(332 days)
SwabTip™ is intended for use on ISO male luer connectors as a cover to protect the luer from potential contamination. The SwabTip™ acts as a physical barrier to contamination between line accesses and also serves as a disinfecting cleaner for use prior to line access. SwabTip™ will disinfect the male luer (30) seconds after application and maintains a disinfected luer surface for up to four days (96 hours) if not removed.
SwabTip™ Male Disinfectant Cap is an accessory to the terminal male luer of an intravenous administration set that is used to disinfect and maintain a physical barrier when the administration set is not in use. The SwabTip™ is a cap that when attached to an ISO compatible male luer slip, lock, or spin luer, delivers a small volume of 70% isopropyl alcohol to the external surfaces of the male luer including the internal threads. SwabTip™ is a single use sterile fluid path cap, provided in multi-unit delivery strip.
The provided document describes the acceptance criteria and study that proves the SwabTip™ Male Disinfectant Cap meets these criteria, supporting its substantial equivalence to a predicate device.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Challenge Strain | Acceptance Criteria (≥ Log$_{10}$ Reduction) | Reported Device Performance (Number of Samples Passing) | Result |
|---|---|---|---|
| P. aeruginosa (ATCC #9027) | ≥4.0 on 10/10 Samples | 10/10 Samples | Pass |
| S. aureus (ATCC #6538) | ≥4.0 on 10/10 Samples | 10/10 Samples | Pass |
| E. coli (ATCC #11229) | ≥4.0 on 10/10 Samples | 10/10 Samples | Pass |
| S. epidermidis (ATCC #14990) | ≥4.0 on 10/10 Samples | 10/10 Samples | Pass |
| C. albicans (ATCC #10231) | ≥4.0 on 10/10 Samples | 10/10 Samples | Pass |
| C. glabrata (ATCC #2001) | ≥4.0 on 10/10 Samples | 10/10 Samples | Pass |
Notes:
- This table specifically refers to the "Efficacy Study" (time-kill study) for antimicrobial activity.
- Other performance data mentioned includes: Microbial Barrier Performance Test, Male Luer Compatibility Testing, Visual Inspection, Foil Functional Test, Lid Peel Force, Integrity by Weight, Seal Leak Testing of Holder and Foil Lid, IPA Ingress/Alcohol Fluid Path Testing, Pyrogenicity Testing, and Particulates. The document states that the results of these tests "demonstrated that the subject device meets the performance requirements and ultimately supports a substantial equivalence determination," and that "Test results from the performance testing conducted demonstrate that SwabTip™ met all acceptance criteria requirements," but does not provide specific numerical outcomes or acceptance criteria for each of these additional tests in the provided text.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Efficacy Study: For the antimicrobial efficacy time-kill study, the sample size was 10 samples for each of the six challenge strains, totaling 60 samples evaluated for antimicrobial activity.
- Data Provenance: The document states "A time kill study was conducted to determine how rapidly and effectively SwabTip™ kills a variety of microorganisms. SwabTip™ was tested for antimicrobial activity against six selected organisms using an industry standard protocol for time-kill assays." There is no specific information about the country of origin of the data or whether it was retrospective or prospective, but it implies a controlled laboratory study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This document describes performance testing of a medical device (disinfectant cap) against specific microbial challenges and physical/chemical properties, not a diagnostic or AI-driven image analysis tool. Therefore, the concept of "experts used to establish the ground truth" in the traditional sense of clinical interpretations (e.g., radiologists for imaging) is not applicable here. The ground truth (e.g., log reduction of bacteria) is established through standardized laboratory protocols and measurements.
4. Adjudication Method for the Test Set
- Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies where human interpretation of data (e.g., medical images) is involved. For the laboratory performance tests described (antimicrobial efficacy, physical integrity, etc.), such adjudication methods are not relevant. The results are based on objective measurements against predefined acceptance criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, particularly in diagnostic imaging. The SwabTip™ is a device with a direct physical and chemical function, not a diagnostic or AI-assisted system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This question is also not applicable. The SwabTip™ is a physical device that performs disinfection, not a software algorithm. The "standalone performance" is the device's inherent ability to disinfect and maintain cleanliness, which was evaluated through the various performance tests listed.
7. The Type of Ground Truth Used
- The ground truth for the efficacy study was based on quantitative microbiological measurements (Log$_{10}$ reduction) of specific microbial strains after exposure to the device, conducted under industry standard protocols for time-kill assays.
- For other tests (e.g., Luer compatibility, physical integrity, biocompatibility), the ground truth was established by meeting specified engineering, material, and safety standards (e.g., ISO standards, USP requirements), against which the device's performance was measured.
8. The Sample Size for the Training Set
- This document describes the validation of a physical medical device, not the development of an AI model. Therefore, there is no "training set" in the context of machine learning. The studies described are performance validation tests.
9. How the Ground Truth for the Training Set was Established
- As there is no "training set" in the context of AI model development, this question is not applicable.
§ 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.