(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.
§ 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).