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K Number
K203085
Device Name
NOVA Patient Warming System
Manufacturer
Encompass Group, LLC
Date Cleared
2020-11-12

(30 days)

Product Code
DWJ
Regulation Number
870.5900
Type
Traditional
Panel
CV
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The NOVA Patient Warming System is intended to prevent or treat hypothermia and to provide warmth to patients. It should be used in circumstances in which patients may not maintain a state of normothermia.

It is intended primarily for use in hospitals and surgical centers including without limitation operating, recovery and emergency rooms and on medical/surgical floors.

Not for use in home health care environment

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter for the NOVA Patient Warming System, which is a thermal regulating system. As such, it does not contain the detailed information necessary to answer your questions about acceptance criteria and a study proving device performance as these relate to AI/ML software or diagnostic devices.

The NOVA Patient Warming System is a physical medical device (a patient warming system), not a software algorithm or an AI/ML-driven diagnostic tool. Therefore, the concepts of a test set, training set, ground truth established by experts, MRMC studies, or standalone algorithm performance are not typically applicable to this type of device clearance.

The 510(k) clearance process for this type of device primarily relies on demonstrating substantial equivalence to a legally marketed predicate device, focusing on technological characteristics and safety/effectiveness data. Performance testing for such a device would typically involve engineering validation and verification tests related to its heating capabilities, temperature control, safety features, and durability, rather than diagnostic accuracy metrics.

Therefore, I cannot provide values for the following based on the provided document:

  1. A table of acceptance criteria and the reported device performance: This document doesn't provide specific performance metrics or acceptance criteria for the warming system in a format that would be found for an AI/ML device.
  2. Sample size used for the test set and the data provenance: Not applicable to this type of device.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
  4. Adjudication method: Not applicable.
  5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
  6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
  7. The type of ground truth used: Not applicable.
  8. The sample size for the training set: Not applicable.
  9. How the ground truth for the training set was established: Not applicable.

§ 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).