(153 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 SP02 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 ait/oxygen mixtures and/or manual ventilation to the infant.
For professional use only, by trained clinicians.
The Ohmeda Medical 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.
Infant radiant warmers may incorporate other features, such as tilting of the bed. elevating base, and data output to remote monitors or nurse call systems. Infant radiant warmers may also allow use with or attachment of an independent phototherapy device or other accessories.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Giraffe and Panda Warmer:
The provided document, K070377, is a 510(k) Premarket Notification for the Giraffe and Panda Warmer. It focuses on demonstrating substantial equivalence to predicate devices and conformance to recognized consensus standards through bench testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Standard | Reported Device Performance |
|---|---|
| Conformance to all applicable clauses of the recognized consensus standard for infant radiant warmers | "The conformance of the Giraffe and Panda Warmers to performance specifications and to multiple recognized performance standards is being established through bench testing." (The specific standards are not listed in the provided text, but such standards typically cover aspects like temperature accuracy, alarm thresholds, safety features, electromagnetic compatibility, and mechanical integrity.) |
| Performance specifications (for the device itself) | "The conformance of the Giraffe and Panda Warmers to performance specifications and to multiple recognized performance standards is being established through bench testing." (Specific performance metrics are not detailed in the provided text, but would ideally include temperature control range and accuracy, alarm functioning, and SpO2 monitoring accuracy if applicable.) |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "animal or clinical testing to support safety and effectiveness is not necessary." Therefore, there is no test set of clinical data (human or animal) to analyze for sample size or provenance. The evaluation was entirely based on bench testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. As stated above, no clinical test set was used, and therefore no experts were required to establish ground truth for such a set. The ground truth for bench testing refers to the calibrated reference instruments and defined test conditions.
4. Adjudication Method for the Test Set
Not applicable. There was no clinical test set requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document does not describe any MRMC comparative effectiveness study. The evaluation focused on the device's standalone performance against engineering and safety standards, not its impact on human reader performance.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
Yes, in spirit, but not in the context of an algorithm. The evaluation focuses solely on the device itself and its components' performance as a medical device, independent of human interaction beyond normal operation. While there isn't an "algorithm" in the typical sense (e.g., for image analysis), the "standalone performance" was assessed in terms of the warmer's ability to meet its technical specifications and regulatory standards through bench testing.
7. Type of Ground Truth Used
The ground truth for this device's evaluation was based on:
- Engineering specifications and design requirements: How the device was designed to function.
- Recognized consensus standards for infant radiant warmers: These standards (e.g., ISO, ASTM, IEC) define specific performance criteria, safety requirements, and test methods that the device must meet.
- Calibration standards: For instruments used in bench testing to measure temperature, power output, SpO2 accuracy (if applicable), etc.
Essentially, the ground truth was derived from established technical and regulatory benchmarks for medical devices of this type.
8. Sample Size for the Training Set
Not applicable. This device is a hardware medical device; it does not involve machine learning or AI models that require a "training set" of data in the conventional sense. The "training" for such a device is its design and manufacturing process, guided by engineering principles and regulatory standards.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set as understood in AI/ML, there's no ground truth established for one. The design and development process for the device relies on fundamental engineering principles, material science, and established medical device design controls, all validated against recognized standards and internal specifications to ensure it performs as intended.
§ 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.