(479 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
The Altrix Precision Temperature Management System 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° C (39.2° F) and 40.0° C (104.0° F) 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.
The controller can supply water to an individual or multiple thermal transfer devices simultaneously with each of these circuits monitored separately. Three operating modes are available to facilitate patient care: Automatic, Manual and Monitor. The patient temperature probe is used with the controller to provide closed loop feedback for automatic patient temperature management and monitoring. The controller alarms activate visual and audible indications for when safety parameters are exceeded or it detects system function or performance irregularities. The Altrix system also includes the ability to provide a patient temperature output reference signal to be connected to a non-specific third party device/system.
The provided document is a 510(k) premarket notification for the Altrix Precision Temperature Management System. It primarily focuses on demonstrating substantial equivalence to a predicate device (Medi-Therm Hyper/Hypothermia System) through a comparison of technological characteristics and non-clinical bench testing.
Therefore, the acceptance criteria and study information requested typically associated with clinical performance studies (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth for training) are not fully available or directly applicable in the same way as they would be for a device that relies on clinical performance data for its clearance.
Here's a breakdown of the information that is available, and what is not:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the sense of predefined thresholds for clinical performance metrics (like sensitivity, specificity, accuracy) using a clinical dataset. Instead, the "acceptance criteria" for this premarket notification are demonstrated through:
- Substantial Equivalence: The primary acceptance criterion is that the Altrix device is substantially equivalent to the predicate device (Medi-Therm Hyper/Hypothermia System) in terms of indications for use, technological characteristics, safety, and performance.
- Compliance with Standards: The device must comply with relevant recognized safety and performance standards.
- Successful Bench Testing: Non-clinical bench testing must successfully verify the device's function and performance to specified engineering requirements.
Table of Performance (derived from "Technological Characteristics and Substantial Equivalence Summary" and "Bench and Standards Testing"):
| Category / Criterion | Acceptance Criteria (Predicate or Standard) | Reported Device Performance (Altrix) |
|---|---|---|
| Indications for Use | Same as Medi-Therm | Same as Medi-Therm |
| Temperature Control Range - Water | 4 - 42° C (Medi-Therm) | 4.0 - 40.0° C |
| Controller Accuracy - Water Temperature | ± 0.8° C (Medi-Therm) | ± 0.3° C |
| Display Accuracy - Water Temperature | ± 0.3° C (Medi-Therm) | ± 0.2° C |
| Settings Range - Patient Temperature | 30 - 41° C (Medi-Therm) | 32.0 - 38.0° C |
| Controller Accuracy - Patient Temperature | ± 0.5° C (Medi-Therm) | ± 0.3°C (25.0° - 45.0° C) |
| Patient Temperature Display Accuracy | ± 0.3° C (Medi-Therm) | ± 0.3° ( 25.0° - 45° C) |
| High Water Temperature Limit (Software) | 43° C (Medi-Therm) | >42.5° C |
| Water Temperature Deviation Alarm | No (Medi-Therm) | Yes; ±0.8° C |
| General Safety Standard Compliance | UL 416 (Medi-Therm) | ANSI/AAMI ES60601-1:2005(R)2012 and A1 2012, C1: 2009/(R)2012 and A2:2010/(R)2012 (and other specific IEC/ISO standards listed) |
| EMC/EMI Standard Compliance | EN60601-1-2 (Medi-Therm) | IEC60601-1-2 |
| Bench Testing (General) | Successful verification of functions and performance to specified requirements | Successfully verified warming/cooling performance, mechanical/thermal overload, controller abuse, environmental, fluid intrusion, packaging. Disinfection validated. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not Applicable in a clinical sense. The device relies on non-clinical bench testing, not a clinical "test set" of patient data. The provenance of the bench testing data would be from Stryker Medical's internal labs.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not Applicable. No clinical test set with human-established ground truth was used for this 510(k) clearance, as clinical testing was deemed not required.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. No clinical test set requiring adjudication was used.
5. 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 Applicable. This is not an AI-assisted diagnostic device, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a temperature management system, not an algorithm, and its performance is evaluated through engineering and functional testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the non-clinical bench testing, the "ground truth" refers to engineering specifications, physical measurements (e.g., temperature, flow rates), and compliance with recognized industry standards. These are objective, measurable criteria.
8. The sample size for the training set
- Not Applicable. There is no mention of a training set as this is not a machine learning/AI device.
9. How the ground truth for the training set was established
- Not Applicable. No training set was used.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 02, 2016
Stryker Medical Brian Orwat Sr. Staff Regulatory Affairs Specialist 3800 East Centre Avenue Portage, Michigan 49002
Re: K152266
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: November 18, 2016 Received: November 21, 2016
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. 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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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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 advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
M.A. Hillebrand
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) K152266
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) |
|---|
| ------------------------------------------------- |
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
escription OSC (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 AvePortage, MI 49002 |
| Contact Person: | Brian L. Orwat |
| Telephone: | 269 389 6817 |
| Date Prepared: | August 10, 2015 |
Device Name
| Proprietary Name: | Altrix Precision Temperature Management System |
|---|---|
| Catalog Number: | 8001 |
| Common/Usual Name: | Hyper/Hypothermia System |
| Classification Name: | Thermal Regulating System (21 CFR 870.5900) |
| Product Code: | DWJ |
| Regulation Class: | Class II |
| Review Panel: | Cardiovascular |
| Classification Name: | Clinical Electronic Thermometer (21 CFR 880.2910) |
| Product Code: | FLL |
| Regulation Class: | Class II |
| Review Panel: | General Hospital |
Predicate Device
Stryker Medical claims substantial equivalence to Stryker Medical (previously Gaymar Industries Inc.) Medi-Therm Hyper/Hypothermia System cleared per K100585.
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Device Description
The Altrix Precision Temperature Management System 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° C (39.2° F) and 40.0° C (104.0° F) 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.
The controller can supply water to an individual or multiple thermal transfer devices simultaneously with each of these circuits monitored separately. Three operating modes are available to facilitate patient care: Automatic, Manual and Monitor. The patient temperature probe is used with the controller to provide closed loop feedback for automatic patient temperature management and monitoring. The controller alarms activate visual and audible indications for when safety parameters are exceeded or it detects system function or performance irregularities. The Altrix system also includes the ability to provide a patient temperature output reference signal to be connected to a non-specific third party device/system.
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 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
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Technological Characteristics and Substantial Equivalence Summary
Both Altrix and Medi-Therm share the same basic principles of operation. Altrix and Medi-Therm are temperature management systems that circulate temperature controlled water via centrifugal pump through a configurable combination of hoses connected to single or multiple thermal transfer devices which can be applied around, placed over or under a patient. Both systems use a heater to increase water temperature and a refrigeration system to decrease water temperature. Delivery and removal of thermal energy to and from the patient occurs at the contact point of the patient skin and thermal transfer device to raise or lower patient temperature. A patient temperature probe can also be used with each device to provide closed-loop feedback for patient temperature control capability.
| Category | Subject Device: Altrix PrecisionTemperature Management System | Predicate Device: Medi-ThermHyper/Hypothermia System | Comparison |
|---|---|---|---|
| 510(k) | K100585 | ||
| General | |||
| Indications forUse | The Altrix system is intended forcirculating temperature controlled warmor cold water via patient contact thermaltransfer devices for the application ofregulating human body temperature insituations where a physician or clinicianwith prescription privileges determinesthat temperature therapy is necessary ordesirable.a. Maintain pre-set body temperatureas determined by the physicianb. Maintain normal body temperatureduring surgical proceduresc. For use in all clinical settingsincluding coronary care units,operating, recovery and emergencydepartments, burn units, andmedical/surgical unitsd. Adult and pediatric patientse. Monitoring and controlling patienttemperaturef. Temperature reduction in patientswhere clinically indicated, e.g. inhyperthermic patients | The Medi-Therm is intended for use insupplying warm or cold water atcontrolled temperatures via watercirculating blankets or body wraps forthe application of regulating patienttemperature in situations where aphysician determines that temperaturetherapy is necessary and desirable.a. To maintain pre-set body temperatureas determined by the physicianb. To maintain normal body temperatureduring surgical proceduresc. For use in all hospital areas includinginvasive and coronary care units, inoperating, recovery and emergencyrooms, in burn units and onmedical/surgical floorsd. This system can be used with adultand pediatric patientse. Monitoring and controlling patienttemperaturef. Temperature reduction in patientswhere clinically indicated, e.g. inhyperthermic patients | Same |
| AnatomicalSite | Trunk; upper and lower extremities | Trunk; upper and lower extremities | Same |
| Sterility | Accessory patient probes only | Non-sterile accessories | Different |
| Rx Only | Yes | Yes | Same |
| Voltage -AC/hertz | 120/60 | 120/60 | Same |
| Current (A) | 12 | 11.5 | Similar |
| Heat Source | 500W Cartridge heater | 500W Cartridge heater | Same |
| CirculatingFluid | Water | Water | Same |
| Flow Rate | 1.2 L/Min (minimum) | 1 L/Min (minimum) | Similar |
| ReservoirVolume | 5.0 L | 9.5 L | Different |
| Outlet Ports | 3 | 2 | Different |
| Control | Microprocessor | Microprocessor | Same |
| Modes | Automatic, Manual, Monitor | Automatic, Manual, Monitor | Same |
| AutomaticModeWarmingRates | Min, Med, Max, Custom | Gradual, Moderate, Rapid | Similar |
| AutomaticMode CoolingRates | Min, Med, Max | Gradual, Moderate, Rapid | Same |
| Setting Range- WaterTemperature | 4.0 - 40.0° C | 4 - 42° C | Different |
| ControllerAccuracy -WaterTemperature | $\pm$ 0.3° C | $\pm$ 0.8° C | Different |
| DisplayAccuracy -WaterTemperature | $\pm$ 0.2° C | $\pm$ 0.3° C | Different |
| Settings Range-PatientTemperature | 32.0 - 38.0° C | 30 - 41° C | Similar |
| ControllerAccuracy -PatientTemperature | $\pm$ 0.3°C (25.0° - 45.0° C) | $\pm$ 0.5° C | Different |
| PatientTemperatureDisplayAccuracy | $\pm$ 0.3° ( 25.0° - 45° C) | $\pm$ 0.3° C | Same |
| PatientTemperatureOutputCapability | Yes | No | Different |
| ControllerDimensions | 42.5" h x 23" d x 15" w | 37"h x18.75"d x14"w | Similar |
| Weight(withoutwater) | 150 lbs | 141 lbs | Similar |
| SAFETY | |||
| Patient ProbeAlarm | Yes | Yes | Same |
| PatientTemperatureDeviationAlarm | Yes | No | Different |
| NormothermiaDeviationAlarm | Yes | No | Different |
| High WaterTemp Limits(software) | $>42.5° C$ | $43° C$ | Similar |
| WaterTemperatureDeviationAlarm | Yes; ±0.8° C | No | Different |
| System Self-Test at Power-up | Yes | Yes | Same |
| Water LevelAlarm | Yes | Yes | Same |
| Water FlowAlarm | Yes (for each water circuit) | Yes | Same |
| Generalrequirementsfor basicsafety andessentialperformance | Yes; ANSI/AAMI ES60601-1:2005(R)2012 and A1 2012, C1: 2009/(R)2012 and A2:2010/(R)2012 | No; UL 416 (Refrigerated MedicalEquipment) | Different |
| EMC/EMI | IEC60601-1-2 | EN60601-1-2 | Same |
| Basic Safetyand EssentialPerformancefor HeatingDevices | IEC80601-2-35 | No | Different |
| Basic Safetyand EssentialPerformanceof ClinicalThermometers | ISO 80601-2-56 | No | Different |
| ACCESSORIES | |||
| Patient Probes | 400 series; Sterile; skin,rectal/esophageal, catheter | 400 series; Non-sterile; skin,rectal/esophageal | Similar |
| Hose | Vinyl with Clik-tite connector andinsulation sleeve; Vinyl with Colderconnector and insulation sleeve | Vinyl with Clik-tite connector | Similar |
| ReusableAdapter Cable | Yes; with IEC compliant connector | Yes; with 1/4" phono connector | Similar |
| PatientContactDevice | Mul·T·Blankets; Rapr·Round BodyWraps | Mul·T·Blankets; Rapr·Round BodyWraps | Same |
Table 5-1 summarizes the main technological characteristics between Altrix and the predicate device.
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Table 5-1 – Altrix Predicate Comparison
The indications for use, basic design, operational and technical characteristics of the Altrix Precision Temperature Management System is substantially equivalent to the predicate Medi-Therm Hyper/Hypothermia System.
Bench and Standards Testing
Non-Clinical bench testing was successfully completed to verify Altrix's function and performance to specified requirements. Bench testing included warming and cooling performance, mechanical and thermal overload conditions, controller abuse, environmental, fluid intrusion, and packaging.
Disinfection of the Altrix internal water system was validated using M. Mucogenicum. Additionally, Altrix was designed and/or tested to be in compliance with the relevant sections of the following standards.
- ISO 14971 Second Edition 2007-03-01 - Medical Devices - Application Of Risk Management To Medical Devices
- AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012, C1:2009/(R)2012 And A2:2010/(R)2012 ● - Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance
- AAMI / ANSI / IEC 60601-1-2:2007/(R)2012 Medical Electrical Equipment Part 1-2: General ● Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests
- IEC 60601-1-6 Ed 3.0 2010-01- Medical Electrical Equipment -- Part 1-6: General . Requirements For Basic Safety And Essential Performance -- Collateral Standard: Usability
- . IEC 60601-1-8 Ed 2.1 - 2012-11- Medical Electrical Equipment - Part 1-8: General Requirements For Basic Safety And Essential Performance - Collateral Standard: General Requirements, Tests And Guidance For Alarm Systems In Medical Electrical Equipment
- IEC 60601-1-10 Ed 1.0 - 2007-11 - Medical Electrical Equipment - Part 1-10: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Requirements For The Development Of Physiologic Closed-Loop Controllers
- . IEC 80601-2-35 Ed 2.0 - 2009-10 - Medical Electrical Equipment - Part 2-35: Particular Requirements For The Basic Safety And Essential Performance Of Heating Devices Using Blankets, Pads Or Mattresses And Intended For Heating In Medical Use
- IEC 62304 First Ed 2006-05- Medical Device Software Software Life Cycle Processes ●
- . AAMI / ANSI / ISO 15223-1:2012 - Medical devices -- Symbols to be used with medical device labels, labeling and information to be supplied -- Part 1: General requirements
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- . AAMI / ANSI / IEC 62366:2007/(R) 2013 - Medical Devices - Application Of Usability Engineering To Medical Devices.
- ISO 80601-2-56 First Ed 2009-10-01- Medical Electrical Equipment - Part 2-56: Particular Requirements For Basic Safety And Essential Performance Of Clinical Thermometers For Body Temperature Measurement
- AAMI / ANSI / ISO 10993-1:2009/(R) 2013 - Biological Evaluation Of Medical Devices -- Part 1: Evaluation And Testing Within A Risk Management Process
- AAMI / ANSI / ISO 10993-5:2009/(R) 2014 - Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
- AAMI / ANSI / ISO 10993-10:2010 Biological Evaluation Of Medical Devices Part 10: Tests . For Irritation And Skin Sensitization
The results of the non-clinical bench and standards testing provides evidence of Altrix's substantial equivalence when compared to the predicate device.
Clinical testing was determined not to be required to prove Altrix's substantial equivalence when compared to the predicate device.
Conclusion
The Altrix Precision Temperature Management System has been designed, tested and confirmed to comply with recognized safety and performance standards applicable to medical devices.
Based on Altrix's technological characteristics, completed non-clinical bench testing and comparison with the predicate device, we conclude that Altrix performs as well or better and is substantially equivalent to the predicate Medi-Therm 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).