(462 days)
Precision Flow® HVNI is intended for use to add warm moisture to breathing gases from an external source for administration to a neonate/infant, pediatric and adult patients in the hospital and subacute institutions settings. It adds heat and moisture to a blended medical air/ oxygen mixture and assures the integrity of the precise air/oxygen mixture via an integral oxygen analyzer. The flow rates may be from 1 to 40 liters per minute via nasal cannula.
Precision Flow® HVNI provides high velocity nasal insufflation (HVNI) with simultaneous oxygen delivery to augment breathing of spontaneously breathing patients suffering from respiratory distress and/or hypoxemia in the hospital setting. Precision Flow® HVNI is not intended to provide total ventilatory requirements of the patient and not for use during field transport.
The Precision Flow® HVNI system delivers high flow rates of heated and humidified blended breathing gas through high flow nasal cannulas. The Precision Flow® HVNI system can connect to air and oxygen source. The Precision Flow® HVNI may be operated with limited performance at gas inlet pressures as low as 4 psi (28 kPa). For the full specified range of gas flows and oxygen percentages, both gas inlet pressures must be at minimum 40 psi (276 kPa).The main unit contains an integrated blender that delivers the targeted gas mixture to the disposable patient circuit (DPC). The Disposable Patient Circuit contains:
- Water path: tubing from sterile water supply to vapor transfer cartridge
- . Vapor transfer (humidification) cartridge: 2 types; low flow (1-8 lpm) and high flow (5-40 lpm)
- Delivery Tube: triple lumen tubing
- . Nasal Cannula
The device automatically senses cartridge type. The available set temperature range is 33 °C to 39 °C. The device also contains a backup battery to provide power only for 15 minutes.
Here's a breakdown of the acceptance criteria and the study information for the Precision Flow® HVNI, based on the provided text:
Acceptance Criteria and Device Performance
The acceptance criteria for the Precision Flow® HVNI are primarily non-clinical, focusing on safety, performance standards, software validation, and labeling requirements. The clinical studies establish safety and effectiveness by demonstrating non-inferiority or comparable outcomes to existing treatments.
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance/Evidence |
|---|---|---|
| Biocompatibility/Materials | Patient-contacting components must be demonstrated to be biocompatible (Special Control 1). Tests include Cytotoxicity, Sensitization, Intracutaneous Reactivity, Extractables and Leachables, Volatile Organic Compounds (VOC), and Particulate Matter (PM2.5). | All biocompatibility tests passed, demonstrating the biocompatibility of the device, in accordance with ISO 10993-1. |
| Shelf Life/Reprocessing/Sterility | Cleaning instructions for reusable components must be validated (Special Control 3). Acceptance criteria for cleaning validation: no visible soil, protein level 1000g). Randomized (38 HFT, 38 NIPPV). Data provenance: Randomized Pilot Study. |
* **Data Provenance for all neonate studies:** Published literature, likely international based on author names and journal types, but not explicitly stated for each study.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Similar to the adult study, ground truth involved clinical outcomes assessed by treating medical professionals (neonatologists, nurses, etc.) within the context of their respective clinical trials or retrospective data collection. Specific expert qualifications beyond clinical roles are not detailed within the provided text.
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Adjudication method for the test set:
- Not explicitly stated as a formal adjudication panel. Outcomes were generally defined by protocol-driven clinical events (e.g., extubation failure, need for intubation, physiological parameters).
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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. These are clinical studies comparing therapies, not AI assistance for human readers.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Outcomes Data: Primary ground truths included extubation failure rates, rates of intubation/mechanical ventilation, occurrences of pneumothorax, nosocomial infection, ROP surgery, bronchopulmonary dysplasia (BPD), air leaks, IVH, NEC, sepsis, duration of respiratory support, need for surfactant, time to full feeds, length of stay, mortality, and nasal trauma scores.
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The sample size for the training set:
- Not applicable.
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How the ground truth for the training set was established:
- Not applicable.
§ 868.5454 High flow humidified oxygen delivery device.
(a)
Identification. A high flow humidified oxygen delivery device is a prescription device that delivers high flow oxygen with humidification for patients who are suffering from respiratory distress and/or hypoxemia.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The patient-contacting components of the device must be demonstrated to be biocompatible.
(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions for use, including the following:
(i) Alarm testing must be performed;
(ii) Continuous use thermal stability testing must be performed;
(iii) Humidity output testing must be performed; and
(iv) Blender performance testing must evaluate fraction of inspired oxygen (
Fi O2 ) blending accuracy.(3) Performance data must validate cleaning instructions for any reusable components of the device.
(4) Electrical safety, thermal safety, mechanical safety, electromagnetic compatibility, and radiofrequency identification testing must be performed.
(5) Software verification, validation, and hazard analysis must be performed.
(6) Labeling must include:
(i) A description of available
Fi O2 ranges for different flowrates and inlet gas pressures;(ii) Instructions for applicable flowrates for all intended populations;
(iii) A warning that patients on high flow oxygen are acute and require appropriate monitoring, to include pulse oximetry;
(iv) A warning regarding the risk of condensation at low set temperatures and certain flows; and
(v) A description of all alarms and their functions.