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The WarmTouch Model 5300 Patient Warming System (warming unit and blanket) is intended for prevention and treatment of hypothermia, for example, with the surgical patient, the patient in the pre-operative holding area, the pregnant woman who shivers during epidural anesthesia due to hypothermia, or any patient who is uncomfortable anywhere in the cold critical care environment.

The WarmTouch Model 5300 Patient Warming System surrounds the patient with warm air and convectively transfers heat across the skin. With the WarmTouch Model 5300 Patient Warming System, air is warmed and delivered into a lightweight blanket (CareQuilt or CareDrape Blanket) that rests over or under the patient.

The modification to the WarmTouch Patient Warming Unit consists of design changes relating to temperature settings.

The provided 510(k) summary for the WarmTouch Model 5300 Patient Warming System does not contain detailed acceptance criteria and a specific study proving the device meets those criteria in the typical format seen for AI/ML medical devices. This submission pertains to a re-submission of a Convective Air Warming System with minor changes relating to temperature settings, which falls under a different regulatory pathway than novel AI/ML devices.

However, based on the information provided, we can infer some aspects related to acceptance criteria and performance testing:

Inferred Acceptance Criteria and Reported Device Performance:

Information Not Present or Applicable to this Submission Type:

The following information is typically relevant for AI/ML device submissions, but is not provided or applicable in this 510(k) for a hardware-based patient warming system with minor modifications:

• Sample size used for the test set and the data provenance: Not provided. The performance testing described suggests engineering and safety verification rather than a clinical trial with a "test set" as understood for AI/ML.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a patient warming device would be based on validated instrumentation for temperature measurement and safety standards.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This device is not designed to assist human readers in interpretation.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical device, not an algorithm.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for a patient warming device's performance would be established through objective measurements of temperature outputs, electrical safety, and electromagnetic compatibility against industry standards.
• The sample size for the training set: Not applicable for this type of device.
• How the ground truth for the training set was established: Not applicable for this type of device.

Summary of the Study Proving Acceptance Criteria:

The "study" or rather, the verification and validation process, involved several types of performance and safety testing:

1. Safe Maximum Temperature Compliance Testing: This likely involved measuring the maximum temperature achievable by the device under various operating conditions to ensure it remains within safe limits for patient contact, using both the CareQuilt and CareDrape Blankets. The criteria for "safe" maximum temperature would be defined by relevant standards and clinical understanding of thermal injury thresholds.
2. Electrical Safety Testing: This encompassed tests to ensure the device poses no electrical hazard, complying with:
   • UL544 Standard for Safety for Medical and Dental Equipment
   • IEC 60601-1-2:1993 1st Edition requirements (likely referring to general requirements for electrical safety and electromagnetic compatibility)
   • CAN/CSA C22.2 No. 125 for Electromedical Equipment
3. Electromagnetic Compatibility (EMC) Testing: This testing ensures the device does not interfere with other electronic equipment and is not adversely affected by electromagnetic fields, specifically complying with IEC 60601-1-2:1993 1st Edition requirements.
4. Patient Warming System Specific Standard Compliance: The device demonstrated compliance with IEC 60601-2-35 Particular Standard for Patient Warming Systems, which sets specific requirements for the safety and essential performance of patient warming systems.
5. ASTM Standard Conformity: The performance testing also showed conformity to a draft ASTM Standard Specification for Circulating Liquid and Forced Air Patient Temperature Management Devices.

Conclusion stated in the 510(k) Summary:

The manufacturer concluded that "The WarmTouch Model 5300 Patient Warming System and the results of testing do not raise new questions of safety or effectiveness when compared to the legally marketed predicate device." This indicates that the purpose of the testing was to demonstrate that the changes in temperature settings did not negatively impact the safety or effectiveness previously established for the predicate device, and that the updated device continues to meet established industry and regulatory standards.

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