(115 days)
The intended use of the Invacare Pro Nebulizer and the Invacare Compact Nebulizer is to spray liquids in aerosol form into gases that are delivered directly to adult or pediatric patients who have been prescribed inhalation therapy or medication.
The Invacare Pro Nebulizer and Compact Nebulizer are indicated for use with any commercially available nebulizer and mouthpiece.
The Invacare Pro Nebulizer and Compact Nebulizer are intended for home health care use.
The intended use of the Invacare Portable Desktop Nebulizer is to spray liquids in aerosol form into gases that are delivered directly to adult or pediatric patients who have been prescribed inhalation therapy or medication.
The Invacare Portable Desktop Nebulizer is used exclusively with its own nebulizer and mouthpiece.
The Invacare Portable Desktop Nebulizer is intended for home health care use.
Invacare Pro Nebulizer: The Invacare Pro Nebulizer is a lightweight, self-contained basic aerosol compressor system intended to provide compressed air to a nebulizer mouthpiece. It is designed to operate with any commercially available, small volume disposable nebulizer mouthpiece. The Invacare Pro Nebulizer supplies pressurized air to the nebulizer mouthpiece. A small piston air compressor provides the compressed air necessary to drive the nebulizer. The Invacare Pro Nebulizer has a maximum output pressure of 39 psi. The maximum flow rate is 8.5 LPM and the operating flow rate is 4.8 LPM @ 16 psi. Air is drawn into the compressor through a filter and exits the unit through a barbed tubing connection. The compressor is kept cool by drawing air across the motor coil using an integral fan. A permanently attached mains power cord supplies AC power for the unit and power is controlled by the use of an ON/OFF switch. The motor incorporates a current/temperature overload protector, which opens the electrical circuit in the event of high current draw or high temperature in the motor winding. The casing for the unit is constructed of ABS flame retardant material.
Invacare Compact Nebulizer: The Invacare Compact is a smaller version of the Invacare Pro. It is a lightweight, self-contained basic aerosol compressor system intended to provide compressed air to a nebulizer's mouthpiece. It is designed to operate with any commercially available, small volume disposable nebulizer mouthpiece. The Invacare Compact Nebulizer supplies pressurized air to the nebulizer mouthpiece. A small piston air compressor provides the compressed air necessary to drive the nebulizer. It has a maximum output pressure of 33 psi. The maximum flow rate is 8 LPM and the operating flow rate is 4.0 LPM (@ 16 PSI. Air is drawn into the compressor through a filter and exits the unit through a barbed tubing connection. The compressor is kept cool by drawing air across the motor coil using an integral fan. A permanently attached mains power cord supplies AC power for the unit and power is controlled by the use of an ON/OFF switch. The motor incorporates a current/temperature overload protector, which opens the electrical circuit in the event of high current draw or high temperature in the motor winding. The casing for the unit is constructed of ABS flame retardant material.
Invacare Portable Desktop Nebulizer: The Invacare Portable Desktop Nebulizer system consists of a nebulizer and a DC powered piston-type compressor that generates compressed air. Small, lightweight and designed for convenience, the Invacare Portable Nebulizer device offers the user a choice of running off of AC power via a universal adapter or DC power via a 12 volt auto adapter or an optional rechargeable battery pack. The compressor unit consists of a motor driven piston compressor, printed circuit board and a switch. The circuit board does not incorporate a microprocessor, but serves as a means to prevent double feed of power. This is a safety feature that allows power draw from either the battery or the input adapter, but not both. There is a thermistor incorporated into the circuit board that provides protection by opening the electrical circuit in the event of high motor temperature. The circuit board is not part of the charging circuit for the battery pack. The unit has a maximum pressure of 36 psi and an operating pressure of 10 psi. The maximum flow rate is 5.2 LPM and the operating flow rate is 2.5 LPM @ 10 psi. The nebulizer mouthpiece employs a venturi effect to convert the medication into a fine aerosol mist. It is used with an extension tube. The nebulizer mouthpiece has a particle size range of ~ 5 microns and a capacity of 7 ml (cc). Providing a connection between the compressor outlet and the nebulizer mouthpiece bottom, the extension tube allows the compressor on a sturdy surface and to simply hold onto the nebulizer mouthpiece. The nebulizer mouthpiece is designed for single patient use, is reusable and intended to be used exclusively with the Invacare Portable Desktop Nebulizer. Use of the nebulizer mouthpiece, compressor or tubing with other compressors, nebulizer mouthpieces or tubing may produce incorrect flow resulting in improper treatment.
This document is a 510(k) premarket notification for three nebulizer devices (Invacare Pro, Invacare Compact, and Invacare Portable Desktop Nebulizer). It describes the devices, their intended use, and claims substantial equivalence to predicate devices. The document does not describe a study to prove acceptance criteria for a general AI/device system, but rather performance testing for mechanical nebulizer devices. Therefore, many of the requested fields are not applicable.
Here's an analysis based on the provided text:
Acceptance Criteria and Study for Nebulizers:
The document describes performance testing for the Invacare nebulizers to demonstrate their functionality according to specifications and safety standards. However, it does not explicitly define "acceptance criteria" in a tabular format as one might for a classification task or an AI device, as the document is for a mechanical medical device seeking 510(k) clearance based on substantial equivalence. Instead, it refers to performance specifications and standards.
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't provide a direct table of "acceptance criteria" versus "reported performance" in the context of an AI device. However, it states the following regarding the nebulizer's performance:
| Performance Metric/Standard | Reported Device Performance |
|---|---|
| Particle Size Testing | Performed according to specification; functioned as intended. |
| Flow/Pressure Testing | Flow characteristic graphed for each device sample; performed according to specification; functioned as intended. |
| Compressor Nebulization Rate Testing | Performed according to specification; functioned as intended. |
| Safety Standards Adherence | Designed and built in accordance with IEC 60601-1-2:2001, EN60601-1-1:1998, ISO 10993:1999, EN 13544:2001, UL 1431, UL 2601-1, applicable sections of IEC 801, CISPR 11 Class B, CSA 22.2 No.68, and FDA November 1993 Reviewer's Guidance for Respiratory Devices. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size (Test Set):
- For Compact and Pro Nebulizers: Three separate samples of each device.
- For Portable Desktop Nebulizer: Three separate samples of the device.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). This is typically not relevant for mechanical device performance testing of this nature. The testing appears to be conducted in-house by the manufacturer to demonstrate compliance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
- Not applicable. This document describes performance testing of mechanical nebulizer devices, not a study involving human interpretation of data where "ground truth" would be established by experts (e.g., radiologists for medical images). The "ground truth" for these tests are objective measurements against engineering specifications and international standards.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set:
- Not applicable. See point 3. This is not a study requiring adjudication of expert opinions.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If So, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:
- Not applicable. This document is for mechanical nebulizer devices, not an AI diagnostic or assistance system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
- Not applicable. See point 5.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
- Ground Truth: For this type of device, the "ground truth" is adherence to established engineering specifications and international performance standards (e.g., specific particle size distribution, flow rates, pressure outputs, nebulization rates, and electrical safety standards). Performance was measured objectively.
8. The Sample Size for the Training Set:
- Not applicable. This document describes performance testing for mechanical devices, not training an AI model.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. See point 8.
§ 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).