(254 days)
K12195-
No
The description mentions "software algorithms" and "automatic modes" but provides no indication of learning, adaptation, or complex pattern recognition characteristic of AI/ML. The performance studies focus on equivalence and verification, not AI/ML model validation.
Yes
The device is used to treat patients unable to clear secretions effectively and provides therapy that mimics a cough to clear bronchopulmonary secretions.
No.
This device, the BiWaze Cough, is designed to clear bronchopulmonary secretions by mimicking a cough through controlled pressure changes. Its purpose is therapeutic, assisting patients in removing secretions, rather than diagnosing a condition or disease.
No
The device description explicitly mentions hardware components such as a power supply, battery, and touch screen panel, indicating it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- This device is used directly on the patient to assist with clearing secretions from the lungs. It is a therapeutic device, not a diagnostic one.
The description clearly outlines a device that provides mechanical assistance to the patient's respiratory system, mimicking a cough. This is a form of respiratory therapy, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
This device is designed for use on patients unable to cough or clear secretions effectively due to reduced peak cough exspiratory flow, resulting from high spinal cord injuries, neuromuscular deficits or severe fatigue associated with intrinsic lung disease. It may be used either with a facemask, mouthpiece, or an adapter to a patient's endotrached tube or tracheostomy tube. For use in hospital, institutional setting, or at home. For use on adult patients 3 years old and up.
Product codes (comma separated list FDA assigned to the subject device)
NHJ
Device Description
The BiWaze Cough is a device intended for clearing bronchopulmonary secretions. The therapy provided by BiWaze Cough mimics a cough and consists of three phases which mimic a cough; inhale, exhale, and pause phase. The inhale phase is positive airway pressure to expand the lungs. Then the exhale phase is a sudden shift to negative pressure to pull the air out of lungs. Finally, the pause phase provides positive pressure which keeps the airways open in between the therapy cycle.
The Peak Inspiratory Flow can be selected on three different levels: High, Medium, Low.
The device can be operated via a power supply and is also battery operated. Performance is controlled from a touch screen panel in manual or automatic modes. The device is controlled by software algorithms, and error messages are displayed in cases where the normal functioning doesn't occur. Advanced features include inspiratory trigger and oscillations.
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
adult patients and pediatric patients 3 years old and up.
Intended User / Care Setting
For use in hospital, institutional setting, or at home.
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 was conducted on BiWaze Cough and the device was found substantially equivalent to the predicate device.
Verification activities have been performed to verify that the device modifications did not affect the safety and effectiveness of the subject device. This included bench testing, software unit testing, and code reviews.
The BiWaze Cough device was designed and tested according to the following standards:
- AAMI ANSI ES 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 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and Testing within a Risk Management Process
- ISO 18562-1 Biocompatibility Evaluation of Breathing Gas Pathways in Healthcare ● Applications - 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 ●
- IEEE C63.27:2017 American National Standard for Evaluation of Wireless Coexistence ●
In summary, bench testing and software code reviews have confirmed that the BiWaze Cough device performs substantially equivalent to the cited predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K12195-
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.
March 27, 2020
ABMRC LLC Sneha P OA/RA Lead 239. Fair Child Street. Daniel Island Charleston, South Carolina 29492
Re: K191912
Trade/Device Name: BiWaze Cough Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: Class II Product Code: NHJ Dated: February 21, 2020 Received: February 26, 2020
Dear Sneha P:
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.
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
1
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 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,
for Michael Ryan Division Director DHT1C: Division of ENT, 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) K191912
Device Name BiWaze Cough
Indications for Use (Describe)
This device is designed for use on patients unable to cough or clear secretions effectively due to reduced peak cough exspiratory flow, resulting from high spinal cord injuries, neuromuscular deficits or severe fatigue associated with intrinsic lung disease. It may be used either with a facemask, mouthpiece, or an adapter to a patient's endotrached tube or tracheostomy tube. For use in hospital, institutional setting, or at home. For use on adult patients 3 years old and up.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☒ Prescription Use (Part 21 CFR 801 Subpart D) |
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary
| Submitter: | ABMRC LLC
239, Fair Child St, Daniel Island,
Charleston, South Carolina 29492
www.abmrespiratorycare.com | |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------|---------|
| Contact: | Chad M Boerst
Director
ABMRC LLC
Email: chadboerst@abmrespiratorycare.com | |
| Prepared By: | Sneha S P
QA/RA Lead
ABMRC LLC
Email: sneha.sp@abmrespiratorycare.com | |
| Date Prepared: | March 27, 2020 | |
| Device Proprietary Name: | BiWaze Cough | |
| Device Common Name: | Secretion Clearance Device | |
| Classification Regulation Number: | 21 CFR 868.5905 | |
| Classification Panel: | Anesthesiology | |
| Device Classification Code/Name: | NHJ - Non-continuous ventilator (IPPB) | |
| Classification: | Class II | |
| Predicate Device: | Philips Respironics Cough Assist T70 | K12195- |
| Reference Devices: | Pegaso Cough | K140598 |
| | Lung Assist Vital Cough | K132988 |
Device Description:
The BiWaze Cough is a device intended for clearing bronchopulmonary secretions. The therapy provided by BiWaze Cough mimics a cough and consists of three phases which mimic a cough; inhale, exhale, and pause phase. The inhale phase is positive airway pressure to expand the lungs. Then the exhale phase is a sudden shift to negative pressure to pull the air out of lungs. Finally, the pause phase provides positive pressure which keeps the airways open in between the therapy cycle.
4
The Peak Inspiratory Flow can be selected on three different levels: High, Medium, Low.
The device can be operated via a power supply and is also battery operated. Performance is controlled from a touch screen panel in manual or automatic modes. The device is controlled by software algorithms, and error messages are displayed in cases where the normal functioning doesn't occur. Advanced features include inspiratory trigger and oscillations.
Indications for Use:
This device is designed for use on patients unable to cough or clear secretions effectively due to reduced peak cough expiratory flow, resulting from high spinal cord injuries, neuromuscular deficits or severe fatigue associated with intrinsic lung disease. It may be used either with a facemask, mouthpiece, or an adapter to a patient's endotracheal tube or tracheostomy tube. For use in hospital, institutional setting, or at home. For use on adult patients and pediatric patients 3 years old and up.
Substantial Equivalence Determination:
The table below summarizes the key technical characteristics of BiWaze Cough and the predicate and reference devices listed in the submission:
5
| Technological
Characteristic | BiWaze Cough
K191912 | Philips Respironics
CoughAssist T70
K121955 | Pegaso Cough
K140598 | Lung Assist Vital Cough
K132988 |
|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| CFR Classification | 868.5905 NHJ | 868.5905 NHJ | 868.5905 NHJ | 868.5905 NHJ |
| Classification Panel and
Class | Anesthesiology
Class II | Anesthesiology
Class II | Anesthesiology
Class II | Anesthesiology
Class II |
| Classification Name | Device, positive pressure
breathing, intermittent
(IPPB) | Device, positive pressure
breathing, intermittent
(IPPB) | Device, positive
pressure breathing,
intermittent (IPPB) | Device, positive pressure
breathing, intermittent
(IPPB) |
| Environments of Use | Hospital, Institutional
Setting, homecare | Hospital, Institutional
Setting, homecare | Hospital, Institutional
Setting, homecare | Hospital, Institutional
Setting, homecare |
| Patient Population | Adult or pediatric patient
unable to cough or clear
secretions effectively | Adult or pediatric patient
unable to cough or clear
secretions effectively | Adult or pediatric
patient unable to cough
or clear secretions
effectively | For use on adult or
pediatric patients |
| Delivery Type | Non-Invasive or Invasive | Non-Invasive or Invasive | Non-Invasive or
Invasive | - |
| Modes of Operation | Auto and Manual | Auto and Manual | Auto and Manual | Auto and Manual |
| Inhalation Pressure | 0 to 70 cmH2O | 0 to 70 cmH2O | 0 to 70 cmH2O | 0 to 50 cmH2O |
| Exhalation Pressure | 0 to -70 cmH2O | 0 to -70 cmH2O | 0 to -70 cmH2O | 0 to -50 cmH2O |
| Inhale Flow | Low, Medium, High | Low, Medium, High | Low, Medium, High | Low, Medium, High |
| Pause Time | 0 to 5 seconds | 0 to 5 seconds | 0 to 9.9 seconds | 0 to 5 seconds |
| Phases of Therapy Cycle | Insufflation, Exsufflation,
Pause | Insufflation, Exsufflation,
Pause | Insufflation,
Exsufflation, Pause | Insufflation, Exsufflation,
Pause |
| Safety protocols | Dynamic Flow and Pressure
control. Sensor malfunction
detection. Altitude
correction. Pressure and | Dynamic stability Analysis.
Flow and Pressure based
Oscillation Detection
Extreme Flow Rate Control
and Response Sensor | Dynamic Flow and
Pressure control.
Manufacturer Software
Calibration eliminates | - |
| | Flow rate control for
smooth pressure output
without fluctuations. Valve
design ensures spontaneous
breathing in event of power
failure/standby when
patient is connected | Malfunction Stability | all undesired
oscillations. Sensor
malfunction detection | |
| Oscillations/Vibrations
Frequency | Up to 20 Hz | N/A | Up to 10 Hz | Up to 20 Hz |
| Therapy Features –
Inspiratory Trigger | Yes | Yes (CoughTrak) | Yes (Easy Start/Auto
Sync) | - |
| Remote Data Access | An internal memory stores
all data. Encrypted and
secure data transfer through
USB (2.0) and Wi-Fi
(WiLink8 802.11 a/b/g/n +
MIMO) | Secure Digital (SD) card | An internal memory
stores therapies data.
RS232/USB adapter
transmits to a PC
therapies and technical
data. | - |
| Remote Control | A remote-control accessory
(foot pedal) and/or
iOS/Android app is provided
to initiate manual therapy by
means of a remote-control
interface | A remote-control accessory
(foot pedal) is provided to
initiate manual therapy by
means of a wired remote-
control interface | | - |
| Energy Source | 100-240 V ac
50/60 Hz | 100-240 V ac
50/60 Hz | 100/240 V ac
50/60 Hz | 100-230 V ac
50-60 Hz |
| Patient Interfaces | Facemask, Mouthpiece, an
adapter to endotracheal tube
or tracheostomy tube | Facemask, Mouthpiece,
endotracheal tube or
tracheostomy tube | Facemask, Mouthpiece,
an adapter to
endotracheal tube or
tracheostomy tube | Facemask, Mouthpiece, an
adapter to endotracheal
tube or tracheostomy tube |
6
7
Comparison of Characteristics with respect to Predicate Device:
The BiWaze Cough device has similar features and indications for use when compared to the Predicate Device, Phillips Respironics Cough Assist T70 and the reference devices, Pegaso Cough and Lung Assist Vital Cough. The core capabilities of the BiWaze Cough and its fundamental scientific technology remain unaltered compared to the Phillips Respironics Cough Assist T70. The device modifications discussed do not alter the BiWaze Cough's safety or effectiveness and neither do they change its intended use compared to the predicate.
The table below provides a description of the modifications to the BiWaze Cough device that are subject of this 510(k) submission:
| Device Features | Description |
|---|---|
| User Interface | A new graphic touch display and a new user interface with hierarchical menu system. |
| SIMILARITIES | |
| The predicate device has similar parameters displayed in the main screen. | |
| Inspiratory | |
| Trigger | A feature for patients who can provide spontaneous breathing effort to trigger the Cough sequence, instead of using manual or auto modes therapy. This software feature monitors the device outlet flow and pressure and initiates the insufflation phase of therapy delivery when the flow increases over a set threshold indicative of patient effort. |
| SIMILARITIES | |
| The Inspiratory Trigger feature is based on the detection of the patient's inspiratory efforts. For this detection a digital flow and pressure sensor is used. The principle is similar to the Respironics CoughAssist T70's CoughTrak and Pegaso Cough's Auto Sync/Easy Start. | |
| Custom Cycle | |
| Settings | A feature to customize each breath cycle in terms of pressure, time and oscillations. |
| REMARKS | |
| This feature is added to provide more flexibility in terms of setting therapy parameters for every individual cycle. This feature is similar to Respironics' T70 Advanced Automatic Mode. | |
| The device can save up to 10 custom therapy profiles. | |
| Custom Profiles | SIMILARITIES |
| The Custom Profiles feature is provided so that User can select a pre-defined set of therapy parameters. This feature is similar to Respironics CoughAssist T70's Preset feature. | |
| A feature that delivers a pressure oscillation based on frequency and amplitude set points. | |
| Oscillations | SIMILARITIES |
| The feature is similar to the Percussor feature of the Pegaso Cough device. | |
| Data Management | All therapy data is stored in an internal memory. On request, data can be securely transferred over authenticated link through USB (2.0), Wi-Fi (WiLink8 802.11 b/g/n) |
| REMARKS | |
| Encrypted data is securely transferred through either USB 2.0, Wi-Fi (WiLink8 802.11 b/g/n) along with additional authentication information. | |
| Wired Remote Control | A remote-control accessory (foot pedal) is provided to initiate manual therapy by means of a wired remote-control interface. |
| SIMILARITIES | |
| This feature/accessory is similar to that of Respironics CoughAssist T70 device. | |
| Wireless Remote Control | A remote-control accessory (mobile app) is provided to initiate manual therapy by means of a wireless (BLE) remote-control interface. |
| Power Management | An internal rechargeable battery is included. |
8
Performance Data:
Performance testing was conducted on BiWaze Cough and the device was found substantially equivalent to the predicate device.
Verification activities have been performed to verify that the device modifications did not affect the safety and effectiveness of the subject device. This included bench testing, software unit testing, and code reviews.
The BiWaze Cough device was designed and tested according to the following standards:
- AAMI ANSI ES 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 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and Testing within a Risk Management Process
- ISO 18562-1 Biocompatibility Evaluation of Breathing Gas Pathways in Healthcare ● Applications - Part 1: Evaluation and Testing within a Risk Management Process
9
- IEC 62304 Medical Device Software Software Life Cycle Processes ●
- ISO 14971 Medical Devices Application of Risk Management to Medical Devices ●
- IEEE C63.27:2017 American National Standard for Evaluation of Wireless Coexistence ●
Conclusion:
In summary, bench testing and software code reviews have confirmed that the BiWaze Cough device performs substantially equivalent to the cited predicate device. The indications for use, technological characteristics, and principles of operation are similar to the predicate device. The BiWaze Cough device is substantially equivalent to the predicate device.