(139 days)
A-Model: The F&P Evora Nasal Mask is intended to be used by adults weighing ≥661bs (30kgs) who have been prescribed noninvasive positive airway pressure therapy such as CPAP or bilevel by a physician. The F&P Evora Nasal Mask is intended for single patient use in the home.
SL Model: The F&P Evora Nasal Mask is intended to be used by adults weighing ≥66lbs (30kgs) who have been prescribed noninvasive positive airway pressure therapy such as CPAP or bilevel by a physician. The F&P Evora Nasal Mask is intended for single patient use in the home and for multiple patient use in the clinical setting where proper disinfection of the device can occur between patient uses.
The F&P Evora Nasal Mask is a non-invasive patient interface with a seal that encloses the airway entrance of the nose. 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 Positive 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 Evora Nasal Mask is a prescription only device, provided in a non-sterile state. The mask will be available in 2 different main models: A-Model, and Sleeplab (SL)-Model. Both models are identical except for Intended Use, Operating Environment; Reusability and High Level Disinfection Methods. This is because the A model is used only by single patients in the home while the SL model is used both by single patients in the home and multiple patients use in the hospital or other clinical setting where proper disinfection of the device can occur between patient uses.
A Model: Offered in 4 different sizes (Small, Medium, Large, Wide), the packaging contains a single mask and a single size seal, intended for single patient use. In addition, to the 4 sizes, a so-called Fit Pack model (EVO1SMLA) is offered which contains a single mask with 3 seal sizes (Small, Medium and Large).
Sleeplab (SL)-Model: Offered in 4 different sizes (Small, Medium, Large, Wide) contains a single mask and a single size seal, intended for single patient use and multi-patient use. In addition, to the 4 sizes, a so-called Fit Pack model (EVO1SMLSL) is offered which contains a single mask with 3 seal sizes (Small, Medium and Large).
Besides the main models, an accessory and spare parts will be made available.
- -Accessory: The only accessory available for the F&P Evora Nasal Mask will be an Oxygen / Pressure Port Connector, which will be packaged and sold separately.
- -Spare parts: F&P Evora Nasal has the below components which are available for purchase as spare parts:
- Evora Nasal Seal Spare (Small, Medium, Large and Wide) o
- Evora Nasal Headgear Spare O
- Evora Nasal Backstrap Spare о
- O F&P Swivel White
- O Evora Nasal Tube & Frame Spare
- Evora Nasal Mask No H/G (Small, Medium, Large and Wide) o
The provided document is an FDA 510(k) K200089 submission for the F&P Evora Nasal Mask. This document describes the device, its intended use, and provides non-clinical performance data to demonstrate substantial equivalence to a predicate device.
Crucially, this document does not contain information about acceptance criteria and reported device performance in the context of a clinical study or a study directly addressing a diagnostic or therapeutic performance metric for which acceptance criteria typically apply (e.g., sensitivity, specificity, accuracy).
Instead, the "performance" data presented here is related to engineering and safety standards for medical devices, such as:
- Shelf life simulation: Based on ASTM F1980-07.
- Transportation simulation: Based on ISTA 2A.
- Performance testing to confirm non-adverse effects on safety and effectiveness: CO2 rebreathing, total mask exhaust flow, resistance to flow and pressure drop.
- Mechanical integrity and performance: Verified after normal and reasonable abuse scenarios (home use/cleaning, multi-patient use/reprocessing, accelerated aging, simulated transportation and storage).
- Compliance with various ISO standards: Including ISO 17510:2015 (Sleep Apnoea Breathing Therapy- Masks and Application Accessories) and a series of ISO 10993 standards for biological evaluation of medical devices.
The "Technological Characteristics Comparison" table (Table 1) compares specific technical parameters like pressure range, resistance to flow, dead space, and sound levels between the F&P Evora Nasal Mask (subject device) and the F&P Brevida Nasal Pillows Mask (predicate device).
Therefore, many of the requested items (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, type of ground truth, training set sample size, ground truth for training set) are not applicable to the information contained in this 510(k) summary. These items are typically relevant for AI/ML-based diagnostic devices or devices that produce a measurable "result" requiring human interpretation or comparison to a definitive reference standard.
However, I can extract the closest analogous information available from the document:
1. A table of acceptance criteria and the reported device performance
Since this is a non-clinical, substantial equivalence submission for a nasal mask, the "acceptance criteria" are primarily established by conformity to recognized standards and comparative performance with a predicate device. The "reported device performance" refers to the measurements taken on the F&P Evora Nasal Mask.
| Performance Metric | Acceptance Criteria (Implied by Standards/Predicate) | Reported Device Performance (F&P Evora Nasal Mask) |
|---|---|---|
| Indications for Use | Substantially equivalent to predicate, adult patients ≥66 lbs (30kgs) needing CPAP/bilevel therapy. | A-Model: Intended for single patient use in the home. |
| SL-Model: Intended for single patient use in the home and for multiple patient use in the hospital or other clinical setting where proper disinfection can occur. | ||
| (Determined to be "Substantially equivalent. Identical intended use, patient population and operating environment" for the respective models compared to predicate). | ||
| Patient Population | Adult (≥66 lbs / 30 kg) | Adult (≥66 lbs / 30 kg). ("Identical") |
| Operating Environment | Home (A-model) / Home, hospital, clinical setting (SL-model) | A-Model: Home. |
| SL-Model: Home, hospital or other clinical setting. | ||
| ("Identical" to predicate for respective models). | ||
| Pressure Range | 4 to 25 cmH2O (matching predicate) | 4 to 25 cmH2O. ("Identical") |
| Resistance to Flow (Pressure Drop) | Conformance with ISO 17510:2015. | Small (50L/min): 1.0 ± 0.1 cmH2O |
| Medium (50L/min): 1.0 ± 0.1 cmH2O | ||
| Large (50L/min): 1.0 ± 0.1 cmH2O | ||
| Wide (50L/min): 1.0 ± 0.1 cmH2O | ||
| Small (100L/min): 1.4 ± 0.25 cmH2O | ||
| Medium (100L/min): 1.2 ± 0.25 cmH2O | ||
| Large (100L/min): 1.2 ± 0.25 cmH2O | ||
| Wide (100L/min): 1.3 ± 0.25 cmH2O | ||
| (Comment: "The subject device is in conformance with ISO 17510:2015 and this difference does not introduce any additional risk to the user.") | ||
| Dead Space | Conformance with ISO 17510:2015. | Small: 28 cc |
| Medium: 26 cc | ||
| Large: 28 cc | ||
| Wide: 34 cc | ||
| (Comment: "All seal sizes are in conformance with ISO 17510:2015 and this difference does not introduce any additional risk to the user.") | ||
| Sound | Conformance with ISO 17510:2015. | Sound Power Level: 26.8 dBA (uncertainty 2.5 dBA) |
| Sound Pressure Level: 18.8 dBA (uncertainty 2.5 dBA) | ||
| (Comment: "The subject device is in conformance with ISO 17510:2015 and this difference does not introduce any additional risk to the user.") | ||
| Shelf-Life | Not explicitly claimed on predicate, but supported by data for subject device. | 1 year. ("The subject device claims a One-year shelf life with supporting data.") |
| Sterility | Not provided sterile (matching predicate). | Device not provided sterile. ("Identical") |
| Reusability | Single Patient Use (A-model) / Reusable - Multi Patient Use (SL-model) (matching predicate). | A-Model: Single Patient Use. |
| SL-Model: Reusable – Multi Patient Use. ("Identical") | ||
| High Level Disinfection Methods | Thermal Disinfection (for SL-model, matching predicate). | SL-Model: Thermal Disinfection. ("Identical") |
| Accessory (Oxygen/Pressure Port) | Available as separate part (matching predicate). | Oxygen/Pressure Port (900HC452) Available as a separate part, not provided with device. ("Identical") |
| Other Non-Clinical Tests | Demonstrates substantial equivalence, confirms safety/effectiveness, meets relevant standards. |
- Shelf life simulation based on ASTM F1980-07.
- Transportation simulation based on ISTA 2A.
- Confirmed non-adverse effects on safety and effectiveness for CO2 rebreathing, total mask exhaust flow, resistance to flow/pressure drop.
- Mechanical integrity/performance verified after abuse scenarios (home use/cleaning, multi-patient use/reprocessing, accelerated aging, transport/storage).
- Tested to ISO 17510:2015, ISO 5356-1:2015, ISO 10993 series (1, 2, 3, 5, 10, 11, 12, 17, 18), ISO 18562 series (1, 2, 3). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not applicable in the context of clinical study data or a specific "test set" as understood for AI/ML performance evaluation. The data presented are from non-clinical engineering and safety tests on the device itself.
- Data provenance: Not explicitly stated as "country of origin" for each test. The submitting company is Fisher & Paykel Healthcare Ltd., located in Auckland, New Zealand. The tests are non-clinical, conducted in a laboratory setting. There is no indication of retrospective or prospective data in the clinical sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not applicable as the document describes non-clinical engineering and performance testing of a physical medical device (nasal mask), not an AI/ML diagnostic algorithm requiring expert "ground truth."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not applicable as there is no human adjudication process involved in these non-clinical tests.
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
- This information is not applicable. No MRMC study was performed as this is not an AI/ML diagnostic or assistive device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This information is not applicable. This is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the non-clinical tests is represented by established engineering standards, regulatory requirements, and measurements against the predicate device's known characteristics. For example, CO2 rebreathing tests would measure actual CO2 levels, and resistance to flow tests would measure physical pressure drops, compared against specified limits or predicate performance.
8. The sample size for the training set
- This information is not applicable as there is no AI/ML training set involved.
9. How the ground truth for the training set was established
- This information is not applicable as there is no AI/ML training set involved.
§ 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).