Search Results

The Nouvo Safety Set IV Catheter are indicated for insertion into a patient's vascular system to sample blood. Infusion of fluids such as solutions, parenteral nutrition of other drugs. The catheters may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused, and duration of therapy. The 18G-22G catheters may be used intravascularly with power injectors at a maximum pressure of 300 psi.

The Nouvo Safety Set is an over the Needle Intravascular Catheter, peripheral, it incorporates the passive safety clip to help prevent needle stick injuries. The catheter is made from a radio-opaque polyurethane (PUR) material. The devices have a septum, stabilization platform, integrated extension tubing, c-clamp, single luer, needle free connector, safety clip, access split septum with site luer and vent plug. The needle cover protects the needle and catheter. The color of the catheter hub identifies the gauge size, the catheter gauge size and length are identified on the product packaging. The Nouvo safety set IV catheter is provided sterile and non-pyrogenic for single use only. The Nouvo safety set IV catheter is not made with natural rubber latex or PVC. The subject device shares the similar technological characteristics, principles of operation and the same fundamental scientific technology as the predicate device. Both devices have needleless adaptors and passive safety features. The Needleless adaptor used in the subject device is FDA cleared. The Nouvo Safety Set has the following features: needle cover, introducer needle, needle hub, radiopaque catheter, colored wings, catheter hub, C-clamp, extension tube with or without the N-Pules needles connection (single port, single port with needle free valve, dual port with needle free valve) cleared under K220288 (NP Medical). The immediate flashback system has a plug that prevents leaking and seepage. Upon removal, the safety clip is engaged to prevent needle sticks. There are no additional accessories included with the Nouvo Safety Set.

The provided text describes a 510(k) premarket notification for the "Nouvo Safety Set" intravascular catheter and does not contain information about a study comparing the device's performance against specific acceptance criteria in the context of an AI/human-in-the-loop study. Instead, it details bench testing, biocompatibility, packaging, sterilization, and shelf-life testing to demonstrate substantial equivalence to a predicate device, as required for FDA clearance.

Therefore, I cannot provide the specific details you requested regarding:

• A table of acceptance criteria and reported device performance related to AI/human-in-the-loop.
• Sample size used for the test set and data provenance for an AI study.
• Number of experts and their qualifications for establishing ground truth in an AI study.
• Adjudication method for an AI study.
• Effect size of human readers with AI vs. without AI assistance.
• Standalone performance (algorithm only) of an AI.
• Type of ground truth used for an AI study.
• Sample size for the training set of an AI.
• How ground truth for the training set of an AI was established.

The document focuses on the safety and effectiveness of a medical device (intravenous catheter) through traditional engineering and biological testing, rather than the performance of an AI algorithm.

Ask a specific question about this device

The Polysafety BC IV Catheter are indicated for short-term use (less than 30 days) for insertion into a patient's vascular system to sample blood or administer fluids such as solutions, parenteral nutrition, and administration of other drugs. The catheters may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused and duration of therapy. The 18G-24G catheters may be used intravascularly with power injectors at a maximum pressure of 300psi.

The Polysafety BC Adva IV Catheter are indicated for short-term use (less than 30 days) for insertion into a patient's vascular system to sample blood or administer fluids such as solutions, parenteral nutrition, and administration of other drugs. The catheters may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused and duration of therapy. The 180-24G catheters may be used intravascularly with power injectors at a maximum pressure of 300psi.

The Polywin Safety IV Catheter are indicated for short term use (less than 30 days) for insertion into a patient's vascular system to sample blood or administer fluids such as solutions, parenteral nutrition and administration of other drugs. The catheters may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused and duration of therapy. The 14G-24G catheters may be used intravascularly with power injectors at a maximum pressure of 300psi.

The Polywin Safety Adva IV Catheter are indicated for short term use (less than 30 days) for insertion into a patient's vascular system to sample blood or administer fluids such as solutions, parenteral nutrition and administration of other drugs. The catheters may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused and duration of therapy. The 14G-24G catheters may be used intravascularly with power injectors at a maximum pressure of 300psi.

The Polysafety-BC safety IV Catheter is an over-the-needle blood control. Peripheral passive Safety IV Catheter incorporates a safety clip to help prevent needle-stick injuries & blood control valve to reduce blood exposure during initial catheter placement, blood sampling, withdrawal of the needle, and connection of the luer. The Polysafety BC Safety IV Catheter is provided with a detachable or integrated, flexible perforated soft wing for providing ventilation & skin maceration. The device also incorporates a 'quick flash back'.

The Polywin safety IV Catheter is an over the needle, Peripheral passive Safety IV Catheter that incorporates a safety clip to help prevent needle- stick injuries. The Polywin Safety Adva IV Catheter provided with quick flash back features.

The provided text describes a 510(k) premarket notification for Poly Medicure Limited's Polysafety BC, Polysafety BC Adva, Polywin Safety, and Polywin Safety Adva Intravascular Catheters. The submission aims to demonstrate substantial equivalence to existing predicate devices.

Crucially, this document is a 510(k) submission, not a study report detailing acceptance criteria for an AI/ML medical device. It describes the safety and effectiveness testing for intravascular catheters, which are physical medical devices, and does not involve an AI/ML component. Therefore, the questions related to AI/ML device performance (like sensitivity, specificity, MRMC studies, training/test sets, expert adjudication, or ground truth for AI models) are not applicable to this document.

The document discusses the physical and functional characteristics of the catheters and compares them to predicate devices based on non-clinical (bench) testing against recognized standards.

Here's an attempt to answer the questions based on the provided document, noting that many AI-specific questions are inapplicable:

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

The document does not present a single table of "acceptance criteria" against "reported device performance" in the way an AI/ML device evaluation would for clinical metrics. Instead, it demonstrates compliance with a series of recognized standards and guidances through bench testing to establish substantial equivalence.

The "acceptance criteria" are implied by successful compliance with these standards. The "reported device performance" is a statement of successful adherence to these standards.

Here's a summary of the standards the devices were tested against:

Summary of Tested Standards (Acceptance Criteria are implied by successful compliance)

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

This information is not provided in a way that is typically presented for AI/ML device testing. The tests are bench tests of physical devices to demonstrate compliance with standards. The document does not specify "sample size for the test set" in terms of patient data or clinical images. The data provenance is related to the manufacturing location (India) and the performance of tests according to international and FDA-recognized standards. The testing is non-clinical (bench testing), not clinical or involving 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. This is not an AI/ML device that requires expert-established ground truth from images or other patient data. The "ground truth" for these physical devices is conformity to engineering and biological standards validated through laboratory testing.

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

Not applicable. This is not an AI/ML device and does not involve adjudication of expert readings or interpretations.

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 is not an AI/ML device. No MRMC study was performed or is relevant.

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 AI algorithm.

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

Not applicable. The "ground truth" for demonstrating substantial equivalence of these physical devices is adherence to established international and national (FDA) standards for medical devices (e.g., ISO, ASTM, USP). This is verified through engineering bench testing and biocompatibility assessments, not clinical "ground truth" from patient outcomes or expert consensus on medical images.

8. The sample size for the training set

Not applicable. This is not an AI/ML device. There is no training set in the context of machine learning.

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

Not applicable. There is no training set or AI-specific ground truth establishment for this physical device.

Ask a specific question about this device

The Polyshield and Polyguard Safety IV Catheters are indicated for short term use (less than 30 days) for insertion into a patient's vascular system to sample blood, monitor blood pressure, or administer fluids. The catheters may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused, and duration of therapy. The 14 - 24G catheters may be used intravascularly with power injectors at a maximum pressure of 300 psi.

The Polyshield and Polyguard Safety IV Catheters are over-the-needle, peripheral safety IV catheters that incorporate an active sharps prevention needle shield. The 'BC' versions also incorporate a blood control feature, and the 'Adva' versions include 'quick flash back' needle technology. The devices are available in multiple gauge sizes and lengths.

The provided text does not describe an AI medical device or a study involving AI assistance. Therefore, I cannot provide information on acceptance criteria, reported device performance, sample size for test sets, data provenance, expert involvement for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or training set details as requested in the prompt.

The document describes the regulatory submission for Polyguard and Polyshield Safety IV Catheters, which are traditional medical devices, not AI-powered. The submission focuses on demonstrating substantial equivalence to a predicate device (BD Insyte Autoguard BC IV Catheter) through non-clinical performance testing and biocompatibility assessments, rather than AI performance metrics.

Ask a specific question about this device

For administration of fluid from a container into the patient vascular system through a vascular access device.

The Polyfusion IV Administration Sets are available in multiple configurations. In more detail:

Polyfusion NFV IV Administration Sets: Used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein. The set may include a vented or non-vented universal spike, drip chamber, fluid delivery tubing, flow regulator, stop cock, back check valve, needle free valves, 0.2 µm inline filter, slide clamp, Luer connectors, and priming filters. Four different drip rates are available, viz: 10 drops/ml, 15 drops/ml and 60 drops/ml. Different lengths are available, from 196 cm to 276 cm, together with options for certain components being made either from PVC which has not been manufactured using DEHP plasticiser or using an alternative material which has not been manufactured with either PVC or DEHP. The sets are labeled for prescription use (Rx only) and are supplied sterile for single use only, with a sterilization assurance level (SAL) of 10-6 achieved by means of a validated ethylene oxide sterilization process.

Polyfusion Air Stop IV Administration Sets: Used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein. The inclusion of an air stop filter maintains a constant fluid level in fluid delivery tubing and reduces the possibility of air entering the line when the I.V. bottle/bag is empty. The set may include a vented or non-vented universal spike, drip chamber, air stop filter, fluid delivery tubing, flow regulator, stop cock, back check valve, needle free valves, 0.2 um inline filter, slide clamps, Luer connectors, and priming filters. Four different drip rates are available, viz: 10 drops/ml, 20 drops/ml and 60 drops/ml. Different lengths are available from 196 cm to 276 cm, together with options for certain components being made either from PVC which has not been manufactured using DEHP plasticiser or using an alternative material which has not been manufactured with either PVC or DEHP. The sets are labeled for prescription use (Rx only) and are supplied sterile for single use only, with a sterilization assurance level (SAL) of 10-6 achieved by means of a validated ethylene oxide sterilization process.

This document describes the Polyfusion IV Administration Sets, a medical device designed for administering fluids from a container into a patient's vascular system. The information provided outlines the device, its performance testing, and a comparison to a predicate device to establish substantial equivalence for FDA clearance.

Here's an analysis of the provided information, focusing on acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are primarily demonstrated through compliance with recognized international and national standards, and internal testing. The document presents a comparison of the subject device (Polyfusion IV Administration Sets) with a predicate device (Baxter Healthcare Corp.'s Intravascular Administration Set, K203609) to show substantial equivalence.

Since this is a 510(k) submission for an IV administration set, the acceptance criteria are not typically expressed as specific performance metrics with explicit pass/fail values in this summary. Instead, they are demonstrated by fulfilling the requirements of the referenced standards and showing comparable safety and effectiveness to the predicate device.

• ISO 8536-4:2019 (Infusion equipment for medical use - Infusion sets for single use, gravity feed) - FDA recognized
• ISO 8536-14:2016 (Infusion equipment for medical use - Infusion sets for single use with pressure infusion apparatus) - Not FDA recognized, but tested
  Comment #4 on Drip Rates: Subject device offers 10, 15, and 60 drops/ml. Predicate has 10 drops/ml. When used at 10 drops/min, both are similar.
  Comment #5 on Priming Volume: Subject device has approx. 25 ml. Predicate has 6.1 to 21.2 ml. Differences noted but do not raise new safety/effectiveness questions. |
  | Connection Integrity (Luer Connectors) | Successful compliance testing with:
• ISO 80369-7:2021 (Small-bore connectors for liquids and gases in healthcare applications - Connectors for intravascular or hypodermic applications) - FDA recognized |
  | Particulate Matter Reduction (0.2 µm inline filter) | Successful compliance testing with:
• USP Method 1 (Particulate Matter in Injections) - Not FDA recognized, but tested |
  | Packaging & Sterility Integrity (during Shipping & Shelf-life) | Successful compliance testing with:
• ISTA-3A:2018 (Shipping performance test) - FDA recognized
• ASTM F-1886 / F-1886M-16 (Seal integrity of flexible packaging) - FDA recognized
• ASTM F-2096 (Detecting gross leaks in nonporous flexible packaging) - FDA recognized
• ASTM F-1929 (Seal integrity of flexible packaging by dye penetration) - FDA recognized
• EN 868-5:2018 (Sterile barrier systems for medical devices - Sealable pouches and reels) - Not FDA recognized, but tested
• Microbial Ingress testing (to confirm sterility barrier)
• Sterilization and shelf life confirmed by testing per ISO 8536-4:2019, ISO 8536-14:2016, ISO 80369-20:2015, USP 2012, ASTM F-1929, ASTM F-2096, ASTM F-88 / F88M-15, USP 2012, all following accelerated aging (ASTM F 1980-16). |
  | Microbial Ingress Prevention | Microbial Ingress testing performed. |
  | Biocompatibility | Biocompatibility established by testing in accordance with ISO 10993-1:2018 Annex A, considering relevant FDA guidance, including:
• Cytotoxicity (ISO 10993-5:2009) - FDA recognized
• Sensitization (ISO 10993-10:2010) - FDA recognized
• Irritation or intracutaneous reactivity (ISO 10993-10:2010) - FDA recognized
• Acute systemic toxicity (ISO 10993-11:2017) - FDA recognized
• Subacute/subchronic toxicity (ISO 10993-11:2017) - FDA recognized
• Material mediated pyrogenicity (ISO 10993-11:2017) - FDA recognized
• Hemocompatibility (ISO 10993-4:2017) - FDA recognized
  Comment #2 on Material in Contact with Fluid: Non-DEHP PVC, TPE, TPO materials demonstrated not to raise new safety/effectiveness questions through bench tests. |
  | Sterility Assurance Level (SAL) | Achieved SAL of 10^-6 through validated ethylene oxide sterilization process. Ethylene oxide residuals within specified limits. Comment #6 on Sterilization: Equivalent SAL to predicate's radiation sterilization. |
  | Shelf-life | Validated shelf-life of 5 years. Comment #7 on Shelf life: Longer than predicate (2 years) but raises no new safety/effectiveness questions. Testing included accelerated aging per ASTM F 1980-16 and compliance with standards listed under "Packaging & Sterility Integrity." |
  | Human Factors | A human factors study carried out in accordance with ISO 23908:2011, considering relevant FDA guidance. |

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

The document does not explicitly state the sample sizes for each specific test or the data provenance (e.g., country of origin, retrospective/prospective). The performance data section broadly states "Non-clinical testing of the Polyfusion IV Administration Sets has included successful compliance testing with the following standards..." and "Biocompatibility of components...has been established by testing in accordance with the matrix included in Annex A of ISO 10993-1:2018...".

Medical device testing for regulatory submission typically involves internal validation data for each standard's requirements, conducted in a controlled lab environment. The provenance of such data would be the testing facility where the tests were carried out, likely located in the manufacturer's region (India, as per the manufacturer's address, with Donawa Lifescience Consulting in Italy handling some regulatory aspects). These are prospective tests conducted specifically for the device's regulatory clearance.

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

This information is not provided in the document. For IV administration sets, "ground truth" typically refers to established and validated performance characteristics derived from testing against recognized standards. There isn't an explicit "expert panel" establishing ground truth in the way it might occur for AI/imaging devices. The "experts" are implicitly the technical personnel, quality assurance teams, and engineers who conduct the tests and ensure compliance with the specified standards.

4. Adjudication Method for the Test Set

This information is not applicable/provided. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or for establishing ground truth in AI/imaging devices where multiple human readers interpret data that is often subjective. For a physical medical device like an IV administration set, performance is measured against objective engineering and biocompatibility standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This information is not applicable. An MRMC study is relevant for diagnostic devices, especially those incorporating AI, where the performance of human readers with and without AI assistance is evaluated across multiple cases. The Polyfusion IV Administration Sets are a physical fluid delivery device and do not involve human readers for diagnostic interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This information is not applicable. Standalone algorithm performance studies are conducted for AI-based medical devices. The Polyfusion IV Administration Sets are a physical medical device, not an AI algorithm.

7. Type of Ground Truth Used

The "ground truth" for this device's performance is established by compliance with recognized international and national standards. This includes:

• Engineering Standards: Such as ISO 8536-4 (gravity feed), ISO 80369-7 (Luer connectors), ISTA-3A (packaging integrity), ASTM F-series (packaging integrity), EN 868-5 (packaging).
• Biocompatibility Standards: ISO 10993 series (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, hemocompatibility).
• Sterilization Standards: Validated ethylene oxide sterilization process achieving a SAL of 10^-6, with residuals within limits.
• Pharmacopoeial Standards: USP (particulate matter).
• Human Factors Standards: ISO 23908.

Essentially, the "ground truth" is that the device, when tested against these prescribed methods and benchmarks, performs as expected and is safe and effective for its intended use, comparable to the predicate device.

8. Sample Size for the Training Set

This information is not applicable. "Training set" is a concept specific to machine learning and AI development. This device is a physical medical product. The "training" in this context would refer to the R&D and design iterations by the manufacturer, but not in the sense of a dataset.

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

This information is not applicable. As mentioned above, there is no "training set" in the AI sense for this type of device. The R&D and design process for such a device relies on established engineering principles, materials science, manufacturing processes, and adherence to relevant standards and regulations, rather than a data-driven "ground truth" for training.

In summary: The submission for the Polyfusion IV Administration Sets relies on extensive non-clinical bench testing for compliance with a wide array of recognized national and international standards. The substantial equivalence argument is built upon demonstrating that the subject device meets these standards and that any differences in features or materials compared to the predicate device do not raise new questions of safety or effectiveness.

Ask a specific question about this device