SIROCCO THERMAL REGULATING SYSTEM

K102856 · Galmaz Biotech S.L. · DWJ · Jun 30, 2011 · Cardiovascular

Device Facts

• Record ID: K102856
• Device Name: SIROCCO THERMAL REGULATING SYSTEM
• Applicant: Galmaz Biotech S.L.
• Product Code: DWJ · Cardiovascular
• Decision Date: Jun 30, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5900
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The Galmaz Biotech® SIROCCO™ Thermal Requlating System is intended to prevent and treat hypothermia and provide warmth to cold or shivering patients. In addition, the Galmaz Biotech® SIROCCO™ Thermal Regulating System should be used whenever conditions exist that could cause patients to become cold.

Device Story

Sirocco™ Thermal Regulating System is a portable forced-air temperature management unit used with disposable forced-air blankets. Device functions by delivering warmed air to patient via blanket to prevent or treat hypothermia. Operated by healthcare professionals in clinical settings. System includes alarms and security features to monitor temperature and pressure. Output is controlled thermal environment for patient. Benefits include maintenance of normothermia and patient comfort during clinical procedures.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), programmable electronic medical systems (IEC 60601-1-4), and biological evaluation (ISO 10993-1, ISO 10993-7). Internal tests verified alarm operation, pressure, temperature, and final assembly integrity.

Technological Characteristics

Forced-air warming unit with disposable blankets. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4, UL 60601-1, ISO 10993-1, and ISO 10993-7. Features electronic control system for temperature and pressure regulation, including alarm and security systems.

Indications for Use

Indicated for patients experiencing or at risk of hypothermia, including those who are cold or shivering, to provide warmth and prevent heat loss.

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

• Augustine Medical, Inc. Bair Hugger Model 750 unit used with Bair Hugger blankets (K001149)
• Augustine Medical, Inc. Bair Hugger Model 505 unit used with Bair Hugger blankets (K960167)

Submission Summary (Full Text)

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# JUN 3 0 2011

5.0 SMDA Summary

# 510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

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The assigned 510(k) number is:

## 1. Name of Submiter:

Chris Zander Director of North American Operations 1064 Labarge Rd Hudson, WI 54016-7340

#### 2. Device Name:

Device Proprietary / Trade Name: Sirocco™ Thermal Regulating System

| Common Name: | Hyper/Hypothermia system |
|------------------------|----------------------------|
| Classification Names: | System, Thermal regulatory |
| Device Classification: | Class II |
| Regulation Number: | 21 CFR 870.5900 |
| Product Codes: | DWJ |

# 3. Legally Marketed Equivalent Device Name:

We are claiming substantial equivalence to:

- Augustine Medical, Inc. Bair Hugger Model 750 unit used with Bair Hugger blankets; . K001149
- . Augustine Medical, Inc. Bair Hugger Model 505 unit used with Bair Hugger blankets; K960167

#### 4. Description of the Device:

The Sirocco™ temperature management system consists of a portable forced-air temperature management unit and a disposable forced-air blanket (various models).

Galmaz Biotech S.L.

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#### 5. Intended Use of the Device:

The Galmaz Biotech® SIROCCO™ Thermal Requlating System is intended to prevent and treat hypothermia and provide warmth to cold or shivering patients. In addition, the Galmaz Biotech® SIROCCO™ Thermal Regulating System should be used whenever conditions exist that could cause patients to become cold.

### 6. Comparison of technological characteristics With Predicate Device:

The Sirocco™ Thermal Requlating System is substantially equivalent in its technological characteristics as the predicate devices.

- Augustine Medical, Inc. Bair Hugger Model 750 unit used with Bair Hugger blankets; . K001149
- Augustine Medical, Inc. Bair Hugger Model 505 unit used with Bair Hugger blankets; . K960167

#### 7. Discussion of Non clinical Studies:

Results of studies conducted on the sterile disposable Sirocco™ Thermal Regulating System forced-air blanket demonstrate the device is substantially equivalent in safety and effectiveness with the predicate devices.

In addition, the following standards and internal tests were conducted to ensure the safety of the user and patient.

| STANDARDS | WARMING UNIT |
|-------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-1:1993<br>+ A1:1996<br>+ A2:1996<br>+ A2:1999 ERRATUM<br>+ A13:1997 | Electronic Medical Equipment. Part 1: General requirements for safety |
| IEC 60601-1-2:2002<br>+A1:2006 | Electronic Medical Equipment. Part 1-2: General requirements for the security. Collateral<br>norm: Electromagnetic compatibility. Requirements and tests (IEC 60601-1-2: 2001/A1:<br>2004 |
| IEC 60601-1-4:1997<br>+A1:2000 | Electronic Medical Equipment. Part 1: General requirements for the security. 4: Collateral<br>norm: Programmable Electronic Medical systems |
| UL 60601-1:2002 | Medical Electrical Equipment, Part 1: General Requirements for Safety |
| IEC ISO 10993-1:2004 | Biological sterile product evaluation. Part 1: Evaluation and tests. |
| IEC ISO 10993-7: 1996 | Biological evaluation of sterile products. Part 7: Remainders in sterilization by ethylene<br>oxide. |

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| INTERNAL<br>TESTS | DESCRIPTION |
|-------------------|-----------------------------------------------------------------------|
| 01 | Initial Test of operation of electronic plates according to INS-B-001 |
| 02 | Final assembly INS-B-001 |
| 03 | Final verification of assembled product INS-B-002 |
| 03 | Visual Inspection |
| 03 | Test of operation of alarms and security systems |
| 03 | Pressure Test |
| 03 | Temperature Test |
| 03 | Electrical Safety Test |
| 03 | Final Test |
| 04 | Final labeling of the equipment INS-B-003 |
| 05 | Final packaging of the equipment INS-B-004 |

# 8. Conclusion:

r -. . The GALMAZ BIOTECH® Sirocco™ Thermal Regulating System has similar technological characteristics and the same intended use as devices currently on the market.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

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

JUNY 3- 0 - 2011

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Galmaz Biotech S.L. c/o Mark Job Regulatory Technology Services, LLC 1394 25th St. NW Buffalo, MN 55313

Re: K102856

> SIROCCO™ Patient Warming System Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal Regulating System Regulatory Class: Class II Product Code: DWJ Dated: June 15, 2011 Received: June 16, 2011

Dear Mr. Job:

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. Ilisting 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

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Page 2 - Mr. Mark Job

CFR Part 807): labeling (21 CFR Part 801): medical device 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.

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/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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#### 4.0 INDICATIONS FOR USE

510(k) Number (if known):

Device Name: Sirocco™ Thermal Regulating System.

# Indications for Use:

The Galmaz Biotech® SIROCCO™ Thermal Regulating System is intended to prevent and treat hypothermia and provide warmth to cold or shivering patients. In addition, the Galmaz Biotech SIROCCO™ Thermal Regulating System should be used whenever conditions exist that could cause patients to become cold.

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign)

Olvision Sign-Off) Division of Cardiovascular Devices

510(k) Number