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K Number
K080908
Device Name
INNERCOOL THERAPIES, INC., RAPIDBLUE SYSTEM
Manufacturer
INNERCOOL THERAPIES, INC.- A DELAWARE CORPORATION
Date Cleared
2008-10-17

(199 days)

Product Code
NCX
Regulation Number
870.5900
Type
Special
Panel
NE
Reference & Predicate Devices
K033623
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The RapidBlue™ System is a thermal regulating system intended to induce, maintain and reverse mild hypothermia in neurosurgical patients in surgery and in recovery/intensive care, to achieve and/or maintain normothermia in cardiac surgery patients in surgery and in recovery/ intensive care, and for use in fever reduction, as an adjunct to other antipyretic therapy, in patients with cerebral infarction and intracerebral hemorrhage who required access to the central venous circulation and who are intubated and sedated.

Device Description

The subject device is a thermal regulating system consisting of three (3) parts:

    1. A console containing refrigeration/heating elements, a heat exchanger to cool and warm the circulating fluid, a pump to circulate that fluid, and controls and software necessary to operate the system.
    1. A sterile cassette to connect the console to the catheter, and through which the heat transfer fluid is circulated to and from the catheter in a closed-loop manner.
    1. An endovascular catheter having a heat exchange element at the distal end, through which a thermal transfer fluid is circulated to cool or warm the blood, and which is available in various diameters from 10.7 french to 14 french.
      The modified system offers a mode, which uses conventional, off-the-shelf temperature probes such as YSI-400 esophageal probes, to monitor patient temperature and control system operation, and one mode that uses an integrated temperature sensor in the catheter.
AI/ML Overview

The provided text is a 510(k) summary for the RapidBlue™ System, a thermal regulating system. It describes the device, its intended use, and its comparison to predicate devices. However, this document does not contain explicit acceptance criteria or a study detailing device performance against such criteria.

The 510(k) summary is a premarket notification to demonstrate substantial equivalence to a legally marketed predicate device, rather than a detailed report of a new clinical trial proving specific performance metrics with acceptance criteria.

Therefore, the requested information cannot be extracted from the provided text for the following reasons:

  1. A table of acceptance criteria and the reported device performance: This information is not present. The document states that the device "has equivalent performance in inducing and reversing hypothermia, and in maintaining normothermia, as do other thermal regulating systems commercially available in the U.S." but does not provide specific metrics or acceptance thresholds.
  2. Sample size used for the test set and the data provenance: No test set is described or analyzed in this document.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no described test set requiring ground truth establishment by experts.
  4. Adjudication method for the test set: Not applicable.
  5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. The device is a physical thermal regulating system, not an AI-assisted diagnostic or therapeutic tool for human readers.
  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.

In summary, the provided document focuses on demonstrating substantial equivalence based on indications for use, design characteristics, biocompatible materials, and general performance equivalence to existing predicate devices, rather than presenting a performance study with specific acceptance criteria and detailed study parameters.

§ 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).