(60 days)
The REMstar Auto A-Flex HT delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea in spontaneously breathing patients weighing over 30kg (66 lbs). It is for use in the home or hospital/institutional environment.
The REMstar Auto A-Flex HT is a microprocessor controlled blower based positive pressure system which is comprised of the therapy device, a heated humidifier and patient tubing (15mm, 22mm, or heated tubing).
The REMstar Auto A-Flex HT includes CPAP and Auto CPAP therapy modes. While in CPAP mode, the device delivers a continuous positive airway pressure throughout the entire therapy session. While in Auto CPAP mode, the device delivers a positive airway pressure that automatically adjusts to the patient's needs as various breathing events, such as apneas and hypopneas, are detected.
In addition to CPAP and Auto CPAP therapy modes, the REMstar Auto A-Flex HT incorporates several optional features to aid with patient comfort. These features include ramp, adjustable pressure relief (FLEX technologies), and humidification options include both a heated humidifier and heated tubing. The heated humidifier adjusts the level of humidification by varying the temperature of a heated plate used to heat up a chamber of water. Optional heated tubing can then be used to maintain that air at a desired temperature until it reaches the patient's mask. This is accomplished through a resistive-wire heating element embedded in the tubing wall.
The submission describes the REMstar Auto A-Flex HT, a CPAP system, and outlines verification activities performed to ensure its safety and effectiveness following modifications to include optional heated tubing. The study provided focuses on non-clinical tests to demonstrate substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Heated Tubing Performance | Meet product specifications through all Humidity Level settings. | "Heated Humidifier performance has been verified to meet product specifications through all Humidity Level settings." |
| Heated Tubing Controls and Indicators | Working as intended. | "The controls and indicators related to the Heated Tubing modification have been verified to be working as intended." |
| Heated Tubing Maximum Outlet Air Temperature | Not exceed 41°C. | "The maximum air temperature delivered to the patient has been verified to not exceed 41°C." |
| Heated Tubing Error Handling | Detect and respond to error conditions related to heated tubing functionality. | "The REMstar Auto A-Flex HT has been verified to detect and respond to error conditions related to the heated tubing functionality." |
| Heated Tubing Materials | Meet requirements of ISO 10993-1. | "Heated tubing materials used in the air flow path of the device have been verified to meet the requirements of ISO 10993-1 (Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process)." |
| Safety Evaluation | Meet requirements of IEC 60601-1. | "The REMstar Auto A-Flex HT has been designed to meet the requirements of IEC 60601-1 (Medical Electrical Equipment - General requirements for safety)" |
| Electromagnetic Compatibility | Meet requirements defined by FDA Reviewer Guidance (Nov 1993). | "The REMstar Auto A-Flex HT has been designed to meet the electromagnetic compatibility requirements as defined by the FDA Reviewer Guidance for Premarket Notification Submissions (Nov 1993)." |
| Mechanical Stress Testing | Meet requirements defined by FDA Reviewer Guidance (Nov 1993). | "The REMstar Auto A-Flex HT has been designed to meet mechanical stress requirements as defined by the FDA Reviewer Guidance for Premarket Notification Submissions (Nov 1993)." |
| Transportation Testing | Maintain functional performance post-shipping. | "Transportation tests were performed using the REMstar Auto A-Flex HT in all final packaging configurations. Functional tests were used to verify device performance post shipping." |
| Overall Safety and Effectiveness (for modifications) | No impact on the safety and effectiveness of the device. | "Respironics has determined that the modifications have no impact on the safety and effectiveness of the device." and "The REMstar Auto A-Flex HT has passed all of the aforementioned non-clinical tests and required no clinical tests in order to demonstrate safety or effectiveness. It is therefore concluded that the REMstar Auto A-Flex HT is substantially equivalent to the predicate device in terms of safety and effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance:
The provided document describes non-clinical verification activities rather than a traditional clinical study with a "test set" in the sense of patient data. The tests focus on device performance, materials, and compliance with standards.
- Sample Size for Test Set: Not applicable in the context of patient data. The "test sets" would refer to the physical devices and components subjected to engineering and safety tests. The specific number of units tested for each verification activity is not provided.
- Data Provenance: Not applicable in the context of patient data. The provenance for the testing is internal to the manufacturer (Respironics, Inc.), performing engineering, safety, and performance evaluations of the device modifications. The tests are "retrospective" in the sense that they assess the final design.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. The ground truth for these non-clinical tests is established by industry standards (e.g., ISO 10993-1, IEC 60601-1) and internal product specifications. The "experts" would be the engineers and regulatory affairs personnel at Respironics, Inc. responsible for designing the tests and evaluating the results against these pre-defined standards and specifications. Their specific number and qualifications are not detailed but are assumed to be appropriate for device development and regulatory submission.
4. Adjudication Method for the Test Set:
Not applicable in the context of expert adjudication. The "adjudication" for these non-clinical tests would involve assessing whether the device's performance meets the pre-defined acceptance criteria and standards. This is typically a pass/fail determination based on objective measurements and compliance documents, rather than human expert consensus on ambiguous data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical tests were not required to demonstrate the safety and effectiveness of the REMstar Auto A-Flex HT. Product functionality has been adequately assessed by non-clinical tests." Therefore, there is no effect size of human readers improving with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The device is a medical apparatus (CPAP system) that includes microprocessor-controlled functionality. The "standalone" performance refers to the device itself operating according to its design specifications. All the non-clinical tests described are evaluations of the device's standalone performance, including software, electrical, and mechanical aspects. There is no "algorithm only" context separate from the device for this type of product.
7. The Type of Ground Truth Used:
The ground truth used for these non-clinical tests is based on:
- Product Specifications: Internal technical requirements defined by Respironics, Inc. for the device's functionality and performance.
- International Standards: Recognized medical device standards such as ISO 10993-1 (Biological evaluation) and IEC 60601-1 (Electrical safety).
- FDA Guidance Documents: Guidance for Premarket Notification Submissions regarding electromagnetic compatibility and mechanical stress testing.
8. The Sample Size for the Training Set:
Not applicable. This submission describes verification of a modified physical device, not an AI/ML algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no training set for an AI/ML algorithm involved in this submission.
§ 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).