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Flexicare Neonatal Heated Wire Breathing Systems are intented for use to connect a patient's arway to a Ventilator and Humidification Chamber as part of a complete system to provide warmed and humidified inspired respiratory gases to ventilated patients and those receiving respiratory support. Intended for Neonatal patients within a hospital environment. Compatible with Fisher & Paykel MR850 Respiratory Gas Humidifier. Available in Neonatal (038-33-201U) size. For flow rates >4L/min.

Humidification Chambers are intended for use to hold water required to humidify the air being delivered to patients. Intended for any patient requiring active humidification within a hospital environment.

Flexicare Neonatal Heated Wire Breathing Systems are sterile single patient use devices which form part of a respiratory humidification system. In this system the inspiratory limb delivers heated humidified gas to the patient and expiratory limb carries the expired gas away from the patient.

Flexicare Neonatal Heated Wire Breathing Systems are supplied with an Auto-fill Humidification chamber. When in use a Humidification Chamber holds a volume of water and is placed onto a heater unit and fills automatically from a suspended water source. The air from the ventilator is passed through the Humidification Chamber, gaining heat and humidity. This air is then channeled through the Heated Wire Breathing System to the patient.

The inclusion of a heated wire within the lumen of both the System tubes the amount that the humidified air cools when travelling to/from the patient. This in turn reduces the amount of condensation and water build-up within the System.

Flexicare's Neonatal Heated Wire Breathing Systems are comprised of disposable connectors, tubing and heated wire assemblies. The systems are intended for Neonatal patients.

The provided text describes the Flexicare Neonatal Heated Wire Breathing Systems and Autofill Humidification Chamber seeking clearance via a 510(k) pathway, asserting substantial equivalence to predicate devices (Fisher & Paykel RT235 Heated Breathing Circuit and MR290 Autofill Humidification Chamber).

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Key Takeaways:

• Substantial Equivalence Study: The entire document is a 510(k) summary, which is a submission to the FDA to demonstrate that a new medical device is at least as safe and effective as a legally marketed predicate device. The "study" here is thus a comprehensive comparison and verification testing program, often referred to as non-clinical performance testing.
• No AI Component: The devices described (heated wire breathing systems and humidification chambers) are hardware-based medical devices. There is no mention of algorithms, artificial intelligence (AI), machine learning (ML), or software with diagnostic or therapeutic capabilities. Therefore, questions related to expert ground truth, adjudication, MRMC studies, or standalone algorithm performance are not applicable.
• Ground Truth for Testing: The "ground truth" for the non-clinical tests is based on established engineering principles, recognized international standards (ISO, ASTM, IEC, BS EN), and pre-determined acceptance criteria derived from the predicate device's performance or general medical device safety and efficacy requirements.

1. Table of Acceptance Criteria and the Reported Device Performance

The document provides two comparison tables (one for the breathing system and one for the humidification chamber) listing characteristics between the Flexicare device and its predicate. Additionally, a "Summary of performance Testing" table (page 10) outlines specific tests, their standards/acceptance criteria, and the outcome.

Flexicare Neonatal Heated Wire Breathing Systems

Flexicare Autofill Humidification Chamber

Performance Testing Summary (Page 10)

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

• Sample Size for Test Set: The document does not specify the exact number of units/samples used for each non-clinical test (e.g., how many systems were visually inspected, or how many were subjected to drop testing). It generally states "Verification tests were performed" or "Testing demonstrated."
• Data Provenance: The tests are explicitly referred to as "Non-clinical Test Results" and "Verification tests." These are laboratory-based engineering and performance tests conducted on the physical devices. The country of origin for the data is implicitly the UK, where Flexicare Medical Limited is located. The nature of testing is prospective in the sense that the new Flexicare devices were manufactured and then specifically tested against established standards and in comparison to a predicate device.

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

• Not Applicable. This is a non-clinical device clearance, not an AI/clinical diagnostic study. The "ground truth" for the test set is determined by the specifications in recognized international standards (ISO, ASTM, IEC, BS EN) and the pre-determined acceptance criteria established by the manufacturer, which are based on engineering requirements and predicate device performance. There are no "experts" establishing a clinical "ground truth" in the diagnostic sense.

4. Adjudication Method for the Test Set

• Not Applicable. As this is non-clinical device testing, there is no need for adjudication as typically understood in clinical or AI performance studies involving human readers. Test results are objectively measured against predefined criteria.

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. The device is not an AI-powered diagnostic tool, and no human-reader study was conducted or is relevant for this type of device clearance.

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

• Not Applicable. The device is a physical medical device (breathing systems and humidification chambers), not an algorithm or software. No standalone algorithm performance was evaluated.

7. The Type of Ground Truth Used

• The "ground truth" for these tests is based on:
  • Recognized International Standards: Such as ISO 5367, ISO 5356, ISO 8185, IEC 60601-1, ISO 10993, BS EN 556, ASTM F1886-09, ASTM F88-09, ASTM F1929-12. These standards define the expected performance metrics, safety requirements, and test methodologies for medical devices of this type.
  • Predicate Device Performance: Direct comparison to the Fisher & Paykel RT235 and MR290 devices forms a key basis for establishing substantial equivalence.
  • Pre-Determined Acceptance Criteria: For tests not covered by specific standards, Flexicare established internal "Pre-Determined Acceptance Criteria" based on engineering specifications and ensuring safety and effectiveness comparable to the predicate.

8. The Sample Size for the Training Set

• Not Applicable. This refers to machine learning models, which are not part of this submission. There is no "training set" in the context of this traditional medical device clearance. The development of the device itself would involve engineering design and iterative prototyping, but not a dataset for training an algorithm.

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

• Not Applicable. As there is no training set, this question is not relevant.

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