(64 days)
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No
The description focuses on standard incubator functionality and a communication module update, with no mention of AI or ML.
Yes.
The device maintains a controlled thermal environment for neonates who are unable to self-thermoregulate, which is a therapeutic intervention.
No
Explanation: The device is an incubator designed to provide a controlled thermal environment for neonates. While it monitors the neonate's temperature, its primary function is therapeutic (maintaining temperature), not diagnostic (identifying or characterizing a disease or condition).
No
The device description clearly states that the modification involves adding a microcontroller to a printed circuit board within the incubator's communications module, indicating a hardware component is being added.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device provides a controlled thermal environment for neonates and facilitates their transition to the external environment. This is a therapeutic and supportive function, not a diagnostic one.
- Device Description: The description focuses on the incubator's hardware, software, and communication capabilities for monitoring and controlling the environment. It does not mention any components or functions related to analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Providing information about a patient's disease state, condition, or health status based on sample analysis.
- Using reagents or assays.
The device is a medical device used for patient care and support, specifically thermoregulation for neonates.
N/A
Intended Use / Indications for 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:
- l. 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 patients needs and clinical status.
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- Patient Control: The clinician sets the desired patient temperature. A skin temperature probe senses the patient temperature and feeds this information to 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.
Product codes
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Device 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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
neonates
Intended User / Care Setting
Clinician
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
The modified design will be verified by bench testing.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 880.5400 Neonatal incubator.
(a)
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.(b)
Classification. Class II (performance standards).
0
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Ohmeda - Ohio® Care Plus® Incubator 510(k) Summary
Predicate Device Information 1.
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.
Intended Use Statement 2.
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:
- l. 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 patients needs and clinical status.
-
- Patient Control: The clinician sets the desired patient temperature. A skin temperature probe senses the patient temperature and feeds this information to 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.
2. 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.