(146 days)
The S9 WANDA VPAP ST is indicated for the treatment of Obstructive Sleep Apnea (OSA) in patients weighing more than 66 lb (30 kg). It is intended for use in the hospital and home.
S9 WANDA VPAP ST System is similar to the predicate device (S9 VPAP ST (K102513)). Key features include: inline power supply; integrated humidifier; tubing; colour LCD; and simple controls. The S9 WANDA VPAP ST contains a Micro-processor controlled blower system that generates Continuous Positive Airway Pressure (CPAP) from 3-25 cmHzO as required to maintain an "air splint" for treatment of OSA. The system comprises the flow generator, patient tubing, mask (patient interface) and humidifier. The S9 WANDA VPAP ST flow generator includes the same therapy modes as the S9 VPAP ST system (K102513) predicate device. These base therapy modes include: CPAP and CPAP with expiratory pressure relief (EPR) modes the device delivers a continuous positive airway pressure throughout the therapy session Bilevel mode the flow generator augments any breath initiated by the patient by detecting the onset of inspiration or expiration and delivering the set Inspiratory Positive Airway Pressure (IPAP) and Expiratory Positive Airway Pressure (EPAP) VAuto mode - the mean air-way pressure (between IPAP and EPAP) will alter based upon breathing events The functional characteristics of the S9 WANDA VPAP ST system includes all the clinician and user friendly features of the predicate device which have been verified during usability studies in accordance with IEC 62366 Medical devices - Application of usability engineering to medical devices.
Acceptance Criteria and Study for S9 WANDA VPAP ST
The submission for the S9 WANDA VPAP ST primarily relied on bench testing to demonstrate substantial equivalence to its predicate device, the S9 VPAP ST (K102513). Therefore, the "acceptance criteria" discussed below primarily refer to the performance standards met during these bench tests, which were deemed sufficient to prove a similar level of safety and effectiveness to the predicate. No clinical studies are mentioned.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a formal "acceptance criteria" table with specific quantitative thresholds for each test. Instead, it states that "All tests confirmed the product met the predetermined acceptance criteria" and that these criteria were "traced to the S9 WANDA VPAP ST System Specification and to the predicate device's performance."
However, the "Characteristics (differences) between predicate and new device" and "Flow Generator comparison" sections provide some comparative performance data, which can be interpreted as demonstrating the device's fulfillment of implied acceptance criteria based on equivalence to the predicate.
| Characteristic | Predicate S9 VPAP ST (K102513) Performance | S9 WANDA VPAP ST Performance | Acceptance Criteria (Implied) | Met/Not Met (as per document) |
|---|---|---|---|---|
| Intended Use | Treatment of Obstructive Sleep Apnea (OSA) in patients weighing > 66 lb (30 kg), for hospital and home use. | Treatment of Obstructive Sleep Apnea (OSA) in patients weighing > 66 lb (30 kg), for hospital and home use. | Equivalent to Predicate | Met (Explicitly stated "Equivalent") |
| Operating System/Controller | Micrium uC/OS-II Software/digital | Microchip: STM32F405ZG micro-controller with ARM 32-bit Cortex™-M4 CPU Software/digital | Updated micro in line with latest technologies appropriate for processing power needed, maintaining functional equivalence. | Met (Explicitly stated "Equivalent") |
| Flow Generator Weight | 1.7 lb | 2.5 lb | Biologically Equivalent (accounts for integrated humidifier) | Met (Explicitly stated "Equivalent") |
| Dimensions H x W x D (inches) | Flow generator unit: 3.4 x 5.5 x 6.0 | Flow generator unit: 4.5 x 9.6 x 6.0 | Biologically Equivalent (accounts for integrated humidifier, larger width) | Met (Explicitly stated "Equivalent") |
| Data Transfer Medium | SD Card | SD Card, Wireless | Equivalent to Predicate (Wireless data transfer equivalent to EasyCare Online (K132371)) | Met (Explicitly stated "Equivalent") |
| Humidifier Output (for > 8 hours) | 12.7 mg/L @ 20cm H2O (50 L/min) | 12.0 mg/L @ 20cm H2O (50 L/min) | Not clinically significant difference compared to predicate. | Met (Explicitly stated "The difference is not clinically significant and acceptance criteria was met (refer to bench testing (section 18)).") |
| Pressure Stability | Not explicitly quantified but implied performance of predicate. | Demonstrated in bench testing. | Equivalent to Predicate | Met (Stated "This performance testing demonstrate successful implementation of therapy modes into the S9 WANDA VPAP ST") |
| Response to Apneas | Not explicitly quantified but implied performance of predicate. | Demonstrated in bench testing. | Equivalent to Predicate | Met (Stated "This performance testing demonstrate successful implementation of therapy modes into the S9 WANDA VPAP ST") |
| Response to Flow Limitations & Snore | Not explicitly quantified but implied performance of predicate. | Demonstrated in bench testing. | Equivalent to Predicate | Met (Stated "This performance testing demonstrate successful implementation of therapy modes into the S9 WANDA VPAP ST") |
| Reporting of Closed Airway Detection (CAD) | Not explicitly quantified but implied performance of predicate. | Demonstrated in bench testing. | Equivalent to Predicate | Met (Stated "This performance testing demonstrate successful implementation of therapy modes into the S9 WANDA VPAP ST") |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable as no human-subject clinical test set was used. The study relied on bench testing using a "breathing machine" and the device itself.
- Data Provenance: The bench testing was performed by ResMed Ltd., an Australian company. The testing is therefore attributed to the manufacturer's internal testing procedures. The data would be considered prospective in relation to the submission, as it was specifically generated for the purpose of demonstrating substantial equivalence.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: Not applicable. The "ground truth" for the bench testing was established by comparing the S9 WANDA VPAP ST's performance to the "S9 WANDA VPAP ST System Specification" and the "predicate device's performance." These are engineering specifications and previously established performance metrics, not expert human interpretations of data.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There was no human "test set" requiring adjudication. The assessment was based on objective measurements against engineering specifications and comparison to the predicate device's measured performance during bench testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. The submission explicitly states "Bench testing alone is sufficient to demonstrate Substantial Equivalence."
- Effect Size of Human Readers with/without AI Assistance: Not applicable, as no human-in-the-loop study with AI assistance was conducted.
6. Standalone (Algorithm Only) Performance Study
- Standalone Study: Yes, in a sense. The "bench testing" represents a standalone performance evaluation of the device's algorithms and hardware without a human operator directly influencing its core therapeutic function during the test. The "breathing machine" simulates patient input, and the device's response is objectively measured. This is not "algorithm only" in the modern sense of a software-as-a-medical-device (SaMD) study, but rather the performance of the integrated device's therapeutic functions.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth for the bench testing was based on:
- Engineering Specifications: The S9 WANDA VPAP ST System Specification defined the expected performance.
- Predicate Device Performance: Direct comparison to the measured performance of the legally marketed S9 VPAP ST (K102513) further served as a "ground truth" for demonstrating equivalence. This is an objective, measured ground truth.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is a hardware-based medical device with integrated software that controls its mechanical functions (like pressure generation and response to breathing patterns). It does not employ machine learning or AI models that require a separate "training set" of data in the way modern AI/ML devices do. The software development likely involved traditional engineering verification and validation.
9. How Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable, as there was no training set in the context of machine learning. The device's operational parameters and control logic were developed through engineering design process, adhering to established medical device standards (e.g., IEC 60601-1, IEC 62304) and based on the predicate device's proven functionality.
§ 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).