(85 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:
- 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 controller of 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.
The modified Care Plus Incubator is substantially equivalent to the currently marketed Care Plus Incubator.
The modifications which are the subject of this submission are summarized below:
a) Created two new models -- Care Plus 1000/2000 modified as follows:
i) The front control switch panel has been simplified to contain nonlanguage specific symbols with a legend located above the front panel which explain the meaning of these symbols.
ii) Twenty-three labels affixed to the current Care Plus have been consolidated into five labels.
iii) The tilt mechanism has been simplified to provide two (0° and 10°) rather than three (0°, 3°, and 6°) tilt positions. Continuous tilt is not an available option for these models
iv) The hood assembly (including the portholes, front access door, and inner walls) have been partially modified to improve access to the infant and reduce cost.
v) The refresher instructions located on the unit have been eliminated (a complete set of instructions continues to be provided in the Operation and Maintenance Manual), the refresher instructions continue to be provided with the Care Plus 3000 and 4000.
vi) The passive humidifier, standard in the Care Plus 3000, has been made an optional feature in these models. The servo-controlled humidifier, standard in the Care Plus 4000 is not an available option for these models
vii) The material of the optional humidifier tray has been changed from Polysulfone to polypropylene.
viii)The Care Plus 1000 can be operated in one mode (air control) only rather than in the two modes (air control and patient control) available in the other models.
b) Modified the printed circuit boards included in all models (1000, 2000, 3000, and 4000) to incorporate surface mount technology rather than the current through hole technology.
c) An optional, larger hood is available for Care Plus 3000 and 4000.
The provided text describes modifications to an infant incubator (Ohmeda - Ohio® Care Plus® Incubator) for a 510(k) submission. It explicitly states that clinical or animal testing to demonstrate safety and effectiveness was not necessary because the modifications did not change how treatment was administered and the care of newborns in incubators is a well-established clinical practice.
Therefore, the following information, typically associated with a medical device algorithm's performance study, is not available from the provided text:
- A table of acceptance criteria and reported device performance (for an algorithm)
- Sample sizes for test sets or training sets
- Data provenance (country of origin, retrospective/prospective)
- Number and qualifications of experts for ground truth
- Adjudication methods
- MRMC comparative effectiveness studies or effect sizes
- Standalone algorithm performance
- Types of ground truth
- How ground truth for training data was established
Instead, the text indicates that the device's acceptance was based on:
- Bench testing: Used to verify the design changes.
- User validation: Used to verify the labeling changes.
- Substantial equivalence: The primary mechanism for clearance, arguing that the modified device is substantially equivalent to a previously marketed device, as the technological changes (Surface Mount Technology PCBs) are mature and do not raise new safety or effectiveness concerns.
Summary of Acceptance and Performance Evidence Based on Provided Text:
| Acceptance Criteria (Implicit for 510(k)) | Reported Device Performance/Verification Method |
|---|---|
| Safety and Effectiveness of Modified Design (simplified control panel, tilt, hood, etc.) | Verified by Bench Testing: The design changes were assessed on the bench to ensure they met specifications and did not introduce new hazards or compromise existing functionality. The submission posits that these modifications "do not change the way in which treatment is being administered." |
| Clarity and Accuracy of Labeling (non-language specific symbols, consolidated labels) | User Validated: The changes to the device's labeling were reviewed and validated by users to ensure clarity and correct interpretation of the new symbols and consolidated information. |
| Safety and Effectiveness of Technological Change (SMT PCBs) | Substantial Equivalence Argument: The use of Surface Mount Technology (SMT) was argued to be a "very mature technology, widely used in most computer and other electronic equipment manufactured today" and thus "does not raise new issues of safety or effectiveness." This was accepted by the FDA for clearance. |
Study Details (Not Applicable/Information Not Provided in Text):
- Sample size for test set and data provenance: Not applicable as no clinical or animal testing was performed. Design changes verified by bench testing, labeling by user validation.
- Number of experts and qualifications: Not applicable.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. No human readers or AI involved in the performance assessment for this device submission.
- Standalone algorithm performance: Not applicable. This is a physical medical device (incubator), not an AI algorithm.
- Type of ground truth: Not applicable. Bench testing and user validation do not rely on "ground truth" in the same way an AI algorithm test does (e.g., expert consensus, pathology).
- Sample size for training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
§ 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).