The Level 1® Convective Warmer is intended to prevent and treat hypothermia when temperature therapy is clinically indicated. The warmer can also be used to provide thermal comfort when conditions exist that may cause patients to become too warm or too cold. The Level 1® Convective Warmer can be used with adult or pediatric patients and is intended for use by appropriately trained healthcare professionals in clinical environments.

Device Description

The Level 1® Convective Warmer, is a forced air thermal regulating systems which includes a connection hose to attach to the Snuggle Warm® Convective Warming Blankets for patients requiring body temperature requlation in clinical environments which are provided non-sterile and intended to be reused. In order to accommodate various clinical environments, the Level 1® Convective Warmer is able to be placed on the floor, placed on a floor cart, or mounted on an I.V. pole to allow flexible portability. The Level 1® Convective Warmer is used with the Snuggle Warm® Convective Warming Blankets.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device, specifically a convective warmer. It is not about an AI/ML medical device. Therefore, the information requested about acceptance criteria, study details, expert involvement, and ground truth for an AI/ML model is not available in this document.

The document focuses on establishing substantial equivalence for a physical medical device (Level 1® Convective Warmer) to a predicate device (Equator® Convective Warmer), particularly noting the introduction of a microprocessor control system in the new device where the predicate used analog circuitry. The "performance testing" described refers to engineering and safety tests for the physical device, not a performance study of an AI model's diagnostic accuracy.

Therefore, I cannot provide a response that directly answers the detailed questions about AI/ML acceptance criteria and study particulars based on the provided text. The prompt's assumptions (e.g., test sets, ground truth establishment, MRMC studies) are applicable to AI/ML device submissions, but not to this specific medical device submission.

Summary

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July 26, 2018

Smiths Medical ASD, Inc. % Mark Job Regulatory Technology Services, LLC 1394 25th Street. Nw Buffalo, Minnesota 55313

Re: K181699

Trade/Device Name: Level 1 Convective Warmer Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal regulating system Regulatory Class: Class II Product Code: DWJ Dated: June 25, 2018 Received: June 27, 2018

Dear Mark Job:

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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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-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)

K181699

Device Name Level 1® Convective Warmer

Indications for Use (Describe)

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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K181699 page 1 of 6

smiths medical

bringing technology to life

Smiths Medical 6000 Nathan Lane North Minneapolis, MN 55442 T: +1 763 383 3000 F: +1 763 383 3679 www.smiths-medical.com

Date of Preparation:	July 20, 2018 (Revised)
Submitter:	Smiths Medical6000 Nathan Lane NorthMinneapolis, MN 55442USA
Establishment RegistrationNumber:	3012307300
Company Contact (Primary):	Donna M. Semlak (Primary Contact)Smiths MedicalVital Care Business Unit, Interim ManagerPrincipal Regulatory Affairs SpecialistRegulatory and Clinical AffairsTel: +1 763-383-3076Email: donna.semlak@smiths-medical.com
Trade Name(s):	Thermal Regulating System
Device Name(s)	Level 1® Convective Warmer
Device Classification	Class II

Regulation Number and Product Codes 21 CFR § 870.5900/ DWJ System, Thermal Regulating

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Purpose

The purpose of this premarket notification Traditional 510(k) is to establish substantial equivalence and obtain FDA Clearance for the Level 1® Convective Warmer which is intended to prevent and treat hypothermia when temperature therapy is clinically indicated.

This submission addresses the introduction of a microprocessor to the subject device to control the monitoring and adjustments of air flow, heating, temperature, and alarms where the predicate device, Equator® Convective Warmer, uses discrete digital and analog circuitry.

Primary Predicate Device

The primary predicate device for this submission is the currently marketed Smiths Medical Equator® Convective Warmer.

Primary Predicate Device Name	Product Code	FDA 510k NumberClearance Date
Equator Convective Warmer	DWJ	K141686Cleared on October 28, 2014

General Device Description:

Indications for Use:

Summary of Technological Characteristics:

The subject device, Level 1® Convective Warmer, shares the same technological characteristics as the cleared FDA 510(k) predicate device, Equator® Convective Warmer. These characteristics include the same intended use, same clinical application, same overall design, and the same convective warming principle of operation by drawing ambient air through a filtered opening then

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heating to the desired temperature for convective warming therapy. Both warmers are forced air heating devices that help to regulate a patient's body temperature and are used with the Snuggle Warm® Convective Warming Blankets.

The difference, however, is that the subject device uses a microprocessor (software) to control. monitor and adjust air flow, heating, temperature, and alarms where the predicate device controls the same outputs through discrete digital and analog circuitry, containing no software.

Also, this submission incorporates three (3) non-significant changes: operating noise level, air temperature settings, and heater power wattage.

Summary of Performance Testing:

The Level 1® Convective Warmer incorporates the same indications for use and the same technological characteristics as the legally marketed predicate device, Equator® Convective Warmer, FDA cleared under K141686, issued October 28, 2014.

Non-clinical testing of the Level 1® Convective Warmer was assessed and tested as a system, including the subject device, connection hose and Snuggle Warm® Convective Warming Blanket, appropriately to design controls; i.e. design verification, design validations. The test results conclude the Level 1® Convective Warmer to be substantially equivalent to the predicate device, Equator® Convective Warmer (EQ-5000HF).

Testing is listed below:

Electrical Safety and Electromagnetic Compatibility testing was conducted per IEC 60601-1 and IEC 60601-1-2 respectively to ensure that the device performs safely under normal use conditions. All requirements were met.
. Particular Safety Testing was completed per IEC 80601-2-35 to ensure the device meets basic safety and essential performance of heating devices using blankets, pads or mattresses in medical use. All requirements were met.
Safety testing was conducted per IEC 60529 to ensure the level of protection by . enclosures meet the specified IP12 rating. The requirement was met.
. Design Validation / Human Factors per IEC 62366 was conducted to ensure the subject device performance is acceptable for its intended use. All requirements were met.
. System validation testing for compatibility with warming blankets was performed to ensure function. All requirements were met.
. Bench testing was conducted to ensure the device meets the System Requirements Specification in DP-0003-938. All requirements were met.

Substantial Equivalence

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Smiths Medical considers the subject device, Level 1® Convective Warmer, performance to be substantially equivalent to the predicate device, Equator® Convective Warmer (EQ-5000HF), based on the performance test results.

There are no significant differences in intended use, mechanical and functional performance and functional scientific technology, except the difference of the addition a microprocessor software control mechanism for the Level 1® Convective Warmer. Smiths Medical demonstrates through performance testing that no new issues of safety and effectiveness are raised due to the change of the subject device's control mechanism. Both the subject and predicate devices are used to treat the same clinical condition and represent a same principle of operation.

Substantial Equivalence Comparison Table
Parameter	Subject DeviceLevel 1 ConvectiveWarmer(L1-CW-120V)	Predicate deviceEquator ConvectiveWarmer(EQ-5000HF)	Comparison
REGULATORY INFORMATION
FDA Product Code	DWJSystem, ThermalRegulating	DWJSystem, ThermalRegulating	SAME
FDA Regulation	21 CFR 870.5900	21 CFR 870.5900	SAME
Classification	Class II	Class II	SAME
Indication for Use	The Level 1®Convective Warmer isintended to prevent andtreat hypothermia whentemperature therapy isclinically indicated. Thewarmer can also beused to provide thermalcomfort whenconditions exist thatmay cause patients tobecome too warm ortoo cold. The Level 1®Convective Warmercan be used with adultor pediatric patientsand is intended for useby appropriately trainedhealthcareprofessionals in clinicalenvironments.	The Equator®Convective Warmer isintended to prevent andtreat hypothermia whentemperature therapy isclinically indicated. Thewarmer can also beused to provide thermalcomfort whenconditions exist thatmay cause patients tobecome too warm ortoo cold. The Equator®Convective Warmercan be used with adultor pediatric patientsand is intended for useby appropriately trainedhealthcareprofessionals in clinicalenvironments.	SAME
Substantial Equivalence Comparison Table
Parameter	Subject DeviceLevel 1 ConvectiveWarmer(L1-CW-120V)	Predicate deviceEquator ConvectiveWarmer(EQ-5000HF)	Comparison
Intended Use	Convective warmingsystem for thermalregulation of a patient'sbody temperature in aclinical environment.	Convective warmingsystem for thermalregulation of a patient'sbody temperature in aclinical environment.	SAME
TECHNICAL SPECIFICATIONS
Air Flow Rate via hosesans blanket	44CFM @0.4 inchesH2O back pressure	43CFM @0.4 inchesH2O back pressure	SIMILAR
Air TemperatureSettings	43 ± 1.0 °C40 ± 1.0 °C37 ± 1.0 °CAmbient	44 ± 1.0 °C40 ± 1.0 °C36 ± 1.0 °CAmbient	DIFFERENT
System PowerRequirement	115VAC, 50/60 Hz	115VAC, 50/60 Hz	SAME
Heater PowerRequirement	950 Watts	800 Watts	DIFFERENT
Dimensions	15.3"x11.0"x12.6"	11.75" X 9.5" X 7.5"	SIMILAR
Weight	13.7 lbs.	15 lbs.	SIMILAR
Materials ofconstruction	Plastic/Metal	Plastic/Metal	SAME
Power On Self-Test	Yes	Yes	SAME
SAFETY
Basic Electrical Safety	IEC 60601-1	IEC 60601-1	SAME
EMI/EMC Compliant	IEC 60601-1-2	IEC 60601-1-2	SAME
Basic Safety andEssential Performancefor Heating Devices	IEC 80601-2-35	IEC 80601-2-35	SAME
Forced Air OverTemperature Protection	Electrical Heater SafetyRelay opens at 47.0 ±1°C	Electrical Heater SafetyRelay opens at 47.0 ±1°C	SAME
Control Mechanism	Microprocessor withsoftware	Discrete digital andanalog circuitry	DIFFERENT
FEATURES
Air Filter	Replaceable 0.2 micron	Replaceable 0.2 micron	SAME
Operating noise level	42dBA	53dBA	DIFFERENT
Substantial Equivalence Comparison Table
Parameter	Subject DeviceLevel 1 ConvectiveWarmer(L1-CW-120V)	Predicate deviceEquator ConvectiveWarmer(EQ-5000HF)	Comparison
Device Photo	Image: Level 1 Convective Warmer (L1-CW-120V)	Image: Equator Convective Warmer (EQ-5000HF)	N/A
Used with the SnuggleWarm® ConvectiveWarming Blankets	Yes	Yes	SAME

Level 1® Convective Warmer compared to Equator® Convective Warmer

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Conclusion

Smiths Medical concludes that the Level 1® Convective Warmer is for use with Snuggle Warm® Convective Warming Blankets for patients requiring body temperature regulation being that it is substantially equivalent to the predicate device, thermal regulating system indications (DWJ), and does not raise new questions of safety risks imposed on the patient or the device user.

Smiths Medical's evaluation concludes the subject device, will perform substantially equivalent to the predicate devices.

Subject Device	Predicate	Predicate 510(k)
Level 1® Convective Warmer	Equator® Convective Warmerand Snuggle Warm®Convective Warming Blankets	K141686

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).