(104 days)
Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonate's transition to the external environment or to provide a controlled open environment. An optional integrated SpO2 monitoring feature may be used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor). An optional integrated resuscitation system may be used to provide the basic equipment required for pulmonary resuscitation of infants. Pulmonary resuscitation includes practices necessary to establish a clear airway and provide oxygen or air/oxygen mixtures and/or manual ventilation to the infant.
The Giraffe and Panda Warmers are devices with a radiant heating source intended to maintain the thermal balance of an infant patient by direct radiation of energy in the infrared region of the electromagnetic spectrum. The warmers operate similarly to warmers currently in use in hospitals. Radiant heat from an infrared heat source is focused onto the bed to warm the patient. The operator may select either the heater power or skin temperature control method. Depending on the control method selected, the heater is either regulated at the operator selected power level or the heater output is modulated to maintain the patient's temperature at the value selected by the operator. Infant radiant warmers are also used to provide thermal support during surgical procedures and during procedures such as extracorporeal membrane oxygenation, resuscitation, or other procedures requiring open access and thermal support. The units also feature optional integrated SpO2 and Resuscitation modules. The Resuscitation Module may feature either a traditional bag-and-mask technology or a T-piece technology. Both the SpO2 module and the Resuscitation Modules use existing technology. The Giraffe and Panda Warmers can be used with the Giraffe Shuttle and UPS, a mobile power source that allows for transport of the patient between care areas within the hospital building and provides power to the Warmers.
The provided GE Healthcare 510(k) Premarket Notification Submission (K123309) describes modifications to existing Giraffe and Panda Warmers, specifically introducing Freestanding and Wall Mount configurations. However, the document explicitly states that clinical studies were not required to support substantial equivalence for these modifications. Therefore, the submission does not contain information about acceptance criteria or a study proving the device meets them in the context of clinical performance or diagnostic efficacy.
The submission focuses on engineering verification and validation (non-clinical tests) to demonstrate that the modified warmers maintain the same safety and effectiveness as the predicate devices.
Here's a breakdown of the requested information based on the provided text, highlighting what is available and what is explicitly not available or applicable:
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A table of acceptance criteria and the reported device performance
No such table is provided in the document for clinical performance. The document describes several non-clinical quality assurance measures and testing but does not detail specific acceptance criteria or performance metrics in a table format for clinical use.
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The document states: "The subject of this premarket submission... did not require clinical studies to support substantial equivalence." Therefore, there was no clinical test set with a specific sample size or data provenance.
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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. As no clinical studies were performed, there was no ground truth to establish for a clinical test set by experts.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As no clinical studies were performed, there was no test set requiring adjudication.
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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 infant radiant warmer, not an AI-assisted diagnostic tool for human readers. No MRMC study was performed.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable in the context of diagnostic AI. The device features an "patient temperature control algorithm previously cleared per 510(k) K090697." The software changes involved scaling heater power and adopting this existing proportional heater control algorithm. The performance of this control algorithm was likely validated during the original 510(k) for the Giraffe and Panda Warmer (K090697) through engineering tests, but not as a "standalone diagnostic algorithm."
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable for clinical ground truth. For the engineering validation of the device (non-clinical tests), the ground truth largely relies on compliance with voluntary standards, design specifications, and safety requirements (e.g., surface touch temperatures at maximum altitude, maximum ambient operating temperature, bed surface height).
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The sample size for the training set
Not applicable. As no AI/machine learning model for clinical/diagnostic use is being described, there is no training set in that context. The "software changes" mentioned relate to control algorithms for heater power, which are typically derived from engineering principles and validated through testing, not "trained" on data in the AI sense.
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How the ground truth for the training set was established
Not applicable, as there is no training set in the AI/machine learning context described in this document.
Summary of Non-Clinical Tests (from the document):
The device underwent the following non-clinical tests to demonstrate substantial equivalence:
- Risk Analysis
- Design Reviews
- Testing on unit level (Module verification)
- Integration testing (System verification)
- Performance testing (Verification)
- Safety testing (Verification)
- Simulated use testing (Validation)
These tests evaluate the device's compliance with engineering specifications, safety standards, and functional performance, but they are not clinical studies designed to establish diagnostic accuracy or compare human reader performance. The main purpose of this 510(k) was to introduce new mechanical configurations and minor software adjustments to an already cleared device, without changing its fundamental technology or indications for use.
§ 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.