Altrix Precision Temperature Management System

K152266 · Stryker Medical · DWJ · Dec 2, 2016 · Cardiovascular

Device Facts

• Record ID: K152266
• Device Name: Altrix Precision Temperature Management System
• Applicant: Stryker Medical
• Product Code: DWJ · Cardiovascular
• Decision Date: Dec 2, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5900
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended 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

Device Story

Altrix Precision Temperature Management System regulates human body temperature by circulating temperature-controlled water through patient-contact thermal transfer devices (blankets/wraps). System inputs include user-selected temperature settings via graphical interface and real-time patient temperature data from 400-series probes. Controller uses a microprocessor to manage a 500W cartridge heater and refrigeration system, providing closed-loop feedback for automatic temperature control. Output includes regulated water flow to single or multiple circuits. Used in clinical settings (OR, ICU, etc.) by physicians/clinicians. System provides visual/audible alarms for safety limit breaches, system irregularities, or temperature deviations. Benefits include precise maintenance of normothermia or therapeutic temperature reduction in hyperthermic patients. Includes patient temperature output reference signal for third-party system integration.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, including warming/cooling performance, mechanical/thermal overload, environmental testing, fluid intrusion, packaging, and disinfection validation (M. Mucogenicum). Compliance with recognized safety and performance standards (IEC/ISO/ANSI) verified.

Technological Characteristics

Microprocessor-controlled thermal regulating system. Materials: Vinyl hoses with Clik-tite/Colder connectors. Energy: 120V/60Hz AC, 500W cartridge heater, refrigeration system. Dimensions: 42.5"h x 23"d x 15"w. Connectivity: Patient temperature output reference signal for third-party systems. Sterilization: Sterile patient probes. Standards: ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-8, IEC 60601-1-10, IEC 80601-2-35, ISO 80601-2-56, ISO 10993.

Indications for Use

Indicated for adult and pediatric patients requiring body temperature regulation (warming or cooling) in clinical settings including coronary care, operating, recovery, emergency, burn, and medical/surgical units. Contraindications not specified.

Regulatory Classification

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.

Predicate Devices

• Medi-Therm Hyper/Hypothermia System (K100585)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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) |
|-------------------------------------------------|
|-------------------------------------------------|

| <span style="font-family: Arial, sans-serif;"> <span style="font-size: 10pt;"> <span style="color: black;"> <span style="font-weight: bold;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </span> </span> |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-family: Arial, sans-serif;"> <span style="font-size: 10pt;"> <span style="color: black;"> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </span> </span> |

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 Ave<br>Portage, 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 Precision<br>Temperature Management System | Predicate Device: Medi-Therm<br>Hyper/Hypothermia System | Comparison |
|--------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| 510(k) | | K100585 | |
| | General | | |
| Indications for<br>Use | The Altrix system is intended for<br>circulating temperature controlled warm<br>or cold water via patient contact thermal<br>transfer devices for the application of<br>regulating human body temperature in<br>situations where a physician or clinician<br>with prescription privileges determines<br>that temperature therapy is necessary or<br>desirable.<br>a. Maintain pre-set body temperature<br>as determined by the physician<br>b. Maintain normal body temperature<br>during surgical procedures<br>c. For use in all clinical settings<br>including coronary care units,<br>operating, recovery and emergency<br>departments, burn units, and<br>medical/surgical units<br>d. Adult and pediatric patients<br>e. Monitoring and controlling patient<br>temperature<br>f. Temperature reduction in patients<br>where clinically indicated, e.g. in<br>hyperthermic patients | The Medi-Therm is intended for use in<br>supplying warm or cold water at<br>controlled temperatures via water<br>circulating blankets or body wraps for<br>the application of regulating patient<br>temperature in situations where a<br>physician determines that temperature<br>therapy is necessary and desirable.<br>a. To maintain pre-set body temperature<br>as determined by the physician<br>b. To maintain normal body temperature<br>during surgical procedures<br>c. For use in all hospital areas including<br>invasive and coronary care units, in<br>operating, recovery and emergency<br>rooms, in burn units and on<br>medical/surgical floors<br>d. This system can be used with adult<br>and pediatric patients<br>e. Monitoring and controlling patient<br>temperature<br>f. Temperature reduction in patients<br>where clinically indicated, e.g. in<br>hyperthermic patients | Same |
| Anatomical<br>Site | 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 -<br>AC/hertz | 120/60 | 120/60 | Same |
| Current (A) | 12 | 11.5 | Similar |
| Heat Source | 500W Cartridge heater | 500W Cartridge heater | Same |
| Circulating<br>Fluid | Water | Water | Same |
| Flow Rate | 1.2 L/Min (minimum) | 1 L/Min (minimum) | Similar |
| Reservoir<br>Volume | 5.0 L | 9.5 L | Different |
| Outlet Ports | 3 | 2 | Different |
| Control | Microprocessor | Microprocessor | Same |
| Modes | Automatic, Manual, Monitor | Automatic, Manual, Monitor | Same |
| Automatic<br>Mode<br>Warming<br>Rates | Min, Med, Max, Custom | Gradual, Moderate, Rapid | Similar |
| Automatic<br>Mode Cooling<br>Rates | Min, Med, Max | Gradual, Moderate, Rapid | Same |
| Setting Range<br>- Water<br>Temperature | 4.0 - 40.0° C | 4 - 42° C | Different |
| Controller<br>Accuracy -<br>Water<br>Temperature | $\pm$ 0.3° C | $\pm$ 0.8° C | Different |
| Display<br>Accuracy -<br>Water<br>Temperature | $\pm$ 0.2° C | $\pm$ 0.3° C | Different |
| Settings Range<br>-Patient<br>Temperature | 32.0 - 38.0° C | 30 - 41° C | Similar |
| Controller<br>Accuracy -<br>Patient<br>Temperature | $\pm$ 0.3°C (25.0° - 45.0° C) | $\pm$ 0.5° C | Different |
| Patient<br>Temperature<br>Display<br>Accuracy | $\pm$ 0.3° ( 25.0° - 45° C) | $\pm$ 0.3° C | Same |
| Patient<br>Temperature<br>Output<br>Capability | Yes | No | Different |
| Controller<br>Dimensions | 42.5" h x 23" d x 15" w | 37"h x18.75"d x14"w | Similar |
| Weight<br>(without<br>water) | 150 lbs | 141 lbs | Similar |
| <b>SAFETY</b> | | | |
| Patient Probe<br>Alarm | Yes | Yes | Same |
| Patient<br>Temperature<br>Deviation<br>Alarm | Yes | No | Different |
| Normothermia<br>Deviation<br>Alarm | Yes | No | Different |
| High Water<br>Temp Limits<br>(software) | $>42.5° C$ | $43° C$ | Similar |
| Water<br>Temperature<br>Deviation<br>Alarm | Yes; ±0.8° C | No | Different |
| System Self-<br>Test at Power-<br>up | Yes | Yes | Same |
| Water Level<br>Alarm | Yes | Yes | Same |
| Water Flow<br>Alarm | Yes (for each water circuit) | Yes…