BiWaze Clear System

K231728 · Abmrc, LLC · NHJ · Apr 8, 2024 · Anesthesiology

Device Facts

• Record ID: K231728
• Device Name: BiWaze Clear System
• Applicant: Abmrc, LLC
• Product Code: NHJ · Anesthesiology
• Decision Date: Apr 8, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The BiWaze Clear System is indicated for the loosening and mobilization of secretions, lung expansion therapy, the treatment and prevention of pulmonary atelectasis, and can provide supplemental oxygen when used with an oxygen supply. The BiWaze Clear System is for use on adult or pediatric patients in acute care (aged 2 years and older) and home care environments (aged 5 years and older). The BiWaze Clear System may be used with patient interfaces including face mask, mouthpiece, a trach adapter to endotracheal or tracheostomy tube in acute and home care environments. The BiWaze Clear System may be used in-line with a ventilator in acute care environment only.

Device Story

BiWaze Clear System is an electro-mechanical device providing lung expansion and high-frequency oscillation therapies to mobilize secretions and treat atelectasis. Inputs include air or oxygen; device provides three modes: Positive Expiratory Pressure (PEP), Oscillation (OSC), and Nebulization (NEB). PEP delivers controlled static positive pressure (≤ 30 cmH2O); OSC delivers pulses of positive pressure (up to 5 Hz, ≤ 70 cmH2O) to thin and mobilize secretions. NEB powers an Aerogen Solo vibrating mesh nebulizer. Used in acute care (including in-line with ventilators) and home care environments by clinicians or patients. Device features a closed-circuit dual lumen breathing circuit with coaxial bacterial/viral filter. Output includes therapy delivery and SpO2/heart rate display via external sensor. Clinicians use touch screen controls to adjust frequency and pressure settings. Benefits include reduced airway obstruction, prevention of respiratory infections, and enhanced gas exchange.

Clinical Evidence

Bench testing only. No clinical data provided. Performance bench testing confirmed substantial equivalence for in-line ventilator use compared to the predicate. Biocompatibility of gas/fluid pathways was maintained from the reference device (K213564).

Technological Characteristics

Electro-mechanical device; air/oxygen source. Modes: PEP, OSC, NEB. PEP: ≤ 30 cmH2O; OSC: up to 5 Hz, ≤ 70 cmH2O. Connectivity: SpO2 sensor support. Power: 100-240 V AC. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-11, IEC 62366-1, ISO 18562-1/2/3/4, ISO 10993-1, IEC 62304, ISO 14971.

Indications for Use

Indicated for loosening/mobilization of secretions, lung expansion therapy, and treatment/prevention of pulmonary atelectasis in adult and pediatric patients. Acute care: patients aged 2 years and older. Home care: patients aged 5 years and older. Can provide supplemental oxygen.

Regulatory Classification

Identification

A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.

Predicate Devices

• Hill-Rom Volara System (Maximus System) (K200988)

Reference Devices

• BiWaze Clear System (K213564)
• Beijing Choice Electronic Technology Co., Ltd. Fingertip Pulse Oximeter (K142888)

Submission Summary (Full Text)

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April 8, 2024

Abmrc LLC Priyanka Paul QA/RA Manager 860 Blue Gentian Road Suite 200 Eagan, Minnesota 55121

Re: K231728

Trade/Device Name: BiWaze Clear System Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous ventilator (IPPB) Regulatory Class: Class II Product Code: NHJ Dated: March 9, 2024 Received: March 11, 2024

Dear Priyanka Paul:

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 (the 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 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"

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(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.

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 (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.

# Rachana Visaria -S

Rachana Visaria, Ph.D. Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices

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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) K231728

Device Name BiWaze Clear System

#### Indications for Use (Describe)

The BiWaze Clear System is indicated for the loosening and mobilization of secretions, lung expansion therapy, the treatment and prevention of pulmonary atelectasis, and can provide supplemental oxygen when used with an oxygen supply.

The BiWaze Clear System is for use on adult or pediatric patients in acute care (aged 2 years and older) and home care environments (aged 5 years and older).

The BiWaze Clear System may be used with patient interfaces including face mask, mouthpiece, a trach adapter to endotracheal or tracheostomy tube in acute and home care environments. The BiWaze Clear System may be used in-line with a ventilator in acute care environment only.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

X 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/1 description: The image shows the logo for ABM Respiratory Care. The logo features the letters "abm" in a modern, sans-serif font, with the letters connected to each other. Above the letters are three colored circles: blue, orange, and green. Below the letters, the words "RESPIRATORY CARE" are written in a smaller, sans-serif font.

## 510(k) Summary

| Submitter | ABMRC LLC<br>860 Blue Gentian Road,<br>Suite 200,<br>Eagan, MN, 55121 USA<br><a href="www.abmrc.com">www.abmrc.com</a> | |
|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|---------|
| Contact | Priyanka Paul<br>QA/RA Manager<br>ABMRC LLC<br>Email: <a href="mailto:[e-mail]">[e-mail]</a> | |
| Date Prepared: | April 05, 2024 | |
| Trade/ Device Name: | BiWaze Clear System | |
| Device Common Name: | Noncontinuous Ventilator (IPPB) | |
| Classification<br>Regulation Number: | 21 CFR 868.5905 | |
| Classification Panel: | Anesthesiology | |
| Regulation Name:<br>Classification: | NHJ - Non-continuous ventilator (IPPB)<br>Class II | |
| Predicate Device<br>(Primary): | Volara ^TM System<br>(Maximus ^TM System when used as a<br>Volara ^TM System) | K200988 |
| Reference Device<br>(Existing 510(k) Cleared | BiWaze Clear System | K213564 |

### Indication for Use:

Device):

The BiWaze Clear System is indicated for the loosening and mobilization of secretions, lung expansion therapy, the treatment and prevention of pulmonary atelectasis, and can provide supplemental oxygen when used with an oxygen supply.

The BiWaze Clear System is for use on adult or pediatric patients in acute care (aged 2 years and older) and home care environments (aged 5 years and older).

The BiWaze Clear System may be used with patient interfaces including face mask, mouthpiece, a trach adapter to endotracheal or tracheostomy tube in acute and home care environments. The BiWaze Clear System may be used in-line with a ventilator in acute care environment only.

## Device Description and Modification:

The BiWaze Clear System is identical to the BiWaze Clear System cleared under K213564. The present submission extends BiWaze Clear System claims to include use in-line with a ventilator in the acute care environment only.

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Image /page/5/Picture/1 description: The image shows the logo for ABM Respiratory Care. The logo features the letters 'abm' in a simple, sans-serif font, with the letters connected. Above the letters are three colored circles in blue, orange, and green. Below the letters, the words 'RESPIRATORY CARE' are written in a smaller, sans-serif font.

The BiWaze Clear System assists patients in loosening and mobilizing secretions as well as treating and preventing atelectasis by providing lung expansion and high frequency oscillation therapies. The oscillating lung expansion therapy of the BiWaze Clear System is intended to reduce airway obstructions caused by secretions occupving the lower airways. prevent respiratory tract infections, re-expand the collapsed areas of the lung, thereby enhancing gas exchanges and reducing inflammatory response.

BiWaze Clear provides three respiratory therapies: PEP, OSC, and NEB.

- Positive Expiratory Pressure (PEP): During PEP, the system delivers a programmed . positive pressure which the patient exhales against to open and expand the patient's airways. The nebulizer can be configured to run during PEP therapy to help move the aerosolized saline solution throughout the airways.
- Oscillation (OSC): During OSC, the system oscillates the airways with pulses of . positive pressure to thin secretions and mobilizes them from the lower airways to the upper airways so they can be coughed or suctioned out. The nebulizer can be configured to run during OSC therapy to help move the aerosolized saline solution throughout the airways.
- . Nebulize (NEB): During NEB. the system powers only the Aerogen Solo vibrating mesh nebulizer. This therapy gives the patient a break from PEP or OSC while the patient receives their nebulized aerosolized saline.

The BiWaze Clear System provides a closed-circuit the Dual Lumen Breathing Circuit that prevents aerosolized exhalation of air from escaping the handset or breathing tube before being filtered by a coaxial bacterial/viral filter.

## Substantial Equivalence Determination:

The BiWaze Clear System has the following similarities to the previously cleared predicate device:

- . Indication for use
- Operating principle
- . Technology

The modified BiWaze Clear System has the secretion clearance functionality substantially equivalent to the following predicate devices:

- Hill-Rom Volara™ System (Maximus™ System, when used as a Volara™ . System) (K200988)- Predicate Device
- ABMRC's FDA 510(k) Cleared Device- BiWaze Clear System (K213564)- Reference . Device

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Image /page/6/Picture/1 description: The image shows the logo for ABM Respiratory Care. The logo features the letters "abm" in a modern, sans-serif font, with the letters connected in a flowing, cursive-like style. Above the letters are three small, colored circles in blue, orange, and green. Below the letters, in a smaller, bolder font, are the words "RESPIRATORY CARE".

| Technological<br>Characteristic | BiWaze Clear System<br>(Proposed Device) | Hill-Rom Volara System<br>(MaximusTM System, when<br>used as a VolaraTM System)<br>(Predicate Device) | BiWaze Clear<br>System<br>(Reference<br>Devices) |
|---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K231728 | K200988 | K213564 |
| CFR<br>Classification | Regulation Number: 21<br>CFR 868.5905 | Regulation Number: 21 CFR<br>868.5905 | Regulation Number:<br>21 CFR 868.5905 |
| Product Code | Product code: NHJ | Product code: NHJ | Product code: NHJ |
| Classification<br>Panel and Class | Anesthesiology<br>Class II | Anesthesiology<br>Class II | Anesthesiology<br>Class II |
| Classification<br>Name | Device, positive<br>pressure breathing,<br>intermittent (IPPB) | Device, positive pressure<br>breathing, intermittent (IPPB) | Device, positive<br>pressure breathing,<br>intermittent (IPPB) |
| Indication For<br>Use | The BiWaze Clear<br>System is indicated<br>for the loosening and<br>mobilization of<br>secretions, lung<br>expansion therapy,<br>the treatment and<br>prevention of<br>pulmonary<br>atelectasis, and can<br>provide supplemental<br>oxygen when used<br>with an oxygen<br>supply.<br>The BiWaze Clear<br>System is for use on<br>adult or pediatric<br>patients in acute care<br>(aged 2 years and<br>older) and home care<br>environments (aged 5<br>years and older).<br>The BiWaze Clear<br>System may be used<br>with patient interfaces<br>including face mask,<br>mouthpiece, a trach<br>adapter to<br>endotracheal or<br>tracheostomy tube in | Indicated for mobilization of<br>secretions, lung expansion<br>therapy, treatment and<br>prevention of pulmonary<br>atelectasis, ability to provide<br>supplemental oxygen when<br>used with oxygen. | The BiWaze Clear<br>System is indicated<br>for the mobilization<br>of secretions, lung<br>expansion therapy,<br>the treatment and<br>prevention of<br>pulmonary<br>atelectasis, and<br>has the ability to<br>provide<br>supplemental<br>oxygen when used<br>with an oxygen<br>supply. |
| ESPIRATORY CARE | | | |
| Technological<br>Characteristic | BiWaze Clear System<br>(Proposed Device) | Hill-Rom Volara System<br>(Maximus™ System, when<br>used as a Volara™ System)<br>(Predicate Device) | BiWaze Clear<br>System<br>(Reference<br>Devices) |
| 510(k) Number | K231728 | K200988 | K213564 |
| | acute and home care<br>environments. The<br>BiWaze Clear System<br>may be used in-line<br>with a ventilator in<br>acute care<br>environment only. | | |
| Environments<br>of Use | Hospital,<br>Sub-acute facilities,<br>Nursing care<br>Homecare | Hospital,<br>Sub-acute facilities,<br>Nursing care<br>Homecare | Hospital<br>sub-acute facilities<br>Nursing care<br>Homecare |
| Patient<br>Population | Adult, Child > 2 years<br>old (Acute care)<br>Adult, Child > 5 year<br>(Home care) | Adult, Child > 2 years old (Acute<br>care)<br>Adult, Child > 5 year (Home<br>care) | Adult, Child > 2<br>years old (Acute<br>care)<br>Adult, Child > 5<br>years old (Home<br>care) |
| Therapy Modes | Positive Expiratory<br>Pressure (PEP),<br>Oscillation (OSC),<br>Nebulizer (NEB) | Continuous Positive Expiratory<br>Pressure (CPEP), Continuous<br>High Frequency Oscillation<br>(CHFO), Aerosol | Positive Expiratory<br>Pressure (PEP),<br>Oscillation (OSC),<br>Nebulizer (NEB) |
| Positive<br>Expiratory<br>Pressure (PEP)/<br>CPEP | Controlled static flow<br>with positive pressure<br>≤ 30 cmH2O | Controlled static flow with<br>positive pressures < 30 cmH2O | Controlled static<br>flow with positive<br>pressures ≤ 30<br>cmH2O |
| Oscillations<br>(OSC)/ CHFO | Controlled continuous<br>flow with frequencies<br>up to 300 beats per<br>minute (5 Hz) and<br>peak positive<br>pressures ≤ 70 cmH2O | Controlled continuous flow with<br>frequencies up to 300 beats per<br>minute and peak positive<br>pressure ≤ 70 cmH2O | Controlled<br>continuous flow with<br>frequencies up to<br>300 beats per<br>minute (5 Hz) and<br>peak positive<br>pressures, ≤ 70<br>cmH2O |
| Technological<br>Characteristic | BiWaze Clear System<br>(Proposed Device) | Hill-Rom Volara System<br>(Maximus™ System, when<br>used as a Volara™ System)<br>(Predicate Device) | BiWaze Clear<br>System<br>(Reference<br>Devices) |
| 510(k) Number | K231728 | K200988 | K213564 |
| NEB/ Aerosol | Controlled continuous<br>constant pressure with<br>in- line nebulizer<br>delivering saline. | Controlled continuous constant<br>pressure to inline nebulizer<br>delivering medicated aerosol<br>only. | Controlled<br>continuous constant<br>pressure with in-<br>line nebulizer<br>delivering saline. |
| Principle of<br>Operation | Electro-Mechanical<br>device<br>Air or Oxygen | Electro-Mechanical device<br>Air or Oxygen | Electro-Mechanical<br>device<br>Air or Oxygen |
| Setting Options | On/Off<br>Frequency selection<br>for OSC mode (Touch<br>Screen Control)<br>Pressure adjustment<br>for OSC mode (Touch<br>Screen Control)<br>Pressure adjustment<br>for PEP mode (Touch<br>Screen Control)<br>Pressure manometer | On/Off<br>Frequency selection<br>for CHFO mode (Touch Screen<br>Control)<br>Pressure adjustment<br>for CHFO mode (Touch Screen<br>Control)<br>Pressure adjustment<br>for CPEP mode (Touch Screen<br>Control)<br>Pressure manometer | On/Off<br>Frequency selection<br>for OSC mode<br>(Touch Screen<br>Control)<br>Pressure<br>adjustment for OSC<br>mode (Touch<br>Screen Control)<br>Pressure<br>adjustment for PEP<br>mode (Touch<br>Screen Control)<br>Pressure<br>manometer |
| Aerosol delivery | Mouthpiece<br>Face Mask<br>Trach Adapter<br>Ventilator Tee Adaptor | Mouthpiece<br>Face Mask<br>Ventilator Tee Adaptor | Mouthpiece<br>Face Mask |
| Patient Circuit<br>Configurations | Disposable circuit<br>including handset with<br>connection for in-line<br>nebulizer. | Disposable circuit referred to as<br>"handset" includes connection<br>for in-line nebulizer.<br>Draw in room air mix with<br>medicated aerosol and gas from<br>controller. | Disposable circuit<br>including handset<br>with connection for<br>in-line nebulizer. |
| Technological<br>Characteristic | BiWaze Clear System<br>(Proposed Device) | Hill-Rom Volara System<br>(Maximus™ System, when<br>used as a Volara™ System)<br>(Predicate Device) | BiWaze Clear<br>System<br>(Reference<br>Devices) |
| 510(k) Number | K231728 | K200988 | K213564 |
| Patient Circuit<br>settings | No resistance<br>adjustment feature on<br>patient circuit.<br>All adjustments done<br>at the control unit. | No resistance adjustment<br>feature on patient circuit.<br>Therapy settings are all done at<br>the control unit. | No resistance<br>adjustment feature<br>on patient circuit.<br>All adjustments<br>done at the control<br>unit. |
| Patient Interface | Acute care:<br>Mouthpiece,<br>Facemask, Insert into<br>ventilator, Adapter to<br>a patient's<br>endotracheal tube or<br>tracheostomy tube.<br>Home care:<br>Mouthpiece,<br>Facemask, Adapter to<br>a patient's<br>tracheostomy tube. | Acute care: Mouthpiece,<br>Facemask, Insert into<br>ventilator, Adapter to a patient's<br>endotracheal tube or<br>tracheostomy tube.<br>Home care: Mouthpiece,<br>Facemask, Insert into ventilator,<br>Adapter to a patient's<br>endotracheal tube or<br>tracheostomy tube. | Acute care:<br>Mouthpiece,<br>Facemask, Adapter<br>to a patient's<br>endotracheal tube<br>or tracheostomy<br>tube.<br>Home care:<br>Mouthpiece,<br>Facemask, Adapter<br>to a patient's<br>endotracheal tube<br>or tracheostomy<br>tube. |
| SpO2<br>Connection | Supports connection<br>and displays SpO2<br>values and heart rate<br>from a SpO2 sensor | Can connect via Bluetooth to<br>Beijing Choice Electronic<br>Technology Co., Ltd. Fingertip<br>Pulse Oximeter, K142888. Only<br>displays the heart rate and<br>SpO2 data<br> | Supports connection<br>and displays SpO2<br>values and heart<br>rate from a SpO2<br>sensor |
| Energy Source | 100-240 V ac 50/60 Hz | 100-240 V ac 50/60 Hz | 100-240 V ac 50/60<br>Hz |

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Image /page/7/Picture/1 description: The image shows the logo for ABM Respiratory Care. The logo features the letters "abm" in a modern, sans-serif font, with the letters connected. Above the letters are three colored circles in blue, orange, and green. Below the letters, the words "RESPIRATORY CARE" are written in a smaller, sans-serif font.

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Image /page/8/Picture/1 description: The image shows the logo for ABM Respiratory Care. The logo features the letters "abm" in a simple, sans-serif font, with the words "RESPIRATORY CARE" written in smaller letters below. Above the letters are three colored circles in blue, orange, and green.

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Image /page/9/Picture/1 description: The image shows the logo for ABM Respiratory Care. The logo features the letters "abm" in a simple, sans-serif font, with the words "RESPIRATORY CARE" written in smaller letters below. Above the letters are three colored circles: blue, orange, and green.

# Substantial Equivalence Discussion

The BiWaze Clear System is viewed as substantially equivalent to the predicate devices because:

Indications – The proposed indication for use for mobilization of secretions, lung expansion therapy, the treatment and prevention of pulmonary atelectasis, and has the ability to provide supplemental oxygen when used with compressed oxygen are identical to the predicate.

Discussion: The indication for use is identical to the predicate device.

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Image /page/10/Picture/1 description: The image shows the logo for ABM Respiratory Care. The logo features the letters "abm" in a thin, gray sans-serif font. Above the letters are three colored circles: blue, orange, and green. Below the letters, the words "RESPIRATORY CARE" are written in a smaller, gray sans-serif font.

Patient Population - The patient population is identical to the predicate.

Environment of Use - The environment of use is identical to the predicate. However, BiWaze Clear use in-line with ventilator is intended only in the acute care environment.

Technology - Functionally, the performance and therapy mode functions are similar to the predicate device. The proposed modifications are changes to the labelling with supporting data from testing without a change in device technology.

Performance Data: Performance bench testing was conducted on modified BiWaze Clear System in-line with a ventilator, and it was found to be substantially equivalent to the predicate, the Hill Rom's Volara System (K200988).

Biocompatibility— There is no change in design and materials in the gas and fluid pathways are identical to the reference device, BiWaze Clear System (K213564).

## Comparison of Characteristics with Respect to the Predicate Device:

The modified BiWaze Clear System has the same features and indications for use when compared to the predicate. The core capabilities of the modified BiWaze Clear System remained unaltered compared to the predicate device. The device modifications discussed do not alter the BiWaze Clear device's safety or effectiveness and neither do they change its indication for use compared to the predicate device.

The modified BiWaze Clear System was designed and tested according to the following standards:

- IEC 60601-1 Medical electrical equipment Part 1: General requirements for basic . safety and essential performance
- IEC 60601-1-2 Medical electrical equipment Part 1-2: General requirements for . basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- . IEC 60601-1-6 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral Standard: Usability
- . IEC 60601-1-11 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
- IEC 62366-1 Medical devices Part 1: Application of usability engineering to medical ● devices
- . ISO 18562-1: Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process
- ISO 18562-2: Biocompatibility evaluation of breathing gas pathways in healthcare . applications - Part 2: Tests for emissions of particulate matter
- . ISO 18562-3: Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic compounds (VOCs)
- ISO 18562-4: Biocompatibility evaluation of breathing gas pathways in healthcare . applications - Part 4: Tests for leachable in condensate

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Image /page/11/Picture/1 description: The image shows the logo for ABM Respiratory Care. The logo features the letters "abm" in a modern, sans-serif font, with the letters connected. Above the letters are three colored circles in blue, orange, and green. Below the letters, the words "RESPIRATORY CARE" are written in a smaller, sans-serif font.

- ISO 10993-1 Biological evaluation of medical devices Part 1: Evaluation and testing ● within a risk management process.
- IEC 62304 Medical Device Software Software Life Cycle Processes ●
- ISO 14971 Medical Devices - Application Of Risk Management To Medical Devices

## Conclusion:

The modifications to the BiWaze Clear System that are the subject of this 510(k) application have been validated through non-clinical bench testing and determined to be substantially equivalent to the predicate. Based upon the risk analysis, comparative performance testing, and non-clinical testing, we have demonstrated that the proposed device and predicate device (K200988) are substantially equivalent.