(26 days)
The Giraffe Incubator is an Infant Incubator. Incubators provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. They achieve this by providing an enclosed temperature controlled environment to the infant. This device may incorporate a Servo Controlled Oxygen Delivery System. This is indicated to provide a stable oxygen concentration within the infant compartment at the value set by the operator (21-65%).
The Giraffe Incubator is an 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 enclosed 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 optional Giraffe Servo Control Oxygen Delivery System is a fully integrated option available on the Giraffe Incubator. The Giraffe Servo Control Oxygen Delivery System is capable of oxygenating the entire infant compartment at oxygen concentrations of 21%-65% by volume. The device uses fuel cell type sensors that generate specific voltages depending on the oxygen concentrations they contact. The microprocessor stores the sensor output and compares it with the value corresponding to the concentration set by the operator. The valves that supply oxygen to the infant compartment are opened and closed as necessary to maintain the oxygen concentration at the set value. Fluctuations in fuel cell performance due to temperature and humidity are compensated for by the microprocessor.
The Giraffe and Panda Uninterruptible Power Supply (UPS) provides a short term source of electrical power to the Giraffe Incubator, thus aiding its intra hospital mobility. The Giraffe UPS does not change the indications for use, control mechanisms, operating principles, performance specifications, or other features of the Giraffe Incubator. The UPS serves as an extension to the Giraffe Incubator by providing uninterrupted electric power to the device. The UPS comprises a medical grade battery and a shelf.
When used with the UPS, the Giraffe Incubator is not intended for use as transport incubator or to be taken outside of the hospital building.
The proposed modification of the Giraffe Incubator is the addition of the Giraffe Shuttle accessory.
The Giraffe Incubator can be used with the Giraffe Shuttle, a mobile power source that allows for transport of the patient between care areas within the hospital building and provides power to the Incubator. These areas include, but are not limited to Labor and Delivery, NICU, Radiology, and Operating Room.
This eliminates the need to transfer the infant to and from a transport incubator for transport within the hospital building, reducing the potential for clinical problems associated with patient touch, handling and movement. This reduces the potential for clinical problems associated with intra-hospital transport that result from interrupted patient thermal regulation. .
Similarly to the UPS accessory, the Shuttle facilitates the mobility of the Giraffe Incubator within the hospital building. Giraffe Incubator when used with the UPS or with the Shuttle is not a transport incubator and is not intended to be used outside of the hospital building.
The Shuttle has two primary active functions: Locking to a bed and providing transportable power to the bed and accessories.
Attaching the Shuttle to a bed is accomplished by guiding the Shuttle between the legs of the bed and stepping on the Lock pedal. This effectively locks the Shuttle and bed together as one unit.
To detach the Shuttle from the bed, the locking arms are rotated back to their unlocked position by stepping on the Unlock pedal. Once unlocked, the Shuttle can be moved away from the bed.
The internal power source of the Shuttle consists of two 12 volt 42 amp hour lead acid batteries. The batteries are high capacity, sealed, no-maintenance batteries and are connected in series to provide a nominal 24 volts supply to the power generation module.
The Shuttle contains two sensor systems:
- One system detects an interference condition.
- The other system determines the attaching status of the device.
The Shuttle features an LED Display Board, which contains the battery runtime indicator and the battery health indicator.
This document is a 510(k) Premarket Notification Submission for a medical device called the "Giraffe Incubator" with the addition of a "Giraffe Shuttle" accessory. It's not a study that proves a device meets acceptance criteria, but rather a regulatory submission demonstrating substantial equivalence to a predicate device for marketing purposes.
Therefore, the information requested regarding acceptance criteria and a study proving performance is largely not applicable in the context of this document. This submission primarily focuses on design changes and compliance with voluntary standards to justify substantial equivalence.
However, I can extract what is provided:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria for specific performance metrics of the device as if it were a new, novel product being tested against defined performance goals. Instead, the submission describes the device's functions and states its compliance with voluntary standards.
The "reported device performance" is essentially that the modified device (Giraffe Incubator with Giraffe Shuttle) is considered as safe, effective, and substantially equivalent in performance to the legally marketed Giraffe Incubator.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable. No specific "test set" in the context of typical clinical or performance studies is described. The document refers to "Testing on unit level," "Integration testing," "Performance testing," and "Safety testing" but does not quantify the sample sizes of devices or patients used in these tests.
- Data Provenance: Not applicable. No clinical study data is presented.
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)
Not applicable. This submission is about a device modification and its regulatory equivalence, not a study requiring expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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 device is an incubator and accessory; it does not involve AI or human readers in the context of diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable.
8. The sample size for the training set
Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable.
Summary of Non-Clinical Tests (from the document):
The submission highlights several quality assurance measures and non-clinical tests applied to the development of the system to support substantial equivalence. These include:
- Risk Analysis
- Requirements Reviews
- Design Reviews
- Testing on unit level (Module verification)
- Integration testing (System verification)
- Performance testing (Verification)
- Safety testing (Verification)
- Usability testing (Validation)
- Biocompatibility testing
Clinical Tests:
The document explicitly states: "The subject of this premarket submission, Giraffe Incubator used with Shuttle, did not require clinical studies to support substantial equivalence."
Conclusion:
GE Healthcare considers the modified Giraffe Incubator, used with the Giraffe Shuttle accessory, to be as safe, as effective, and performance is substantially equivalent to the legally marketed Giraffe Incubator.
§ 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).