The Guarded Luer Connector is a fluid transfer device used in the pharmacy to provide the fluid path for transferring large source container ingredients into a smaller container.

Device Description

The Guarded Luer Connector (GLC) is a polypropylene, sterile device, single use product intended to provide the fluid path for transferring large source container ingredients into smaller containers. The product is offered in two configurations; Female Luer lock (57-400) and Female-Male Luer Lock (57-401); both configurations meet the intended use. The Guarded Luer Connector is a connector for connecting two devices with fittings conforming to ISO 80369-7 for intravascular connectors and ISO 8536-10 for fluid line accessories.

AI/ML Overview

The provided text describes a 510(k) summary for a medical device called the "Guarded Luer Connector." This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific performance criteria. Therefore, several of the requested categories of information, particularly those related to clinical studies, human readers, ground truth establishment, and training data, are not applicable or not present in this type of regulatory submission.

However, based on the context of a 510(k) for a connector, the acceptance criteria would primarily revolve around engineering and material performance standards to ensure safe and effective fluid transfer.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Test Name	Acceptance Criteria (Implied by standard compliance)	Reported Device Performance
ISO 80369-7:2016	Compliance with requirements for small-bore connectors (6% Luer taper) for intravascular/hypodermic applications.	Met the bench testing requirements per ISO 80369-7:2016.
ISO 8536-10:2015	Compliance with requirements for accessories for fluid lines for single use with pressure infusion equipment.	Met the bench testing requirements per ISO 8536-10:2015.
Shipping Shelf Life Evaluation	Device functionality and integrity maintained over its shelf life.	Design verification of the shelf life was performed.
Resistance to Override	Engineering specification for torque performance (likely similar to predicate).	Engineering study of torque performance specification for evaluation was done.
ANSI/AAMI/ISO 11737-2:2009 (R) 2014 & ISO 11135:2014	Sterility Assurance Level (SAL) of 10-6.	Met 10-6 SAL requirement.
ANSI/AAMI ST72:2011	Bacterial endotoxin level < 2.0 EU/device.	Limulus Amoebocyte Lysate test result: < 2.0 EU/device.
Biocompatibility (ISO 10993-1)	Passed specific tests as per ISO 10993-1 guidance for prolonged duration, external communicating indirect blood path.	Passed all biocompatibility tests (Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Acute Systemic Toxicity, Materials Mediated Pyrogenicity, Hemocompatibility).

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

Sample Size for Test Set: Not explicitly stated in the document. For engineering bench testing, sample sizes are typically determined by statistical methods or regulatory guidelines for device testing (e.g., AQL – Acceptable Quality Limit).
Data Provenance: The studies are described as "bench testing requirements" and "design verification," "engineering study," and "biocompatibility tests." This indicates the data was generated in a lab setting, likely by the manufacturer, and is prospective experimentation (though not a clinical trial).
Countries of Origin: Not specified, but generally assumed to be from the manufacturer's testing facilities or contract labs.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

This is not applicable as the device is a piece of hardware (a Luer connector), not an AI/imaging device requiring expert interpretation for ground truth. The "ground truth" for these tests are the objective measurements against established technical standards.

4. Adjudication Method for the Test Set:

Not applicable. This concept (adjudication) is typically used in clinical studies or expert review processes, which are not described here. The results of the bench tests are objective measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC study was not done. This type of study is relevant for AI-powered diagnostic tools where human readers (e.g., radiologists) interpret cases with and without AI assistance. This device is a fluid transfer connector.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This device is a mechanical connector, not an algorithm.

7. The Type of Ground Truth Used:

The ground truth used for this device's evaluation is primarily objective measurements against established performance standards and material specifications. For instance:

Fluid leak rates (implied by ISO 80369-7)
Dimensional accuracy (implied by ISO 80369-7)
Torque strength (Resistance to Override)
Bacterial endotoxin levels (<2.0 EU/device)
Sterility (SAL 10-6)
Biocompatibility (based on specific test results like cytotoxicity, sensitization, etc.)

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI/machine learning model, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established:

Not applicable. There is no training set for this type of device.

Study Proving Acceptance Criteria:

The "study" proving the device meets the acceptance criteria is the collection of bench testing, design verification, and biocompatibility testing as summarized in the document. The document states:

"Guarded Luer Connector meets the bench testing requirements per ISO 80369-7... and ISO 8536-10..."
"Compliance with these international standards demonstrates that the proposed cap device is substantially equivalent to the predicate device."
"All pre-determined acceptance criteria were met."
"The device Guarded Luer Connector passed all biocompatibility tests."

The primary goal of this FDA 510(k) submission is to demonstrate substantial equivalence to an already legally marketed predicate device (TUBING SETS FOR BAXA EXACTA-MED PHARMACY PUMP, K900585), rather than proving novel efficacy. The testing (bench tests and biocompatibility) is used to show that despite minor design differences, the new device performs equivalently and safely according to recognized standards.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 7, 2018

International Medical Industries Inc. Kathleen Lavender Director of Quality and Compliance 2981 Gateway Drive Pompano Beach, Florida 33069

Re: K173577

Trade/Device Name: Guarded Luer Connector Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: LHI Dated: May 8, 2018 Received: May 10, 2018

Dear Kathleen Lavender:

We have reviewed vour 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.

{1}------------------------------------------------

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 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.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Tina Kiang -S

Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K173577

Device Name Guarded Luer Connector

Indications for Use (Describe)

The Guarded Luer Connector is a fluid transfer device used in the pharmacy to provide the fluid path for transferring large source container ingredients into a smaller container.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X | Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

K173577 510(k) Summary

Company:Address:	International Medical Industries, Inc.2981 Gateway DrivePompano Beach, Florida 33069
Contact:Telephone Number:Email:	Kathleen LavenderDirector of Quality and Compliance954.917.9570 x 283klavender @ imiweb .com
Preparation Date:	November 16, 2017
Trade Name:Device Common Name:Classification Regulation:Classification Name:Class:Panel:Product Code:	Guarded Luer ConnectorLuer Connector(s)21 CFR 880.5440Intravascular Administration SetIIGeneral HospitalLHI
Predicate Device:	TUBING SETS FOR BAXA EXACTA-MEDPHARMACY PUMP(K900585)

Device Description

Indication for Use

SUBJECT(K173577)Indications for Use	PREDICATE(K900585)Indications for Use
The Guarded Luer Connector is a fluidtransfer device used in the pharmacy toprovide the fluid path for transferring largesource container ingredients into a smallercontainer	Identical to the FDA cleared 510(k)Indications for Use

{4}------------------------------------------------

Basis for Substantial Equivalence

The Guarded Luer Connector is substantially equivalent to the connectors in the predicate device, TUBING SETS FOR BAXA EXACTA-MED PHARMACY PUMP (K900585). The devices have the same indications for use, are made of the same material, and are provided sterile. They are both indicated as fluid transfer devices used in the pharmacy to provide the fluid path for transferring large source container ingredients into a smaller container.

The substantial equivalence of the Guarded Luer Connector is adequately supported by the testing rationale and data provided, materials information, and comparison of design characteristics as found in the comparison table below. The testing provided supports the equivalence of the Guarded Luer Connector to the predicate, and shows no new questions of safety and effectiveness have been introduced with this device.

Parameter	Proposed DeviceK173577	Predicate DeviceK900585
Image	Image: Yellow and red plastic connectors	Image: Red plastic connector
Proprietary Device Name	Guarded Luer Connector	TUBING SETS FOR BAXA EXACTA-MED PHARMACY PUMP
Company Name	International Medical Industries, Inc.	BAXA CORP.
Indications for Use	The Guarded Luer Connector is a fluidtransfer device used in the pharmacy toprovide the fluid path for transferringlarge source container ingredients into asmall container(s).	The Rapid-Fill Tubeset, manufactured byBaxa (Baxter) Corporation, is a fluidtransfer device used in the pharmacy toprovide the fluid path for transferring largesource container ingredients into a smallcontainer(s).
Product Code	LHI	LHI
Regulation No.	21 CFR 880.5440	21 CFR 880.5440
Classification	Class II	Class II
Sterilization Method	Ethylene Oxide, SAL 10-6	Ethylene Oxide
Number of Uses	Single Use, RX Only	Single Use, RX Only
Closure Cap Materia 1	Polypropylene	Polypropylene
Biocompatibility	Per ISO 10993-1 for prolonged duration,external communicating indirect blood path	From 510(k) summary: Per ISO 10993-1 forprolonged duration, external communicating,indirect blood path
Connection	Female Luer Lock to Female Luer Lock	Female Luer Lock to Female Luer Lock

Comparison Between the Guarded Luer Connector and the Predicate Device:

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows a logo with the letters I, M, and I stacked vertically inside an oval shape. The oval is surrounded by several curved lines that create a ripple effect. The logo is primarily blue and white, with the letters in black.

Technological Characteristics

The Guarded Luer Connector is an injection molded Luer connector component made of Polypropylene and colorant. The intended use and function of the proposed Guarded Luer Connector is identical to the predicate device in design and operation. The primary difference between the proposed device and the predicate device is that proposed product contains two configurations; Female-to-Female Luer connector (GLC 57-400) or Female-to-Male Luer connector (GLC 57-401). The second difference in the proposed device is that the outer guards of device have a recessed section to visually distinguish the device from the predicate while still allowing for a contactfree surface, reducing the potential for contamination during use equivalent to the predicate. The proposed device's intended use and function are the same as that of the predicate device. The two differences are in the proposed device 's design. The first difference, the additional configuration, does not negatively impact the safety of the device as the connections are the same as the predicate device in that they are luer lock. The second difference, the recessed design feature, is for a visual distinction from the predicate device and does not affect the device's functionality nor does it negatively impact safety or effectiveness. Furthermore, the proposed device was tested to the same testing requirements as the predicate device.

Performance Data

Guarded Luer Connector meets the bench testing requirements per ISO 80369-7 Small-bore connectors for Liquids and Gases in Healthcare Applications -Part 7: Connectors with 6% (Luer) Taper for Intravascular of Hypodermic Applications and ISO 8536-10 Infusion for Medical Use - Accessories for fluid lines for single use with pressure infusion equipment. Compliance with these international standards demonstrates that the proposed cap device is substantially equivalent to the predicate device. Sterilization by Ethylene Oxide has been validated for Guarded Luer Connectors. A summary of the performance tests performed is presented below. All pre-determined acceptance criteria were met.

Test Name	Test Description
ISO 80369-7:2016	Design verification to ISO 80369-7:2016 Small-boreconnectors for liquids and gases in healthcare applications --Part 7: Connectors for intravascular or hypodermicapplications
ISO 8536-10:2015	Design verification to ISO 8536-10:2015 Infusionequipment for medical use -Part 10: Accessories for fluidlines for single use with pressure infusion equipment
Shipping Shelf Life Evaluation	Design verification of the shelf life

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows a logo with the letters IMI stacked vertically inside an oval shape. The oval is made up of several concentric blue lines, creating a ripple effect. The letters IMI are in a dark color, contrasting with the lighter background within the oval.

Resistance to Override	Engineering study of torque performancespecification for evaluation of predicate device
ANSI/AAMI/ISO 11737-2:2009 (R)2014	Sterilization of medical devices -Microbiological methods – part 2: Test ofsterility performed in the definition,validation and maintenance of a sterilizationprocessRemoval of microorganisms fromproduct and transfer of removedmicroorganisms to growth mediumfollowed by incubation
ISO 11135:2014	Sterilization of health-care products- Ethylene oxide -Requirements for the development, validation androutine control of a sterilization process for medicaldevicesMet 10-6 SAL requirement
ANSI/AAMI ST72:2011	Bacterial endotoxins - Test methods, routinemonitoring, and alternatives to batch testingLimulus Amoebocyte Lysate test -<2.0 EU/device

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image shows a logo with the letters IMI stacked vertically inside of an oval shape. The oval is made up of several concentric blue lines. The letters IMI are in a dark color, contrasting with the white background inside the oval. There is a small circle with a dot in the bottom right corner of the oval.

Biocompatibility Testing

The device Guarded Luer Connector passed all biocompatibility tests. In accordance to Guidance Document "Use of International Standard ISO 10993-1. "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"; Guidance for Industry and Food and Drug Administration Staff, Jun 16, 2016, the following biocompatibility tests were required and therefore performed for a Surface device, Skin/Blood Path, Indirect Contact, Prolonged Duration: Cytotoxicity, Sensitization, Irritation / Intracutaneous Reactivity, Acute Systemic Toxicity, Materials Mediated Pyrogenicity and Hemocompatibility.

Conclusion

Review of the in-vitro performance test data as well as comparison of the device classification, indications for use, operating principle, technological characteristics, sterility, and biocompatibility demonstrate that the subject device, Guarded Luer Connector (GLC) is substantially equivalent to the connectors cited in the predicate device TUBING SETS FOR BAXA EXACTA-MED PHARMACY PUMP. Any differences between the subject and the predicate devices do not raise any issues of safety and effectiveness.

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.