices have been shown to be substantially equivalent to the currently cleared predicate RIVS device in terms of design, performance and intended use. There are no new issues raised regarding safety or effectiveness of the modified or additional gauge devices.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -- WO66-G609 Silver Spring, MD 20993-0002

Vascular Pathways, Incorporated C/O Michael A. Daniel President Daniel & Daniel Consulting 8 Snowberry Court Orinda, California 94563

SEP 22 2011

Re: K112347

Trade/Device Name: Vascular Pathways RIVS Rapid Intravascular Catheter Start System Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: September 8, 2011 Received: September 14. 2011

Dear Mr. Daniel:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind vou. however, that device labeling must be truthful and not misleading.

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 2 - Ms. Daniel

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 fisting (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/Safetv/ReportalProblem/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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Anthony L. Anutson

Anthony D. Watson. B.S., M.S., M.B.A. 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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#### INDICATIONS FOR USE 8.3

510(k) Number (if known): K112347

Device Name: Yascular 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.

Prescription Use __ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Rld C. Chagn

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

510(k) Number: K112347