(199 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI or ML.
No.
The device is a fluid transfer device used in the pharmacy for transferring ingredients between containers, not for treating a disease or condition.
No
The device is described as a 'fluid transfer device' used for 'transferring large source container ingredients into a smaller container'. It is a 'connector' for connecting two devices. There is no mention of it being used to diagnose a medical condition or disease.
No
The device description explicitly states it is a "polypropylene, sterile device, single use product" and describes physical configurations (Female Luer lock, Female-Male Luer Lock). This indicates it is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "fluid transfer device used in the pharmacy to provide the fluid path for transferring large source container ingredients into a smaller container." This describes a device used for preparing medications or solutions, not for analyzing biological samples to diagnose a condition.
- Device Description: The description focuses on the physical characteristics and function of a connector for fluid transfer. It doesn't mention any components or processes related to analyzing biological specimens.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
- Care Setting: The intended user is in a "pharmacy," which is consistent with preparing medications, not performing diagnostic tests.
- Performance Studies: The performance studies focus on physical and biological compatibility (ISO standards for connectors, sterilization, biocompatibility), not on the accuracy or reliability of a diagnostic test.
In vitro diagnostics are devices used to examine specimens taken from the human body (such as blood, tissue, and urine) to detect diseases, conditions, or infections. This device's function is purely for fluid transfer in a pharmacy setting, which falls outside the scope of IVD regulation.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
LHI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
pharmacy
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The 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. Sterilization by Ethylene Oxide has been validated. All pre-determined acceptance criteria were met.
Tests performed include:
- ISO 80369-7:2016: Design verification for small-bore connectors.
- ISO 8536-10:2015: Design verification for infusion equipment accessories.
- Shipping Shelf Life Evaluation: Design verification of the shelf life.
- Resistance to Override: Engineering study of torque performance specification for evaluation of predicate device.
- ANSI/AAMI/ISO 11737-2:2009 (R) 2014: Sterilization of medical devices - Microbiological methods – part 2: Test of sterility.
- ISO 11135:2014: Sterilization of health-care products- Ethylene oxide. Met 10-6 SAL requirement.
- ANSI/AAMI ST72:2011: Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing. Limulus Amoebocyte Lysate test - Less than 2.0 EU/device.
Biocompatibility tests passed: Cytotoxicity, Sensitization, Irritation / Intracutaneous Reactivity, Acute Systemic Toxicity, Materials Mediated Pyrogenicity and Hemocompatibility for a Surface device, Skin/Blood Path, Indirect Contact, Prolonged Duration.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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)
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3
K173577 510(k) Summary
| Company:
Address: | International Medical Industries, Inc.
2981 Gateway Drive
Pompano Beach, Florida 33069 |
|-------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Contact:
Telephone Number:
Email: | Kathleen Lavender
Director of Quality and Compliance
954.917.9570 x 283
klavender @ imiweb .com |
| Preparation Date: | November 16, 2017 |
| Trade Name:
Device Common Name:
Classification Regulation:
Classification Name:
Class:
Panel:
Product Code: | Guarded Luer Connector
Luer Connector(s)
21 CFR 880.5440
Intravascular Administration Set
II
General Hospital
LHI |
| Predicate Device: | TUBING SETS FOR BAXA EXACTA-MED
PHARMACY PUMP
(K900585) |
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.
Indication for Use
| SUBJECT
(K173577)
Indications for Use | PREDICATE
(K900585)
Indications for Use |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|
| 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 | 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 Device
K173577 | Predicate Device
K900585 |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 fluid
transfer device used in the pharmacy to
provide the fluid path for transferring
large source container ingredients into a
small container(s). | The Rapid-Fill Tubeset, manufactured by
Baxa (Baxter) Corporation, is a fluid
transfer device used in the pharmacy to
provide the fluid path for transferring large
source container ingredients into a small
container(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 for
prolonged 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:
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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-bore |
| connectors for liquids and gases in healthcare applications -- | |
| Part 7: Connectors for intravascular or hypodermic | |
| applications | |
| ISO 8536-10:2015 | Design verification to ISO 8536-10:2015 Infusion |
| equipment for medical use -Part 10: Accessories for fluid | |
| lines for single use with pressure infusion equipment | |
| Shipping Shelf Life Evaluation | Design verification of the shelf life |
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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 performance
specification for evaluation of predicate device |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ANSI/AAMI/ISO 11737-2:2009 (R)
2014 | Sterilization of medical devices -
Microbiological methods – part 2: Test of
sterility performed in the definition,
validation and maintenance of a sterilization
process
Removal of microorganisms from
product and transfer of removed
microorganisms to growth medium
followed by incubation |
| ISO 11135:2014 | Sterilization of health-care products- Ethylene oxide -
Requirements for the development, validation and
routine control of a sterilization process for medical
devices
Met 10-6 SAL requirement |
| ANSI/AAMI ST72:2011 | Bacterial endotoxins - Test methods, routine
monitoring, and alternatives to batch testing
Limulus Amoebocyte Lysate test -