(161 days)
The transport incubator is a neonatal transport incubator. The incubator circulates warmed air at an operator selected, controlled temperature into a transparent chamber containing an infant. The structural integrity and weight of the incubator makes it suitable for ground and air transport. Auxiliary equipment for airway management and vital signs monitoring are not standard equipment. The system is to be operated by trained medical technical personnel.
The 185A+ Transport Incubator with PulseOx (hereafter referred to as the transport incubator) maintains a thermally regulated environment to prevent infant 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 integrated pulse 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; oxygen analyzers; air and oxygen cylinders; air compressors; etc.
The integrated pulse oximeter feature is designed to use either Nellcor or Masimo technology. The Nellcor PulseOx model utilizes a daughter board and patient cabling provided by Nellcor. The Masimo PulseOx model utilizes a daughter board and patient cabling provided by Masimo.
This document describes a Special 510(k) for a device modification, specifically the addition of PulseOx functionality to an existing transport incubator. The provided text, however, focuses on regulatory compliance and functional description rather than detailed performance studies with acceptance criteria, sample sizes, and ground truth establishment for a device leveraging AI/ML.
Therefore, many of the requested sections about acceptance criteria and study details cannot be fully populated as the document does not contain this type of information. It primarily indicates that performance testing for functional and design verification and validation was conducted in compliance with recognized consensus standards for medical electrical equipment and pulse oximetry.
Here's an attempt to extract and describe what information is available based on the request:
1. A table of acceptance criteria and the reported device performance
The document does not provide specific acceptance criteria or reported device performance metrics in a tabular format for the integrated PulseOx functionality. It states that "The testing indicates the incubator is in compliance with the following recognized consensus standards," implying that meeting the requirements of these standards serves as the acceptance criteria.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with IEC 60601-1 (General Safety) | Testing indicates compliance. |
| Compliance with IEC 60601-1-2 (EMC) | Testing indicates compliance. |
| Compliance with IEC 60601-2-20 (Transport Incubators) | Testing indicates compliance. |
| Compliance with ISO 9919 (Pulse Oximeter Equipment) | Testing indicates compliance. |
| Compliance with ISO 21647 (Respiratory Gas Monitors - though PulseOx is for oxygen saturation, not respiratory gas monitoring, this may be a typo or an overarching standard for respiratory-related measurements) | Testing indicates compliance. |
| Functional and design verification and validation | Conducted, indicating compliance with standards. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The submission focuses on regulatory compliance through standard adherence rather than a clinical performance study with defined test sets and data provenance for the PulseOx enhancement.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided as the document does not describe the establishment of a ground truth for a test set in the context of a clinical study or AI/ML evaluation. The evaluation is based on adherence to recognized engineering and safety standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. An adjudication method is typically relevant for studies involving human interpretation or subjective assessment, which is not described here for the PulseOx integration.
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
A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned and is not applicable here. The device is a hardware modification (adding PulseOx) to an incubator, not an AI/ML-driven diagnostic tool intended to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided and is not directly applicable. The PulseOx is an integrated measurement device, not an algorithm in the sense of AI/ML. Its performance would be evaluated as a standalone sensor system, which is implicitly covered by adherence to ISO 9919.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" as typically applied to image analysis, pathology, or outcomes data is not directly relevant or described in the context of this device modification. The "ground truth" for the PulseOx functionality would be established by reference to a gold standard measurement technique for oxygen saturation (e.g., arterial blood gas analysis in a clinical setting, or calibrated test equipment in a lab setting) as part of the validation for ISO 9919. However, the document does not detail how this was performed.
8. The sample size for the training set
This information is not provided. There is no mention of a "training set" as this device does not utilize machine learning or AI that would require such a set.
9. How the ground truth for the training set was established
This information is not provided and is not applicable, as there is no mention of a training set for machine learning.
§ 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).