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510(k) Data Aggregation
(59 days)
The VITAHEAT™ Patient Warming System is intended to prevent or treat hypothermia and to provide warmth to patients. The VITAHEAT™ Patient Warming System 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 VITAHEAT™ Patient Warming System consists of a Controller, a reusable Warming Mattress, single use disposable covers and accessories. The Controller is powered by a rechargeable 18V lithium ion battery and a separate charging unit is provided with the device. Each System also includes a second rechargeable 18V lithium ion battery to allow for uninterrupted operation. Typical battery life is 3-5 hours maximum on a fully charged battery depending on the usage. Other accessories provided with the device include a non-heating Thigh Pad that may be used by the patient for thigh support while lying on the mattress and an extension cord to connect the Controller to the Warming Mattress. The specific mechanism of action/heating is detailed further in Section 12.3.
To operate the VITAHEAT™ Patient Warming System, the Controller is connected to the reusable Warming Mattress using the extension cord provided with the device. The Controller may be placed on hospital bed rail, stretcher rail or on patient bed. The reusable Warming Mattress is then placed into a pocket on a single use disposable sheet cover also provided with the device. The patient then lies on top of the covered Warming Mattress for safe warmth. After the patient is in position on the covered Warming Mattress, it is recommended that the VITAHEAT™ Thigh Pad be placed under the patient's thighs to provide thigh support.
The VITAHEAT™ Patient Warming System is designed to be controlled by either the patient or the clinician. The output temperature range of the device is 35°C - 38.5°C ± 1.5°C: temperatures are adjusted to depending on the power setting selected by the user. From the time the device is turned ON, it takes 8-10 minutes for the Warming Mattress to reach the maximum temperature of 38.5℃ ± 1.5℃ when the highest power setting is selected. When the 'LOWER' button is pressed, the desired temperature setpoint is lowered and correspondingly when the HIGHER button is pressed, the setpoint is raised gradually. A different set of LED lights on the Controller indicate the battery life. If the temperature of the Warming Mattress exceeds a maximum safety limit of 41ºC, an automatic system cutoff initiates and the Warming Mattress is discontinued and the unit becomes inoperable.
The VITAHEAT™ device contains a controllable thermal warming component comprised of a series of connected lines printed with conductive ink on a substrate.
Acceptance Criteria and Study for VitaHEAT™ Patient Warming System
The provided text describes a 510(k) premarket notification for the VitaHEAT™ Patient Warming System. This document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It does not include information about clinical studies with human participants for effectiveness or safety as would be the case for a standalone algorithm or a multi-reader multi-case study.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantified, pass/fail format for each test. Instead, it lists the types of non-clinical tests performed and implies that the device met the "predetermined specifications" for each. The reported performance is generally qualitative, stating the device is able to achieve or shuts off at certain parameters.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Cleaning Effectiveness: Patient-contacting components are adequately cleaned. | Cleaning method validation of patient contacting components supplied was performed. (Assumed successful based on overall conclusion of substantial equivalence). |
| Packaging Integrity: Packaging protects the device during transport. | Drop testing, simulated shipping, and overall packaging validation were performed. (Assumed successful). |
| Biocompatibility: Device materials are not harmful to patients. | Cytotoxicity, Irritation, and Sensitization testing were performed. (Assumed successful, aligned with ISO 10993-1). |
| Software Functionality: Software operates as intended. | A complete testing of the software used in the device was performed. (Assumed successful). |
| Electromagnetic Compatibility & Electrical Safety: Device meets relevant standards. | Electrical safety testing per relevant standards (IEC 60601-1, IEC 60601-2-35) was conducted, considering the battery-operated nature. (Assumed successful). The device is also considered safer due to battery operation compared to AC mains. |
| Temperature Performance: Achieves and maintains specified temperature range. | Testing showed the device is able to achieve the temperature range provided in labeling (35°C - 38.5°C ± 1.5°C) and maintain a heating set point once steady state is reached. It takes 8-10 minutes to reach maximum temperature (38.5°C ± 1.5°C) on highest power. |
| High Temperature Cutoff: Device shuts off at a safe maximum temperature. | Testing showed the VITAHEAT™ device shuts off at an acceptable predetermined cutoff temperature of 41°C. |
| Pressure & Burns Safety: Device does not cause thermal injury under pressure. | Testing showed that even when pressure is applied to any portion of the device (surrogate for pressure points), the surface temperature does not exceed the threshold temperature that could cause thermal injury to patients. (Assumed successful). |
| General Functional, Mechanical, Dimensional Performance: Device meets specifications. | General functional, mechanical, dimensional, and other performance testing against predetermined specifications was conducted. (Assumed successful). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify exact sample sizes for each test mentioned (e.g., how many units were drop-tested, how many samples for biocompatibility, etc.). It generally refers to "multiple tests" or "testing was conducted."
- Data Provenance: The data is generated from non-clinical laboratory testing performed by the submitter (VitaHEAT Medical, LLC) or their contractors, as part of the device design, development, and validation process. The country of origin for this data is not explicitly stated but can be inferred as the USA, where the company and contact information are located. The data is prospective in the sense that it was specifically generated for this 510(k) submission to demonstrate compliance with standards and equivalence.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This section is not applicable as the described study is a series of non-clinical, engineering, and performance tests rather than a study requiring expert readers or interpretation of results against a "ground truth" established by experts (e.g., image-based diagnostic systems). The "ground truth" for these tests is defined by the relevant engineering standards (e.g., IEC 60601-1, IEC 60601-2-35) and predetermined device specifications.
4. Adjudication Method for the Test Set
This section is not applicable for the same reasons as point 3. There is no human interpretation or adjudication process described for these non-clinical performance and safety tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically conducted for diagnostic devices (e.g., AI in radiology) where human readers interpret medical images or data. The VitaHEAT™ Patient Warming System is a patient warming device, and its evaluation focuses on its physical and electrical safety and performance, not on diagnostic accuracy or human interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done
No, a "standalone" study in the artificial intelligence/algorithm sense was not done. The VitaHEAT™ Patient Warming System is a physical medical device with associated embedded software and controls, not a standalone AI algorithm. The software testing mentioned is to ensure the device's operational software functions correctly, not to evaluate an AI's performance.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The "ground truth" for the non-clinical tests conducted was primarily based on:
- Engineering and Safety Standards: Compliance with recognized international standards such as IEC 60601-1 and IEC 60601-2-35.
- Predetermined Device Specifications: Internal design specifications for temperature range, cutoff temperature, material properties, etc.
- Biocompatibility Standards: ISO 10993-1 for biological evaluation of medical devices.
- Physical Measurements and Observations: Direct measurement of temperatures, forces, observation of packaging integrity, etc.
8. The Sample Size for the Training Set
This section is not applicable. The VitaHEAT™ Patient Warming System is not an AI/machine learning model where "training sets" are used. The device's operation is based on established engineering principles and pre-programmed controls, not on learning from data.
9. How the Ground Truth for the Training Set was Established
This section is not applicable for the same reasons as point 8.
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