Patient Warming System is a modular, electrically conductive Temperature Management System with adjustable temperature in a pre-defined range. The Patient Warming System is intended to prevent or treat hypothermia and maintain normothermia.

The Patient Warming System is intended primarily for use in hospital and surgical centers.

The Patient Warming System patient population includes adult and pediatric patients but excludes infant and neonatal patients.

Device Description

Patient Warming System is a modular conductive patient warming system to be used during the pre-, intra-, and post-operative stages of surgical procedures to provide heating to patients for treatment of hypothermia, maintenance of normothermia and provide thermal comfort when conditions exist.

The STERIS Patient Warming System is a new product addition to STERIS. The STERIS Patient Warming System consists of a controller and one to three heating accessories as desired by the user such as the Heated Torso Pad and Overbody Warming Blanket. The controller uses software to control the heating elements for warming the contact surface of the accessory to the user selected temperature.

The Patient Warming System will be available in the following configurations.

Controller, Power Supply, and Torso Pad Set (Foot Pad, Heated Torso Pad, ● and Head Pad)
- o Foot Pad and Head Pad are not heated and not subject to this 510(k)
Controller and Power Supply
. Torso Pad Set (Foot Pad, Heated Torso Pad, and Head Pad)
- o Foot Pad and Head Pad are not heated and not subject to this 510(k)
Heated Torso Pad
Overbody Warming Blanket ●

AI/ML Overview

The provided document is a 510(k) Summary for the STERIS Patient Warming System, which is a medical device. It does not describe a study involving an AI/Machine Learning device or a diagnostic device. The acceptance criteria and the study described are for a patient warming system, focusing on its safety, performance, and functionality in maintaining patient normothermia, rather than a diagnostic or imaging-based AI system.

Therefore, many of the requested elements (sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, type of ground truth for AI, etc.) are not applicable to this type of device and the information provided in the document.

However, I can extract the acceptance criteria and reported device performance for the STERIS Patient Warming System as detailed in the document.

Acceptance Criteria and Reported Device Performance for STERIS Patient Warming System

The STERIS Patient Warming System is a patient warming device, not an AI or diagnostic device. The "acceptance criteria" and "study" refer to the non-clinical performance testing conducted to demonstrate substantial equivalence to a predicate device for FDA clearance.

1. Table of Acceptance Criteria and Reported Device Performance:

Test	Acceptance Criteria	Reported Device Performance
Performance Testing	The STERIS Patient Warming System and warming accessories were tested for conformance to IEC 80601-2-35: Particular requirements of the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use.	PASS
Pressure Management	The Underbody Warming Pad must not exhibit a peak pressure higher than 20% more than the existing torso pad. For 5th Percentile female peak pressure shall be below 70 mmHg. For 95th Percentile male peak pressure shall be below 100 mmHg.	PASS
Human Factors	Typical users are capable of following the written instructions for use to correctly use the STERIS Patient Warming System with simulated patients.	PASS
Electromagnetic Compatibility	IEC 60601-1-2:2014 General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests.	PASS
Electrical Safety Conformance	IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance.	PASS
Software Validation	The software that controls the system was validated and determined to operate effectively and as designed.	PASS

Points 2-9 in the Request are Not Applicable to this Device/Submission:

As this is a 510(k) summary for a physical patient warming system and not an AI or diagnostic imaging device, the following points are not addressed by the provided document:

2. Sample sized used for the test set and the data provenance: Not applicable. Tests are functional/safety tests, not data set evaluations.
3. Number of experts used to establish the ground truth... and qualifications: Not applicable. Ground truth for an AI/diagnostic device.
4. Adjudication method for the test set: Not applicable. Ground truth for an AI/diagnostic device.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done...: Not applicable. This is for diagnostic interpretation, not a warming device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. No algorithm for standalone diagnostic performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. "Ground truth" in this context would be physical measurements of temperature, pressure, electrical safety parameters, and successful operation based on standards.
8. The sample size for the training set: Not applicable. No training set for an AI model.
9. How the ground truth for the training set was established: Not applicable. No training set for an AI model.

The document demonstrates that the STERIS Patient Warming System met the established non-clinical performance criteria, confirming its safety and effectiveness relative to a legally marketed predicate device.

Summary

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June 13, 2020

STERIS Corporation Gregory Land Senior Regulatory Affairs Specialist 5960 Heislev Road Mentor, Ohio 44060

Re: K200446

Trade/Device Name: STERIS Patient Warming System Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal Regulating System Regulatory Class: Class II Product Code: DWJ Dated: February 21, 2020 Received: February 24, 2020

Dear Gregory Land:

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/cdrh/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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Fernando Aguel Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K200446

Device Name STERIS Patient Warming System

Indications for Use (Describe)

The Patient Warming System is intended primarily for use in hospital and surgical centers.

The Patient Warming System patient population includes adult and pediatric patients but excludes infant and neonatal 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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510(k) Summary For STERIS Patient Warming System

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 357-9198

Contact:

Mr Gregory Land Senior Regulatory Affairs Specialist Tel: 440-392-7424 Fax: 440-357-9198 greg_land@steris.com

Submission Date: February 21, 2020

K Number: K200446

STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600

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1. Device Name

Trade Name:	STERIS Patient Warming System
Device Class:	Class II
Common/usual Name:	Patient Warming System
Classification Name:	System, Thermal Regulating
Classification Number:	21 CFR 870.5900
Product Code:	DWJ

2. Predicate Device

K112488 - HotDog Patient Warming System Model Numbers: WC0X, WC5X, BXXX, UXXX

3. Device Description

The Patient Warming System will be available in the following configurations.

Controller, Power Supply, and Torso Pad Set (Foot Pad, Heated Torso Pad, ● and Head Pad)
- o Foot Pad and Head Pad are not heated and not subject to this 510(k)
Controller and Power Supply
. Torso Pad Set (Foot Pad, Heated Torso Pad, and Head Pad)
- o Foot Pad and Head Pad are not heated and not subject to this 510(k)
Heated Torso Pad
Overbody Warming Blanket ●

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4. Indications for Use

The Patient Warming System is intended primarily for use in hospital and surgical centers.

The Patient Warming System patient population includes adult and pediatric patients but excludes infant and neonatal patients.

Technological Characteristics Comparison Table ട.

A comparison of technical characteristics between the proposed and predicate devices is summarized in Table 1.

Feature	Proposed DeviceSTERIS Patient WarmingSystem	Predicate DeviceHotDog Patient WarmingSystem (K112488)	Comparison
Indicationsfor Use	Patient Warming System is amodular, electricallyconductive TemperatureManagement System withadjustable temperature in apre-defined range. The PatientWarming System is intendedto prevent or treat hypothermiaand maintain normothermia.The Patient Warming Systemis intended primarily for use inhospital and surgical centers.The Patient Warming Systempatient population includesadult and pediatric patients butexcludes infant and neonatalpatients.	The Hot Dog PatientWarming System is intendedto prevent or treathypothermia and to providewarmth to patients. The HotDog Patient WarmingSystem should be used incircumstances in whichpatients may not maintain astate of normothermia. Thepatient warming system canbe used with adult andpediatric patients.The System is intendedprimarily for use in hospitaland surgical centersincluding without limitationoperating, recovery andemergency rooms and onmedical/surgical floors.	Similar
OperatingPrinciples/Technology	A temperature control unitmonitors and controls thetemperature of a patientwarming mattress and blanket	A temperature control unitmonitors and controls thetemperature of a patientwarming blanket or mattress	Same
Feature	Proposed DeviceSTERIS Patient WarmingSystem	Predicate DeviceHotDog Patient WarmingSystem (K112488)	Comparison
	which provides conductiveheating to a patient.	which provides conductiveheating to a patient.
Where Used	Operating rooms, recoveryrooms and emergency rooms	Operating rooms, recoveryrooms and emergency rooms	Same
SystemComponents	Temperature control unit,blanket, mattress	Temperature control unit,blanket, mattress	Same
TemperatureControl Unit	48 Volt software drivencontrol unit capable ofregulating three warmingaccessories simultaneously. ALCD screen communicatesinformation to the user. Fivebuttons are available to set thetemperature of the system topredefined values.	48 Volt software drivencontrol unit capable ofregulating three warmingaccessories simultaneously.Three LED screenscommunicate information tothe user. Three buttons, areused to set the temperatureof each accessoryindependently.	Similar
Mattress PadMaterial	Pressure relieving foam padand conductive heater encasedin a urethane coated fabricshell	Pressure relieving foam padand conductive polymercoated fabric heater encasedin a polymer shell.	Similar
BlanketMaterial	Insulating foam and aconductive heater encased in aurethane coated fabric shell	Conductive polymer coatedfabric heater encased in apolymer shell	Similar
Specification	Conforms to IEC 80601-2-35:Particular requirements of thebasic safety and essentialperformance of heatingdevices using blankets, pads ormattresses and intended forheating in medical use, edition1	Conforms to IEC 60601-2-35: Particular requirementsfor the safety of blankets,pad and mattresses intendedfor heating in medical use,edition 1	Similar

Table 1. Technological Characteristics Comparison Table

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Summary of Non-Clinical Performance Testing 6.

Testing was performed to evaluate performance and demonstrate substantial equivalence to the predicate as summarized in Table 2.

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Test	Acceptance Criteria	Result
PerformanceTesting	The STERIS Patient Warming System and warmingaccessories were tested for conformance to IEC 80601-2-35:Particular requirements of the basic safety and essentialperformance of heating devices using blankets, pads ormattresses and intended for heating in medical use	PASS
PressureManagement	The Underbody Warming Pad must not exhibit a peakpressure higher than 20% more than the existing torsopad.For 5th Percentile female peak pressure shall bebelow 70 mmHgFor 95th Percentile male peak pressure shall bebelow 100 mmHg	PASS
Human Factors	Typical users are capable of following the writteninstructions for use to correctly use the STERIS PatientWarming System with simulated patients.	PASS
ElectromagneticCompatibility	IEC 60601-1-2:2014 General Requirements for Basic Safetyand Essential Performance - Collateral Standard:Electromagnetic Compatibility - Requirements and Tests	PASS
Electrical SafetyConformance	IEC 60601-1 Medical electrical equipment – Part 1: Generalrequirements for basic safety and essential performance	PASS
SoftwareValidation	The software that controls the system was validated anddetermined to operate effectively and as designed.	PASS

Table 2. Performance Testing

7. Conclusion

The STERIS Patient Warming System has met the established performance criteria. Based on the intended use, technological characteristics and non-clinical performance data, the subject device is as safe, as effective, and performs as well as the legally marketed predicate device (K112488), Class II (21 CFR 870.5900), product code DWJ.

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).