(135 days)
The transport incubator is intended for use by personnel trained in neonatal care to facilitate the movements of neonates by air or ambulance.
The Aviator Transport Incubator with PulseOx (hereafter referred to as the transport incubator) maintains a thermally regulated environment to ar uc heat loss when transporting neonatal infants to hospitals prepared for neonatal infant care. The transport incubator maintains a thermally regulated environment with either externally supplied power or internal power supplied by a rechargeable battery. The transport incubator is also designed to offer interes of a rece oximetry and oxygen monitoring capability on the display panel. The transport incubator is also designed to carry equipment designed for life support and monitoring of the neonatal infant's status. The equipment includes but is not restricted to: hand and mechanical operated ventilator's; ventilator monitors; infusion pumps; patient monitors indicating blood pressure, respiration. electrocardiogram, oxygen saturation, pulse, etc.; suction pumps; axygen analyzers; air and oxygen cylinders; air compressors; etc. The integrate pulse oximeter feature is designed to use either Nellcor or Masimo technology. The Nellcor PulseOx model utilizes a daughter board or of Wiest cabling provided by Nellcor. The Masimo PulseOx model utilizes a daughter board and patient cabling provided by Masimo.
This document describes the Aviator Transport Incubator with PulseOx, a medical device, and its conformance to established performance standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| IEC 60601-1 (Medical Electrical Equipment, Part 1: General Requirements for Safety) | In compliance. Functional and design verification and validation testing conducted indicate compliance. |
| IEC 60601-1-2 (Medical Electrical Equipment, Part 1: General Requirements for Safety, Electromagnetic Compatibility-Requirements and Tests) | In compliance. Functional and design verification and validation testing conducted indicate compliance. |
| IEC 60601-2-20 (Medical Electrical Equipment, Part 2: Particular Requirements for Safety of Transport Incubators) | In compliance. Functional and design verification and validation testing conducted indicate compliance. |
| ISO 9919 (Medical Electrical Equipment Particular Requirements for the Basic Safety and Essential Performance of Pulse Oximeter Equipment for Medical Use) | In compliance. Functional and design verification and validation testing conducted indicate compliance. |
| ISO 21647 (Medical Electrical Equipment Particular Requirements for the Basic Safety and Essential Performance of Respiratory Gas Monitors) | In compliance. Functional and design verification and validation testing conducted indicate compliance. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size for a "test set" in the context of clinical or observational data. The testing mentioned is related to engineering and safety standards compliance. Therefore, no information on data provenance (country of origin, retrospective/prospective) is available because the document describes device safety and performance testing against industry standards, not a clinical study involving patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable and not provided in the document. The "ground truth" for the device's performance in this context is defined by the technical specifications and requirements outlined in the listed international consensus standards (IEC, ISO). Device performance is measured against these technical specifications, not against expert human consensus on clinical outcomes.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. Adjudication methods are typically used in studies involving expert review of clinical cases. The testing described here is focused on engineering validation and verification against predefined technical standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or described in this submission. The document focuses on the technical safety and performance of the device itself, not on how human readers or operators interact with or are augmented by the device's specific new feature (PulseOx).
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The device is a physical medical instrument (transport incubator) with integrated features, not a standalone AI algorithm. The performance testing described is for the device's functional and design verification and validation. Therefore, the concept of a "standalone algorithm" performance is not applicable. The PulseOx feature is integrated into the device and its performance would be assessed as part of the overall system.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by conformance to recognized international consensus standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-20, ISO 9919, ISO 21647). These standards specify safety, essential performance, and electromagnetic compatibility requirements for medical electrical equipment, particularly transport incubators and pulse oximeters/respiratory gas monitors.
8. The Sample Size for the Training Set
This information is not applicable and not provided. The device is a hardware product with integrated sensors (PulseOx). It is not described as utilizing a machine learning algorithm that requires a "training set" of data in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided for the reasons outlined in point 8. The device's functionality is based on established engineering principles and sensor technology, not on a machine learning model trained on a specific dataset.
§ 880.5410 Neonatal transport incubator.
(a)
Identification. A neonatal transport incubator is a device consisting of a portable rigid boxlike enclosure with insulated walls in which an infant may be kept in a controlled environment while being transported for medical care. The device may include straps to secure the infant, a battery-operated heater, an AC-powered battery charger, a fan to circulate the warmed air, a container for water to add humidity, and provision for a portable oxygen bottle.(b)
Classification. Class II (performance standards).