(408 days)
Not Found
No
The 510(k) summary describes a temperature-controlled electric warming system and a vacuum mattress. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the device description, intended use, or performance studies. The predicate device is also a portable electric blanket, further suggesting a non-AI/ML technology.
Yes
The device is intended for "preventing or treating the effects of incidental hypothermia," which describes a therapeutic purpose.
No
The device is a whole body warming system used to prevent or treat hypothermia, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states it is a combination product made of two primary hardware components: an electrically warmed panel and an integrated vacuum mattress/stretcher.
Based on the provided information, the Geratherm SOS-Vacutherm is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to prevent or treat hypothermia in adults by warming the whole body. This is a therapeutic intervention applied directly to the patient, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device consists of an electrically warmed panel and a vacuum mattress/stretcher. These are physical components used for warming and transport, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), using reagents, or providing diagnostic information based on in vitro testing.
Therefore, the Geratherm SOS-Vacutherm falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Geratherm SOS-Vacutherm system is designed to prevent or reduce the effects of hypothermia and hypothermia related symptoms. It may be used in the transport of trauma victims or critical care patients to a hospital by ambulance, helicopter, or fixed wing aircraft. Using the Geratherm® SOS Vacutherm System lowers susceptibility to shock caused by the cold. In addition, patients experience a subjective reduced perception of pain.
The Geratherm SOS-Vacutherm is a temperature-controlled electric whole body warming system intended for use in preventing or treating the effects of incidental hypothermia in adults while at the rescue scene or during transport by air or ground to a medical facility
Product codes
DWJ, FPP
Device Description
The Geratherm SOS-Vacutherm System is a combination product made of two primary components:
- An electrically warmed panel. - Class II
- A integrated vacuum mattress / stretcher - Class I (exempt from 510(k) premarket notification).
Vacutherm description:
- Warming Panel: The main functional warming panel element is a 54 inches (137.0 cm) by 31.5 inches (80.0 cm). The active warming panel is constructed of electrically resistive carbon fiber woven cloth enclosed between two layers of Dacron® polyester hollow fiber fleece panels. The carbon fiber cloth is stitched to a lower fleece panel. The polyester fleece layers are permanently enclosed in a waterproof polyurethane / polyester cloth laminate cover. The active warming panel has a permanently affixed power cable that is attached to the power control module via color coded quick connect power connections. The active panel is attached to the vacuum mattress with quick attach / disconnects.
2: Insulated Heat Reflective Panel: A reflective panel overlays the active panel from the opposite side of the patient. The passive insulation panel is attached to the vacuum mattress on the opposite side of the active panel with quick attach /disconnects. - Control Module: The control module is a molded high impact plastic housing that contains the electronic circuitry. The module regulates the warming panel temperature through a feedback circuit employing two thermistor temperature sensing systems located in the interior of the SOS-Vacutherm warming panel. Operator control is achieved through the use of four buttons located on the face of the module: an on button, off button, a 37° C (98.6°F) select button, and a 42° C (107.6°F) select button. The control module displays both warming panel temperature level and battery power status. Normal functions are monitored both through visual displays and audible signal. The control module power sources are the following; the auxiliary battery, an automotive type 12 Volt power supply outlet, or an aircraft power supply outlet, The control module automatically adjusts output current to either 12 volt DC automotive or 24-28 volt DC aircraft power sources. The control module body may be attached to the warming panel using a form-fitting pocket that is permanently attached to the insulated heat reflective panel.
- Battery: The Geratherm SOS-Vacutherm system uses a sealed lead-acid gel rechargeable battery of 10-ampere hour capacity.
- Cabling: The Geratherm SOS-Vacutherm System has a power cable permanently attached to the upper corner. The cable attaches from the warming panel directly to the Control Module. The cable supplying power to the power module has a color-coded quick connect at one end and an auxiliary battery /automotive/aircraft DC power outlet at the other.
- AC to DC Charger: The Geratherm SOS-Vacutherm System employs a 12 volt, DC, 2-ampere hour output battery charger to charge the battery or maintain full battery status. The charger may be used with either 120 or 240 Volt, 50 or 60 Hertz, AC input electric current.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
whole body
Indicated Patient Age Range
adults
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)
A formal clinical evaluation was performed at the Mayo Clinic comparing passive warming and active warming using Geratherm resistive carbon fiber electrical warming technology. Patients who were transported using Geratherm electric / carbon fiber active warming systems experienced significantly lesser degrees of hypothermia than those who were transported using passive warming techniques.
The Geratherm SOS-Vacutherm System was tested according to the Operating Manual.and was found to prevent or reduce hypothermia by the following organizations: CE 0118, SAMU 38 - Helicopter Mountain Rescue Grenoble, France, ADAC Helicopter Helicopter Rescueservice Munich, Germany, Royal Dutch Army, Helicopter Catastrophe Rescueteam Netherlands, REGA - Mountain rescue service REGA - Centre Zürich Airport Zürich, Switzerland.
The Gerathrerm SOS-Vacutherm System performed according to specification and compared favorably to the Predicate Device. No new issues of safety or effectiveness were found to arise in the Geratherm Vacutherm System when compared to the Predicate Device.
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
Image /page/0/Picture/1 description: The image shows a logo for RG Medical Diagnostics. The logo features the letters "RG" in a large, bold font at the top. Below the letters, there is a graphic that resembles a heartbeat line or a mountain range. Underneath the graphic, the words "medical" and "DIAGNOSTICS" are stacked on top of each other in a smaller font.
RG Medical Diagnostics
JUN 2 9 2006
510(k) Premarket Notification Summary
Geratherm® SOS-Vacutherm
Common Name - Warming Blanket Classification name - Thermal Regulating System (870.5900) AND Stretcher, Hand Carried (21 CFR, 880.6900) Predicate Device - ChillBuster™ Portable Electric Blanket (Thermogear, Inc. K991684)
The following material presents the 510 (k) Summary for the Geratherm® SOS-Vacutherm
21130 Bridge Street · Southfield, MI 48034 Phone: 888-596-9498 · Fax: 248-750-0187 · Website: www.rgmd.com
Section 5, page 1 of 7
1
Premarket (510K) Summary
Submitter Information
RG Enterprises, Inc. (dba) RG Medical Diagnostics 21130 Bridge Street Southfield, MI 48034 888-596-9498 Date Prepared: 04/15/05
Device Name:
Proprietary name: Geratherm SOS-Vacutherm (Thermamed "Smartcare") Common name: Hypothermic Therapy System CDRH Product Regulation: Thermal Regulation System (21 CFR, 870.5900)
AND,
Stretcher, Hand Carried (21 CFR, 880.6900) (510(k) exempt)
| Establishment Registration Number: | 1835242 |
|---|---|
| ------------------------------------ | --------- |
Classification: Combination Product, Class II (DWJ) AND Class I (FPP)
Predicate Device:
RG Medical Diagnostics, 21130 Bridge Street, Southfield, Michigan, 48034 has designated The Chillbuster Portable Electric Blanket System, Model 8001, (K991684) manufactured by Thermogear, Inc. 18005 Lower Boones Ferry Rd., Togart. OR 977224 as the Predicate Device for the Geratherm SOS-Vacutherm System. manufactured by Geratherm AG, Fahrenheitstrasse 1, D-98716 Geschwenda/Germany.
Statement of Substantial Equivalence:
Geratherm SOS-Vacutherm Optimal is substantially equivalent to:
- ChillBuster™ Portable Electric Blanket (Thermogear, Inc. K991684)
Description of Device:
The Geratherm SOS-Vacutherm System is a combination product made of two primary components:
-
An electrically warmed panel. - Class II
-
A integrated vacuum mattress / stretcher - Class I (exempt from 510(k) premarket notification).
21130 Bridge Street • • Southfield, MI 48034 Phone: 888-596-9498 · Fax: 248-750-0187 · Website: www.rgmd.com
Section 5, page 2 of 7
2
Vacutherm description:
- Warming Panel: The main functional warming panel element is a 54 inches (137.0 cm) by 31.5 inches (80.0 cm). The active warming panel is constructed of electrically resistive carbon fiber woven cloth enclosed between two layers of Dacron® polyester hollow fiber fleece panels. The carbon fiber cloth is stitched to a lower fleece panel. The polyester fleece layers are permanently enclosed in a waterproof polyurethane / polyester cloth laminate cover. The active warming panel has a permanently affixed power cable that is attached to the power control module via color coded quick connect power connections. The active panel is attached to the vacuum mattress with quick attach / disconnects.
2: Insulated Heat Reflective Panel: A reflective panel overlays the active panel from the opposite side of the patient. The passive insulation panel is attached to the vacuum mattress on the opposite side of the active panel with quick attach /disconnects.
-
Control Module: The control module is a molded high impact plastic housing that contains the electronic circuitry. The module regulates the warming panel temperature through a feedback circuit employing two thermistor temperature sensing systems located in the interior of the SOS-Vacutherm warming panel. Operator control is achieved through the use of four buttons located on the face of the module: an on button, off button, a 37° C (98.6°F) select button, and a 42° C (107.6°F) select button. The control module displays both warming panel temperature level and battery power status. Normal functions are monitored both through visual displays and audible signal. The control module power sources are the following; the auxiliary battery, an automotive type 12 Volt power supply outlet, or an aircraft power supply outlet, The control module automatically adjusts output current to either 12 volt DC automotive or 24-28 volt DC aircraft power sources. The control module body may be attached to the warming panel using a form-fitting pocket that is permanently attached to the insulated heat reflective panel.
-
Battery: The Geratherm SOS-Vacutherm system uses a sealed lead-acid gel rechargeable battery of 10-ampere hour capacity.
-
Cabling: The Geratherm SOS-Vacutherm System has a power cable permanently attached to the upper corner. The cable attaches from the warming panel directly to the Control Module. The cable supplying power to the power module has a color-coded quick connect at one end and an auxiliary battery /automotive/aircraft DC power outlet at the other.
Section 5, page 3 of 7
3
- AC to DC Charger: The Geratherm SOS-Vacutherm System employs a 12 volt, DC, 2-ampere hour output battery charger to charge the battery or maintain full battery status. The charger may be used with either 120 or 240 Volt, 50 or 60 Hertz, AC input electric current.
Intended Use
The Geratherm SOS-Vacutherm system is designed to prevent or reduce the effects of hypothermia and hypothermia related symptoms. It may be used in the transport of trauma victims or critical care patients to a hospital by ambulance, helicopter, or fixed wing aircraft. Using the Geratherm® SOS Vacutherm System lowers susceptibility to shock caused by the cold. In addition, patients experience a subjective reduced perception of pain.
Non-Clinical Performance Data
The studies reported in this subsection were conducted by CE-LAB GmbH, iMG gGmbH, TREO Electrooptik GmbH, and TÜV GmbH
- Standards: The Geratherm SOS-Vacutherm has been tested to the following standards:
General Medical Safety:
EMC Specification EN 60601-1-2:2001. NATO Standard DCS01, DCE01. Generic Specification of SPAME ( Special Purpose Aeromedical Equipment) Issue 3, page 16, No. 62 (vibration). IEC 60601-1:1990 + A1:1993 + A2:1995 IEC 60601-2-35:1996 EN 60601-2-35:1996 C 0118 ISO 13485:2003 UL AWM Style 1007 & 1589 UL VW-1 FT
Clinical Performance Data
A formal clinical evaluation was performed at the Mayo Clinic comparing passive warming and active warming using Geratherm resistive carbon fiber electrical warming technology.
Alexander Kober, MD; Thomas Scheck, BS; Béla Fülesdi, MD; Frank Lieba, BS; Wolfgang Vlach, BS; Alexander Friedman, MD; & Daniel I. Sessler, MD. "Effectiveness of Resistive Heating Compared With Passive Warming in Treating Hypothermia Associated With Minor Trauma: A Randomized Trial," Mayo Clinic Proc. 2001;76:369-375
21130 Bridge Street · Southfield. MI 48034 Phone: 888-596-9498 • Fax: 248-750-0187 • Website: www.rgmd.com
Section 5, page 4 of 7
4
Results: Patients who were transported using Geratherm electric / carbon fiber active warming systems experienced significantly lesser degrees of hypothermia than those who were transported using passive warming techniques.
Verification of Operation Under Non-Laboratory Conditions
The Geratherm SOS-Vacutherm System was tested according to the Operating Manual.and was found to prevent or reduce hypothermia by the following organizations:
CE 0118
SAMU 38 - Helicopter Mountain Rescue Grenoble, France
ADAC Helicopter Helicopter Rescueservice Munich, Germany
Royal Dutch Army, Helicopter Catastrophe Rescueteam Netherlands
REGA - Mountain rescue service REGA - Centre Zürich Airport Zürich, Switzerland
Conclusions Drawn from Clinical and Non-Clinical Testing
The Gerathrerm SOS-Vacutherm System performed according to specification and compared favorably to the Predicate Device. No new issues of safety or effectiveness were found to arise in the Geratherm Vacutherm System when compared to the Predicate Device
Section 5, page 5 of 7
5
| Features | Geratherm® SOS -Vacutherm | ChillBuster™ Model 8001 |
|---|---|---|
| Indications for Use | Preventing / counteracting hypothermia | Preventing / counteracting hypothermia |
| Function | Low-level distributed heat to patient | Low-level distributed heat to patient |
| Heat Delivery Mechanism | Conduction | Conduction |
| Heat Source | Resistive carbon fiber cloth in panel | Thermal wire in blanket |
| Electrical Requirements | 12 VDC & 24-28 VDC @ 7 Amp | 12 VDC @ 3.2 Amp |
| Heating Element Power | 120 W (max) | 40 W (approx.) |
| Heat Presented to Patient | 37° C (98.6° F) or, 42° C (107.6° F) | 105° F |
| User Heat Output Control | Regulated 37° C or, Regulated 42° C | Un-calibrated continuous 20W-40W |
| Thermal Temperature Cutoff | 37° C (98.6° F) or, 42° C (107.6° F) | 105° F |
| Alarms | Audible and Visual | none |
| Circuit Protection | Multiple fault sensors, circuit breaker and fused controller | Fused positive battery lead |
| Internal Diagnostics | Continuous automatic self testing | none |
| Safety Agency Approvals | TUV Munich | TUV Rheinland |
| EMC Compatibility Testing | IEC 601-1-2 | IEC 601-1-2 |
| Cross-Contamination Protection | Disposable single use liner | Disposable single use liner |
| Cytotoxicity | L 929-Proliferation; EN 30993-5,-12; OSI 10993-5,- 12; LM SOP 4-06-01 | |
| Controller Diagnostic Display | Panel temperature, battery power level, fault detection, fault identification | |
| Blanket Material | Polyurethane and Dacron® polyester cloth laminate with Dacron® hollow filament fleece interior | Oxford nylon and nylon acrylic |
| Control Unit Construction | Impact resistant polycarbonate | Flame retardant polycarbonate |
| Cleaning | Hand wash all segments | Machine wash and dry |
| System Weight | 19 lbs (8.7 kg) | 8 lbs |
| Disinfection | Suitable for spray or sponge applied water based disinfectants | No information |
Comparison of Technological Characteristics ( SOS - Vacutherm vs Predicate device)
21130 Bridge Street ▪ ▪ Southfield, MI 48034
Phone: 888-596-9498 ▪ Fax: 248-750-0187 ▪ ▪ Website: www.rgmd.com
Section 5, page 6 of 7
6
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 9 2006
R.G. Enterprises, Inc. c/o Mr. Ronald G. Letoutneau President 21130 Bridge Street Southfield, MI 48034
Re: K051278
Geratherm SOS-Vacutherm Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal Regulating System Regulatory Class: Class II (Two) Product Code: DWJ Dated: June 21, 2006 . Received: June 23. 2006
Dear Mr. Letoutneau:
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.
7
Page 2 - Mr. Ronald G. Letoutneau
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 atterrenuirements 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 (2) CFR Parphy, W11); 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 10(t) 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 Office of Compliance at (240) 276-0120. Also, please note the regulation ventitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours.
Dmna R. buchner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
8
Indications for Use
510(k) Number (if known):
Device Name:
Geratherm SOS-Vacutherm
Indications For Use:
The Geratherm SOS-Vacutherm is a temperature-controlled electric whole body warming system intended for use in preventing or treating the effects of incidental hypothermia in adults while at the rescue scene or during transport by air or ground to a medical facility
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS L.INE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Duma R. Vachner
Division Sign-Off) Division of Cardiovascular Devices
510(k) Number Kos 12 78
. ... .
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Section 12, pg. 1 of 1