OHMEDA-OHIO CAE PLUS INCUBATOR

K962806 · Ohmeda Medical · FMZ · Sep 20, 1996 · General Hospital

Device Facts

• Record ID: K962806
• Device Name: OHMEDA-OHIO CAE PLUS INCUBATOR
• Applicant: Ohmeda Medical
• Product Code: FMZ · General Hospital
• Decision Date: Sep 20, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5400
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

Incubators provide a controlled thermal environment for neonates who are unable to provide their own thermoregulation. They may also be used for short periods of time to facilitate the neonate’s transition from the uterus to the external environment. Most incubators can be used in two operating modes: 1. Air Control: The clinician sets the appropriate air temperature for maintaining the desired patient temperature. The air temperature is initially selected based on the clinician’s training and experience and then is adjusted based on the patient’s needs and clinical status. 2. Patient Control: The clinician sets the desired patient temperature. A skin temperature probe senses the patient temperature and feeds this information to the controller of the incubator. 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. Incubators 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. Incubators may incorporate other features, such as humidification of the infant environment, tilting of the bed, oxygen supply, and data output to remote monitors or nurse call systems.

Device Story

Device provides controlled thermal environment for neonates; operates in Air Control or Patient Control modes. Air Control uses clinician-set air temperature; Patient Control uses skin temperature probe feedback to adjust heater output. Includes alarms for malfunctions or temperature deviations; optional features include humidification, bed tilting, oxygen supply, and data output. Modification adds a microcontroller to the communications module to enable interface with Hewlett Packard VueLink monitors via proprietary protocol, in addition to existing ThermaLink/SpaceLabs Flexport support. Used in clinical settings by healthcare providers. Output data facilitates remote monitoring; does not alter primary incubator function or patient-facing controls.

Clinical Evidence

Bench testing only; no clinical or animal testing performed. Modification does not affect basic incubator operation.

Technological Characteristics

Microcontroller-based thermal and humidity control. Includes RS-232 communications module with added microcontroller for protocol identification and data output. Supports ThermaLink, SpaceLabs Flexport, and Hewlett Packard VueLink protocols. No changes to primary incubator hardware or software.

Indications for Use

Indicated for neonates requiring a controlled thermal environment due to inability to thermoregulate or during transition from uterus to external environment.

Regulatory Classification

Identification

A neonatal incubator is a device consisting of a rigid boxlike enclosure in which an infant may be kept in a controlled environment for medical care. The device may include an AC-powered heater, a fan to circulate the warmed air, a container for water to add humidity, a control valve through which oxygen may be added, and access ports for nursing care.

Predicate Devices

• Care Plus Incubator (K962806)

Reference Devices

• SpaceLabs Flexport monitors
• Hewlett Packard VueLink monitor

Submission Summary (Full Text)

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K 96 2806

SEP 20 1996

# Ohmeda - Ohio® Care Plus® Incubator 510(k) Summary

## 1. Predicate Device Information

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

## 2. Intended Use Statement

Incubators provide a controlled thermal environment for neonates who are unable to provide their own thermoregulation. They may also be used for short periods of time to facilitate the neonate’s transition from the uterus to the external environment. Most incubators can be used in two operating modes:

1. **Air Control**: The clinician sets the appropriate air temperature for maintaining the desired patient temperature. The air temperature is initially selected based on the clinician’s training and experience and then is adjusted based on the patient’s needs and clinical status.

2. **Patient Control**: The clinician sets the desired patient temperature. A skin temperature probe senses the patient temperature and feeds this information to the controller of the incubator. 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.

Incubators 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.

Incubators may incorporate other features, such as humidification of the infant environment, tilting of the bed, oxygen supply, and data output to remote monitors or nurse call systems.

## 3. Functional Description

All functions of the modified Care Plus Incubator, with the exemption of the optional communications module, remain the same as in the predicate device. The current Care Plus Incubator 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 Care Plus Incubator 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 incubator 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.

## 4. Assessment of Technological Characteristics

Technological characteristics of the modified Care Plus Incubator remain the same as in the predicate device. The existing Care Plus Incubator 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

510(k) Summary
Ohmeda - Ohio Care Plus Incubator
Page 1 of 2

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# 5. Performance Data

Since (1) care of newborns in incubators 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.

510(k) Summary
Ohmeda - Ohio Care Plus Incubator
Page 2 of 2