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510(k) Data Aggregation
(92 days)
INFANT RADIANT WARMER - MODELS IW910 AND IW920
The intended use of Infant Radiant Warmers is to provide thermal support for newborn babies in the first few weeks of life This may include in the delivery room in the period immediately after birth, and in the neonatal intensive care unit for critically ill babies which may require frequent intervention from hospital personnel.
The Fisher & Paykel Healthcare IW910 Servo-Control and IW920 Manual-Control Mobile Infant Warmers consist of a heater assembly, controller unit, and mounting pole and base sections. The heater assembly includes a single rod infrared heating element housed inside a parabolic reflector An observation lamp is mounted at the back of the heater unit. The thermoplastic enclosure is of similar cross-sectional shape to the reflector and is approx. 125mm high × 197mm wide × 625mm deep. It can be rotated to either side of the warmer, clear of the infant bed. A metal grill on the underside of the heater assembly prevents contact with the element. The heater assembly is mounted on top of the controller unit. The transformer and Power PCB are mounted to the aluminum extrusion back section. The Control PCB is mounted on the inside of the thermoplastic front panel. This panel contains the control buttons, displays, main power switch and temperature sensor socket. Controls consist of buttons to select operating modes, timer functions and lamp operation. A control knob selects temperature or power level. LED displays include indicators for operating mode, alarms, timer, lamp and heater power, and 3-digit displays for temperature and timer readings. The main labe. Is located on the controller unit rear panel, with the power inlet socket mounted in the underside. Dimensions of the controller are approx. 329mm high × 193mm wide × 104mm deep. The controller section is supported by a single pole mounting system, with two sections of stainless steel tubing of 25mm and 32mm diameters. The upper pole section fits inside the lower to provide a height adjustment function. The tubes are secured to prevent inadvertent separation, and a polypropylene collet is used to fix the assembly at the required height. An internal spring provides support for the weight of the heater and controller assemblies. A height indication scale is etched into the upper and lower pole sections to enable correct heater-to-mattress distance to be set. The lower pole section is mounted into a steel stabilizer weight attached to the fivearm thermoplastic base unit. The radius of the base is approximately 315mm. The base is supported by five 50mm casters used to position the unit. All the casters include a foot-operated brake lever. In Baby mode, the IW910 provides stable control of the baby's skin temperature by automatically adjusting the heater power to compensate for varying metabolic and environmental conditions. In Manual mode, both the IW910 and IW920 provide useradjustable heater power. In Prewarm mode the IW910 and IW920 maintain power at a constant level of 25% ready for use. A double thermistor sensor probe measures the baby's skin temperature, and audible and visual alarms alert the user to high or low temperature situations, equipment fault, power failure and periodic reminders to reassess the baby's clinical condition, depending on the control mode being used. Various independent safety features are included to control maximum output and avoid thermal injury to the infant.
The provided text describes a 510(k) summary for the Fisher & Paykel Healthcare IW910 and IW920 Mobile Infant Warmers. It details the device, its intended use, and its equivalence to a predicate device. It also briefly mentions performance testing. However, the document does not contain the specific information required to complete the table and answer the questions regarding acceptance criteria and a study proving those criteria are met. The document states that "The proposed devices meet specific aspects of performance required by the standard for Infant Radiant Warmers, IEC 601-2-21," and lists some of those aspects, but it does not provide quantitative acceptance criteria or detailed study results with sample sizes, ground truth information, or expert details.
Therefore, I cannot provide a complete answer with the requested details based solely on the provided text.
However, I can extract the types of performance aspects mentioned and general statements about testing:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Aspect (Derived from IEC 601-2-21) | Reported Device Performance |
|---|---|
| Temperatures achieved on the mattress surface for different materials | "demonstrates the safety, uniform distribution, accuracy and absolute accuracy of temperatures achieved on an infant bed" |
| Temperature distribution and variance across the mattress surface | "demonstrates the safety, uniform distribution, accuracy and absolute accuracy of temperatures achieved on an infant bed" |
| Accuracy of temperature control in the servo-controlled mode. | "The temperature controlling system and software used to regulate this allow for very accurate and stable control of an infant's skin temperature" |
| Absolute accuracy of temperature measurement against an external comparison. | "Improvements in safety and effectiveness include the use of a dual-thermistor skin temperature sensor, the comparison of readings from which allows the equipment to detect any variation in the sensor performance, and ensure accurate temperature measurement." |
| Maximum irradiance levels for overall IR and near IR spectrum regions. | "maximum irradiance levels for overall IR and near IR spectrum regions." |
| Ability to warm babies to a stable desired set temperature level accurately. | "Clinical verification studies demonstrated the ability of the warmers to warm up babies to a stable desired set temperature level accurately in a short period of time" |
| Ability to control set temperature very accurately for a stable situation. | "and the ability to control the set temperature very accurately for a stable situation." |
The following information cannot be extracted from the provided text:
- 2. Sample sized used for the test set and the data provenance: Not mentioned.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/mentioned for this type of device testing. The "ground truth" here would primarily be physical measurements from calibrated instruments.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/mentioned.
- 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, not an AI-assisted diagnostic tool.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device has a "servo-controlled mode" which implies autonomous control, but this is not an "algorithm-only" study in the typical AI sense.
- 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): For the performance testing, the ground truth would be from calibrated measurement equipment (e.g., thermometers, irradiance meters) and potentially clinical observations for "clinical verification studies." The specific methodology is not detailed.
- 8. The sample size for the training set: Not applicable as this is not an AI/machine learning model in the typical sense requiring a training set for algorithm development.
- 9. How the ground truth for the training set was established: Not applicable.
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