(300 days)
No
The summary describes a device that provides respiratory therapies (PEP, OSC, NEB) based on programmed pressure and oscillation, without mentioning any adaptive or learning capabilities. The description focuses on the mechanical and functional aspects of the device and its therapies.
Yes
The device is indicated for medical treatments such as loosening secretions, lung expansion, and preventing atelectasis, directly aiming to treat or prevent a disease or condition.
No
The device is described as a therapeutic device for loosening and mobilizing secretions, lung expansion therapy, and the treatment and prevention of pulmonary atelectasis, using therapies such as PEP, OSC, and NEB. It does not perform any diagnostic functions.
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 describes therapies involving the delivery of positive pressure and oscillation, which require physical mechanisms. The mention of a nebulizer further indicates hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The BiWaze Clear System is a therapeutic device that assists patients with respiratory issues by providing therapies like PEP, oscillation, and nebulization. It works directly on the patient's airways and lungs.
- No Sample Analysis: The description does not mention the device analyzing any samples taken from the patient's body. Its function is to deliver therapy and assist with secretion clearance and lung expansion.
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 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.
Product codes
NHJ
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.
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 or pediatric patients in acute care (aged 2 years and older) and home care environments (aged 5 years and older).
Intended User / Care Setting
acute care and home care environments.
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
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).
Key Metrics
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).
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 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.
| 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/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 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 | |
| Date Prepared: | April 05, 2024 | |
| Trade/ Device Name: | BiWaze Clear System | |
| Device Common Name: | Noncontinuous Ventilator (IPPB) | |
| Classification
Regulation 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 a
Volara TM System) | K200988 |
| Reference Device
(Existing 510(k) Cleared | BiWaze Clear System | K213564 |
Indication for Use:
Device):
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 and Modification:
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.
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.
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.
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".
| Technological
Characteristic | BiWaze Clear System
(Proposed Device) | Hill-Rom Volara System
(MaximusTM System, when
used as a VolaraTM System)
(Predicate Device) | BiWaze Clear
System
(Reference
Devices) |
|---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K231728 | K200988 | K213564 |
| 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 | 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) |
| Indication For
Use | 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 | Indicated for mobilization of
secretions, lung expansion
therapy, treatment and
prevention of pulmonary
atelectasis, ability to provide
supplemental oxygen when
used with oxygen. | 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. |
| ESPIRATORY CARE | | | |
| Technological
Characteristic | BiWaze Clear System
(Proposed Device) | Hill-Rom Volara System
(Maximus™ System, when
used as a Volara™ System)
(Predicate Device) | BiWaze Clear
System
(Reference
Devices) |
| 510(k) Number | K231728 | K200988 | K213564 |
| | acute and home care
environments. The
BiWaze Clear System
may be used in-line
with a ventilator in
acute care
environment only. | | |
| 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 care)
Adult, Child > 5 year
(Home care) | Adult, Child > 2 years old (Acute
care)
Adult, Child > 5 year (Home
care) | Adult, Child > 2
years old (Acute
care)
Adult, Child > 5
years old (Home
care) |
| Therapy Modes | Positive Expiratory
Pressure (PEP),
Oscillation (OSC),
Nebulizer (NEB) | Continuous Positive Expiratory
Pressure (CPEP), Continuous
High Frequency Oscillation
(CHFO), Aerosol | Positive Expiratory
Pressure (PEP),
Oscillation (OSC),
Nebulizer (NEB) |
| Positive
Expiratory
Pressure (PEP)/
CPEP | Controlled static flow
with positive pressure
≤ 30 cmH2O | Controlled static flow with
positive pressures