(280 days)
The AMSafe® Sure-Lok™ Needle-Free Connector is an accessory to an Intra-vascular Administration Set used as a secondary sterile injection site for delivery of fluids to a patient's vascular system through a cannula inserted into a vein.
The AMSafe® Sure-Lok™ Needle-Free Connector is a Needle-Free connector intended for single patient use, for direct injection, intermittent infusion, continuous infusion or aspiration of drugs, blood and fluids used as an accessory to an Intravascular administration set without the use of a needle, thus eliminating the risk of needlestick injuries. The AMSafe® Sure-Lok™ Needle-Free Connector is a closed, Luer activated device that allows for negative fluid displacement. The AMSafe® Sure-Lok™ Needle-Free Connector individually packaged is supplied as a sterile, non-pyrogenic, single use, disposable device.
The provided text is a 510(k) Summary for the AMSafe® Sure-Lok™ Needle-Free Connector, a medical device. This document describes the device, its intended use, and the testing conducted to demonstrate its safety and effectiveness in comparison to a predicate device.
Here's an analysis of the acceptance criteria and study information, organized as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Testing Items | Test Criteria (Acceptance Criteria) | Reported Device Performance |
|---|---|---|
| Visual inspection | Conform with the internal criteria | Met the acceptance criterion |
| Leakage test | Conform with ISO 8536-4 Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed [Including: Amendment 1 (2013)]; Conform with ISO 8536-8: 2015 Infusion Equipment for Medical Use - Part 8: Infusion Sets for Single Use with Pressure Infusion Apparatus | Met the acceptance criterion |
| Compatible with MLL fitting | Section 3: Dimensions and tolerances in ISO 594-2:1998 Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings) | Met the acceptance criterion |
| Sealing performance | Section 4.2: leakage in ISO 594-2:1998 Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings) | Met the acceptance criterion |
| Free Flow Rate | Conform with ISO 8536-4:2010 Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed [Including: Amendment 1 (2013) | Met the acceptance criterion |
| Liquid leakage | Conform with ISO80369-7: 2016 Small-Bore Connectors For Liquids And Gases In Healthcare Applications - Part 7: Connectors For Intravascular or Hypodermic Applications | Met the acceptance criterion |
| Air leakage | Conform with ISO80369-7: 2016 Small-Bore Connectors For Liquids And Gases In Healthcare Applications - Part 7: Connectors For Intravascular or Hypodermic Applications | Met the acceptance criterion |
| Separation force | Conform with ISO80369-7: 2016 Small-Bore Connectors For Liquids And Gases In Healthcare Applications - Part 7: Connectors For Intravascular or Hypodermic Applications | Met the acceptance criterion |
| Stress cracking | Conform with ISO80369-7: 2016 Small-Bore Connectors For Liquids And Gases In Healthcare Applications - Part 7: Connectors For Intravascular or Hypodermic Applications | Met the acceptance criterion |
| Unscrewing torque | Conform with ISO80369-7: 2016 Small-Bore Connectors For Liquids And Gases In Healthcare Applications - Part 7: Connectors For Intravascular or Hypodermic Applications | Met the acceptance criterion |
| Ease of assembly | Section 5.6: Ease of assembly in ISO 594-2:1998 Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings) | Met the acceptance criterion |
| Resistance to overriding | Conform with ISO80369-7: 2016 Small-Bore Connectors For Liquids And Gases In Healthcare Applications - Part 7: Connectors For Intravascular or Hypodermic Applications | Met the acceptance criterion |
| Weld strength test | Conform with the internal criteria | Met the acceptance criterion |
| Cytotoxicity | ISO 10993-5: 2009 Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity | Met the acceptance criterion |
| Sensitization | ISO 10993-10: 2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization | Met the acceptance criterion |
| Intracutaneous Reactivity Test | ISO 10993-10: 2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization | Met the acceptance criterion |
| Acute systemic toxicity | ISO 10993-11: 2006 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity | Met the acceptance criterion |
| Haemolysis | ASTM F 756-13: Standard Practice for Assessment of Hemolytic Properties of Materials | Met the acceptance criterion |
| Pyrogenicity | ISO 10993-11: 2006 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity | Met the acceptance criterion |
| Subchronic Toxicity | ISO 10993-11: 2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity | Met the acceptance criterion |
| Sterility | ISO 11135:2007, Sterilization of Health Care Products-Ethylene Oxide; ISO 10993-7: 1995 and 2008, Biological Evaluation of Medical Devices-Part 7: Ethylene Oxide sterilization residuals. | Assessed in accordance with standards and met acceptance criteria. Based on the conclusion, it implies that the device is sterile after processing. |
| Microbial ingress testing | Internal standard | Met the acceptance criterion |
| Biocompatibility (Overall Assessment) | ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (for "External communicating device, Blood path, indirect (>24 hours to 30 days)") | Assessed in accordance with the standard. Results from Cytotoxicity, Sensitization, Intracutaneous Reactivity Test, Acute systemic toxicity, Haemolysis, Pyrogenicity, and Subchronic Toxicity demonstrate no new issues of safety and efficacy. |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states that "Bench testing of the proposed devices is performed," and tests were conducted according to various ISO and ASTM standards. However, the specific sample sizes used for each individual test or for a comprehensive "test set" are not mentioned. The document does not specify data provenance (country of origin) or if the data was retrospective or prospective, as these are bench tests rather than clinical studies with patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable as the described studies are bench tests (physical and chemical testing of the device) rather than clinical studies requiring expert interpretation or ground truth establishment based on clinical observations or diagnoses.
4. Adjudication Method for the Test Set
This section is not applicable for the same reason as point 3. Bench testing adherence to standards usually relies on measurement and observation against pre-defined criteria, not expert adjudication of subjective findings.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document describes bench testing and biocompatibility assessments, not comparative effectiveness studies with human readers or clinical outcomes. The goal was to demonstrate substantial equivalence to a predicate device through engineering and biological testing.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
This question is not applicable as the device is a physical medical connector, not an AI algorithm.
7. The Type of Ground Truth Used
For the bench testing, the "ground truth" is defined by the specific requirements and limits set forth in the referenced international standards (ISO, ASTM) and the manufacturer's own internal criteria. For example, for a leakage test, the ground truth is "no leakage" or leakage within a specified limit according to the standard. For biocompatibility tests, the ground truth is a lack of cytotoxic, sensitizing, or toxic effects as defined by the respective ISO standards.
8. The Sample Size for the Training Set
This question is not applicable. This is a physical medical device, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set was Established
This question is not applicable as there is no training set for a physical medical device.
§ 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.