(153 days)
SwabCap ™ is intended for use on swab-able luer access valves as a disinfecting cleaner prior to line access and to act as a physical barrier to contamination between line accesses. SwabCap ™ will disinfect the valve five (5) minutes after application and act as a physical barrier to contamination for up to ninety-six (96) hours under normal conditions if not removed.
The SwabCap™ is designed to securely fit on swab-able luer access valves. The cap contains 70% isopropyl alcohol. The product is intended for single-use and is provided sterile, latex free, preservative free and DEHP free.
The provided text describes a medical device called "SwabCap™" and its regulatory clearance based on substantial equivalence to predicate devices. However, the document does not contain specific acceptance criteria, study details, or performance data in the format requested. Instead, it focuses on the administrative aspects of its FDA 510(k) clearance.
Therefore, I cannot populate the table or provide detailed answers to most of your questions as the information is not present in the provided text.
Here's what I can extract from the document regarding the device and its claims, alongside areas where information is missing:
Device: SwabCap™
Intended Use: For use on swab-able luer access valves as a disinfecting cleaner prior to line access and to act as a physical barrier to contamination between line accesses. It is claimed to disinfect the valve 5 minutes after application and act as a physical barrier for up to 96 hours.
I cannot create a table of acceptance criteria and reported device performance because this information is not provided in the document. The document states that the device is "substantially equivalent" to predicate devices based on intended use, design, technology, antimicrobial agent, and performance, but it does not detail the specific performance metrics or acceptance criteria used to establish this.
Here’s a breakdown of the specific information requested and whether it's available:
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A table of acceptance criteria and the reported device performance:
- Not available. The document asserts substantial equivalence based on performance but does not quantify or present specific acceptance criteria or corresponding performance results.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not available. There is no mention of specific studies or test sets (like clinical trials or lab tests with sample sizes) used to support the performance claims. The clearance is based on substantial equivalence to existing predicate devices.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable/Not available. Since there are no detailed de novo performance studies described, there's no mention of experts establishing ground truth for a test set. The review process involved FDA officials evaluating the submission for substantial equivalence.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not available. No test set or adjudication method is described.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a medical accessory, not an AI imaging or diagnostic tool. Therefore, an MRMC study related to AI assistance is not relevant or mentioned.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an algorithm-based device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not available directly for this device. The concept of "ground truth" as typically used for AI or diagnostic devices is not explicitly stated. The regulatory decision is based on comparing the device's characteristics and claims to those of legally marketed predicate devices, implying that the established safety and effectiveness of the predicates serve as a benchmark.
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The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that requires a training set.
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How the ground truth for the training set was established:
- Not applicable. This is not an AI/machine learning device.
What the document does tell us:
- Predicate Devices:
- Key features of SwabCap™ for comparison:
- Intended Use: Same as the description above.
- Antimicrobial Agent: 70% Isopropyl Alcohol (similar to predicates)
- Additional Claims: DEHP, Latex, and Preservative Free.
- Sterilization: Gamma Irradiated.
- Packaging: Individually wrapped with peel-off foil lid.
- Basis of Clearance: Substantial equivalence to the listed predicate devices based on intended use, design, technology, antimicrobial agent, and performance. The clearance is a reaffirmation of a prior determination, with an administrative change to its categorization.
§ 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.