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

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).

AI/ML Overview

The provided text describes the Geratherm® SOS-Vacutherm, a thermal regulating system designed to prevent or reduce hypothermia. The submission focuses on demonstrating substantial equivalence to a predicate device and adherence to various standards rather than presenting extensive device performance data against specific acceptance criteria.

Therefore, the response will reflect the information available in the provided document.

Acceptance Criteria and Device Performance

The submission primarily focuses on functional equivalence to a predicate device and adherence to safety standards, rather than defining specific numerical acceptance criteria for clinical performance.

Acceptance Criteria (Implied)	Reported Device Performance
Prevent/reduce hypothermia (primary intended function)	Clinical study showed "Patients who were transported using Geratherm electric / carbon fiber active warming systems experienced significantly lesser degrees of hypothermia than those who transported using passive warming techniques." Verification by various rescue organizations.
Meet General Medical Safety Standards	Tested to IEC 60601-1:1990 + A1:1993 + A2:1995, IEC 60601-2-35:1996, EN 60601-2-35:1996 C 0118.
Meet EMC Specifications	Tested to EN 60601-1-2:2001, NATO Standard DCS01, DCE01.
Vibration Resistance	Tested to Generic Specification of SPAME (Special Purpose Aeromedical Equipment) Issue 3, page 16, No. 62 (vibration).
Thermal Temperature Control (specific to active warming)	Maintains 37° C (98.6°F) or 42° C (107.6°F) with thermal temperature cutoff at these levels.
Safety Features	Audible and Visual alarms, multiple fault sensors, circuit breaker, fused controller, continuous automatic self-testing.
Comparison to Predicate Device (functional and technological)	"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." (See comparison table for details).

Study Information

Sample Size used for the test set and the data provenance:
- Clinical Study: The clinical performance data references a study: 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.
  - Sample Size: The document does not explicitly state the sample size (number of patients) used in this randomized trial. The provided document only references the publication.
  - Data Provenance: The study was conducted at the Mayo Clinic, implying US-based data. It is described as a "Randomized Trial," indicating it was a prospective study.
- Non-Clinical Performance Data: The document mentions studies conducted by CE-LAB GmbH, iMG gGmbH, TREO Electrooptik GmbH, and TÜV GmbH, focusing on adherence to various technical standards. No sample sizes are applicable for these standard compliance tests.
- Verification of Operation Under Non-Laboratory Conditions: The device was tested by several European rescue organizations (SAMU 38 - Helicopter Mountain Rescue Grenoble, France; ADAC Helicopter Rescueservice Munich, Germany; Royal Dutch Army, Helicopter Catastrophe Rescueteam Netherlands; REGA - Mountain rescue service REGA - Centre Zürich Airport Zürich, Switzerland). The document does not specify a "sample size" for these real-world verifications, nor does it detail the specific data collected, but rather states the device was "found to prevent or reduce hypothermia."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For the clinical study ("Effectiveness of Resistive Heating Compared With Passive Warming in Treating Hypothermia Associated With Minor Trauma: A Randomized Trial"), the authors listed include MDs (Alexander Kober, Béla Fülesdi, Alexander Friedman, Daniel I. Sessler) and BS (Thomas Scheck, Frank Lieba, Wolfgang Vlach). Daniel I. Sessler, MD, is a well-known expert in perioperative temperature management. The "ground truth" in this context would be the measured patient core body temperature and the diagnosis of hypothermia, which would be established by medical professionals involved in the care and monitoring of the patients receiving the treatment, as per the randomized trial protocol. The document does not specify the exact number of experts involved in establishing this clinical ground truth beyond the listed authors, nor does it give specific years of experience for each, but refers to them as medical professionals at the Mayo Clinic.
Adjudication method for the test set:
- The document does not explicitly detail an adjudication method (such as 2+1 or 3+1) for the clinical study's outcomes. In a randomized controlled trial measuring physiological parameters like body temperature, the "adjudication" is typically inherent in the standardized measurement protocols and statistical analysis of the collected data. The outcome (degree of hypothermia) would be objectively measured, not subjectively adjudicated by experts beyond the initial data collection.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC or AI-assisted comparative effectiveness study was conducted or mentioned. The device is a physical warming blanket system, not an AI-enabled diagnostic or assistance tool that would involve human readers/interpreters.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. The device is a hardware system, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the clinical study, the ground truth was clinical outcomes data, specifically patient core body temperature measurements and the clinical determination of hypothermia based on those measurements.
- For regulatory compliance and non-clinical testing, the "ground truth" was adherence to established international and national standards (e.g., IEC, EN, NATO, ISO, UL).
The sample size for the training set:
- Not applicable as this is a hardware device where the clinical study focused on performance rather than training a machine learning model.
How the ground truth for the training set was established:
- Not applicable for the reasons stated above.

Summary

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K051278

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

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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

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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

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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

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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

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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

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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.

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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

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Indications for Use

510(k) Number (if known):

K051278

Device Name:

Geratherm SOS-Vacutherm

Indications For Use:

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

. ... .

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

Section 12, pg. 1 of 1

Regulation Number and Section

§ 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).