INFANT WARMER SYSTEM

K963058 · Ohmeda Medical · FMT · Oct 1, 1996 · General Hospital

Device Facts

• Record ID: K963058
• Device Name: INFANT WARMER SYSTEM
• Applicant: Ohmeda Medical
• Product Code: FMT · General Hospital
• Decision Date: Oct 1, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5130
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

Infant radiant warmers provide infrared heat, in a controlled manner, to neonates who are unable to thermoregulate based on their own physiology or necessitate external heat to smoothen the transition from the uterus to the external environment. They fulfill the same purpose of neonatal incubators but they may be preferred over incubators when total access to the patient is needed or desirable (e.g., surgical procedures, extracorporeal membrane oxygenation, frequent resuscitation, etc.). Most infant radiant warmers can be used in two operating modes: a) Manual: The clinician sets the appropriate heater output for maintaining the desired patient temperature. The heater output is initially selected based on the clinician’s training and experience and then is adjusted based on the patient’s needs and clinical status. b) Servo: The clinician sets the desired patient temperature. A skin temperature probe senses the patient temperature and feeds this information to the controller of the infant radiant warmer. The controller then adjusts the heater output to maintain the patient temperature at the set value. These adjustments to the heater output are made in such a way to gradually change the patient’s temperature while minimizing overshooting and patient stress. Infant radiant warmers have alarms to alert clinicians when certain patient or equipment conditions occur, such as a malfunction, or an excessive departure of the patient’s temperature from the set value. Infant radiant warmers may incorporate other features, such as phototherapy, observation light, tilting of the bed, and data output to remote monitors or nurse call systems.

Device Story

Infant radiant warmer provides infrared heat to neonates. Operates in manual mode (clinician-set heater output) or servo mode (automated heater adjustment based on skin temperature probe feedback). Used in clinical settings (e.g., NICU, OR) by clinicians. Modification adds a communications module with a microcontroller to interface with Hewlett Packard VueLink monitors via proprietary protocol, in addition to existing ThermaLink/SpaceLabs support. Device outputs patient data to remote monitors or nurse call systems. Alarms alert clinicians to malfunctions or temperature deviations. Benefits include stable thermoregulation and improved patient access during procedures.

Clinical Evidence

Bench testing only. No clinical or animal testing performed as the modification does not affect the basic operation of the device.

Technological Characteristics

Infant radiant warmer with infrared heating element. Uses microcontrollers for temperature and humidity control. Connectivity via RS-232 communications module (ThermaLink) supporting SpaceLabs Flexport and Hewlett Packard VueLink protocols. Includes skin temperature probe for servo-control loop.

Indications for Use

Indicated for neonates unable to thermoregulate or requiring external heat for transition from uterus to external environment; used when total patient access is required (e.g., surgery, ECMO, resuscitation).

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 (IWS)

Reference Devices

• SpaceLabs Flexport monitors
• Hewlett Packard VueLink monitor

Submission Summary (Full Text)

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OCT 1 1996 K963058

# Ohmeda - Ohio® Infant Warmer System
## 510(k) Summary

### 1. Device Information:

a) Proprietary Name: Ohmeda - Ohio Infant Warmer System
b) Common Name: Infant Radiant Warmer
c) Classification Name: Infant Radiant Warmer
d) Regulatory Class: III
e) Classification Panel: General Hospital
f) Classification Code: 80FMT
g) Regulation: 21 CFR 880.5130

### 2. Manufacturers Information:

Ohmeda, Inc.
Specialty Products Division
9065 Guilford Road
Columbia, MD 21046-1801
Contact Person: Alberto F. Profumo, Director of Product Assurance

### 3. Predicate Device Information

The modified IWS which is the subject of this Premarket Notification is substantially equivalent to the currently marketed IWS. A description of the modification that made this submission necessary is provided in the Functional Description section of this summary.

### 4. Intended Use Statement

Infant radiant warmers provide infrared heat, in a controlled manner, to neonates who are unable to thermoregulate based on their own physiology or necessitate external heat to smoothen the transition from the uterus to the external environment. They fulfill the same purpose of neonatal incubators but they may be preferred over incubators when total access to the patient is needed or desirable (e.g., surgical procedures, extracorporeal membrane oxygenation, frequent resuscitation, etc.). Most infant radiant warmers can be used in two operating modes:

a) **Manual**: The clinician sets the appropriate heater output for maintaining the desired patient temperature. The heater output is initially selected based on the clinician’s training and experience and then is adjusted based on the patient’s needs and clinical status.

b) **Servo**: The clinician sets the desired patient temperature. A skin temperature probe senses the patient temperature and feeds this information to the controller of the infant radiant warmer. The controller then adjusts the heater output to maintain the patient temperature at the set value. These adjustments to the heater output are made in such a way to gradually change the patient’s temperature while minimizing overshooting and patient stress.

Infant radiant warmers have alarms to alert clinicians when certain patient or equipment conditions occur, such as a malfunction, or an excessive departure of the patient’s temperature from the set value.

Infant radiant warmers may incorporate other features, such as phototherapy, observation light, tilting of the bed, and data output to remote monitors or nurse call systems.

510(k) Summary
Ohmeda - Ohio IWS
Page 1 of 2

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# 5. Functional Description

All functions of the modified IWS, with the exemption of the optional communications module, remain the same as in the predicate device. The current IWS includes an optional RS-232 communications module (ThermaLink) that interfaces with the SpaceLabs Flexport monitors or other monitors that adhere to the ThermaLink protocol. The communications module of the modified IWS will also be able to interface with the Hewlett Packard VueLink monitor using the Hewlett Packard proprietary protocol. This change does not affect the operation (displays, alarms, user’s controls, etc.) of the incubator. The hardware and software of the IWS controller have not been changed. A microcontroller has been added to the communications module printed circuit board to (a) identify the connected monitor and (b) output data to the monitor using the applicable protocol.

# 6. Assessment of Technological Characteristics

Technological characteristics of the modified IWS remain the same as in the predicate device. The existing IWS already incorporates microcontrollers to control temperature and humidity. The addition of a third microcontroller to output information to monitors using different protocols does not change the technological characteristics of the device.

# 7. Performance Data

Since (1) care of newborns in infant radiant warmers is a well established clinical practice and (2) the modification which is the subject of this submission does not affect the basic operation of the incubator, Ohmeda submits that clinical or animal testing to demonstrate safety and effectiveness is not necessary. The modified design will be verified by bench testing.

Prepared by: *Willett F. Profumo*
Date: *8/5/96*

510(k) Summary
Ohmeda - Ohio IWS
Page 2 of 2