(23 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. 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.
The proposed modification of the Giraffe and Panda Warmers is the addition of the Giraffe Shuttle accessory. The Giraffe and Panda Warmers can be used with the Giraffe Shuttle, 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 Shuttle has two primary active functions: Locking to a bed and providing transportable power to the bed and accessories. The internal power source of the Shuttle consists of two 12 volt 42 amp hour lead acid batteries. The Shuttle contains two sensor systems: One system detects an interference condition. The other system determines the attaching status of the device. The Shuttle features an LED Display Board, which contains the battery runtime indicator and the battery health indicator.
This document describes a Special 510(k) Premarket Notification Submission for the addition of the Giraffe Shuttle accessory to the existing Giraffe and Panda Warmers. The submission argues that the modified device is substantially equivalent to the legally marketed predicate devices and does not require clinical studies.
Here's an analysis of the provided text, focusing on the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not provide specific, quantifiable acceptance criteria or performance metrics for the Giraffe Shuttle. Instead, it relies on a general statement of compliance with voluntary standards and a series of quality assurance measures.
| Acceptance Criteria (Quantitative/Qualitative) | Reported Device Performance |
|---|---|
| Not specified quantitatively | "The Giraffe and Panda Warmers and their applications with the Giraffe Shuttle, comply with voluntary standards as detailed in Section 9, 11 and 17 of this premarket submission." |
| Functional: Locking to a bed | "Attaching the Shuttle to a bed is accomplished by guiding the Shuttle between the legs of the bed and stepping on the Lock pedal. This effectively locks the Shuttle and bed together as one unit." |
| Functional: Providing transportable power | "The Shuttle is configured to attach to the Giraffe and Panda Warmers and provide electrical power to the bed and selected accessories." |
| "The internal power source of the Shuttle consists of two 12 volt 42 amp hour lead acid batteries. The batteries are high capacity, sealed, no-maintenance batteries and are connected in series to provide a nominal 24 volts supply to the power generation module." | |
| Safety: Interference detection | "One system [sensor] detects an interference condition." |
| Functional: Attaching status detection | "The other system [sensor] determines the attaching status of the device." |
| Battery runtime indication (visual) | "The Shuttle features an LED Display Board, which contains the battery runtime indicator..." |
| Battery health indication (visual) | "...and the battery health indicator." |
| No change in primary device indications for use | "The UPS does not change the indications for use, control mechanisms, operating principles, performance specifications, or other features of the Giraffe and Panda Warmers." (This also applies to the Shuttle, as it's an accessory with similar functionality to the UPS in terms of power provision.) |
| "The intended use of the legally marketed device and the proposed modified device is identica!." | |
| Non-clinical testing | "Risk Analysis, Requirements Reviews, Design Reviews, Testing on unit level (Module verification), Integration testing (System verification), Performance testing (Verification), Safety testing (Verification), Usability testing (Validation), Biocompatibility testing." |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "Clinical Tests: The subject of this premarket submission, Giraffe and Panda Warmers, used with Shuttle, did not require clinical studies to support substantial equivalence."
Therefore, there is no test set in the traditional sense of a clinical study, and thus no sample size for a test set, nor data provenance (country of origin, retrospective/prospective). The evaluation was based on non-clinical testing and comparison to predicate devices, not patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
As no clinical studies were performed, there was no "ground truth" established by external experts for a test set in the context of device performance on patients. The ground truth for the non-clinical testing referenced would have been established by internal GE Healthcare engineers and quality assurance personnel, following their defined testing protocols and design specifications. Their qualifications are not specified but would typically include relevant engineering and technical expertise.
4. Adjudication Method for the Test Set
Since no clinical test set was used, there was no adjudication method for a test set of clinical outcomes.
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
No MRMC comparative effectiveness study was done. This device is an infant warmer accessory (mobile power source), not an image analysis or diagnostic AI device that would involve human readers or AI assistance in interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a medical accessory (mobile power source for an infant warmer) and does not involve an algorithm or AI.
7. The Type of Ground Truth Used
For the non-clinical tests conducted (e.g., performance, safety, usability, biocompatibility), the "ground truth" would be established by:
- Design Specifications: The device was tested against its own design requirements and specifications.
- Voluntary Standards: Compliance with relevant industry and safety standards (as mentioned in "Section 9, 11 and 17" of the submission, though not detailed in the provided text).
- Engineering Measurement and QA: Direct measurement and verification by engineers and quality assurance teams during the development and testing phases.
8. The Sample Size for the Training Set
This question is not applicable as the device does not employ machine learning or AI, and therefore does not have a "training set."
9. How the Ground Truth for the Training Set was Established
This question is not applicable for the same reason as above.
§ 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.