(73 days)
The HotDog Patient Warming System is intended to prevent or treat hypothermia and to provide warmth to patients. The HotDog Temperature Management Controller should be used in circumstances in which patients may not maintain a state of normothermia. The System is intended primarily for use in hospitals and surgical centers including, without limitation, operating, recovery, and emergency rooms and on medical/surgical floors.
The HotDog Temperature Management Controller is part of a System intended to prevent or treat hypothermia and to provide warmth to patients. The System should be used in circumstances in which patients could become cold. The HotDog Temperature Management Controller is designed to provide power to the HotDog warming devices and to control the devices to set temperature.
The provided text describes a 510(k) premarket notification for the "HotDog Temperature Management Controller." This is a medical device submission, and the focus is on proving substantial equivalence to previously cleared predicate devices, rather than a clinical study establishing novel efficacy or diagnostic performance. Therefore, many of the requested categories for acceptance criteria and study details (like sample size, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth for training) are not applicable in this context.
The document indicates that bench testing was performed to demonstrate substantial equivalence. The acceptance criteria for this type of submission are typically adherence to recognized performance standards and comparability to predicate devices in terms of technological characteristics and intended use.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Standards) | Reported Device Performance |
|---|---|
| IEC 60601-1 Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance, edition: 3.0 | Assessed and found to meet this standard. |
| IEC 60601-1-2, Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic Compatibility - Requirements and Tests, edition: 3.1 | Assessed and found to meet this standard. |
| IEC 60601-1-4:2000. Medical electrical equipment - Part 1: General requirements for safety - 4 - Collateral standard: Programmable electrical medical systems, edition 1.1. | Assessed and found to meet this standard. |
| IEC 80601-2-35, Particular requirements for the safety of blankets, pads and mattresses intended for heating in medical use, edition 1 | Assessed and found to meet this standard. |
| IEC 62366, Medical Device – Application of usability engineering to medical devices | Assessed and found to meet this standard. |
| IEC 62304, Medical Device Software - Software Life Cycle Processes | Assessed and found to meet this standard. |
| Comparable Temperature Characteristics and Safety Systems to Predicate Devices | Temperature characteristics and safety systems were assessed and found to be comparable to predicate devices (HotDog Patient Warming System K052392 and HotDog Multi-Function Controller K094056). |
| Similar designs, materials, components, and dimensions to predicate devices. | A comparison between the new and predicate devices shows that the technological characteristics and indications for use are equivalent. The products have similar designs, materials, components, and dimensions. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. The submission relies on "bench testing" and a comparison of technical specifications to predicate devices, not a clinical test set with human or patient data.
- Data Provenance: Not applicable. The assessment is based on engineering and performance evaluations against recognized standards and comparison to existing device specifications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not applicable. This is not a study requiring expert-established ground truth for a test set. The evaluation is based on engineering principles and regulatory compliance.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. There was no test set requiring expert adjudication.
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 temperature management controller, not an AI-assisted diagnostic or interpretative system.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an algorithmic device in the context of diagnostic performance. The "algorithm" here would be the control logic for temperature management, whose performance is validated through bench testing against established standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Ground Truth: For this type of submission, the "ground truth" is adherence to established engineering and safety standards (e.g., IEC 60601 series) and the documented specifications and performance of the predicate devices.
8. The sample size for the training set:
- Not applicable. This device does not use machine learning or AI that would require a "training set" in the conventional sense.
9. How the ground truth for the training set was established:
- Not applicable. There is no training set for this device.
§ 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).