(90 days)
Not Found
No
The document describes a temperature management system that circulates water for thermal transfer. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the provided text. The performance studies focus on bench testing of the device's function and performance, not on the evaluation of an AI/ML algorithm.
Yes
The device is described as "regulating human body temperature" and is used for "temperature therapy," which are therapeutic applications.
No
Explanation: The device is intended for regulating human body temperature through thermal transfer, not for diagnosing medical conditions. While it monitors and controls temperature (section 'e' of 'Indications for Use'), this function is for therapeutic purposes rather than diagnostic identification of disease states.
No
The device description explicitly mentions "The Altrix Temperature Management Wraps" which are described as "patient contact accessory" and "made from multiple layers of materials sealed together" with a "hose is used to connect the Wraps to the Altrix controller device." This indicates the device includes physical hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Altrix system and its Wraps are designed for external application to the patient's body to regulate temperature through thermal transfer. They do not analyze samples taken from the body.
- Intended Use: The intended use clearly describes regulating human body temperature through patient contact, not analyzing biological samples.
- Device Description: The description focuses on the physical components and how they are applied to the patient's body.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, laboratory procedures, or diagnostic information derived from such analysis.
Therefore, the Altrix system falls under the category of a therapeutic device used for temperature management, not an in vitro diagnostic device.
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
Device Description
The Altrix Temperature Management Wraps are the patient contact accessory for the Altrix Precision Temperature Management System. The Wraps are applied around the patient's thigh and torso. The Wraps are made from multiple layers of materials sealed together. A hose is used to connect the Wraps to the Altrix controller device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Torso, Thigh
Indicated Patient Age Range
Adult and pediatric patients
Intended User / Care Setting
physician or clinician with prescription privileges; 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)
Non-Clinical bench testing was successfully completed to verify Altrix Wraps function and performance to specified requirements. Bench testing included temperature warming and cooling performance, mechanical overload conditions, environmental, and packaging.
The results of the non-clinical bench and standards testing concluded Altrix Wraps are substantially equivalent to the predicate device.
Clinical testing was determined not to be required to prove substantial equivalence 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.
Rapr-Round accessory of the Altrix Precision Temperature Management System - K152266 Stryker Medical
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
Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is a symbol of medicine and healing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 18, 2017
Stryker Medical Brian Orwat Principal Regulatory Affairs Specialist 3800 East Centre Avenue Portage, Michigan 49002
Re: K171149
Trade/Device Name: Altrix Temperature Management Wraps Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal Regulating System Regulatory Class: Class II Product Code: DWJ Dated: April 17, 2017 Received: April 19, 2017
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 of medical device
1
related adverse events) (21 CFR 803); 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.
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,
Kenneth J. Cavanaugh -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) K171149
Device Name Altrix Temperature Management Wraps
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/1 description: The image shows the word "stryker" in a bold, sans-serif font. The letters are all lowercase and black. The word is centered in the image and takes up most of the space. The background is white.
Section 5
510(k) Summary
Altrix Temperature Management Wraps
Submitter / 510(k) Holder
| Name: | Stryker Medical |
|---|---|
| Address: | 3800 E. Centre Ave |
| Portage, MI 49002 | |
| Contact Person: | Brian L. Orwat |
| Telephone: | 269 389 6817 |
| Date Prepared: | April 12, 2017 |
Device Information
| Proprietary Name: | Altrix Temperature Management Wraps |
|---|---|
| Catalog Number: | 8003 |
| Common/Usual Name: | Thermal Regulating System |
| Classification Name: | Thermal Regulating System (21 CFR 870.5900 |
| Product Code: | DWJ |
| Regulation Class: | Class II |
| Review Panel: | Cardiovascular |
Purpose of Traditional 510(k)
The purpose of this 510(k) is to add the accessory patient contacting Altrix Temperature Management Wraps ("Wraps") for use with the Altrix Precision Temperature Management System.
Predicate Device
Rapr-Round accessory of the Altrix Precision Temperature Management System - K152266 Stryker Medical
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 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
Device Description
The Altrix Temperature Management Wraps are the patient contact accessory for the Altrix Precision Temperature Management System. The Wraps are applied around the patient's thigh and torso. The Wraps are made from multiple layers of materials sealed together. A hose is used to connect the Wraps to the Altrix controller device.
Technological Characteristics Predicate Comparison Summary
Temperature controlled water is circulated through the Wraps and Rapr-Round which are applied around the patient for the purpose of thermal regulation through conduction. The Wraps include layers of thin polymer film, nonwoven and insulation materials sealed together to create channels for water flow. Insulated tubing protrudes from the Wraps which connect to hoses which terminate at the Altrix controller.
Table 5-1 summarizes the main technological characteristics between the Wraps and predicate Rapr·Round.
5
| Category | Subject Device: Altrix Temperature
Management Wraps | Predicate Device: Altrix Precision
Temperature Management System - | Comparison |
|---------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|------------|
| | | Rapr·Round | |
| 510(k) | | K152266 | |
| 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:
Maintain pre-set body temperature as determined by the physician
a.
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 | | Same |
| Anatomical Site | Torso. Thigh | | Same |
| Sterilitv | Non-sterile | | Same |
| Material | Polymer film, nonwoven, insulation
material | Polymer film, nonwoven | Different |
| Basic Safety and
Essential
Performance | ANSI/AAMI ES60601-1:2005 (R)2012 and A1 2012, C1: 2009(R) 2012 and
A2:2010/(R)2012 | | Same |
| Basic Safety and
Essential
Performance for
Heating Devices | IEC80601-2-35: 2009 | | Same |
| Biocompatibility | ISO 10993-1; ISO 10993-5; ISO 10993-10 | | Same |
Table 5-1 – Predicate Comparison
Performance/Standards Testing
Non-Clinical bench testing was successfully completed to verify Altrix Wraps function and performance to specified requirements. Bench testing included temperature warming and cooling performance, mechanical overload conditions, environmental, and packaging.
Additionally, Altrix Wraps were 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
6
- 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
- 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
- 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 concluded Altrix Wraps are substantially equivalent to the predicate device.
Clinical testing was determined not to be required to prove substantial equivalence to the predicate device.
Substantial Equivalence Summary
The Altrix Wraps and Rapr Round share the same basic principles of operation, intended/indications for use, basic design, operational and technical characteristics. The Altrix Wraps are substantially equivalent to the predicate Rapr·Round.
Conclusion
The Altrix Wraps have been designed, tested and confirmed to comply with recognized safety and performance standards applicable to this type of medical device.
Based on Altrix Wraps' technological characteristics, completed non-clinical bench testing and comparison with the predicate device, we conclude that Altrix Wraps are substantially equivalent to the predicate Rapr·Round device.