(185 days)
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.
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.
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 | <16 mg/l at 250 ml/500 ml/1000 ml tidal volume | The average moisture loss met the acceptance criteria for the specified tidal volumes | |
| HME moisture output | Greater than 30 mg/L | Pass | |
| ISO 9360-1:2000 | Measurement of pressure drop | Pressure drop at 30L/min, 60L/min and 90L/min should not be greater than 5hPa. | Pass |
| HMEF gas leakage | Leakage less than 4ml/min @ 7kpa, and 15kpa | Pass | |
| Compliance | Methodology only, no acceptance criteria | Meets requirements | |
| ISO 23328-1:2008 | Salt test method to assess filtration performance | Bacterial filter and HMEF efficiency shall be > 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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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "U.S. Food & Drug Administration" in blue.
November 14, 2024
Besmed Health Business Corp. Steven Wong Manager, Regulatory Affairs No. 5, Lane 116 Wu-Kong 2nd Rd Wu-Ku District New Taipei City, Taiwan 24888
Re: K241339
Trade/Device Name: Besmed Bacterial Filter and HMEF Regulation Number: 21 CFR 868.5260 Regulation Name: Breathing Circuit Bacterial Filter Regulatory Class: Class II Product Code: CAH Dated: April 23, 2024 Received: October 15, 2024
Dear Steven Wong:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of
{1}------------------------------------------------
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn
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(https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Katharine Segars -S
Katharine Segars, Ph.D. Assistant Director DHT4C: Division of Infection Control Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K241339
Device Name Besmed Bacterial Filter and HMEF
Indications for Use (Describe)
Besmed HMEF
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.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/4/Picture/0 description: The image shows the text "BESMED HEALTH BUSINESS CORP." in bold, sans-serif font. The text is arranged on a single line and is the only element in the image. The background is plain white.
No. 5, Lane 116, Wu-Kong 2nd Rd, Wu-Ku District, New Taipei City, Taiwan. 24888
☎:+886-2-2290-3959 幅:+886-2-2299-9076
: info@besmed.com & : www.besmed.com
510(k) Summary - K241339
| Date Prepared: | 14-November-2024 |
|---|---|
| Company Name and Address: | Besmed Health Business Corp.No. 5, Lane 116, Wu-Kong 2nd Road,Wu-Ku District, New Taipei City, Taiwan 24888Tel: +886-2-2290-3959Fax: +886-2-2299-9076www.besmed.com |
| Prepared and Submitted by: | Steven WongManager, Regulatory Affairs & Quality AffairsTel: +886-2-2290-3959 ext 211Email: research6@besmed.com |
| Official Contact: | Sarah Lu (Ms.)Vice PresidentTel: +886-2-2290-3959Email: sarah.lu@besmed.com |
| Proprietary or Trade Name:Common Name: | Besmed Bacterial Filter and HMEFFilter, Bacterial, Breathing-Circuit |
| Classification Regulation Name: | 21 CFR § 868.5260, Breathing circuit bacterial filter |
| FDA Product Code: | CAH |
| Regulatory Class: | Class II |
| Type of Submission: | Traditional |
| Predicate DeviceTrade Name: | ThermoShield HME Filter |
| 510(k) Number: | K163300 |
| Manufacturer Name: | Flexicare Medical Limited |
| Reference DeviceTrade Name: | HepaShield Bacterial Viral Breathing System Filter |
| 510(k) Number: | K191909 |
Image /page/4/Picture/7 description: The image contains the word "Besmed" in a dark brown, sans-serif font. To the right of the word is a green symbol that resembles a plus sign inside of a letter "D". The plus sign is white, and the "D" is green.
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Image /page/5/Picture/0 description: The image shows the text "BESMED HEALTH BUSINESS CORP." in bold, sans-serif font. The text is arranged on a single line and appears to be a company name. The letters are uniformly sized and spaced, creating a clear and legible presentation.
Image /page/5/Picture/1 description: The image shows the logo for Besmed. The word "Besmed" is written in black font on the left side of the image. To the right of the word is a green symbol that looks like the letter "B" with a white medical cross in the middle.
1.1 Indications for Use Besmed HMEF
. 5, Lane 116, Wu-Kong 2nd Rd, Wu-Ku District,
6-2-2290-3959
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 in conjunction 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.
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Image /page/6/Picture/0 description: The image shows the logo for Besmed, a medical device company. The logo features the company name in a bold, sans-serif font, with a green plus sign incorporated into the "B". Below the logo, the text "1.2 Device Description Besmed HMEF" is displayed in a smaller, bold font. The text indicates that the image is related to a device description for a Besmed HMEF product.
Image /page/6/Picture/1 description: The image shows the contact information for BESMED HEALTH BUSINESS CORP. The address is No. 5, Lane 116, Wu-Kong 2nd Rd, Wu-Ku District, New Taipei City, Taiwan. 24888. The phone number is +886-2-2290-3959 and the fax number is +886-2-2299-9076. The email address is info@besmed.com and the website is www.besmed.com.
- 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.
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Image /page/7/Picture/0 description: The image shows the text "BESMED HEALTH BUSINESS CORP." in bold, sans-serif font. The text is arranged on a single line and appears to be the name of a company. The background is plain and white, which makes the text stand out.
Image /page/7/Picture/1 description: The image contains the word "Besmed" in a dark brown, sans-serif font. To the right of the word is a large, green letter "B" with a white plus sign in the middle. The plus sign is formed by the negative space within the "B" shape.
5 Lane 116 Wil-Kong 2nd
☎ : +886-2-2290-3959 📠 : +886-2-229
✉ : info@bosmed.com 🌐 : www.bosm
besmed.com : www.besmed.com
1.3 Comparison of Technological Characteristic with the Predicate Device
The subject and predicate devices have technical characteristics in terms of the intended use, principle of operation, design specification, consisting of the filter media and housing. Additionally, both the subject and predicate devices utilize an electrostatic filtration mechanism, which employs electric charges to enhance particle capture.
The tables below show the similarities and differences between the subject and predicate/reference device.
| Device feature | Subject Device(K241339) | Predicate Device(K163300) | Comparison | |
|---|---|---|---|---|
| Manufacturer | Besmed Health Business Corp. | Flexicare MedicalLimited | N/A | |
| Proprietary Name | Besmed HMEF with Luer LockPortBesmed HMEF | ThermoShield HMEFilter | N/A | |
| Device models | SterilemodelsFL-70311FL-70312FL-70313 | Non-sterilemodelsFL-70301FL-70302FL-70303 | Not stated in the 510(k)summary | N/A |
| Intended PatientPopulation | Child and Adult | Adult and Mini(Pediatric) | Similar | |
| Color | Transparent and Green | Clear/ colorless, Blue | Different | |
| Emergency use | Yes | Yes | Same | |
| Primary components | Luer port cap | Tethered luer port cap | Similar | |
| Filter housing top | Filter housing top | |||
| Filter paper | Filter pad | |||
| HME paper medium | HME paper | |||
| Filter housing bottom | HME paper medium | |||
| Outer stickers | Outer shrink sleeve | |||
| Assembly Method | Ultrasonic welded housing | Snap Fit casing | Different | |
| Port diameter | 22M/15F | 22M/15F | Same | |
| Configurations | Straightwith luerportStraight withoutluer port | Straight with luer port | Same | |
| Filtration Method | Electrostatic | Electrostatic | Same | |
| Placement within circuit | Patient side | Patient side | Same | |
| Weight (g) | Straight with luer port 34.50g | Straight with luer port 38g | Different | |
| Indications for Use | 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. | Flexicare's ThermoShield HME (Heat and Moisture Exchange) Filters are intended to reduce the transmission of bacteria and viruses. to/from a patient, and to maintain moisture levels in the patient's respiratory tract during anesthesia, artificial respiration and other types of assisted ventilation. An HMEF is normally positioned at the patient end of the breathing system between the circuit Y- piece and the catheter mount or patient airway device. Flexicare's ThermoShield HME Filters are single use devices for use on a single patient for up to 24hrs and are available in Adult and Mini (pediatric) sizes. Flexicare's ThermoShield HME Filters are designed to be used in pre-hospital, hospital and homecare environments by trained personnel. Expert clinical judgment must be used in assessing patient humidification requirements | Similar. Both devices are intended to minimize the transfer of bacteria and viruses to/from a patient. It also aids in maintaining moisture levels in the patient's respiratory tract while administering anesthesia gas, providing artificial respiration, or assisting with ventilation. Both devices are single use devices for use on a single patient for up to 24hrs, there is a difference in the intended use environment in which both devices are operated. It will not alter the device's intended purpose. | |
| Environment of Use | Critical care and Hospital/ Institutional Environment | Pre-hospital, Hospital & Homecare Environment | Similar | |
| Device Type | Disposable | Disposable | Same |
Table 1. A Comparison between the Subject and Predicate Device
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No. 5, Lane 116, Wu-Kong 2nd Rd, Wu-Ku District, New Taipei City, Taiwan. 24888
☎:+886-2-2290-3959 幅:+886-2-2299-9076 info@besmed.com
Image /page/8/Picture/6 description: The image shows the logo for Besmed. The word "Besmed" is written in a dark brown, bold font. To the right of the word is a green symbol that looks like a stylized letter "B" with a white cross in the middle.
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No. 5, Lane 116, Wu-Kong 2nd Rd, Wu-Ku District,
New Taipei City, Taiwan. 24888
Image /page/9/Picture/2 description: The image shows the logo for Besmed. The word "Besmed" is written in a dark brown font. To the right of the word is a green letter "B" with a white medical cross in the middle.
☎:+886-2-2290-3959 幅:+886-2-2299-9076
| :+886-2-2290-3959 | :+886-2-2299-9076 | |||||
|---|---|---|---|---|---|---|
| Patient UsageType | Single patient use | Single patient use | Same | |||
| Duration of contact | Limited (≤ 24 h) | Limited (≤ 24 h) | Same | |||
| Mode ofapplication | Non-invasive | Non-invasive | Same | |||
| Supplied sterile | Sterile and Non-SterileVariants | Non-Sterile | Differences in the devicesterility have no impact onthe indication for use andHMEF's principle ofoperation. | |||
| Technical | Material | Luer port cap: | PP | Tetheredluer portcap: | PVC | Different |
| Filter housingtop: | ABS | Filterhousingtop: | PP | |||
| Filter paper: | Filter paper | Filter pad: | PP | |||
| HME papermedium: | Filter paperimpregnatedCaCl2 | HMEpaper: | Paper | |||
| Filter housingbottom: | ABS | Filterhousingbottom: | PP | |||
| Outershrinksleeve: | LDPE | |||||
| Latex/ DEHPcontent | No | No | Same | |||
| InternalVolume/deadspace as perISO 9360-1 | 19 mldeadspacemodelFL-70311/FL-70301 | Available forchildren andadultpopulation | 47ml | Different | ||
| 45 mldeadspacemodelFL-70312/ FL-70302 | Available foradultpopulation | |||||
| 60 mldeadspacemodelFL-70313/ FL-70303 | Available foradultpopulation |
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No. 5, Lane 116, Wu-Kong 2nd Rd, Wu-Ku District,
New Taipei City, Taiwan. 24888
Image /page/10/Picture/2 description: The image shows the logo for Besmed. The word "Besmed" is written in a bold, dark brown font. To the right of the word is a green symbol that resembles a "B" with a white medical cross in the middle.
| Image: Besmed logo | New Taipei City, Taiwan. 24888: +886-2-2290-3959 : +886-2-2299-9076: info@besmed.com www.besmed.com | |||
|---|---|---|---|---|
| HMEmoisture output(mg/L) | 19ml deadspace model repFL-7031135.23 mg/L at TV 250ml32.79 mg/L at TV 500ml32.49 mg/L at TV 1000ml45ml deadspace model repFL-7031235.23 mg/L at TV 250ml32.79 mg/L at TV 500ml32.49 mg/L at TV 1000ml60 ml deadspace model repFL-7031335.23 mg/L at TV 250ml32.79 mg/L at TV 500ml32.49 mg/L at TV 1000ml | 30.4 mg/L at TV 500ml | Different.The subject device'smoisture outputperformance is above theclinical acceptance criteriaof 30 mg/L, as well as thatof the predicate device,under varying conditionsof tidal volume, respiratoryrate, and flow rate. | |
| HME moistureloss (mg/L) | 19ml deadspace model repFL-703116.81 mg/L at TV 250ml11.71 mg/L at TV 500ml11.06 mg/L at TV 1000ml45ml deadspace model repFL-703126.81 mg/L at TV 250ml11.71 mg/L at TV 500ml11.06 mg/L at TV 1000ml60 ml deadspace model repFL-703136.81 mg/L at TV 250ml11.71 mg/L at TV 500ml11.06 mg/L at TV 1000ml | 6.8 mg/L at TV 500ml | Different.The subject device'smoisture loss results aregenerally higher thanthose of the predicatedevice under varyingconditions of tidalvolume, respiratory rate,and flow rate. | |
| Tidal VolumeRange (ml) | 150 - 1000ml | 138~800ml | Different.Tidal volume for bothdevices varies. | |
| Pressure Drop/Flow resistance | 19ml deadspace model repFL-70313At 0 hour0.15 hPa @30L/min0.27 hPa @60L/min1.34 hPa @90L/minAt 24 hour0.17 hPa @30L/min0.32 hPa @60L/min1.41 hPa @90L/min45ml deadspace model repFL-70312At 0 hour0.58 hPa @30L/min1.58 hPa @60L/min | 1.71 hPa @30L/min4.31 hPa @60L/min7.82 hPa @90L/min | Different.The pressure drop results ofthe subject device, are lowerthan those of the predicatedevice under varying flowrates. | |
| 3.25 hPa @90L/minAt 24 hour0.58 hPa @30L/min1.60 hPa @60L/min3.45 hPa @90L/min60 ml deadspace model repFL-70312At 0 hour0.58 hPa @30L/min1.60 hPa @60L/min4.03 hPa @90L/minAt 24 hour0.57 hPa @30L/min1.63 hPa @60L/min3.94 hPa @90L/min | ||||
| Gas leakage perISO 9360-1, 6.4 | FL-703132.29 ml/min @7kpa2.65 ml/min @15kpa | 1.53 ml/min @7kpa1.67 ml/min @15kpa | Different.The pressure gas leakage results of the subject device at 7kPa and 15kPa are below than 4 ml/min as per the requirements. | |
| Leakage bypressure decayper ISO 80369-7:2021, 6.1.2 | FL-703130.00048 Pa·m³/s | 0.00054 Pa·m³/s | Different.The subject device's leakage rate did not exceed 0.005 Pa·m³/s, as per ISO 80369-7 requirements. | |
| Sub-atmosphericpressure airleakage per ISO80369-7:2021, 6.2 | FL-703130.00053 Pa·m³/sNo leak at 101 kPa | 0.00048 Pa·m³/sNo leak at 101 kPa | Different.The sub-atmospheric pressure leakage rate for the subject device did not exceed leak of 0.005 Pa·m³/s in luer connector. | |
| Compliance perISO 9360-16.5 | 0.83 ml/kPa | 14.02 ml/kPa | Different than the predicate. | |
| Standard22/15mmconnections incompliance withISO 5356-1 | Yes | Yes | Same | |
| Luer port for gassampling incompliance withISO 80369-7 | Yes | Yes | Same | |
| Bacterialfiltrationefficiency-ASTMF2101 | FL-70313BFE - 99.99 %VFE - 99.99 % | BFE - 99.99 %VFE - 99.99 % | Same | |
| Salt test method | Availableforchildren | FL-70312At 0 hour99.99% @15LPM |
{11}------------------------------------------------
No. 5, Lane 116, Wu-Kong 2nd Rd, Wu-Ku District, New Taipei City, Taiwan. 24888
Image /page/11/Picture/2 description: The image features the logo for "Besmed". The word "Besmed" is written in a bold, sans-serif font, with the letters in black. To the right of the word, there is a stylized green symbol that resembles a plus sign integrated into a letter "B". The plus sign is formed by the negative space within the green shape.
省:+886-2-2290-3959 昌:+886-2-2299-9076 info@b 1
{12}------------------------------------------------
No. 5, Lane 116, Wu-Kong 2nd Rd, Wu-Ku District,
| New Taipei City, Taiwan. 24888 | ||
|---|---|---|
| +886-2-2290-3959info@besmed.com | +886-2-2299-9076www.besmed.com | |
| 99.98% @30LPMAt 24 hour99.99% @15LPM99.99% @30LPMFL-70313 | 98.90% | Different.The filtration efficiency forthe subject device is higherthan the predicate device. |
| At 0 hour99.98% @30LPMAt 24 hour99.98% @30LPM | ||
| m Temperature | 25+5℃ Room | Same |
| Availablefor adultpopulation | FL-70313At 0 hour99.98% @30LPMAt 24 hour99.98% @30LPM | |||
|---|---|---|---|---|
| Operationtemperature | 25±5 °C, Room Temperature | 25±5 °C, RoomTemperature | Same | |
| Storage condition | -20~60 °C,30-70% RH | -20 to 60 °C,15-95% RH | Similar.The storage humidity for thesubject device iswithin the range of thepredicate device. | |
| Packaging | RST 80/XPA film | Non-SterilePrimary - Polybag -(LDPE)SterilePrimary - Top Web -EO Permeable PaperBlister Pack -(PVC) | Different | |
| Sterilizationmethod | Ethylene oxide sterilization | N/A | Different | |
| Shelf life | 5 years | 4 years | Different.The stability of thesubject device wasverified by conducting a5-year real time aging testand 5-year acceleratedaging test. | |
| Biocompatibilitytest in compliancewith ISO 10993-1 | Cytotoxicity, Skin Irritation,Sensitization, Acute Systemictoxicity - All test Pass | Cytotoxicity, Implant,Sensitization,Genotoxicity- All testpass | Biocompatibility testing forboth devices wasconducted in accordancewith use of InternationalStandard ISO 10993-1,"Biological evaluation ofmedical devices - Part 1:Evaluation and testingwithin a risk managementprocess". |
Image /page/12/Picture/4 description: The image contains the word "Besmed" in a bold, dark font. To the right of the word is a green symbol that resembles a stylized letter "B" with a white cross in the center. The cross is formed by the negative space within the green shape, creating a medical or healthcare-related visual element.
filtration
23328-1
performance ISO population
and adult
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No. 5, Lane 116, Wu-Kong 2nd Rd, Wu-Ku District, New Taipei City, Taiwan. 24888
☎:+886-2-2290-3959 幅:+886-2-2299-9076
: info@besmed.com & : www.besmed.com
Table 2. A Comparison between the Subject and Reference Device
| Device feature | Subject Device(K241339) | Reference Device(K191909) | Comparison | |
|---|---|---|---|---|
| Manufacturer | Besmed Health Business Corp. | Flexicare MedicalLimited | N/A | |
| Proprietary Name | Besmed Bacterial Filter with LuerLock PortBesmed Bacterial Filter | HepaShield BacterialViral Breathing SystemFilter | N/A | |
| Device models | Sterile modelsFL-70210FL-70220FL-70226 | Non-sterilemodelsFL-70211FL-70221FL-70223 | Not stated in the 510(k)summary | N/A |
| Intended PatientPopulation | Child and Adult | Adult | Different | |
| Transparent and Green | Different | |||
| Emergency use | Yes | Yes | Same | |
| Port diameter | 22M/15F | 22M/15F | Same | |
| Assembly Method | Ultrasonic welded housing | Ultrasonic weldedhousing | Same | |
| Type of use | Prescription Use | Prescription Use | Same | |
| Primary components | Luer port cap | Tethered luer port cap | ||
| Filter housing top | Filter housing top | Same | ||
| Filter | Filter Media pack | |||
| Filter housing bottom | Filter housing bottom | |||
| Configurations | Straight withluer port | Straightwithout luer port | Straight with luer port | Same |
| Filtration Method | Electrostatic | Mechanical | Different. | |
| In both devices filtrationmechanism are used totrap particles, includingbacteria and virus, as airor liquidpasses through a filtermedium. | ||||
| Patient connection | Breathing circuit, manualresuscitator, Air cushion mask,resuscitation | ET tube, Laryngeal MaskAirway, Catheter mount,Breathing circuit | Different | |
| Placement within Circuit | Patient side | Patient side Machineside | Different.The predicate deviceincludes an additionalmachine side placement. | |
| Weight (g) | Straight with luer port 23.60g | Straight with luer port 42g | Different | |
| Indications for Use | ■ The purpose of the BesmedBacterial Filter is to diminishthe passage of bacteria andviruses to patients receivinganesthesia gas. BesmedBacterial Filter is designedfor utilization in conjunctionwith ventilators, anesthesiamachines, and open flowsystems where there is a needfor filtration of inhaled gases.■ The Besmed Bacterial Filter isa disposable device intendedfor the exclusive use of a singlepatient within a 24-hourtimeframe. Bacterial Filter isdesigned for utilization inhospital environments bymedical professionals whopossess adequate training in theoperation of mechanicalventilators, respiratory systems,and humidification systems. | Flexicare's HepaShieldBacterial Viral BreathingSystem Filters are intended toreduce the transmission ofbacteria and viruses to/from apatient during anesthesia. Foruse with ventilators.anesthesia machines and openflow systems where filtrationof inspired and/or expiredgases is desired. Flexicare'sHepaShield Bacterial ViralBreathing System Filters aresingle use devices for use ona single patient for up to 24hrsand are available in Adultsize. Flexicare's HepaShieldBacterial Viral BreathingSystem Filters are designed tobe used in hospitalenvironments by trainedpersonnel. | Similar.There is no distinctionin the intended purpose.clinical usage, andintended useenvironment of bothdevices. |
Image /page/13/Picture/6 description: The image shows the logo for Besmed. The word "Besmed" is written in a dark brown, bold, italicized font. To the right of the word is a green letter "D" with a white plus sign in the middle. The plus sign is formed by the negative space within the "D".
{14}------------------------------------------------
No. 5, Lane 116, Wu-Kong 2nd Rd, Wu-Ku District, New Taipei City, Taiwan. 24888
☎:+886-2-2290-3959 幅:+886-2-2299-9076 : info@besmed.com & : www.besmed.com
Besmed ■
{15}------------------------------------------------
No. 5, Lane 116, Wu-Kong 2nd Rd, Wu-Ku District, New Taipei City, Taiwan. 24888
☎:+886-2-2290-3959 冒:+886-2-2299-9076
▽ : info@besmed.com Q:www.besmed.com
| 0-0000 2000 000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000 | |
|---|---|
| ed.com & : www.besmed.com |
| Contraindications | ■ Avoid positioning the BesmedBacterial filter between ahumidification device ornebulizing device and thepatient end.■ This device is strictlyrestricted to single patient use,do not attempt to re- sterilizeor reuse the device.■ Do not try to cleanse ordecontaminate this deviceusing any method, such asrinsing, washing, or subjectingit to gas, heat, steam, orboiling water. | ■ DO NOT place theHepaShield BacterialViral Breathing SystemFilter between ahumidification device ornebulizing device and thepatient.■ Single Use. Do not reuse.■ DO NOT attempt todecontaminate thisproduct in any way. Thisincludes rinsing, washingor decontamination usinggas, heat, steam, orboiling water.■ When used inconjunction with ahumidified breathingsystem, the HepaShieldBacterial Viral BreathingSystem Filter iscontraindicated for use atthe patient end. | Similar | |||
|---|---|---|---|---|---|---|
| Environment of Use | Hospital Environments | Hospital | Similar | |||
| Device Type | Disposable | Disposable | Same | |||
| Patient Usage Type | Single patient use | Single patient use | Same | |||
| Duration of contact | Limited (≤ 24 h) | Limited (≤ 24 h) | Same | |||
| Mode of application | Non-invasive | Non-invasive | Same | |||
| Supplied sterile | Both Non-sterile & sterilevariants | Both Non-sterile & sterilevariants | Same | |||
| Luer port cap: | PP | Tethered luerport cap: | PVC | |||
| Filter housingtop: | ABS | Filter housingtop: | ABS | Different | ||
| Technical | Materials | Filter : | Filter Paper | Filter Mediapack: | Hydro-phobicpleatedpaper | |
| Filter housingbottom | ABS | Filter housingbottom: | ABS |
Besmed ■
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No. 5, Lane 116, Wu-Kong 2nd Rd, Wu-Ku District, New Taipei City, Taiwan. 24888
☎ : +886-2-2290-395
| : +886-2-2290-3959 | : +886-2-2299-9076 |
|---|---|
| : info@besmed.com | : www.besmed.com |
| Latex/DEHPcontent | No | No | Same | |
|---|---|---|---|---|
| InternalVolume / deadspace as perISO9360-1 | 32mldeadspacemodelFL-70210/FL-70211/FL-70226/FL-7022373mldeadspacemodelFL-70220/FL-70221 | Available forchildren andadultpopulationAvailable foradultpopulation | 47ml | Different.The subject deviceoffers lower limit forthe recommendedtidal volume rangeuse for the identifiedpatient population. |
| TidalVolumeRange (ml) | 150 - 1000ml | 141~800ml | Different | |
| PressureDrop/ Flowresistance | 32ml deadspace model repFL-70210At 0 hour0.65 hPa @30L/min1.57 hPa @60L/min2.69 hPa @90L/minAt 24 hour0.64 hPa @30L/min1.57 hPa @60L/min2.54 hPa @90L/min73ml deadspace model repFL-70220At 0 hour0.70 hPa @30L/min1.62 hPa @60L/min2.79 hPa @90L/minAt 24 hour0.75 hPa @30L/min1.74 hPa @60L/min2.89 hPa @90L/min | 1.70 hPa @30L/min3.92 hPa @60L/min6.56 hPa @90L/min | Different.The pressure dropresults for the subjectdevice, are lowerthan those of thepredicate deviceunder varying flowrates. | |
| Gas leakage | 1.49 ml/min @7kpa2.24 ml/min @15kpa | 1.61ml/min @7kpa2.03 ml/min @15kpa | Different | |
| Leakage bypressuredecay perISO 80369 -7:2021, 6.1.2 | FL-702100.00051 Pa·m³/s | 0.00059 Pa·m³/s | Different.The subject device'sleakage rate did notexceed 0.005 Pa·m³/sas per ISO 80369-7requirements. | |
| Sub-atmosphericpressure airleakage perISO 80369-7:2021, 6.2 | FL-703130.00051 Pa·m³/sNo leak at 101 kPa | 0.00051 Pa·m³/s Noleak at 101 kPa | Same | |
| Complianceper ISO9360-16.5 | 0.63 ml/kPa | 0.06 ml/kPa | Different.The subject device'scompliance results arehigher than thepredicate device, butleakage performanceare similar to predicatedevice. | |
| Standard22/15mmconnectionsincompliancewith ISO5356-1 | Yes | Yes | Same | |
| Luer portfor gassampling incompliancewith ISO80369-7 | Yes | Yes | Same | |
| BacterialfiltrationefficiencyASTMF2101 | FL-70210BFE – 99.999 %VFE – 99.99 % | BFE – 99.99999%VFE – 99.9999% | Same | |
| Salt testmethod -filtrationperformance ISO23328-1 | Availableforchildren andadultpopulation | FL-70210At 0 hour99.98% @15 LPM99.98% @30 LPMAt 24 hour99.98% @15 LPM99.98% @30 LPM | Different.The subject device'sfiltration efficiency is> 99.9%. | |
| Availableforadultpopulation | FL-70220At 0 hour99.97% @30 LPMAt 24 hour99.98% @30 LPM | |||
| 99.89% | ||||
| Operationtemperature | 25±5 °C, RoomTemperature | 25±5 °C, RoomTemperature | Same | |
| Storage condition | -20~60 °C, 30-70% RH | -20 to 60 °C,15-95% RH | Similar | |
| Packaging | RST 80/XPA film | Polybag | Different | |
| Sterilizationmethod | Ethylene oxide sterilization | Non-sterile | Different | |
| Shelf life | 5 years | 5 years | Same | |
| Biocompatibilitytest incompliancewith ISO10993-1 | Cytotoxicity, SkinIrritation,Sensitization, AcuteSystemic toxicity -All test Pass | Cytotoxicity,Irritation,Sensitization,Systemictoxicity,MaterialMediatedPyrogenicity-All test pass | Testing was conductedin accordance with useof International StandardISO 10993- 1,"Biological evaluation ofmedical devices - Part 1:Evaluation and testingwithin a riskmanagement process". | |
| Biocompatibilitytest incompliance withISO 18562 | Compliant | Compliant | Same |
Image /page/16/Picture/6 description: The image shows the logo for Besmed. The word "Besmed" is written in a dark brown, sans-serif font. To the right of the word is a green square with a white plus sign in the center, which is slightly tilted.
{17}------------------------------------------------
No. 5, Lane 116, Wu-Kong 2nd Rd, Wu-Ku District, New Taipei City, Taiwan. 24888
省:+886-2-2290-3959 昌:+886-2-2299-9076 : info@besmed.com & : www.besmed.com
Image /page/17/Picture/4 description: The image is a close-up, abstract shot of a white background with a single, thick black vertical line running along the left side of the frame. The line is straight and appears to be in sharp focus, contrasting with the bright, uniform white space that dominates the rest of the image. The composition is simple, emphasizing the stark contrast between the black line and the white background.
Besmed ■
{18}------------------------------------------------
No. 5, Lane 116, Wu-Kong 2nd Rd, Wu-Ku District, New Taipei City, Taiwan. 24888
☎:+886-2-2290-3959 幅:+886-2-2299-9076 : info@besmed.com & : www.besmed.com
Image /page/18/Picture/4 description: The image contains the word "Besmed" in a bold, dark brown font. To the right of the word is a green symbol that resembles a plus sign inside of a letter B. The plus sign is white, and the letter B is green.
{19}------------------------------------------------
Image /page/19/Picture/0 description: The image shows the text "BESMED HEALTH BUSINESS CORP." in bold, sans-serif font. The text is arranged on a single line and is the only element in the image. The background is plain white.
Image /page/19/Picture/1 description: The image contains the word "Besmed" in a dark brown, bolded font. To the right of the word is a green symbol that resembles a plus sign inside of a letter "D". The plus sign is white, and the "D" is green.
No. 5, Lane 116, Wu-Kong 2nd Rd, Wu-Ku District, New Taipei City, Taiwan. 24888
☎:+886-2-2290-3959 幅:+886-2-2299-9076
: info@besmed.com & : www.besmed.com
1.4 Summary of Nonclinical Testing
Table 3. Summary of non-clinical Testing
| Test Standards | Test Performed | Acceptance Criteria | Results |
|---|---|---|---|
| Packaging for Terminally Sterilized Medical Devices | |||
| ISO 11737-2:2020 | Sterility test | Negative | Pass |
| ISO 10993-7:2008 | EO/ ECH/ EG residualtest | Non-Detected | Pass |
| ASTM F1929-23 | Dye Penetration Test | No Penetration | Pass |
| ASTM F1140/F1140M-13(2020)e1 | Burst test | Package successfully heldfor creep duration | Pass |
| Creep test | It should maintain thespecified pressure for 30seconds | Pass | |
| ASTM F88/F88M-23 | Seal strength of flexiblebarrier materials test | Seal strength shall not greaterthan ± 2SD compare to pretransit 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 agingsimulation | Device meets itsperformancespecification |
| Performance Test | |||
| Measurement ofmoisture loss | <16 mg/l at250 ml/500 ml/1000 ml tidalvolume | The averagemoisture loss metthe acceptancecriteria for thespecified tidalvolumes | |
| HME moisture output | Greater than 30 mg/L | Pass | |
| ISO 9360-1:2000 | Measurement ofpressure drop | Pressure drop at 30L/min,60L/min and 90L/min shouldnot be greater than 5hPa. | Pass |
| HMEF gas leakage | Leakage less than 4ml/min @7kpa, and 15kpa | Pass | |
| Compliance | Methodology only, noacceptance criteria | Meets requirements | |
| ISO 23328-1:2008 | Salt test method to assessfiltration performance | Bacterial filter and HMEFefficiency shall be > 99.9%@15 LPM and 30 LPM under 0hour and 24 hour conditioning | Pass |
| ISO 80369-7:2021 | Leakage by pressure decay | Leakage rate should not exceed0.005 Pa·m³/s @ 330kPa for 20 s | Pass |
| Sub-atmospheric pressureair leakage | Leakage rate should not exceed0.005 Pa·m³/s @101kPa for 20 s | Pass | |
| Stress cracking | No signs of seal break andleakage @101 kPa after beingstress | Pass | |
| Resistance to separationfrom axial load | No disconnections observed atan axial force of 35 N | Pass | |
| Resistance to separationfrom unscrewing | No disconnections observed atunscrewing torque of0.020Nm | Pass | |
| Resistance to overriding | No override the threadsobserved at torque of 0.17 Nm | Pass | |
| ISO 5356-1:2015 | Security of engagement | No disconnections observed ataxial separation force of (50± 5) N for 10 s | Pass |
| Leakage from 22 mmlatching sockets | No signs of leakage at (8 ±0.5) kPa | Pass | |
| Drop procedure for 22 mmlatching sockets | No signs of damage during thetest | Pass | |
| ASTM F2101-19 | Bacterial / Virus FiltrationEfficiency test | Evaluate BFE/VFE filterefficiency shall be greater than90% | Pass |
| Biocompatibility Test | |||
| ISO 10993-5:2009 | In Vitro Cytotoxicity test | Not more than 50 % of thecells are round | Pass |
| ISO 10993-10:2021 | Skin sensitization tests(Maximization Test) | Did not produce skinsensitization on Guinea pig | Pass |
| ISO 10993-23:2021 | Tests for irritation | Did not cause intracutaneousirritation | Pass |
| ISO 10993-11:2017 | Acute systemic toxicitystudy | Did not cause systemictoxicity reaction or death | Pass |
| USP 151 | Pyrogenicity Test | Did not induce pyrogenicresponse | Pass |
| ISO 18562-2:2024 | Emissions of particulatematter | Measured concentrations ofparticulate matter PM2.5 ≤35µg/m³PM10 ≤ 150µg/m³ | Pass |
| ISO 18562-3:2024 | Emissions of VOCs | The MOS (Margin Of Safety)value shall be higher than 1 foridentified substances. | Pass |
{20}------------------------------------------------
Image /page/20/Picture/0 description: The image shows the word "Besmed" in a bold, dark font. To the right of the word is a green symbol that resembles a stylized letter "B" with a white cross in the middle. The cross is formed by two intersecting bars, and the green "B" shape has a checkered pattern on its edges.
No. 5, Lane 116, Wu-Kong 2nd Rd, Wu-Ku District, New Taipei City, Taiwan. 24888
☎:+886-2-2290-3959 幅:+886-2-2299-9076
3935
: 1-800-2-223-9016
d.com : www.besmed.com
{21}------------------------------------------------
Image /page/21/Picture/0 description: The image contains the word "Besmed" in a dark brown, sans-serif font. To the right of the word is a green symbol that resembles a stylized letter "B" with a white cross in the middle. The symbol is likely a logo or trademark associated with the brand name "Besmed."
BESMED HEALTH BUSINESS CORP. No. 5, Lane 116, Wu-Kong 2nd Rd, Wu-Ku District,
New Taipei City, Taiwan. 24888 : +886-2-2290-3959 물 : +886-2-2299-9076
i : info@besmed.com 6 : www.besmed.com
1.5 Summary of Clinical Testing
Clinical test study was neither included nor required for this submission.
2. Conclusion
Based on the intended use, technological characteristics and the non-clinical performance tests, the subject device is as safe, as effective, and performs at least as safely and effectively as the predicate device.
§ 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).