STERIS Patient Warming System

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out next to it. 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 (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 {2}------------------------------------------------ # 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) ## 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/0 description: The image shows the STERIS logo. The word STERIS is in all caps and in a serif font. Below the word STERIS is a graphic of several horizontal wavy lines that are blue. # 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 {4}------------------------------------------------ #### 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 ● {5}------------------------------------------------ #### 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<br>STERIS Patient Warming<br>System | Predicate Device<br>HotDog Patient Warming<br>System (K112488) | Comparison | |--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | Indications<br>for Use | Patient Warming System is a<br>modular, electrically<br>conductive Temperature<br>Management System with<br>adjustable temperature in a<br>pre-defined range. The Patient<br>Warming System is intended<br>to prevent or treat hypothermia<br>and maintain normothermia.<br>The Patient Warming System<br>is intended primarily for use in<br>hospital and surgical centers.<br>The Patient Warming System<br>patient population includes<br>adult and pediatric patients but<br>excludes infant and neonatal<br>patients. | The Hot Dog Patient<br>Warming System is intended<br>to prevent or treat<br>hypothermia and to provide<br>warmth to patients. The Hot<br>Dog Patient Warming<br>System should be used in<br>circumstances in which<br>patients may not maintain a<br>state of normothermia. The<br>patient warming system can<br>be used with adult and<br>pediatric patients.<br>The System is intended<br>primarily for use in hospital<br>and surgical centers<br>including without limitation<br>operating, recovery and<br>emergency rooms and on<br>medical/surgical floors. | Similar | | Operating<br>Principles<br>/<br>Technology | A temperature control unit<br>monitors and controls the<br>temperature of a patient<br>warming mattress and blanket | A temperature control unit<br>monitors and controls the<br>temperature of a patient<br>warming blanket or mattress | Same | | Feature | Proposed Device<br>STERIS Patient Warming<br>System | Predicate Device<br>HotDog Patient Warming<br>System (K112488) | Comparison | | | which provides conductive<br>heating to a patient. | which provides conductive<br>heating to a patient. | | | Where Used | Operating rooms, recovery<br>rooms and emergency rooms | Operating rooms, recovery<br>rooms and emergency rooms | Same | | System<br>Components | Temperature control unit,<br>blanket, mattress | Temperature control unit,<br>blanket, mattress | Same | | Temperature<br>Control Unit | 48 Volt software driven<br>control unit capable of<br>regulating three warming<br>accessories simultaneously. A<br>LCD screen communicates<br>information to the user. Five<br>buttons are available to set the<br>temperature of the system to<br>predefined values. | 48 Volt software driven<br>control unit capable of<br>regulating three warming<br>accessories simultaneously.<br>Three LED screens<br>communicate information to<br>the user. Three buttons, are<br>used to set the temperature<br>of each accessory<br>independently. | Similar | | Mattress Pad<br>Material | Pressure relieving foam pad<br>and conductive heater encased<br>in a urethane coated fabric<br>shell | Pressure relieving foam pad<br>and conductive polymer<br>coated fabric heater encased<br>in a polymer shell. | Similar | | Blanket<br>Material | Insulating foam and a<br>conductive heater encased in a<br>urethane coated fabric shell | Conductive polymer coated<br>fabric heater encased in a<br>polymer shell | Similar | | Specification | Conforms to IEC 80601-2-35:<br>Particular requirements of the<br>basic safety and essential<br>performance of heating<br>devices using blankets, pads or<br>mattresses and intended for<br>heating in medical use, edition<br>1 | Conforms to IEC 60601-2-<br>35: Particular requirements<br>for the safety of blankets,<br>pad and mattresses intended<br>for heating in medical use,<br>edition 1 | Similar | ## Table 1. Technological Characteristics Comparison Table {6}------------------------------------------------ #### 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. {7}------------------------------------------------ | Test | Acceptance Criteria | Result | |----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------| | Performance<br>Testing | The STERIS Patient Warming System and warming<br>accessories were tested for conformance to IEC 80601-2-35:<br>Particular requirements of the basic safety and essential<br>performance of heating devices using blankets, pads or<br>mattresses and intended for heating in medical use | PASS | | Pressure<br>Management | The Underbody Warming Pad must not exhibit a peak<br>pressure higher than 20% more than the existing torso<br>pad.<br>For 5th Percentile female peak pressure shall be<br>below 70 mmHgFor 95th Percentile male peak pressure shall be<br>below 100 mmHg | PASS | | Human Factors | Typical users are capable of following the written<br>instructions for use to correctly use the STERIS Patient<br>Warming System with simulated patients. | PASS | | Electromagnetic<br>Compatibility | IEC 60601-1-2:2014 General Requirements for Basic Safety<br>and Essential Performance - Collateral Standard:<br>Electromagnetic Compatibility - Requirements and Tests | PASS | | Electrical Safety<br>Conformance | IEC 60601-1 Medical electrical equipment – Part 1: General<br>requirements for basic safety and essential performance | PASS | | Software<br>Validation | The software that controls the system was validated and<br>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.