(101 days)
Not Found
No
The summary describes a passive filter and heat/moisture exchanger with no mention of computational analysis, learning, or adaptive capabilities.
Yes
The device, an HMEF (Heat and Moisture Exchanger Filter), is used with ventilators and anesthesia machines to filter and add moisture to inspired/expired gases for patients. These functions are directly related to patient care and lung health, indicating a therapeutic purpose.
No
The device is described as an HMEF (Heat and Moisture Exchanger Filter) used for filtration and moisture retention in ventilator and anesthesia circuits, not for diagnosing medical conditions. It performs functions like filtration efficiency and retaining moisture, which are therapeutic and supportive, not diagnostic.
No
The device description clearly outlines physical components like housing, fittings, filter media, and foam, and the performance studies focus on physical characteristics and filtration efficiency, indicating it is a hardware device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for filtering and humidifying gases in respiratory circuits connected to ventilators, anesthesia machines, and open flow systems. This is a direct interaction with the patient's respiratory system, not the examination of specimens derived from the human body.
- Device Description: The description focuses on the physical components (housing, fittings, filter media, HME media) and their mechanical and physical functions (filtration, moisture retention). There is no mention of reagents, calibrators, controls, or any components used for analyzing biological samples.
- Principle of Operation: The principle of operation describes physical processes (electrostatic attraction for filtration, hygroscopic properties for moisture retention). It does not involve chemical or biological reactions used for diagnostic purposes.
- Performance Studies: The performance studies focus on physical and filtration characteristics (pressure drop, dead space, leakage, burst strength, filtration efficiency). These are relevant to the device's function in a respiratory circuit, not to diagnostic accuracy or analytical performance.
In summary, the HydroMax™ HMEF is a device that physically interacts with the gases being delivered to and from a patient's lungs. It does not perform any diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
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 10 psi 99.99969% @ 30 lpm
- Viral Filtration Efficiency (VFE) %: >99.9946% @ 30 lpm
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Bacterial / Viral filtration efficiency (Nelson Labs):
BFE->99.99969%
VFE->99.9946%
Moisture Output (mg/L):
Vt 250 - 36.5
Vt 500 - 35.13
Vt 750 - 33.2
Vt 1000 - 32.53.
Moisture Loss (mg/L):
Vt 250 - 7.63
Vt 500 - 8.97
Vt 750 - 10.9
Vt 1000 - 11.57
Pressure Drop:
0.7 cmH2O @ 30 lpm
2.0 cmH2O @ 60 lpm
3.5 cmH2O @ 90 lpm
Filter integrity per ASTM F316-80: 244.43 microns
Housing burst strength: >10 psi
§ 868.5260 Breathing circuit bacterial filter.
(a)
Identification. A breathing circuit bacterial filter is a device that is intended to remove microbiological and particulate matter from the gases in the breathing circuit.(b)
Classification. Class II (performance standards).
0
510(k) Summary Page 1 of 5 18-Jun-13
JUN 2 1 2013
| A-M Systems, Inc.
131 Business Park Loop
Sequim, WA 98382 | Tel - 360-683-8300
Fax - 360-683-3525 | |
|-----------------------------------------------------------------|---------------------------------------------------------------------------|--|
| Official Contact: | David Green, Product Manager | |
| Proprietary or Trade Name: | HydroMax™ HMEF | |
| Common/Usual Name: | Bacterial / Viral Filter | |
| Classification Name: | Filter, Bacterial, Breathing Circuit,
CAH - 21 CFR 868.5260
Class 2 | |
| Predicate Devices: | GE (Engstrom) HMEF 1000 - K964204 | |
Device Description
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
Indications for Use
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 300 ml | Tidal volume > 250 ml |
| Contraindications | None | None |
| Standard 22 / 15 mm connections | Yes | Yes |
| Per ISO 5356-1 | Yes | Yes |
| Luer port for gas sampling
Per ISO 594-2 | Yes | Yes |
| Various configurations | Straight, angled | Straight |
| Filtration method | Electrostatic | Electrostatic |
| Placement within the circuit | Patient-side | Patient-side |
| Weight (gm) | 24 gm | 21 gm |
| Internal volume/ Dead space per ISO 9360-1 | 77ml | 56 ml |
| Bacterial / Viral filtration efficiency (Nelson Labs) | BFE->99.9999%
VFE->99.99% | BFE->99.99969%
VFE->99.9946% |
| Moisture Output (mg/L) | Vt 250 - N/A
Vt 500 - 33
Vt 750 - 32
Vt 1000 - 30 | Vt 250 - 36.5
Vt 500 - 35.13
Vt 750 - 33.2
Vt 1000 - 32.53. |
| Moisture Loss (mg/L) | Vt 250 - N/A
Vt 500 - 4.5
Vt 750 - 5.5
Vt 1000 - 7.5 | Vt 250 - 7.63
Vt 500 - 8.97
Vt 750 - 10.9
Vt 1000 - 11.57 |
| Features | Predicate
GE (Engstrom) HMEF 1000
K964204 | Proposed
HydroMAXTM HME/F |
| Pressure Drop | 1.0 cmH2O @ 30 lpm
2.3 cmH2O @ 60 lpm
N/A | 0.7 cmH2O @ 30 lpm
2.0 cmH2O @ 60 lpm
3.5 cmH2O @ 90 lpm |
| Filter integrity
per ASTM F316-80 | N/A | 244.43 microns |
| Housing burst strength | N/A | >10 psi 10 psi 99.99969% @ 30 lpm |
| Viral Filtration Efficiency (VFE) % | >99.9946% @ 30 lpm |
Material - Biocompatibility
- The materials are identical to predicates that have the identical intended use. .
- . This device would be considered -
.
- External communicating / Tissue / mucosal / limited duration ( 250 ml.
Duration of use