(79 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 for 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 anable to provided 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. the ur temperature of the patient is obtained through the side portholes or by opening one of the side doors.
The optional Giraffe Servo Controlled Oxygen System is a fully integrated option available on the Giraffe I Incubator. The Servo Controlled Oxygen 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 specific volue and compares it with the value corresponding to the concentration set by the operator. The school output and compartment compartment are opened and closed as necessary to maintain the varves that suppy only goll w set value. Fluctuations in fuel cell performance due to temperature and humidity are compensated for by the microprocessor.
The provided document is a 510(k) summary for the Ohmeda Medical Giraffe® Incubator. It states that "clinical or animal testing to demonstrate safety and effectiveness is not necessary" because "care of newborns in incubators, with or without supplemental oxygen, is a well established clinical practice."
Therefore, the document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way typically associated with AI/ML device evaluations (e.g., performance metrics, ground truth, expert adjudication).
Instead, the submission relies on:
- Substantial equivalence to previously cleared predicate devices (Ohmeda Medical Giraffe Incubator (original), Drager Incubator 8000 IC, and Isolette Infant Incubator Model C2HS).
- Bench testing: "The product was subject to extensive bench testing." No specific details about the nature of this testing, acceptance criteria, or results are provided.
- Software validation: "the software was validated." No details about the validation methodology, criteria, or results are provided.
- Compliance with design controls: "the requirements of 21 CFR 820, Subpart C -- Design Controls - were satisfied." This refers to general quality system regulations, not specific performance criteria.
Given the nature of the device (an incubator) and the submission type (510(k) for a non-AI/ML device from 2002), the requested information categories (sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth for test/training sets, training set size, ground truth establishment for training set) are not applicable or not provided in this regulatory document.
§ 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).