(79 days)
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No
The document describes a needle-free valve and administration sets for fluid delivery, with no mention of AI, ML, or related concepts. The focus is on mechanical function and pressure ratings.
No
The device is described as an administration set and valve for delivering fluids, medications, blood, and blood products, and does not claim to treat or cure any condition.
No
Explanation: The device is an administration set used for delivering fluids, medications, blood, and blood products, and allows for medication addition without a needle. It does not perform any diagnostic functions.
No
The device description clearly describes physical components (SmartSite Needle Free Valve, administration sets, extension sets) used for fluid delivery and medication administration, 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 "infusion systems for the delivery of fluids, medications, blood and blood products." This is a therapeutic or delivery function, not a diagnostic one.
- Device Description: The description reinforces its use for "IV administration of drugs and fluids" and adding these substances to the primary line.
- Lack of Diagnostic Language: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to facilitate the delivery of substances into the body.
N/A
Intended Use / Indications for Use
The SmartSite Needle Free Valve Administration Sets are intended for use in today's growing professional healthcare environment including healthcare facilities, home care, and medical transport that utilize infusion systems for the delivery of fluids, medications, blood and blood products. The SmartSite valve allows the user to add medication into the primary line without the use of a needle. The SmartSite valve may also be used with low pressure power injectors rated for a maximum setting of 325psi.
Product codes (comma separated list FDA assigned to the subject device)
FPA
Device Description
As originally submitted, the SmartSite Administration Sets (K960280) are intended to be used for IV administration of drugs and fluids, and the specific purpose for the SmartSite Valve is to allow the user to add drugs and fluids into the primary line without the use of a needle. This Traditional 510(k) Premarket Notification will add a new indication for the SmartSite Valve and qualified extension sets to allow use with low pressure devices up to 325psi. When used with a low pressure power injector, the SmartSite Valve must be secured to other devices with a luer lock connection and the other devices must also be rated for up to 325 psi. This new indication will require no changes to the current device design, materials, manufacturing processes, method of operation or basic scientific technology.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
professional healthcare environment including healthcare facilities, home care, and medical transport
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance data indicate that the Cardinal Health, Alaris Products SmartSite Sets with Additional Indication meets specified requirements and is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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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JUL 26 2006 SUMMARY OF SAFETY AND EFFECTIVENESS
Cardinal Health 303, Inc. DBA Cardinal Health, Alaris® Products
SmartSite Valve Sets with Additional Indication
SUBMITTER INFORMATION
| A. | Company Name: | Cardinal Health, Alaris® Products | |
|---|---|---|---|
| B. | Company Address: | 10221 Wateridge Circle | |
| San Diego, CA 92121-2733 | |||
| C. | Company Phone: | ||
| Company Fax: | (858) 458-7830 | ||
| (858) 458-6114 | |||
| D. | Contact Person: | Stacy L. Lewis | |
| Sr. Regulatory Affairs Specialist | |||
| E. | Date Summary Prepared: | May 5, 2006 | |
| ICE IDENTIFICATION | |||
| A. | Generic Device Name: | Administration Set | |
| B. | Trade/Proprietary Name: | SmartSite Needle Free Valve | |
| Administration Sets | |||
| C. | Classification: | Class II | |
| D. | Product Code: | FPA, Intravascular Administration Set |
DEVICE DESCRIPTION
DEVI
As originally submitted, the SmartSite Administration Sets (K960280) are intended to be used for IV administration of drugs and fluids, and the specific purpose for the SmartSite Valve is to allow the user to add drugs and fluids into the primary line without the use of a needle. This Traditional 510(k) Premarket Notification will add a new indication for the SmartSite Valve and qualified extension sets to allow use with low pressure devices up to 325psi. When used with a low pressure power injector, the SmartSite Valve must be secured to other devices with a luer lock connection and the other devices must also be rated for up to 325 psi. This new indication will require no changes to the current device design, materials, manufacturing processes, method of operation or basic scientific technology.
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SUMMARY OF SAFETY AND EFFECTIVENESS Cardinal Health, Alaris Products SmartSite Valve Sets with Additional Indication Page 2 of 2
SUBSTANTIAL EQUIVALENCE
The Cardinal Health, Alaris Products SmartSite Valve Sets with Additional Indication is of comparable type and is substantially equivalent to the following predicate device:
| Predicate Device | Manufacturer | 510(k) No. | Date Cleared |
|---|---|---|---|
| SmartSite Administration | |||
| Sets | Cardinal Health, Alaris | ||
| Products | K960280 | April 4, 1996 |
INTENDED USE
The intended use for the SmartSite Valve and sets is to allow IV fluid delivery of a wide range of fluids. The needle free valve allows the user to add medication into the primary line without the use of a needle. This new indication will allow the SmartSite Valve and qualified sets to also be used with low pressure power injectors for which the maximum pressure setting is 325 psi. When used with a power injector, the SmartSite Valve must be secured to other devices with a luer lock connection; other devices must also be rated for up to 325 psi.
TECHNOLOGICAL CHARACTERISTICS
A comparison of the technological characteristics of the Cardinal Health, Alaris Products SmartSite Valve Administration Sets with Additional Indication and the predicate devices has been performed. The results of this comparison demonstrate that the SmartSite Valve Sets with Additional Indication is equivalent to the marketed predicate device in technological characteristics.
PERFORMANCE DATA
The performance data indicate that the Cardinal Health, Alaris Products SmartSite Sets with Additional Indication meets specified requirements and is substantially equivalent to the predicate device.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 26 2006
Ms. Stacy L. Lewis Sr. Regulatory Affairs Specialist Cardinal Health, Alaris® Products 10221 Wateridge Circle San Diego, California 92121-2733
Re: K061285
Trade/Device Name: SmartSite Needle Free Valve Administration Sets Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: May 6, 2006 Reccived: May 8, 2006
Dear Ms. Lewis:
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 Mcdical 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. Lewis
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrlv/industry/support/index.html.
Sincerely yours.
Chris Van Pelt
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
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INDICATIONS FOR USE
510(k) Number:
K061285 (To Be Assigned By FDA)
Device Trade Name:
SmartSite Needle Free Valve Administration Sets
Indications For Use:
The SmartSite Needle Free Valve Administration Sets are intended for use in today's growing professional healthcare environment including healthcare facilities, home care, and medical transport that utilize infusion systems for the delivery of fluids, medications, blood and blood products. The SmartSite valve allows the user to add medication into the primary line without the use of a needle. The SmartSite valve may also be used with low pressure power injectors rated for a maximum setting of 325psi.
Prescription Use OR X (Per 21 CFR 801.109)
Over-The-Counter Use
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Cintron L.h