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The F&P 950 Respiratory Humidifier is intended to provide heat and humidity to respiratory gases delivered to patients. It is for use in a hospital or long-term care facility by a health professional.

F&P 950 Breathing Circuit Kits: 950A80J, 950A81J, 950A82J, 950A61J, 950A61J, 950A40J, AA451SU
The breathing set is an accessory to the F&P 950 Respiratory Humidifier. It is intended for delivery of heated humidified respiratory gases to adult, adolescent and child patients, within the limits of its stated technical specifications.

F&P 950 Breathing Circuit Kits: 950P81J, 950P40J
The breathing set is an accessory to the F&P 950 Respiratory Humidifier. It is intended for delivery of heated humidified respiratory gases to neonatal, infant, child and adolescent patients of its stated technical specifications.

F&P 950 Breathing Circuit Kits: 950N80J, 950N81J, 950N61J, 950N40J
The breathing set is an accessory to the F&P 950 Respiratory Humidifier. It is intended for delivery of heated humidified respiratory gases to neonatal, infant and child patients, within the limits of its stated technical specifications.

The F&P 950 Respiratory Humidifier is designed to warm and humidify air after it leaves a commercially available flow source and to maintain the air in a warmed and humidified condition to the point of delivery into the patient via heated tubing.

The F&P 950 Respiratory Humidifier is made up of a heaterbase, sensor cartridge and expiratory heater wire adapter with breathing circuit kits to support the use with adult, pediatric and neonatal patients. Breathing circuit kits enable the use of the F&P 950 Respiratory Humidifier with clinical procedures such as invasive ventilation and nasal high flow.

The device is a programmable electrical medical device that uses sensors throughout the system to humidify the gas. Gas travels through the chamber where it is humidity is requlated through monitoring the gas temperature exiting the chamber to achieve the target humidity level. The gas is then transported to the patient through a heated delivery tube. The gas temperature exiting the heated delivery tube is monitored to minimize the formation of condensate.

The document is a 510(k) Summary for the F&P 950 Respiratory Humidifier and its accessory breathing circuit kits. It outlines the device's indications for use and compares its technological characteristics to a primary predicate device (F&P MR850 Respiratory Humidifier) and several secondary predicate devices for the various breathing circuit kits. The summary also details the non-clinical tests performed to demonstrate substantial equivalence.

Here's the requested information based on the provided text, focusing on acceptance criteria and supporting studies:

1. Table of acceptance criteria and the reported device performance:

   Acceptance Criteria	Reported Device Performance
   Delivered humidity level (Bypassed airway)	>33mg/L for flow < 60 L/min
   Delivered humidity level (Non-bypassed airway)	>12mg/L for flow < 120 L/min
   Time to reach set temperature	<30min
   Alarms (auditory)	Exceed 45 dbA @1m
   Auditory alarm pause	120 seconds
   Ambient operating conditions (Adult)	18-26°C
   Ambient operating conditions (Neonatal and Pediatric)	20-26°C
   Storage conditions (Hardware)	-20°C - 60°C
   Service life (Hardware)	7 years
   shelf life for circuit kits	3 years (Note: some predicate devices had 5 years; for the subject device, this is stated as "Equivalent - The subject device falls within the secondary predicate device shelf life duration," implying 3 years meets the criteria for substantial equivalence, though less than some predicates).
   Storage conditions for circuit kits	-10°C – 50°C (Note: some predicate devices had -30°C – 50°C; for the subject device, this is stated as "Equivalent - The subject device falls within the secondary predicate device storage condition range.")

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

   The document does not explicitly state the sample sizes for specific performance tests (e.g., number of devices tested, number of runs for humidification accuracy). It refers to testing being "in line with" or conforming to various ISO and ASTM standards, which would define appropriate sample sizes for those tests. The data provenance (country of origin, retrospective/prospective) is not mentioned.

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):

   This information is not applicable to the type of device and studies described. The studies are non-clinical (bench/performance testing, biocompatibility, electrical safety, software verification, human factors), not clinical studies involving expert interpretation of data like imaging.

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

   This information is not applicable as the studies described are non-clinical performance and safety tests, not clinical studies involving expert adjudication of findings.

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:

   No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically relevant for interpretative medical devices, often those incorporating AI, and is not applicable to a respiratory humidifier.

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

   Not applicable. The F&P 950 Respiratory Humidifier is a hardware device with embedded software, not an AI algorithm intended for standalone performance evaluation in the context of interpretation tasks. Performance testing was done on the device as a whole system.

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

   For the non-clinical performance tests, "ground truth" is established by adherence to recognized standards:

   • Humidification output, thermal overshoot, surface temperature: ISO 80601-2-74:2017
   • Resistance to flow, compliance, gas leak: ISO 5367:2014
   • Electrical safety: ANSI AAMI ES 60601-1:2005/(R)2012 and A1:2012
   • EMC: IEC 60601-1-2:2014 + AMD1:2020 Ed 4.1 and AIM Standard 7351731 Rev. 2.00 2017-02-23
   • Alarms: IEC 60601-1-8:2006 and A1:2012
   • Biocompatibility: ISO 10993-1:2018 and ISO 18562-1:2017
   • Software verification and validation: FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
   • Human Factors Testing: FDA's Guidance for Industry and FDA Staff, "Applying Human Factors and Usability Engineering to Medical Devices."

   The "ground truth" is essentially the specified requirements and acceptance criteria outlined in these internationally recognized standards and guidance documents.

8. The sample size for the training set:

   Not applicable. This device does not appear to involve machine learning or AI algorithms that require a "training set" in the conventional sense of supervised learning. The software verification and validation is for embedded software controlling the device's functions.

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

   Not applicable, as there is no "training set" described for this type of device.

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The bellavista 1000/1000e ventilator is intended to provide positive pressure ventilatory support to adult and pediatric patients and optionally infant and neonatal patients by qualified, trained personnel under the direction of a physician.

Environment of use: hospitals, sub-acute care facilities and intra-hospital transfer

When used on neonatal patients: The environment of use is the Neonatal Intensive Care Unit (NICU).

bellavista is an electronically controlled pneumatic ventilation system. It is powered by AC or DC and also provided with an internal battery. The bellavista pneumatic system supplies respiratory gas whilst the electrical systems control the pneumatics and provides the power supply.

The user can enter values or parameters in the bellavista via the touch screen. These inputs entail instructions for bellavista's pneumatic system to ventilate the patient with a precisely controlled gas mixture. bellavista gathers readings from the proximal flow sensor within the ventilator.

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter and summary for a medical device (ventilator). It describes the device, its intended use, a comparison to predicate devices, and the basis for substantial equivalence.

However, it does not include details about acceptance criteria, specific device performance numerical results, sample sizes for test or training sets, data provenance, expert qualifications, ground truth establishment, or any details about a multi-reader multi-case (MRMC) study or standalone algorithm performance, as these are typically part of a clinical validation study and not usually found in a 510(k) summary for a ventilator.

The document discusses the ventilatory support capabilities and patient populations for which the device is intended, but not the kind of detailed performance metrics usually required for AI/algorithm-based diagnostic devices.

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