(181 days)
There are two modes of operation for temperature control in incubators and infant warmers where these products are used, air or manual mode and baby or skin temperature control mode.
When operating in the air or manual mode, a skin temperature probe may be used just to monitor the patient's skin temperature. Here, a nurse would control the heater output manually.
When operating in the "Baby" or "Skin Temperature Control Mode" the warming units controller utilizes the skin temperature probe, connected between the controller and the infant, to automatically adjust the heater output of the unit to maintain a pre-selected skin temperature.
There are two modes of operation for temperature control in incubators and infant warmers where these products are used, air or manual mode and baby or skin temperature control mode.
When operating in the air or manual mode, the skin temperature probe may be used just to monitor the patient's skin temperature. Here, a nurse would control the heater output manually.
When operating in the "Baby" or "Skin Temperature Control Mode" the warming units controller utilizes the skin temperature to automatically adjust the heater output of the unit to maintain a pre-selected skin temperature.
The thermistor tip which gets taped to the infant is made of a material whose resistance to electrical flow changes when the tip materials temperature changes. Two small wires run from the plug end at the incubator or warmer to the thermistor tip. One wire to each side.
A very small current goes to the tip and depending on how warm the tip is has to do with how much current returns via the other wire to the plug. That current is computed into temperatures.
These products fit the Steinhart-Hart equation which is the standard for describing thermistor curves.
The provided text outlines the safety and effectiveness summary for a Reusable Temperature SENSOR (probe) called "Accutemp-Probe". However, it is a 510(k) submission for substantial equivalence to a predicate device, not a study demonstrating performance against specific acceptance criteria.
The document claims substantial equivalence based on the device's technological characteristics and intended use being the same as the predicate device (Air Shields/Ohmeda). It does not present specific performance criteria or the results of a study designed to meet such criteria in the format requested.
Therefore, many of the requested sections regarding a study cannot be directly extracted from this document.
Here's a breakdown of what can be inferred or stated based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated as a table of performance metrics with specific thresholds. The acceptance criteria for this submission appear to be demonstrating substantial equivalence to a predicate device, primarily based on the device functioning and intended use being identical, and fitting the Steinhart-Hart equation for thermistor curves.
- Reported Device Performance:
- Functionality: "The thermistor tip which gets taped to the infant is made of a material whose resistance to electrical flow changes when the tip materials temperature changes. Two small wires run from the plug end at the incubator or warmer to the thermistor tip. One wire to each side. A very small current goes to the tip and depending on how warm the tip is has to do with how much current returns via the other wire to the plug. That current is computed into temperatures."
- Scientific Basis: "These products fit the Steinhart-Hart equation which is the standard for describing thermistor curves."
- Comparison to Predicate: "None [technological characteristics difference] – other than, possibly, the color." and "This product looks like and has identical indications for use as the disposable products we now sell under 510(k) # 960080, issued May 1, 1996. This product differs only in its durability. It uses heavier wire and a disc type tip (which primarily identifies it as a reusable unit.)"
2. Sample Size Used for the Test Set and Data Provenance:
- Not Applicable. The document does not describe a performance study with a test set. This is a 510(k) premarket notification claiming substantial equivalence, not a clinical or performance validation study with a test set of data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not Applicable. No ground truth establishment for a test set is described.
4. Adjudication Method for the Test Set:
- Not Applicable. No test set or adjudication method is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. This type of study is not described. The device is a temperature sensor, not an AI or imaging diagnostic tool that would typically involve human readers.
6. Standalone (Algorithm Only) Performance Study:
- Not Applicable. The device is a physical temperature sensor, not an algorithm. Its performance is based on its physical properties and adherence to established thermistor curve standards.
7. Type of Ground Truth Used:
- Not Applicable. For this 510(k) submission, the "ground truth" for demonstrating substantial equivalence is primarily the technological characteristics and intended use of the predicate device (Air Shields/Ohmeda) and adherence to a recognized scientific standard (Steinhart-Hart equation). No "expert consensus," "pathology," or "outcomes data" ground truth is mentioned in the context of a performance study.
8. Sample Size for the Training Set:
- Not Applicable. The document does not describe a training set as this is not an AI/machine learning device. The design principles are based on established physics of thermistors.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. There is no training set mentioned.
§ 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.