UNIVERSAL VIAL ACCESS SPIKE

K080989 · Icu Medical, Inc. · FMF · May 2, 2008 · General Hospital

Device Facts

• Record ID: K080989
• Device Name: UNIVERSAL VIAL ACCESS SPIKE
• Applicant: Icu Medical, Inc.
• Product Code: FMF · General Hospital
• Decision Date: May 2, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5860
• Device Class: Class 2

Intended Use

Accessory to a piston syringe for needleless access to sterile drug vials without the use of needles.

Device Story

Universal Vial Access Device is a single-use, needleless drug container access disposable. Device integrates a vial access spike with a proprietary Clave needleless access port and an adjustable clip to accommodate various drug vial sizes. Includes a 0.2um hydrophobic filter to prevent airborne contamination. Operated by clinicians in clinical settings to facilitate medication withdrawal from vials into piston syringes without needles. Provides a closed, needleless interface for fluid transfer, reducing needle-stick risks and maintaining sterility during drug preparation.

Clinical Evidence

Bench testing only. Device conforms to published international standards and FDA-recognized guidelines. Sterility Assurance Level (SAL) validated to 10^-6. Manufacturing complies with cGMPs.

Technological Characteristics

Single-use, needleless vial access spike with integrated Clave port and adjustable clip. Features 0.2um hydrophobic filter for airborne contaminant exclusion. Materials and performance validated against international standards. Non-powered, mechanical device.

Indications for Use

Indicated for use as an accessory to a piston syringe to provide needleless access to sterile drug vials.

Regulatory Classification

Identification

A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.

Predicate Devices

• One Time Vial Access (K934561)
• Clave Vial Access Spike (K934591)

Submission Summary (Full Text)

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ICU MEDICAL INC. 4455 Atherton Drive Salt Lake City, Utah (801) 264 - 1332, Phone (801) 264 - 1755, Fax Tracy S. Best, Sr. Regulatory Affairs Specialist Preparation Date: April 04, 2008

K080989

ICU Medical, Inc.

MAY - 2 2008

# SPECIAL 510(K) Summary of Safety and Effectiveness for the:

| Trade Name: | Universal Vial Access Device |
|----------------------|------------------------------------------------------------|
| Common Name: | Accessory to Piston Syringe, Needleless |
| Classification Name: | Piston Syringe, Accessory 21 CFR 880.5860, Class II Device |
| Product Code: | FMF |

## Legally Marketed Predicate Devices for Substantial Equivalence:

*K934561 - One Time Vial Access - ICU Medical, Inc. *K934591 - Clave Vial Access Spike -- ICU Medical, Inc.

## Rationale for SE:

These combo device is the vial access spike and the proprietary Clave® needleless access device. This device integrates the spike portion and the Clave with an improved clip that can adapt to all sizes of drug vials. A hydrophobic filter ensures airborne contaminates larger than 0.2um. There are no functional differences between any of the predicate devices or the proposed devices in terms of use.

## Description of Submitted Device:

The ICU Medical Universal Vial Access Device is a single use - universally adaptable and needleless drug container access disposable. The proprietary technology of the Clave enables the device to have a needleless port for withdrawal of medications or other IV fluids as directed by the physician.

## Intended Use:

Accessory to a piston syringe for needleless access to sterile drug vials without the use of needles.

#### Safety and Performance:

ICU Medical Universal Vial Access Device conform to the requirements of published international standards as well as those FDA recognized standards and/or published guidelines prior to marketing the device. Additionally, ICU Medical's Sterility Assurance Level, (SAL) has an established and validated history of meeting the 10% level. These devices are be packaged in a way as to ensure conformity with that SAL level. The manufacturing of these devices will be assembled in a quality environment that is certified independently and complies with cGMPs.

#### Conclusion:

The matcrials, performance, and operational features of both the submitted device and the predicate devices are substantially equivalent and safe and effective for their intended use.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Tracy Best Senior Regulatory Affairs Specialist ICU Medical, Incorporated 4455 Atherton Drive Salt Lake City, Utah 84123

Re: K080989

Trade/Device Name: ICU Medical Universal Vial Access Device Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: April 4, 2008 Received: April 7, 2008

Dear Ms. Best:

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.

MAY - 2 2008

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. Best

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Clus

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 (if known):

K080989

Device Name:

ICU Medical Universal Vial Access Device

Indications for Use:

Accessory to a piston syringe for needleless access to sterile drug vials without the use of needles.

Prescription Use _ XX (Part 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)

Jas all fin AD

(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital Division Control, Dental Devices

510(k) Number: K080989