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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.

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