(407 days)
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.
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.
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.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance metrics for each criterion against a specific threshold. Instead, it focuses on demonstrating substantial equivalence to a predicate device through various performance data and comparisons. The "acceptance criteria" are implied by the performance characteristics of the predicate device and the new device's ability to match or be comparable to them.
However, based on the text, we can infer the key areas of performance that were evaluated and for which the new device (BiWaze Clear System) was found to be "substantially equivalent" to the predicate (Volara™ System).
| Acceptance Criteria (Implied) | Reported Device Performance (BiWaze Clear System) |
|---|---|
| Functional Equivalence Across Therapy Modes: | |
| – Positive Expiratory Pressure (PEP) | Controlled static flow with positive pressure ≤ 30 cmH2O (Similar to predicate) |
| – Oscillation (OSC) | Controlled continuous flow with frequencies up to 300 beats per minute (5 Hz) and peak positive pressures ≤ 70 cmH2O (Similar to predicate, though predicate's CHFO is ≤ 70 cmH2O, and reference device's CHFO is ≤ 30 cmH2O – the BiWaze Clear System aligns with the predicate's higher pressure capability) |
| – Nebulize (NEB) | Controlled continuous constant pressure with in-line nebulizer delivering saline (Functionally similar to predicate's aerosol delivery) |
| Performance in Different Patient Circuits/Interfaces: | Demonstrates comparable performance across various patient interfaces (facemask, mouthpiece, trach adapter). |
| Biocompatibility: | Materials in gas and fluid pathway are categorized as externally communicating, tissue contacting with a permanent duration (>30 days), and meet ISO 10993-1 and ISO 18562-1 standards. |
| Electrical Safety, EMI/EMC: | Complies with IEC 60601-1 and IEC 60601-1-2 standards. |
| Usability: | Complies with IEC 60601-1-6 and IEC 62366-1 standards. |
| Software & Firmware Verification and Validation: | Complies with IEC 62304 standards. |
| Risk Management: | Complies with ISO 14971 standards. |
| Cleaning Validation: | Cleaning validation performed. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a numerical "sample size" in terms of number of patient cases or units for the test set. The performance data is based on "bench testing" and "non-clinical testing." This implies laboratory-based tests on device units rather than patient data.
- Data Provenance: Not applicable in the context of patient data, as no clinical studies with human subjects were conducted or submitted. The testing was entirely non-clinical bench testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This question is not applicable as there was no ground truth established by experts in the context of human physiological or pathological conditions. The "ground truth" for the device's performance was established by engineering and performance specifications and comparison to the predicate device's measured performance in a bench setting.
4. Adjudication Method for the Test Set
- This question is not applicable as there was no expert adjudication process due to the absence of clinical studies and human-based ground truth establishment. Performance was directly measured against specifications and predicate device behavior.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- This question is not applicable. The BiWaze Clear System is a mechanical therapeutic device (Noncontinuous Ventilator for secretion mobilization and lung expansion), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study or AI assistance effect size is irrelevant to this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This question is not applicable. The device is not an algorithm; it is a standalone mechanical medical device that performs therapies. Its performance is inherent to the device itself, not dependent on or enhanced by a human-in-the-loop interaction in the way AI algorithms are evaluated.
7. The Type of Ground Truth Used
- The ground truth used for demonstrating substantial equivalence was primarily engineering specifications, direct comparative measurements against a legally marketed predicate device (Volara™ System), and compliance with recognized industry standards (e.g., IEC 60601-1, ISO 10993-1). No expert consensus, pathology, or outcomes data from human patients were used.
8. The Sample Size for the Training Set
- This question is not applicable. The BiWaze Clear System is a physical device, not a machine learning model. Therefore, it does not have a "training set" in the context of AI.
9. How the Ground Truth for the Training Set Was Established
- This question is not applicable for the same reason as point 8; there is no training set. Design and development would have been guided by engineering principles and existing medical knowledge of respiratory therapies.
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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 (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 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: priyanka.paul@abmrc.com | ||
| Prepared By: | Priyanka Paul | |
| QA/RA Manager ABMRC LLC | ||
| Email: priyanka.paul@abmrc.com | ||
| 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.
| TechnologicalCharacteristic | BiWaze Clear System(Proposed Device) | Hill-Rom Volara System(Maximus™ System,when used as a Volara™System) (PredicateDevice) | Hill-Rom MetaNab® 4System (ReferenceDevice) | |
|---|---|---|---|---|
| 510(k) Number | K213564 | K200988 | K151689 | |
| CFRClassification | Regulation Number: 21CFR 868.5905 | Regulation Number: 21CFR 868.5905 | Regulation Number: 21CFR 868.5905 | |
| Product Code | Product code:NHJ | Product code: NHJ | Product code: NHJ | |
| ClassificationPaneland Class | AnaesthesiologyClass II | AnaesthesiologyClass II | AnaesthesiologyClass II | |
| ClassificationName | Device, positive pressurebreathing, intermittent(IPPB) | Device,positivepressurebreathing, intermittent(IPPB) | Device, positivepressure breathing,intermittent (IPPB) | |
| Indication ForUse | The BiWaze ClearSystem is indicated forthe mobilization ofsecretions, lungexpansion therapy, thetreatment and preventionof pulmonary atelectasisand has the ability toprovide supplementaloxygen when used withan oxygen supply.The BiWaze ClearSystem is indicated todeliver therapy to adultsand children over the ageof 2 years in the acutecare setting.The BiWaze ClearSystem is indicated todeliver therapy to adultsand children over the ageof 5 years in the homecare setting. | Indicated for mobilization ofsecretions, lung expansiontherapy, treatment andprevention of pulmonaryatelectasis, ability to providesupplemental oxygen whenused with oxygen. | Indicated formobilization ofsecretions, lungexpansion therapy, thetreatment andprevention ofpulmonary atelectasis,and also has the abilityto providesupplemental oxygenwhen used withcompressed oxygen. | |
| Environments ofUse | Hospital,Sub-acute facilities,Nursing care Homecare | Hospital, Sub-acuteFacilities, Nursing care,Homecare | Hospital sub-acutefacilities Nursing careHomecare | |
| Environments ofUse | Hospital,Sub-acute facilities,Nursing care Homecare | Hospital,Sub-acute facilities,Nursing careHomecare | Hospitalsub-acute facilitiesNursing careHomecare | |
| PatientPopulation | Adult, Child > 2 yearsold (acute)Adult, Child >5 year(home care) | Adult, Child > 2 years old(acute)Adult, Child > 5 year(homecare) | Adult, Child > 2 yearsold (Acute care)Adult, Child > 5years old (homecare) (K151689) | |
| Therapy Type | Positive ExpiratoryPressure (PEP),Oscillation (OSC), NEB | Continuous PositiveExpiratory Pressure(CPEP), Continuous HighFrequency Oscillation(CHFO), Aerosol | CPEP, CHFO, AerosolOnly | |
| PositiveExpiratoryPressure (PEP) /CPEP | Controlled static flow withpositive pressure ≤ 30cmH2O | Controlled static flow withpositive pressures < 30cmH2O | Controlled static flowwith positive pressures≤ 30 cmH2O | |
| Oscillations(OSC) / CHFO | Controlled continuousflow with frequencies upto 300 beats per minute(5 Hz) and peak positivepressures ≤ 70 cmH2O | Controlled continuous flowwith frequencies up to 300beats per minute and peakpositive pressure ≤ 70cmH2O | Controlled continuousflow with frequencies upto 300 beats per minuteand peak positivepressure ≤ 30 cmH2O | |
| NEB / Aerosol | Controlled continuousconstant pressure within- line nebulizerdelivering saline. | Controlled continuousconstant pressure to in-linenebulizer deliveringmedicated aerosol only viamouthpiece and face mask.Aerosol may not be deliveredwhen the in-line ventilatoradapter is used. | Controlled continuousconstant flow to in-linenebulizer deliveringmedicated aerosol only. | |
| Patient CircuitConfigurations | Disposable circuitincluding handset withconnection for in-linenebulizer to deliversaline. | Disposable circuit referred to as"handset" includesconnection for in-linenebulizer.Draw in room air mix withmedicated aerosol and gasfrom controller. | Disposable circuitreferred to as "handset"includes connection forin- line nebulizer.Draw in room air mix withmedicated aerosol andgas from controller. | |
| Patient Circuitsettings | No resistance adjustmentfeature on patient circuit. | No resistance adjustmentfeature on patient circuit.All adjustments done at the | Expiratory resistanceadjustment ≤ 30 cmH2O | |
| control unit. | ||||
| All adjustments done at thecontrol unit | ||||
| Patient Interface | Acute care: Mouthpiece,Facemask, Adapter to apatient's endotrachealtube or tracheostomytube.Home care: Mouthpiece,Facemask, Adapter to apatient's endotrachealtube or tracheostomy tube. | Acute care: Mouthpiece,Facemask, Insert intoventilator, Adapter to apatient's endotracheal tubeor tracheostomy tube.Home care: Mouthpiece,Facemask, Insert intoventilator, Adapter to apatient's endotracheal tubeor tracheostomy tube. | Mouthpiece Face maskInsert into ventilatorcircuit | |
| Principle ofOperation | Electro-MechanicaldeviceAir or Oxygen | Electro-Mechanical deviceAir or Oxygen | Pneumatic Air oroxygen | |
| Setting Options | On/OffFrequency selection forOSC mode (TouchScreen Control) | On/OffFrequency selection forCHFO mode(TouchScreen Control) | On/OffFrequency selectionfor CHFO mode(control knob) | |
| Pressure adjustment forOSC mode (TouchScreenControl) | Pressure adjustment forCHFO mode(TouchScreen Control)Pressure adjustment for | Pressure adjustment forCPEP mode (controlknob)Pressure manometer - | ||
| Pressure adjustment forPEP mode (TouchScreen Control)Pressure manometer | CPEP mode (Touch ScreenControl)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.SIMILARITIESThe 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.REMARKSIn 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).REMARKSThe 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.REMARKSEncrypted 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.
§ 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).