(185 days)
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, 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.
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 thermal transfer fluid is circulated.
Two (2) models of the System are available: One which uses conventional, off-the-shelf thermistor probes such as YSI-400 esophageal probes, to monitor patient temperature and control System operation, and one that uses a thermistor integral to the catheter.
The provided text is a 510(k) Summary for the INNERCOOL therapies, Inc. Celsius Control™ System. It describes the device, its intended use, and comparison to predicate devices, but it does not contain information about specific acceptance criteria, device performance testing results, sample sizes for test or training sets, ground truth establishment, expert qualifications, or MRMC studies. Therefore, I am unable to fill out the requested table and answer the questions based solely on the provided text.
The document focuses on establishing substantial equivalence to predicate devices for regulatory clearance, rather than detailing the specifics of performance studies against defined acceptance criteria.
Information NOT Found in the Document:
- A table of acceptance criteria and the reported device performance: Not present. The document states "The subject device has equivalent performance in inducing and reversing hypothermia, and in maintaining normothermia," but it doesn't provide specific quantitative acceptance criteria or reported performance metrics.
- Sample sized used for the test set and the data provenance: Not present.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not present.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not present. This device is a thermal regulating system, not an AI-assisted diagnostic tool for human readers.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not present. This device is a physical therapeutic system, not an algorithm.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable in the context of this device's type of evaluation as described. Performance for a thermal regulating system would typically involve physiological measurements in subjects or bench testing.
- The sample size for the training set: Not present.
- How the ground truth for the training set was established: Not present.
{0}------------------------------------------------
033623 1/2
MAY 2 1 2004
510(k) SUMMARY
STO(K) SOMMEREE If accerdance with and the end 807 (21 CFR §807), and in particular §807.92, the following summary of safety and effectiveness information is provided:
| 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: | September 26, 2003 |
| Device Name | |
| Trade or Proprietary Name: | Celsius Control™ System |
| Common or Usual Name: | Thermal Regulating System |
| Classification Name: | Thermal Regulating System |
Predicate Devices
Classification Name:
The subject device is substantially equivalent, in whole or in part, to predicate devices manufactured by Radiant Medical (K012512), and Alsius (K014241, K030421).
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/lieating 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 � a sterite cabing over
10033623
4/2
Two (2) models of the System are available: One which uses conventional, off-theshelf thermistor probes such as YSI-400 esophageal probes, to monitor patient temperature and control System operation, and one that uses a thermistor integral to the catheter.
Intended 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, to achieve and/or patients in surgery rmia in cardiac surgery patients in surgery and in maintain normosive 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.
Warning - Fever Reduction
The safety of this device has not been demonstrated for fever reduction in patients presenting with subarachnoid hemorrhage or primary traumatic brain injury. A randomized controlled study of endovascular cooling in patients with subarachnoid hemorrhage and primary traumatic brain injury has shown increased mortality as compared to patients receiving standard of cure.
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.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 21 2004
Mr. Steve Reitzler Vice President, Regulatory Affairs and Quality Assurance INNERCOOL Therapies, Inc. 3931 Sorrento Valley Boulevard San Diego, California 92121
Re: K033623
Trade/Device Namc: Celsius Control System Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal Regulating System Regulatory Class: Class II Product Code: NCX Dated: February 19, 2004 Received: February 23, 2004
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 cnclosure) to legally marketed predicate devices marketed in interstate for associated in the 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). You may, therefore, market the device, subject to the general controls and Ocentral the Act and the limitations described below. The general controls provisions of the provisions of are recessarion, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
The Office of Device Evaluation has determined that there is a reasonable likelihood that this I no Orivel be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following evalu vaaler nust appear in the Warnings section of the device's labeling as a box warning immediately following the indications for use statement:
Warning - Fever Reduction
The safety of this device has not been demonstrated for fever reduction in patients r ne saling with subarrachnoid hemorrhage or primary traumatic brain injury. A procomized controlled study of endovascular cooling in patients with subarrachnoid hemorrhage and primary traumatic brain injury has shown increased mortality as compared to patients receiving standard of care.
{3}------------------------------------------------
Page 2 - Mr. Steve Reitzler
Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.
The FDA finding of substantial equivalence of your device to a legally marketed predicate I no a Dreams in a classification for your device and permits your device to procced to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it your be subject to 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 docs not mean r toase be determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I 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.
If you desire specific information about the application of other labeling requirements to your device (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, at note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
VoeleTu
Donna-Bea Tillman, Ph.D. Acting Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
DRAFT LABELING 5.0
Indications for Use న. 1
510(k) Number (if known):
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 thatee, maintain and work of to achieve and/or maintain surgery and in recordiac surgery patients in surgery and in recovery/ intensive normont final as our were enduction, as an adjunct to other antipyretic therapy, cure, and for use in Jore. Fearction and intracerebral hemorrhage who required in patchis while venous circulation and who are intubated and sedated."
V.P.C.A.T.M.
Division of General, Restorative. and Neurological Devices
510(k) Number K033623
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Pcr 21 CFR 801.109)
OR
Over-The-Counter Use
§ 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).