(30 days)
Not Found
No
The summary describes a thermal regulating system with warming blankets and a control unit. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML applications in medical devices. The performance studies listed are standard for a device of this type and do not suggest AI/ML components.
Yes.
The device is intended to treat hypothermia, which is a therapeutic indication.
No
Explanation: The device is intended to prevent or treat hypothermia and provide warmth, which are therapeutic functions, not diagnostic. It does not identify or detect a disease or condition.
No
The device description explicitly states the system includes a control unit and warming blankets, which are hardware components. The performance studies also include testing for electrical safety, mechanical testing, and thermal testing, further indicating the presence of hardware.
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 provide warmth to patients. This is a therapeutic and supportive function, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is a thermal regulating system with warming blankets. This aligns with a physical therapy or supportive care device, not a device that analyzes biological samples.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, diagnostic purposes, or any of the typical characteristics of an IVD.
Therefore, the ASTOPAD Patient Warming System is a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
DWJ
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:
COV070-NAwarming 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
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
pediatric and adult
Intended User / Care Setting
appropriately trained healthcare professionals; all areas of healthcare facilities
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)
- 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 Cytotoxicity, Sensitization, and Irritation tests.
- Electrical Safety and Electromagnetic Compatibility (EMC) testing: Testing shows the system complies with the applicable 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: Software verification and validation testing were conducted, and 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." The software for this device was considered as a "minor" level of concern.
- Mechanical testing: Testing shows the system complies with the applicable mechanical requirements of IEC 60601-1 and IEC 80601-2-35 standards.
- Thermal testing: Testing shows the system complies with the applicable thermal requirements of IEC 60601-1 and IEC 80601-2-35 standards.
- Human Factors Validation Testing: The ASTOPAD system has been found to be safe and effective for the intended users, use and use environments. Conducted as recommended by FDA's Guidance for Industry and FDA Staff, "Applying Human Factors and Usability Engineering to Medical Devices".
- 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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
HotDog Patient Warming System, K112488
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
1
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)
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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3
STIHLER ELECTRONIC
510(k) Summary K202197
| I. SUBMITTER | Stihler Electronic GmbH
Julius-Hoelder-Strasse 36
70597 Stuttgart
Germany |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Phone: +49-711-720670
Fax: +49-711-7206757 |
| Contact person: | Christina Miracle
Gentherm Medical, LLC
Director of Quality Assurance & Regulatory Affairs
phone: 513.326.5295
mail: christina.miracle@gentherm.com |
| Date of Preparation: | 4 Sep 2020 |
| Manufacturer: | Stihler Electronic GmbH
Julius-Hoelder-Strasse 36
70597 Stuttgart
Germany |
| 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, K112488
This 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
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.
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
7
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."
8
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.