(407 days)
No
The summary describes a device that provides respiratory therapies (PEP, OSC, NEB) based on programmed pressures and oscillations. There is no mention of AI or ML in the device description, intended use, or performance studies. The testing focuses on comparative performance against a predicate device and standard medical device testing (biocompatibility, electrical safety, usability, etc.).
Yes
The device is indicated for the "mobilization of secretions, lung expansion therapy, the treatment and prevention of pulmonary atelectasis," and "to deliver therapy," which are direct therapeutic actions.
No
Explanation: The device is described as a therapeutic system for mobilizing secretions, treating atelectasis, and providing lung expansion and high-frequency oscillation therapies. It delivers treatments such as PEP, OSC, and NEB. It is not designed to diagnose conditions or process diagnostic images.
No
The device description clearly outlines hardware components like a "Dual Lumen Breathing Circuit," "handset," "breathing tube," and a "coaxial bacterial/viral filter." It also mentions powering an "Aerogen Solo vibrating mesh nebulizer." The verification and validation section includes testing of "Main Unit and Dual Lumen Breathing Circuit Components," "Electrical Safety, EMI /EMC," and "Cleaning Validation," all indicative of a physical device.
Based on the provided information, the BiWaze Clear System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- BiWaze Clear Function: The BiWaze Clear System is a therapeutic device that directly interacts with the patient's respiratory system to mobilize secretions and expand the lungs. It delivers therapies like PEP, OSC, and NEB.
- Lack of Specimen Analysis: The description does not mention the device analyzing any biological specimens from the patient. Its function is entirely focused on delivering physical and aerosolized therapy to the airways.
Therefore, the BiWaze Clear System falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
NHJ
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adults and children over the age of 2 years in the acute care setting.
Adults and children over the age of 5 years in the home care setting.
Intended User / Care Setting
Acute care setting, home care setting, Hospital, Sub-acute facilities, Nursing care
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing – Bench testing was conducted on BiWaze Clear, and it was found to be substantially equivalent to the predicate.
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 .
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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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.
1
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
2
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.
4
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
Characteristic | BiWaze Clear System
(Proposed Device) | Hill-Rom Volara System
(Maximus™ System,
when used as a Volara™
System) (Predicate
Device) | Hill-Rom MetaNab® 4
System (Reference
Device) | |
|----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| 510(k) Number | K213564 | K200988 | K151689 | |
| CFR
Classification | Regulation Number: 21
CFR 868.5905 | Regulation Number: 21
CFR 868.5905 | Regulation Number: 21
CFR 868.5905 | |
| Product Code | Product code:
NHJ | Product code: NHJ | Product code: NHJ | |
| Classification
Panel
and Class | Anaesthesiology
Class II | Anaesthesiology
Class II | Anaesthesiology
Class II | |
| Classification
Name | Device, positive pressure
breathing, intermittent
(IPPB) | Device,
positive
pressure
breathing, intermittent
(IPPB) | Device, positive
pressure breathing,
intermittent (IPPB) | |
| Indication For
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 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. | Indicated for mobilization of
secretions, lung expansion
therapy, treatment and
prevention of pulmonary
atelectasis, ability to provide
supplemental oxygen when
used with oxygen. | Indicated for
mobilization of
secretions, lung
expansion therapy, the
treatment and
prevention of
pulmonary atelectasis,
and also has the ability
to provide
supplemental oxygen
when used with
compressed oxygen. | |
| | | | | |
| Environments of
Use | Hospital,
Sub-acute facilities,
Nursing care Homecare | Hospital, Sub-acute
Facilities, Nursing care,
Homecare | Hospital sub-acute
facilities Nursing care
Homecare | |
| Environments of
Use | Hospital,
Sub-acute facilities,
Nursing care Homecare | Hospital,
Sub-acute facilities,
Nursing care
Homecare | Hospital
sub-acute facilities
Nursing care
Homecare | |
| Patient
Population | Adult, Child > 2 years
old (acute)
Adult, Child >5 year
(home care) | Adult, Child > 2 years old
(acute)
Adult, Child > 5 year
(home
care) | Adult, Child > 2 years
old (Acute care)
Adult, Child > 5
years old (home
care) (K151689) | |
| Therapy Type | Positive Expiratory
Pressure (PEP),
Oscillation (OSC), NEB | Continuous Positive
Expiratory Pressure
(CPEP), Continuous High
Frequency Oscillation
(CHFO), Aerosol | CPEP, CHFO, Aerosol
Only | |
| Positive
Expiratory
Pressure (PEP) /
CPEP | Controlled static flow with
positive pressure ≤ 30
cmH2O | Controlled static flow with
positive pressures SIMILARITIES
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.
REMARKS
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).
REMARKS
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.
REMARKS
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.