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Besmed HME Filter (Heat and Moisture Exchange) is intended to decrease the transmission of bacteria and viruses to/from a patient, and to maintain moisture levels in the patient's respiratory tract while administering anesthesia gas, providing artificial respiration, or assisting with ventilation.

The Besmed HME Filter is typically placed at the patient's end of the breathing system, specifically between the circuits Y - piece and either the catheter mount or patient airway device. It is essential to note that the Besmed HME Filter is intended for single-use only and should be used on a single patient for up to 24 hours.

Besmed HME Filter is intended to be used within critical care and hospital/ institutional environments by qualified personnel.

Besmed Bacterial Filter

The purpose of the Besmed Bacterial Filter is to diminish the passage of bacteria and viruses to patients receiving anesthesia gas. Besmed Bacterial Filter is designed for utilization with ventilators, anesthesia machines, and open flow systems where there is a need for filtration of inhaled gases.

The Besmed Bacterial Filter is a disposable device intended for the exclusive use of a single patient within a 24-hour timeframe. Bacterial Filter is designed for utilization in hospital environments by medical professionals who possess adequate training in the operation of mechanical ventilators, respiratory systems, and humidification systems.

Device Description

Besmed HMEF

The Besmed HME Filter absorbs the heat and moisture exhaled by the patients. Upon inhalation, it releases the previously retained heat and humidity to the dry inhalation gases. The HME filter is designed with electrostatic cotton for filtration, as well as a heat-preserved and moisture-absorbed paper roll for maintaining the warmth and humidity of the airway in a respiratory system. Additionally, it eliminates bacterial and viral contaminants from the breathing circuit gas. To ensure passive humidification treatment, it is recommended to install the Heat and Moisture Exchanger Filter (HMEF) on the patient's end. Besmed HME Filter is intended for adult and child patients with the tidal volume between 150ml-1000ml.

Besmed Bacterial Filter

Besmed Bacterial Filter is for single-use purpose. The intended use is achieved through the implementation of an electrostatic filtration mechanism. Transparent and compact housing material makes it easy to check the surface of the filter media for a foreign substance.

AI/ML Overview

The provided text describes the acceptance criteria and the results of non-clinical testing for the "Besmed Bacterial Filter and HMEF." This summary focuses on the non-clinical test results, as no clinical testing was performed or required.

Acceptance Criteria and Reported Device Performance

The device's performance was evaluated against a set of predetermined acceptance criteria across various standards. The table below summarizes these criteria and the reported results.

Test Standards	Test Performed	Acceptance Criteria	Reported Device Performance
Packaging for Terminally Sterilized Medical Devices
ISO 11737-2:2020	Sterility test	Negative	Pass
ISO 10993-7:2008	EO/ ECH/ EG residual test	Non-Detected	Pass
ASTM F1929-23	Dye Penetration Test	No Penetration	Pass
ASTM F1140/F1140M-13(2020)e1	Burst test	Package successfully held for creep duration	Pass
	Creep test	It should maintain the specified pressure for 30 seconds	Pass
ASTM F88/F88M-23	Seal strength of flexible barrier materials test	Seal strength shall not be greater than ± 2SD compare to pre transit package	Pass
ASTM F1608-21	Microbial Ranking Test	LRV>3.0 (99.9%)	Pass
ISTA 2A:2011	Packaged products test	No visible damage	Pass
Shelf Life Test
ASTM F1980-21	Accelerated aging test	No visible damage after aging simulation	Device meets its performance specification
Performance Test
	Measurement of moisture loss	99.9% @15 LPM and 30 LPM under 0 hour and 24 hour conditioning	Pass
ISO 80369-7:2021	Leakage by pressure decay	Leakage rate should not exceed 0.005 Pa·m³/s @ 330 kPa for 20 s	Pass
	Sub-atmospheric pressure air leakage	Leakage rate should not exceed 0.005 Pa·m³/s @ 101kPa for 20 s	Pass
	Stress cracking	No signs of seal break and leakage @101 kPa after being stress	Pass
	Resistance to separation from axial load	No disconnections observed at an axial force of 35 N	Pass
	Resistance to separation from unscrewing	No disconnections observed at unscrewing torque of 0.020Nm	Pass
	Resistance to overriding	No override the threads observed at torque of 0.17 Nm	Pass
ISO 5356-1:2015	Security of engagement	No disconnections observed at axial separation force of (50 ± 5) N for 10 s	Pass
	Leakage from 22 mm latching sockets	No signs of leakage at (8 ± 0.5) kPa	Pass
	Drop procedure for 22 mm latching sockets	No signs of damage during the test	Pass
ASTM F2101-19	Bacterial / Virus Filtration Efficiency test	Evaluate BFE/VFE filter efficiency shall be greater than 90%	Pass
Biocompatibility Test
ISO 10993-5:2009	In Vitro Cytotoxicity test	Not more than 50 % of the cells are round	Pass
ISO 10993-10:2021	Skin sensitization tests (Maximization Test)	Did not produce skin sensitization on Guinea pig	Pass
ISO 10993-23:2021	Tests for irritation	Did not cause intracutaneous irritation	Pass
ISO 10993-11:2017	Acute systemic toxicity study	Did not cause systemic toxicity reaction or death	Pass
USP 151	Pyrogenicity Test	Did not induce pyrogenic response	Pass
ISO 18562-2:2024	Emissions of particulate matter	Measured concentrations of particulate matter PM2.5 ≤ 35µg/m³; PM10 ≤ 150µg/m³	Pass
ISO 18562-3:2024	Emissions of VOCs	The MOS (Margin Of Safety) value shall be higher than 1 for identified substances.	Pass

Study Details

The provided document describes a non-clinical testing summary to support the substantial equivalence of the "Besmed Bacterial Filter and HMEF."

Sample Size used for the test set and the data provenance: The document does not specify the exact sample sizes (number of devices) used for each individual test. The data provenance is implied to be from internal testing conducted by Besmed Health Business Corp., likely in Taiwan (New Taipei City, Taiwan is their address). The nature of the tests (performance, packaging, biocompatibility) indicates that these were prospective evaluations of manufactured devices.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not applicable as the studies are non-clinical, laboratory-based tests against established international and ASTM standards. Ground truth would be defined by the criteria within these standards, which are met if the device passes the specified thresholds. No human expert consensus for "ground truth" in clinical interpretation is relevant here.
Adjudication method for the test set: Not applicable for non-clinical, objective laboratory tests against defined standards.
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 is not applicable as the device is a physical medical device (breathing circuit bacterial filter and HMEF), not an AI-powered diagnostic or assistive technology.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is not applicable as the device is a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for these tests is based on the acceptance criteria defined by international standards (ISO) and ASTM standards. These standards provide objective, measurable thresholds for performance, safety, and biocompatibility.
The sample size for the training set: This is not applicable as the device is a physical medical device, not a machine learning model that requires a training set.
How the ground truth for the training set was established: This is not applicable for the same reason as above.

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