STERIS Patient Warming System

• K Number: K200446
• Device Name: STERIS Patient Warming System
• Manufacturer: STERIS Corporation
• Date Cleared: 2020-06-13 ( 110 days)
• Product Code: DWJ
• Regulation Number: 870.5900

Intended Use

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 ●

Predicate Devices

K112488

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on basic temperature control using software and heating elements, with no mention of AI or ML algorithms for decision-making, prediction, or adaptation.

Therapeutic

Yes
The device is described as being "intended to prevent or treat hypothermia and maintain normothermia." The function of preventing or treating a medical condition (hypothermia) makes it a therapeutic device.

Diagnostic

No

The device is described as a "Patient Warming System" intended to prevent or treat hypothermia and maintain normothermia by providing heating. Its function is therapeutic, not diagnostic.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the system consists of a controller, power supply, and heating accessories (Heated Torso Pad, Overbody Warming Blanket). These are hardware components, making it a hardware-based medical device with software control.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is to prevent or treat hypothermia and maintain normothermia by directly warming the patient. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
• Device Description: The device is a physical system that applies heat to the patient's body through conductive accessories. It does not involve the analysis of biological samples.
• Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. The device's function is entirely external and focused on temperature regulation.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This patient warming system does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

DWJ

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)
  • 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)
  • Foot Pad and Head Pad are not heated and not subject to this 510(k)
• Heated Torso Pad
• Overbody Warming Blanket

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

adult and pediatric patients but excludes infant and neonatal patients.

Intended User / Care Setting

hospital and surgical centers.

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)

Testing was performed to evaluate performance and demonstrate substantial equivalence to the predicate.

• 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. Result: 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. Result: 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. Result: PASS
• Electromagnetic Compatibility: IEC 60601-1-2:2014 General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests. Result: PASS
• Electrical Safety Conformance: IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance. Result: PASS
• Software Validation: The software that controls the system was validated and determined to operate effectively and as designed. Result: PASS

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K112488

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

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

1

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 ([e-mail]) or phone [phone] 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)

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.

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: [phone] Fax No: [phone]

Contact:

Mr Gregory Land Senior Regulatory Affairs Specialist Tel: [phone] Fax: [phone] [e-mail]

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

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 ●

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4. Indications for Use

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.

Technological Characteristics Comparison Table ട.

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

| Feature | Proposed Device
STERIS Patient Warming
System | Predicate Device
HotDog Patient Warming
System (K112488) | Comparison |
|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Indications
for Use | 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. | The Hot Dog Patient
Warming System is intended
to prevent or treat
hypothermia and to provide
warmth to patients. The Hot
Dog Patient Warming
System should be used in
circumstances in which
patients may not maintain a
state of normothermia. The
patient warming system can
be used with adult and
pediatric patients.
The System is intended
primarily for use in hospital
and surgical centers
including without limitation
operating, recovery and
emergency rooms and on
medical/surgical floors. | Similar |
| Operating
Principles
/
Technology | A temperature control unit
monitors and controls the
temperature of a patient
warming mattress and blanket | A temperature control unit
monitors and controls the
temperature of a patient
warming blanket or mattress | Same |
| Feature | Proposed Device
STERIS Patient Warming
System | Predicate Device
HotDog Patient Warming
System (K112488) | Comparison |
| | which provides conductive
heating to a patient. | which provides conductive
heating to a patient. | |
| Where Used | Operating rooms, recovery
rooms and emergency rooms | Operating rooms, recovery
rooms and emergency rooms | Same |
| System
Components | Temperature control unit,
blanket, mattress | Temperature control unit,
blanket, mattress | Same |
| Temperature
Control Unit | 48 Volt software driven
control unit capable of
regulating three warming
accessories simultaneously. A
LCD screen communicates
information to the user. Five
buttons are available to set the
temperature of the system to
predefined values. | 48 Volt software driven
control unit capable of
regulating three warming
accessories simultaneously.
Three LED screens
communicate information to
the user. Three buttons, are
used to set the temperature
of each accessory
independently. | Similar |
| Mattress Pad
Material | Pressure relieving foam pad
and conductive heater encased
in a urethane coated fabric
shell | Pressure relieving foam pad
and conductive polymer
coated fabric heater encased
in a polymer shell. | Similar |
| Blanket
Material | Insulating foam and a
conductive heater encased in a
urethane coated fabric shell | Conductive polymer coated
fabric heater encased in a
polymer shell | Similar |
| Specification | Conforms 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, edition
1 | Conforms to IEC 60601-2-
35: Particular requirements
for the safety of blankets,
pad and mattresses intended
for 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
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 mmHgFor 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

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.