← Product Code [FMG](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMG) · K071400

# SMARTSITE STOPCOCK (K071400)

_Cardinal Health, Alaris Products · FMG · Dec 14, 2007 · General Hospital · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMG/K071400

## Device Facts

- **Applicant:** Cardinal Health, Alaris Products
- **Product Code:** [FMG](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMG.md)
- **Decision Date:** Dec 14, 2007
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 880.5440
- **Device Class:** Class 2
- **Review Panel:** General Hospital

## Indications for Use

The SmartSite® Stopcock is indicated for fluid flow, directional control and for providing access port(s) for administration of solutions and blood products. Typical uses include pressure monitoring, intravenous fluid administration and transfusion. The SmartSite® valve port allows the user to access the primary line without the use of a needle.

## Device Story

Single-use 4-way stopcock; features integrated SmartSite needle-free valve on side port. Device acts as accessory to IV administration sets; regulates directional flow to patient vascular system; provides access for solution/blood product administration. Needle-free valve seals upon removal; eliminates need for re-capping. Used in clinical settings by healthcare providers for pressure monitoring, IV therapy, and transfusions. Provides closed access to primary line; reduces needle-stick risk; maintains system integrity.

## Clinical Evidence

Bench testing only. No clinical data provided.

## Technological Characteristics

Single-use 4-way stopcock with integrated needle-free valve. Materials and design are equivalent to predicate stopcocks. Mechanical flow control via handle; needle-free valve provides closed access. Non-powered, manual device.

## Regulatory 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

- Elcam Closed Swabbable Stopcock ([K060231](/device/K060231.md))
- SmartSite® Needle Free Valve ([K960280](/device/K960280.md))

## Submission Summary (Full Text)

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ORIGINAL PR

# SUMMARY OF SAFETY AND EFFECTIVENESS Cardinal Health, Alaris® Products® SMARTSITE® STOPCOCK

DEC 1 4 2007

#### 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: | (858) 617-5889<br>(858) 617-5960                                                               |
| D. | Contact Person:                | Stacy L. Lewis<br>Principal Regulatory Affairs Specialist<br>Cardinal Health, Alaris® Products |
| E. | Date Summary Prepared:         | December 12, 2007                                                                              |

#### DEVICE IDENTIFICATION

| A. | Generic Device Name:    | Stopcock                            |
|----|-------------------------|-------------------------------------|
| B. | Trade/Proprietary Name: | SmartSite® Stopcock                 |
| C. | Classification:         | Class II                            |
| D. | Product Code:           | FMG, Stopcock, IV Administration Se |

## DEVICE DESCRIPTION

The SmartSite® Stopcock is a single use 4-way stopcock with an integrated SmartSite® needle free valve on the side port. Arrows on the handle point to the direction of flow. The side port consists of a SmartSite® needle free valve that provides closed, needle-free access that seals upon removal and does not require re-capping between uses.

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## SUMMARY OF SAFETY AND EFFECTIVENESS Cardinal Health, Alaris® Products SMARTSITE® STOPCOCK Page 2 of 3

#### DEVICE DESCRIPTION (Continued)

The SmartSite® Stopcock share similar characteristics and will operate the same as currently marketed stopcocks, as an accessory to an IV administration set that regulates the directional flow to a patient's vascular system and provides an access port(s) for the administration of solutions.

#### SUBSTANTIAL EQUIVALENCE

The Cardinal Health, Alaris® Products SmartSite® Stopcock is of comparable type and is substantially equivalent to the following predicate devices:

| Predicate Device                   | Manufacturer                        | 510(k) No. | Date Cleared |
|------------------------------------|-------------------------------------|------------|--------------|
| Elcam Closed Swabbable<br>Stopcock | Elcam Medical                       | K060231    | 04/13/06     |
| SmartSite® Needle Free Valve       | Cardinal Health, Alaris<br>Products | K960280    | 04/04/96     |

#### INTENDED USE

The SmartSite® Stopcock is indicated for fluid flow, directional control and for providing access port(s) for administration of solutions and blood products. Typical uses include pressure monitoring, intravenous fluid administration and transfusion. The SmartSite® valve port allows the user to access the primary line without the use of a needle.

#### TECHNOLOGICAL CHARACTERISTICS

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

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## SUMMARY OF SAFETY AND EFFECTIVENESS Cardinal Health, Alaris® Products SMARTSITE® STOPCOCK Page 3 of 3

### PERFORMANCE DATA

The performance data indicate that the SmartSite® Stopcock meets specified requirements and is substantially equivalent to the predicate devices.

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Image /page/3/Picture/1 description: The image contains the text "Public Health Service". The text is in a simple, sans-serif font and is horizontally aligned. The text is black and the background is white.

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DEC 1 4 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Stacy L. Lewis Principal Regulatory Affairs Specialist Cardinal Health, Alaris Products 10020 Pacific Mesa Boulevard San Diego, California 92121-2772

Re: K071400

Trade/Device Name: SmartSite® StopCock Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FMG Dated: November 27, 2007 Received: November 28, 2007

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 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.

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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 (OS) 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) 276-00115. 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 tollfree number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Anthon D.mister for
Shirin, 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

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## ATTACHMENT A

## INDICATIONS FOR USE

510(k) Number: K071400

SmartSite® Stopcock Device Trade Name:

#### Indications For Use:

The SmartSite® Stopcock is indicated for fluid flow, directional control and for providing access port(s) for administration of solutions and blood products. Typical uses include pressure monitoring, intravenous fluid administration and transfusion. The SmartSite® valve port allows the user to access the primary line without the use of a needle.

Prescription Use X (Per 21 CFR 801.109)

Over-The-Counter Use

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

OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Cenir Homan

To

1471444

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