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 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.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called "Altrix Temperature Management Wraps". This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance acceptance criteria through the kind of study typically associated with AI/ML-based medical devices (e.g., studies for diagnostic accuracy, sensitivity, specificity, or human improvement with AI assistance).

The device in question, a temperature management wrap, is a physical device that circulates temperature-controlled water for body temperature regulation. It is not an AI/ML-driven diagnostic or assistive device. Therefore, the questions about MRMC studies, standalone algorithm performance, expert ground truth adjudication, training set sizes, and deep learning model specific criteria are not applicable to the information contained in this 510(k) submission.

This document primarily assesses the device's safety and performance through non-clinical bench testing and compliance with recognized standards, and compares its technological characteristics to a legally marketed predicate device.

Given this context, I will address the relevant points based on the provided text, and explicitly state when a question is not applicable.

Acceptance Criteria and Device Performance (for a physical temperature management wrap)

Since this is a physical device aiming for substantial equivalence to a predicate, the "acceptance criteria" are primarily established by compliance with recognized safety and performance standards for thermal regulating systems and demonstration of equivalent physical and functional characteristics to the predicate. The "reported device performance" refers to the successful completion of these tests.

Table of Acceptance Criteria and Reported Device Performance (as inferred from the document):

Acceptance Criteria Category	Specific Criteria (Implied)	Reported Device Performance (Study Outcome)
Compliance to Safety & Essential Performance Standards	Adherence to relevant sections of: - ANSI/AAMI ES60601-1:2005 (R)2012 and A1 2012, C1: 2009(R) 2012 and A2:2010/(R)2012 (Medical Electrical Equipment - General Requirements for Basic Safety and Essential Performance)- IEC80601-2-35: 2009 (Safety and Essential Performance of Heating Devices Using Blankets, Pads or Mattresses)	"Altrix Wraps were designed and/or tested to be in compliance with the relevant sections of the following standards: ... AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012, C1:2009(R)2012 And A2:2010/(R)2012 ... IEC 80601-2-35 Ed 2.0 - 2009-10 ... The results of the non-clinical bench and standards testing concluded Altrix Wraps are substantially equivalent to the predicate device."
Biocompatibility	Adherence to ISO 10993 series (ISO 10993-1, ISO 10993-5, ISO 10993-10)	"Biocompatibility: ISO 10993-1; ISO 10993-5; ISO 10993-10" (under Predicate Comparison Table indicating "Same" as predicate). "Altrix Wraps were designed and/or tested to be in compliance with the relevant sections of the following standards: ... AAMI / ANSI / ISO 10993-1:2009/(R) 2013 ... AAMI / ANSI / ISO 10993-5:2009/(R) 2014 ... AAMI / ANSI / ISO 10993-10:2010." The results concluded substantial equivalence.
Device Function & Performance	Expected performance in temperature warming/cooling, mechanical overload conditions, environmental stability, and packaging integrity.	"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."
Risk Management	Compliance with ISO 14971 (Application of Risk Management To Medical Devices)	"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." The results concluded substantial equivalence.
Substantial Equivalence to Predicate Device (Rapr-Round)	The device should have the same intended/indications for use, basic principles of operation, basic design, operational characteristics, and comparable technological characteristics, or any differences do not raise new questions of safety and effectiveness.	"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." The comparison table (Table 5-1) explicitly states "Same" for Indications for Use, Anatomical Site, Sterility, Basic Safety and Essential Performance Standards, Basic Safety and Essential Performance for Heating Devices, and Biocompatibility. The material is noted as "Different" but this was addressed through testing to still demonstrate equivalence overall. The conclusion states: "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."

Addressing Specific Questions (in the context of this device type):

A table of acceptance criteria and the reported device performance: See the table above. The "acceptance criteria" here are largely defined by adherence to recognized standards and successful outcomes of non-clinical bench tests demonstrating equivalent performance to the predicate.
Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Sample Size for Test Set: Not applicable in the context of human data or AI model testing. The "test set" here refers to the physical samples of the Altrix Temperature Management Wraps and components used for various non-clinical bench tests (e.g., temperature warming/cooling performance, mechanical overload, environmental, packaging), and material samples for biocompatibility testing. The specific number of wraps/components tested for each bench test is not specified in this summary, which is typical for a 510(k) summary as detailed test protocols and results are in the full submission, not the public summary.
- Data Provenance: Not applicable as this is not a study involving human patient data or AI algorithm performance on such data. The data originates from internal engineering and biocompatibility laboratory testing conducted by Stryker Medical.
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. This device does not involve subjective assessment or diagnostic interpretation where "ground truth" established by human experts is required (as it would be for an AI diagnostic algorithm). The "ground truth" for this device is based on objective, quantifiable physical properties, performance metrics, and adherence to engineering and safety standards.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. There is no human interpretation or subjective assessment that would require an adjudication method.
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/ML device that assists human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" (or basis for verification) for this physical device is primarily:
- Objective Engineering Specifications: Defined performance parameters for temperature regulation, mechanical durability, etc.
- Recognized Industry Standards: Compliance with ISO and ANSI/AAMI standards for medical electrical equipment, heating devices, biocompatibility, and risk management.
- Predicate Device Characteristics: The established safety and performance profile of the legally marketed predicate device (Altrix Precision Temperature Management System - Rapr-Round).
The sample size for the training set: Not applicable. There is no "training set" as this is not an AI/ML device.
How the ground truth for the training set was established: Not applicable, as there is no training set for an AI/ML model.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K171149

Device Name Altrix Temperature Management Wraps

Indications for Use (Describe)

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)

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Section 5

510(k) Summary

Altrix Temperature Management Wraps

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:	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

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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 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

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.

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Category	Subject Device: Altrix TemperatureManagement Wraps	Predicate Device: Altrix PrecisionTemperature Management System -	Comparison
		Rapr·Round
510(k)		K152266
Indications forUse	The Altrix system is intended for circulating temperature controlled warm or cold watervia patient contact thermal transfer devices for the application of regulating human bodytemperature in situations where a physician or clinician with prescription privilegesdetermines that temperature therapy is necessary or desirable.Indications for use for the Altrix system include:Maintain pre-set body temperature as determined by the physiciana.b. Maintain normal body temperature during surgical proceduresc. For use in all clinical settings including coronary care units. operating, recovery andemergency departments, burn units, and medical/surgical unitsd. Adult and pediatric patientse. Monitoring and controlling patient temperaturef. Temperature reduction in patients where clinically indicated, e.g. in hyperthermicpatients		Same
Anatomical Site	Torso. Thigh		Same
Sterilitv	Non-sterile		Same
Material	Polymer film, nonwoven, insulationmaterial	Polymer film, nonwoven	Different
Basic Safety andEssentialPerformance	ANSI/AAMI ES60601-1:2005 (R)2012 and A1 2012, C1: 2009(R) 2012 andA2:2010/(R)2012		Same
Basic Safety andEssentialPerformance forHeating 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

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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.

Regulation Number and Section

§ 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).