Search Results

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

Study Details (Applicable to this device type)

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. The sample size for the training set:

   • Not applicable. This device is a physical product, not an AI model that requires a training set.

8. How the ground truth for the training set was established:

   • Not applicable. No training set for an AI model.

Ask a specific question about this device

The intended use for the SmartSite Access Pin is to allow access to IV administration sets, medication vials, blood tubes, and solution bags with one convenient device without the use of needles or blunt cannulas.

The SmartSite Access Pin is a stand alone accessory and is the same device as the currently marketed /VAC Needle Free Valve (K960280) with the exception of a modified housing. The housing for the SmartSite Access Pin has been modified to accommodate the needs of an access pin by adding a protected spike and finger grips. Functionally, the SmartSite Access Pin is the same as the currently marketed /VAC Needle Free Valve in that it allows access to IV administration sets. As an access pin device, the SmartSite Access Pin also allows access to medication vials, blood tubes, and solution bags without the use of needles or blunt cannulas.

This is a medical device 510(k) premarket notification, not a study evaluating an AI algorithm or diagnostic device. Therefore, most of the requested information regarding acceptance criteria for device performance in a study setting, sample sizes for test/training sets, expert involvement, and ground truth establishment, is not applicable.

Instead, this document describes a conventional medical device (SmartSite™ Access Pin) and its substantial equivalence to previously cleared devices. The "acceptance criteria" here would refer to the regulatory requirements for substantial equivalence, rather than statistical performance metrics of a diagnostic algorithm.

Here's a breakdown of the relevant information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This is a 510(k) premarket notification for a traditional medical device, not a study involving a test set of data for an algorithm. The "testing" involved would be engineering and functional testing to ensure the device meets its specifications and is safe, but not in the context of diagnostic performance on patient data.

3. 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. Ground truth and expert adjudication are not relevant for this type of medical device submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable.

5. 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 not an AI algorithm and does not involve human readers for diagnostic interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable.

8. The sample size for the training set

Not applicable.

9. How the ground truth for the training set was established

Not applicable.

Ask a specific question about this device