Q-FLO CLOSED MALE LUER CONNECTOR

K121554 · Us Fusion, LLC. Dba Truecare Biomedix-USA · FPA · Jun 8, 2012 · General Hospital

Device Facts

• Record ID: K121554
• Device Name: Q-FLO CLOSED MALE LUER CONNECTOR
• Applicant: Us Fusion, LLC. Dba Truecare Biomedix-USA
• Product Code: FPA · General Hospital
• Decision Date: Jun 8, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

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, administering, and disposal of potentially hazardous fluids, such as chemotherapy, radioactive isotopes, and blood products, as well as non-hazardous fluids.

Device Story

Q-Flo™ Closed Male Luer Connector is a sterile, single-use, needleless connector for IV administration sets. It facilitates fluid handling—reconstitution, transfer, administration, and disposal—of hazardous and non-hazardous fluids. Device features a sequential locking mechanism with a colored visual indicator to confirm connection status: disconnected (closed/drip-less), connected/deactivated (no flow), and connected/actuated (flow permitted). Thread engagement moves the male luer forward, providing visual confirmation of full connection. Silicone sealing member ensures a leak-free state. Used by healthcare professionals in clinical settings. Benefits include reduced exposure to hazardous fluids during fluid path management. Device weighs <2.5g and is 12.8mm in diameter.

Clinical Evidence

Bench testing only. Performance verified against ISO 594-2 (luer retention, dimensional/performance), ISO 8536-4 (dimensional/performance), ISO 10993-1 (biocompatibility), and ISO 11137-2 (sterility). Comparative testing against predicates included residual volume, gravity fluid flow, and multiple activation durability.

Technological Characteristics

Materials: Polycarbonate (female/male luer, inner housing), Copolyester (external housing), Silicone (sealing surface). Principle: Sequential thread-engagement locking mechanism. Energy: Mechanical. Dimensions: <2.5g, 12.8mm diameter. Sterilization: Radiation. Connectivity: Standard luer interface. No software/electronics.

Indications for Use

Indicated for healthcare professionals to connect with standard open female luers for the reconstitution, transfer, administration, and disposal of hazardous (chemotherapy, radioactive isotopes, blood products) and non-hazardous fluids.

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

• Alaris Safety Male Luer (K053049)
• Spiros Closed Male Luer (K070532)

Submission Summary (Full Text)

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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 Avenue<br>La Jolla CA 92037 |
| | [phone] |
| | [phone] (fax) |
| Contact Person: | Babak Nemati, Ph.D.<br>President, CEO<br>Infusion 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: | FPA<br>Intravascular Administration Set<br>21 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

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

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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 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.

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 Male<br>Luer Connector | Alaris Safety Male Luer | Spiros Closed Male Luer |
|-------------------------------------------|-----------------------------------------------------------------------------------------------|---------------------------------------------------------------------|---------------------------------------------------------------------|
| Functional Use | Needleless connector | Needleless connector | Needleless connector |
| Engagement States | Disconnected<br>Luer connected/No flow<br>Luer engages female<br>connector and allows<br>flow | Disconnected<br>Luer engages female<br>connector and allows<br>flow | Disconnected<br>Luer engages female<br>connector and allows<br>flow |
| Residual Volume | 0.02 mL | 0.03 mL | 0.06 mL |
| Gravity Fluid Flow @ 1<br>meter height | 193 mL/min | 97 mL/min | 195 mL/min |
| Syringe Disconnect:<br>Fluid Displacement | Less than 0.05 mL | Not stated | 0.01 - 0.03 mL |
| Multiple Activations | 25 activations or 72<br>hours (whichever occurs<br>first) | 50 activations or 72<br>hours (whichever occurs<br>first) | 10 activations |
| Luer Retention | ISO 594-2(5.4) | ISO 594-2(5.4) | ISO 594-2 (5.4) |
| Chemical<br>Compatibility | Lipid & alcohol based<br>fluids | Not stated | Lipid & alcohol based<br>fluids |
| Sterilization Method | Radiation | Radiation | Radiation |
| Packaging | Peel pouch | Peel pouch or packaged<br>with other IV set<br>components | Peel pouch or packaged<br>with other IV set<br>components |

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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<br>(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 [phone] or [phone] 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:

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.

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