(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/min | ||
| Without 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/min | |||
| Without 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 |
§ 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).