(55 days)
The HYDRO-TEMP Neonatal Skin Surface Temperature Sensor is a non-sterile device intended for connection to an infant radiant warmer to monitor the neonatal patient's skin surface temperature.
The HYDRO-TEMP Neonatal Skin Surface Temperature Sensor consists of a probe used to monitor a neonate's skin surface temperature used as an accessory while the patient is on an infant radiant warmer. The probe is a wire set with a thermistor chip at the distal end that passively modifies the electrical current traveling through the device. A colored connector at the proximal end of the wire set interfaces with the warming bed or a cable that interfaces with the bed. The probe is packaged with an adhesive pad used to affix the sensor to the patient's skin surface. The device is non-sterile and individually packaged in a resealable plastic bag.
Based on the provided text, the device in question is the HYDRO-TEMP Neonatal Skin Surface Temperature Sensor.
Here's the breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Predicate Device) | Reported Device Performance (Subject Device) |
|---|---|---|
| Accuracy | ±0.2°C | ±0.2°C |
| Sterility | Non-Sterile | Non-Sterile |
| Biocompatibility | ISO 10993-1 compliant | ISO 10993-1 compliant |
| Shelf Life | 3 years | 1 year (intent to extend to 5 years) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set in terms of the number of individual devices or patients. It mentions that "All testing was performed on final, finished product manufactured with the proposed modification." However, it does not specify how many units constituted this "final, finished product."
Regarding data provenance, the document does not specify the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided in the document. The studies performed are primarily technical performance tests.
4. Adjudication Method
This information is not applicable and not provided in the document, as the studies are technical performance tests rather than clinical evaluations requiring expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC comparative effectiveness study was not done. The device is a temperature sensor, and the studies performed are related to its technical performance and safety, not diagnostic interpretation by human readers.
6. Standalone Performance Study
Yes, standalone performance studies were done. The document states:
- "Accuracy testing was performed to IEC 60601-2-21 demonstrating the tolerance range of temperature readings with the proposed change."
- "Additionally, a time response test in accordance with ISO 80601-2-56 also was performed."
- "Evaluation and testing according to IEC 60601-1 and IEC 60601-1-2 also was performed to ensure the change to the thermistor encapsulation did not affect the electrical safety of the device."
- "The following biocompatibility tests were performed on the final, finished proposed device in accordance with ISO 10993 and FDA guidance: cytotoxicity, sensitization, and irritation."
These are all standalone tests evaluating the device's technical performance and safety characteristics.
7. Type of Ground Truth Used
The ground truth for the performance tests was based on established engineering standards and specifications:
- Accuracy: Reference to IEC 60601-2-21, implying comparison against a calibrated temperature standard.
- Time Response: Reference to ISO 80601-2-56, implying comparison against a defined response time standard.
- Biocompatibility: Reference to ISO 10993 and FDA guidance, ensuring compliance with established biological safety benchmarks.
- Electrical Safety: Reference to IEC 60601-1 and IEC 60601-1-2, ensuring compliance with established electrical safety standards.
8. Sample Size for the Training Set
This information is not applicable and not provided in the document. The device is a physical sensor, not an AI or machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided in the document. The device is a physical sensor, not an AI or machine learning algorithm that requires a training set and associated ground truth.
§ 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.