ALARIS SAFETY MALE LUER

K053049 · Cardinal Health, Alaris Products · FPA · Jan 12, 2006 · General Hospital

Device Facts

• Record ID: K053049
• Device Name: ALARIS SAFETY MALE LUER
• Applicant: Cardinal Health, Alaris Products
• Product Code: FPA · General Hospital
• Decision Date: Jan 12, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

The Safety Male Luer is intended to provide leak-free handling of potentially hazardous fluids, such as chemotherapy, radioactive isotopes, and blood products, during all three phases of drug handling when the SML is used in conjunction with the SmartSite® Needle Free Valve port: the preparation of the drug, the administration of the drug to the patient, and waste handling.. The Safety Male Luer is intended to reduce environmental surface contamination of the work area.

Device Story

Passive, sealed male luer connector; prevents fluid dripping/spillage during disconnection. Used for handling hazardous/non-hazardous fluids (chemotherapy, isotopes, blood). Operates by internal mechanism that automatically seals upon disconnection from SmartSite® Needle Free Valve or standard female luer. Used by clinicians in clinical settings during drug preparation, administration, and waste disposal. Reduces environmental surface contamination; improves safety for healthcare workers handling hazardous drugs.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Passive male luer connector; internal sealing mechanism; no external cap required for sealing. Compatible with SmartSite® Needle Free Valve and standard female luers. Includes optional female transport cap and priming cap.

Indications for Use

Indicated for the reconstitution, transfer, administration, and disposal of hazardous (chemotherapy, radioactive isotopes, blood products) and non-hazardous fluids. Intended for use with SmartSite® Needle Free Valve ports or standard open female luers.

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

• PhaSeal System (K972527)
• CML 1000 (K051437)

Submission Summary (Full Text)

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K053049

ORIGINAL PREMARKET 510

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

## SAFETY MALE LUER

# JAN 1 2 2006

## 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: | October 25, 2005 |

## DEVICE IDENTIFICATION

| A. | Generic Device Name: | Intravascular Administration Set |
|----|-------------------------|---------------------------------------|
| B. | Trade/Proprietary Name: | Alaris® Safety Male Luer |
| C. | Classification: | Class II |
| D. | Product Code: | FPA, Intravascular Administration Set |

# DEVICE DESCRIPTION

The SML is a sealed male luer. The SML is designed to promote safe handling of fluids and medications, particularly hazardous or cytotoxic drugs. Leakage of drug into the environments is effectively avoided during all phases of drug handling when the SML is used in conjunction with the SmartSite® Needle Free Valve port: the preparation of the drug, the administration of the drug to the patient, and waste handling.

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

# DEVICE DESCRIPTION (Continued)

The SML is a passive device – it requires no cap and automatically seals upon disconnection. An optional female cap will be provided for transport and an optional priming cap will be provided to allow the user to prime as necessary.

The Safety Male Luer (SML) is a unique male luer connector that is intended to be used with the currently marketed SmartSite® Needle Free Valve port and standard open female luers. The SML design includes an internal mechanism that causes the luer to seal when disconnected. In doing so, it prevents the dripping or accidental spillage of fluids that otherwise occur when using a standard, unsealed male luer. Thus, the SML is intended to provide leak-free handling of potentially hazardous fluids, such as chemotherapy, radioactive isotopes, and blood products. Furthermore, the SML reduces environmental surface contamination of the work surface when used to reconstitute, dispense/transfer, administer, and dispose of hazardous or non-hazardous fluids when used in conjunction with SmarSite® Needle-Free Valve port.

## SUBSTANTIAL EQUIVALENCE

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

| Predicate Device | Manufacturer | 510(k) No. | Date Cleared |
|------------------|-------------------|------------|--------------|
| PhaSeal System | Carmel Pharma AB | K972527 | 9/18/97 |
| CML 1000 | ICU Medical, Inc. | K051437 | 8/3/05 |

### INTENDED USE

The Safety Male Luer is intended to provide leak-free handling of potentially hazardous fluids, such as chemotherapy, radioactive isotopes, and blood products, during all three phases of drug handling when the SML is used in conjunction with the SmartSite®

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KOS-304-9

ORIGINAL PREMARK

## SUMMARY OF SAFETY AND EFFECTIVENESS Cardinal Health, Alaris® Products SAFETY MALE LUER Page 3 of 3

## INTENDED USE (Continued)

Needle Free Valve port: the preparation of the drug, the administration of the drug to the patient, and waste handling.. The Safety Male Luer is intended to reduce environmental surface contamination of the work area.

# TECHNOLOGICAL CHARACTERISTICS

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

## PERFORMANCE DATA

The performance data indicate that the Alaris® Safety Male Luer meets specified requirements and is substantially equivalent to the predicate devices.

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#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JAN 1 2 2006

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

Re: K053049

Trade/Device Name: Alaris® Safety Male Luer Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: October 25, 2005 Received: October 28, 2005

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 cnactment 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. Fxisting 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 vou 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,

Chiu Lin, 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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# INDICATIONS FOR USE

510(k) Number:

K053049 (To Be Assigned By FDA)

Device Trade Name:

## Indications For Use:

The Safety Male Luer is indicated for use when reconstituting, dispensing/ transferring, administering, and disposal of potentially hazardous fluids, such as chemotherapy, radioactive isotopes, and blood products, as well as non-hazardous fluids. The Safety Male Luer is intended for use with the SmartSite® Needle Free Valve port or standard open female luers.

Prescription Use X (Per 21 CFR 801.109)

Over-The-Counter Use

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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