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510(k) Data Aggregation
(288 days)
The F&P Eson™ 2 Nasal Mask is intended to be used by individuals who have been diagnosed by a physician as requiring CPAP or Bi-level therapy. The F&P Eson™ 2 Nasal Mask is intended for single patient adult (≥ 66lb (30kg)) use in the home and for multiple patient adult use in the clinical setting where proper disinfection of the device can occur between patient uses.
The F&P Eson™ 2 Nasal Mask is a non-invasive patient interface with a silicone seal which covers around the nose of a patient held in place by adjustable headgear straps.
The mask connects to a single breathing tube via a 22mm swivel adaptor to receive pressurized gases from a continuous airway pressure device (CPAP or Bi-level). The exhaust holes on the elbow of the mask allow exhaled gases to be flushed out while the system is in operation.
The F&P Eson™ 2 Nasal Mask is a prescription only device, provided in a non-sterile state.
An oxygen pressure port accessory is available to be used with the device for oxygen therapy and/or gas monitoring (previously covered by K121597 F&P Eson Nasal Mask).
This document describes a 510(k) premarket notification for the F&P Eson™ 2 Nasal Mask, which is a non-invasive patient interface for CPAP or Bi-level therapy. The purpose of the submission is to demonstrate substantial equivalence to a predicate device, the Eson™ Nasal Mask (K121597).
Here's an analysis of the provided information, focusing on acceptance criteria and supporting studies, formatted to your request:
1. Table of Acceptance Criteria and Reported Device Performance
The submission doesn't explicitly list "acceptance criteria" in a separate table for performance metrics in the same way one might find for an AI medical device. Instead, it compares the F&P Eson™ 2 Nasal Mask to its predicate device and states conformance to relevant standards. The "Comments" column in the comparison tables serves as an implicit acceptance of the observed performance relative to the predicate or standard.
| Feature | Implicit Acceptance Criteria / Standard | Predicate Device (K121597) Performance | F&P Eson™ 2 Nasal Mask Performance | Device Meets Criteria? |
|---|---|---|---|---|
| Classification Regulation | 21 CFR §868.5905 | 868.5905 | 868.5905 | Yes (Identical) |
| Product Code | BZD (Anaesthesiology) | BZD | BZD | Yes (Identical) |
| Indications for Use | Substantially equivalent to predicate, adult patient population (>= 30kg) | For individuals requiring CPAP or Bi-Level therapy, adult (single/multiple patient use) | For individuals requiring CPAP or Bi-Level therapy, adult (>= 66lb (30kg)) (single/multiple patient use) | Yes (Substantially equivalent with minor clarification) |
| Resistance to Flow | Conformance with ISO 17510-2 | With diffuser: 0.14 ± 0.1cmH2O @ 50L/min, 0.65 ± 0.1cmH2O @ 100L/minWithout diffuser: 0.15 ± 0.1cmH2O @ 50L/min, 0.62 ± 0.1cmH2O @ 100L/min | With diffuser: 0.19 ± 0.1cmH2O @ 50L/min, 0.80 ± 0.1cmH2O @ 100L/minWithout diffuser: 0.17 ± 0.1cmH2O @ 50L/min, 0.73 ± 0.1cmH2O @ 100L/min | Yes (In conformance with ISO 17510-2 despite higher values) |
| Dead Space | Conformance with ISO 17510-2 | Small: 61 cc, Medium: 67 cc, Large: 79 cc | Small: 69 cc, Medium: 86 cc, Large: 98 cc | Yes (In conformance with ISO 17510-2 despite higher values) |
| Pressure Range | Allowable pressure range | 4 to 25cmH2O | 4 to 30 cmH2O | Yes (Higher allowable pressure is acceptable) |
| Sound Emissions | Sound power level < 25 dBA | With diffuser: 30 dBA (power), 22 dBA (pressure)Without diffuser: 32 dBA (power), 24 dBA (pressure) | With diffuser: 21.3 dBA (power), 13.3 dBA (pressure)Without diffuser: 31.4 dBA (power), 23.4 dBA (pressure) | Yes (Quieter with diffuser, overall acceptable) |
| Biocompatibility | Conformance with ISO 10993 | (Implied compliant) | Differences in materials from predicate underwent cytotoxicity, sensitization and extractables and leachables testing to demonstrate biocompatibility as per ISO 10993. | Yes (Demonstrated) |
| Transportation & Storage | Perform as intended, no deformation, sufficient CO2 removal, no lint, no odor, intact packaging | (Not explicitly stated but implied compliant for predicate) | No visible deformations, sufficiently removed CO2, no visible lint, no offensive odor, packaging intact. | Yes |
| Automatic High-Level Disinfection | Minimum 6 log reduction | (Not explicitly stated but implied compliant for predicate) | Achieved minimum 6 log reduction. | Yes |
| Thermal Disinfection | Effective disinfection at specified cycles (75°C for 30min, 80°C for 10min, 90°C for 1min) | (Not explicitly stated but implied compliant for predicate) | Able to be thermally disinfected through predetermined cycles. | Yes |
| Carbon Dioxide Flushing | Meet minimum flush rate | (Not explicitly stated but implied compliant for predicate) | Sufficiently flushed carbon dioxide at a suitable rate under worst-case. | Yes |
| Shelf Life Assessment | Retain structural integrity; very remote risk of degradation within 10 years | (Not explicitly stated but implied compliant for predicate) | Materials have well-known, stable properties, very remote risk of degradation within 10 years. | Yes |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This submission does not involve an AI device and thus does not refer to "test sets" in the context of machine learning model evaluation. The non-clinical tests performed (e.g., resistance to flow, dead space, sound emissions, disinfection, shelf life, CO2 flushing) are likely in-house laboratory tests on a representative number of device samples. The document does not specify the exact sample sizes for these tests or the country of origin of the data, but it implies the testing was conducted by Fisher & Paykel Healthcare based in New Zealand. These were likely prospective tests conducted for the purpose of this submission.
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)
Not applicable. As this is not an AI device, there is no "ground truth" establishment by experts in the context of image interpretation or similar AI applications. Performance is measured using objective engineering and laboratory standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not an AI device submission requiring adjudication of expert interpretations for a test set.
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
Not applicable. This is a medical device (nasal mask), not an AI diagnostic or assistive tool. Therefore, MRMC studies and "human reader improvement with AI" are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI device. The device itself is the "standalone" component being evaluated functionally.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the F&P Eson™ 2 Nasal Mask's performance is established by objective engineering and laboratory measurements against recognized international standards (ISO 17510-2, ISO 10993-1) and internal functional specifications. For biocompatibility, the ground truth is adherence to the toxicological profiles defined by ISO 10993. For disinfection, the ground truth is achieving a specified log reduction of microorganisms.
8. The sample size for the training set
Not applicable. This is not an AI device and does not involve training data sets.
9. How the ground truth for the training set was established
Not applicable. This is not an AI device and does not involve training data sets or their ground truth establishment.
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