(326 days)
The SuperNOsY A™ Device is a mask that creates a seal when positioned over a patient's nose and mouth, or nose only, to direct anesthesia gas, air, and / or oxygen to the continum of anesthesia care. To be used under clinical supervision with adequate alarms and safety systems for monitoring and treatment of ventilatory failure.
The SuperNOsVA™ Device is intended for short-term (30 kg.) It is a single patient use, disposable.
The SuperNOsY A™ Device is contraindicated for use in long-term ventilation and treatment of sleep apnea.
The SuperNO>VA™ is a 2-piece construction with a nasal and an oral portion. When assembled together the oral portion is connected to the nasal portion (chamber) contains 2 one way (duck bill) valves which are normally closed until the oral chamber is connected. Then gas passes through each portion to the patient. If one desires to remove the oral chamber during a procedure which requires oral access, then gas can still be provided via the nasal portion. Depending upon the equipment and the clinician's desire one can provide non-invasive positive pressure ventilation as well.
This document (K163277) is a 510(k) summary for the SuperNO2VA™ Device, an anesthetic gas mask. It focuses on demonstrating substantial equivalence to a predicate device (K953107) rather than proving the device meets specific acceptance criteria based on a clinical study or AI performance metrics.
Therefore, the provided text does not contain the information necessary to answer the questions about acceptance criteria and a study proving a device meets those criteria, especially in the context of an AI/ML device study.
The document describes a medical device (an anesthetic gas mask) and its regulatory review for market clearance. It outlines:
- Device Name: SuperNO2VA™ Device
- Regulation Number: 21 CFR 868.5550 (Anesthetic Gas Mask, Class I)
- Indications for Use: Creating a seal over a patient's nose and mouth (or nose only) to direct anesthesia gas, air, and/or oxygen to the upper airway during anesthesia care. Also for short-term (30 kg), single patient use, disposable. Contraindicated for long-term ventilation and sleep apnea.
- Predicate Device: K953107 - Medical Marketing Concepts – Anesthesia Respiratory Face Mask
- Comparison to Predicate: A detailed table comparing features like product classification, indications for use, patient population, environment of use, duration of use, anatomical seal, components, and other features.
- Non-Clinical Testing Summary: Internal volume/dead space, resistance through connector, age and shelf-life, seal of duck-bill valves, drop testing, and biocompatibility testing. These are physical/performance tests of the mask itself, not a study evaluating diagnostic or prognostic capabilities (which would be relevant for an AI device).
- Biocompatibility Testing: Cytotoxicity, Sensitization, Irritation.
In summary, the provided document does not support answering the questions about acceptance criteria and study design for an AI/ML device. It pertains to the regulatory clearance of a physical medical device (anesthetic mask) based on substantial equivalence to a predicate, predominantly through non-clinical performance and material testing.
§ 868.5550 Anesthetic gas mask.
(a)
Identification. An anesthetic gas mask is a device, usually made of conductive rubber, that is positioned over a patient's nose or mouth to direct anesthetic gases to the upper airway.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.