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510(k) Data Aggregation
(408 days)
The breathing set is an accessory to the F&P 950 Respiratory Humidifier. It is intended to provide heated and humidified CPAP to spontaneously breathing premature and full term neonates and infant patients (up to a weight of 10 kg) who require breathing support, due to conditions associated with prematurity (such as Respiratory Distress Syndrome) or other conditions where CPAP is required or desired. It is intended for use within a hospital clinical environment such as a NICU (Neonatal Intensive Care Unit) and PICU (Pediatric Intensive Care Unit), within the limits of its stated technical specifications.
The subject devices of this 510(k) are the F&P 950 Bubble CPAP Breathing Circuit Kits (950N60J and 950N62J). The F&P 950 Bubble CPAP Breathing Circuit Kits are single patient use and designed for use with the F&P 950 Respiratory Humidifier. The F&P 950 Bubble CPAP (continuous positive airway pressure) Breathing Circuit Kits provide breathing support to spontaneously breathing neonates and infants. The F&P 950 Bubble CPAP breathing circuit kits deliver heated and humidified respiratory gas through an inspiratory limb to the infant via a nasal interface. An expiratory limb connects to a Bubble CPAP generator to generate CPAP. The device is intended to be operated at input gas flows of 4 - 15 L/min with available CPAP levels of 3 - 10 cmH2O.
This document outlines the acceptance criteria and supporting studies for the F&P 950 Bubble CPAP Breathing Circuit Kits.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the F&P 950 Bubble CPAP Breathing Circuit Kits are primarily established through compliance with recognized medical device standards and comparison to a predicate device. The performance data section summarizes various tests conducted to demonstrate this compliance.
Since the document does not present specific quantitative acceptance criteria with corresponding performance metrics in a direct table format, I will reconstruct a table based on the information provided, inferring acceptance as "compliance" or "demonstrated safety/effectiveness" where specific numerical targets are not explicitly stated for the "acceptance criteria" column. The "reported device performance" will refer to the conclusion of the tests.
| Acceptance Criteria Category | Regulatory/Standard-Based Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Intended Use Equivalence | To deliver heated and humidified respiratory gases to provide CPAP to spontaneously breathing premature and full-term neonates and infants up to 10kg, in a hospital clinical environment (NICU/PICU). | Equivalent to Predicate: Subject and predicate devices are both intended to provide CPAP to patients. |
| Patient Population Equivalence | Neonatal and infant patients weighing 30 days). | Compliant: Testing demonstrated an appropriate biocompatibility profile for the device, confirming compliance with specified ISO standards. |
| Electrical Safety & Electromagnetic Compatibility (EMC) | Compliance with ANSI AAMI ES 60601-1:2005/(R)2012 and A1:2012, IEC 60601-1-2:2014 + AMD1:2020 Ed 4.1, and AIM Standard 7351731 Rev. 2.00 2017-02-23. | Compliant: Testing demonstrated appropriate electrical safety and electromagnetic compatibility profile, confirming compliance with specified standards. |
| Human Factors & Usability | Conducted in accordance with FDA's "Applying Human Factors and Usability Engineering to Medical Devices" guidance. | Safe and Effective: Validation study demonstrated the device to be safe and effective for intended users, uses, and environments according to applicable guidance. |
| Humidification Output, Thermal Overshoot, Surface Temp. | Compliance with ISO 80601-2-74:2017. | Compliant: Performance testing for these parameters was conducted in line with ISO 80601-2-74:2017 to demonstrate substantial equivalence. (Implies compliance, though specific figures are not provided in this summary). |
| Resistance to Flow, Compliance, Gas Leak | Compliance with ISO 5367:2014. | Compliant: Performance testing for these parameters was conducted in line with ISO 5367:2014 to demonstrate substantial equivalence. (Implies compliance). |
| Comparative System Level Pneumatic Performance | Demonstrated equivalence. | Demonstrated: Testing conducted to demonstrate substantial equivalence. (Implied successful demonstration). |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample sizes (number of devices or tests performed per device type) for the non-clinical tests (biocompatibility, electrical safety, human factors, bench/performance testing). It generally refers to "testing" or "studies" in the plural.
The data provenance is from non-clinical tests performed by the manufacturer, Fisher & Paykel Healthcare Limited, to evaluate the device against specified international standards and to demonstrate equivalence to a predicate device. This is prospective testing of the manufactured device components and systems. No country of origin for the data is explicitly mentioned beyond the manufacturer's location in New Zealand, but the tests are conducted against universally recognized international standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The studies listed are primarily non-clinical engineering and performance tests, not clinical studies requiring expert ground truth for diagnostic or clinical outcomes. For the Human Factors testing, "intended users" would have been involved, but their number and specific qualifications are not detailed.
4. Adjudication method for the test set
Not applicable. The tests described are objective, standard-based compliance evaluations or measurements, not clinical studies requiring expert adjudication of subjective outcomes.
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 device is a mechanical breathing circuit kit, not an AI-powered diagnostic or assistive technology.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a mechanical breathing circuit kit; there is no algorithm involved.
7. The type of ground truth used
For the non-clinical tests, the "ground truth" is defined by the requirements and methodologies outlined in the referenced international standards (e.g., ISO, ASTM, ANSI, IEC). For example, a successful biocompatibility test means the materials met the specified criteria of the ISO 10993 series. A successful electrical safety test means the device operated within the limits defined by IEC 60601-1-2.
8. The sample size for the training set
Not applicable. This device is a mechanical medical device, not an AI/machine learning product that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As above, this device does not utilize AI and therefore has no training set or associated ground truth.
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