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VentStar Helix dual heated N Exten. Kit (MP02280): Inspiratory heated disposable breathing circuit with humidifier chamber for connection to a humidifier MR850 by Fisher & Paykel, for neonatal patients with a tidal volume of up to 100 mL, for conducting humidified breathing gas from humidifier to patient.

VentStar Helix heated (N) Plus (MP02608): Inspiratory heated disposable breathing circuit with humidifier chamber for connection to a humidifier MR850 by Fisher & Paykel, for neonatal patients with a tidal volume of up to 100 mL, for conducting humidified breathing gas from humidifier to patient.

The subject devices (VentStar Helix Dual Heated N Exten. Kit and VentStar Helix Heated (N) Plus), two inspiratory (and expiratory) heated disposable breathing circuits with humidifier chamber are designed for neonatal patients with a tidal volume of up to 100 mL, for conduction of humidified breathing gas from the humidifier to the patient. VentStar Helix Dual Heated N Exten. Kit is a dual heated breathing circuit and VentStar Helix Heated (N) Plus is a single heated breathing circuit to be connected to a humidifier MR850 by Fisher and Paykel, both tested for system compatibility and released for use with Dräger Babylog VN-Series ventilators.

Additionally, this submission comprises a neonatal humidifier chamber and a double connector for connection to the ventilators as accessories to the above mentioned medical devices.

This is a 510(k) premarket notification for breathing system heaters, not an AI/ML device. Therefore, the requested information about acceptance criteria for AI performance, sample sizes for test/training sets, ground truth establishment, expert consensus, MRMC studies, or standalone algorithm performance is not applicable.

The document discusses the substantial equivalence of the VentStar Helix Dual Heated N Exten. Kit (MP02280) and VentStar Helix Heated (N) Plus (MP02608) to previously cleared predicate devices. Substantial equivalence is determined by demonstrating that the new devices are as safe and effective as the predicate devices, despite some technological differences.

Here's the relevant information about the device's technical specifications and the non-clinical studies performed to demonstrate its safety and effectiveness:

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides extensive comparison tables (Table 1 and Table 2) between the new devices and their predicate devices. These tables list various technical characteristics and performance parameters, indicating whether they are "Same," "Similar," or "Different" compared to the predicate. For characteristics marked "Different," numerical values are provided for both the subject device and the predicate device. These differences were evaluated through non-clinical testing to ensure they do not raise new questions of safety or effectiveness.

Due to the extensive nature of the comparison, which lists numerous parameters like hose diameter, length, resistance, compliance, leakage, volume, warm-up time, humidification output, and electrical data, a comprehensive reproduction of all "acceptance criteria" (which are implicitly the performance of the predicate device or established standards) and "reported device performance" in a single table format is beyond the scope of a short answer. However, the tables clearly highlight these comparisons.

For example, for VentStar Helix Dual Heated N Exten. Kit (MP02280) compared to predicate RT265 (K103767):

The document states that "Performance data related to each proposed modification has been tested and evaluated" and "High level summary reports included in this 510(k) demonstrate that the subject devices are substantially equivalent to the predicate device." This implies that the acceptance criteria are met if these differences do not negatively impact safety and effectiveness, as determined by the non-clinical testing against relevant standards.

2. Sample size used for the test set and the data provenance: Not applicable. This is not an AI/ML device that uses test sets of data in the common understanding for AI performance evaluation. The "test set" here refers to the physical devices and materials subjected to non-clinical laboratory testing. The provenance of these physical samples is from the manufacturer, Drägerwerk AG & Co. KGaA (Germany). The studies are prospective in the sense that they are conducted specifically for this 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for AI/ML validation (e.g., expert annotations on medical images) is not relevant for this type of device submission, which relies on engineering and biocompatibility testing against established standards.

4. Adjudication method for the test set: Not applicable. This concept is not relevant for the type of non-clinical testing performed for this device.

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.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.

7. The type of ground truth used: For this device, "ground truth" refers to the established requirements and performance limits defined by international consensus standards and the performance characteristics of the predicate devices. For example, specific thresholds for electrical safety, biocompatibility, resistance, and humidification output are defined by standards like IEC 60601-1, ISO 5367, and ISO 18562. The device's performance is measured against these objective, quantifiable benchmarks.

8. The sample size for the training set: Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable.

Summary of Non-Clinical Studies and Standards:

The study that proves the device meets the acceptance criteria is a series of non-clinical tests covering various aspects:

• Mechanical Performance: Demonstrated conformance to ISO 5367 (Breathing sets and connectors) and ISO 80601-2-12 (Critical care ventilators).
• Thermal Safety: Implied by testing against the aforementioned standards and the device's function as a heated breathing circuit.
• Environmental Conditions: Not explicitly detailed beyond compliance with relevant standards.
• Electrical Safety and Electromagnetic Compatibility (EMC): Tested according to IEC 60601-1 (basic safety and performance) and IEC 60601-1-2 (EMC).
• Functional Verification and Performance Capacity and Accuracy: Demonstrated through compliance with ISO 5367, ISO 80601-2-12, ISO 5356-1 (Conical connectors), and ISO 80601-2-74 (Respiratory humidifying equipment).
• Biocompatibility Testing: Materials and completed products were evaluated through biological qualification safety tests as outlined in ISO 10993-1 ("Biological Evaluation of Medical Devices") and ISO 18562 series ("Biocompatibility evaluation of breathing gas pathways in healthcare"). Specific tests included:
  • Emissions of particulate matter (ISO 18562-2)
  • Emission of VOC with additional humidity (ISO 18562-3)
  • Leachables in condensate (ISO 18562-4)
  • Extraction (ISO 10993-18)
  • Material characterization (ISO 10993-18)
  • Cytotoxicity (ISO 10993-5)
  • Sensitization (ISO 10993-10)
  • Irritation (ISO 10993-10)

The "acceptance criteria" are implicitly defined by the requirements of these recognized consensus standards and the performance characteristics of the predicate devices, which the subject devices "meet all applicable requirements of" and are found to be "substantially equivalent" to. The testing demonstrates that despite some technological differences, no new safety or effectiveness concerns are raised compared to the predicate devices.

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