(75 days)
The VitalHeat™ is designed to Non-Invasively treat hypothermic patients by warming their body core. This is achieved by local application of negative pressure and thermal load (heat) to a distal appendage.
The Dynatherm Medical, Inc. VitalHeat™ - Warming Mitt - Control Unit The VitalHeat™ is a compact, thermal warming device for use in health care facilities to help patients recover from the discomfort and consequences of lowered core temperature. The device utilizes a technology, which combines sub-atmospheric pressure (SAP) and a heating element on one heat tooknology, which cornent design is to be utilized on a hand). The combination of sub-atmospheric pressure and a heating element allow for the maximum transfer of heat through the heat exchange prosoulature. The compact design allows for minimum coverage of the patient (hand), which should not impede standard patient care and/o full body access.
The VitalHeat™ device is a thermal warming device intended to non-invasively treat hypothermic patients by rewarming their body core through the application of negative pressure and a thermal load to the hand.
Here's an analysis of its acceptance criteria and the study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text focuses on the comparative table with predicate devices rather than explicit acceptance criteria with specific performance values. However, the comparative table implicitly sets the performance expectations for the VitalHeat™ by aligning with or improving upon predicate devices.
| Acceptance Criterion (Implicit) | VitalHeat™ Reported Performance |
|---|---|
| Intended Use | Patient Temperature Control and Maintain |
| Intended Environment of Use | Healthcare Facilities |
| Contraindications | Patients 1000 ml/Min. |
| High Temperature Alarm | Yes |
| Water Level Alarm | Yes - Water Flow |
| Sub-Atmospheric Pressure Indicator | Yes |
| Alarms/Indicators | LED and Audible |
| Timer | Yes |
| Seal | Yes |
2. Sample Size Used for the Test Set and Data Provenance
The provided summary does not contain information about a test set sample size or data provenance (e.g., country of origin, retrospective or prospective data) for a clinical study. The submission relies on a comparison to predicate devices, electrical safety, EMC, and environmental testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
No information is provided regarding experts used to establish a ground truth for a clinical test set. The submission is a 510(k) premarket notification, which often relies on comparison to predicate devices and bench testing rather than extensive clinical trials with expert-adjudicated ground truth.
4. Adjudication Method for the Test Set
No information is provided regarding an adjudication method, as no clinical test set with a need for ground truth adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No information is provided to suggest that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed. The document focuses on the technical specifications and substantial equivalence to predicate devices, not on human reader performance with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The VitalHeat™ is a physical medical device, not an algorithm that performs diagnostic or analytical tasks requiring standalone performance evaluation. Therefore, no standalone algorithm-only performance study was conducted or is applicable.
7. Type of Ground Truth Used
Based on the provided information, the primary "ground truth" used for substantial equivalence is the performance and specifications of the legally marketed predicate devices (Aquarius Medical Corporation Thermo-STAT - K970367 and AcroTherm - K003368).
For the device's technical specifications, the ground truth would be established by bench testing and engineering measurements to confirm performance against design specifications (e.g., temperature range, pressure levels, flow rate, alarm functionality).
8. Sample Size for the Training Set
The device is a physical therapeutic device, not an AI/ML algorithm that requires a training set. Therefore, the concept of a "training set sample size" is not applicable to this submission.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for an AI/ML algorithm involved, this question is not applicable. The device's functionality and safety are established through adherence to engineering specifications and comparison to predicate devices.
§ 870.5900 Thermal regulating system.
(a)
Identification. A thermal regulating system is an external system consisting of a device that is placed in contact with the patient and a temperature controller for the device. The system is used to regulate patient temperature.(b)
Classification. Class II (performance standards).