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.

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.

AI/ML Overview

The provided document is a 510(k) summary for the Cardinal Health, Alaris® Products SmartSite Valve Sets with Additional Indication. It is a submission for a medical device and describes its intended use and performance data. However, it does not include the detailed information requested regarding specific acceptance criteria, study design elements (sample sizes, expert qualifications, adjudication methods), or detailed performance metrics.

Based on the provided text, here’s a summary of what can be extracted and an explanation of why other requested information is not available:

Acceptance Criteria and Reported Device Performance

The document states: "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."

However, the document does not provide a table of acceptance criteria or specific reported device performance metrics. It focuses on demonstrating substantial equivalence to a predicate device (SmartSite Administration Sets, K960280) for a new indication (use with low-pressure power injectors up to 325 psi). The "specified requirements" are implied to be related to safety and functionality under the new indication, but the specific values or thresholds are not detailed.

Limitations in the Provided Document for Detailed Study Information

The document is a "Summary of Safety and Effectiveness" which often provides a high-level overview. It specifically mentions "Performance Data" but does not elaborate on the details of the studies conducted. Therefore, the following information is not present in the provided text:

Sample sizes used for the test set and the data provenance: Not mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
Adjudication method for the test set: Not mentioned.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is an administration set, not an AI-powered diagnostic or assistive tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as it's a physical medical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned, but for a physical device, ground truth would likely refer to engineering specifications, stress testing results, and biological compatibility, rather than clinical diagnostic "ground truth."
The sample size for the training set: Not applicable, as this is a physical device and not an AI/algorithm-based product that undergoes "training."
How the ground truth for the training set was established: Not applicable.

Summary of What is Available:

Device Name: SmartSite Needle Free Valve Administration Sets
New Indication: Allows use with low pressure power injectors for which the maximum pressure setting is 325 psi.
Predicate Device: SmartSite Administration Sets (K960280)
Basis for Approval: Substantial equivalence to the predicate device and performance data indicating it "meets specified requirements."
Nature of Study: While not explicitly detailed, the "Performance Data" section implies that tests were conducted to ensure the device's compatibility and safety under the new 325 psi pressure indication. These would typically be engineering and material science tests.

Summary

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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 CircleSan Diego, CA 92121-2733
C.	Company Phone:Company Fax:	(858) 458-7830(858) 458-6114
D.	Contact Person:	Stacy L. LewisSr. 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 ValveAdministration Sets
C.	Classification:	Class II
D.	Product Code:	FPA, Intravascular Administration Set

DEVICE DESCRIPTION

DEVI

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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 AdministrationSets	Cardinal Health, AlarisProducts	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:

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<

nesiology, General Hospr.

K66225

00024

Regulation Number and Section

§ 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.