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510(k) Data Aggregation
(234 days)
Star Mountain Medical, Inc.
When left in place for 3 minutes, the CapKlenZ disinfects needleless luer access valves; thereafter the CapKlenZ provide a physical barrier to contamination up to 168 hours under normal conditions if not removed.
CapKlenZ consists of a solid reservoir made of polyethylene, which contains an absorbent material and 70% isopropyl alcohol (70% IPA).
The opening of the reservoir is mechanically attached to a threaded membrane made of non-DEHP, non-latex elastomer, which lays in the internal geometry of the reservoir, this membrane is intended to be threaded to a needleless port connector and adapt to its shape. The reservoir and its contents are sealed with an extrusion laminated composite of polyester, polyethylene, aluminum foil, and a peelable sealant, which has to be removed before use.
Once the needleless port connector is threaded, the shape and elasticity of the threaded membrane, isolates the proximal end of the needleless port connector within the interior of the reservoir along with the absorbent material and 70% IPA. When the needleless port connector is threaded into the membrane, the circular movement of the connector scrubs its tip against the absorbent material and exposes it to 70% IPA in order to disinfect it.
This document describes the acceptance criteria and supporting studies for the CapKlenZ device, a disinfectant cap for needleless luer access valves.
1. Tabular Summary of Acceptance Criteria and Reported Device Performance:
| Test Category | Test Name | Acceptance Criteria | Reported Performance |
|---|---|---|---|
| Antimicrobial Efficacy | Log Reduction for various organisms | ≥ 4.0 log reduction in bacterial count for 2 gram-positive bacteria (Staphylococcus aureus, Staphylococcus epidermidis), 2 gram-negative bacteria (Escherichia coli, Pseudomonas aeruginosa), and 3 fungus/yeast microorganisms (Candida albicans, Candida glabrata, Candida auris) at 3, 5, and 60 minutes exposure. | Pass for all organisms and time points |
| Microbial Barrier Testing | Microbial Ingress (% ) | 0% microbial ingress | Pass for 1, 24, and 168 hours exposure |
| Alcohol in Fluid Path | Isopropyl alcohol dosage mean (mmol/L) | Not explicitly stated as a numerical criterion; implied to be below a level causing toxicity based on reference methodology. | 0.00748 mmol/L (23°C active circuits) |
| 0.00780 mmol/L (35°C active circuits) | |||
| Not Applicable (Passive circuits) | |||
| Visual Inspection | Pass (no change in appearance of luer access valve) | Pass | |
| Functional Inspection | Pass (no change in function of luer access valve) | Pass | |
| Performance Testing | Dimensional, physical and functional attributes | Internal Test Method: Pass | Pass at T=0 and T=2 years |
| Disassembly Force | Internal Test Method: Pass | Pass at T=0 and T=2 years | |
| Air Leakage | Internal Test Method: Pass | Pass at T=0 and T=2 years | |
| Liquid Leakage | Internal Test Method: Pass | Pass at T=0 and T=2 years | |
| Packaging Integrity (Seal Peel Strength) | ASTM F88/88M-15: Pass | Pass at T=0 and T=2 years | |
| Packaging Integrity (Bubble Test) | ASTM F2096-11: Pass | Pass at T=0 and T=2 years | |
| Unscrewing Torque | ISO 594-2: Pass | Pass at T=0 and T=2 years | |
| Ease of Assembly | ISO 594-2: Pass | Pass at T=0 and T=2 years | |
| Resistance to Overriding | ISO 594-2: Pass | Pass at T=0 and T=2 years | |
| Stress Cracking | ISO 594-2: Pass | Pass at T=0 and T=2 years | |
| Shipping and Transit | ISTA 3A: Pass | Pass at T=0 and T=2 years | |
| Biocompatibility Testing | Cytotoxicity | ISO 10993-5 (L929 MEM Elution): Compliance | Not explicitly stated "Pass" but implied compliance |
| Sensitization | ISO 10993-10 (Murine Local Lymph Node Assay): Compliance | Not explicitly stated "Pass" but implied compliance | |
| Irritation or Intracutaneous Reactivity | ISO 10993-10 (Intracutaneous Injection Assay): Compliance | Not explicitly stated "Pass" but implied compliance | |
| Acute Systemic Toxicity | ISO 10993-11 (Acute Systemic Injection Assay): Compliance | Not explicitly stated "Pass" but implied compliance | |
| Pyrogenicity | ISO 10993-11 (Material-Mediated Rabbit-Pyrogen, Bacterial endotoxin testing (LAL)): Compliance | Not explicitly stated "Pass" but implied compliance | |
| Hemocompatibility | ISO 10993-4 (Hemolysis (Indirect) in Rabbit Blood (ASTM Method)): Compliance | Not explicitly stated "Pass" but implied compliance | |
| Subacute/Subchronic Toxicity | ISO 10993-11 (Subchronic IV Toxicity in mice, Subacute IP Toxicity in mice): Compliance | Not explicitly stated "Pass" but implied compliance | |
| Particulate Matters in Injections | USP : Compliance | Not explicitly stated "Pass" but implied compliance | |
| Sterilization Testing | Gamma Radiation Sterilization | Sterility Assurance Level (SAL) of 10⁻⁶ | Pass |
2. Sample Size and Data Provenance for Test Set:
- Antimicrobial Efficacy Testing: Not explicitly stated, but testing was performed on "baseline (T=0)" and "aged devices (T=2 years)". This suggests a study design involving new and aged samples of the device. The data provenance is internal testing by Star Mountain Medical, Inc. The nature of the test (in-vitro) indicates a controlled laboratory setting, not patient data.
- Microbial Barrier Testing: Not explicitly stated, but testing was performed on "baseline (T=0)" and "aged devices (T=2 years)". Similar to antimicrobial efficacy, this suggests a study design involving new and aged samples. The data provenance is internal testing by Star Mountain Medical, Inc.
- Alcohol in the fluid path Testing: Not explicitly stated. The study referenced "Sauron et. al., 2015, 'Using isopropyl alcohol impregnated disinfection caps in the neonatal intensive care unit can cause alcohol toxicity'" for methodology. This testing was performed internally by Star Mountain Medical, Inc.
3. Number of Experts and Qualifications for Ground Truth - Test Set:
- The document describes non-clinical performance and laboratory testing, not studies involving human interpretation or expert evaluation of test results. Therefore, no information on human experts used to establish a ground truth for a test set is provided or applicable in the context of this device's non-clinical evaluation.
4. Adjudication Method for the Test Set:
- Not applicable, as this involves non-clinical laboratory testing with objective measurements against predefined acceptance criteria, rather than subjective interpretation by human readers.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is a physical disinfectant cap, and its effectiveness is evaluated through microbiological, chemical, and physical bench tests, not through human reader interpretation of images or data that would typically involve an MRMC study.
6. Standalone (Algorithm Only) Performance:
- Not applicable. The CapKlenZ is a physical medical device, not an algorithm or AI software. Therefore, the concept of "standalone performance" (algorithm only without human-in-the-loop) does not apply.
7. Type of Ground Truth Used:
- For the antimicrobial efficacy tests, the ground truth was quantitative bacterial and fungal count reductions measured in a laboratory setting.
- For the microbial barrier tests, the ground truth was absence of microbial ingress measured in a laboratory setting.
- For the alcohol in fluid path testing, the ground truth was quantification of alcohol leakage by gas chromatography and visual/functional inspection outcomes (Pass/Fail criteria).
- For performance testing, the ground truth was objective measurements against established engineering standards (ISO, ASTM, ISTA) and internal test methods, resulting in Pass/Fail outcomes.
- For biocompatibility and sterilization testing, the ground truth was compliance with established ISO and USP standards.
8. Sample Size for the Training Set:
- Not applicable. This device is a physical product, not a machine learning algorithm. Therefore, there is no "training set" in the context of AI/ML models. The reported testing is for device validation and verification.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no "training set" for this physical medical device.
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