(29 days)
OPT94X Model:
The F&P Optiflow+ is a nasal cannula patient interface for use with specified respiratory gas humidifiers to treat spontaneously breathing pediatric (3 years and older) to adult patients who would benefit from receiving high flow warmed and humidified respiratory gases to the upper airway.
This device is designed to be used in a hospital, sub-acute facility or long-term care facility by appropriately qualified healthcare professionals.
MYOPT9X Model:
The F&P Optiflow+ is a nasal cannula patient interface for use with specified respiratory gas humidifiers to treat spontaneously breathing pediatric (3 years and older) to adult patients who would benefit from receiving high flow warmed and and humidified respiratory gases to the upper airway.
This device is designed to be used in a long-term care facility by appropriately qualified healthcare professionals, or in the home by lay users operating the device as prescribed by a healthcare professional.
The F&P Optiflow+ Nasal Cannula range is a nasal cannula interface for use with a respiratory gas humidifier and flow generator to deliver Nasal High Flow (NHF) therapy.
The F&P Optiflow+ Nasal Cannula range is a prescription-only device, provided in a non-sterile state and intended to be used in a hospital, sub-acute facility, or long-term (managed) care facility by appropriately qualified healthcare professionals, or in the home by lay users operating the device as prescribed by a healthcare professional. The device is single patient use only for up to 14 days in the hospital and up to 30 days in the home/long-term care facilities.
The provided FDA 510(k) clearance letter and summary for the F&P Optiflow+ Nasal Cannula Range does not contain specific acceptance criteria or an analytical study proving the device meets those criteria.
This submission is for a labeling change only. The document explicitly states:
- "The modification in scope of this 510(k) submission is to change the labeling of the subject device only, specifically to the Indications for Use statement."
- "The subject device's technological characteristics, material composition, and intended use remain identical to those of the predicate device."
- "No new performance or biocompatibility testing was conducted on the subject device since the device design is identical to the predicate device."
Therefore, the information requested regarding acceptance criteria, reported performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth for training/test sets cannot be extracted from this document because such studies were not conducted for this specific 510(k) submission.
The clearance is based on the device being substantially equivalent to a previously cleared device (F&P Optiflow+ Nasal Cannula range, K162553), with the only change being an updated Indications for Use statement to be more defined and aligned with current labeling requirements. The original predicate device (K162553) would have had performance data supporting its clearance, but that data is not detailed in this particular document.
Summary based on the provided document:
- Table of Acceptance Criteria and Reported Device Performance: Not provided in the document as no new performance testing was conducted. The document states the device's characteristics and performance are identical to the predicate device.
- Sample Size for Test Set and Data Provenance: Not applicable, as no new performance testing was conducted.
- Number of Experts and Qualifications: Not applicable, as no new clinical study requiring expert review was conducted.
- Adjudication Method: Not applicable.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable, as no new clinical study was conducted.
- Standalone Performance (Algorithm only): Not applicable, as this is a medical device (nasal cannula), not an AI/algorithm-based device.
- Type of Ground Truth Used: Not applicable, as no new performance testing was conducted.
- Sample Size for Training Set: Not applicable.
- How Ground Truth for Training Set Established: Not applicable.
§ 868.5450 Respiratory gas humidifier.
(a)
Identification. A respiratory gas humidifier is a device that is intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient. Cascade, gas, heated, and prefilled humidifiers are included in this generic type of device.(b)
Classification. Class II (performance standards).