(81 days)
The OmniBed 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 other 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%).
Giraffe OmniBed is an infant bed, which provides thermal support to infants who are unable to thermo-regulate based on their own physiology. The bed has two modes of operation, enclosed bed operation and open bed operation. In an open mode, the device functions as an incubator and in an enclosed mode it functions as a conventional, infant radiant warmer.
The Giraffe Uninterruptible Power Supply (UPS) is intended to provide a short term source of electrical power Giraffe OmniBed, 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 Omnibed.
The UPS serves as an extension to the Giraffe OmniBed by providing uninterrupted electric power to the device. The UPS comprises a medical grade battery and a shelf.
Here's an analysis of the provided text regarding the K071175 510(k) submission, focusing on acceptance criteria and the study proving device performance:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Battery life | 15 minutes at 37°C and 70% RH at steady state |
| Battery recharge time | 6 hours |
| Alarm decibel level reduction when UPS is added | Less than 1 dB reduction |
| Minimum lower level of alarm decibel (as per IEC 601-2-21 Amend 1 clause 102.1 and IEC-601-2-19 Amend 1 clause 102.3) | Within (or above) the minimum lower level of 50dB |
| Performance of OmniBed with UPS against product specifications and consensus standards | Established by bench testing (implicitly met, as no failures are reported) |
2. Sample Size Used for the Test Set and Data Provenance
This submission does not involve a "test set" in the context of AI/ML or clinical efficacy studies with patient data. The performance claims are related to the functional characteristics of a new accessory (UPS) for an existing medical device (Giraffe OmniBed).
- Sample Size: Not applicable in the traditional sense of patient or image data. The testing was conducted on the Giraffe OmniBed device with the addition of the UPS.
- Data Provenance: The 'data' are results from bench testing performed on the physical device in a controlled environment. There is no information regarding the country of origin, but generally, such testing would be conducted at the manufacturer's facilities. The testing is prospective in the sense that it's designed to evaluate a new component.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth for clinical outcomes or image interpretation is not relevant for this type of device modification. The performance criteria are objective engineering specifications (e.g., battery life, decibel levels).
4. Adjudication Method for the Test Set
Not applicable. There are no subjective assessments or disagreements to adjudicate.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs without AI assistance
Not applicable. This device is an infant incubator/warmer with an uninterruptible power supply, not an AI-powered diagnostic tool. Hence, no MRMC study was conducted or is relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an algorithm, but a hardware accessory.
7. The Type of Ground Truth Used
The ground truth used for this submission is based on objective engineering and performance specifications derived from:
- Product specifications of the Giraffe OmniBed and the new UPS.
- Recognized consensus standards (specifically mentioning IEC 601-2-21 Amend 1 clause 102.1 and IEC-601-2-19 Amend 1 clause 102.3 related to alarm decibel levels).
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set mentioned or implied in this 510(k) submission.
§ 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).