(309 days)
No
The summary describes a system for temperature management using a catheter, heat exchange cassette, and controller. There is no mention of AI or ML in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is described as raising, lowering, and/or maintaining blood temperature in cardiac surgery patients during surgery and recovery/intensive care, which is a therapeutic intervention.
No
The SetPoint® System's intended use is to raise, lower, and/or maintain blood temperature, which is a therapeutic function, not a diagnostic one. It does not mention analyzing or interpreting any physiological data to determine the presence or nature of a disease or condition.
No
The device description explicitly lists hardware components such as a catheter, heat exchange cassette, and external controller, in addition to the user interface.
Based on the provided information, the SetPoint® System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "raise, lower, and/or maintain blood temperature" in cardiac surgery patients. This is a therapeutic and physiological intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device description details a system that directly interacts with the patient's blood circulation (via a central venous catheter) to control temperature. This is a direct treatment method.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition. The device's function is purely to manage temperature.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The SetPoint® System does not fit this description.
N/A
Intended Use / Indications for Use
The SetPoint® System is to raise, lower, and/or maintain blood temperature. The SetPoint® System is indicated for use in cardiac surgery patients to achieve and/or maintain normothermia during surgery and recovery/intensive care.
Product codes (comma separated list FDA assigned to the subject device)
NCX
Device Description
The SetPoint System is used to raise, lower, and/or maintain blood temperature. It consists of a single-use, heparin-coated, central venous catheter; a single-use, heat exchange cassette; an external controller; and associated accessories. The Controller unit has a user interface to select operating parameters and is connected to the Catheter via insulated lines. The catheter is designed for placement in the inforior vena cava via the femoral vein using a 10 Fr hemostatic introducer sheath. The Cassette is an integral part to the Catheter and an interface to the Controller.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
inferior vena cava via the femoral vein
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)
The SetPoint® Endovascular Tcmpcrature Management System has been tested for system performance. In addition the Catheter has been tested for functionality in accordance to the BS EN ISO 10555, for biocompatibility in accordance to ISO 10993. The controller has been tested for electrical safety in accordance to EN 60601.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K003724, K894980, K924642, K811742, K873745, K010338, K904404
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 a sequence of handwritten alphanumeric characters. The sequence starts with the letter 'K', followed by the number '0', then '12512'. The characters are written in a cursive style, with varying stroke thicknesses.
Premarket (510[k]) Notification
JUN 1 1 2002
510[k] Summary of Safety and Effectiveness
112
Submitter Information
| Company: | Radiant Medical, Inc. |
|---|---|
| 250 Chesapeake Drive | |
| Redwood City, CA 94063 | |
| (650) 363-8000 | |
| Contact Person: | Andrew Cleeland |
| Vice President of Regulatory, Clinical and Quality Affairs | |
| Summary Date: | August 3, 2001 |
Name and Classification
| Proprietary Name: | SetPoint® Endovascular Temperature Management System |
|---|---|
| Classification Name: | Cardiopulmonary bypass heat exchanger (DTR) [21 CFR 870.4240] |
| Thermal regulating system (DWJ) [21 CFR 870.5900] | |
| Percutaneous catheter (DQY) [21 CFR 870.1250] | |
| Class: | II |
Predicate Devices
The SetPoint System has the same intended use as a number of commercially available medical devices, operates within an cstablished range of temperatures, and uses existing, established technology
- a) The Medtronic cardiopulmonary bypass circuit composed of the: MYOTherm XPTM Cardioplegia Delivery System (K003724), Bio-Cal 370 Temperature Control Module (K894980), and Femoral cannula with introducer (K924642).
- b) The Cincinnati Sub-Zero Hemotherm 400 (K811742).
- c) The Augustine Medical, Inc. Bair Hugger® Patient Warming System (K873745).
- d) The Medivance Artic Sun™ Temperature Management System (K010338).
- e) The Arrow International Inc. Multi-Lumen Central Venous Catheter (K904404).
1
Image /page/1/Picture/0 description: The image shows a logo for Radiant Medical. The logo includes a stylized graphic to the left of the word "Radiant" in large, bold letters. Below "Radiant" is the word "MEDICAL" in smaller letters. Below the logo is the address "10 Chesapeake Drive" followed by "Ashland City".
The Mallinokrodt Mon-a-Therm™ General Purpose Temperature Probe (K890484) ੀ
KO12512
Intended Use
Reinsed
Premarket (510fk]) Notification
The intended use of the SetPoint® System is to raise, lower, and/or maintain blood temperature. The SetPoint® System is indicated for use in cardiac surgery patients to achieve and/or maintain normothermia during surgery and recovery/intensive carc.
Description of Device
The SetPoint System is used to raise, lower, and/or maintain blood temperature. It consists of a single-use, heparin-coated, central venous catheter; a single-use, heat exchange cassette; an external controller; and associated accessories. The Controller unit has a user interface to select operating parameters and is connected to the Catheter via insulated lines. The catheter is designed for placement in the inforior vena cava via the femoral vein using a 10 Fr hemostatic introducer sheath. The Cassette is an integral part to the Catheter and an interface to the Controller.
Summary of Technological Characteristics
The SetPoint System uses established technology, materials, and construction techniques. The system employs standard heat conduction technology to warm or cool the blood using circulating warm or cool fluid in a closed loop system. The SetPoint System accomplishes this heat exchange through a catheter. Jocated in the inferior vena cava, via the femoral vein, thereby adding heat to or removing heat from the blood by means of counter current heat exchange. The microprocessor based Controller circulates the fluid through the system and allows the fluid temperature to be raised or lowered as it passes over a thermoclectric unit within the Controller. Patient temperature is measured by the Controller using common 400 series thermistors.
Performance Test
The SetPoint® Endovascular Tcmpcrature Management System has been tested for system performance. In addition the Catheter has been tested for functionality in accordance to the BS EN ISO 10555, for biocompatibility in accordance to ISO 10993. The controller has been tested for electrical safety in accordance to EN 60601.
Conclusion
Based upon the successful performance tests and the comparison to the predicate devices, the SetPoint® Endovascular Temperature Management System consisting performs with similar safety and effectiveness.
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with three parallel lines above them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Andrew Cleeland Vice President of Regulatory, Clinical and Quality Affairs Radiant Medical, Inc. 250 Chesapeake Drive Redwood City, CA 94063
JUN 1 1 2002
Re: K012512
Trade/Device Name: SetPoint® Endovascular Temperature Management System Regulation Number: 870.5900 Regulation Name: Thermal regulating system Regulatory Class: II Product Code: NCX Dated: May 31, 2002 Received: June 3, 2002
Dear Mr. Cleeland:
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.
3
Page 2 - Mr. Andrew Cleeland
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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,
Celia M. Witten, Ph.D., M.D.
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
4
Radiant Medical Inc.
012512
Statement of Indications for Use
The SetPoint® System is indicated for use in cardiac surgery patients to achieve and/or maintain normothermia during surgery and recovery/intensive care.
Cly Witt
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number k0|2512
Strictly Confidential I his document and the data contained herein may not be reproduced, used or disclosed without the written permission of Radiant Medical Inc.