(133 days)
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
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.
Note: The provided text is a 510(k) summary for a medical device (Altrix Precision Temperature Management System). It describes the device, its intended use, and the basis for its substantial equivalence to a predicate device. This document focuses on regulatory approval and does not contain detailed information about a clinical study or performance evaluation with specific acceptance criteria and outcome metrics that would typically be found in a study report.
Therefore, for aspects like acceptance criteria expressed numerically, sample sizes for test sets, expert involvement in ground truth establishment, MRMC studies, and detailed standalone performance, the information is not present in the provided text. The document primarily discusses bench testing for software modifications and mentions "acceptable results" without quantifying them.
Here's an attempt to structure the answer based on the provided text, highlighting where information is absent and where inferences might be drawn from the context of regulatory submission:
The provided document describes the 510(k) submission for the Altrix Precision Temperature Management System, focusing on modifications to the device's software, minor components, and labeling. The core of the submission is to demonstrate substantial equivalence to a previously cleared predicate device (Altrix Precision Temperature Management System - K152266).
Given the nature of a 510(k) summary for modifications, the "study" proving the device meets acceptance criteria is primarily an engineering verification and validation process, not a clinical trial with human subjects testing the primary efficacy of the device.
Acceptance Criteria and Device Performance (Inferred from Regulatory Context)
Since this 510(k) is for modifications, the acceptance criteria would revolve around demonstrating that the modifications do not adversely affect the device's safety and effectiveness and that the modified device continues to meet the performance specifications established for the original predicate device. The "reported device performance" is described qualitatively as "successfully completed" and "acceptable results."
| Acceptance Criteria (Inferred from 510(k) Submission for Modifications) | Reported Device Performance (From Text) |
|---|---|
| Software Modifications: | |
| Compliance with ANSI AAMI IEC 62304:2006 (Medical device software - Software life cycle processes) and related guidances. | "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." |
| Meet specified requirements through non-clinical bench testing. | "Non-clinical bench testing was successfully completed to verify the software modifications meet specified requirements." |
| Validate user needs with acceptable results. | "Software modifications were also validated to user needs with acceptable results." |
| Other Modifications (minor components, labeling): | |
| Meet specified requirements through verification. | "Other modifications were also successfully verified to meet specified requirements." |
| Overall Performance: | |
| Maintain substantial equivalence to the predicate device. | "The results of the non-clinical bench testing concluded that the subject device is substantially equivalent to the predicate device." |
| No adverse impact on safety or effectiveness due to modifications. | Implied by the conclusion of substantial equivalence. |
Study Details:
-
Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: Not specified quantitatively. The testing involved "non-clinical bench testing." This typically implies testing on devices themselves rather than a dataset of patient images or readings.
- Data Provenance: Not applicable in the traditional sense of patient data. The "testing" refers to the verification and validation of software and hardware changes on the device itself.
- Retrospective or Prospective: Not applicable as it's bench testing, not a clinical data study.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. As this was bench testing for software and minor component modifications, the "ground truth" would be established by engineering specifications, validated test protocols, and potentially expert review of the software design and functionality, rather than human experts labeling medical data.
-
Adjudication method for the test set:
- Not Applicable. There is no mention of human adjudication for the test results described, as the testing focuses on internal device performance against specifications.
-
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:
- No. An MRMC study was not conducted. This device is a thermal regulating system, not an imaging AI diagnostic aid, and the submission is for device modifications, not a de novo AI product. The text does not mention any AI components assisting human readers.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Partially Applicable / Assumed. The "Software modifications were also validated to user needs with acceptable results" and "Non-clinical bench testing was successfully completed to verify the software modifications meet specified requirements" implies testing the algorithm's performance in isolation to ensure it functions as intended based on its design specifications. However, specific standalone performance metrics (e.g., accuracy, precision for a measurement) are not provided in this summary.
-
The type of ground truth used:
- Engineering Specifications / Functional Requirements. For software and hardware modifications, the "ground truth" is defined by the device's design specifications, functional requirements, and the expected output under various conditions, as opposed to clinical outcomes or expert consensus on patient data.
-
The sample size for the training set:
- Not Applicable. This is a 510(k) for modifications to a traditional medical device, not a machine learning or AI model development that requires a "training set" of data.
-
How the ground truth for the training set was established:
- Not Applicable. (See point 7).
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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
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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
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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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Section 5
510(k) Summary
Altrix Precision Temperature Management System
Submitter / 510(k) Holder
| Name: | Stryker Medical |
|---|---|
| Address: | 3800 E. Centre AvenuePortage, 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
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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
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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.
§ 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).