Mistral-Air Warming Unit
Device Facts
| Record ID | K171234 |
|---|---|
| Device Name | Mistral-Air Warming Unit |
| Applicant | The Surgical Company International BV (As the 37company) |
| Product Code | DWJ · Cardiovascular |
| Decision Date | May 26, 2017 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 870.5900 |
| Device Class | Class 2 |
| Attributes | Therapeutic, 3rd-Party Reviewed |
Indications for Use
The Mistral-Air® Warming System is a forced air warming device and comprises of a warming unit and a variety of blankets. It is intended to raise and maintain patient temperature by means of surface warming.
Device Story
The Mistral-Air® Warming System is a forced-air patient warming device consisting of a control unit (MA1200-PM) and various single-use warming blankets (sterile and non-sterile). The unit contains a fan, heating element, air filter, and temperature sensors. It draws in ambient air, filters it, heats it via a 1000W resistive heater, and delivers the warmed air through a flexible hose to a blanket draped over or under the patient. The system is operated by healthcare professionals in clinical settings to prevent or treat hypothermia. The microprocessor-based control circuitry monitors and regulates output temperature. The device provides thermal support to maintain normothermia, potentially improving patient outcomes during surgical or clinical procedures.
Clinical Evidence
Bench testing only. Performance verified through air flow, pressure, filtering, temperature, endurance, and keyboard testing. Compliance with AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8, IEC 62304, IEC 62366-1, IEC 60529, IEC 80601-2-35, ISTA 3A, ASTM D4169, ASTM D642, ISO 10993-1, and ISO 11135.
Technological Characteristics
Warming unit: metal, electronics, ABS/PC housing; HEPA air filter; single-phase AC motor; 1000W resistive heater; microprocessor-based control. Blankets: polypropylene, polyethylene, aluminum, polyurethane. Connectivity: standalone. Sterilization: Ethylene Oxide (for sterile blankets). Software: IEC 62304 compliant.
Indications for Use
Indicated for patients requiring maintenance or elevation of body temperature via surface warming using forced air warming blankets.
Regulatory Classification
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.
Predicate Devices
- Mistral-Air® Warming System (K101705)
Submission Summary (Full Text)
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 26, 2017
The Surgical Company International BV c/o Dave Yungvirt Third Party Review Group, LLC 24 Lackawanna Place Millburn, NJ 07041
Re: K171234
Trade/Device Name: Mistral-Air Warming Unit Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal regulating system Regulatory Class: Class II Product Code: DWJ Dated: April 26, 2017 Received: April 27, 2017
Dear Dave Yungvirt:
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 (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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Fernando
Aguel-S
Fernando Agnel
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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# Change Control Table, Change History
## Change Control Table
| | Version Document Author | Document Approver | Date Approved |
|------|------------------------------|---------------------|---------------|
| 1.00 | Name, Title, Office | Name, Title, Office | MM/DD/YYYY |
Complete Change Control Table (all versions) retained in SWIFT Docs.
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Image /page/4/Picture/3 description: The image shows the logo for The 37 Company. The logo is purple and yellow. The text "Solutions for Patient Warming" is below the company name.
# 510(k) Summary
### Applicant:
| 510(k) owner's name: | The Surgical Company International BV<br>(doing business as The 37Company) |
|----------------------|----------------------------------------------------------------------------|
| Address: | Beeldschermweg 6F<br>3821 AH Amersfoort<br>The Netherlands |
| Contact person: | Kees van Hassel |
| Telephone: | +31 (0) 33-4507 240 |
| Fax: | +31-(0) 33-4507 260 |
| E-mail: | vanhassel.kees@the37company.com |
| Date prepared: | April 21, 2017 |
## Device name:
| Proprietary Name: | Mistral-Air® Warming System |
|-------------------------|-------------------------------------------------------------------------------|
| Common/usual name: | Forced air warming system, an comprises of: |
| | Mistral-Air® - SYK, Forced Air Warming unit: |
| | circulating-air whole-body heating system control unit:<br>(GMDN-code: 36954) |
| | Mistral-Air® warming blanket (non-sterile): |
| | Circulating-air whole-body heating/cooling system pad, |
| | single-use, non-sterile (GMDN code: 47681) |
| | Mistral-Air® warming blanket (sterile): |
| | Circulating-air whole-body heating/cooling system pad, |
| | single use, sterile (GMDN-code: 47682) |
| Regulation number: | 21 CFR 870.5900 |
| Regulation Description: | Thermal regulating system |
| Device class: | Class II |
| Product Code: | DWJ |
### Predicate:
- [K101705] Mistral-Air® Warming System .
| Regulation number: | 21 CFR 870.5900 |
|------------------------|----------------------------|
| Regulation Description | Thermal regulating system. |
| Device class: | Class II |
| Product Code: | DWJ |
Image /page/4/Picture/12 description: The image shows four different abstract logos. The first logo is an oval shape with orange and purple curved lines. The second logo has three curved lines, two orange and one purple, that intersect. The third logo is a crescent shape with orange and purple curved lines. The fourth logo is a square shape with orange and purple curved lines.
Image /page/4/Picture/14 description: The image shows a DEKRA certification logo. The logo is circular and contains the text "DEKRA Certified" in the center. Above the text is a triangle pointing downwards. The text "Management System ISO 13485" is at the top of the logo. The text "Accredited by RvA C-589" is at the bottom of the logo.
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Image /page/5/Picture/2 description: The image shows the logo for The 37 Company. The words "The" and "Company" are in purple, while the number "37" is in orange. Below the company name is the text "Solutions for Patient Warming".
### Device description:
The Mistral-Air® Warming System comprises of the following devices:
- One warming unit of models: ● MA1200-PM Mistral-Air® - SYK (forced air warming unit 100-125 V~, 50/60 Hz) c
Connected to
- One warming blanket of models:
Non-sterile Accessory: Stryker REF / Stryker Proprietary name MA02010-PM Faceshield - SYK
Non-sterile blankets: Stryker REF / Stryker Proprietary name MA0220-PM / Adult White - SYK MA0230-PM / Paediatric White - SYK MA0250-PM / Lower Body White - SYK MA0260-PM / Upper Body White - SYK MA0265-PM / Half Upper Body White - SYK MA0270-PM / Torso White - SYK MA0290-PM / Surgical Access White - SYK MA0320-PM / Adult Reflective - SYK MA0330-PM / Paediatric Reflective - SYK MA0340-PM / Neonatal Reflective - SYK MA0350-PM / Lower Body Reflective - SYK MA0360-PM / Upper Body Reflective - SYK MA0365-PM / Half Upper Body Reflective - SYK MA0400-PM / Full Underbody Reflective - SYK MA0450-PM / Underbody Reflective - SYK MA0510-PM / Tube - SYK
Sterile blankets: Stryker REF / Stryker Proprietary name MA0280-PM / Surgical Access White (sterile) - SYK MA0285A-PM / Lower Surgical Access White (sterile) - SYK MA0286-PM / Cardiac Blanket (sterile) - SYK
Non-sterile blankets:
Stryker REF / Stryker Proprietary name MA1610-PM / Premium Warming Suit S - SYK MA1620-PM / Premium Warming Suit M - SYK MA1630-PM / Premium Warming Suit L - SYK MA1640-PM / Premium Warming Suit XL - SYK MA1710-PM / Warming Suit S - SYK MA1720-PM / Warming Suit M - SYK MA1730-PM / Warming Suit L - SYK MA1740-PM / Warming Suit XL - SYK
Non-sterile blankets: Stryker REF / Stryker Proprietary name MA2220-PM / Adult Plus - SYK MA2230-PM / Paediatric Plus - SYK MA2240-PM / Neonatal Plus - SYK MA2250-PM / Lower Body Plus - SYK MA2260-PM / Upper Body Plus - SYK
Image /page/5/Picture/14 description: The image shows four different abstract logos. The logos are all made up of curved lines in purple and orange. The first logo is a sphere, the second logo is three lines crossing each other, the third logo is a crescent shape, and the fourth logo is a wave.
The 37Company | Beeldschermweg 6F | 3821 AH Amersfoort | The Netherlands +31 (0) 33 450 72 50 | info@the37company.com | www.the37company.com BAN: NL15 INGB 0653 7522 02 | BIC: INGBNL2A | CC no. 31029240 | VAT no. NL 8111.49
Image /page/5/Picture/16 description: The image is a DEKRA certification logo. The logo is circular and contains the text "Management System ISO 13485" at the top. The DEKRA logo is in the center, and the text "Certified by DEKRA Certification GmbH" is at the bottom. The logo is in grayscale.
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MA2265-PM / Half Upper Body Plus - SYK MA2270-PM / Torso Plus - SYK MA2290-PM / Surgical Access Plus - SYK MA2400-PM / Full Underbody Plus - SYK MA2450-PM / Half Underbody Plus - SYK MA2475-PM / Paediatric Underbody Plus - SYK MA3320-PM / Premium Adult - SYK MA3330-PM / Premium Paediatric - SYK MA3340-PM / Premium Neonatal - SYK MA3350-PM / Premium Lower Body - SYK MA3360-PM / Premium Upper Body - SYK MA3365-PM / Premium Half Upper Body - SYK MA3400-PM / Premium Full Underbody - SYK MA3450-PM / Premium Half Underbody - SYK MA3475-PM / Premium Paediatric Underbody - SYK
Sterile blankets: Stryker REF / Stryker Proprietary name MA2280-PM / Surgical Access Plus (sterile) - SYK MA2285-PM / Lower Surgical Access Plus (sterile) - SYK MA2286-PM / Cardiac Blanket Plus (sterile) - SYK
The principle of operation is an electrically powered forced air warming unit (consists of a control circuit, an air filter, a fan, a heating element and temperature sensors) that propels warmed air via a flexible hose to a warming blanket (sterile or non-sterile, depending on the model) draped over the patient. Some warming blankets allow for the patient to be placed on top of the blanket or surrounded by a warming tube. All warming blankets are intended for single patient use only.
### Intended use:
The Mistral-Air® Warming System is a forced air warming device and comprises of a warming unit and a variety of blankets. It is intended to raise and maintain patient temperature by means of surface warming.
### Technological characteristics:
The main technological characteristics of the Mistral-Air® warming unit are:
- . Materials: metal, electronics and ABS/PC.
- Air filter material: HEPA ●
- Motor: single phase AC powered ●
- Heater: 1000W resistive ●
- . Control circuitry: microprocessor-based
The main technological characteristics of the Mistral-Air® Blankets are:
- Materials: polypropylene and polyethylene (and aluminium and polyurethane for ● reflective blankets).
These and other technological characteristics are the same or similar as the predicate devices.
Image /page/6/Picture/18 description: The image shows four different abstract logos. Each logo is made up of curved lines in purple and orange colors. The first logo is a sphere shape, the second logo has lines that intersect, the third logo is a crescent shape, and the fourth logo is a wave shape.
Image /page/6/Picture/20 description: The image shows a DEKRA certification logo. The logo is circular and contains the text "DEKRA Certified" around the perimeter. In the center of the logo is the DEKRA logo. Above the logo, the text "Management System ISO 13485" is visible.
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Image /page/7/Picture/2 description: The image shows the logo for The 37 Company. The logo is in purple and yellow. The words "The" and "Company" are in purple, while the number "37" is in yellow. Below the company name is the tagline "Solutions for Patient Warming".
### Summary of the main non-clinical tests and results:
In order to verify the performance of the Mistral-Air® Warming System the following bench tests were conducted:
- Air flow performance ●
- Air pressure performance ●
- Filtering performance ●
- Temperature performance ●
- Endurance test
- Extreme Temperatures
- Keyboard test
It was demonstrated that the Mistral-Air® Warming System is in compliance with the set performance specifications and the standards in Table 1.
### Table 1 Standards where the Mistral-Air® warming system complies with.
| Number/code | Title | Version | Pass/Fail |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|-----------|
| AAMI/ANSI ES60601-1 | Medical electrical equipment - Part 1: General Requirements for Basic<br>Safety and Essential Performance<br>(edition 3.1; FDA rec. # 19-4) | 2005/(R)2012 +<br>A1:2012 +<br>C1:2009/(r)2012 +<br>A2:2010/(r)2012 | Pass |
| IEC 60601-1-2 | Medical electrical equipment - Part 1-2: Collateral Standard:<br>Electromagnetic Compatibility - Requirements and tests<br>(edition 3.0; FDA rec. # 19-1) | 2007 | Pass |
| IEC 60601-1-6 | Medical electrical equipment - Part 1-6: Collateral Standard: Usability<br>(edition 3.1; FDA rec. # 5-89) | 2010 + A1:2013 | Pass |
| IEC 60601-1-8 | Medical electrical equipment - Part 1-8: Collateral Standard:<br>Requirements and Tests and Guidance for Alarm Systems in Medical<br>Electrical Equipment<br>(edition 2.1; FDA rec. # 5-76) | 2006 + A1:2012 | Pass |
| IEC 62304 | Medical Device Software - Software Life Cycle Processes<br>(edition 1.0; FDA rec. # 13-92) | 2006 | Pass |
| IEC 62366-1 | Medical devices - Application of usability engineering to medical devices<br>(edition 1.0; FDA rec. # 5-95) | 2015 | Pass |
| IEC 60529 | Degrees of protection by enclosures (IP Code)<br>(edition 2.1) | 2001 | Pass |
| IEC 80601-2-35 | Medical Electrical Equipment - Part 2-35: Particular Requirements for the<br>Basic Safety and Essential Performance of Heating Devices using<br>Blankets, Pads or Mattresses and Intended for Heating in Medical Use<br>(Edition 2.1) | 2016 | Pass |
| ISTA ЗА | Packaged-Products for Parcel Delivery System Shipment 70 kg (150 lb)<br>or Less<br>(FDA rec. #: 5-110) | 2008 | Pass |
| ASTM D4169 | Standard practice of performance testing of shipping containers and<br>systems<br>(FDA rec. #: 14-462) | 2014 | Pass |
| ASTM D642 | Standard test method for determining compressive resistance of shipping<br>containers, components and unit loads | 2000 | Pass |
| ISO 10993-1 | Biological Evaluation Of Medical Devices - Part 1: Evaluation And<br>Testing Within A Risk Management Process<br>(FDA rec. #: 2-156) | 2009/(R)2013 | Pass |
| ISO 11135 | Sterilization Of Health-Care Products - Ethylene Oxide - Requirements<br>For The Development, Validation And Routine Control Of A Sterilization<br>Process For Medical Devices<br>(FDA rec. #: 14-452) | 2016 | Pass |
### Conclusion:
The Mistral-Air® Warming System has the same intended use and performance as the predicate devices. Therefore, The Surgical Company International BV believes the proposed device does not raise any new safety or effectiveness issues.
Image /page/7/Picture/17 description: The image shows four different abstract logos. The logos are all made up of curved lines in purple and orange colors. The first logo is a sphere shape, the second logo is three curved lines, the third logo is a crescent shape, and the fourth logo is a square shape.
The 37Company | Beeldschermweg 6F | 3821 AH Amersfoort | The Netherlands T +31 (0) 33 450 72 50 | info@the37company.com | www.the37company.com IBAN: NL15 INGB 0653 7522 02 | BIC: INGBNL2A | CC no. 31029240 | VAT no. NL 8111.49.948.03
Image /page/7/Picture/19 description: The image shows a DEKRA certification logo. The logo is circular and features the DEKRA logo in the center. The text "Management System ISO 13485" is at the top of the logo. The text "DEKRA Certified" is at the bottom of the logo.
