SERVO-CONTROL COSYCOT INFANT WARMER, MANUAL-CONTROL COSYCOT INFANT WARMER

K971695 · Fisher & Paykel Electronics , Ltd. · FMT · Jul 28, 1997 · General Hospital

Device Facts

• Record ID: K971695
• Device Name: SERVO-CONTROL COSYCOT INFANT WARMER, MANUAL-CONTROL COSYCOT INFANT WARMER
• Applicant: Fisher & Paykel Electronics , Ltd.
• Product Code: FMT · General Hospital
• Decision Date: Jul 28, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5130
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Fisher & Paykel Healthcare IW930 Servo-Control CosyCot Infant Warmer and IW950 Manual-Control CosyCot Infant Warmer are infant radiant warmers (as per 80 FMT, CFR §880.5130) containing an infrared heating element mounted above a builtin pediatric bed assembly, in order to maintain an infant's body temperature by means of controlled radiant heat. The IW930 and IW950 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.

Device Story

Infant radiant warmers provide thermal support via infrared heating element mounted above pediatric bed. Input: skin temperature via dual-thermistor probe (IW930) or manual power settings (IW930/IW950). Operation: microprocessor-controlled circuitry adjusts heater power to maintain set skin temperature (Servo mode) or constant power (Manual/Prewarm modes). Output: controlled radiant heat to infant. Used in NICU, SCBU, or delivery rooms by clinicians. Provides stable thermal environment to minimize metabolic rate, supporting growth/healing. Features include tiltable bassinet, x-ray tray, and accessory mounting. Safety: audible/visual alarms for temperature, power, or equipment faults; independent safety circuits prevent thermal injury.

Clinical Evidence

Clinical verification studies demonstrated the ability of the warmers to warm infants to a stable set temperature accurately and maintain that temperature in a stable clinical environment. Bench testing confirmed compliance with IEC 601-2-21, including mattress surface temperature accuracy, temperature distribution/variance, and maximum irradiance levels for IR and near-IR spectrums.

Technological Characteristics

Infrared heating element with parabolic reflector; microprocessor-controlled; dual-thermistor skin temperature sensor; aluminum/thermoplastic construction; lockable casters; electrical/mechanical height adjustment; LED displays; 100-240V power; IEC 601-2-21 compliant.

Indications for Use

Indicated for newborn infants, including premature or low birth-weight infants, and critically ill infants in NICUs, SCBUs, or delivery rooms requiring thermal support due to reduced self-thermoregulation capacity or when unobstructed access is necessary for procedures.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Ohmeda, Ohio Infant Warmer System, Model 5000 (K921766)
• Fisher & Paykel, RD1000 Infant Resuscitator (K892885)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings and head. The eagle is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" in a sans-serif font.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Chris Mander Regulatory Affairs Engineer JUL 2 8 1997 Regaracer & Paykel Electronics Ltd. Healthcare Division 25 Carbine Road Auckland, New Zealand

K971695 Re : IW930 Servo-Control CosyCot™ Infant Warmer, Trade Name: IW950 Manual-Control CosyCot™ Infant Warmer Regulatory Class: II Product Code: FMT Dated: April 30, 1997 Received: May 8, 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 abe beated in the enough, 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 requlations 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 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: this response to your premarket notification submission does

{1}------------------------------------------------

Page 2 - Mr. Mander

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 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 labelinq requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertisinq of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the logo for Fisher & Paykel Healthcare. The words "Fisher & Paykel" are on the top line, with a horizontal line underneath. The word "HEALTHCARE" is on the second line.

[510(k)] Number:

K971695

Fisher & Paykel Electronics Limited
25 Carbine Road, Panmure, Auckland, New Zealand
P.O. Box 14-348, Panmure, Auckland, New Zealand
Tel: [phone] Fax: [phone]

30 April, 1997

## Fisher & Paykel IW930 and IW950 CosyCot Infant Warmers

## PREMARKET NOTIFICATION 510(k) INDICATIONS FOR USE STATEMENT

The Fisher & Paykel Healthcare IW930 Servo-Control CosyCot Infant Warmer and IW950 Manual-Control CosyCot Infant Warmer are infant radiant warmers (as per 80 FMT, CFR §880.5130) containing an infrared heating element mounted above a builtin pediatric bed assembly, in order to maintain an infant's body temperature by means of controlled radiant heat.

The IW930 and IW950 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)

(Division Sign-Off) Patricia Cuconti
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K971695

Prescription Use (Per 21 CFR §801.109)

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for Fisher & Paykel Healthcare. The logo is composed of two lines of text, with "Fisher & Paykel" on the top line and "HEALTHCARE" on the bottom line. A horizontal line is placed under the top line of text. The text is in a bold, sans-serif font.

K971695

ine Road Panmure -64-9-574-0100

2 Mav. 1997

JUL 28 1997

## 510(k) Summary of Safety and Effectiveness Information

| Model Number / Name: | IW930 Servo-Control CosyCot™ Infant Warmer |
|----------------------|--------------------------------------------------------|
| | IW950 Manual-Control CosyCot™ Infant Warmer |
| Classification Name: | Warmer, Infant Radiant - 80 FMT |
| | General Hospital Devices, 21 CFR §880.5130 (Class III) |
| Predicate Devices: | Ohmeda, Ohio Infant Warmer System, Model 5000, K921766 |
| | 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 IW930 Servo-Control and IW950 Manual-Control CosyCot Infant Warmers consist of a heater assembly, controller unit, support column, built-in bed assembly, and base section.

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 support column, which extends down to the base of the unit, and 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. Identification 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 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.

{4}------------------------------------------------

## 510(k) Summary continued - Fisher & Paykel IW930 & IW950 Infant Warmers

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 x 86mm high, with side barrier panels 127mm above the bassinet surface.

The base assembly consists of a steel main chassis with thermoplastic leg sections. The leg assemblies pivot at their connection points at each end of the main chassis to allow for height adjustment. The height may be mechanically fixed at one of three positions, or an optional electrical height adjustment system allows bassinet heights between 93 and 108 cm. It is activated by foot-controlled buttons on the right front leg of the unit. An electrical actuator system moving rods connected to the leg assemblies changes their angle with respect to the chassis and hence alters the warmer height. Four casters provide for positioning of the unit, two are lockable to prevent inadvertent movement. The main chassis of the base assembly is approx. 87mm high × 207mm wide × 582mm deep. The base has a rectangular 'footprint' area 770mm wide and a depth variable from 120mm to 110mm depending on height adjustment position.

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. 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, venturi suction unit mounting blocks and accessory hooks. Storage trays and bins may be mounted under the bassinet area also using this mounting system. Labeling is provided on the support column stating the maximum accessory loads which may be used depending on the height of the load, in order to ensure stability of the unit is maintained.

In Baby mode, the IW930 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 IW930 and IW950 provide useradjustable heater power. In Prewarm mode, the IW930 and IW950 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.

{5}------------------------------------------------

510(k) Summary continued - Fisher & Paykel IW930 & IW950 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 IW930 and IW950 CosyCot Infant Warmers are equivalent to those of the predicate device.

The built-in bed assembly configuration, location of heater and controller sections, and mounting on lockable casters to enable positioning 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.

{6}------------------------------------------------

510(k) Summary continued - Fisher & Paykel IW930 & IW950 Infant Warmers

Performance testing for the IW930 and IW950 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 spectrym. 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 IW930 and IW950 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: 2 May 1997