(189 days)
Not Found
No
The description focuses on hardware components and basic control software for temperature regulation, with no mention of AI or ML terms or functionalities.
Yes
The device is intended to induce, maintain, and reverse mild hypothermia in neurosurgical patients, which is a therapeutic intervention.
No
The device is described as a "thermal regulating device intended to induce, maintain, and reverse mild hypothermia," which is a therapeutic function, not a diagnostic one.
No
The device description clearly outlines hardware components including an endovascular catheter, a console with refrigeration/heating elements, a pump, and a sterile tubing set. While software is mentioned as part of the console, it is integral to the operation of the physical device and not a standalone software product.
Based on the provided information, the Celsius Control™ System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "induce, maintain, and reverse mild hypothermia in neurosurgical patients in surgery and in recovery/intensive care." This describes a therapeutic intervention performed directly on a patient's body to regulate their temperature.
- Device Description: The device description details a system that physically interacts with the patient's blood flow (via an endovascular catheter) to directly cool or warm it. This is a physical treatment, not a diagnostic test performed on samples taken from the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue, etc.) outside of the body to provide diagnostic information. The device's function is to alter a physiological state (temperature), not to analyze biological samples for diagnostic purposes.
IVD devices are used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The Celsius Control™ System does not fit this description.
N/A
Intended Use / Indications for Use
The Celsius Control™ System is a thermal regulating device intended to induce, maintain, and reverse mild hypothermia in neurosurgical patients in surgery and in recovery/intensive care.
Product codes
NCX
Device Description
The subject device is a thermal regulating system consisting of three (3) parts:
- . 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 9 french to 14 french;
- 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; and
- a sterile tubing set to connect the console to the catheter, and through . which the heat transfer fluid is circulated to and from the catheter.
Two (2) models of the System are available: One which uses conventional, off-the-shelf thermistor probes such as esophageal probes, to monitor patient temperature and control System operation, and one that uses a thermistor integral to the catheter.
Blood contact components of the device have been demonstrated biocompatible through testing in accordance with EN ISO 10993. The System meets applicable standards for electrical safety and electromagnetic compatibility, including EN 60601-1-2 and EN 61003-3-3.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
neurosurgical patients in surgery and in recovery/intensive care
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Summary of Non-Clinical Tests: Both in vitro and in vivo studies demonstrate the ability of the subject device to quickly cool and rewarm a subject to user-designated target temperatures, to accurately control subject temperature at a user-designated target temperature - whether hypothermic or normothermic - and to do so without presenting measurable safety hazards.
Summary of Clinical Tests: Clinical studies have established that the Celsius Control ™ System can rapidly cool a patient to a physician-designated hypothermic target temperature, can maintain that temperature within narrow tolerances, and can return the patient to normothermia as effectively as can predicate thermal regulating systems. Clinical studies have also demonstrated that the incidence of adverse events associated with use of the Celsius Control TM System is comparable to that associated with other comparable medical devices.
Key Metrics
Not Found
Predicate Device(s)
K002577, K003349, K902756, K811743, K912051, K012512
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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 §807), and in particular §807.92, the following summary of safety and effectiveness information is provided:
KO22366
Submitted by
INNERCOOL therapies, Inc. 3931 Sorrento Valley Boulevard San Diego, California 92121 Telephone: (858) 713-9507 Contact: Steve Reitzler, Vice President, Regulatory Affairs & Quality Assurance Date Prepared: July 19, 2002 (Revised: January 17, 2003) Device Name
| Trade or Proprietary Name: | Celsius Control™ 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 Medivance, Inc. (K002577), MTRE Advanced Technology, Ltd. (K003349), Seabrook Medical Systems (K902756), Cincinnati Sub-Zero Products, Inc. (K811743), Gaymar Industries, Inc. (K912051), and Radiant Medical (K012512).
Device Description
The subject device is a thermal regulating system consisting of three (3) parts:
- . 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 9 french to 14 french;
- 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; and
1
- a sterile tubing set to connect the console to the catheter, and through . which the heat transfer fluid is circulated to and from the catheter.
Two (2) models of the System are available: One which uses conventional, off-the-shelf thermistor probes such as esophageal probes, to monitor patient temperature and control System operation, and one that uses a thermistor integral to the catheter.
Blood contact components of the device have been demonstrated biocompatible through testing in accordance with EN ISO 10993. The System meets applicable standards for electrical safety and electromagnetic compatibility, including EN 60601-1-2 and EN 61003-3-3.
Intended Use
The Celsius Control™ System is a thermal regulating device intended to induce, maintain, and reverse mild hypothermia in neurosurgical patients in surgery and in recovery/intensive care.
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 mecting the requirements of ISO 10993-1, as are other devices cleared for commercial distribution in the U.S .;
The subject device has been shown through non-clinical and clinical studies to have equivalent performance in inducing and reversing hypothermia, and in maintaining normothermia, as other thermal regulating systems commercially available in the U.S.
2
K°22366 3/3
Summary of Non-Clinical Tests
Both in vitro and in vivo studies demonstrate the ability of the subject device to quickly cool and rewarm a subject to user-designated target temperatures, to accurately control subject temperature at a user-designated target temperature - whether hypothermic or normothermic - and to do so without presenting measurable safety hazards.
Summary of Clinical Tests
Clinical studies have established that the Celsius Control ™ System can rapidly cool a patient to a physician-designated hypothermic target temperature, can maintain that temperature within narrow tolerances, and can return the patient to normothermia as effectively as can predicate thermal regulating systems. Clinical studies have also demonstrated that the incidence of adverse events associated with use of the Celsius Control TM System is comparable to that associated with other comparable medical devices.
3
JAN 2 7 2003
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
INNERCOOL Therapies, Inc. Stephen Reitzler Vice President, Regulatory Affairs and Quality Assurance 3931 Sorrento Valley Boulevard San Diego, California 92121
Re: K022366
Trade/Device Name: INNERCOOL Therapies, Inc., Celsius Control™ System Regulation Number: 870.5900 Regulation Name: Thermal regulating system Regulatory Class: Class II Product Code: NCX Dated: November 5, 2002 Received: November 7, 2002
Dear Mr. Reitzler:
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
4
Page 2 - Mr. Steve Reitzler
(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. 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 Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address
http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
DRAFT LABELING 5.0
Indications for Use 5.1
510(k) Number (if known): K022366
Device Name: INNERCOOL therapies, Inc., Celsius Control™ System
Indications for Use:
The Celsius Control™ System is a thermal regulating system intended to induce, maintain and reverse mild hypothermia in neurosurgical patients in surgery and in recovery/intensive care.
Muriam C. Provost
Division of General, Restorative and Neurological Devices
Number K022366
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________