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The nPulse™ neutral displacement connector is a single patient use, sterile, nonpyrogenic device for needleless access to the IV line and/or IV catheter during IV therapy. The nPulse™ connector can be used for direct injection, intermittent infusion, continuous infusion, or aspiration.

The nPulse K150 Neutral Displacement Needle Free Connector is a single patient use, sterile, non-pyrogenic device for needleless access to the IV line and/or IV catheter during IV therapy. The nPulse K150 Neutral Displacement Needle Free Connector can be used for direct injection, intermittent infusion, continuous infusion, or aspiration. The nPulse K150 valve is a normally closed, luer-activated, valved connector which has an open mode that permits bi-directional fluid flow and a closed mode that prevents fluid flow.

The provided text describes a medical device, the NP Medical nPulse™ K150 Neutral Displacement Needle Free Connector, and its substantial equivalence to a predicate device (NP Medical K100 Neutral Displacement Needle Free Connector) for FDA 510(k) clearance.

The document highlights performance testing conducted to support this equivalence. Here's extraction of relevant information regarding acceptance criteria and study details:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria alongside performance data in a direct row-by-row comparison. Instead, it lists the performance tests conducted and generally states that the device "has been evaluated using the appropriate methodology as specified in the FDA recognized consensus standards and in conjunction with NP Medical established test protocols" and that differences from the predicate "demonstrated applicable performance" or "aligns with current best practices."

However, specific performance claims and how they relate to the predicate and established standards are mentioned for certain differences:

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

The document does not specify the exact sample sizes used for each of the performance tests (e.g., number of devices tested for Air Bolus, Repeat Insertion, etc.). It mentions "all test device replicates" for microbial ingress testing but doesn't quantify this.

The provenance of the data (country of origin, retrospective/prospective) is not explicitly stated in the provided text. It implies internal testing by NP Medical, Inc., located in Clinton, MA, USA.

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)

This information is not applicable to this type of device and study. The testing for the NP Medical nPulse™ K150 connector involves technical performance benchmarks (e.g., flow rates, pressure resistance, sterility) rather than clinical evaluations requiring expert interpretation of diagnostic images or patient outcomes.

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

This information is not applicable. Adjudication methods are typically used in clinical studies, particularly when interpreting subjective data or reaching consensus on diagnoses, which is not the nature of the bench testing described here.

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

This information is not applicable. MRMC studies and AI assistance are relevant to diagnostic tools or image analysis, not to a needle-free connector's performance.

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

This information is not applicable. This device is a physical medical device, not an algorithm or AI system.

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

The "ground truth" for the performance tests conducted on the NP Medical nPulse™ K150 connector and its predicate device is established by specified functional requirements and consensus standards. For example:

• Microbial ingress testing: The ground truth is the absence of microbial growth (0 CFU recovered), demonstrating sterility barrier integrity.
• Pressure ratings, flow rates, etc.: The ground truth is compliance with pre-defined engineering specifications and relevant FDA recognized consensus standards (e.g., ISO standards) for intravascular administration sets.

8. The sample size for the training set

This information is not applicable. This is not a machine learning or AI device that requires a training set.

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

This information is not applicable. As in point 8, this device does not utilize machine learning or AI requiring a training set with established ground truth.

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The nPro surgical masks are intended for operating room personnel health care workers to protect both patients and healthcare workers from the transfer of microorganisms, blood and particulate materials. nPro Surgical Masks are single use, disposable devices provided non-sterile.

The nPro surgical mask meets ASTM F2100-19 Level 1 performance requirements for bacterial filtration efficiency, differential pressure, sub-micron particulate filtration efficiency, resistance to penetration by synthetic blood and flame spread.

The three-ply pleated mask fabric can be vertically adjusted to cover the user's mouth and nose. The inner and outer layers are constructed of non-woven fabric. The middle layer is constructed of melt-blown negative charge non-woven fabric and includes a flexible nose wire to the user's nose and reduce air gaps. The three layers of the mask body are collated and ultrasonically welded around the edges to enclose the filter media and nose wire. The polyester-spandex ear loops are ultrasonically welded to the mask body. All materials are not made with natural rubber latex. The nPro Surgical Masks are single use, disposable devices that are provided non-sterile in a dispensing carton.

This document is a 510(k) premarket notification for a surgical mask, not an AI-powered medical device. Therefore, the information typically requested regarding AI/ML device performance (like MRMC studies, training set details, or multiple expert ground truth establishment) is not applicable here.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the non-clinical performance testing conducted on the surgical mask to demonstrate its substantial equivalence to a predicate device.

Here's the breakdown of the relevant information provided:

1. A table of acceptance criteria and the reported device performance

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The K100 Neutral Displacement Connector is a single patient use, sterile, non-pyrogenic device for needleless access to the IV line and/or IV catheter during IV therapy. The K100 connector can be used for direct injection, intermittent infusion, continuous infusion, or aspiration.

The K100 Neutral Displacement Needleless Connector is a sterile, single patient use, swabable, normally closed, luer-activated, valved connector. The K100 valve is comprised of a: a housing (inlet and outlet), a fluid channel, a translating member (or lower gland) secured to a longitudinal wall of the housing and bounding a variable volume region of the fluid channel, a post having a lumen terminating at a distal head of the post and biased in the proximal direction by the lower gland when in the closed mode, and an upper seal having a sealing ring and secured to the longitudinal wall of the housing, the sealing ring contacting the distal head of the post when in the closed mode to prevent flow through the fluid channel, Moving components within the assembly are lubricated with silicone oil.

The provided text is a 510(k) summary for the K100 Neutral Displacement Needle Free Connector. It outlines the device's description, intended use, comparison to a predicate device, and performance testing. However, it does not contain acceptance criteria for specific performance metrics nor detailed study results that prove the device meets these criteria in a quantitative manner.

Instead, it states that "All test results meet the acceptance criteria, and support that the devices are appropriately designed for their intended use." without providing the criteria themselves or the specific data showing compliance.

Therefore, I cannot populate the table with acceptance criteria and reported device performance, nor can I provide specific details on sample sizes, ground truth establishment, or clinical study types (like MRMC or standalone) because this information is not present in the provided document.

Here's an overview of what is available in the document related to performance claims:

1. Table of acceptance criteria and the reported device performance:

This information is not explicitly provided in a quantifiable manner. The document lists the tests performed and states that "All test results meet the acceptance criteria." without detailing what those criteria are or the specific results.

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: Not specified for any of the performance tests.
• Data Provenance: The tests were "conducted by NP Medical," indicating internal testing. The country of origin and whether the data is retrospective or prospective are not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable/Not specified. These are bench tests, not involving human interpretation or subjective assessments typically requiring expert consensus as ground truth.

4. Adjudication method for the test set:

• Not applicable/Not specified. This pertains to expert review of ambiguous cases, which is not relevant for bench testing of medical devices like this connector.

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:

• No. This type of study is for evaluating AI systems in diagnostic imaging or similar fields. This document describes a medical device (needle-free connector) and its mechanical/physical performance, not an AI system.

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

• No. This question is relevant for AI algorithms. The document describes a physical medical device. The "standalone" performance here refers to the device's functional integrity as a component.

7. The type of ground truth used:

• For the bench tests listed (e.g., Air Bolus, Flow Rate, Hydraulic Burst Leak), the "ground truth" would be established by physical measurement against a predefined engineering specification or standard. The document states that "All test results meet the acceptance criteria," implying such specifications were used.

8. The sample size for the training set:

• Not applicable. This device is not an AI algorithm that requires a "training set."

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

• Not applicable. This device is not an AI algorithm that requires a "training set."

Summary of available performance claims:

The document lists the following bench tests that were conducted, and for each, it explicitly states that "All tests met acceptance criteria."

• Air Bolus and Bubble Free Priming
• Repeat Insertion
• Blood Flushing Evaluation
• Bolus Back Pressure
• Docking Stability
• Flow Rate
• Fluid Displacement
• Gland Height Determination
• Hydraulic Burst Leak
• ISO 594 Test Methods
• Lipid Resistance
• Priming Volume
• Residual Volume
• Stress Resistance to Swabbing Chemicals (IPA and CHG).
• Torque Testing
• Microbial Ingress testing
• Sterilization Validation
• Packaging/Shelf Life Validation

The comparison to the predicate device also highlights some performance aspects:

• Multiple Activations: K100 (96 intermittent) vs. Predicate (96 intermittent)
• Indwell: K100 (96 hours) vs. Predicate (96 hours)
• Pressure Rating: K100 (325 psi) vs. Predicate (> 60 psi)
• Priming Volume: K100 (0.12 mL) vs. Predicate (0.25 mL)
• Microbial Ingress Test: K100 (Pass) vs. Predicate (Pass)

The document concludes that "The K100 Neutral Displacement Needle Free Connector is substantially equivalent to the identified predicate system based on the indication for use, design features, operating principles, performance tests and material composition."

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The Capless Luer Activated Valve, incorporating a luer activated valve, is intended for use in facilitating needleless fluid delivery and may be swabbed with antiseptic just prior to use, thereby eliminating the need for capping between uses.

The Capless Luer Activated Valve is a two-part device consisting of a Gland Housing Assembly and a Gland/Center Post Assembly, as described below:

The Gland is a valve/gasket which provides a seal against the syringe/luer connector when the device is being utilized. The Gland incorporates a slit to accept the syringe/luer connector. The Gland is also the swabbable surface of the Capless Luer Activated Valve. The valve can be easily swabbed per hospital protocol before each connection.

The Center Post mechanically supports the Gland and serves as the primary high pressure seal to keep the fluid path closed during the resting state.

The Gland and the Center Post are mechanically press-fit together to form the Gland/Center Post Assembly.

In the resting state, the Center Post is flush with the walls of the Gland Housing, ensuring that there is no fluid path. As the device is activated by a syringe/male luer connector, the flexible Gland is forced open and the Center Post is pushed down. As the Center Post is forced further down into the Gland Housing, the fluid path is established.

The provided text describes a 510(k) submission for a medical device, the "NP Medical Capless Luer Activated Valve." However, it does not contain the detailed information necessary to fully answer all aspects of your request, particularly regarding specific numerical acceptance criteria and the results of a study that quantifies device performance against those criteria. The submission states that performance requirements were met but does not provide the specific metrics or values.

Here's a breakdown of the available information based on your requested points:

1. A table of acceptance criteria and the reported device performance

The document mentions that mechanical, biocompatibility, and microbial challenge testing were performed and that the device "meets their performance requirements" or "passed all" tests. However, it does not specify the exact acceptance criteria or the quantitative results achieved. Without specific numerical values for acceptance criteria and device performance from the document, a table cannot be constructed with the requested level of detail.

Illustrative Table (Based on available qualitative information):

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

The document does not specify the sample sizes used for any of the tests (Mechanical, Biocompatibility, Microbial Challenge). It also does not explicitly state the provenance of the data (country of origin, retrospective or prospective). Given that NP Medical, Inc. is located in Clinton, MA, and the submission is to the FDA, it is highly probable the testing was conducted in the USA by or for the manufacturer. The testing described (mechanical, biocompatibility, microbial challenge) is typically prospective and laboratory-based.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable and therefore not available in the provided document. The device is a physical medical device (a luer activated valve), not an AI or diagnostic imaging device that requires expert review for ground truth establishment. The performance is assessed through laboratory testing (mechanical, chemical, microbial) rather than interpretation by human experts.

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

This information is not applicable and therefore not available in the provided document. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving human expert assessment where there might be disagreement in interpretations (e.g., in radiology studies). This submission describes laboratory-based engineering and biological tests for a physical device, not an interpretive process.

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

This information is not applicable and therefore not available in the provided document. An MRMC study is relevant for evaluating diagnostic tools, often AI-powered, where human readers interpret patient cases. The Capless Luer Activated Valve is a physical device for fluid delivery, not a diagnostic tool, and involves no "human readers" in its intended function or performance testing described.

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

This information is not applicable and therefore not available in the provided document. "Standalone performance" in this context usually refers to the performance of an AI algorithm alone. The NP Medical Capless Luer Activated Valve is a physical medical device, not an algorithm. Its performance is inherent in its physical and material properties.

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

For the mechanical testing, the "ground truth" would be defined by engineering specifications and established test methods (e.g., pressure resistance, flow rates, number of activation cycles without failure). For biocompatibility, the "ground truth" is determined by standardized biological assays according to ISO 10993. For microbial challenge testing, the "ground truth" is the absence of microbial growth in the fluid pathway after being subjected to a known microbial load, following established microbiological testing protocols.

8. The sample size for the training set

This information is not applicable and therefore not available in the provided document. "Training set" refers to data used to train machine learning models. As this is a physical medical device, there is no "training set" in the context of AI. The device's design and manufacturing rely on engineering principles and material science, not machine learning.

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

This information is not applicable and therefore not available in the provided document. As there is no AI training set for this physical device, there is no ground truth to be established for it.

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