SMARTSITE VENTED VIAL ACCESS DEVICE, MODEL TBD

K052790 · Cardinal Health, Alaris Products · LHI · Dec 23, 2005 · General Hospital

Device Facts

• Record ID: K052790
• Device Name: SMARTSITE VENTED VIAL ACCESS DEVICE, MODEL TBD
• Applicant: Cardinal Health, Alaris Products
• Product Code: LHI · General Hospital
• Decision Date: Dec 23, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

The SmartSite® Vented Vial Access Device is intended for use by healthcare professionals in a wide variety of healthcare environments including hospitals, healthcare facilities, and pharmacics when reconstituting lyophilized drugs and/or dispensing of medication, particularly hazardous drugs such as chemotherapeutics.

Device Story

SmartSite® Vented Vial Access Device is a single-use, needle-free, vented vial access device. It incorporates a SmartSite® needle-free valve and a 0.2-micron hydrophobic air-venting filter. Designed for use with rubber-stopper vials, it facilitates the safe reconstitution and dispensing of lyophilized drugs and hazardous medications, such as chemotherapeutics. Operated by healthcare professionals in clinical settings, the device allows for closed-system-like access to medication vials, reducing exposure risks during drug preparation. The device functions as a mechanical interface between the vial and the delivery system, ensuring sterile air exchange via the hydrophobic filter while preventing fluid leakage. It provides a standardized, needle-free connection point for drug transfer, enhancing safety for clinicians handling hazardous substances.

Clinical Evidence

Bench testing only.

Technological Characteristics

Single-use, needle-free vial access device. Features a SmartSite® needle-free valve and a 0.2-micron hydrophobic air-venting filter. Designed for rubber-stopper vial compatibility. Mechanical device; no energy source or software components.

Indications for Use

Indicated for healthcare professionals in hospitals, healthcare facilities, and pharmacies for the reconstitution or dispensing of medications, including chemotherapy agents, using rubber-stopper medication vials.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Chemo Dispensing Pin (K983794)
• SmartSite® Access Pin (K970485)

Submission Summary (Full Text)

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K052790
CARDINAL HEALTH, ALARIS PRODUCTS

# DEC 2 3 2005 SUMMARY OF SAFETY AND EFFECTIVENESS Cardinal Health, Alaris Products® VENTED VIAL ACCESS DEVICE

### SUBMITTER INFORMATION

| A. | Company Name: | Cardinal Health, Alaris Products |
|----|--------------------------------|-----------------------------------------------------------------------------------------|
| B. | Company Address: | 10221 Wateridge Circle<br>San Diego, CA 92121-2733 |
| C. | Company Phone:<br>Company Fax: | [phone]<br>[phone] |
| D. | Contact Person: | Stacy L. Lewis<br>Sr. Regulatory Affairs Specialist<br>Cardinal Health, Alaris Products |
| E. | Date Summary Prepared: | September 30, 2005 |

#### DEVICE IDENTIFICATION

| A. | Generic Device Name: | IV Fluid Transfer Pin |
|----|-------------------------|--------------------------------------|
| B. | Trade/Proprietary Name: | SmartSite® Vented Vial Access Device |
| C. | Classification: | Class II |
| D. | Product Code: | LHI |

#### DEVICE DESCRIPTION

The SmartSite® Vented Vial Access Device (Vented VAD) is a stand-alone, single use, multiple-dose device with a SmartSite® Needle Free Valve and a 0.2 micron hydrophobic air-venting filter for use with rubber-stopper vials. The device is intended for use when reconstituting Ivophilized drugs and/or when dispensing medications, particularly hazardous drugs such as chemotherapeuties.

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CARDINAL HEALTH, ALARIS PRODUCT

Kosaэro

ORIGINAI

## SUMMARY OF SAFETY AND EFFECTIVENESS Cardinal Health, Alaris Products® SmartSite® Vented Vial Access Device Page 2 of 2

## SUBSTANTIAL EQUIVALENCE

The SmartSite® Vented Vial Access Device is of comparable type and is substantially

equivalent to the following predicate devices:

| Predicate Device | Manufacturer | 510(k) No. | Date Cleared |
|-----------------------|--------------------------------------|------------|--------------|
| Chemo Dispensing Pin | B. Braun | K983794 | 3/23/99 |
| SmartSite® Access Pin | Cardinal Health, Alaris<br>Products* | K970485 | 4/21/97 |

* Originally submitted by IVAC Holdings. Cardinal Health, Alaris Products was previously known as Alaris Medical Systems, which was the result of the merger of IVAC and IMEI) Corporation.

#### INTENDED USE

The SmartSite® Vented Vial Access Device is intended for use by healthcare professionals in a wide variety of healthcare environments including hospitals, healthcare facilities, and pharmacics when reconstituting lyophilized drugs and/or dispensing of medication, particularly hazardous drugs such as chemotherapeutics.

### TECHNOLOGICAL CHARACTERISTICS

A comparison of the technological characteristics of the SmartSite® Vented Vial Access Device and the predicate devices has been performed. The results of this comparison demonstrate that the SmartSite® Vented Vial Access Device is equivalent to the marketed predicate devices in technological characteristics.

#### PERFORMANCE DATA

The performance data indicate that the SmartSite® Vented Vial Access Device meets specified requirements and is substantially equivalent to the predicate devices.

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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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.

Public Health Service

DEC 2 3 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Stacy L. Lewis Senior Regulatory Affairs Specialist Cardinal Health, Alaris® Products 10221 Wateridge Circle San Diego, California 92121-2772

Re: K052790

K032790
Trade/Device Name: SmartSite Vented Vial Access Device, Model TBD Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: LHI Dated: September 30, 2005 Received: October 3, 2005

Dear Ms. Lewis:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection 910(4) the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in indications for use stated in the enclosers, to engage of the Medical Device interstate commerce prior to that have been reclassified in accordance with the provisions of Amendments, on to devices that have occi results to not require approval of a premarket the Federal Pood, Drug, and Oosmette , to ecefore, market the device, subject to the general approval appreation (1 Mr.). Four general controls provisions of the Act include controls provisions of the Act. "The genting 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 If your device is classified (see above) into enontrols. Existing major regulations afflecting a (PMA), it may be subject to such additions, Title 21, Parts 800 to 898. In your device can be found in the Sous of Internants 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 Please be advised that PDA s issualled of a backanting with other requirements
mean that FDA has made a determination that your device for lieferal executes mean that FDA has made a decemmanon that your ministered by other Federal agencies.
of the Act or any Federal statutes and regulations administered by segistration of the Act or any rederal statutes and reguirements, including, but not limited to: registration
You must comply with all the Act's requirements and securing programs and You must colliply with an the Act 3 requirements (21 CFR Part 801); good manufacturing practices
and listing (21 CFR Part 807); labeling (21 CFR Part 801); CFR Part 800); and and listing (21 CFR Part 607), laceling (21 cm (QS) regulation (21 CFR Part 820); and if requirements as set form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your decise to a This letter will anow you to begin mailering your device of your device to a premarket notification. The PDA miding of substants of 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), if you desire specific advice for your device on and the Also, please note the regulation please contact the Office of Comphanes at (210) - 10 - 10 - 10 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 entitled, "Misoranding by reference to premained on your responsibilities under that the may obtain other general miormation on your respectiver Assistance at its toll-free DIVIsion of Sman Manufactors [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Syrita y. Mcclain Oatts

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

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## INDICATIONS FOR USE

510(k) Number:

(To Be Assigned By FDA)

Device Trade Name:

## Indications For Use:

The SmartSite® Vented Vial Access Device is intended for use by healthcarc professionals in a wide variety of healthcare environments including hospitals, healthcare facilities, and pharmacies for reconstitution or dispensing of medication. The SmartSite® Vented Vial Access Device is indicated for use with rubber-stopper medication vials for reconstitution or dispensing of medications, including chemotherapy agents.

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ OR Prescription Use X (Per 21 CFR 801.109)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sohal Ahr for ADw 12/23/05

K052790