(64 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 (Sp02) and pulse rate (measured by a 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. Both 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 a UPS module, 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 document is a 510(k) Premarket Notification Submission for the GE Healthcare Giraffe and Panda Warmers, specifically concerning the addition of Nellcor pulse oximetry. The document states that no clinical studies were required to support substantial equivalence for this modification. Therefore, it does not contain the detailed information necessary to answer all aspects of your request regarding acceptance criteria and a study proving the device meets those criteria.
However, based on the non-clinical information provided, here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance:
The document mentions compliance with voluntary standards but does not provide a specific table of acceptance criteria with corresponding performance metrics for the Nellcor pulse oximetry addition. It states that the SpO2 performance is "substantially equivalent to the corresponding parameters in the Masimo SET technology," which implies the acceptance criteria would be those met by the predicate Masimo SET technology. Without information on the Masimo SET technology's specific performance criteria, a table cannot be constructed.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable, as no clinical human testing was conducted for the Nellcor SpO2 addition to establish performance in a test set. Non-clinical testing was performed, but details on sample sizes for specific non-clinical tests (e.g., number of units tested) are not provided in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as no clinical human testing requiring expert-established ground truth was reported.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as no clinical human testing requiring adjudication was reported.
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 infant warmer with integrated pulse oximetry, not an AI-assisted diagnostic imaging device that would typically undergo MRMC studies with human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
The document implies "standalone" technical performance was assessed during non-clinical testing (e.g., "Testing on unit level (Module verification)", "Integration testing (System verification)", "Performance testing (Verification)"), but specific details on performance metrics for the Nellcor module in isolation are not provided. The key claim is "substantially equivalent to the corresponding parameters in the Masimo SET technology."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the non-clinical testing, the "ground truth" would likely refer to engineering specifications and established performance standards for pulse oximetry. For example, in performance testing, calibration references or simulated physiological signals would serve as ground truth for accuracy measurements. These details are not explicitly described.
8. The sample size for the training set:
Not applicable. This device is a medical monitoring device, not a machine learning or AI algorithm that requires a training set.
9. How the ground truth for the training set was established:
Not applicable, as no training set for an AI algorithm was used.
Summary of Non-Clinical Tests (from the document):
The document states that the following quality assurance measures were applied to the development of the system:
- 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 non-clinical tests, along with compliance with voluntary standards (mentioned in Sections 9, 11, and 17, though not included in the provided excerpt), were deemed sufficient to demonstrate substantial equivalence to the predicate device (K101804). The core argument is that the Nellcor pulse oximetry technology is "fundamentally equivalent to Masimo Pulse Oximetry" and its integration technique is "extremely similar" to the previously cleared Masimo SpO2 option.
§ 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.