(266 days)
The InfuSite Needleless Access Device is a closed system needleless accessory, which permits blood sampling, intermittent injection or infusion of fluids or medications when connected exclusively to luer systems.
The InfuSite Needleless Access Device is a closed system needleless multi-purpose catheter accessory, permitting blood sampling, intermittent injection or continuous infusion of fluids or medications. Connection is exclusively with the Luer systems. The InfuSite Needleless Access Device has a polycarbonate male/female luer housing with a swabable silicone membrane, which opens automatically upon connection with a male luer and closes automatically when the male luer is disconnected. Disinfection must be carried out before and after use. The InfuSite contains no metallic components.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the InfuSite Needleless Access Device:
Important Note: The provided document is a 510(k) summary for a medical device (Needleless Access Device), not a diagnostic algorithm or AI software. Therefore, many of the requested categories like "multi reader multi case (MRMC) comparative effectiveness study," "standalone algorithm performance," "number of experts for ground truth," and "training set details" are not applicable to this type of device submission. The focus of this submission is on demonstrating substantial equivalence to predicate devices through performance testing and biocompatibility, not on diagnostic accuracy of an AI.
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Specific Criteria (if stated) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Non-irritant, non-toxic | "Biocompatibility data demonstrates that the materials used are non-irritant and non-toxic." |
| Performance Testing | Substantial equivalence to predicate devices (SmartSite K960280, Swabsite K002689) | "Performance testing demonstrates that the device is substantially equivalent to the predicate devices." |
| Risk Assessment | Compliance with ISO 14971 | "Risk Assessment was conducted in compliance with ISO 14971." |
| Material Equivalence | Equivalent to predicate devices, no new safety/efficacy issues | "The materials and technology of the InfuSite Needleless Access Device are equivalent to the predicate devices and no new issues of safety and efficacy have been introduced with this device." |
| Indications for Use | Identical to predicate devices | "The indications for use are identical to the predicate devices." |
Study Details (Applicable to this device type)
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Sample size used for the test set and the data provenance:
- The document does not explicitly state the sample sizes for the performance testing. This information would typically be detailed in the full 510(k) submission, not the summary.
- Data Provenance: Not specified. It's likely that the testing was conducted in a laboratory setting by the manufacturer or contracted labs, rather than involving patient data from specific countries. The testing would be prospective in the sense that the device was specifically tested to meet certain criteria.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable for this type of device (needleless access device). Ground truth for diagnostic accuracy (which requires experts) is not relevant here. The "truth" for this device's performance would be objective measurements (e.g., fluid flow rates, leak testing, material integrity, microbiological barrier testing) against established engineering and regulatory standards.
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Adjudication method for the test set:
- Not applicable. As the "ground truth" is based on objective, measurable performance characteristics rather than expert interpretation, adjudication methods used for diagnostic studies (like 2+1) are not relevant here.
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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 physical medical device, not an AI or diagnostic algorithm that interacts with human readers.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a physical medical device, not an algorithm.
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The type of ground truth used:
- The "ground truth" for this device's performance is based on objective engineering and regulatory standards, including:
- Biocompatibility test results (e.g., cytotoxicity, sensitization, irritation indices).
- Physical performance metrics (e.g., flow rates, pressure resistance, leakage, connection integrity, seal integrity after disconnections, microbial barrier performance).
- Compliance with recognized standards (e.g., ISO, specifically ISO 14971 for risk assessment, and likely other ISO fluid connector standards).
- Comparison to the performance characteristics of predicate devices.
- The "ground truth" for this device's performance is based on objective engineering and regulatory standards, including:
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The sample size for the training set:
- Not applicable. This device is a physical product, not an AI model that requires a training set.
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How the ground truth for the training set was established:
- Not applicable. No training set for an AI model.
§ 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.