BiWaze Clear System

K213564 · Abmrc, LLC · NHJ · Dec 21, 2022 · Anesthesiology

Device Facts

• Record ID: K213564
• Device Name: BiWaze Clear System
• Applicant: Abmrc, LLC
• Product Code: NHJ · Anesthesiology
• Decision Date: Dec 21, 2022
• 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 mobilization of secretions, lung expansion therapy, the treatment and prevention of pulmonary atelectasis and has the ability to provide supplemental oxygen supply. The BiWaze Clear System is indicated to deliver therapy to adults and children over the age of 2 years in the acute care setting. The BiWaze Clear System is indicated to deliver therapy to adults and children over the age of 5 years in the home care setting.

Device Story

BiWaze Clear System provides respiratory therapy via three modes: Positive Expiratory Pressure (PEP), Oscillation (OSC), and Nebulization (NEB). Device uses electro-mechanical control unit to deliver controlled air/oxygen flows. PEP delivers static positive pressure; OSC delivers pulses of positive pressure to mobilize secretions; NEB powers an in-line vibrating mesh nebulizer. Used in acute, post-acute, and home care settings by clinicians or patients. System utilizes a dual-lumen breathing circuit with coaxial bacterial/viral filter to prevent aerosol escape. Healthcare providers configure therapy settings via touch display; output assists in airway clearance and lung expansion. Benefits include reduced airway obstruction, improved gas exchange, and decreased inflammatory response.

Clinical Evidence

No clinical or animal studies submitted. Evidence consists of non-clinical bench testing, including comparative performance studies across all therapy modes (OSC, PEP, Neb), nebulizer performance testing, biocompatibility (ISO 10993-1, ISO 18562), electrical safety (IEC 60601-1), EMI/EMC, usability, and cleaning validation.

Technological Characteristics

Electro-mechanical noncontinuous ventilator (IPPB). Features touch screen interface, vibrating mesh nebulizer, and dual-lumen breathing circuit. Powered by 100-240V AC. Connectivity via USB 2.0 and Wi-Fi (WiLink8 802.11 a/b/g/n + MIMO). Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-11, IEC 62366-1, IEC 62304, ISO 14971, and ISO 18562 series.

Indications for Use

Indicated for mobilization of secretions, lung expansion therapy, and treatment/prevention of pulmonary atelectasis in adults and children >2 years (acute care) and >5 years (home care). 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

• Volara™ System (K200988)

Reference Devices

• MetaNeb® 4 System (K151689)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 21, 2022

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

Re: K213564

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: November 17, 2022 Received: November 18, 2022

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 (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 located 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.

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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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 medical devices and radiation-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 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) K213564

Device Name BiWaze Clear System

Indications for Use (Describe)

The BiWaze Clear System is indicated for the mobilization of secretions, lung expansion therapy, the treatment and prevention of pulmonary atelectasis and has the ability to provide supplemental oxygen supply.

The BiWaze Clear System is indicated to deliver therapy to adults and children over the age of 2 years in the acute care setting.

The BiWaze Clear System is indicated to deliver therapy to adults and children over the age of 5 years in the home care setting.

| 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/3/Picture/0 description: The image shows the logo for ABM Respiratory Cares. The logo features the letters "abm" in a simple, sans-serif font, with three colored circles (blue, orange, and green) above the letters. Below the letters, the words "RESPIRATORY CARES" are written in a smaller, sans-serif font.

#### 510(k) Summary

| Submitter | ABMRC LLC | |
|-----------------------------------|-------------------------------------------------|---------|
| | 860 Blue Gentian Road, | |
| | Suite 200, | |
| | Eagan, MN, 55121 USA | |
| | www.abmrc.com | |
| Contact | Priyanka Paul | |
| | QA/RA Manager | |
| | ABMRC LLC | |
| | Email: [e-mail] | |
| Prepared By: | Priyanka Paul | |
| | QA/RA Manager ABMRC LLC | |
| | Email: [e-mail] | |
| Date Prepared: | December 21, 2022 | |
| Trade/ Device Name: | BiWaze Clear System | |
| Device Common Name: | Noncontinuous Ventilator (IPPB) | |
| Classification Regulation Number: | 21 CFR 868.5905 | |
| Classification Panel: | Anesthesiology | |
| Regulation Name: | NHJ - Non-continuous ventilator (IPPB) | |
| Classification: | Class II | |
| Predicate Device: | Volara™ System | K200988 |
| | (Maximus™ System when used as a Volara™ System) | |
| Reference Devices: | MetaNeb® 4 System | K151689 |

#### Device Description:

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 occupying the lower airways, prevent respiratory tract infections, re-expand the collapsed areas of the lung, thereby enhancing gas exchanges and reducing inflammatory response.

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Image /page/4/Picture/0 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 dots: blue, orange, and green. Below the letters, the words 'RESPIRATORY CARE' are written in a smaller font.

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 aqainst to open and expand the patient's airways. The nebulizer can be configured to run during PEP therapy to help move saline throughout the airways.
- Oscillation (OSC): During OSC, the system oscillates the airways with pulses of . positive pressure to thin secretions and mobilize 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 saline throughout the airways.
- Nebulize (NEB): During NEB, the system powers only the Aerogen Solo vibrating mesh . nebulizer. This therapy qives the patient a break from PEP or OSC while the patient receives nebulized saline.

The BiWaze Clear System can be used in coniunction with the various patient interfaces such as facemask, mouthpiece or a trach adapter which connects to a patient's endotracheal or tracheostomy tube. It is intended to deliver therapy to pediatric and adult patients in acute. post-acute, and home care settings.

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

#### Indication for Use:

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

The BiWaze Clear System is indicated to deliver therapy to adults and children over the age of 2 years in the acute care setting.

The BiWaze Clear System is indicated to deliver therapy to adults and children over the age of 5 years in the home care setting.

#### Substantial Equivalence Determination:

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

- Indication for use .
- Operating principle .
- . Technology

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

- Hill-Rom Volara™ System (Maximus™ System, when used as a Volara™ . System) (K200988) - Predicate Device

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Image /page/5/Picture/0 description: The image shows the logo for ABM Respiratory Care. The logo features the letters "abm" in a simple, sans-serif font, with three colored circles (blue, orange, and green) above the letters. Below the letters, the words "RESPIRATORY CARE" are written in a smaller, sans-serif font.

| Technological<br>Characteristic | BiWaze Clear System<br>(Proposed Device) | Hill-Rom Volara System<br>(Maximus™ System,<br>when used as a Volara™<br>System) (Predicate<br>Device) | Hill-Rom MetaNab® 4<br>System (Reference<br>Device) | |
|----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| 510(k) Number | K213564 | K200988 | K151689 | |
| CFR<br>Classification | Regulation Number: 21<br>CFR 868.5905 | Regulation Number: 21<br>CFR 868.5905 | Regulation Number: 21<br>CFR 868.5905 | |
| Product Code | Product code:<br>NHJ | Product code: NHJ | Product code: NHJ | |
| Classification<br>Panel<br>and Class | Anaesthesiology<br>Class II | Anaesthesiology<br>Class II | Anaesthesiology<br>Class II | |
| Classification<br>Name | Device, positive pressure<br>breathing, intermittent<br>(IPPB) | Device,<br>positive<br>pressure<br>breathing, intermittent<br>(IPPB) | Device, positive<br>pressure breathing,<br>intermittent (IPPB) | |
| Indication For<br>Use | The BiWaze Clear<br>System is indicated for<br>the mobilization of<br>secretions, lung<br>expansion therapy, the<br>treatment and prevention<br>of pulmonary atelectasis<br>and has the ability to<br>provide supplemental<br>oxygen when used with<br>an oxygen supply.<br><br>The BiWaze Clear<br>System is indicated to<br>deliver therapy to adults<br>and children over the age<br>of 2 years in the acute<br>care setting.<br><br>The BiWaze Clear<br>System is indicated to<br>deliver therapy to adults<br>and children over the age<br>of 5 years in the home<br>care setting. | 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. | Indicated for<br>mobilization of<br>secretions, lung<br>expansion therapy, the<br>treatment and<br>prevention of<br>pulmonary atelectasis,<br>and also has the ability<br>to provide<br>supplemental oxygen<br>when used with<br>compressed oxygen. | |
| | | | | |
| Environments of<br>Use | Hospital,<br>Sub-acute facilities,<br>Nursing care Homecare | Hospital, Sub-acute<br>Facilities, Nursing care,<br>Homecare | Hospital sub-acute<br>facilities Nursing care<br>Homecare | |
| Environments of<br>Use | Hospital,<br>Sub-acute facilities,<br>Nursing care 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)<br>Adult, Child >5 year<br>(home care) | Adult, Child > 2 years old<br>(acute)<br>Adult, Child > 5 year<br>(home<br>care) | Adult, Child > 2 years<br>old (Acute care)<br>Adult, Child > 5<br>years old (home<br>care) (K151689) | |
| Therapy Type | Positive Expiratory<br>Pressure (PEP),<br>Oscillation (OSC), NEB | Continuous Positive<br>Expiratory Pressure<br>(CPEP), Continuous High<br>Frequency Oscillation<br>(CHFO), Aerosol | CPEP, CHFO, Aerosol<br>Only | |
| Positive<br>Expiratory<br>Pressure (PEP) /<br>CPEP | Controlled static flow with<br>positive pressure ≤ 30<br>cmH2O | Controlled static flow with<br>positive pressures < 30<br>cmH2O | Controlled static flow<br>with positive pressures<br>≤ 30 cmH2O | |
| Oscillations<br>(OSC) / CHFO | Controlled continuous<br>flow with frequencies up<br>to 300 beats per minute<br>(5 Hz) and peak positive<br>pressures ≤ 70 cmH2O | Controlled continuous flow<br>with frequencies up to 300<br>beats per minute and peak<br>positive pressure ≤ 70<br>cmH2O | Controlled continuous<br>flow with frequencies up<br>to 300 beats per minute<br>and peak positive<br>pressure ≤ 30 cmH2O | |
| NEB / Aerosol | Controlled continuous<br>constant pressure with<br>in- line nebulizer<br>delivering saline. | Controlled continuous<br>constant pressure to in-line<br>nebulizer delivering<br>medicated aerosol only via<br>mouthpiece and face mask.<br>Aerosol may not be delivered<br>when the in-line ventilator<br>adapter is used. | Controlled continuous<br>constant flow to in-line<br>nebulizer delivering<br>medicated aerosol only. | |
| Patient Circuit<br>Configurations | Disposable circuit<br>including handset with<br>connection for in-line<br>nebulizer to deliver<br>saline. | Disposable circuit referred to as<br>"handset" includes<br>connection for in-line<br>nebulizer.<br>Draw in room air mix with<br>medicated aerosol and gas<br>from controller. | Disposable circuit<br>referred to as "handset"<br>includes connection for<br>in- line nebulizer.<br>Draw in room air mix with<br>medicated aerosol and<br>gas from controller. | |
| Patient Circuit<br>settings | No resistance adjustment<br>feature on patient circuit. | No resistance adjustment<br>feature on patient circuit.<br>All adjustments done at the | Expiratory resistance<br>adjustment ≤ 30 cmH2O | |
| | | | control unit. | |
| | All adjustments done at the<br>control unit | | | |
| | Patient Interface | Acute care: Mouthpiece,<br>Facemask, Adapter to a<br>patient's endotracheal<br>tube or tracheostomy<br>tube.<br>Home care: Mouthpiece,<br>Facemask, Adapter to a<br>patient's endotracheal<br>tube or tracheostomy tube. | Acute care: Mouthpiece,<br>Facemask, Insert into<br>ventilator, Adapter to a<br>patient's endotracheal tube<br>or tracheostomy tube.<br>Home care: Mouthpiece,<br>Facemask, Insert into<br>ventilator, Adapter to a<br>patient's endotracheal tube<br>or tracheostomy tube. | Mouthpiece Face mask<br>Insert into ventilator<br>circuit |
| | Principle of<br>Operation | Electro-Mechanical<br>device<br>Air or Oxygen | Electro-Mechanical device<br>Air or Oxygen | Pneumatic Air or<br>oxygen |
| | Setting Options | On/Off<br>Frequency selection for<br>OSC mode (Touch<br>Screen Control) | On/Off<br>Frequency selection for<br>CHFO mode<br>(Touch<br>Screen Control) | On/Off<br>Frequency selection<br>for CHFO mode<br>(control knob) |
| | | Pressure adjustment for<br>OSC mode (Touch<br>Screen<br>Control) | Pressure adjustment for<br>CHFO mode<br>(Touch<br>Screen Control)<br>Pressure adjustment for | Pressure adjustment for<br>CPEP mode (control<br>knob)<br>Pressure manometer - |
| | | Pressure adjustment for<br>PEP mode (Touch<br>Screen Control)<br>Pressure manometer | CPEP mode (Touch Screen<br>Control)<br>Pressure manometer | |
| | Energy Source | 100-240 V ac 50/60 Hz | 100-240 V ac 50/60 Hz | Pneumatic Source |

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Image /page/6/Picture/0 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 "m" are three colored circles in blue, orange, and green. Below the letters is the text "RESPIRATORY CARE\$" in a smaller font.

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Image /page/7/Picture/0 description: The image shows the logo for ABM Respiratory Care. The logo features the letters 'abm' in a thin, gray sans-serif font, with three colored circles (blue, orange, and green) above the 'm'. Below the letters, the words 'RESPIRATORY CARE\$' are printed in a smaller, gray sans-serif font.

The table below summarizes the key technical characteristics of BiWaze Clear System and the predicate and reference devices listed in the submission.

Table below provides a description of the modifications to the BiWaze Clear System:

Device Features Description

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Image /page/8/Picture/0 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: blue, orange, and green. Below the letters, the words 'RESPIRATORY CARES' are written in a smaller, sans-serif font.

| User Interface | A new graphic touch display and a new simplified user interface with hierarchical menu system.<br><br><b>SIMILARITIES</b><br>The predicate devices have similar parameters displayed in the main screen. |
|-------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Nebulizer | A vibrating mesh-based nebulizer is used for aerosol or nebulizer therapy in BiWaze clear System.<br><br><b>REMARKS</b><br>In the predicate device, a jet pump nebulizer is used for aerosol or nebulizer therapy. |
| Breathing Circuit | The BiWaze Clear System uses a customized breathing circuit that includes a coaxial breathing tube, coaxial bacterial / viral filter, handset or spacer with a nebulizer port and an optional patient interface (facemask, mouthpiece or flexible trach adapter).<br><br><b>REMARKS</b><br>The predicate device uses a breathing circuit that has a single path breathing tube with single path bacterial/viral filter. |
| Data Management | All therapy data is encrypted and stored in the control unit's internal memory. When connected to a Wi-Fi network, the control unit can send the therapy data to a remote server.<br><br><b>REMARKS</b><br>Encrypted data is securely transferred through either USB 2.0 or a Wi-Fi (WiLink8 802.11 a/b/g/n + MIMO) Network. |

## Substantial Equivalence Discussion

The BiWaze Clear System is viewed as substantially equivalent to the predicate devices for the following reasons:

Indications - The proposed indication for use is identical to the predicate.

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

Patient Population - The patient populations are identical to the predicate.

Discussion: The patient population is identical to the predicate device.

Environment of Use – The environment of use is identical to the predicate.

Technology – Functionally the performance and therapy mode functions are identical to the predicate device.

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Image /page/9/Picture/0 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 manner. Above the 'm' are three small circles in blue, orange, and green. Below the letters, the words 'RESPIRATORY CARES' are printed in a smaller, bolder font.

#### Comparison of Characteristics with respect to Predicate Device:

The BiWaze Clear System has similar features and indications for use when compared to the predicate. The core capabilities of BiWaze Clear and its fundamental scientific technology remain unaltered compared to the predicate. The modifications discussed do not alter BiWaze Clear's safety or effectiveness and neither do they change its indication for use compared to the predicate.

#### Performance Data:

Performance testing – Bench testing was conducted on BiWaze Clear, and it was found to be substantially equivalent to the predicate.

Biocompatibility of Patient Contacting Materials - The materials in the gas and fluid pathway are categorized as externally communicating, tissue contacting with permanent duration (>30 days).

Verification and Validation - This includes non-clinical bench testing and software unit testing as listed below. There have been no animal or clinical studies submitted.

- . Comparative Performance Bench Study across all therapy modes (OSC, PEP, Neb) against the predicate
- Comparative Nebulizer Performance Study across all therapy modes and patient ● interfaces for adult and pediatric flow rates
- Biocompatibility Main Unit and Dual Lumen Breathing Circuit Components as per ISO ● 10993-1 and ISO 18562-1
- Software & Firmware verification and validation
- Electrical Safety, EMI /EMC ●
- Usabilitv ●
- Cleaning Validation .

The 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

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Image /page/10/Picture/0 description: The image shows the logo for ABM Respiratory Care. The logo features the letters "abm" in a simple, sans-serif font, with three colored circles (blue, orange, and green) above the letters. Below the letters, the words "RESPIRATORY CARES" are written in a smaller font.

- 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
- 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 testing and determined to be substantially equivalent. In conclusion, bench testing and system verification have confirmed that the performance of the BiWaze Clear System is equivalent to that of the predicate. The indications for use, technological characteristics, and operating principles are comparable the predicate. The BiWaze Clear System is substantially equivalent to the predicate.