(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.
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Image /page/0/Picture/0 description: The image shows the word "HEALTHCARE" in all caps. The font is a simple sans-serif style. There is a horizontal line above the word, and some blurred text above the line.
Fisher & Paykel Electronics Limited 25 Carbine Road, Panmure, Auckland, New Zealand P.O. Box 14-348. Panmure, Auckland, New Zealand Tel: +64-9-574-0100 Fax:
OCT 30 1997
30 July, 1997
510(k) Summary of Safety and Effectiveness Information
IW960 Servo-Control Wall-Mount CosyCot™ Infant Warmer Model No. / Name: IW970 Manual-Control Wall-Mount CosyCot™ Infant Warmer Classification Name: Warmer, Infant Radiant - 80 FMT General Hospital Devices, 21 CFR §880.5130 (Class III) Ohmeda, Ohio Infant Warmer System, Model 3150, K921766 Predicate Devices: Fisher & Paykel, RD1000 Infant Resuscitator, K892885
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
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.
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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.
page 2-5
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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. New-born babies (including low birth-weight or premature infants) and critically ill babies may have a reduced self-thermoregulation capacity. Body heat can be lost through the mechanisms of conduction, convection, radiation and evaporation. Low quantities of internal energy and insulating fat, and a high surface area-to-mass ratio can also be contributing factors. In these cases, or when thermal support is required or desirable, radiant heat may be provided to prevent the various clinical consequences of excessive heat loss.
Infant Radiant Warmers contain an infrared heating element intended to be placed over an infant in a pediatric hospital bed, to maintain an infant's body temperature by means of controlled radiant heat. Heat energy is absorbed through an infant's skin, increasing local blood flow which transfers heat to the rest of the body by blood convection and tissue conduction.
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 object of providing controlled radiant heat is to stabilize the infant's temperature at the level where metabolic rate is at a minimum. At this state the infant's internal energy sources are used primarily for growth and healing, and not trying to keep warm or cool.
The technological characteristics of the IW960 and IW970 Wall-Mount CosyCot Infant Warmers are equivalent to those of the predicate device. The built-in bed assembly and wall-mounting configurations, location of heater and controller sections, and capacity to swing aside the heater section are equivalent. Both feature a single-bar radiant heating element with a parabolic metal reflector design. Heater output is regulated by microprocessor-controlled circuitry. The modes of operation, alarm configurations and user controls are very similar between the devices. Both devices use self-monitoring software and hardware options to ensure device faults are detected and do not result in hazardous states. The power used and irradiance levels achieved on a mattress surface by the two devices are very similar in quantity.
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. The temperature controlling system and software used to regulate this allow for very accurate and stable control of an infant's skin temperature, hence providing optimal environmental clinical conditions.
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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.
This testing demonstrates the safety, uniform distribution, accuracy and absolute accuracy of temperatures achieved on an infant bed, and the qualitative nature of the irradiance distribution pattern on the mattress, including irradiance in specific regions of the infra-red spectrum. 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, and the ability to control the set temperature very accurately for a stable situation. The proposed devices meet specific aspects of performance required by the standard for Infant Radiant Warmers, IEC 601-2-21, including:
- temperatures achieved on the mattress surface for different materials.
- temperature distribution and variance across the mattress surface.
- accuracy of temperature control in the servo-controlled mode.
- absolute accuracy of temperature measurement against an external comparison.
- maximum irradiance levels for overall IR and near IR spectrum regions.
The product testing carried out for the IW960 and IW970 Wall-Mount CosyCot Infant Warmers indicate that they meet their design and performance functional requirements. Clinical verification studies demonstrate the successful use of the warmers and their ability to provide accurate and stable warming of infants. The proposed devices also meet the requirements of the international standard for Infant Radiant Warmers, IEC 601-2-21.
signed:
Chris Mander Fisher & Paykel Healthcare
te: 30 July 1997
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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes forming its body and wings, symbolizing health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Chris Mander Requlatory Affairs Engineer Fisher & Paykel Electronics Ltd. Healthcare Division 25 Carbine Road Panmure, Auckland New Zealand
OCT 30 1997
Re : K972885 Trade Name: Servo-Control Wall-Mount Cosycot Infant Warmer Model IW960 and IW970 Regulatory Class: II Product Code: FMT Dated: July 30, 1997 Received: August 5, 1997
Dear Mr. Mander:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਚੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note:
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Page 2 - Mr. Mander
this response to your premarket notification submission does. not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to beqin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy J. Ulatowski
Timothy I Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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- [510(k)] Number:
HEALTHCARE
Fisher & Paykel Flectronics | imited 25 Carbine Road, Panmure, Auckland, New Zealand P.O. Box 14-348. Panmure, Auckland, New +64-9-574-0100 +64-9-574-0158
30 July, 1997
Fisher & Paykel IW960 and IW970 Wall-Mount CosyCot Infant Warmers
PREMARKET NOTIFICATION 510(k) INDICATIONS FOR USE STATEMENT
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.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Patricia Cusciola
(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices
510(k) Number 4972885
Prescription Use (Per 21 CFR §801.109)
§ 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.