(100 days)
The Sunflower Warmer is intended for thermoregulation, skin temperature monitoring, and Apgar timing of newborn infants.
The Sunflower Warmer is a radiant-warming open-type incubator for newborns and premature neonates. It is intended for pre-operative and post-operative intensive care in neonatal surgery, temperature control in neonatal hypothermia, observation and examination in newborn nurseries, prevention of body temperature drop shortly after delivery, etc. The Sunflower Warmer has the capability to control the infant's skin temperature as well as the CPR timer. It is provided in eight mechanical variants, the canopy (heat source) is identical in all variants.
Acceptance Criteria and Device Performance Study for the Sunflower Radiant Warmer
The provided document describes the substantial equivalence of the Sunflower Radiant Warmer to its predicate device, the Hill-Rom Air-Shields (Draeger) - Resuscitaire Radiant Warmer K003335. The device's performance was evaluated through bench testing against established standards and internal criteria.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Sunflower Radiant Warmer are primarily demonstrated through compliance with international standards and equivalent performance specifications compared to the predicate device. Specific quantitative acceptance criteria are given for skin temperature accuracy.
| Feature / Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Compliance with Standards | Adherence to IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-21. | Met all cited standards requirements. |
| Alarm Testing | All specified alarms (Baby Check, Set temperature, High Temperature, Probe Short/Open circuit/No probe, Power failure, System failure) must function correctly. | Met all pass/fail criteria. |
| Skin Temperature Accuracy | Skin Temperature Display: ±0.3°C | Achieved accuracy within ±0.3°C (as per specifications). |
| Temperature Control Testing | Effective thermoregulation within specified ranges and modes. | Met all pass/fail criteria. |
| Mattress Temperature Distribution Testing | Uniformity in mattress temperature; specific criteria not detailed but assumed to be within acceptable physiological limits. | Met all pass/fail criteria. |
| Pre-warming Mode | Functionality as designed. | Met all pass/fail criteria. |
| Power Switch Malfunction under Heat Stress | Power switch must not malfunction under heat stress. | Tested and found to not malfunction. |
| Heater Capacity | 500W | 500W |
| Set Temperature Range | 34.0~38.0°C (in 0.1°C increments) | 34.0~38.0°C (in 0.1°C increments) |
| Skin Temperature Display Range | 30.0~42.0°C | 30.0~42.0°C |
| Heater Output Setting Range | 0~100% (in 5% increments) | 0~100% (in 5% increments) |
| Modes | Manual, Servo (automatic based on skin temperature probe) | Manual, Servo (automatic based on skin temperature probe) |
| Operating Environmental Conditions | 18 to 30°C, RH 30 to 75% (non-condensing) | Operates within 18 to 30°C, RH 30 to 75%. |
| Storage Environmental Conditions | 0°C to 50°C, RH 30-75% (non-condensing) | Stores within 0°C to 50°C, RH 30-75%. |
2. Sample Size Used for the Test Set and Data Provenance
The document states that "bench tests" were performed. However, it does not specify the sample size used for these tests. The data provenance is implied to be from internal laboratory testing conducted by Atom Medical Corporation, Japan, making it retrospective in the sense that the testing was completed prior to submission. The country of origin for the testing is Japan, where Atom Medical Corporation is based.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This type of information is not applicable to this submission. The device is an infant radiant warmer, and its performance testing focuses on technical specifications, safety standards, and functional benchmarks rather than subjective interpretations by human experts. The "ground truth" for these tests would be defined by the technical specifications, standard requirements (e.g., IEC 60601-1), and accurate measurements from calibrated equipment.
4. Adjudication Method for the Test Set
This information is not applicable. As the testing involves objective measurements and compliance with technical standards for a medical device, an adjudication method for reconciling expert opinions is not relevant. Pass/fail criteria are determined by pre-defined technical thresholds and compliance with regulatory standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic or AI-assisted interpretation devices where human performance (with and without aid) is a primary outcome. For an infant radiant warmer, the focus is on the device's physical performance, safety, and functional equivalence to a predicate.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance evaluation was done. The entire "Performance Testing" section describes bench tests of the device itself (the "algorithm only" in a functional sense, as there's no diagnostic algorithm) without human operators as part of the primary performance metric. The tests evaluate the warner's ability to maintain temperature, manage alarms, and comply with safety standards independently.
7. The Type of Ground Truth Used
The ground truth for the performance testing was based on:
- International Standards: Primarily IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-21.
- Manufacturer's Specifications: The design specifications for the device, such as set temperature range, skin temperature display accuracy, and heater capacity.
- Predicate Device Performance: The functional and performance characteristics of the Hill-Rom Air-Shields (Draeger) - Resuscitaire Radiant Warmer K003335 served as a benchmark for equivalence.
- Bench Test Pass/Fail Criteria: Specific objective criteria established for each internal test (e.g., alarm activation at correct thresholds, stable temperature control).
8. The Sample Size for the Training Set
Not applicable. The Sunflower Radiant Warmer is a hardware device with embedded control systems, not an AI/ML algorithm that requires a "training set" in the conventional sense of machine learning. Its internal control logic is designed and validated, not trained on data.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As explained above, there is no "training set" for this type of medical device. The "ground truth" for its design and performance validation relies on engineering principles, recognized safety standards, and performance specifications derived from the intended use and predicate device.
§ 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.