MISTRAL-AIR WARMING SYSTEM

K101705 · The Surgical Company International B.V. · DWJ · Jul 2, 2010 · Cardiovascular

Device Facts

• Record ID: K101705
• Device Name: MISTRAL-AIR WARMING SYSTEM
• Applicant: The Surgical Company International B.V.
• Product Code: DWJ · Cardiovascular
• Decision Date: Jul 2, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5900
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

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. The principle of operation is an electrically powered unit (the Mistral-Air Plus Warming Unit) consisting of a fan and heating element that propels warmed air via a flexible hose to a blanket (the Mistral-Air Blanket) draped over the patient. Some configurations allow for the patient to be placed on top of the blanket or surrounded by a warming tube. Almost all types of Mistral-Air Blankets types are provided non-sterile. However, one type of Mistral-Air Blankets is provided sterile. The Mistral-Air Blankets (both non-sterile versions) are intended for single patient use only.

Device Story

Mistral-Air Warming System consists of a warming unit (MA1100-US) and various single-patient-use blankets; unit contains fan and 1000W resistive heating element; propels warmed air through flexible hose to blanket draped over, under, or surrounding patient; intended for surface warming to raise/maintain patient temperature; operated by healthcare professionals in clinical settings; output is controlled warm air; benefits include prevention or treatment of hypothermia.

Clinical Evidence

Bench testing only. Tests included air flow performance, air pressure performance, filtering performance, temperature performance, endurance testing, extreme temperature testing, and keyboard testing. Results confirmed compliance with performance specifications.

Technological Characteristics

Warming unit: metal, electronics, ABS housing; 75W motor; 1000W resistive heater; HEPA air filter; microprocessor-based control circuitry. Blankets: polypropylene and polyethylene. System is electrically powered (110-120V, 60Hz).

Indications for Use

Indicated for raising and maintaining patient body temperature via surface warming using forced air.

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

• Soft-Air Patient Warming System Model SA 4000 (K073712)
• Bair Hugger Model 750 Total Temperature Management System (K001149)
• CSZ WarmAir Hyperthermia System (K942599 and K942790)

Submission Summary (Full Text)

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Beeldschermweg 6F 3821 AH Amersfoort The Netherlands

T [phone] F [phone] [e-mail], www.tsci.n

K101705

# 510(k) Summary

# Applicant:

JUL -- 2 2010

The Surgical Company International BV (TSCI) Beeldschermweg 6F 3821 AH Amersfoort The Netherlands

| Contact Person: | Adriaan P. Intveld, Regulatory Affairs & Quality Assurance Manager |
|-----------------|--------------------------------------------------------------------|
| Telephone: | [phone] |
| Fax: | [phone] |
| E-mail: | [e-mail] |
| Date Prepared: | 25 January 2010 |

#### Device name:

| Proprietary Name: | Mistral-Air Warming System |
|----------------------|-------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Heating pad control unit, air: (GMDN-code: P 36954)<br>Heating pad system under/overlay, air (GMDN-code: P 36931) |
| Classification Name: | Thermal regulating system (21 CFR 870.5900) |
| Product Code: | DWJ |

## Predicates:

- Soft-Air Patient Warming System Model SA 4000 [K073712] .
- Bair Hugger Model 750 Total Temperature Management System [K001149] .
- CSZ WarmAir Hyperthermia System [K942599 and K942790] .

# Device description:

The Mistral-Air Warming System comprises of the following devices:

- MA1100-US Mistral-Air Plus Warming Unit 110-120V~, 60Hz .
- Mistral-Air Adult Blanket (white) MA0220 .
- Mistral-Air Paediatric Blanket (white) MA0230 .
- Mistral-Air Lower Body Blanket (white) MA0250 ●
- Mistral-Air Upper Body Blanket (white) MA0260 ●
- Mistral-Air Half Upper Body Blanket (white) MA0265 .
- Mistral-Air Torso Blanket (white) ● MA0270
- Mistral-Air Full Body Surgical Access Sterile (white) MA0280 .
- MA0290 Mistral-Air Full Body Surgical Access - Non-sterile (white) .
- Mistral-Air Adult Blanket (silver) MA0320 ◆
- Mistral-Air Paediatric Blanket (silver) MA0330
- Mistral-Air Neonatal Blanket (silver) MA0340 ●
- Mistral-Air Lower Body Blanket (silver) MA0350 ●
- Mistral-Air Upper Body Blanket (silver) MA0360
- Mistral-Air Half Upper Body Blanket (silver) MA0365
- MA0400 Mistral-Air Full Underbody (silver) .
- Mistral-Air Underbody (silver) MA0450 .
- Mistral-Air Tube (blue) MA0510

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Image /page/1/Picture/0 description: The image shows the letters TSCI in a bold, sans-serif font. The letters are large and black, contrasting with the white background. The letters are closely spaced together, creating a compact and impactful visual. The image is simple and clear, with a focus on the typography.

Beeldschermweg 6F 3821 AH Amersfoort The Netherlands

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#### 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.

The principle of operation is an electrically powered unit (the Mistral-Air Plus Warming Unit) consisting of a fan and heating element that propels warmed air via a flexible hose to a blanket (the Mistral-Air Blanket) draped over the patient. Some configurations allow for the patient to be placed on top of the blanket or surrounded by a warming tube. Almost all types of Mistral-Air Blankets types are provided non-sterile. However, one type of Mistral-Air Blankets is provided sterile. The Mistral-Air Blankets (both non-sterile versions) are intended for single patient use only.

## Technological characteristics:

The main technological characteristics of the Mistral-Air Plus Warming Unit are:

- metal, electronics and ABS. . Materials:
- HEPA . Air filter:
- Single phase AC, 75 W Motor: .
- 1000W resistive Heater: ●
- microprocessor-based Control circuitry: .

The main technological characteristics of the Mistral-Air Blankets are:

- polypropylene and polyethylene. Materials: .
These and other technological characteristics are the same or similar as the predicate devices.

# 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.

#### Conclusion:

The Mistral-Air Warming System has the same intended use and performance as the predicate devices. The Surgical Company International BV believes these proposed devices do not raise any new safety or effectiveness issues.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right. The eagle is composed of three thick, curved lines that suggest the shape of the bird in flight.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

The Surgical Company International B.V. c/o Mr. Casey Conry Underwriters Laboratories Inc. 71285 Walt Whitman Rd Melville, NY 11747

JUL .- 2 2010

Re: K101705

Trade/Device Name: Mistral Air Warming System Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal Regulating System Regulatory Class: Class II (two) Product Code: DWJ Dated: June 16, 2010 Received: June 17, 2010

Dear Mr. Conry:

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.

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#### Page 2 - Mr. Casey Conry

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-setforth 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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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Image /page/4/Picture/0 description: The image contains the letters 'SCI' in a bold, textured font. To the right of the letters, there is some faded text that appears to say 'The St International'. The letters 'SCI' are the most prominent part of the image, with the other text being less clear.

The Surgical Company International B.V.

Beeldschermweg 6F 3821 AH Amersfoort The Netherlands

T [phone] F [phone] [e-mail], www.tsci.n

# Indications for Use Statement

510(k) Number: to be determined

Mistral-Air® Warming System Device Name:

The Mistral-Air® Warming System is a forced air warming device and Indications for Use: comprises of a warming unit and a variety of blankets. It is intended to raise and maintain patient temperature by means of surface warming.

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | X |
|-------------------------------------------------|---|
| AND/OR | |
| Over-The-Counter Use<br>(21 CFR 801 Subpart C) | |

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

WME

iovascular Devices 510(k) Number