(86 days)
The Fisher & Paykel Healthcare IW960 Servo-Control Wall-Mount CosyCot Infant Warmer and IW970 Manual-Control Wall-Mount CosyCot Infant Warmer are infant radiant warmers (as per 80 FMT, CFR §880.5130) containing an infrared heating element mounted above a built-in pediatric bed assembly, in order to maintain an infant's body temperature by means of controlled radiant heat.
The IW960 and IW970 are designed to provide warmth to babies in the first few weeks of life, when an infant's self-thermoregulation capacity may be reduced, or if external thermal support is required or desirable. This may include new-born babies in delivery room applications, including premature / low birth-weight infants, and support of critically ill babies in neonatal intensive care units (NICU's) or special care baby units (SCBU's). Situations which necessitate unobstructed access to an infant, including during resuscitation or surgical procedures, may indicate the need for a radiant heat source instead of equivalent support devices such as infant incubators.
The Fisher & Paykel Healthcare IW960 Servo-Control and IW970 Manual-Control Wall-Mount CosyCot Infant Warmers consist of a heater assembly, controller unit, support column, built-in bed assembly, and wall mounting hardware components. The heater assembly includes a single rod infrared healing clement 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 support column, which consists of a single aluminum extrusion section with thermoplastic front panel sections attached. Instruction / warning labeling is located on the back at the top of the support column, with a duplicate copy of label instructions provided. Identification / specification labeling is located on the front panel at the base of the support column, with the power inlet and auxiliary power outlet sockets. The dimensions of the support column are approx. 1448mm high × 193mm wide × 90mm deep (104mm deep at controller section top). The column section is supported by dual wall-mounting brackets, attached to the top and bottom of the column extrusion. The controller unit is built into the top of the support column. 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 bassinet assembly is supported by a four-bar link system attached to the support column extrusion. It consists of a stretched fabric surface over an aluminum extrusion frame. Removable barriers on each side may be folded down for access to an infant, and latch into clips in the bassinet frame. The bassinet may be tilted continuously through +10° to -10° to achieve Trendelenburg and Fowler positions. A spring-loaded cable brake system is used to change the tilt position. An x-ray tray module can be mounted underneath the bassinet for placement of an x-ray cassette. The bassinet assembly is approx. 650mm square × 86mm high, with side barrier panels 127mm above the bassinet surface. A variety of accessory mounting and storage options are available. Infant resuscitator and oxygen flowmeter modules may be mounted in column front panels. A gas supply module may be mounted to the back of the support column extrusion. The column extrusion features a channel mounting system in either side to support mounting blocks for further accessories, which may be fixed at the required height. These include short and long mounting poles, side shelves, gas supply and venturi suction unit mounting blocks and accessory hooks. Storage trays and bins may also be mounted under the bassinet area using this mounting system. In Baby mode, the IW960 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 IW960 and IW970 provide useradiustable heater power. In Prewarm mode, the IW960 and IW970 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 document describes the Fisher & Paykel Healthcare IW960 and IW970 Wall-Mount CosyCot Infant Warmers. It is a 510(k) Summary of Safety and Effectiveness Information for a medical device cleared in 1997. Due to the nature and age of the document, it does not contain the detailed, quantitative efficacy study data typically found in modern AI/ML device submissions. The information provided focuses on demonstrating substantial equivalence to a predicate device and meeting relevant performance standards for infant radiant warmers.
Here's an analysis based on the available information:
1. A table of acceptance criteria and the reported device performance
The document mentions that the proposed devices meet specific aspects of performance required by the standard for Infant Radiant Warmers, IEC 601-2-21. While it lists categories of performance, it does not provide specific numerical acceptance criteria or reported numerical performance values in a table format.
| Acceptance Criteria Category (from IEC 601-2-21 aspects) | Reported Device Performance (Qualitative) |
|---|---|
| Temperatures achieved on the mattress surface for different materials | Demonstrates safety, uniform distribution, accuracy, and absolute accuracy of temperatures achieved on an infant bed. |
| Temperature distribution and variance across the mattress surface | Demonstrates safety, uniform distribution, accuracy, and absolute accuracy of temperatures achieved on an infant bed. |
| Accuracy of temperature control in the servo-controlled mode | Very accurate and stable control of an infant's skin temperature. |
| Absolute accuracy of temperature measurement against an external comparison | Ensures accurate temperature measurement. |
| Maximum irradiance levels for overall IR and near IR spectrum regions | Qualitative nature of the irradiance distribution pattern on the mattress, including irradiance in specific regions of the infra-red spectrum. |
| General Functional Requirements | Meets design and performance functional requirements. |
| Clinical Efficacy | Ability to warm up babies to a stable desired set temperature level accurately in a short period of time, and to control the set temperature very accurately for a stable situation. |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample size for any test set in terms of patient data. The "Clinical verification studies" mentioned seem to refer to human-factors or usability testing in a clinical environment, rather than a clinical trial with a defined patient cohort for performance evaluation, as would be expected for AI/ML devices.
- Test Set Sample Size: Not specified.
- Data Provenance: Not specified, but "Clinical verification studies" imply a clinical setting, presumably in New Zealand, where the company is located. The studies would be considered prospective in nature for device validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not mention the use of experts to establish a "ground truth" for a test set in the context of diagnostic or interpretive outcomes, as would be relevant for AI/ML. The device is an infant warmer, and its performance is measured against physical parameters of temperature, irradiance, and stability, as well as its ability to generally warm infants.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no information about an adjudication process for this type of device and performance testing.
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/ML diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to a physical device performance, not an algorithm. The "standalone" performance would be the device's ability to control temperature and irradiance under various conditions, which was tested. The "algorithm" for this device relates to the control circuitry for temperature regulation.
- Standalone Performance: Yes, the device's physical performance (temperature control, irradiance) was tested independently. The document states: "Performance testing for the IW960 and IW970 has been carried out in the areas of functional verification, temperature control, irradiance distribution patterns and clinical verifications."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance would be:
- Physical Measurements: Accurate and stable temperature readings from calibrated sensors.
- Engineering Standards: Compliance with the requirements of IEC 601-2-21 for various physical parameters (e.g., maximum irradiance, temperature distribution).
- Clinical Efficacy (Qualitative): The observation that the warmers successfully warm babies to a stable desired temperature, implying the "ground truth" is a clinically recognized stable infant temperature.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set of data. The device's control system is based on classical control theory and pre-programmed parameters, not machine learning.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for an AI/ML model. The "ground truth" for the device's control logic would be established through engineering design, physiological principles of thermoregulation, and compliance with safety standards for medical electrical equipment.
§ 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.