(28 days)
- MediHEAT Infant Heel Warmer is primarily used in hospitals, Doctor's offices, and other healthcare facilities.
- Normally, Medical Practitioners squeeze the heels of Infants to increase blood circulation in the area before drawing blood for analyses.
- The Infant Heel Warmer is used to warm the heel of an Infant to increase blood circulation to the area to facilitate blood sampling.
The MediHeat Infant Heel Warmer is a self-contained unit comprised of a flexible Nylon/Polyethylene bag containing the ingredients: a) Food grade sodium acetate, b) Water and c) Activator disk. When the disk is clicked, it activates the sodium acetate solution causing it to pass from the liquid phase to a solid phase (crystallization), making it exothermic. d) An adhesive tape to hold the warmer in place. It heats up to a maximum temperature of up to 105°F and gradually diminishes.
Here is the detailed breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance Study
The MediHEAT Infant Heel Warmer is a simple device designed to warm an infant's heel to facilitate blood drawing. The acceptance criteria and supporting study primarily focus on its temperature characteristics and equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Maximum Temperature | Up to 105°F |
| Duration of Heat | Approximately 30 minutes |
| Gradual Diminishment of Temperature | Temperature diminished gradually |
| Equivalence to Predicate Devices (chemical reaction) | Substantially equivalent to listed predicate devices (PRISM, Omni Warm, Baxter, DeRoyal, Tempra) |
| Equivalence to Predicate Devices (temperature output) | Temperature output is well within the range of the predicate devices. |
Conclusion from Studies: The performance of MediHEAT Infant Heel Warmer is similar and substantially equivalent to that of other commercially available Infant Heel Warmers.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated, but the study compared the MediHEAT Infant Heel Warmer against "Predicate devices, bought in open market." This implies testing was done on at least one unit of each predicate device and at least one unit of the MediHEAT device.
- Data Provenance: The testing was conducted "in our lab" (referring to MediHeat, Inc.'s lab) which suggests internal testing. The country of origin for the data is therefore likely the USA (Dalton, GA). The study appears to be prospective as it involved testing new devices for their performance characteristics.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- None. For this type of device (a heat pack), the "ground truth" is objective physical measurements (temperature, duration) rather than expert interpretation. Experts are not mentioned as being involved in establishing the ground truth for this device's performance study.
4. Adjudication Method for the Test Set
- None. Adjudication methods like 2+1 or 3+1 are typically used for studies involving subjective human interpretation of data (e.g., medical images). This study involves direct physical measurements of temperature over time, which do not require interpretive adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. An MRMC study is not applicable here. This device warms a physical object (an infant's heel) and its performance is measured by objective temperature readings, not by human reader interpretation of complex data.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, effectively. The "study" described is a standalone performance test of the device itself. There is no algorithm or human-in-the-loop component for the function of a heel warmer; it's a direct physical-chemical reaction. The performance characteristics (temperature, duration) were measured directly from the device.
7. The Type of Ground Truth Used
- Objective Physical Measurements: The ground truth was established through direct measurement of temperature and duration of heat from the devices.
8. The Sample Size for the Training Set
- Not Applicable. This device is a physical product, not an AI or machine learning algorithm. Therefore, there is no "training set" in the computational sense. The device's performance is inherent to its design and chemical composition, not learned from data.
9. How the Ground Truth for the Training Set was Established
- Not Applicable (as there is no training set for this type of device).
§ 890.5710 Hot or cold disposable pack.
(a)
Identification. A hot or cold disposable pack is a device intended for medical purposes that consists of a sealed plastic bag incorporating chemicals that, upon activation, provides hot or cold therapy for body surfaces.(b)
Classification. Class I (general controls). Except when intended for use on infants, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 890.9.