(260 days)
SwabCap® is intended for use on swab-able luer access valves as a cover to protect the luer access valves from potential contamination. The SwabCap® acts as a physical barrier to contamination between line accesses and also serves as a disinfecting cleaner for use prior to line access. SwabCap® will disinfect the valve five (5) minutes after application and maintains a disinfected valve surface for up to seven (7) days if not removed.
SwabCap is a plastic threaded cap that houses a small sponge saturated with 70% isopropyl alcohol. The device is designed to securely fit on swab-able luer access valves to disinfect the valve surface and maintain antiseptic conditions between line accesses. SwabCap" is a sterile, single-use device, provided as a stand-alone product.
This FDA 510(k) summary for the SwabCap® device (K130975) focuses on demonstrating substantial equivalence to a predicate device (SwabCap® K083508) rather than providing a detailed study proving the device meets specific acceptance criteria in the traditional sense of a clinical trial for a novel AI device. The submission is primarily aimed at extending the indications for use (from 96 hours to 7 days of disinfection) for a modified version of an already cleared device.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts, MRMC study, sample size for training set, ground truth for training set) are not applicable or explicitly mentioned in this type of regulatory submission as they would be for an AI/ML medical device.
However, I can extract the relevant information and infer some aspects based on the provided document.
Acceptance Criteria and Device Performance
The acceptance criteria here are implicitly related to maintaining the efficacy of disinfection for an extended period (up to 7 days) while demonstrating safety and substantial equivalence to the predicate device. The performance is assessed through non-clinical testing.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Disinfect the valve within five (5) minutes after application. | SwabCap® will disinfect the valve five (5) minutes after application. (Stated in Indications for Use document, consistent with predicate). |
| Maintain a disinfected valve surface for up to seven (7) days. | SwabCap® maintains a disinfected valve surface for up to seven (7) days if not removed. (This is the new extended indication and is the primary performance claim supported by the non-clinical testing). |
| Act as a physical barrier to contamination. | The SwabCap® acts as a physical barrier to contamination between line accesses. (Stated in Indications for Use document, consistent with predicate). |
| Biocompatibility | Biocompatibility studies were undertaken to support the changes to the product. (Implied successful completion to meet safety requirements). |
| Sterilization validation | Sterilization validation was undertaken to support the changes to the product. (Implied successful completion to ensure sterility, device is sterile via Gamma irradiation). |
| Antimicrobial efficacy for extended duration (up to 7 days). | Antimicrobial testing was undertaken to support the changes to the product and its intended use. (Implied successful completion to demonstrate efficacy for the 7-day claim). |
| Substantial Equivalence to Predicate (K083508) | The data provided within the 510(k) submission support that the product is as safe and as effective as the predicate device, and therefore, is substantially equivalent to the identified predicate device. |
Study Details (Based on available information)
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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)
- Sample Size: Not specified in the provided summary. As this is a non-clinical submission for a device component, these "test sets" would likely refer to laboratory samples (e.g., luer access valves, material samples) subjected to standardized testing protocols, not a human patient cohort.
- Data Provenance: Not specified. Experiments would typically be conducted in a controlled lab setting, likely in the US where the manufacturer is located, or by certified contract research organizations. The testing described is prospective, in that it evaluates the device's performance under controlled conditions.
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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/mentioned. For non-clinical antimicrobial efficacy, toxicology, and sterilization testing, the "ground truth" is established by validated laboratory assays and adherence to relevant standards (e.g., ISO, ASTM, USP). The expertise would be in microbiology, material science, and toxicology, employed by the testing facility, rather than clinical experts for ground truth labeling.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This concept is relevant for human interpretation tasks, not for non-clinical laboratory testing of device efficacy. Assays have defined endpoints and criteria for success, typically interpreted by a single qualified lab technician or scientist according to a protocol.
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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
- No. This is not an AI/ML device, and thus an MRMC study is not relevant.
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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 AI/ML algorithm; it is a physical medical device (disinfectant cap). Its performance is inherently "standalone" in the sense that it mechanically disinfects, without human interpretation in its function.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Validated Laboratory Assays: This includes standardized microbiological methods to quantify bacterial reduction/inhibition, chemical analysis to verify alcohol concentration, and material science tests for biocompatibility and structural integrity. The "ground truth" is the quantitative result of these assays compared against predetermined acceptance limits derived from regulatory standards and scientific principles.
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The sample size for the training set
- Not applicable. This is not an AI/ML device requiring a training set.
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How the ground truth for the training set was established
- Not applicable. This is not an AI/ML 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.