(56 days)
Not Found
Not Found
No
The document describes a standard infant radiant warmer with manual and servo control modes. The modification involves an updated communications module for interfacing with different monitors. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device provides infrared heat to neonates to help them thermoregulate, serving a medical purpose to improve a patient's physiological state.
No
The device is an infant radiant warmer, which provides heat to neonates for thermoregulation. While it senses patient temperature (in servo mode), its primary function is therapeutic (providing heat), not diagnostic (identifying or characterizing a medical condition).
No
The device description explicitly mentions hardware components, specifically a microcontroller added to a printed circuit board within a communications module. The submission also discusses modifications to the hardware and software of the communications module, not just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the infant radiant warmer provides infrared heat to neonates to help them regulate their body temperature. It is a therapeutic device that directly interacts with the patient's external environment.
- No Sample Analysis: There is no mention of the device analyzing any biological samples from the patient. Its function is purely external heating and monitoring of skin temperature.
Therefore, the infant radiant warmer falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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, cxtracorporcal 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 patients' needs and clinical status.
- Servo: The clinician sets the desired patient temperature. A skin temperature probe senses the patient temperature and feeds this information to 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 alart 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.
Product codes
80FMT
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
neonates
Intended User / Care Setting
clinician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5130 Infant radiant warmer.
(a)
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.(b)
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.
0
OCT 1 1996
Ohmeda - Ohio® Infant Warmer System 510(k) Summary
l. Device Information:
- Proprietary Name: Olimeda Ohio Infant Warmer System a)
- Common Name: Infant Radiant Warmer b)
- Classification Name: Infant Radiant Warmer c)
- d) Regulatory Class: III
- Classification Panel: General Hospital e)
- f) Classification Code: 80FMT
- Regulation: 21 CFR 880.5130 g)
2. Manufacturers Information:
Ohmeda, Inc. Specialty Products Division 9065 Guilford Road Columbia, MD 21046-1801 Contact Person: Alberto F. Profumo, Director of Product Assurance
Predicate Device Information 3.
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, cxtracorporcal 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 patients' needs and clinical status.
- Servo: The clinician sets the desired patient temperature. A skin temperature probe senses the ﻫ patient temperature and feeds this information to 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 alart 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
1
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.
Alberto F. Trofumo
Date: 8/5/96
Prepared by:
510(k) Summary Ohmeda - Ohio IWS Page 2 of 2