(90 days)
Not Found
No
The device description and intended use are for a simple IV extension set, a passive fluid delivery device. There is no mention of any computational or analytical capabilities that would suggest the use of AI or ML.
No.
The device is an IV extension set intended for the aspiration and/or delivery of fluids, functioning as a conduit for fluid transfer, rather than providing a therapeutic effect itself.
No
Explanation: The device is an intravenous extension set used for fluid delivery and aspiration, not for diagnosis.
No
The device description clearly details physical components such as PVC tubing, luer locks, a slide clamp, and potentially a needle-free valve, indicating it is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "aspiration, injection or gravity/pump flow of fluids" and is used with power injectors. This describes a device used for administering substances into the body, not for testing samples taken from the body.
- Device Description: The description details the physical components of an IV extension set (tubing, luers, clamp, optional valve). This aligns with a device for fluid delivery, not for performing diagnostic tests on biological samples.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide information about a patient's health status based on such analysis.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used in vivo (within the body) for fluid administration.
N/A
Intended Use / Indications for Use
The Intravenous Power Injector Extension Set is intended to allow for the aspiration, injection or gravity/pump flow of fluids and may be used with low pressure power injectors having a maximum pressure setting of 325 psi and maximum flow rate of 10 ml/second. When used with a low pressure power injector, the Intravenous Power Injector Extension Set must be secured with other devices rated for pressures up to 325 psi with a luer lock connection.
Product codes
FPA
Device Description
The Intravenous Power Injector Extension Set is an IV extension set intended for the aspiration and/or delivery of fluids and may be used with power injectors having a maximum pressure setting of 325 psi and maximum flow rate of 10 ml/second.
The Intravenous Power Injector Extension Set consists of polyvinyl chloride (PVC) tubing with non-DEHP plasticizer, configured with a male luer with hex lock hub on its distal end and a female luer lock on its proximal end. A slide clamp is positioned over the tubing to obstruct the fluid flow when needed by sliding the tubing into the narrow portion of the slide clamp.
The Intravenous Power Injector Extension Set is available in a configuration with and without a needle-free valve. The configuration with the valve allows access to the fluid delivery pathway without the use of a needle while maintaing a closed system for the fluid path. The valve is attached to the female luer lock.
The Intravenous Power Injector Extension Set is provided sterile for single use only. It is packaged with a commercially available skin protectant prep pad and a commercially available StatLock® stabilization device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
The results of performance testing demonstrated that the functionality, integrity, and safety of the Intravenous Power Injector Extension Set are adequate for its intended use and supports a determination of substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.
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APR 2 1 2009
510(k) SUMMARY
This 510(k) summary is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.87
Establishment Registration Number:
Address of Manufacturer:
Contact Person:
Date Prepared:
Trade or Proprietary Name:
Common or Usual Name:
Classification Name:
Predicate Device Identification:
1018223
Bard Medical Division C. R. Bard, Inc. 8195 Industrial Blvd. Covington, Georgia 30014 USA Phone: (770) 784-6774 Fax: (770) 784-6340
Scott Pease Senior Manager, Regulatory Affairs
April 2, 2009
Intravenous Power Injector Extension Set
Set, Administration, Intravenous
Intravascular administration set (21 CFR 880.5440)
Product code: FPA
Class II
IV Administration Sets (extension set) with Needleless Access Device (K980992)
SmartSite® Needle-Free Valve Administration Set (K061285)
Device Description:
The Intravenous Power Injector Extension Set is an IV extension set intended for the aspiration and/or delivery of fluids and may be used with power injectors having a maximum pressure setting of 325 psi and maximum flow rate of 10 ml/second.
The Intravenous Power Injector Extension Set consists of polyvinyl chloride (PVC) tubing with non-DEHP plasticizer, configured with a male luer with hex lock hub on its distal end and a female luer lock on its proximal end. A slide clamp is positioned over
1
the tubing to obstruct the fluid flow when needed by sliding the tubing into the narrow portion of the slide clamp.
The Intravenous Power Injector Extension Set is available in a configuration with and without a needle-free valve. The configuration with the valve allows access to the fluid delivery pathway without the use of a needle while maintaing a closed system for the fluid path. The valve is attached to the female luer lock.
The Intravenous Power Injector Extension Set is provided sterile for single use only. It is packaged with a commercially available skin protectant prep pad and a commercially available StatLock® stabilization device.
Intended Use
The Intravenous Power Injector Extension Set is intended to allow for the aspiration, injection or gravity/pump flow of fluids and may be used with low pressure power injectors having a maximum pressure setting of 325 psi and maximum flow rate of 10 ml/second. When used with a low pressure power injector, the Intravenous Power Injector Extension Set must be secured with other devices rated for pressures up to 325 psi with a luer lock connection.
Technological Characteristics and Comparison to Predicate Devices
The differences in technological characteristics (e.g., design specifications) between the subject and predicate devices do not raise new types of safety or effectiveness questions. Accepted scientific methods, such as performance (bench) testing, do exist for assessing the effect of the differences in characteristics.
Performance Data
The results of performance testing demonstrated that the functionality, integrity, and safety of the Intravenous Power Injector Extension Set are adequate for its intended use and supports a determination of substantial equivalence.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with outstretched arms, representing care and protection. To the left of the figure is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Scott Pease Senior Manager, Regulatory Affairs C.R. Bard, Incorporated Bard Medical Division 8195 Industrial Boulevard Covington, Georgia 30014
APR 2 1 2009
Re: K090134
Trade/Device Name: Intravenous Power Injector Extension Set Regulation Number: 21 CFR 880.5440 Regulatory Class: II Product Code: FPA Dated: April 3, 2009 Received: April 6, 2009
Dear Mr. Pease:
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 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.
3
Page 2- Mr. Pease
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0100. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Anthony D. Martin for
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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Indications for Use
510(k) Number (if known): K090134 (To be assigned by FDA)
Device Name: Intravenous Power Injector Extension Set
Indications for Use:
The Intravenous Power Injector Extension Set is intended to allow for the aspiration, injection or gravity/pump flow of fluids and may be used with low pressure power injectors having a maximum pressure setting of 325 psi and maximum flow rate of 10 ml/second. When used with a low pressure power injector, the Intravenous Power Injector Extension Set must be secured with other devices rated for pressures up to 325 psi with a luer lock connection.
Prescription Use: X (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)
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(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K090134
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