The ASTOPAD® Patient Warming System is intended to prevent or treat hypothermia and to provide warmth to patients. The ASTOPAD Patient Warming System is indicated for use in all areas of healthcare facilities for preventing or treating hypothermia or maintaining normothermia. The warming blankets can be used over or under the patient (pediatric and adult) by appropriately trained healthcare professionals.

Device Description

The ASTOPAD Patient Warming System is a thermal regulating system which includes a connection cable that attaches to reusable conductive warming blankets for patient warming in clinical environments. The system consists of a control unit (DUO310-NA) and one or optionally two applied parts (warming blankets/COVXXX-NA) with different sizes to fit different applications.

AI/ML Overview

The provided text describes the Stihler Electronic GmbH's ASTOPAD Patient Warming System. However, it does not contain information about acceptance criteria for device performance related to diagnostic accuracy, a study proving the device meets said criteria, or any details about sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, as these are typically associated with artificial intelligence/machine learning diagnostic devices.

The document is a 510(k) summary for a medical device (a patient warming system) and focuses on establishing substantial equivalence to a predicate device through performance data for safety and effectiveness related to its function as a warming device.

Therefore, most of the requested information is not applicable or cannot be extracted from this document.

Here's an attempt to answer based on the available information:

1. A table of acceptance criteria and the reported device performance:

The document primarily references compliance with various international standards for safety and effectiveness, rather than specific performance metrics directly related to diagnostic accuracy. The "acceptance criteria" are implied by meeting the requirements of these standards.

Acceptance Criteria (Implied by standard compliance)	Reported Device Performance (Compliance)
Biocompatibility: Absence of cytotoxicity, sensitization, and irritation as per ISO 10993-1.	The device passed cytotoxicity, sensitization, and irritation tests as recommended by FDA guidance.
Electrical Safety: Compliance with IEC 60601-1, IEC 60601-1-6, IEC 60601-1-8, and IEC 80601-2-35.	The system complies with applicable electrical safety requirements of these standards.
Electromagnetic Compatibility (EMC): Compliance with IEC 60601-1-2.	The system complies with applicable EMC requirements of the standard, as documented per FDA guidance.
Software Verification & Validation: Adherence to FDA guidance for software in medical devices (minor level of concern).	Software verification and validation were conducted, and documentation provided, as recommended by FDA guidance.
Mechanical Safety: Compliance with IEC 60601-1 and IEC 80601-2-35 standards.	The system complies with applicable mechanical requirements of these standards.
Thermal Performance: Compliance with IEC 60601-1 and IEC 80601-2-35 standards.	The system complies with applicable thermal requirements of these standards.
Human Factors/Usability: Safety and effectiveness for intended users, use, and environments as per FDA guidance.	The system was found to be safe and effective for intended users, use, and use environments.
Reprocessing Effectiveness: Validation of cleaning and disinfection as per FDA guidance.	The system meets applicable cleaning & disinfecting performance criteria when cleaned and disinfected as labeled.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

This information is not provided in the document as it is not an AI/ML diagnostic device study. The performance data listed (biocompatibility, electrical safety, etc.) are standard engineering and laboratory tests, not clinical studies with patient data in the typical sense.

3. 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):

This information is not provided and is not applicable to the type of device and testing described in the document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not provided and is not applicable to the type of device and testing described in the document.

5. 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:

This information is not provided and is not applicable. The device is a patient warming system, not a diagnostic imaging device with human readers and AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This information is not provided and is not applicable. The ASTOPAD Patient Warming System does not involve an algorithm for standalone diagnostic performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

The "ground truth" for the various performance tests (biocompatibility, electrical safety, etc.) is the adherence to the specifications and limits defined within the referenced international standards (e.g., IEC 60601 series, ISO 10993-1). This is verified through laboratory testing and validation protocols rather than clinical outcomes or expert consensus on a diagnostic task.

8. The sample size for the training set:

This information is not provided and is not applicable. The device does not use an AI/ML model that requires a training set.

9. How the ground truth for the training set was established:

This information is not provided and is not applicable. The device does not use an AI/ML model that requires a training set with established ground truth.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal 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 written out to the right of it.

September 4, 2020

Stihler Electronic GmbH % Dave Yungvirt CEO Third Party Review Group, LLC 25 Independence Blvd Warren, New Jersey 07059

Re: K202197

Trade/Device Name: Astopad Patient Warming System Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal regulating system Regulatory Class: Class II Product Code: DWJ Dated: August 4, 2020 Received: August 5, 2020

Dear Dave Yungvirt:

We have reviewed vour 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/cfpmp/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

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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) 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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device (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)

K202197

Device Name ASTOPAD Patient Warming System

Indications for Use (Describe)

The ASTOPAD® Patient Warming System is intended to prevent or treat hypothermia and to provide warmth to patients. The ASTOPAD Patient Warming System is indicated for use in all areas of healthcare facilities for preventing or treating hypothermia or maintaining normothermia. The warming blankets can be used over or under the patient and adult) by appropriately trained healthcare professionals.

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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STIHLER ELECTRONIC

510(k) Summary K202197

I. SUBMITTER	Stihler Electronic GmbHJulius-Hoelder-Strasse 3670597 StuttgartGermany
	Phone: +49-711-720670Fax: +49-711-7206757
Contact person:	Christina MiracleGentherm Medical, LLCDirector of Quality Assurance & Regulatory Affairsphone: 513.326.5295mail: christina.miracle@gentherm.com
Date of Preparation:	4 Sep 2020
Manufacturer:	Stihler Electronic GmbHJulius-Hoelder-Strasse 3670597 StuttgartGermany
Establishment Registration Number:	9617473
II. DEVICE
Trade name:	ASTOPAD® Patient Warming System
Model numbers:	DUO310-NA, COV070-NA, COV105-NA, COV150-NA, COV155-NA, COV180-NA
Common name:	Thermal Regulating System
Classification name:	System, Thermal Regulation (21 CFR Part 870.5900, Product Code DWJ)
Class:	Class II
III. PREDICATE DEVICE	HotDog Patient Warming System, K112488This predicate has not been subject to a design-related recall. 1
IV. DEVICE DESCRIPTION	The ASTOPAD Patient Warming System is a thermal regulating system which includes a connection cable that attaches to reusable conductive warming blankets for patient warming in clinical environments The

ve warming blankets for patient warming in clinical environments. The system consists of a control unit (DUO310-NA) and one or optionally two applied parts (warming blankets/COVXXX-NA) with different sizes to fit different applications:

1 Source: FDA Medical Device Recalls database, last update 02/14/2020

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COV070-NA2 warming blanket, 680x480 mm COV105-NA warming blanket, 1050x500 mm COV150-NA warming blanket, 1500x500 mm COV155-NA Arm-chest-warming blanket, 1500x500 mm (with cut-outs) COV180-NA warming blanket 1800x800 mm

The ASTOPAD control unit is equipped with a universal mounting clamp for attaching to standard medical equipment rails or an infusion stand, two outputs for connecting one or two applied parts, connection to mains by detachable power supply cord, connector for potential equalization, the electronic boards and the control panel for the user/operator.

The control unit has two outputs (connecting sockets) A and B for connecting ASTOPAD applied parts. The desired set temperature can be selected in the range of 32.0 ℃ - 39.0 ℃ in 0.5 ℃ increments for each connected applied part, independent of each other, on the control panel of the control unit. The control unit can also be used with only one of the outputs, A or B. The selected set temperature and the current temperature are displayed individually for each applied part in the control panel.

The control unit supplies the applied part(s) with electrical current (low voltage) and monitors and controls the temperature of the applied part(s). When error conditions occur, the control unit draws the operator's attention to the error condition by means of alarm signals (optical & acoustical). In the event of failure conditions (overheating, heater defect, sensor defect), the control unit reacts immediately by shutting off the power supply to the applied part.

Optionally the control unit can be fitted with a battery. When the battery is installed, it is possible to operate the device independently from the mains for approximately two hours.

The ASTOPAD control unit does not control or indicate the actual temperature of the patient, but rather only the actual temperature of the applied part.

Temperature regulation of the individual applied parts is performed with several integrated sensors.

Safety of ASTOPAD is provided by the following measures per output:

Several temperature sensors for each applied part ●
Double independent sensor monitoring ●
Heater monitoring .
Time shut-off .
Visual and acoustic alarm signals ●
Overheating and low-temperature alarm if the contact surface ● temperature deviates from the temperature controller setting

2 "NA" Refers to North America, with English labeling.

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V. INDICATIONS FOR USE

Both the subject device and the predicate device have the same intended use: to prevent or treat hypothermia and to provide warmth to patients.

The Indications for Use of the subject device are similar as that of the predicate device; however, the differences in wording do not alter the intended therapeutic use of the device nor do they affect the safety and effectiveness of the device. Both the subject and predicate devices have the same intended use for the prevention or treatment of hypothermia and maintenance of normothermia for pediatric and adult patients in all areas of healthcare facilities.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

Subject (New) Device

Control Unit

Image /page/5/Picture/9 description: The image shows a medical device, specifically an ASTOPAD system, which appears to be a temperature control unit. The device has a digital display showing a temperature of 38.5 degrees Celsius on both sides, labeled A and B. It features multiple buttons for adjustments and two connector ports at the front, suggesting it can be connected to other medical equipment. The device is white and has warning labels at the bottom.

Predicate Devices

Image /page/5/Picture/11 description: The image shows a blue HotDog warming system. The top portion of the device has a digital display showing the number 43. Below the display are several ports for connecting the warming blankets. The bottom of the device has the HotDog logo.

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STIHLER ELECTRONIC

Stihler Electronic GmbH Traditional 510(k) Premarket Notification for ASTOPAD Patient Warming System

Image /page/6/Picture/2 description: The image shows medical warming blankets. On the left side of the image, there are three orange warming blankets. On the right side of the image, there is a blue and a black warming blanket.

Heat transfer to the patient, using conductive heat, is the technological Comparison principle for both the subject and predicate devices. It is based on the use of applied parts which have thermal contact with the patient to provide heat.
At a high level, the subject and predicate devices are based on the following same technological elements:
· Applied parts in the form of blankets are lightweight and flexible and both are made from coated plastics.
· Applied parts are powered by electrical energy (low voltage).
· Electrical energy is transformed to warmth by a heating element which opposes the current by an electrical resistance.
· Temperature of the applied parts is controlled by temperature sensors.
· The systems include a control unit and applied parts in different sizes.
· Control units and applied parts are connected together by a detachable cable.
· Control units include attachment device for IV-pole or medical rail, control and monitoring electronics, control panel for the user, outputs to connect applied parts simultaneously, and input for power supply cord.
· User can select set temperature of the applied parts within a limited range.
· Control panels show set temperature of the applied part.
. The control units inform the user about alarm conditions by means of optical and acoustic signals.
· Control units react with an alarm in the case of sensor defects
· Control units include a connector for potential equalization.
. Control units have a grip tray on the upper backside, with which the device can be transported with one hand.

The following technological differences exist between the subject and predicate devices:

· The subject device uses 8 temperature sensors for temperature control and monitoring, whereas the predicate device uses 2 temperature sensors for temperature control and monitoring.
· Each blanket of the subject device can be placed over or under the patient and can be used on either side, whereas the applied parts of the

ASTOPAD® Patient Warming System – 510(k) Summary Page 4 of 6

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predicate device are either over blankets or underbody mattresses that cannot be used interchangeably and can only be used on one side.

· The subject device is classified as "defibrillation-proof" according to the requirements of IEC 60601-1, whereas the predicate device is not.
. The subject device shows the user selected set temperature and the current temperature of the applied part simultaneously, whereas in operation mode the predicate device shows only the set temperature of the applied part.
Based on the requirements of IEC 80601-2-35 the subject device has a . set temperature range from 32℃ to 39℃ in 0.5℃ increments. The predicate device has a selectable set temperature range from 37°C to 43°C in 1°C increments for blankets and 35°C to 39°C for mattresses.
· The subject device uses hardware for controlling and monitoring the temperature of the applied part, whereas the temperature control of the predicate device is managed by Microprocessor utilization.
· The subject device can optionally be fitted with a chargeable battery which makes it possible to operate the device independently from the mains for approximately two hours.

VII. PERFORMANCE DATA The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility testing The biocompatibility evaluation for the ASTOPAD Patient Warming System was conducted as recommended by FDA's Guidance for Industry and FDA Staff, "Use of International ISO 10993-1, Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process".

The battery of testing included the following tests:

Cytotoxicity
Sensitization
Irritation ●

Electrical Safety and Electrical safety and EMC testing were conducted on the ASTOPAD Patient Warming System, consisting of the control unit and different electromagnetic compatibility applied parts. Testing shows the system complies with the applicable (EMC) requirements of IEC 60601-1, IEC 60601-1-6, IEC 60601-1-8 and IEC 80601-2-35 standards for safety and IEC 60601-1-2 standard for EMC.

Documentation for claiming electromagnetic compatibility was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices".

Software verification and validation testing were conducted, and Software Verification and Validation Testing documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."

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The software for this device was considered as a "minor" level of concern, since a failure or a latent flaw in the software could not result in injury to the patient or operator.

Mechanical testing Mechanical testing was conducted on the ASTOPAD Patient Warming System within the testing of the standards IEC 60601-1 and IEC 80601-2-35.
Testing shows the system complies with the applicable mechanical requirements of the standards.
Thermal testing was conducted on the ASTOPAD Patient Warming Thermal testing System within the testing of the standards IEC 60601-1 and IEC 80601-2-35.
Testing shows the system complies with the applicable thermal requirements of the standards.

Human Factors Validation Human factors validation testing for the ASTOPAD Patient Warming Testing System was conducted as recommended by FDA's Guidance for Industry and FDA Staff, "Applying Human Factors and Usability Engineering to Medical Devices".

The ASTOPAD system has been found to be safe and effective for the intended users, use and use environments.

Reprocessing Testing The ASTOPAD Patient Warming System is classified as a reusable medical device which requires cleaning and disinfecting after each use. Cleaning and disinfecting validation were conducted as recommended by FDA's Guidance for Industry and FDA Staff, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling".
Required cleaning and disinfection validation testing were conducted on the control unit and on the applied part.

ASTOPAD Patient Warming System meets the applicable cleaning & disinfecting performance criteria, when cleaned and disinfected as labeled.

Animal Study Not required

Clinical Study Not required
CONCLUSION Electronic GmbH considers the ASTOPAD Stihler Patient VIII. Warming System substantially equivalent to the predicate device because they have the same intended use and the same operating principles (warming by convection), any differences between the subject and predicate device do not raise new questions of safety and effectiveness. Testing has been conducted and the subject device meets all requirements of the applicable standards demonstrating that the subject device is substantially equivalent to the predicate 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).