(27 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 Ohmeda Medical 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 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.
The provided text is a 510(k) summary for the Ohmeda Medical Giraffe Incubator, which is an infant incubator designed to provide thermal support for neonates. The document describes the device, its intended use, and the studies performed to demonstrate its safety and effectiveness.
Here’s a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission primarily focuses on the safety and performance of the Giraffe Incubator, particularly with the addition of the Uninterruptible Power Supply (UPS) option. The acceptance criteria and performance are outlined for the UPS battery life.
| Acceptance Criteria (Performance Specification) | Reported Device Performance |
|---|---|
| UPS battery life in nominal operating conditions (37°C, 70% RH) | 15 minutes |
| UPS battery life at worst-case operation condition (39°C, 95% RH) | 10 minutes |
| UPS battery life at worst-case operation condition with phototherapy accessory and all available lights on (39°C, 95% RH) | 7 minutes |
| UPS battery recharge time | 6 hours |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a numerical "sample size" in terms of a number of units tested for a specific performance metric. Instead, it states that the product was subjected to "extensive bench testing."
- Data Provenance: The testing was conducted in-house by GE Healthcare (Ohmeda Medical), a US-based company. The data is from retrospective bench testing. The document states, "The product was subject to extensive bench testing, the software was validated and, to the best of Ohmeda Medical's knowledge, the requirements of 21 CFR 820, Subpart C-Design Controls were satisfied."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Number of Experts: Not applicable. The "ground truth" for the performance specifications, specifically for the UPS battery life, was established through direct measurement during bench testing against predefined product specifications and consensus standards, not through expert consensus or clinical judgment.
- Qualifications of Experts: Not applicable for establishing ground truth as described above.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. Performance was measured directly against engineering specifications and consensus standards rather than requiring adjudication of subjective assessments.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, an MRMC comparative effectiveness study was not conducted. This device is an infant incubator, a life-support system where direct performance metrics (like temperature control, oxygen delivery, battery life) are assessed, not diagnostic interpretations by human readers. Therefore, the concept of "human readers improve with AI vs without AI" is not relevant to this device's evaluation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
- Standalone Study: Yes, in a sense, the primary evaluation was a standalone performance assessment of the device (including its optional Servo Control Oxygen Delivery System and UPS) based on its engineering design and mechanical/electrical functionality. The incubator's ability to maintain temperature and oxygen levels (algorithm-driven controls in the case of servo systems) and the UPS's battery life were evaluated directly and independently of human operational input for the performance metrics specified. The document states, "Performance of the Giraffe Incubator with the addition of UPS has been established by bench testing against product specifications and recognized consensus standards."
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth for this device's performance was based on product specifications and recognized consensus standards. This is an engineering and regulatory approach, where the device must meet quantifiable, pre-defined operational parameters. For example, battery life was measured to meet specific duration targets under various operational conditions.
8. The Sample Size for the Training Set
- Sample Size: Not applicable. The device is a physical medical device (infant incubator) with electro-mechanical systems. It does not employ machine learning or artificial intelligence in a way that requires a "training set" of data for an algorithm to learn from. Its control systems are based on established engineering principles and pre-programmed parameters, not a data-driven training process.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there was no training set in the context of machine learning. The "ground truth" for the device's design and control algorithms would be established through engineering design specifications, scientific principles, and regulatory requirements for medical device functionality and safety.
§ 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).