(29 days)
Not Found
No
The summary describes a physical catheter and a thermal regulation system, with no mention of AI, ML, or any software-based decision-making or analysis.
Yes
The device is described as being used in cardiac surgery patients to achieve and/or maintain normothermia and to induce, maintain, and reverse mild hypothermia in neurosurgery patients. These applications directly involve treating or managing physiological conditions, which falls under the definition of a therapeutic device.
No
Explanation: The device is used to regulate body temperature (normothermia or hypothermia) by exchanging heat with the central venous blood supply. This is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a multi-lumen intravascular catheter, which is a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. They are used outside of the body.
- Device Function: The Quattro Catheter is an intravascular catheter that is inserted into the patient's central venous blood supply. Its function is to directly exchange heat with the blood to regulate body temperature. This is a therapeutic intervention performed within the body.
- Intended Use: The intended use is to achieve and maintain normothermia or induce, maintain, and reverse mild hypothermia in patients during surgery and recovery. This is a treatment or management function, not a diagnostic test.
Therefore, the Quattro Catheter is a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Quattro Catheter Model IC4593, connected to an Alsius Catheter Thermal Regulation System, is indicated for use:
- . in cardiac surgery patients to achieve and or maintain normothermia during surgery and recovery/intensive care, and
- to induce, maintain and reverse mild hypothermia in neurosurgery patients in surgery . and recovery/intensive care.
Product codes
NCX
Device Description
The QUATTRO catheters are multi lumen intravascular catheters in various sizes. In common across the models, the catheters have two lumens that are used to circulate sterile saline to exchange heat with the central venous blood supply. When the heat exchange feature of the catheter is in use, heated/chilled saline is pumped through the heat exchange lumen, expanding the diameter of the distal portion of the catheter to a nominal 5mm or 8mm where the heating/cooling membranes interface with the patient's circulating blood.
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
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
Image /page/0/Picture/0 description: The image shows the logo for Alsius Corporation. The logo is in a serif font and is black and white. The word "Alsius" is in a larger font than the word "Corporation". The word "Corporation" is in all caps and is spaced out.
510K Summary ﮧ
510(K) SUMMARY FOR ALSIUS CORPORTATION'S QUATTRO CATHETER MODEL IC4593
Submitter's Name, Address, Telephone Number, and Contact Person:
ALSIUS CORPORATION 15770 Laguna Canyon Road, Suite 150 Irvine, CA 92618
FEB 1 5 2007
Contact: Ken Collins Phone: 949-453-0150 Fax: 949-453-0250 Email: kcollins@alsius.com
Name of Device:
Quattro Catheter Model IC4593
Common or Usual Name:
Central Venous Catheter (short term) and Thermal Regulating System.
Classification Name:
21 CFR 870.5900 System, hypothermia, intravenous, cooling
Predicate Device:
K052443 Alsius Icy Catheter Kit Model IC-3893A Decision Date 10/17/2005
Substantially equivalent (SE) Decision
Indications for Use
The Quattro Catheter Model IC4593, connected to an Alsius Catheter Thermal Regulation System, is indicated for use:
- . in cardiac surgery patients to achieve and or maintain normothermia during surgery and recovery/intensive care, and
- to induce, maintain and reverse mild hypothermia in neurosurgery patients in surgery . and recovery/intensive care.
Technical Characteristics:
The QUATTRO catheters are multi lumen intravascular catheters in various sizes. In common across the models, the catheters have two lumens that are used to circulate sterile saline to exchange heat with the central venous blood supply. When the heat exchange feature of the catheter is in use, heated/chilled saline is pumped through the heat exchange lumen, expanding the diameter of the distal portion of the catheter to a nominal 5mm or 8mm where the heating/cooling membranes interface with the patient's circulating blood.
Page 21
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with a serpent entwined around it. The caduceus is positioned to the right of the text, which reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement around the left side of the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Alsius Corporation % Kenneth A. Collins, MD Executive Vice President 15770 Laguna Canyon Road Suite 150 Irvine, California 92618
FEB 1 5 2007
Re: K070161
Trade/Device Name: Alsius Quattro Catheter Model IC4593 Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal regulating system Regulatory Class: II Product Code: NCX Dated: January 12, 2007 Received: January 17, 2007
Dear Dr. Collins:
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
2
Page 2 - Kenneth A. Collins, MD
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 Ilegally marketed predicate device results in a classification for your device and thus, perroots 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 (240) 276-0115. Also, please 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Mark N. Mekerson
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): K07XXXXX
Device Name:
Alsius Quattro Catheter Model IC4593
Indications for Use:
The Quattro Catheter Model IC4593, connected to an Alsius Catheter Thermal Regulation System, is indicated for use:
- in cardiac surgery patients to achieve and or maintain normothermia during � surgery and recovery/intensive care, and
- to induce, maintain and reverse mild hypothermia in neurosurgery patients in . surgery and recovery/intensive care.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of General, Restoralive, and Neurological Devices
Page 1 of 1
Neurological Devices
510(k) Number K070162
Page 19 of 61