(109 days)
The VPAP III ST-A system is intended to provide non-invasive ventilation for adult patients (>66 Ibs) and pediatric patients aged 7 years or older (>40 lbs) with respiratory insufficiency or obstructive sleep apnea (OSA). The device is intended for use in the hospital or home.
The VPAP III ST-A is a flow-cycled, pressure-limited ventilator. A blower assembly generates airway pressure. A flow sensor and a pressure sensor in the patient airway feed data on measured flow and pressure into a microprocessor controller, which in turn regulates the blower assembly. The device constantly adjusts air flow to maintain pressure and breath synchronisation, can deliver an operating pressure up to 30cmH2O, and compensates for pressure drop in air tubing. A user interface displays clinical data and enables the operator to set and adjust certain clinical parameters.
The VPAP III ST-A provides a mode of non-invasive positive pressure ventilation (NPPV) called Pressure Support with PEEP, which delivers two treatment pressures (bi-level ventilation). A higher pressure is applied when the patient inhales - IPAP or inspiratory positive airway pressure, and a lower pressure is applied when the patient exhales - EPAP or expiratory positive airway pressure, sometimes referred to as PEEP or positive end-expiratory pressure. The difference between the two treatment pressures represents the amount of pressure support provided to the patient. The VPAP III ST-A has a CPAP mode in which a fixed pressure is delivered, and three bi-level operating modes which determine how the changes between IPAP and EPAP pressures are made: Spontaneous, Spontaneous/Timed and Timed. Patients indicated for Obstructive Sleep Apnea (OSA) are treated through the device providing a splint to keep the airway open, whilst patients indicated for respiratory insufficiency are treating through the device providing breathing assistance through pressure support. The VPAP III ST-A is fitted with alarms to alert the user to changes that will affect the treatment. Some of the alarms are pre-set (fixed), others are user adjustable.
The addition of the Mirage Micro for Kidz Mask provides an additional mask option for pediatric users. The small sized frame and cushion and the small size headgear from the previously cleared Mirage Micro (K072940) has been adopted as the standard configuration for the Mirage Micro for Kidz Mask, to meet the requirements of the pediatric population. The Mirage Micro for Kidz Mask provides therapy through the nose only. The Mirage Micro for Kidz Mask comprises a mask frame and elbow with integrated exhaust vent, mask cushion and laminated headgear. The anthopometric profile of the Mirage Micro for Kidz Mask matches that of the Kidsta Mask cleared in K060105. The patient exposure materials used in the device are predicate materials.
The provided text describes a 510(k) submission for a non-continuous ventilator, the VPAP III ST-A, with an additional pediatric mask. The submission focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than presenting a de novo study with detailed acceptance criteria and performance data for a new device.
Therefore, the requested information about acceptance criteria, specific device performance metrics, sample sizes, expert involvement, and ground truth establishment from a clinical or performance study is not available in the provided text, as this type of submission relies on demonstrating equivalence to existing cleared devices.
However, I can extract what is explicitly stated regarding the compatibility assessment for the new pediatric mask and the general statement about meeting acceptance criteria:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that a compatibility assessment of the Mirage Micro for Kidz Mask with the VPAP III ST-A was performed. This assessment included:
| Acceptance Criteria Category | Reported Device Performance (as stated in the document) |
|---|---|
| Mask Pressure & Flow Characterization | "All testing met the predetermined acceptance criteria." |
| Functional Deadspace & CO2 Flushing | "All testing met the predetermined acceptance criteria." |
| Anthropometric Analysis | "The anthropometric profile of the Mirage Micro for Kidz Mask matches that of the Kidsta Mask cleared in K060105." |
| Pressure Performance (VPAP III ST-A) | "Existing device testing ... remained valid." |
| Triggering & Cycling (VPAP III ST-A) | "Existing device testing ... remained valid." |
| Alarm Performance (VPAP III ST-A) | "Existing device testing ... remained valid." |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify sample sizes for any of the tests conducted for the compatibility assessment. It also doesn't provide data provenance in terms of country of origin or whether the data was retrospective or prospective. The testing appears to be in-house engineering and functional testing rather than clinical trials.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
The document does not mention the use of experts to establish "ground truth" in the context of clinical interpretation or diagnosis for the reported compatibility assessment. The assessment focuses on engineering and functional performance.
4. Adjudication Method for the Test Set:
No adjudication method is mentioned, as the testing described is primarily focused on meeting technical specifications and demonstrating equivalence rather than interpreting clinical outcomes.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No MRMC comparative effectiveness study is mentioned. The submission is for a ventilator system, and the focus is on the device's functional equivalence and safety, not on human reader performance with or without AI assistance.
6. If a Standalone Performance Study Was Done:
The document indicates that compatibility assessment was performed for the new mask, and existing device testing for the VPAP III ST-A (pressure performance, triggering & cycling, and alarm performance) was considered valid. This implies standalone testing of the mask's characteristics (pressure & flow, deadspace, CO2 flushing) was done as part of the compatibility assessment. However, "standalone" in the context of an algorithm or AI is not applicable here.
7. The Type of Ground Truth Used:
For the compatibility assessment, the "ground truth" would be the predetermined engineering specifications, safety standards, and functional requirements for respiratory devices and masks, as well as the characteristics of the predicate devices (K060105 and K072940). For anthropometric analysis, the ground truth was the "profile of the Kidsta Mask cleared in K060105."
8. The Sample Size for the Training Set:
This information is not applicable. The device is a hardware ventilator with an additional mask. There is no mention of a "training set" in the context of machine learning or AI models. The design and testing are based on engineering principles and regulatory standards.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the reasons stated 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).