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.

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.

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.

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.

AI/ML Overview

The provided text describes the regulatory submission for the Alaris® Safety Male Luer (SML), focusing on its substantial equivalence to predicate devices rather than detailing specific performance studies with acceptance criteria and their results. The document is a "SUMMARY OF SAFETY AND EFFECTIVENESS" for a 510(k) premarket notification.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or detailed reported device performance in a table format. It broadly claims:

"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 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..."
"Furthermore, the SML reduces environmental surface contamination of the work surface..."
"The performance data indicate that the Alaris® Safety Male Luer meets specified requirements and is substantially equivalent to the predicate devices."

These are statements of intended function and general conclusions, not specific, measurable acceptance criteria with corresponding performance data. The FDA letter confirms the device is "substantially equivalent" which often relies on demonstrating that the new device performs at least as well as a legally marketed predicate, rather than meeting novel, pre-defined quantitative acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance

The document does not mention a specific "test set" in terms of patient data or clinical trials for device performance. The "performance data" mentioned is not described in detail. Given the nature of a 510(k) for a passive medical device, the "test set" likely consisted of in-vitro bench testing, rather than human subject data.

There is no information regarding:

Sample size for any test set.
Data provenance (country of origin, retrospective/prospective).

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the document. For a passive mechanical device like a luer connector, "ground truth" would typically refer to objective measurements of leakage, sealing force, compatibility, etc., rather than expert consensus on clinical findings.

4. Adjudication Method for the Test Set

This information is not provided.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

No MRMC study is mentioned. This type of study is typically relevant for interpretative devices (e.g., imaging devices analyzed by multiple clinicians), not for a passive mechanical connector.

6. Standalone Performance Study (Algorithm Only)

This concept is not applicable. The Alaris® Safety Male Luer is a physical medical device, not an algorithm.

7. Type of Ground Truth Used

The document implies the ground truth for performance was established through objective measurements and testing demonstrating the device's ability to prevent leakage and reduce spillage, thereby showing it "meets specified requirements." This would primarily involve:

Mechanical testing (e.g., force to connect/disconnect, burst pressure, sealing integrity).
Fluid leakage tests.
Compatibility testing with specified predicate devices (SmartSite® Needle Free Valve port and standard open female luers).

It's likely based on bench testing and engineering validation rather than pathology, outcomes data, or expert consensus in a clinical setting.

8. Sample Size for the Training Set

This information is not provided and is not directly relevant for a physical medical device. "Training set" usually refers to data used to train an algorithm or AI model. For a mechanical device, iterative design and testing might occur, but it's not typically framed as a "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable as there is no "training set" in the AI sense. Design validation and verification for a mechanical device involve testing prototypes against design specifications and relevant standards.

Summary

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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 CircleSan Diego, CA 92121-2733
C.	Company Phone:Company Fax:	(858) 458-7830(858) 458-6114
D.	Contact Person:	Stacy L. LewisSr. Regulatory Affairs SpecialistCardinal 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

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

DEVICE DESCRIPTION (Continued)

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

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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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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized eagle or bird in flight, with three curved lines representing the wings and a human profile in the negative space.

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 (240) 276-0120. 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 (301) 443-6597 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:

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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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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.