(64 days)
Incubators provide a controlled thermal environment for neonates who are unable to provide their own thermoregulation. They may also be used for short periods of time to facilitate the neonate's transition from the uterus to the external environment. Most incubators can be used in two operating modes:
- l. Air Control: The clinician sets the appropriate air temperature for maintaining the desired patient temperature. The air temperature is initially selected based on the clinician's training and experience and then is adjusted based on the patients needs and clinical status.
-
- Patient Control: The clinician sets the desired patient temperature. A skin temperature probe senses the patient temperature and feeds this information to the incubator. The controller then adjusts the heater output to maintain the patient temperature at the set value. These adjustments to the heater output are made in such a way to gradually change the patient's temperature while minimizing overshooting and patient stress.
Incubators have alarms to alert clinicians when certain patient or equipment conditions occur, such as a malfunction, or an excessive departure of the patient's temperature from the set value.
Incubators may incorporate other features, such as humidification of the infant environment, tilting of the bed, oxygen supply, and data output to remote monitors or nurse call systems.
- Patient Control: The clinician sets the desired patient temperature. A skin temperature probe senses the patient temperature and feeds this information to the incubator. The controller then adjusts the heater output to maintain the patient temperature at the set value. These adjustments to the heater output are made in such a way to gradually change the patient's temperature while minimizing overshooting and patient stress.
All functions of the modified Care Plus Incubator, with the exemption of the optional communications module, remain the same as in the predicate device. The current Care Plus Incubator includes an optional RS-232 communications module (ThermaLink) that interfaces with the SpaceLabs Flexport monitors or other monitors that adhere to the ThermaLink protocol. The communications module of the modified Care Plus Incubator will also be able to interface with the Hewlett Packard VueLink monitor using the Hewlett Packard proprietary protocol. This change does not affect the operation (displays, alarms, user's controls, etc.) of the incubator. The hardware and software of the incubator controller have not been changed. A microcontroller has been added to the communications module printed circuit board to (a) identify the connected monitor and (b) output data to the monitor using the applicable protocol.
This document describes a 510(k) summary for the Ohmeda - Ohio® Care Plus® Incubator. The modification is the addition of a communications module to interface with the Hewlett Packard VueLink monitor, in addition to existing compatibility with SpaceLabs Flexport monitors. The manufacturer explicitly states that no clinical or animal testing was performed.
Therefore, this submission does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way typically associated with diagnostic AI/ML devices. The relevant section from the provided text is:
"Since (1) care of newborns in incubators is a well established clinical practice and (2) the modification which is the subject of this submission does not affect the basic operation of the incubator , Ohmeda submits that clinical or animal testing to demonstrate safety and effectiveness is not necessary. The modified design will be verified by bench testing."
Given this statement, I cannot fill in the requested table and information as it would be applicable to a study demonstrating performance against acceptance criteria for a diagnostic device. The provided text indicates that:
- No clinical or animal testing was performed to demonstrate safety and effectiveness.
- The modification is related to a communications module and does not affect the basic operation of the incubator.
- Verification was done through bench testing.
Therefore, the following table and points will reflect the lack of such information in the provided document, based on the manufacturer's justification for not conducting clinical studies.
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified for clinical performance as per the 510(k) summary. The modification relates to a communication module, not core incubator function. | Not reported for clinical performance as per the 510(k) summary. Verification was stated to be "bench testing" for the modified design. |
Study Details (based on the provided 510(k) summary)
- Sample size used for the test set and the data provenance: Not applicable. No clinical test set or data provenance is mentioned as clinical or animal testing was deemed unnecessary.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set or ground truth established by experts is mentioned.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No clinical test set or adjudication method is mentioned.
- 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. No MRMC study was done, as clinical testing was not performed for this modification. The device is an incubator, not an AI diagnostic tool for human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is an incubator with a communication module, not a standalone diagnostic algorithm. No such performance study was described.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No clinical ground truth was established or used, as no clinical studies were performed.
- The sample size for the training set: Not applicable. No training set is mentioned as no clinical studies or AI algorithm development in this context were performed.
- How the ground truth for the training set was established: Not applicable. No training set or ground truth establishment is mentioned.
§ 880.5400 Neonatal incubator.
(a)
Identification. A neonatal incubator is a device consisting of a rigid boxlike enclosure in which an infant may be kept in a controlled environment for medical care. The device may include an AC-powered heater, a fan to circulate the warmed air, a container for water to add humidity, a control valve through which oxygen may be added, and access ports for nursing care.(b)
Classification. Class II (performance standards).