(433 days)
The BPAP System is a Bi-level PAP (Bi-level Positive Airway Pressure) device, which is intended to provide noninvasive ventilation for patients with Obstructive Sleep Apnea (OSA) or Respiratory Insufficiency. The integrated humidifier is indicated for the humidification and warming of air from the flow generator device. The device is intended for adult patients weighing more than 66lbs (30 kg) by prescription. The device is intended for single patient use in the home environment and multi-patient re-use in the hospital/institutional environment.
The proposed device is a non-invasive, continuous positive airway pressure ventilator, incorporating a heated respiratory humidifier. The device is intended to treat obstructive sleep apnea or respiratory insufficiency by delivering a flow of positive airway pressure at a level prescribed by a physician to splint open the airway and prevent airway collapse.
The proposed device is available in different models designed with different therapy modes and pressure ranges. The therapy modes are available in six types, which are CPAP, Spontaneous (S), Spontaneous/Timed (S/T), Timed (T), Auto CPAP and Auto S. The pressure range for the proposed devices is available in two types, which are 4-25cm H2O and 4-30 cm H2O.
Alarm module is incorporated in the device. The device will generate audio and visual alarm for any abnormal conditions. The proposed device is provided non-sterile, and not to be sterilized by the user prior to use. The proposed device can be reused by single patient and multi-patients
The provided text describes a 510(k) premarket notification for a BPAP System, stating that "No clinical study is included in this submission." Therefore, there is no information in the provided document about acceptance criteria, device performance, sample sizes for test and training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone performance. The document focuses on demonstrating substantial equivalence to predicate devices through non-clinical tests and feature comparison.
However, I can extract the non-clinical test conclusions and how they "prove the device meets acceptance criteria" in that context.
Here's a breakdown of what the document does provide:
Non-Clinical Test Data and Compliance
The document states that non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated compliance with various international standards, which serve as the "acceptance criteria" for these non-clinical aspects.
1. A table of acceptance criteria (standards) and the reported device performance (compliance):
| Acceptance Criteria (Standard) | Reported Device Performance (Compliance) |
|---|---|
| AAMI/ANSI/ES60601-1: 2005/(R)2012 And A1: 2012 (Medical electrical equipment - General requirements for basic safety and essential performance) | Complied |
| IEC 60601-1-8:2006+A1: 2012 (Alarm systems in medical electrical equipment) | Complied |
| IEC 60601-1-11:2015 (Medical electrical equipment - Home healthcare environment) | Complied |
| IEC 60601-1-2: 2014 (Electromagnetic disturbances - Requirements and tests) | Complied |
| ISO 80601-2-70: 2015 (Sleep apnoea breathing therapy equipment) | Complied |
| ISO 80601-2-74: 2017 (Respiratory humidifying equipment) | Complied |
| ISO 80601-2-79: 2018 (Ventilatory support equipment for ventilatory impairment) | Complied |
| ISO 10993-5 (Cytotoxicity) | Complied |
| ISO 10993-10 (Skin Irritation, Sensitization) | Complied |
| ISO 18562-2 (Particulate matter) | Complied |
| ISO 18562-3 (Volatile organic compounds (VOCs)) | Complied |
| ISO 18562-4 (Leachables in condensate) | Complied |
Additionally, the device's specific technical performance attributes were compared to predicate devices, demonstrating substantial equivalence rather than meeting independent clinical acceptance criteria:
| Acceptance Criteria (Attribute) | Proposed Device Performance |
|---|---|
| Humidity Output | ≥ 15 mg/L, as required by ISO80601-2-74 |
| Humidifier Setting | 1-5 (95 to 154.4°F/35 to 68°C) |
| Pressure regulation | ±0.5 cmH2O |
| Ramp (time) | 0-60 minutes |
| Expiratory Pressure Relief | Reslex® function Level 1-3 |
| Material Properties | (All relevant biocompatibility tests per ISO 10993 standards and material emissions tests per ISO 18562 standards were complied with.) Cleaning and disinfection methods for multi-patient reuse were validated per FDA recognized standards and found acceptable. |
| Pressure Range | CPAP: 4 |
2. Sample size used for the test set and the data provenance:
No clinical study test set or data provenance is mentioned as "No clinical study is included in this submission." The "test set" in this context refers to the physical device prototypes undergoing non-clinical bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as no clinical study or expert-driven ground truth establishment is described. The "ground truth" for non-clinical tests is based on engineering specifications and adherence to international standards.
4. Adjudication method for the test set:
Not applicable, as no clinical study is conducted.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done:
No. As explicitly stated: "No clinical study is included in this submission." Therefore, no MRMC study or effect size for human reader improvement with AI assistance was performed or reported here.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is a physical medical device (BPAP system), not an AI algorithm. Its performance is inherent to the device itself, as demonstrated through non-clinical testing against standards.
7. The type of ground truth used:
For the non-clinical tests, the "ground truth" is defined by the requirements and specifications of the cited international standards (e.g., IEC 60601 series, ISO 80601 series, ISO 10993 series, ISO 18562 series) and the manufacturer's internal design specifications.
8. The sample size for the training set:
Not applicable, as "No clinical study is included in this submission." This is a hardware device cleared based on substantial equivalence, not a machine learning algorithm requiring a training set.
9. How the ground truth for the training set was established:
Not applicable for the same reason as above.
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).