(206 days)
A Model: The F&P Vitera Full Face mask is intended to be used by adults weighing ≥ 66lbs (30kgs) who have been diagnosed by a physician as requiring CPAP or Bi-Level therapy. The F&P Vitera Full Face mask is intended for single patient use in the home.
SL Model: The F&P Vitera Full Face mask is intended to be used by adults weighing ≥ 66lbs (30kgs) who have been diagnosed by a physician as requiring CPAP or Bi-Level therapy. The F&P Vitera Full Face mask is intended for single patient use in the home and for multiple patient use in the hospital or other clinical setting where proper disinfection of the device can occur between patient uses.
The F&P Vitera Full Face Mask is a non-invasive patient interface with a seal that encloses the oral and nasal airway. The mask is held on the face with a headgear. The mask connects to a single breathing tube by a 22mm male swivel adaptor to receive pressurized gases from a continuous airway pressure device (CPAP or Bi-Level). The exhaust holes on the seal of the mask allow exhaled gases to be flushed out while the system is in operation.
The F&P Vitera Full Face Mask is a prescription only device, provided in a non-sterile state.
This document is a 510(k) Premarket Notification for the F&P Vitera Full Face Mask. It primarily focuses on demonstrating substantial equivalence to a predicate device, the F&P Simplus Full Face Mask (K130328), rather than detailing an acceptance criteria study for a novel AI/Machine Learning (ML) enabled medical device.
Therefore, most of the requested information regarding AI/ML device acceptance criteria and study particulars (like AI performance metrics, sample sizes for test/training sets, expert consensus, MRMC studies, ground truth establishment) is not present in this document.
However, I can extract the relevant information regarding the device's performance testing and general acceptance criteria that are mentioned to support its substantial equivalence claim.
Based on the provided document, here's what can be gathered regarding acceptance criteria and performance studies for the F&P Vitera Full Face Mask:
The document aims to demonstrate that the F&P Vitera Full Face Mask is substantially equivalent to a legally marketed predicate device (F&P Simplus Full Face Mask). This means the acceptance criteria are primarily focused on showing that the new device performs comparably to the predicate and does not introduce new questions of safety or effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance (Comparative):
The acceptance criteria here are implicitly defined by compliance with relevant ISO standards and comparison to the predicate device's performance. The "Comments" column indicates whether the differences are considered acceptable or "substantially equivalent."
| Characteristic / Test | Acceptance Criteria (Implicit) | Reported Device Performance (F&P Vitera Full Face Mask) | Predicate Device Performance (F&P Simplus Full Face Mask) | Substantial Equivalence Comment |
|---|---|---|---|---|
| Intended Use | Identical to predicate | Adults ≥ 66lbs (30kgs), CPAP/Bi-Level therapy. A model: single patient home. SL model: single patient home + multi-patient hospital/clinical. | Individuals (adults), CPAP/Bi-Level Ventilator treatment. Single-patient home + multi-patient hospital/clinical. | Substantially equivalent. Minimum weight specified in Vitera, but no new risks. |
| Availability | Prescription Use Only | Prescription Use Only | Prescription Use Only | Identical |
| Patient Population | Adult | Adult | Adult | Identical |
| Pressure Range | Conformance to ISO 17510:2015, no new risks | 4 to 30 cmH2O | 4 to 25 cmH2O | Substantially equivalent. Higher upper limit, but conforms to ISO 17510:2015, no new risk. |
| Resistance to Flow | Conformance to ISO 17510:2015, no new risks | • 50 L/min: 0.24 cmH2O | ||
| • 100 L/min: 0.47 cmH2O | • 50 L/min: 0.17 cmH2O | |||
| • 100 L/min: 0.64 cmH2O | Substantially equivalent. Conforms to ISO 17510:2015, no new risk. | |||
| Inspiratory & Expiratory Resistance | Conformance to ISO 17510:2015, no new risks | • Inspiratory: 1.05 cmH2O | ||
| • Expiratory: 0.80 cmH2O | • Inspiratory: 0.67 cmH2O | |||
| • Expiratory: 0.12 cmH2O | Substantially equivalent. Conforms to ISO 17510:2015, no new risk. | |||
| Dead Space | Conformance to ISO 17510:2015, no new risks | Small: 245.8 cc, Medium: 274.1 cc, Large: 321.8 cc | Small: 251 cc, Medium: 278 cc, Large: 310 cc | Substantially equivalent. Conforms to ISO 17510:2015, no new risk. |
| Sound | Conformance to ISO 17510:2015, no new risks | Power: 29.8 dBA, Pressure: 21.8 dBA | Power: 28.8 dBA, Pressure: 17.8 dBA | Substantially equivalent. Conforms to ISO 17510:2015, no new risk. |
| Shelf-Life | Supported by data | 5 years | Not claimed on labeling | Substantially equivalent. Supported by data for Vitera. |
| Sterility | Not provided sterile | Device not provided sterile | Device not provided sterile | Identical |
| Reusability | Single/Multi-patient use | A model: Single Patient Use | ||
| SL model: Multi Patient Use | Multi Patient Use | Identical (for SL model comparative) | ||
| High Level Disinfection Methods | Acceptable thermal disinfection parameters | Thermal: 80°C for 10 mins; 75°C for 30 mins; 90°C for 1 min | Thermal: 80°C for 10 mins | Substantially equivalent. Validated additional temp/time configurations. |
| CO2 Rebreathing | Not adversely affected | Data available * (tested to confirm no adverse effect) | N/A (implied acceptable for predicate) | Performance testing completed to confirm no adverse effect. |
| NRV Activation/Deactivation Pressure | Not adversely affected | Data available * (tested to confirm no adverse effect) | N/A (implied acceptable for predicate) | Performance testing completed to confirm no adverse effect. |
| Total Mask Exhaust Flow | Not adversely affected | Data available * (tested to confirm no adverse effect) | N/A (implied acceptable for predicate) | Performance testing completed to confirm no adverse effect. |
| Mechanical Integrity/Performance | Verified after normal/abuse scenarios | Data available * (incl. home/cleaning, multi-patient reprocessing, accelerated aging, transport/storage) | N/A (implied acceptable for predicate) | Verified after normal and reasonable abuse scenarios. |
| Biocompatibility | Safe for use, conform to ISO 10993/18562 | Classified as externally communicating device, tissue contact, permanent duration. Tested for cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, genotoxicity, extractables, particulate/VOC emissions. Concluded safe for use with patients ≥ 30 kg. | N/A (implied acceptable for predicate) | Biological risk assessment concluded safe for use. |
Note: The document states "Performance testing was completed to confirm the F&P Vitera Full Face Mask does not adversely affect safety and effectiveness" for CO2 rebreathing, NRV, and total exhaust flow. Specific numerical data for these tests are not provided in this summary, but the conclusion of non-adverse effect implies meeting an internal acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified in terms of number of masks or test runs for each performance criterion. The document broadly states "Performance testing... was completed to determine that device design changes... do not raise questions of safety or effectiveness."
- Data Provenance: Implied to be bench testing conducted by the manufacturer, Fisher & Paykel Healthcare Ltd. The address provided is in Auckland, New Zealand, suggesting the testing likely occurred there. The data is retrospective in the sense that it supports a premarket notification for a finalized device. No clinical (human subject) test data is required or provided for this device application.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not Applicable. This document describes bench testing and comparison to a predicate device, not an AI/ML enabled device requiring human expert ground truth for image interpretation or similar tasks. The "ground truth" for performance is based on physical measurements and compliance with engineering standards.
4. Adjudication Method for the Test Set:
- Not Applicable. As no human experts were involved in establishing ground truth for a test set (as in AI/ML performance evaluation), no adjudication method was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. This is not an AI/ML device, and no MRMC study was conducted or required. The study described is bench testing for mechanical and physiological characteristics, not a human reader study.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a hardware medical device (a mask for CPAP/Bi-Level therapy), not an algorithm or AI/ML product.
7. The Type of Ground Truth Used:
- For the performance testing, the "ground truth" is derived from:
- Engineering specifications and measurements: e.g., pressure drop, resistance, dead space, sound levels.
- Compliance with international standards: Specifically, ISO 17510:2015, ISO 5356-1:2015, ISO 10993 series (biological evaluation), and ISO 18562 series (biocompatibility of breathing gas pathways).
- Benchmarking against a predicate device: Comparisons are made to the F&P Simplus Full Face Mask.
8. The Sample Size for the Training Set:
- Not Applicable. This is not an AI/ML device; therefore, there is no "training set."
9. How the Ground Truth for the Training Set was Established:
- Not Applicable. As no training set exists, no ground truth needed to be established for it.
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).