(356 days)
BD PureHub™ Disinfecting Caps are intended to be used as a disinfecting cleaner for swabbable needle-free luer connectors prior to access and to act as a physical barrier between line accesses.
BD PureHub™ Disinfecting Cap will disinfect the needle-free luer connector one (1) minute after application and act as a physical barrier for up to seven (7) days, if not removed.
BD PureHub™ Disinfecting Cap is a sterile, single use disinfectant cap designed for needle-free Luer connectors. It has high-density polyethylene housing and polyester urethane sponge saturated with 70% Isopropyl Alcohol (IPA) solution. PureHub™ disinfects needle-free Luer connectors one minute after application and acts as a physical barrier for up to seven days, if not removed. It is available in two packaging configurations - Bulk Single Unit and IV Pole Strip.
The BD PureHub™ Disinfecting Cap is intended to be used as a disinfecting cleaner for swabbable needle-free luer connectors prior to access and to act as a physical barrier between line accesses. It will disinfect the needle-free luer connector one (1) minute after application and act as a physical barrier for up to seven (7) days, if not removed.
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly list "acceptance criteria" alongside specific numerical targets and then directly compare them to reported device performance in a single table for each test. Instead, it states that "The subject device met all the predetermined acceptance criteria for the above listed performance tests and demonstrated substantial equivalence to the predicate device."
However, we can infer some criteria and reported performance from the comparison table and the list of non-clinical tests:
| Acceptance Criteria (Inferred/Stated) | Reported Device Performance |
|---|---|
| Antimicrobial Efficacy: | |
| Disinfects needle-free luer connector | Disinfects in 1 minute |
| Reduces microorganism growth by > 4-log reduction (similar to predicate) | > 4-log reduction (tested against Staphylococcus aureus, Staphylococcus epidermidis, Escherichia coli, Pseudomonas aeruginosa, Candida albicans, Candida glabrata, Acinetobacter baumannii) |
| Physical Barrier: | |
| Acts as a physical barrier for up to 7 days | Acts as a physical barrier for up to 7 days |
| Biocompatibility (as per ISO 10993-1): | Met predetermined acceptance criteria for: Cytotoxicity, Sensitization, Irritation or Intracutaneous Activity, Acute Systemic Toxicity, Material Mediated Pyrogenicity, LAL Endotoxin, Hemocompatibility, Subacute/Subchronic. Additionally, Chemical Extractable Analysis was performed. |
| Sterilization Assurance Level (SAL): | 10⁻⁶ |
| Sterilization Method: | Gamma Irradiation (validated in accordance with ISO 11137-2:2013 (VDmax25)) |
| Shelf Life: | 3 years |
| Other Performance Tests: | Met all predetermined acceptance criteria for: Particulate Matter Ingress (USP 788), 70% IPA Weight and % Isopropyl Alcohol/Water Solution Concentration, Cap to Connector Interface, Device Retention to Luer activated valve (LAV), Material Compatibility of subject device and LAV, Air Leakage, Weld Retention, Packaging Integrity, Tensile Strength on IV Pole Strip, PureHub™ Connector Air Leak Testing, Physical Barrier Testing. |
2. Sample Sizes Used for the Test Set and Data Provenance:
The document does not provide specific sample sizes for each non-clinical test. It lists the types of tests performed.
The data provenance is not explicitly stated in terms of country of origin or retrospective/prospective. The tests were performed "in accordance with 21 CFR §820.30" and various ISO standards, implying controlled laboratory conditions rather than human clinical trials.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not applicable as the study involved non-clinical performance and biocompatibility testing, not expert-adjudicated clinical ground truth. The "ground truth" for these tests would be established by the methodologies defined in the respective ISO standards (e.g., ISO 10993 for biocompatibility) and internal specifications.
4. Adjudication Method for the Test Set:
Not applicable. The tests are laboratory-based and follow standardized protocols, not human adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a physical disinfecting cap, not an AI-powered diagnostic or assistive tool for human readers.
6. Standalone Performance Study (i.e., algorithm only without human-in-the-loop performance):
Yes, a standalone study was performed, as the device is a physical product and its performance (e.g., antimicrobial efficacy, physical barrier, biocompatibility) was evaluated directly through laboratory testing without human intervention being part of the device's function.
7. Type of Ground Truth Used:
The ground truth for the non-clinical tests was established by:
- Established Test Methods and Standards: e.g., ISO 10993-1 for biocompatibility, ISO 11137-2:2013 (VDmax25) for sterilization, USP 788 for particulate matter.
- Defined Performance Criteria: For tests like antimicrobial efficacy, the "ground truth" is a measurable reduction in microorganism count (> 4-log reduction).
- Internal Specifications: Tests were performed "to an internal specification or a Standard."
8. Sample Size for the Training Set:
Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. (See #8)
§ 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.