(184 days)
The 800 Series EasyNeb is designed to deliver aerosol medications to mechanically-ventilated patients. It is intended for use with the Puritan Bennett Model 840 Ventilator System operating in continuous mode in ventilation (not anesthetic) breathing circuits only.
The intended patient population includes neonatal, pediatric and adult patients (tidal volume 0.005 - 2 L) who require continuous respiratory support and nebulized medication.
The 800 Series EasyNeb is intended for use in hospitals and institutions that provide care for patients requiring respiratory support. The Model 840 Ventilator System may be used for transport within the hospital or other facility. It s intended for sale by or on the order of a physician, intended for operation by qualified clinicians only, and not to be used in the presence of flammable anesthetics.
The 800 Series EasyNeb is intended to serve as an accessory to the Puritan Bennett Model 840 Ventilator to provide nebulization of medications.
The 800 Series EasyNeb is an ultrasonic nebulizer that is designed to deliver aerosol medications to patients being mechanically ventilated. It is powered by a 24V DC power supply and controlled by a mechanical timer. It contains a piezoelectric crystal that generates ultrasonic waves which are transmitted through buffer water to a medication cup and which convert the liquid medication into an aerosol. The nebulizer medication cup is designed for single-patient use and holds up to 10 mL of medication.
The provided text does not contain information about acceptance criteria or a study proving that an AI device meets acceptance criteria. The document is a 510(k) summary for a medical device called the "800 Series EasyNeb Nebulizer," which is an ultrasonic nebulizer designed to deliver aerosol medications to mechanically-ventilated patients.
The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (the 700 Series Ventilator incorporating the EasyNeb Nebulizer, K990897). It describes the device, its intended use, and the modifications compared to the predicate device. The text mentions that "Environmental testing was conducted per internal company requirements using FDA's Reviewer Guidance for Premarket Notification Submissions, Nov. 1993 draft as a guideline" and that the device design and testing are compliant with various voluntary, international standards. It concludes that "The combined testing and analysis of results provide assurance that the device meets its specifications and is safe and effective for its intended use."
However, this is a traditional medical device, not an AI device, and the document does not include the detailed performance study information requested (e.g., acceptance criteria table, sample size for test/training sets, ground truth establishment, expert qualifications, MRMC study, or standalone algorithm performance).
§ 868.5630 Nebulizer.
(a)
Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.(b)
Classification. Class II (performance standards).