(237 days)
The DeRoyal HYDRO-TEMP® Neonatal Skin Temperature Probe Covers are used to adhere the thermistor of the temperature probe to the patient and insulate the thermistor from ambient room temperature ensuring correct temperature readings.
The HYDRO-TEMP® Neonatal Skin Temperature Probe Cover is an accessory to be used with DeRoyal-branded NICU neonatal skin temperature probes used with an infant radiant warmer. They have not been evaluated for use with other manufacturer's products. It is an adhesive pad used to affix a temperature sensor to a neonate's skin to monitor the skin surface temperature. The cover also insulates the temperature sensor from ambient room temperature to ensure temperature readings are accurate.
There are two configurations of the probe cover. Both of these configurations contain a release liner, a patient-contacting hydrogel adhesive, and a metallized polyester backing. One configuration contains an additional foam material that is placed in between the hydrogel adhesive and metallic backing. The device is non-sterile and can be packaged on its own in a foil pouch or in a resealable plastic bag with a temperature probe.
The provided text describes the regulatory filing for the DeRoyal HYDRO-TEMP® Neonatal Skin Temperature Probe Cover (K191425) and its equivalence to a predicate device. The information is focused on mechanical and biocompatibility testing, rather than a clinical study evaluating the device's performance in terms of temperature reading accuracy.
Therefore, many of the requested categories related to clinical study design, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication method, MRMC studies, and training set information, cannot be fully addressed from the provided document.
Here's a summary of the available information structured to answer your questions:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Test Performed | Reported Device Performance (HYDRO-TEMP® Neonatal Skin Temperature Probe Cover) | Predicate Device Performance (HYDRO-TEMP® NICU and Skin Surface Temperature Sensor (K925006)) |
|---|---|---|
| Average peel force per ASTM D903-98 | 4.42 N | 4.28 N |
| Average force required to remove cover from surface (Internal Standard) | 10.1 N | 9.1 N |
| Biocompatibility | ISO 10993-1 compliant (Cytotoxicity, Sensitization, Irritation) | ISO 10993-1 compliant |
| Insulation Testing | Did not result in a temperature difference from the predicate device | Not explicitly stated, but implied as a baseline for comparison |
| Accuracy Testing (IEC 60601-2-21) | Demonstrated the tolerance range of temperature readings when the probe cover was used | Not explicitly stated for the predicate in this context |
Note: The document states "The proposed device is similar to the predicate but with a modified hydrogel material to improve the adhesive strength, which is supported by performance testing." This implies the acceptance criterion for adhesive strength was to be at least equivalent to, if not better than, the predicate. The data shows it is better.
2. Sample size used for the test set and the data provenance
- Sample size: Not specified for any of the individual tests (peel force, pull test, insulation, accuracy, biocompatibility).
- Data provenance: The tests were conducted internally by DeRoyal Industries, Inc. (or contracted labs for biocompatibility) as part of their 510(k) submission. The data is retrospective for the purpose of demonstrating substantial equivalence to a legally marketed predicate device. Country of origin not explicitly stated, but DeRoyal is a U.S.-based company.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This was not a clinical study involving human judgment or "ground truth" established by experts in the context of diagnoses or interpretations. The tests were objective mechanical and biological safety assessments.
4. Adjudication method for the test set
Not applicable. This was not a study requiring adjudication of expert opinions.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a passive accessory (probe cover) and does not involve AI or human "readers" making interpretations.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical accessory, not an algorithm.
7. The type of ground truth used
The "ground truth" for the performance tests would be the standardized testing methods themselves (e.g., ASTM D903-98 for peel strength, IEC 60601-2-21 for accuracy, ISO 10993 for biocompatibility) and the physical measurements obtained from those tests. There is no expert consensus, pathology, or outcomes data used as "ground truth" in the way it might be for a diagnostic device.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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.