(133 days)
Not Found
No
The description focuses on standard temperature regulation and control mechanisms, with no mention of AI or ML terms or functionalities.
Yes.
The device is intended for "regulating human body temperature" and "temperature reduction in patients where clinically indicated," which are therapeutic applications.
No
The device is intended for regulating human body temperature through thermal transfer, not for diagnosing medical conditions. It monitors temperature as part of its therapeutic function, but monitoring alone does not make it a diagnostic device.
No
The device description explicitly lists hardware components such as a controller, hose sets, thermal transfer devices, patient temperature probes, and adaptor cables, indicating it is not solely software.
Based on the provided information, the Altrix system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the system is for "regulating human body temperature" through "patient contact thermal transfer devices." This is a therapeutic function, not a diagnostic one.
- Device Description: The description details a system that circulates temperature-controlled water for external application to the patient's body. This aligns with a temperature management device, not a device used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information based on laboratory tests.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Altrix system's function is to directly influence the patient's body temperature, which is a therapeutic intervention.
N/A
Intended Use / Indications for Use
The Altrix system is intended for circulating temperature controlled warm or cold water via patient contact thermal transfer devices for the application of regulating human body temperature in situations where a physician with prescription privileges determines that temperature therapy is necessary or desirable.
Indications for use for the Altrix system include:
a. Maintain pre-set body temperature as determined by the physician
b. Maintain normal body temperature during surgical procedures
c. For use in all clinical settings including coronary care units, operating, recovery and emergency departments, burn units, and medical/surgical units
d. Adult and pediatric patients
e. Monitoring and controlling patient temperature
f. Temperature reduction in patients where clinically indicated, e.g. in hyperthermic patients
Product codes (comma separated list FDA assigned to the subject device)
DWJ, FLL
Device Description
Altrix components include the controller, reusable hose set(s), thermal transfer devices, patient temperature probes and reusable adaptor cable(s). The controller regulates water temperatures between 4.0 - 40.0° C and circulates the heated or cooled water via hose set(s) through the thermal transfer device(s). A graphical display provides the user an interface for selecting desired water or patient temperature settings, operating modes, help menus and other key parameters. Visual indicators are displayed to inform the user of system status or when the user must confirm a setting selection. The system's water temperature and flow outputs are monitored to ensure optimal system operation.
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
Adult and pediatric patients
Intended User / Care Setting
For use in all clinical settings including coronary care units, operating, recovery and emergency departments, burn units, and medical/surgical units
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)
Software modifications were completed using a software development life cycle process in accordance with FDA recognized standard 13-32, ANSI AAMI IEC, 62304:2006, Medical device software - Software life cycle processes, and related guidances. Non-clinical bench testing was successfully completed to verify the software modifications meet specified requirements. Software modifications were also validated to user needs with acceptable results. Other modifications were also successfully verified to meet specified requirements. The results of the non-clinical bench testing concluded that the subject device is substantially equivalent to the predicate device.
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.
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.
Not Found
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
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August 10, 2018
Stryker Medical Brian Orwat Principal RA Specialist 3800 East Centre Avenue Portage, Michigan 49002
Re: K180834
Trade/Device Name: Altrix Precision Temperature Management System Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal Regulating System Regulatory Class: Class II Product Code: DWJ. FLL Dated: July 6, 2018 Received: July 9, 2018
Dear Brian Orwat:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrl/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may 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 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Fernanda Aguel Fernando Aguel - S
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K180834
Device Name
Altrix Precision Temperature Management System
Indications for Use (Describe)
The Altrix system is intended for circulating temperature controlled warm or cold water via patient contact thermal transfer devices for the application of regulating human body temperature in situations where a physician with prescription privileges determines that temperature therapy is necessary or desirable.
Indications for use for the Altrix system include:
a. Maintain pre-set body temperature as determined by the physician
b. Maintain normal body temperature during surgical procedures
c. For use in all clinical settings including coronary care units, operating, recovery and emergency departments, burn units, and medical/surgical units
d. Adult and pediatric patients
e. Monitoring and controlling patient temperature
f. Temperature reduction in patients where clinically indicated, e.g. in hyperthermic patients
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Section 5
510(k) Summary
Altrix Precision Temperature Management System
Submitter / 510(k) Holder
| Name: | Stryker Medical |
|---|---|
| Address: | 3800 E. Centre Avenue |
| Portage, MI 49002 | |
| Contact Person: | Brian L. Orwat |
| Telephone: | 269 389 6817 |
| Date Prepared: | March 30, 2018 |
Device Information
| Proprietary Name: | Altrix Precision Temperature Management System
("Altrix") |
|----------------------|-----------------------------------------------------------------------------------------------------|
| Catalog Number: | 8001 |
| Common/Usual Name: | Thermal Regulating System |
| Classification Name: | Thermal Regulating System (21 CFR §870.5900);
Clinical Electronic Thermometer (21 CFR §880.2910) |
| Product Code: | DWJ; FLL |
| Regulation Class: | Class II |
| Review Panel: | Cardiovascular; General Hospital |
Purpose of Traditional 510(k)
The purpose of this Traditional 510(k) is due to modifications of the Altrix software, minor components and labeling related to the modifications.
Predicate Device
Altrix Precision Temperature Management System - K152266
4
Indications for Use
The Altrix system is intended for circulating temperature controlled warm or cold water via patient contact thermal transfer devices for the application human body temperature in situations where a physician or clinician with prescription privileges determines that temperature therapy is necessary or desirable.
Indications for use for the Altrix system include:
- a. Maintain pre-set body temperature as determined by the physician
- b. Maintain normal body temperature during surgical procedures
- c. For use in all clinical settings including coronary care units, operating, recovery and emergency departments, burn units, and medical/surgical units
- d. Adult and pediatric patients
- e. Monitoring and controlling patient temperature
- f. Temperature reduction in patients where clinically indicated, e.g. in hyperthermic patients
Device Description
Altrix components include the controller, reusable hose set(s), thermal transfer devices, patient temperature probes and reusable adaptor cable(s). The controller regulates water temperatures between 4.0 - 40.0° C and circulates the heated or cooled water via hose set(s) through the thermal transfer device(s). A graphical display provides the user an interface for selecting desired water or patient temperature settings, operating modes, help menus and other key parameters. Visual indicators are displayed to inform the user of system status or when the user must confirm a setting selection. The system's water temperature and flow outputs are monitored to ensure optimal system operation.
Technological Characteristics Predicate Comparison Summary
The indications for use, basic functionality and technological characteristics of the subject and predicate devices are the same as cleared per K152266. Modifications to Altrix include:
- Patient temperature control algorithm ●
- Patient temperature deviation alarm configuration
- Water flow alarm configuration
- Minor component changes
- Various Operations Manual updates related to the modifications o
5
Performance/Standards Testing
Software modifications were completed using a software development life cycle process in accordance with FDA recognized standard 13-32, ANSI AAMI IEC, 62304:2006, Medical device software - Software life cycle processes, and related guidances. Non-clinical bench testing was successfully completed to verify the software modifications meet specified requirements. Software modifications were also validated to user needs with acceptable results. Other modifications were also successfully verified to meet specified requirements. The results of the non-clinical bench testing concluded that the subject device is substantially equivalent to the predicate device.
Substantial Equivalence Summary
The Altrix predicate shares the same basic principles of operation, intended/indications for use, basic design, operational and technical characteristics. Altrix is concluded to be substantially equivalent to the predicate device.
Conclusion
Based on Altrix's technological characteristics, completed non-clinical bench testing and comparison with the predicate, it is concluded that the modified Altrix is substantially equivalent to the predicate device.