INCUWARMER

K971366 · Hill-Rom, Inc. · FMT · Jan 5, 1998 · General Hospital

Device Facts

• Record ID: K971366
• Device Name: INCUWARMER
• Applicant: Hill-Rom, Inc.
• Product Code: FMT · General Hospital
• Decision Date: Jan 5, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5130
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The IncuWarmer is a mobile, caster mounted, neonatal device which is used to assist in maintaining an infant's skin temperature and thermal environment. The device accomplishes this through the use of radiant and convective heat. Accessories and options to the device permit environmental control and monitoring including phototherapy capability, scale, and humidification. It is intended for in-patient use in maternity nurseries, and neonatal care environments of hospitals or other healthcare facilities.

Device Story

IncuWarmer is a mobile, caster-mounted neonatal warming device combining incubator and radiant warmer technologies. It provides thermal isolation via a convective air system with canopies and side panels; supplementary heat is provided by two tubular stainless steel infrared heaters in the overhead arm. The overhead arm can be raised for full infant access. The device supports accessories including humidification, phototherapy, and an integrated scale. Used in hospital maternity nurseries and neonatal care units, it is operated by healthcare professionals. The device uses a microprocessor-based control system to manage thermal output. By maintaining the infant's skin temperature and thermal environment, the device assists in neonatal care and clinical management.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, materials, and technological characteristics compared to predicate devices.

Technological Characteristics

Materials: steel, aluminum, plastic. Heating: convective air system and dual tubular stainless steel infrared heaters. Control: microprocessor-based. Form factor: mobile, caster-mounted enclosure with adjustable canopies and side panels. Accessories: humidification, phototherapy, scale. Regulatory: 21 CFR 880.5130.

Indications for Use

Indicated for neonates requiring thermal support and maintenance of skin temperature in hospital maternity nurseries or neonatal care environments.

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

• Resuscitaire® Radiant Warmer (K940951)
• ISOLETTE® Infant Incubator (K960980)
• Care Plus Infant Incubator (K943360)
• Stabilet™ Infant Radiant Warmer (K970074)

Submission Summary (Full Text)

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K971366

#### 510(k) Summary

JAN - 5 1998

April 11, 1996

## Applicant:

Hill-Rom, Inc. 1069 St. Route 46 East Batesville, IN 47006 Reg. No: 1824206

## Contact Person:

James G. Carpenter Ph: [phone] Fx: [phone]

# Device trade/proprietary name:

IncuWarmer

#### Device common/usual/classification name:

Infant Radiant Warmer

## Classification:

General Hospital and Personal Use Device, 21 CFR 880.5130 , Infant Radiant Warmer, 80FMT, Class III

## Performance Standards:

21 CFR Part 1020, "Performance Standard for Ionizing Radiation Emitting Products"

#### Predicate (Current) Device:

K940951 Resuscitaire® Radiant Warmer, ISOLETTE® Infant Incubator, K960980 Care Plus Infant Incubator, K943360 Stabilet™ Infant Radiant Warmer, K970074

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## Device Description

The IncuWarmer is a warming device that combines the heating technologies of both incubators and radiant warmers into one product. The IncuWarmer provides thermal isolation primarily through a convective air system with canopies and side panels to form an enclosure that isolates the air surrounding the infant from the room air. The IncuWarmer offers access to the infant by allowing the cargiver to open port holes, side panels, canopies, and, if more access is needed, raising up of the over head arm. The over head arm is the upper half of the infant enclosure containing the canopies. The over head arm can be is raised to obtain full access to the infant. The over head arm contains two tubular stainless steel infrared heaters that provide supplementary heat when the canopies and side panels are closed and primary heat when the canopies are opened or the over head arm is raised.

In addition to providing thermal support, the IncuWarmer is capable of controlling options and accessories to aid the caregiver in rendering care to the infant. The IncuWarmer accessories are designed to operate with the IncuWarmer and consist of a humidification accessory, phototherapy accessory, and scale accessory for weighing the infant.

## Intended Use:

The IncuWarmer is a mobile, caster mounted, neonatal device which is used to assist in maintaining an infant's skin temperature and thermal environment. The device accomplishes this through the use of radiant and convective heat. Accessories and options to the device permit environmental control and monitoring including phototherapy capability, scale, and humidification. It is intended for in-patient use in maternity nurseries, and neonatal care environments of hospitals or other healthcare facilities.

## Design and Construction:

Both the new and predicate device(s) utilize the same materials and methods of construction. They are fabricated from steel, aluminum, and plastic. The new device's most highly stressed areas utilize only steel and aluminum. Plastics are used in less stressed areas. Steel and aluminum components are welded or assembled with commercially available fasteners. Plastics used in less stressed areas are assembled with fasteners.

The new device electronics are controlled by a microprocessor as are the predicate devices except the Hill-Rom Stabilet- . The Stabilet- uses an analog control system. The differences in the control systems are transparent to the user.

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The subject device and predicate device(s) in this submission are substantially equivalent. All issues concerning the safety and effectiveness of the IncuWarmer are addressed in the design, labeling , and manufacture of the device.

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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure, composed of three overlapping profiles.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN - 5 1998

Mr. James G. Carpenter Manager, Regulatory Affairs Hill-Rom, Incorporated 1069 State Route 46E Batesville, Indiana 47006-9167

Re: K971366 Trade Name: IncuWarmer Regulatory Class: II FMT Product Code: Dated: October 3, 1997 Received: October 7, 1997

Dear Mr. Carpenter:

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, qood 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 requlation (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 not affect any obligation you might have under sections 531

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Page 2 - Mr. Carpenter

through 542 of the Act for devices under the Electronic enroagn sadiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA asboing 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 diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising 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

Tim 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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# Indications for Use

510(k) Number: Unknown

Device Name: IncuWarmer

Indications for Use:

The IncuWarmer is a mobile,caster mounted, neonatal device which is used to assist in maintaining an infant's skin temperature and thermal environment. The device accomplishes this through the use of radiant and convective heat. Accessories and options to the device permit environmental control and monitoring including phototherapy capability, scale, and humidification. It is intended for in-patient use in maternity nurseries, and neonatal care environments of hospitals or other healthcare facilities.

# (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

| | Concurrence of CDRH, Office of Device Evaluation (ODE) | | |
|-----------------------------------------------------------------------------------------|--------------------------------------------------------|----|----------------------|
| (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices | | | |
| 510(k) Number | K971366 | | |
| Prescription Use (Per 21 CFR 801.109) | X | OR | Over-The-Counter Use |

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