Besmed Bacterial Filter and HMEF

K241339 · Besmed Health Business Corp · CAH · Nov 14, 2024 · Anesthesiology

Device Facts

• Record ID: K241339
• Device Name: Besmed Bacterial Filter and HMEF
• Applicant: Besmed Health Business Corp
• Product Code: CAH · Anesthesiology
• Decision Date: Nov 14, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5260
• Device Class: Class 2
• Attributes: Pediatric

Intended 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. 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 Story

Device consists of a bacterial filter and Heat and Moisture Exchanger Filter (HMEF) for use in breathing circuits. Inputs: inhaled/exhaled gases from anesthesia machines or ventilators. Operation: electrostatic filtration mechanism traps particles; HMEF uses heat-preserved and moisture-absorbed paper roll to retain exhaled heat/humidity for release during inhalation. Output: filtered, humidified gas delivered to patient. Used in hospital/critical care by trained personnel. Placed between circuit Y-piece and patient airway device. Benefits: reduces cross-contamination risk; maintains airway moisture. Single-use, 24-hour duration.

Clinical Evidence

No clinical data. Bench testing only. Performance verified via ISO 9360-1 (moisture output/loss, pressure drop), ISO 23328-1 (filtration efficiency >99.9%), ISO 80369-7 (leakage), and ASTM F2101 (BFE/VFE >99.9%). Biocompatibility confirmed per ISO 10993 and ISO 18562.

Technological Characteristics

Materials: ABS housing, electrostatic filter paper, HME paper medium (CaCl2 impregnated). Principle: Electrostatic filtration and passive heat/moisture exchange. Form factor: 22M/15F connections per ISO 5356-1. Connectivity: None. Sterilization: Ethylene oxide. Software: None.

Indications for Use

Indicated for adult and child patients requiring anesthesia, artificial respiration, or assisted ventilation in critical care and hospital environments to reduce bacterial/viral transmission and maintain respiratory tract moisture.

Regulatory Classification

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.

Predicate Devices

• ThermoShield HME Filter (K163300)

Reference Devices

• HepaShield Bacterial Viral Breathing System Filter (K191909)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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*)

| <span>☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> |
|-------------------------------------------------------------|
| <span>☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

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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

☎:[phone] 幅:[phone]

: [e-mail] & : www.besmed.com

# 510(k) Summary - K241339

| Date Prepared: | 14-November-2024 |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Name and Address: | Besmed Health Business Corp.<br>No. 5, Lane 116, Wu-Kong 2nd Road,<br>Wu-Ku District, New Taipei City, Taiwan 24888<br>Tel: [phone]<br>Fax: [phone]<br>www.besmed.com |
| Prepared and Submitted by: | Steven Wong<br>Manager, Regulatory Affairs & Quality Affairs<br>Tel: [phone] ext 211<br>Email: [e-mail] |
| Official Contact: | Sarah Lu (Ms.)<br>Vice President<br>Tel: [phone]<br>Email: [e-mail] |
| Proprietary or Trade Name:<br>Common Name: | Besmed Bacterial Filter and HMEF<br>Filter, 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 Device<br>Trade Name: | ThermoShield HME Filter |
| 510(k) Number: | K163300 |
| Manufacturer Name: | Flexicare Medical Limited |
| Reference Device<br>Trade 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 [phone] and the fax number is [phone]. The email address is [e-mail] 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

☎ : [phone] 📠 : +886-2-229
✉ : [e-mail] 🌐 : 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<br>(K241339) | Predicate Device<br>(K163300) | Comparison | |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|
| Manufacturer | Besmed Health Business Corp. | Flexicare Medical<br>Limited | N/A | |
| Proprietary Name | Besmed HMEF with Luer Lock<br>Port<br>Besmed HMEF | ThermoShield HME<br>Filter | N/A | |
| Device models | Sterile<br>models<br>FL-70311<br>FL-70312<br>FL-70313 | Non-sterile<br>models<br>FL-70301<br>FL-70302<br>FL-70303 | Not stated in the 510(k)<br>summary | N/A |
| Intended Patient<br>Population | Child and Adult | Adult and Mini<br>(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 | Straight<br>with luer<br>port<br>Straight without<br>luer 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

☎:[phone] 幅:[phone] [e-mail]

金:www.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.

☎:[phone] 幅:[phone]

| | | :[phone] | | :[phone] | | |
|------------------|-------------------------------------------------------|----------------------------------------------------------|------------------------------------------------------|-------------------------------|-------|-----------------------------------------------------------------------------------------------------------------------------|
| | Patient Usage<br>Type | Single patient use | | Single patient use | | Same |
| | Duration of contact | Limited (≤ 24 h) | | Limited (≤ 24 h) | | Same |
| | Mode of<br>application | Non-invasive | | Non-invasive | | Same |
| Supplied sterile | | Sterile and Non-Sterile<br>Variants | | Non-Sterile | | Differences in the device<br>sterility have no impact on<br>the indication for use and<br>HMEF's principle of<br>operation. |
| Technical | Material | Luer port cap: | PP | Tethered<br>luer port<br>cap: | PVC | Different |
| | | Filter housing<br>top: | ABS | Filter<br>housing<br>top: | PP | |
| | | Filter paper: | Filter paper | Filter pad: | PP | |
| | | HME paper<br>medium: | Filter paper<br>impregnated<br>CaCl2 | HME<br>paper: | Paper | |
| | | Filter housing<br>bottom: | ABS | Filter<br>housing<br>bottom: | PP | |
| | | | | Outer<br>shrink<br>sleeve: | LDPE | |
| | Latex/ DEHP<br>content | No | | | No | Same |
| | Internal<br>Volume/dead<br>space as per<br>ISO 9360-1 | 19 ml<br>deadspace<br>model<br>FL-<br>70311/FL-<br>70301 | Available for<br>children and<br>adult<br>population | 47ml | | Different |
| | | 45 ml<br>deadspace<br>model<br>FL-70312/ FL-<br>70302 | Available for<br>adult<br>population | | | |
| | | 60 ml<br>deadspace<br>model<br>FL-70313/ FL-<br>70303 | Available for<br>adult<br>population | | | |

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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<br>: [phone] : [phone]<br>: [e-mail] www.besmed.com | |
|-----------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| HME<br>moisture output<br>(mg/L) | 19ml deadspace model rep<br>FL-70311<br>35.23 mg/L at TV 250ml<br>32.79 mg/L at TV 500ml<br>32.49 mg/L at TV 1000ml<br>45ml deadspace model rep<br>FL-70312<br>35.23 mg/L at TV 250ml<br>32.79 mg/L at TV 500ml<br>32.49 mg/L at TV 1000ml<br>60 ml deadspace model rep<br>FL-70313<br>35.23 mg/L at TV 250ml<br>32.79 mg/L at TV 500ml<br>32.49 mg/L at TV 1000ml | 30.4 mg/L at TV 500ml | Different.<br>The subject device's<br>moisture output<br>performance is above the<br>clinical acceptance criteria<br>of 30 mg/L, as well as that<br>of the predicate device,<br>under varying conditions<br>of tidal volume, respiratory<br>rate, and flow rate. | |
| HME moisture<br>loss (mg/L) | 19ml deadspace model rep<br>FL-70311<br>6.81 mg/L at TV 250ml<br>11.71 mg/L at TV 500ml<br>11.06 mg/L at TV 1000ml<br>45ml deadspace model rep<br>FL-70312<br>6.81 mg/L at TV 250ml<br>11.71 mg/L at TV 500ml<br>11.06 mg/L at TV 1000ml<br>60 ml deadspace model rep<br>FL-70313<br>6.81 mg/L at TV 250ml<br>11.71 mg/L at TV 500ml<br>11.06 mg/L at TV 1000ml | 6.8 mg/L at TV 500ml | Different.<br>The subject device's<br>moisture loss results are<br>generally higher than<br>those of the predicate<br>device under varying<br>conditions of tidal<br>volume, respiratory rate,<br>and flow rate. | |
| Tidal Volume<br>Range (ml) | 150 - 1000ml | 138~800ml | Different.<br>Tidal volume for both<br>devices varies. | |
| Pressure Drop/<br>Flow resistance | 19ml deadspace model rep<br>FL-70313<br>At 0 hour<br>0.15 hPa @30L/min<br>0.27 hPa @60L/min<br>1.34 hP…