(84 days)
Not Found
No
The summary describes a standard intravascular catheter with a safety mechanism and does not mention any AI/ML related terms or functionalities.
No
The device's intended uses are to sample blood, monitor blood pressure, or administer fluids intravenously, which are diagnostic or supportive functions, not therapeutic. While it mentions "duration of therapy" in the context of fluid administration, the device itself is an access tool rather than a therapeutic agent.
No.
The device is described as an intravascular catheter for sampling blood, monitoring blood pressure, or administering fluids. These functions are for accessing the vascular system and delivering or withdrawing substances, not for diagnosing medical conditions.
No
The device description clearly states it is a "single use, sterile intravascular catheter," which is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "sample blood, monitor blood pressure, or administer fluids intravenously." These are procedures performed directly on the patient's body, not on samples of bodily fluids or tissues outside the body for diagnostic purposes.
- Device Description: The device is an "intravascular catheter designed to provide access to veins." This is a medical device used for accessing the circulatory system, not for analyzing samples.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples, detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device's function is to access the body for sampling, monitoring, or administration, which falls under the category of a general medical device, not an IVD.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
FOZ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
veins
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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