(274 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML models. The device description and intended use are purely focused on thermal regulation through forced air.
Yes
The device is intended to prevent and treat hypothermia and provide warmth, which are therapeutic actions.
No
The device is a thermal regulating system designed to prevent and treat hypothermia and provide warmth. Its stated intended use does not involve the diagnosis of any medical condition or disease.
No
The device description explicitly states it consists of a "portable forced-air temperature management unit and a disposable forced-air blanket," which are hardware components.
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 and treat hypothermia and provide warmth to patients. This is a therapeutic and supportive function, not a diagnostic one.
- Device Description: The device is a thermal regulating system using forced air and a blanket. This is a physical intervention, not a test performed on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / 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.
Product codes
DWJ
Device Description
The Sirocco™ temperature management system consists of a portable forced-air temperature management unit and a disposable forced-air blanket (various models).
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
Not Found
Intended User / Care Setting
Not Found
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)
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:
IEC 60601-1:1993+ A1:1996+ A2:1996+ A2:1999 ERRATUM+ A13:1997 - Electronic Medical Equipment. Part 1: General requirements for safety
IEC 60601-1-2:2002+A1:2006 - Electronic Medical Equipment. Part 1-2: General requirements for the security. Collateral norm: Electromagnetic compatibility. Requirements and tests (IEC 60601-1-2: 2001/A1: 2004)
IEC 60601-1-4:1997+A1:2000 - Electronic Medical Equipment. Part 1: General requirements for the security. 4: Collateral 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 oxide.
INTERNAL TESTS:
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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.
: {
. :: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :
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.
1
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 |
- A1:1996
- A2:1996
- A2:1999 ERRATUM
- A13:1997 | Electronic Medical Equipment. Part 1: General requirements for safety |
| IEC 60601-1-2:2002
+A1:2006 | Electronic Medical Equipment. Part 1-2: General requirements for the security. Collateral
norm: Electromagnetic compatibility. Requirements and tests (IEC 60601-1-2: 2001/A1:
2004 |
| IEC 60601-1-4:1997
+A1:2000 | Electronic Medical Equipment. Part 1: General requirements for the security. 4: Collateral
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
oxide. |
2
| INTERNAL
| 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.
3
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
:在
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
4
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 (800) 638-2041 or (301) 796-7100 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