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510(k) Data Aggregation
(101 days)
For use with ventilators, anesthesia machines and open flow systems where filtration of inspired and / or expired gases is desired and to add and retain moisture in the circuit as required.
It is single patient use, disposable for patients with Tidal Volumes > 250 ml.
Duration of use
The HydroMax™ HMEF is standard configuration housing with a CO2 sampling port.
The common features are:
- All have standard conical 15 mm / 22 mm fittings for connections ●
- Female luer lock port for gas sampling for end-tidal CO2 .
The principle of operation:
- The filter media is an electrostatic type of media and filters via electrostatic attraction .
- . The HME media a porous foam that has hygroscopic properties to retain and release moisture from the patient
The A-M Systems, Inc. HydroMax™ HMEF (Heat and Moisture Exchanger Filter) is a bacterial/viral filter intended for use with ventilators, anesthesia machines, and open flow systems to filter inspired and/or expired gases and retain moisture in the circuit. It is a single-patient use, disposable device for patients with tidal volumes greater than 250 ml and a duration of use of less than 24 hours. The device's performance was evaluated through bench testing.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the HydroMax™ HMEF are generally established by comparing its performance to a legally marketed predicate device, the GE (Engstrom) HMEF 1000 (K964204), and by meeting relevant international standards for medical devices (e.g., ISO 9360-1, ASTM F316-80). The "acceptance criteria" are implied by demonstrating substantial equivalence to the predicate and meeting the performance characteristics of the relevant standards.
| Performance Characteristic | Predicate Device (GE (Engstrom) HMEF 1000) Performance | Acceptance Criteria (Implied) | Reported Device Performance (HydroMax™ HMEF) |
|---|---|---|---|
| Filtration Efficiency | |||
| Bacterial Filtration Efficiency (BFE) | >99.9999% | ≥ 99.9999% (based on predicate) | >99.99969% @ 30 lpm |
| Viral Filtration Efficiency (VFE) | >99.99% | ≥ 99.99% (based on predicate) | >99.9946% @ 30 lpm |
| Humidification Performance | |||
| Moisture Output (Vt 250 ml) | N/A | (Comparable to predicate/industry standard for HME) | 36.5 mg/L |
| Moisture Output (Vt 500 ml) | 33 mg/L | ≥ 33 mg/L (based on predicate) | 35.13 mg/L |
| Moisture Output (Vt 750 ml) | 32 mg/L | ≥ 32 mg/L (based on predicate) | 33.2 mg/L |
| Moisture Output (Vt 1000 ml) | 30 mg/L | ≥ 30 mg/L (based on predicate) | 32.53 mg/L |
| Moisture Loss (Vt 250 ml) | N/A | (Comparable to industry standard for HME) | 7.63 mg/L |
| Moisture Loss (Vt 500 ml) | 4.5 mg/L | (Comparable to predicate/industry standard for HME) | 8.97 mg/L |
| Moisture Loss (Vt 750 ml) | 5.5 mg/L | (Comparable to predicate/industry standard for HME) | 10.9 mg/L |
| Moisture Loss (Vt 1000 ml) | 7.5 mg/L | (Comparable to predicate/industry standard for HME) | 11.57 mg/L |
| Respiratory Mechanics | |||
| Pressure Drop @ 30 lpm | 1.0 cmH2O | ≤ 1.0 cmH2O (based on predicate) | 0.7 cmH2O |
| Pressure Drop @ 60 lpm | 2.3 cmH2O | ≤ 2.3 cmH2O (based on predicate) | 2.0 cmH2O |
| Pressure Drop @ 90 lpm | N/A | (Comparable to industry standard for HME) | 3.5 cmH2O |
| Dead Space (Internal Volume) | 77 ml | Not explicitly defined as 'criteria', but for comparison. | 56 ml |
| Structural Integrity & Safety | |||
| Filter Integrity (Bubble Point) | N/A | (Meet ASTM F316-80 requirements) | 244.43 microns |
| Housing Burst Strength | N/A | (Meet safety requirements/industry standard) | >10 psi |
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