(114 days)
The Giraffe OmniBed Carestation is a combination of an infant incubator and an infant warmer. The device can be operated as an incubator or as a warmer and can transition from one mode to the on user's demand. It cannot be operated in both modes at the same time. Incubators and warmers provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology.
Incubators provide an enclosed, temperature-controlled environment and warmers provide infrared heat in an open environment. They may also be used for short periods of time to facilitate the neonate's transition from the uterus to the external environment.
This device may incorporate a Servo Controlled Oxygen Delivery System. This is indicated to provide stable oxygen concentration within the infant compartment at the value set by the operator (21-65%).
The Giraffe Incubator Carestation is an enclosed infant bed, which provides thermal support for infants who are unable to provide for their own heat requirements. The device maintains the infant's temperature by circulating heated air within the closed bed compartment. The operator may select either the air or skin temperature control method. Depending on the control method selected, heat is regulated based on either the air temperature or the infant's skin temperature compared to the operator selected control temperature. Physical access to the patient is obtained through the side portholes or by opening one of the side doors. The Giraffe Incubator Carestation has a color touchscreen user interface (UI) and includes a Hands-Free Alarm Silence (HFAS) feature. The incubator includes a mattress for patient comfort. The Giraffe Incubator Carestation incorporates an optional weighing scale, Servo O2, Uninterruptible Power Supply (UPS) & Shuttle, Mounting Accessories Rail and Shelves and Storage drawers.
The provided document describes the Giraffe Incubator Carestation CS1, a medical device. The submission focuses on modifications to the porthole and wall latches of an existing predicate device (K152809). The document does not describe the device's main performance in terms of medical outcomes but rather the safety and functionality of the latch modifications.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of numerical acceptance criteria for the overall medical device performance (e.g., temperature control accuracy, humidity control). Instead, it focuses on demonstrating that the modified latch mechanisms continue to meet existing safety and performance standards, and that their functionality is equivalent or improved compared to the predicate without introducing new risks.
However, the document lists system performance specifications that are identical to the predicate device, implying these are the baseline acceptance criteria for the overall incubator function. For the latch modifications, the acceptance criteria are demonstrated through successful completion of various tests.
Acceptance Criteria (Implied from "Identical" or "Meets all performance and standards requirements") and Reported Performance for the General Device:
| Characteristic | Acceptance Criteria (from Predicate Device K152809) | Reported Device Performance (Proposed Device) |
|---|---|---|
| Temp Control Accuracy | ± 1.0℃ (Control Temp vs. Avg. Incubator Temp) | Identical to Predicate |
| Temp Variability | ± 0.5℃ (Incubator Temp vs. Avg. Incubator Temp) | Identical to Predicate |
| Warm-up time | 12 hours | Identical to Predicate |
| Porthole Latch Action | User action: Press to open. Push to close. | User action: Rotate to open. Turn to close. |
| Wall Latch Function | Two latches, one latching point, pinch to open. | North side latches: Two latching points (primary and secondary), pinch to open. South side unchanged. |
| Latch Functionality | Ensure proper securing of panels, allow operation, meet performance and standards (IEC 60601-2-19 Clause 201.9.8.3.101) | Meets all performance and standards requirements. |
| Usability | No new risks or use-related issues. | No findings from summative usability testing that led to changes or new risks. |
2. Sample size used for the test set and the data provenance
The document describes non-clinical testing which includes various functional and reliability bench tests for the modified latches, as well as summative usability testing.
- Test Set Sample Size: The document does not specify a numerical sample size for the bench tests (e.g., number of latches tested, number of cycles for reliability). It lists the types of tests performed. For the "Summative Usability Testing," the sample size of participants is not provided.
- Data Provenance: The testing appears to be prospective and conducted by GE Healthcare (the submitter) in their own labs, as part of their quality system. The country of origin of the data is not explicitly stated but can be inferred to be internally generated by the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not specified for the bench tests. For the "Summative Usability Testing," the number of participants is not provided, and whether these participants are considered "experts" (e.g., clinicians) or typical end-users is not detailed.
- Qualifications of Experts: Not specified.
4. Adjudication method for the test set
Not applicable. This is not a study requiring adjudication of expert opinions (e.g., for image interpretation). The testing involves physical and functional evaluation against established standards and internal quality criteria. For usability, the findings are reported, implying evaluation against predefined usability metrics and safety outcomes.
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 submission is for an infant incubator with modified latches, not an AI-powered diagnostic or interpretive device. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device does not have an "algorithm only" component that would require standalone performance evaluation typical of AI/ML software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the latch modifications, the "ground truth" is defined by:
- Compliance with Voluntary Standards: IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-19.
- Engineering Specifications: Internal design requirements for load, torque, cycles, and physical dimensions that ensure safety and functionality.
- Risk Analysis: Identification and mitigation of potential risks associated with the changes.
- Usability Objectives: Ensuring the modified latches do not introduce new use errors or significantly alter the user experience negatively.
8. The sample size for the training set
- Not applicable. This device submission does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
- Not applicable. As there is no training set mentioned or relevant for this device, there is no ground truth established for one.
§ 880.5130 Infant radiant warmer.
(a)
Identification. The infant radiant warmer is a device consisting of an infrared heating element intended to be placed over an infant to maintain the infant's body temperature by means of radiant heat. The device may also contain a temperature monitoring sensor, a heat output control mechanism, and an alarm system (infant temperature, manual mode if present, and failure alarms) to alert operators of a temperature condition over or under the set temperature, manual mode time limits, and device component failure, respectively. The device may be placed over a pediatric hospital bed or it may be built into the bed as a complete unit.(b)
Classification. Class II (Special Controls):(1) The Association for the Advancement of Medical Instrumentation (AAMI) Voluntary Standard for the Infant Radiant Warmer;
(2) A prescription statement in accordance with § 801.109 of this chapter (restricted to use by or upon the order of qualified practitioners as determined by the States); and
(3) Labeling for use only in health care facilities and only by persons with specific training and experience in the use of the device.