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For the administration of fluids from a container into the patient's vascular system through a vascular access device.

The proposed devices consist of Intravascular Administration Sets. These devices include Basic, Secondary, and CONTINU-FLO solution sets. They are single use disposable, non-pyrogenic, sterile devices intended for the administration of fluids from a container into the patient's vascular system.

The provided text is a 510(k) summary for Baxter Healthcare Corporation's Intravascular Administration Sets (K203609). It details the substantial equivalence determination for this medical device to a predicate device (Solution Administration Sets, K112893).

However, the summary does not contain the specific information requested in the prompt regarding acceptance criteria, device performance, sample sizes, expert involvement, ground truth establishment, or multi-reader multi-case studies.

The document primarily focuses on:

• Device Description: What the Intravascular Administration Sets are, their components, and how they function.
• Predicate Device Comparison: A detailed table comparing the technological characteristics of the proposed device to the predicate device, highlighting differences in length, priming volume, dimensions, and material components.
• Discussion of Differences: Explanations for each technological difference and assurance that these differences do not raise new questions of safety or effectiveness.
• Nonclinical Tests: A list of bench tests (Luer tests, particulate matter, non-DEHP claim, solvent bond tests, flow rate tests, pump compatibility), biocompatibility tests (cytotoxicity, sensitization, toxicity, hemolysis), and sterility tests (barrier packaging, fluid path, shelf life, sterilization dose establishment, pyrogen testing, microbial ingress). It states that all test results meet their acceptance criteria.

Therefore, I cannot populate the table or provide detailed answers to questions 1-9 as the necessary information is not present in the provided document. The document states that "All test results meet their acceptance criteria," but it does not define what those criteria are or report specific performance metrics against those criteria. It also does not discuss any studies involving human readers or expert consensus for ground truth.

Here's what I can infer from the document, though it falls short of the requested detail:

• Acceptance Criteria & Reported Performance: The document states, "All test results meet their acceptance criteria." This implies that acceptance criteria were established for each of the listed bench, biocompatibility, and sterility tests. However, the specific quantitative acceptance criteria (e.g., maximum allowable particulate matter, minimum burst pressure, flow rate accuracy range) and the reported device performance (e.g., actual particulate count, measured burst pressure, achieved flow rate accuracy) are not provided.
• Sample Sizes: The document does not specify sample sizes used for any of the tests.
• Data Provenance: The tests are described as "bench tests," "biocompatibility," and "sterility" tests conducted by the manufacturer (Baxter Healthcare Corporation). The data would therefore be prospective, internal testing data. No country of origin for data is specified beyond the manufacturer's location (Round Lake, Illinois).
• Experts for Ground Truth / Adjudication / MRMC Study / Standalone Performance: This section of the prompt is highly relevant for AI/ML device clearances (e.g., software as a medical device). This document describes a traditional Class II medical device (intravascular administration sets). There is no mention of AI/ML components, human readers, expert panels, or comparative effectiveness studies in the context of diagnostic or interpretive performance. Therefore, questions regarding these aspects are not applicable to the content provided.
• Type of Ground Truth: For this type of physical device, "ground truth" would be established by the physical and chemical properties and performance characteristics measured in the listed bench, biocompatibility, and sterility tests, compared against established engineering standards (e.g., ISO, USP, ASTM) and internal specifications. There is no subjective human interpretation or diagnostic outcome data involved.
• Training Set Sample Size / Ground Truth Establishment (for AI/ML): These questions are entirely irrelevant to this device and the provided document, as it is not an AI/ML product. The "training set" here would metaphorically be the design and manufacturing processes refined over time.

In summary, the provided document is a regulatory submission for a physical medical device, not an AI/enabled one. Therefore, many of the questions asked, particularly those related to data sets, expert involvement, and reader studies, are not applicable to the content provided.

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The Delta Fly F20μ Micro Bore Winged Safety Needles and the Delta Fly Micro Bore Winged Safety Needles are intended for short term use to access the peripheral vascular system for intravenous administration of fluids using a syringe or other compatible / appropriate devices.

The Delta Med Delta Fly Winged Safety Needles are available in four versions, as follows:

• o Delta Fly F20μ Micro Bore Winged Safety Needle 25G x 35 cm
• . Delta Fly F20μ Micro Bore Winged Safety Needle 23G x 35 cm
• Delta Fly Micro Bore Winged Safety Needle 25G x 35 cm ●
• Delta Fly Micro Bore Winged Safety Needle 23G x 35 cm

The devices consist of a stainless steel needle encased in a body of plastic material, attached to a micro bore tube, ending proximally with a female Luer lock fitting closed by a final male Luer lock cap. The female Luer lock fitting includes a 20μ woven mesh filter in the F20μ versions of the device. The devices are equipped with a passive needle stick safety system for covering the tip of the needle upon needle withdrawal, in order to protect the operator from accidental needle stick injury.

To help identification between the two types (with and without filter), the male Luer lock proximal end cap is colored white on the versions with the filter and is transparent on the versions without the filter. To identify the needle size of each version, the winged body of the devices are color-coded blue for the 23G versions and orange for the 25G versions.

The distal end of the device is a stainless steel needle point has a triple bevel design. At the proximal end is a Luer lock fitting. Both device versions (with and without the mesh filter) have a final female connection in compliance with the requirements of ISO 594-2.

Delta Fly Micro Bore Winged Safety Needles are supplied for short term use only, sterile for single use, sterilized with ethylene oxide (EO) gas, and meet the biocompatibility requirements of ISO 10993-1:2009.

The provided document describes the Delta Fly F20u Micro Bore Winged Safety Needles and Delta Fly Micro Bore Winged Safety Needles. Here's an analysis of the acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by adherence to established international standards and specific performance tests. The reported device performance indicates that these criteria were met.

2. Sample Sizes Used for the Test Set and Data Provenance

• Sample Size for Test Set: The document explicitly states that the Simulated Clinical Usage test was conducted at "four different hospitals to allow a sufficient number of healthcare professional who routinely use Winged Needles". However, the exact number of devices or uses tested is not specified within the provided text.
• Data Provenance: The manufacturer, Delta Med SpA, is located in Viadana (Mantova), Italy. Given the context, the tests were likely conducted in Italy or within Europe under the manufacturer's supervision, but the specific country of origin for the data (other than the manufacturer's location) for all tests is not detailed. The Simulated Clinical Usage test was performed at "four different hospitals," implying a prospective collection of data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

• Number of Experts: The Simulated Clinical Usage test involved "healthcare professional who routinely use Winged Needles." The exact number of individual healthcare professionals is not specified.
• Qualifications of Experts: They are described as "healthcare professional who routinely use Winged Needles," indicating practical experience with the device type. Specific qualifications (e.g., nurse, physician, years of experience) are not provided.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (like 2+1 or 3+1). The "Simulated Clinical Usage test" results state that "100% of the safety mechanism of the devices activated correctly" and "No tests failures occurred," suggesting observation and recording of outcomes without mentioning a specific adjudication process for discrepancies, if any. Given the nature of the test (device activation and failure), it might have been a direct observation without requiring expert adjudication in the traditional sense of diagnostic interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document describes performance testing and a simulated clinical usage test to demonstrate the device's functionality and safety, and substantial equivalence to predicate devices. It does not describe a multi-reader multi-case comparative effectiveness study comparing human readers with and without AI assistance. This device is a medical needle, not an AI diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable as the device is a physical medical needle, not an algorithm or AI system.

7. The Type of Ground Truth Used

For the performance tests (e.g., surface testing, corrosion, gauging, leakage, tensile strength, flow rate), the ground truth is established by compliance with specified international standards (ISO 594-2, ISO 9626, ISO 23908). This is a form of empirical and objective measurement against defined benchmarks.

For the "Simulated Clinical Usage test," the ground truth for "correct activation of the safety mechanism" and "test failures" would be based on direct observation and operational assessment by the participating healthcare professionals against the device's intended functionality and safety design.

8. The Sample Size for the Training Set

This question is not applicable as the device is a physical medical needle and does not involve AI or machine learning models that require a training set.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable as the device is a physical medical needle and does not involve AI or machine learning models that require a training set.

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Acta Medical Intravascular administration set intended use is to deliver sterile, infusion fluid from a container to the patient with or without flow control features. Acta Medical infusion tubing may act as an extension of other infusion tubing in delivering intravenous fluids from a container to patient.

Acta Medical, LLC Intravascular administration set is sterile/pvrogen free. non-DEHP PVC tubing with the following combination of components.

• Universal Spike.
• Drip chamber with 15 micron filter.
• Non-DEHP PVC tubing.
• Flow Regulator.
• Roller clamp.
• Slide clamp.
• Luer locks.
• Filters.
• Latex free "Y" site or pre-approved needleless "Y" site for secondary infusions or medication administration.

This document is a 510(k) premarket notification for an Intravascular Administration Set. It primarily establishes substantial equivalence to a predicate device and does not contain detailed acceptance criteria or a dedicated study report, especially concerning performance metrics typically associated with AI/ML devices. Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or training set details from the provided text.

The document states:
"Acta Medical, LLC Intravascular Administration Set is substantially equivalent to the predicate device, Truecare Biomedix Intravascular Administration Set (K111351). Acta Medical utilizes the same contract manufacturer and manufacturing location (Wei De Li Trade Co. Ltd) as utilized by predicate device, identical component materials, identical indication for use, identical manufacturing process, identical sterilization process & SAL. Acta Medical Intravascular Administration Sets are identical to predicate device and present no additional safety concerns as compared to the predicate device."

This statement indicates that the submission relies on the established safety and effectiveness of the predicate device due to identical characteristics, rather than presenting new performance data against specific acceptance criteria for a novel device.

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The Intravascular Administration Set and Extension Set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the patient's artery or vein. The Intravascular Administration Set and Extension Set may incorporate componentry that aid in the prevention of accidental needle sticks.

The Intravascular Administration Set and Extension Set is components commonly found on intravascular administration sets. Intravascular administration sets consists of various components such as: bag spike, drip chamber, burette, tubing, Y-site, clamp, flow controller, check valve injection site, needleless injection site, stopcock, manifold, filter, flash bulb, luer connectors and bag hanger. Extension sets consist of various parts such as: luer connector, tubing, clamp, check valve flow controller, Y-site, injection port, needleless injection port, stopcock, filter, and manifold. For custom applications, a customer may request a certain length, priming volume and componentry. So. the set and actual components will vary with customer specifications.

Components will be assembled into standard configurations specified by the customer and packaged.

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance metrics, clinical study design, or expert involvement as described in your request. The document appears to be a 510(k) summary for an "Intravascular Administration Set and Extension Set," primarily focusing on regulatory information, device description, intended use, and biocompatibility, but not on clinical performance evaluation details.

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Indicated as a single use, sterile device for use in I.V. therapy when an extended fluid path is required for administration.
Environment of use: Hospital, Emergency Medical Services, Home care settings wherever I.V. fluid administration may be indicated.

The Custom Assemblies Extension Set is a tubing set with various connectors, and accessories, such as drip chambers, infusion line filters, clamps, integral check valves, spikes, Y-site injection sits used as an extension of a fluid pathway for I.V. administration.

The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) submission for a medical device (Extension set/Intravascular Administration Set), focusing on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with acceptance criteria.

Therefore, I cannot extract the requested information from the provided text.

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Intravascular Administration Set and Extension Set is a device used to serve as a conduit for delivery of I.V. fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. Additional indications for use of this device is to provide multiple secondary sterile injection sites for other infusion fluids. The device may include a drip chamber with a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container, an infusion line filter, a 2 or 3 port manifold or I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a Y-site injection site, a PRN injection site, a Y-site with integral check valve, a Spin-Loc connector and one or more Roller/Slide/Pinch clamps.

Intravascular Administration Set/Extension Set

This document is a 510(k) clearance letter from the FDA for an "Intravascular Administration Set/Extension Set." It does not contain information about acceptance criteria, device performance studies, or details relevant to the performance evaluation of a medical device based on specific metrics like sensitivity, specificity, or accuracy.

The letter primarily:

• Confirms substantial equivalence: States that the device is substantially equivalent to legally marketed devices.
• Outlines regulatory requirements: Refers to general controls, special controls, GMP regulations, and other relevant FDA provisions.
• Approves marketing: Allows the manufacturer to begin marketing the device.
• Specifies intended use: Provides a brief description of the device's function as a conduit for IV fluids and details some of its components.

Therefore, I cannot provide a response to your request as the provided text does not contain the necessary information regarding:

1. Acceptance criteria and reported device performance: No performance metrics are mentioned.
2. Sample size and data provenance: No study data is presented.
3. Number and qualifications of experts for ground truth: Not applicable as no ground truth was established for this type of regulatory submission.
4. Adjudication method: Not applicable.
5. MRMC comparative effectiveness study: Not conducted or mentioned.
6. Standalone performance: Not conducted or mentioned.
7. Type of ground truth: Not applicable.
8. Training set sample size: Not applicable.
9. Ground truth establishment for training set: Not applicable.

This type of FDA letter is a regulatory approval, not a scientific publication detailing a device's performance study.

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