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:

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.
Sample size used for the test set and the data provenance: No test set is described or analyzed in this document.
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.
Adjudication method for the test set: Not applicable.
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.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: Not applicable.
The sample size for the training set: Not applicable.
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.

Summary

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510(k) Summary

In accordance with the Safe Medical Devices Act (SMDA) of 1990 and Title 21 of the Code of Federal Regulations Part 807 (21 CFR 8807), and in particular §807.92, the following summary of safety and effectiveness information is provided:

Submitted by

INNERCOOL therapies, Inc.

6740 Top Gun Road

San Diego, California 92121

Telephone: (858) 677-6390

Contact: Jennifer Spinella, Vice President, Regulatory Affairs & Quality Assurance

Date Prepared: February 15, 2008

Device Name

Trade or Proprietary Name: RapidBlue™ System

Common or Usual Name: Thermal Regulating System

Classification Name: Thermal Regulating System

Predicate Devices

The subject device is substantially equivalent, in whole or in part, to predicate devices manufactured by INNERCOOL therapies (K033623).

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.

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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.

Intended Use

Comparison to Predicate Devices

The subject device has the same, or equivalent, indications for use as do other thermal regulating systems cleared for commercial distribution in the U.S .;

The subject device has the same or equivalent design characteristics as other thermal regulating systems cleared for commercial distribution in the U.S .;

The subject device is composed of biocompatible materials meeting the requirements of ISO 10993-1, as are other devices cleared for commercial distribution in the U.S .;

The subject 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.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the bird symbol.

OCT 1 7 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Innercool Therapies, Inc. % Ms. Jennifer Spinella VP, Regulatory Affairs and Quality Assurance 6740 Top Gun Street San Diego, California 92121

Re: K080908

Trade/Device Name: RapidBlue™ System Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal regulating system. Regulatory Class: II Product Code: NCX Dated: August 08, 2008 Received: August 11, 2008

Dear Ms. Spinella:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 – Ms. Jennifer Spinella

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Millman

Mark N. Melkerson Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Special 510(k): Device Modification RapidBlue™ System

5.1 Indications for Use

08 09 08 510(k) Number (if known):

Device Name: INNERCOOL therapies, Inc., RapidBlue™ System

Indications for 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. "

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Part 21 CFR 801 Subpart D)
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AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)
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(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

510(k) Number	K080908
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Regulation Number and Section

§ 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).