(266 days)
The DELTAWAVE Nasal Pillows System is intended to noninvasively channel pressurized airflow to a patient from a Continuous Positive Airway Pressure (CPAP) or Bi-Level medical device.
This medical device is intended for adult patients weighing 66 lbs (30kg), and for whom noninvasive Continuous Positive Airway Pressure (CPAP) or Bi-Level therapy has been prescribed by a physician or other authorized healthcare professional. It is intended for single-patient reuse in the home.
The DELTAWAVE™ Nasal Pillow System is the subject device for this submission. It is a non-invasive medical device that directs pressurized air from a Continuous Positive Airway Pressure (CPAP) or Bi-level medical device to the patient. The subject device is a type of medical device prescribed by a physician or authorized professional for patients who have been diagnosed with Sleep Apnea.
The subject device is designed to prevent pressure drop from the CPAP machine to the patient's nasal passages. That is accomplished by maintaining the same, or greater flow space from the machine output to the patient's nostrils. To further ensure the least amount of pressure drop the nasal pillows are designed to gently dilate the patient's nostrils to avoid restrictions to incoming air entering the nostrils. This allows air to enter the patient's nostrils at a lower driving pressure.
The DELTAWAVE Nasal Pillows System is a medical device intended to noninvasively deliver pressurized airflow from a CPAP or Bi-Level device to adult patients (weighing 66 lbs or 30kg) who have been prescribed such therapy. It is designed for single-patient reuse in the home.
Here's an analysis of the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document does not explicitly list "acceptance criteria" in a separate section with pass/fail thresholds. Instead, it presents a comparison of the DELTAWAVE Nasal Pillow System (subject device) to a predicate device, the Fisher & Paykel EVORA™ Nasal Mask (Model A), across various characteristics and performance metrics. The underlying acceptance criterion for substantial equivalence is that the differences do not raise new or different questions of safety or effectiveness.
Below is a table summarizing the reported device performance, with the implicit acceptance being "similar" or "does not raise new/different questions of safety and effectiveness" compared to the predicate.
| Characteristic | DELTAWAVE™ Nasal Pillow System (K233415) | Predicate F&P EVORA™ A Model (K200089) | Acceptance Criteria & Comments (Implied) |
|---|---|---|---|
| Classification Characteristics | |||
| Intended Use/Indications For Use | Same as predicate. For adults ≥66lbs (30kg), prescribed CPAP/Bi-Level therapy, single-patient reuse in home. | Same as predicate. | Pass: SAME. No new or different questions of safety and effectiveness. |
| Product Code | BZD | BZD | Pass: SAME. |
| Regulation # | 868.5905 | 868.5905 | Pass: SAME. |
| Patient Population | Adults ≥66 lbs. (30kg). Home use only. | Adults ≥66 lbs. (30kg). Home use. | Pass: SAME. |
| Availability to Patient | By Prescription | By Prescription | Pass: SAME. |
| Sterile or Non-sterile | Non-Sterile | Non-Sterile | Pass: SAME. |
| Physical Characteristics | |||
| Operating Environment | Home | Home | Pass: SAME. |
| Mask Type | Nasal Pillow | Nasal | Pass: Both confined to patient's nose area. Design differences do not raise new/different questions of safety and effectiveness. |
| Exhalation Vent | Small vents in nasal cannula/mask serve as exhaust ports. | Small vents in the Frame which attaches to the Seal serve as the exhaust ports. | Pass: SAME function. |
| Tubing to connect to CPAP Device | 22 mm | 22 mm | Pass: SAME. |
| Operating Characteristics | |||
| Dead Space volume for nasal pillows | Small = 19.50 cc, Medium = 19.50 cc, Large = 19.50 cc. | Small = 28 cc, Medium = 26 cc, Large = 28 cc, Wide = 34 cc. | Pass: All subject device cannula/masks have the same Dead Space volume and Internal Measurements regardless of size. Dead Space is disclosed per ISO 17510. Design differences do not raise new/different questions of safety and effectiveness. (Subject device dead space is lower than predicate). |
| Pressure Range | 4 to 20 cmH2O | 4 to 25 cmH2O | Pass: Subject device has a narrower pressure range. Design differences do not raise new/different questions of safety and effectiveness. |
| Exhaust Flow Rates | Provided for Small, Medium, Large at 4, 8, 12, 16, 20 cmH2O. | Unavailable | Pass: Pressure – Flow curves of Exhaust flow are disclosed to the user per Clause 4 of ISO 17510. Design differences do not raise new/different questions of safety and effectiveness. |
| Resistance – Pressure Drop** (cmH2O) | @50L/min: Small = 0.4, Medium = 0.2, Large = 0.2. @100L/min: Small = 1.5, Medium = 1.0, Large = 0.8. | @50L/min: Small, Medium, Large, Wide = 1.0 ± 0.1. @100L/min: Small = 1.4 ± 0.25, Medium = 1.2 ± 0.25, Large = 1.2 ± 0.25, Wide = 1.3 ± 0.25. | Pass: SIMILAR. Resistance at 50 L/min and 100 L/min are disclosed to user per Clause 4 of ISO 17510. The subject device does not have a cannula/mask in a size Wide. Design differences do not raise new/different questions of safety and effectiveness. (Subject device generally has lower resistance). |
| CO2 Rebreathing cm H2O | Small: Pre 2%, Post 4% (Diff 2%). Medium: Pre 0%, Post 3% (Diff 3%). Large: Pre 0%, Post 1% (Diff 1%). | Unavailable from predicate. | Pass: PRE values measured prior to aging, POST after aging. Relative Increase % is the difference between Baseline and Cannula/Mask measurement (ETCO2%). Implicitly, the rebreathing levels are considered acceptable, as no safety concerns are raised. |
| Sound Pressure & Power Level | A-weighted Sound Pressure: 29.7 dBA (at 10 cm H20). A-weighted Sound Power Level: 37.7 dBA (at 10 cm H20). | A-weighted sound pressure level: 18.8 dBA, uncertainty of 2.5 dBA. A-weighted sound power level: 26.8 dBA, uncertainty of 2.5 dBA. | Pass: Adheres to Clause 5.3.1 of ISO 17510. Values disclosed to user per Clause 6 of ISO 17510. These differences do not raise different risk concerns. (Subject device has demonstrably higher sound levels than the predicate, but deemed acceptable by conforming to standards and disclosure). |
| Cleaning | Single patient, reusable. Hand wash. | Unavailable (from predicate). | Pass: Cleaning method supported through validation. Any differences do not raise different questions of safety or effectiveness. |
2. Sample size used for the test set and the data provenance:
The document describes non-clinical performance testing. For specific performance metrics like Dead Space, Resistance, CO2 Rebreathing, and Sound Levels, it is likely that a sample size appropriate for engineering and laboratory testing (e.g., several units per size/type) was used, rather than a large clinical test set. The document does not specify the exact number of devices tested for each non-clinical performance test.
The data provenance is from non-clinical performance testing conducted by the manufacturer of the DELTAWAVE Nasal Pillows System (REMSLEEP Holdings Inc.). This type of data is typically collected prospectively in a laboratory setting. No country of origin for the non-clinical test data is specified, but it accompanies a US FDA submission, implying compliance with US regulatory standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This device is not an AI/CADe/CADx device that would typically rely on expert human interpretation to establish ground truth for a test set. The "ground truth" for the non-clinical performance tests (e.g., resistance, dead space, CO2 rebreathing) is established by using calibrated measurement equipment and adhering to recognized test standards (e.g., ISO, AAMI). Therefore, no human experts were used in this context to establish ground truth for a "test set" in the way it's understood for diagnostic imaging or AI devices. The product development and testing would involve engineers and quality control personnel with relevant expertise.
4. Adjudication method for the test set:
Not applicable, as this is primarily a non-clinical performance evaluation against predefined engineering specifications and international standards, not a diagnostic or AI performance study requiring human adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
No. This is a physical medical device (nasal pillows system) and not an AI or imaging-based diagnostic tool. Therefore, an MRMC study is not relevant or applicable.
6. If a standalone (i.e., algorithm-only without human-in-the-loop performance) was done:
Not applicable, as this is not an algorithm or AI device. It is a physical accessory for CPAP/Bi-Level therapy.
7. The type of ground truth used:
The ground truth for the performance characteristics (e.g., Dead Space, Pressure Drop, CO2 Rebreathing, Sound Levels) is established through objective, standardized measurements and adherence to international consensus standards (e.g., ISO 17510, ISO 5356-1, various ISO 10993 and ISO 18562 standards for biocompatibility). For biocompatibility, the "ground truth" is defined by the absence of toxicity, irritation, etc., as assessed by validated biological test methods.
8. The sample size for the training set:
Not applicable, as this is not a machine learning device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable, as this is not a machine learning device.
§ 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).