SOFT AIR, MODEL SA 4000 AND MISTRAL AIR, MODEL MA0100

K073712 · Adroit Medical Systems, Inc. · DWJ · Jun 6, 2008 · Cardiovascular

Device Facts

• Record ID: K073712
• Device Name: SOFT AIR, MODEL SA 4000 AND MISTRAL AIR, MODEL MA0100
• Applicant: Adroit Medical Systems, Inc.
• Product Code: DWJ · Cardiovascular
• Decision Date: Jun 6, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5900
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Patient Warming System manufactured by Adroit Medical Systems is designed for the operating room (exclusive of the sterile surgical field), recovery room, anesthetic room, ICU, Medical/Surgical floors, in-hospital patient transport and emergency rooms. The Patient Warming System provides safe and controlled surface warming to assist adult patients to maintain normal body temperature.

Device Story

Patient warming system consists of blower units (SA4000/MA0100) and non-sterile blankets (models 1187, 1843, 1846). System provides forced-air surface warming to adult patients. Used in OR, recovery, ICU, and medical/surgical floors to maintain normothermia. Blower unit generates heated air, delivered through hose to blanket placed on patient. Clinicians operate system to prevent or treat hypothermia. Benefits include maintenance of normal body temperature during clinical procedures or recovery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Forced-air thermal regulating system. Includes blower units (110V/220V) and non-sterile blankets. Class II device (21 CFR 870.5900).

Indications for Use

Indicated for adult patients requiring surface warming to maintain normal body temperature in clinical settings including OR, recovery, ICU, and medical/surgical floors.

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.

Submission Summary (Full Text)

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Public Health Service

Image /page/0/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 200 Corporate Boulevard Rockville MD 20850

JUN - 6 2008

Adroit Medical Systems c/o Mr. Scott Gammons Vice President 1146 Carding Machine Road London, TN 37774

Re: K073712

Soft-Air SA4000, Mistral-Air MA0100 Blanket Model numbers 1187, 1846 and 1843 Regulation Number: 21 CFR 870.5900 Regulation Name: System, Thermal Regulating Regulatory Class: Class II (two) Product Code: DWJ Dated: May 21, 2008 Received: May 22, 2008

Dear Mr. Gammons:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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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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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.

Sincerely yours,

R. Kirchner

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

Device Name: Soft Air Patient Warming System: Blower Model SA4000 (110V)

Mistral Air Patient Warming System: Blower Model MA0100 (220V)

Soft Air Blankets (Non-sterile):

Model 1187: Adult Full Body

Model 1843: Adult Lower Body

Model 1846: Adult Upper Body

Indications for Use: The Patient Warming System manufactured by Adroit Medical Systems is designed for the operating room (exclusive of the sterile surgical field), recovery room, anesthetic room, ICU, Medical/Surgical floors, in-hospital patient transport and emergency rooms. The Patient Warming System provides safe and controlled surface warming to assist

adult patients to maintain normal body temperature.

Prescription Use x AND/OR 801 Subpart D) (21 CFR 801 Subpart C)

Over-The-Counter Use _______________ (Part 21 CFR

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number Ko73712_

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