(190 days)
The S9 VPAP Adapt is indicated for the treatment of patients weighing more than 66 lb (30 kg) with obstructive sleep apnea (OSA), central and/or mixed apneas, or periodic breathing. It is intended for home and hospital use.
S9 VPAP Adapt System (S9 VPAP Adapt with H5i) is similar to the predicate device(s), using a blower based positive pressure system with an integrated heater controller. The device platform is similar to the S8 Aspen with H4i Plus (K091947) and contains a Micro-processor controlled blower system that generates controlled positive airway pressure between 3-25 cmHzO as required to maintain an "air splint" for effective treatment of OSA. The system comprises the flow generator, patient interface) and humidifier.
The S9 VPAP Adapt is a flow generator device designed to provide adaptive servo-ventifation therapy (ASV) to stabilize a patient's ventilation during sleep. The device continually measures the patient's instantaneous ventilation, and calculates a target ventilation based on to the patient's recent average. It then adjusts the degree of pressure support to servo-control the patient's ventilation to at least equal the target ventilation. Therapy modes contained in the S9 VPAP Adapt are CPAP, CPAP with EPR, and Auto Servo Ventilation (ASV). Therapy modes come from the VPAP Tx system (K092186) and VPAP Adapt (K051364).
The functional characteristics of the S9 VPAP Adapt system includes all the dinician and user friendly features of the predicate devices.
The S9 VPAP Adapt is a non-continuous ventilator indicated for the treatment of patients weighing over 30 kg with obstructive sleep apnea (OSA), central and/or mixed apneas, or periodic breathing. It is intended for home and hospital use.
The provided document describes a 510(k) submission for the S9 VPAP Adapt, focusing on demonstrating substantial equivalence to predicate devices rather than a standalone clinical study with detailed performance metrics against specific acceptance criteria.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly provide a table of acceptance criteria with corresponding performance results for the S9 VPAP Adapt. Instead, it states that "All tests (predicate bench testing) confirmed the product met the predetermined acceptance criteria." However, specific quantitative criteria or performance values are not listed.
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "predicate bench testing and clinical studies" were used to show substantial equivalence. However, it does not provide any details regarding the sample size used for the test set or the data provenance (e.g., country of origin of the data, retrospective or prospective) for these studies.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
There is no information provided in the document about experts used to establish ground truth for any test set or their qualifications. The evaluation primarily relies on "predicate bench testing and clinical studies" for substantial equivalence.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method (e.g., 2+1, 3+1, none) for a test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study or any effect size of how much human readers improve with AI vs. without AI assistance. The S9 VPAP Adapt is described as a device that provides adaptive servo-ventilation therapy, not an AI-based diagnostic or assistive tool for human readers.
6. Standalone Performance Study (Algorithm Only)
While the device includes a "Micro-processor controlled blower system" and "adjusts the degree of pressure support to servo-control the patient's ventilation," the document does not describe a standalone performance study for an algorithm in isolation without human interaction. The device's operation is inherently integrated into a patient's breathing cycle.
7. Type of Ground Truth Used
The document does not explicitly state the type of ground truth used in the "clinical studies" mentioned. Given the nature of the device (ventilator for sleep apnea), it is most likely that ground truth would be established through polysomnography (PSG) or other objective measures of respiratory events and ventilation effectiveness, but this is not specified.
8. Sample Size for the Training Set
The document does not provide information on the sample size used for any training set.
9. How Ground Truth for the Training Set Was Established
The document does not provide information on how ground truth was established for any training set.
Summary of Evidence Regarding Acceptance Criteria and Studies:
The submission for the S9 VPAP Adapt focuses on demonstrating substantial equivalence to pre-existing predicate devices (VPAP Tx, S8 Aspen with H4i Plus, VPAP Adapt). The core argument for meeting acceptance criteria is that "All tests (predicate bench testing) confirmed the product met the predetermined acceptance criteria" and that "predicate bench testing and clinical studies were used to show substantial equivalence." However, the abstract does not provide the detailed quantitative acceptance criteria, the specific results against those criteria, or the methodology and sample sizes of the mentioned "clinical studies." The document primarily affirms that the new device has "not altered the safety and effectiveness of CPAP treatment" and complies with relevant FDA guidance documents.
§ 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).