The Q-Flo™ Closed Male Luer Connector is intended for use by healthcare professionals for connection with standard open female luers 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.

Device Description

The Q-Flo™ Closed Male Luer Connector is a sterile, non-pyrogenic, and single-use luer device. It enables clinical personnel to handle fluids, including hazardous materials such as chemotherapy, radioactive isotopes, and blood products when used in conjunction with a compatible female luer connector. This includes the preparation and administration of fluids to the patient and waste handling. This provides access for the administration of fluids from a container to a patient's vascular system through an administration needle or catheter which is inserted into an artery or vein.

The Q-Flo™ CML connector uses a sequential locking mechanism with a colored visual indicator to provide the user with confirmation of the status of the connection. There are three (3) connection states possible. When the device is not connected to a female luer it is closed and drip-less. When the device is connected to a female luer but the connection is deactivated, the visual indicator is not present and no flow is permitted. Continuing to turn the device and female luer connection together actuates the connection and opens the system to permit flow.

The Q-Flo™ CML connector utilizes the engagement of the luer threads to open the fluid path and, with the silicone sealing member, to provide a leak free state. The action of the thread engagement moves the male luer connector forward and visible to the used thus giving visual confirmation of full connection.

The Q-Flo™ CML connector has been designed with a weight and size to be consistent with IV administration set connections. It weighs less than 2.5 grams and is 12.8 mm in diameter.

AI/ML Overview

The provided document describes the Q-Flo™ Closed Male Luer Connector and its nonclinical testing. This device is a medical apparatus and not an AI/ML device, therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set size, and ground truth for training set) are not applicable to the information provided.

However, based on the nonclinical tests conducted, here's a summary of the acceptance criteria and the device's performance:

1. Table of Acceptance Criteria and Reported Device Performance

Characteristic	Standard/Test Method	Acceptance Criteria	Device Performance
Biocompatibility	ISO 10993-1	Met standard requirements	Passed
Dimensional and Performance	ISO 594-2	Met standard requirements	Passed
Dimensional and Performance	ISO 8536-4	Met standard requirements	Passed
Sterility Assurance	ISO 11137-2	Met standard requirements	Passed

2. Sample size used for the test set and the data provenance:

Sample Size: Not explicitly stated in the provided text. The document indicates "Risk analyses were conduct for the Q-Flo™ Closed Male Luer Connector and design verification and validation tests were based on the results of those analyses." This implies multiple units were tested to ensure compliance with the standards, but the exact number is not given.
Data Provenance: Not specified. It's internal testing conducted by the manufacturer, Infusion Innovations, Inc. The document is for a 510(k) submission to the FDA (USA).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable as this is not an AI/ML device requiring expert ground truth for classification or diagnosis. The ground truth here is adherence to established international standards for medical devices.

4. Adjudication method for the test set:

Not applicable. The testing involves standardized laboratory methods against established technical criteria, not human adjudication of results.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is a physical medical device, not an AI/ML system, so MRMC studies are not relevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a physical medical device, not an AI/ML system. The device's performance is inherently "standalone" in that its physical properties and functionality are tested directly.

7. The type of ground truth used:

The ground truth for this device is based on established international standards for medical devices (ISO 10993-1, ISO 594-2, ISO 8536-4, ISO 11137-2). Compliance with these standards indicates the device meets safety and performance requirements.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not an AI/ML system requiring a training set.

9. How the ground truth for the training set was established:

Not applicable. This is a physical medical device, not an AI/ML system.

Summary

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Page 110 of 162

K121554

JUN - 8*2012

510(k) Summary Infusion Innovations, Inc. Q-Flo™ Closed Male Luer Connector

Submitter Information

Company Name:	Infusion Innovations, Inc.
Company Address:	7514 Girard AvenueLa Jolla CA 92037
	(858) 456-6116
	(858) 777-3375 (fax)
Contact Person:	Babak Nemati, Ph.D.President, CEOInfusion Innovations
Date of Summary:	April 12, 2011

Device Identification

Generic Device Name:	Closed Male Luer Connector
----------------------	----------------------------

Trade/Proprietary Name:	Q-Flo™ Closed Male Luer Connector
Classification:	Class II
Product Code:	FPAIntravascular Administration Set21 CFR 880.5440

Predicate Device

The Q-Flo™ Closed Male Luer Connector is of a comparable type and is substantially equivalent to the following predicate devices.

Alaris Safety Male Luer	Spiros Closed Male Luer
Cardinal Health, Alaris Products	ICU Medical, Inc.
K053049	K070532
Cleared: January 12, 2006	Cleared: March 20. 2007

Device Description

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access for the administration of fluids from a container to a patient's vascular system through an administration needle or catheter which is inserted into an artery or vein.

The Q-Flo™ CML connector has been designed with a weight and size to be consistent with IV administration set connections. It weighs less than 2.5 grams and is 12.8 mm in diameter.

There are no questions regarding the new product safety and effectiveness that are raised due to the Q-Flo™ CML connector design.

Intended Use

The Q-Flo™ Closed Male Luer Connector is intended for use by healthcare professionals for connection with standard open female luers when reconstituting, dispensing/transferring, and disposal of potentially hazardous fluids, such as chemotherapy, radioactive isotopes, and blood products, as well as non-hazardous fluids.

Technical Characteristics and Substantial Equivalence

	Q-Flo Closed MaleLuer Connector	Alaris Safety Male Luer	Spiros Closed Male Luer
Functional Use	Needleless connector	Needleless connector	Needleless connector
Engagement States	DisconnectedLuer connected/No flowLuer engages femaleconnector and allowsflow	DisconnectedLuer engages femaleconnector and allowsflow	DisconnectedLuer engages femaleconnector and allowsflow
Residual Volume	0.02 mL	0.03 mL	0.06 mL
Gravity Fluid Flow @ 1meter height	193 mL/min	97 mL/min	195 mL/min
Syringe Disconnect:Fluid Displacement	Less than 0.05 mL	Not stated	0.01 - 0.03 mL
Multiple Activations	25 activations or 72hours (whichever occursfirst)	50 activations or 72hours (whichever occursfirst)	10 activations
Luer Retention	ISO 594-2(5.4)	ISO 594-2(5.4)	ISO 594-2 (5.4)
ChemicalCompatibility	Lipid & alcohol basedfluids	Not stated	Lipid & alcohol basedfluids
Sterilization Method	Radiation	Radiation	Radiation
Packaging	Peel pouch	Peel pouch or packagedwith other IV setcomponents	Peel pouch or packagedwith other IV setcomponents

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Materials
Female luer	Polycarbonate	-Polycarbonate	Polycarbonate
Male luer	Polycarbonate	-Polycarbonate	Polycarbonate
External Housing	Copolyester	-Polycarbonate	Polycarbonate
Inner housing or backing	Polycarbonate	-Polypropylene(actuator)	Polycarbonate (poppet)
Sealing surface	Silicone	-Silicone	Silicone

Technological Characteristics

The technological characteristics of the Q-Flo™ Closed Male Luer Connector and the predicate devices were compared. This demonstrated that the Q-Flo™ Closed Male Luer Connector is substantially equivalent to those predicate devices.

Discussion of Nonclinical Tests

Risk analyses were conduct for the Q-Flo™ Closed Male Luer Connector and design verification and validation tests were based on the results of those analyses. All test results meet the acceptance criteria and support that the device is appropriately designed for its intended use. This testing confirmed the physical attributes and device performance meet requirements of the standards listed below.

Characteristic	Standard/Test Method	Device Performance
Biocompatibility	ISO 10993-1	Passed
Dimensional and Performance	ISO 594-2	Passed
Dimensional and Performance	ISO 8536-4	Passed
Sterility Assurance	ISO 11137-2	Passed

Conclusion

The Q-Flo™ Closed Male Luer Connector device meets the functional claims and intended use as described in the product labeling. The safety and effectiveness are substantially equivalent to the predicate devices Alaris Safety Male Luer and Spiros Closed Male Luer.

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Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is a stylized eagle with its wings spread, symbolizing the department's mission to protect and promote the health and well-being of the nation.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Infusion Innovations, Incorporated c/o Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, Minnesota 55313

JUN - 8 2012

Re: K121554

Trade/Device Name: Q-Flo Closed Male Luer Connector Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular administration set Regulatory Class: II Product Code: FPA Dated: May 24, 2012 Received: May 25, 2012

Dear Mr. Job:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 - Mr. Job

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

For G. Blanton Ford

Anthony D. Watson, B.S., M.S., M.B.A. 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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Q-Flo™ Closed Male Luer Connector Infusion Innovations, Inc.

Traditional 510{k} Premarket Notification Page 33 of 202 Attachment 1

510(k) Number (if known):

Device Name:

Q-Flo™ Closed Male Luer Connector

Indications for Use:

Prescription Use (Part 21 CFR §801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR §801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ali C. Chen 6/6/12

Division Sign-Olit) vision of Anesthesiology, General Hospital ection Control, Dental Devices

10(k) Number: K121554

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.