(178 days)
For use with ventilators, anesthesia machines and open flow systems where filtration of inspired and / or expired gases is desired and to add maintain and retain moisture for the exhaled breathe of the patient
The EMS HEPA Filter and combined HEPA filter / HME are available in multiple sizes and shapes, recogular and round, and incorporate standard 15 / 22 mm connectors with a gas sampling luer port. recoalignar and round, and morporativer for filtration and a foam media for the HME media. Each filter is individually tested for rating performance according to BS 3928 Sodium Flame for Air filters. The "HEPA" performance was in accordance to DOE 3202-97 and ASTM D2986 – DOP.
The provided text describes a 510(k) premarket notification for the EMS HEPA Filter and HEPA Filter / HME, which are bacterial/viral filters and heat and moisture exchangers. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a full study report with detailed performance metrics against those criteria.
However, the "General Technical Characteristics" table [1] lists several performance attributes of the proposed devices, which can be interpreted as acceptance criteria based on established standards and the characteristics of predicate devices. The "Reported Device Performance" column reflects the device's measured or designed specifications.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" and "reported device performance" in separate columns, nor does it present a formal study showing the device meets these criteria with numerical results from a specific test. Instead, it lists technical characteristics, which by their nature in a 510(k) summary, imply that the device performance meets or is equivalent to these values for substantial equivalence.
| Acceptance Criteria (Implied from "General Technical Characteristics") | Reported Device Performance (Implied from "EMS - Proposed Devices" column) |
|---|---|
| Indications for use - To filter inspired and / or expired gases. | Same (as predicate) |
| Intended for single patient, up to 24 hours | Yes |
| Prescription | Yes |
| Intended population | Any patient |
| Intended Environment of Use | Home, Hospital, sub-acute, Emergency services |
| Placement in various locations in circuit | Yes |
| Gas sampling port | Yes |
| Standard 15/22 mm connectors | Yes |
| Dead Space (ml) | 45 to 80 ml |
| Resistance to flow |
§ 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).