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.

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.

AI/ML Overview

The provided document describes an infant warmer and its performance characteristics but does not contain the level of detail required to answer all parts of your request regarding acceptance criteria and a specific study proving device meets those criteria, particularly in the context of an AI/ML device. This document is for a traditional medical device (infant warmer) and was approved in 1997, predating the widespread use of the detailed AI/ML study reporting you are asking for.

However, I can extract the information that is present and indicate where information is missing based on your query structure.

Here's an attempt to answer based on the provided text:

1. Table of acceptance criteria and the reported device performance

The document hints at acceptance criteria by referencing compliance with IEC 601-2-21 and detailing areas of performance testing.

Acceptance Criteria (Implied / Referenced Standard)	Reported Device Performance (from text)
Compliance with IEC 601-2-21 standard for Infant Radiant Warmers	"The proposed devices meet specific aspects of performance required by the standard for Infant Radiant Warmers, IEC 601-2-21."
Temperatures achieved on the mattress surface for different materials	Testing demonstrated "absolute accuracy of temperatures achieved on an infant bed". Specific values or ranges not provided.
Temperature distribution and variance across the mattress surface	Testing demonstrated "uniform distribution" and "temperature distribution and variance across the mattress surface". Specific values not provided.
Accuracy of temperature control in the servo-controlled mode (IW980)	"The temperature controlling system and software used to regulate this allow for very accurate and stable control of an infant's skin temperature". Clinical studies demonstrate "the ability to control the set temperature very accurately for a stable situation."
Absolute accuracy of temperature measurement against an external comparison	Testing demonstrated "absolute accuracy of temperature measurement against an external comparison". Specific values not provided.
Maximum irradiance levels for overall IR and near IR spectrum regions	Testing demonstrated "qualitative nature of the irradiance distribution pattern on the mattress, including irradiance in specific regions of the infra-red spectrum" and addressed "maximum irradiance levels for overall IR and near IR". Specific levels not provided.
Functional verification	"Performance testing for the IW980 and IW990 has been carried out in the areas of functional verification."
Clinical verification (warming babies to stable set temperature, accuracy, and speed)	"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." Also "Clinical verification studies demonstrate the successful use of the warmers and their ability to provide accurate and stable warming of infants."
Safety features (e.g., maximum output, thermal injury avoidance, sensor detection)	"Various independent safety features are included to control maximum output and avoid thermal injury to the infant." "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."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample size for test set: Not specified. The document mentions "Performance testing" and "Clinical verification studies" but does not provide details on the number of subjects or test cases.
Data provenance: Not specified. The manufacturer is based in New Zealand, but the location of the clinical verification studies is not mentioned. It can be inferred as prospective based on "clinical verification studies demonstrate the ability of the warmers to warm up babies..." indicating active testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided as the device is an infant warmer, not an AI/ML diagnostic tool that requires expert-established ground truth in the typical sense. Expertise would have been involved in the design and interpretation of the clinical verification studies, but not in establishing ground truth for a test set as would be relevant for an AI model.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not specified. This question is typically relevant for studies validating diagnostic AI/ML devices where reader disagreement needs resolution. For an infant warmer, performance is measured against physical parameters and clinical outcomes, not expert interpretation.

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

No. This is explicitly a traditional medical device, not an AI-assisted diagnostic tool. Therefore, an MRMC study and AI assistance effect size are not relevant or discussed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical infant warmer, not an algorithm. Its operation is inherently "standalone" in that it performs its warming function directly, but it's not an algorithm whose performance needs to be evaluated in isolation from hardware.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance would be established through objective physical measurements (temperature, irradiance) and clinical outcomes (infant's stable temperature, warming time). This is implicitly "outcomes data" in a clinical setting and objective measurement in laboratory settings.

8. The sample size for the training set

Not applicable. This device is not an AI/ML model that requires a training set.

9. How the ground truth for the training set was established

Not applicable. As above, there is no AI/ML training set.

Summary

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K971461

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 WarmerIW990 Manual-Control Wall-Mount Infant Warmer
Classification Name:	Warmer, Infant Radiant - 80 FMTGeneral 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.

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510(k) Summary continued - Fisher & Paykel IW980 and IW990 Infant Warmers

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.

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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:

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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 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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[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

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)

Regulation Number and Section

§ 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.