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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 < 24 hours.
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 < 20 psi |
| Leakage per ISO 9360-1 6.4 | N/A | 0 ml/min @ 70 cm H2O (per ISO standard) | 0 ml/min @ 70 cm H2O |
| Compliance per ISO 9360-1 6.5 | N/A | (Meet ISO standard requirements) | 1.1 ml/kPa |
| Other | |||
| Standard 22/15 mm connections | Yes | Yes (per ISO 5356-1) | Yes |
| Luer port for gas sampling (ISO 594-2) | Yes | Yes (per ISO 594-2) | Yes |
| Material Biocompatibility | Standard materials to ISO 10993-1 | Standard materials to ISO 10993-1 | Standard materials to ISO 10993-1 |
Note: "N/A" for the predicate indicates the information was not provided in this specific comparison table, not necessarily that the predicate does not meet these parameters. The "Acceptance Criteria (Implied)" are derived from the direct comparison to the predicate device and the referenced ISO/ASTM standards.
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample sizes for each specific test (e.g., how many filters were tested for BFE, VFE, pressure drop, etc.). It refers to "a number of bench tests."
The data provenance is from bench testing performed by Nelson Laboratories (for Bacterial/Viral filtration efficiency) and potentially other internal or external labs for other physical characteristics.
The data is retrospective in the sense that the device was manufactured, and then tested. There is no information on the geographical origin of the data beyond "Nelson Laboratories" and "bench testing."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable as the study described is a non-clinical bench testing study of a medical device, not a human reader study or a diagnostic accuracy study involving human expert interpretation. The "ground truth" for these tests is established by standardized testing methodologies and instrument readings (e.g., filtration efficiency is determined by particle count, pressure drop by manometry).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This section is not applicable as the study is a non-clinical bench testing study. Adjudication methods like 2+1 or 3+1 are used in clinical studies or reader studies where human interpreters are involved in making decisions or interpretations that need to be reconciled.
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 section is not applicable as the study described is a non-clinical bench testing study for a physical medical device (a filter), not an AI-powered diagnostic tool. Therefore, there is no human reader component or AI assistance to evaluate.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This section is not applicable as the device is a physical medical device (filter), not an algorithm or AI product. The "standalone performance" refers to the device's inherent physical characteristics as measured by the bench tests.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc.)
For this non-clinical bench testing study, the "ground truth" for the device's performance characteristics is established by:
- Standardized laboratory measurements: Using calibrated equipment and established protocols (e.g., ISO 9360-1, ASTM F316-80) to measure physical properties like filtration efficiency, pressure drop, moisture output, etc.
- Predicate device performance: The performance of the legally marketed predicate device serves as a benchmark for substantial equivalence.
8. The sample size for the training set
This section is not applicable as this is a non-clinical bench testing study of a physical medical device, not a machine learning or AI model. Therefore, there is no "training set."
9. How the ground truth for the training set was established
This section is not applicable for the same reasons as #8.
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