(118 days)
The device is intended to provide ventilation for non-dependent, spontaneously breathing adult and pediatric patients (30 lb / 13 kg and above) with respiratory insufficiency or respiratory failure, with or without obstructive sleep apnea. The device is for non-invasive use, or invasive use (with the use of the ResMed Leak Valve). Operation of the device includes both stationary, such as in hospital or home, or mobile, such as wheelchair usage.
The Stellar 150 is a pressure controlled ventilator using a single limb vented circuit, product code MNT and is substantially equivalent to the already marketed Stellar 150 device (K103167). For both devices as they are substantial equivalent, it is essential that a microprocessor controlled blower generates the required airway pressure. CPAP and Bi-level modes are implemented. With ongoing technological progress, the device is further suitable to include a population above 30 lbs (13 kg) for CPAP and Bilevel modes. The device also includes a volume assured pressure support mode (iVAPS), indicated for patients above 66 lbs (30 kg). The Stellar 150 in combination with the new developed ResMed Leak Valve supports the invasive use therapy. The ResMed Leak Valve incorporates a leak port as well as an integrated anti-asphyxia valve.
The provided document describes a 510(k) submission for the ResMed Stellar 150 ventilator, focusing on a change in the indication for use to include invasive therapy with a new ResMed Leak Valve. The submission asserts substantial equivalence to a previously cleared device (K103167).
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Test | Reported Device Performance |
|---|---|
| For the Stellar 150 (existing device): | "Design and verification activities which were performed on the previously cleared Stellar 150 as a result of the risk analysis and product requirements remain still valid. All tests confirmed the product met the predetermined acceptance criteria." |
| For the ResMed Leak Valve (new component): | Performance tests comply with: |
- ISO 5356-1 Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets
- ASTM F 1246-91 Specification for Electrically Powered Home Care Ventilators, Part 1 - Positive-Pressure Ventilators and Ventilator Circuits |
| System Verification (Stellar 150 + Leak Valve): | "System verification testing was performed as well as bench testing. The side-by-side testing demonstrated that there is no significant difference in delivering invasive therapy using the new ResMed Leak Valve (leak port with integrated anti-asphyxia valve) and therefore the Stellar 150 is Substantially Equivalent to the predicate device."
"Performance and side-by-side testing demonstrated that there is no significant difference in [safety and effectiveness] between the ResMed Leak Valve and the new ResMed Leak Valve (leak port with integrated anti-asphyxia valve)." (likely a typo, intended to compare the new system to the predicate or non-invasive system) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document mentions "performance testing," "system verification testing," and "bench testing," but does not provide specific numbers of units tested, test runs, or patient data (as this appears to be a device performance and safety study, not a clinical trial with patient data).
- Data Provenance: Not explicitly stated. Given it's a submission for regulatory clearance of a medical device, the studies are typically conducted by the manufacturer (ResMed) in a controlled environment. The nature of the tests (bench and system verification) suggests laboratory-based testing rather than patient data from a specific country. This is retrospective in the sense that it relies on previously established performance for the core device and new testing for the new component.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- The document does not describe a ground truth established by human experts for a test set in the context of diagnostic accuracy. This submission is for a ventilator, and the performance criteria are based on engineering standards (ISO, ASTM) and functional comparisons, not expert interpretation of diagnostic output.
4. Adjudication Method for the Test Set
- Not applicable as there is no "test set" requiring expert adjudication in the context of diagnostic accuracy. The performance is assessed against engineering standards and functional equivalence.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, an MRMC comparative effectiveness study was not done. This is a regulatory submission for a continuous ventilator, not an AI-powered diagnostic tool. The concept of "human readers" and "AI assistance" is not relevant to this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This is not an algorithm-only device. The device itself (ventilator) operates as a standalone unit in delivering therapy. The performance tests described (ISO, ASTM, bench testing) are standalone in the sense that they evaluate the device's functional attributes, not human interaction with an algorithm's output.
7. The Type of Ground Truth Used
- The "ground truth" for the performance evaluation of the new ResMed Leak Valve and the combined system is based on:
- Engineering Standards: Compliance with ISO 5356-1 and ASTM F 1246-91.
- Functional Equivalence: Demonstrated "no significant difference" in delivering invasive therapy when compared side-by-side to the predicate device/system.
- Predetermined Acceptance Criteria: The core Stellar 150 device already met these from its prior clearance (K103167).
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for this device.
§ 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).