(86 days)
Not Found
No
The description focuses on standard servo-control and manual control mechanisms based on temperature readings, with no mention of AI or ML algorithms for decision-making or control.
Yes
The device is described as "infant radiant warmers" intended to "maintain the infant's body temperature by means of controlled radiant heat" and to "provide warmth to babies...when an infant's self-thermoregulation capacity may be reduced, or if external thermal support is required or desirable," which directly indicates a therapeutic function.
No
The device is an infant warmer, intended to maintain body temperature through controlled radiant heat. Its primary function is therapeutic, not diagnostic. While it monitors temperature, this monitoring is for the purpose of controlling heat delivery, not for diagnosing a condition.
No
The device description explicitly details hardware components such as a heater assembly, controller unit, heating element, reflector, observation lamp, PCBs, control buttons, displays, power switch, temperature sensor socket, and mounting hardware. This is not a software-only device.
Based on the provided information, the Fisher & Paykel Healthcare IW980 and IW990 Infant Warmers are not IVD (In Vitro Diagnostic) devices.
Here's why:
- IVD devices are used to examine specimens from the human body. The intended use and device description clearly state that these warmers are used to provide radiant heat directly to an infant's body to maintain their temperature. They do not involve the analysis of biological samples like blood, urine, or tissue.
- The device description focuses on physical components and functions related to heating and temperature control. There is no mention of reagents, assays, or any components typically associated with in vitro diagnostic testing.
- The performance studies described relate to temperature control, irradiance, and clinical warming of infants. These are not studies related to the accuracy or performance of diagnostic tests.
Therefore, these infant warmers fall under the category of therapeutic or life support medical devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Fisher & Paykel Healthcare IW980 Servo-Control Wall-Mount Infant Warmer and IW990 Manual-Control Wall-Mount Infant Warmer are infant radiant warmers (as per 80 FMT, CFR §880.5130) containing an infrared heating element intended to be mounted over an infant in a pediatric hospital bed, to maintain the infant's body temperature by means of controlled radiant heat.
The IW980 and IW990 are designed to provide warmth to bables 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.
Product codes (comma separated list FDA assigned to the subject device)
FMT
Device Description
The Fisher & Paykel Healthcare IW980 Servo-Control and IW990 Manual-Control Wall-Mount Infant Warmers consist of heater assembly and controller unit sections, with wall mounting hardware components.
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 label is located on the controller unit rear panel, with a duplicate copy of label instructions provided. The power inlet socket is mounted in the underside, and dimensions of the controller are approx. 329mm high × 193mm wide × 104mm deep.
The controller section is supported by a dual 30mm channel bracket mounting system, attached via a mounting frame to a wall. The channel brackets enable the entire warmer unit to be lifted clear of the mounting hardware for purposes of cleaning, maintenance, or moving the unit to an alternate mounting position.
In Baby mode, the IW980 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 IW980 and IW990 provide useradjustable heater power. In Prewarm mode, the IW980 and IW990 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Infant's body
Indicated Patient Age Range
Newborn babies in the first few weeks of life, including premature / low birth-weight infants.
Intended User / Care Setting
Hospital personnel, in delivery room applications, neonatal intensive care units (NICU's) or special care baby units (SCBU's).
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing for the IW980 and IW990 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 demonstrate 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 IW980 and IW990 Wall-Mount 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Ohmeda, Ohio Infant Warmer System, Model 3050, K921766
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for Fisher & Paykel Healthcare. The words "Fisher & Paykel" are on the top line in a bold, sans-serif font. The word "HEALTHCARE" is on the second line, in a similar font but slightly smaller size.
JUL 16 1997
Box 14-348 Panmure Auckland New Zea
4 April, 1997
510(k) Summary of Safety and Effectiveness Information
| Model Number / Name: | IW980 Servo-Control Wall-Mount Infant Warmer
IW990 Manual-Control Wall-Mount Infant Warmer |
|----------------------|-----------------------------------------------------------------------------------------------|
| Classification Name: | Warmer, Infant Radiant - 80 FMT
General Hospital Devices, 21 CFR §880.5130 (Class III) |
| Predicate Device: | Ohmeda, Ohio Infant Warmer System, Model 3050, K921766 |
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 IW980 Servo-Control and IW990 Manual-Control Wall-Mount Infant Warmers consist of heater assembly and controller unit sections, with wall mounting hardware components.
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 label is located on the controller unit rear panel, with a duplicate copy of label instructions provided. The power inlet socket is mounted in the underside, and dimensions of the controller are approx. 329mm high × 193mm wide × 104mm deep.
The controller section is supported by a dual 30mm channel bracket mounting system, attached via a mounting frame to a wall. The channel brackets enable the entire warmer unit to be lifted clear of the mounting hardware for purposes of cleaning, maintenance, or moving the unit to an alternate mounting position.
1
510(k) Summary continued - Fisher & Paykel IW980 and IW990 Infant Warmers
In Baby mode, the IW980 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 IW980 and IW990 provide useradjustable heater power. In Prewarm mode, the IW980 and IW990 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 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 W980 and IW990 Wall-Mount Infant Warmers are equivalent to those of the predicate device.
The wall-mount configuration, 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 requlated by microprocessor-controlled circuitry. The modes of operation, alarm configurations and user controls are very similar between the devices. Both devices use selfmonitoring 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.
2
510(k) Summary continued - Fisher & Paykel IW980 and IW990 Infant Warmers
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.
Performance testing for the IW980 and IW990 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 demonstrate 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 IW980 and IW990 Wall-Mount 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: 4 April 1997
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird design, with three profiles facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 16 1997
Mr. Chris Mander Regulatory Affairs Engineer Fisher & Paykel Electronics Ltd. Healthcare Division 25 Carbine Road Auckland New Zealand
Re : K971461 Trade Name: Servo-Control Wall-Mount Infant Warmer (IW980)/Manual-Control Wall-Mount Infant Warmer Regulatory Class: III Product Code: FMT Dated: April 4, 1997 Received: April 21, 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 The general controls provisions of the Act 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (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 action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note:
4
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 requlations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA acborizon in formalence 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 diagnostic 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.fpa.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy R. Ulatowski
Timo hy A. Ulatowski 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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Image /page/5/Picture/3 description: The image shows the logo for Fisher & Paykel Healthcare. The words "Fisher & Paykel" are in a bold, sans-serif font on the top line. Below that, there is a horizontal line, and below that, the word "HEALTHCARE" is in a similar font, but slightly smaller.
[510(k)] Number:
K 971461
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: +64-9-574-0158
4 April, 1997
Fisher & Paykel IW980 and IW990 Wall-Mount Infant Warmers
PREMARKET NOTIFICATION 510(k) INDICATIONS FOR USE STATEMENT
The Fisher & Paykel Healthcare IW980 Servo-Control Wall-Mount Infant Warmer and IW990 Manual-Control Wall-Mount Infant Warmer are infant radiant warmers (as per 80 FMT, CFR §880.5130) containing an infrared heating element intended to be mounted over an infant in a pediatric hospital bed, to maintain the infant's body temperature by means of controlled radiant heat.
The IW980 and IW990 are designed to provide warmth to bables 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.
C.J. Shadr
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Patricia Crucentr
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K971461
Prescription Use (Per 21 CFR §801.109)