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

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.

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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the BiWaze Clear System.

Important Note: The provided document is a 510(k) summary for a medical device and describes its substantial equivalence to a predicate device, rather than providing a detailed clinical study with specific performance metrics against pre-defined acceptance criteria for a new AI/software diagnostic device. The "acceptance criteria" here refer to the criteria for demonstrating substantial equivalence for a non-continuous ventilator, and the "study" is primarily non-clinical bench testing. Therefore, many of the requested fields are not directly applicable or cannot be extracted from this type of document, particularly those related to AI algorithm performance, human readers, ground truth establishment, and sample sizes for training/test sets in an AI context.

Description of Acceptance Criteria and Supporting Study

The BiWaze Clear System (K231728) is a non-continuous ventilator. The acceptance criteria described in this 510(k) summary are centered around demonstrating substantial equivalence to a predicate device (Hill-Rom Volara™ System, K200988) and a reference device (BiWaze Clear System, K213564). This involves showing that the proposed device has similar indications for use, operating principles, technology, and performance, with a specific focus on extending its claims to include "use in-line with a ventilator in the acute care environment only."

The "study" that proves the device meets these acceptance criteria primarily consists of performance bench testing and adherence to various medical device standards.

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (for Substantial Equivalence)	Reported Device Performance (as per non-clinical bench testing)
Indications for Use:	- Mobilization of secretions, lung expansion therapy, treatment/prevention of pulmonary atelectasis, provision of supplemental oxygen when used with oxygen.
- Specific extended claim: use in-line with a ventilator in the acute care environment only.	- "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)."
Patient Population:	- Adult or pediatric patients in acute care (aged 2 years and older) and home care environments (aged 5 years and older).
Environment of Use:	- Hospital, Sub-acute facilities, Nursing care, Homecare. - Specific extended claim: BiWaze Clear use in-line with ventilator is intended only in the acute care environment.
Technology/Performance (Functionality, Safety, Effectiveness):	- Operating principle (Electro-Mechanical device, Air or Oxygen). - Therapy Modes (PEP, OSC, NEB, with specified pressure/frequency limits). - Patient Circuit Configurations (Disposable circuit with handset and in-line nebulizer connection). - Patient Interface (Mouthpiece, Facemask, Trach Adapter, Ventilator Tee Adaptor). - SpO2 Connection (Supports connection and displays SpO2 values and heart rate). - Adherence to relevant medical device standards (e.g., IEC 60601 series, ISO 18562 series, ISO 10993-1, IEC 62304, ISO 14971).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document because it pertains to performance data typical for diagnostic AI devices, clinical studies, or usability studies involving human participants. The "test set" here refers to the actual physical device undergoing non-clinical bench testing, not a dataset in the AI sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided and is not applicable for this type of device submission, which relies on engineering and performance standards rather than expert-established ground truth for diagnostic accuracy.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided and is not applicable for this type of device submission. Adjudication methods are typically used in clinical studies or when establishing ground truth for AI algorithms, which is not the focus here.

5. 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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic devices, which is not what the BiWaze Clear System is.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable. The BiWaze Clear System is a physical medical device (ventilator) that the document clarifies has no change in underlying technology, but an extended use claim supported by bench testing. It does not employ a standalone AI algorithm in the context typically discussed for diagnostic or assistive AI software.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this submission is based on established engineering and performance standards for non-continuous ventilators, as well as the performance characteristics of the legally marketed predicate device (Volara™ System). The equivalence is demonstrated through non-clinical bench testing according to these standards, not against a clinical "ground truth" like pathology or outcomes data in the usual sense for a diagnostic device.

8. The sample size for the training set

This information is not provided and is not applicable. The device is not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

This information is not provided and is not applicable, as there is no training set for an AI/ML algorithm in this context.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which 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.

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"

{1}------------------------------------------------

(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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

{2}------------------------------------------------

Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

Indications for Use

510(k) Number (if known) K231728

Device Name BiWaze Clear System

Indications for Use (Describe)

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).

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

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 LLC860 Blue Gentian Road,Suite 200,Eagan, MN, 55121 USAwww.abmrc.com
Contact	Priyanka PaulQA/RA ManagerABMRC LLCEmail: priyanka.paul@abmrc.com
Date Prepared:	April 05, 2024
Trade/ Device Name:	BiWaze Clear System
Device Common Name:	Noncontinuous Ventilator (IPPB)
ClassificationRegulation Number:	21 CFR 868.5905
Classification Panel:	Anesthesiology
Regulation Name:Classification:	NHJ - Non-continuous ventilator (IPPB)Class II
Predicate Device(Primary):	Volara TM System(Maximus TM System when used as aVolara TM System)	K200988
Reference Device(Existing 510(k) Cleared	BiWaze Clear System	K213564

Indication for Use:

Device):

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).

Device Description and Modification:

{5}------------------------------------------------

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.

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.

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

{6}------------------------------------------------

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".

TechnologicalCharacteristic	BiWaze Clear System(Proposed Device)	Hill-Rom Volara System(MaximusTM System, whenused as a VolaraTM System)(Predicate Device)	BiWaze ClearSystem(ReferenceDevices)
510(k) Number	K231728	K200988	K213564
CFRClassification	Regulation Number: 21CFR 868.5905	Regulation Number: 21 CFR868.5905	Regulation Number:21 CFR 868.5905
Product Code	Product code: NHJ	Product code: NHJ	Product code: NHJ
ClassificationPanel and Class	AnesthesiologyClass II	AnesthesiologyClass II	AnesthesiologyClass II
ClassificationName	Device, positivepressure breathing,intermittent (IPPB)	Device, positive pressurebreathing, intermittent (IPPB)	Device, positivepressure breathing,intermittent (IPPB)
Indication ForUse	The BiWaze ClearSystem is indicatedfor the loosening andmobilization ofsecretions, lungexpansion therapy,the treatment andprevention ofpulmonaryatelectasis, and canprovide supplementaloxygen when usedwith an oxygensupply.The BiWaze ClearSystem is for use onadult or pediatricpatients in acute care(aged 2 years andolder) and home careenvironments (aged 5years and older).The BiWaze ClearSystem may be usedwith patient interfacesincluding face mask,mouthpiece, a trachadapter toendotracheal ortracheostomy tube in	Indicated for mobilization ofsecretions, lung expansiontherapy, treatment andprevention of pulmonaryatelectasis, ability to providesupplemental oxygen whenused with oxygen.	The BiWaze ClearSystem is indicatedfor the mobilizationof secretions, lungexpansion therapy,the treatment andprevention ofpulmonaryatelectasis, andhas the ability toprovidesupplementaloxygen when usedwith an oxygensupply.
ESPIRATORY CARE
TechnologicalCharacteristic	BiWaze Clear System(Proposed Device)	Hill-Rom Volara System(Maximus™ System, whenused as a Volara™ System)(Predicate Device)	BiWaze ClearSystem(ReferenceDevices)
510(k) Number	K231728	K200988	K213564
	acute and home careenvironments. TheBiWaze Clear Systemmay be used in-linewith a ventilator inacute careenvironment only.
Environmentsof Use	Hospital,Sub-acute facilities,Nursing careHomecare	Hospital,Sub-acute facilities,Nursing careHomecare	Hospitalsub-acute facilitiesNursing careHomecare
PatientPopulation	Adult, Child > 2 yearsold (Acute care)Adult, Child > 5 year(Home care)	Adult, Child > 2 years old (Acutecare)Adult, Child > 5 year (Homecare)	Adult, Child > 2years old (Acutecare)Adult, Child > 5years old (Homecare)
Therapy Modes	Positive ExpiratoryPressure (PEP),Oscillation (OSC),Nebulizer (NEB)	Continuous Positive ExpiratoryPressure (CPEP), ContinuousHigh Frequency Oscillation(CHFO), Aerosol	Positive ExpiratoryPressure (PEP),Oscillation (OSC),Nebulizer (NEB)
PositiveExpiratoryPressure (PEP)/CPEP	Controlled static flowwith positive pressure≤ 30 cmH2O	Controlled static flow withpositive pressures < 30 cmH2O	Controlled staticflow with positivepressures ≤ 30cmH2O
Oscillations(OSC)/ CHFO	Controlled continuousflow with frequenciesup to 300 beats perminute (5 Hz) andpeak positivepressures ≤ 70 cmH2O	Controlled continuous flow withfrequencies up to 300 beats perminute and peak positivepressure ≤ 70 cmH2O	Controlledcontinuous flow withfrequencies up to300 beats perminute (5 Hz) andpeak positivepressures, ≤ 70cmH2O
TechnologicalCharacteristic	BiWaze Clear System(Proposed Device)	Hill-Rom Volara System(Maximus™ System, whenused as a Volara™ System)(Predicate Device)	BiWaze ClearSystem(ReferenceDevices)
510(k) Number	K231728	K200988	K213564
NEB/ Aerosol	Controlled continuousconstant pressure within- line nebulizerdelivering saline.	Controlled continuous constantpressure to inline nebulizerdelivering medicated aerosolonly.	Controlledcontinuous constantpressure with in-line nebulizerdelivering saline.
Principle ofOperation	Electro-MechanicaldeviceAir or Oxygen	Electro-Mechanical deviceAir or Oxygen	Electro-MechanicaldeviceAir or Oxygen
Setting Options	On/OffFrequency selectionfor OSC mode (TouchScreen Control)Pressure adjustmentfor OSC mode (TouchScreen Control)Pressure adjustmentfor PEP mode (TouchScreen Control)Pressure manometer	On/OffFrequency selectionfor CHFO mode (Touch ScreenControl)Pressure adjustmentfor CHFO mode (Touch ScreenControl)Pressure adjustmentfor CPEP mode (Touch ScreenControl)Pressure manometer	On/OffFrequency selectionfor OSC mode(Touch ScreenControl)Pressureadjustment for OSCmode (TouchScreen Control)Pressureadjustment for PEPmode (TouchScreen Control)Pressuremanometer
Aerosol delivery	MouthpieceFace MaskTrach AdapterVentilator Tee Adaptor	MouthpieceFace MaskVentilator Tee Adaptor	MouthpieceFace Mask
Patient CircuitConfigurations	Disposable circuitincluding handset withconnection for in-linenebulizer.	Disposable circuit referred to as"handset" includes connectionfor in-line nebulizer.Draw in room air mix withmedicated aerosol and gas fromcontroller.	Disposable circuitincluding handsetwith connection forin-line nebulizer.
TechnologicalCharacteristic	BiWaze Clear System(Proposed Device)	Hill-Rom Volara System(Maximus™ System, whenused as a Volara™ System)(Predicate Device)	BiWaze ClearSystem(ReferenceDevices)
510(k) Number	K231728	K200988	K213564
Patient Circuitsettings	No resistanceadjustment feature onpatient circuit.All adjustments doneat the control unit.	No resistance adjustmentfeature on patient circuit.Therapy settings are all done atthe control unit.	No resistanceadjustment featureon patient circuit.All adjustmentsdone at the controlunit.
Patient Interface	Acute care:Mouthpiece,Facemask, Insert intoventilator, Adapter toa patient'sendotracheal tube ortracheostomy tube.Home care:Mouthpiece,Facemask, Adapter toa patient'stracheostomy tube.	Acute care: Mouthpiece,Facemask, Insert intoventilator, Adapter to a patient'sendotracheal tube ortracheostomy tube.Home care: Mouthpiece,Facemask, Insert into ventilator,Adapter to a patient'sendotracheal tube ortracheostomy tube.	Acute care:Mouthpiece,Facemask, Adapterto a patient'sendotracheal tubeor tracheostomytube.Home care:Mouthpiece,Facemask, Adapterto a patient'sendotracheal tubeor tracheostomytube.
SpO2Connection	Supports connectionand displays SpO2values and heart ratefrom a SpO2 sensor	Can connect via Bluetooth toBeijing Choice ElectronicTechnology Co., Ltd. FingertipPulse Oximeter, K142888. Onlydisplays the heart rate andSpO2 data	Supports connectionand displays SpO2values and heartrate from a SpO2sensor
Energy Source	100-240 V ac 50/60 Hz	100-240 V ac 50/60 Hz	100-240 V ac 50/60Hz

{7}------------------------------------------------

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.

{8}------------------------------------------------

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.

{9}------------------------------------------------

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.

{10}------------------------------------------------

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

{11}------------------------------------------------

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.

Regulation Number and Section

§ 868.5905 Noncontinuous ventilator (IPPB).

(a)
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.(b)
Classification. Class II (performance standards).