The DM-EMG portable heating blanket is intended to efficiently keep hypothermia under control and to counteract accidental hypothermia of accident victims and patients during emergency rescue / transport (helicopter, ambulance, automobile, sea and other rescue means). Additionally it can also be used during the routine transport and warming of patients to counteract hypothermia, encountered during a surgical procedure or medical crisis.

Device Description

The DM --EMG portable warming device is made up of 5 major components: 1. Heating mattress SCL-EMG, 2. Cable DC-DC for the connection to the 12Vdc, 3. Rechargeable battery pack NL2024HD22, 4. Dedicated electronic converter VAR100A-EMG, 5. DM-ZN1 Carrying Case.

AI/ML Overview

Acceptance Criteria and Device Performance for DM-EMG Hypothermic Therapy System

This document outlines the acceptance criteria and the results of a study conducted to demonstrate the performance of the DM-EMG Hypothermic Therapy System.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state formal "acceptance criteria" with quantitative thresholds for all attributes in the same way one might find for a diagnostic algorithm. Instead, it presents performance characteristics and safety standards that the device was tested against and met. The "reported device performance" is derived from the "Non Clinical Performance Studies" section and the "Independent Study" section.

Acceptance Criterion (Derived)	Reported Device Performance (DM-EMG)
Safety Standards Adherence	EN60601-1, EN60601-1-2, EN60601-2-35, EN60601-2-38, EN20366, Regulation 10 Automotive, CAN / CSA-C22.2 No.601.1M90, UL 60601-1, 2nd edition cCSAus (All standards met as per IMQ and internal lab tests)
Infusion Bag Warming Capability (USA1)	Maintained warmed surface temperatures between 29°C and 35°C during a 2.5-hour test for 1-liter and 0.5-liter infusion bags. (1-liter bag absorbed more heat, requiring more time to reach 33°C).
Blanket Surface Temperature Stabilization (USA2)	Stabilized around 32°C in the middle of the pad. Reached a maximum temperature of +33°C after the first thermal cut-off switch-off. Contact temperature over 33°C reached at the very beginning of warming. (Tested for 1 hour with battery pack).
Surface Temperature Maintenance (USA3)	Maintained surface temperatures around 31°C / 32°C for 2 hours, emphasizing the need for insulation.
Thermal Cut-off Functionality (USA4)	First thermal cut-off controls temperature. Second thermal cut-off avoids dangerous temperatures in case of default. Maximum temperature reached was 40°C with maximum power supply from a new, fully charged battery pack.
Efficacy in Counteracting Hypothermia (Independent Study)	Mean core temperature increase of +0.6°C in actively warmed patients (vs. +0.3°C in passively warmed patients). Subjective feeling of well-being noted in 5 minutes in all active warming cases. Immediate disappearance of shiver in one pediatric patient.
Safety in Clinical Use (Independent Study)	No complications occurred during active warming in 12 actively warmed patients.
Technological Equivalence to Predicate Device	Demonstrated "substantial technological equivalence" to the Chill Buster 8001 System across various features (e.g., indications, function, heat delivery, power, max heat, thermal cut-off, circuit protection, materials). (No issues of safety or effectiveness found.)

2. Sample Size and Data Provenance

Test Set (for the Independent Study):
- Sample Size: 25 patients (12 in the active warming group, 13 in the passive warming group).
- Data Provenance: Prospective, from the Regional Helicopter Rescue Service in Bergamo, Orio al Serio, Italy. The study involved a "field comparison" during actual helicopter rescue operations.
Training Set: Not applicable as this is a medical device (warming blanket) and not an AI/algorithm-driven system that requires a "training set" in the conventional sense. The device's performance is tested through physical operational attributes and clinical efficacy, not through learning from data.

3. Number of Experts and Qualifications for Ground Truth

For Operational Verification Studies (USA1-4): These were "lab test" studies performed by GVP Elettronica srl. While implicitly requiring expert knowledge in engineering and device testing, the document does not specify the "number of experts" or their specific qualifications (e.g., "electrical engineer with X years of experience") for establishing the ground truth of these physical tests. The tests themselves provide objective measurements against defined parameters.
For Independent Study (Clinical Efficacy): The study was conducted by the "Regional Helicopter Rescue Service, Bergamo in Orio al Serio Italy." The "ground truth" (patient core temperature, shivering presence, subjective well-being, complications) was established by the medical personnel involved in the rescue operations. The document does not specify the exact number of experts or their specific qualifications (e.g., "paramedic with X years of experience," "emergency physician"). However, it implies medically qualified personnel given the context of a "Helicopter Rescue Service."

4. Adjudication Method

For Operational Verification Studies (USA1-4): No explicit adjudication method is mentioned. These are lab tests generating objective data (temperatures, timings). The results are presented as direct measurements.
For Independent Study (Clinical Efficacy): No explicit adjudication method is described. Data (core temperature, subjective feeling, shiver presence, complications) was presumably gathered by the medical team involved in the rescue operation.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices or AI systems where human readers interpret medical images or data, and the AI's effect on their performance is measured (e.g., improved accuracy, reduced reading time). The DM-EMG is a therapeutic warming device, and its efficacy is measured directly on patients, not through human interpretation of data.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)

Yes, in essence, the "Non Clinical Performance Studies" (USA1-4) represent standalone performance. These studies test the device's inherent functional capabilities (warming infusion bags, blanket temperature stabilization, thermal cut-off efficacy) independent of human-in-the-loop operation, although a human operator would initiate and monitor the device in a real-world setting. The "Independent Study" involves the device's performance in situ with patients. Given the nature of a warming blanket, an "algorithm only" standalone performance is not directly applicable as it's a physical device, not a diagnostic algorithm.

7. Type of Ground Truth Used

For Operational Verification Studies (USA1-4): The ground truth was objective physical measurements (e.g., temperature readings, time) in a controlled lab environment, verifying the device's intended physical and electrical functions against internal specifications and safety standards.
For Independent Study (Clinical Efficacy): The ground truth was a combination of:
- Clinical Measurements: Patient mean core temperature (objective).
- Clinical Observation: Presence/absence of shivering (objective observation, though can have subjective component).
- Patient Reported Outcomes: Subjective feeling of well-being (subjective, patient-reported).
- Absence of Adverse Events: No complications (objective clinical outcome).

8. Sample Size for the Training Set

Not applicable. As stated in section 2, the DM-EMG is a physical medical device (warming blanket) and not an AI/algorithm-driven system that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. See section 8.

Summary

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510(k) Summary

OEC 7 2007

Submitter Information	GVP Elettronica
	Via S. Luccia 65
	Caronna Pertusella
	Gian Vittorio Pizzi
Contact Person:	John Romano
	Application Correspondent
Summary Preparation Date	September 5, 2007
Device Information

Trade or Proprietary Name

Device Common or Usual Name CDRH Product Nomenciature Classification

DM- EMG Hypothermic Therapy System Thermal Regulation System (21 CFR 870.5900) DWJ

Predicate Device

Medvation has designated the Chill Buster 8001 Portable Electric Blanket manufactured by Thermo Gear, Inc of Tigard Or as the Predicate Device for the DM -EM G

Device Description

The DM --EMG portable warming device is made up of 5 major components

1. Heating mattress SCL-EMG

"Low heating transfer" device made with a strong polyester textile and thousands of micro carbon fibres. The finishing is made with biocompatible PVC. Two on/off switching thermal cut-offs control and maintain warming under the temperature limits provided by Device construction ensures a soft, light and manageable device, the standards. comfortable for the patient. Warming is provided to patient's body by thermal conduction.

2. Cable DC-DC for the connection to the 12Vdc

This cable supplies a very low voltage of 12Vdc to the heating mattress by the 12vdc output of the rescue means. Safety is ensured by an 8A fuse while a green led brightens during working.

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3. Rechargeable battery pack NL2024HD22

This is a DM-EMG accessory and it can be supplied under request with its own charger. It is a Class I device, with a nylon bag for portability and the cable has a dedicated connector to the SCL-EMG cable. The battery has about 2, 5 hours of useable life and it allows for patient and infusion bags warming where other power is not available ...

4. Dedicated electronic converter VAR100A-EMG

It supplies 12Vac to the SCL-EMG heating mattress when a 230Vac 50 Hz power supply is suitable. It can be connected to the SCL-EMG when inside its DM-ZN1 handbag to warm and maintain warmed infusion bags

5. DM-ZN1 Carrying Case

It is used to carry and protect the SCL-EMG device, especially when it is warming the infusion bags (connected to the battery DC2717-B or 12Vdc of the rescue vehicle (power source).

Intended Use

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Technological Comparison

Submitted Device

Predicate Device

Features	DM-EMG System	Model 8001 System
Indications For Use	Counteract HypothermiaLow -level heat distributed topatient	Counteract HypothermiaLow -level heat distributed topatient
Function	Conduction	Conduction
Heat Delivery Mechanism	Conduction	Conduction
Heat Source	Thermal Carbon Fibers andCopperWires in Blanket	Thermal Wire in Blanket
Electrical Requirements	12vac and 12 vdc / 3-3,5 Amp	12 vdc @3.2 AMP
Heating Element Power	About 35-40 W depending uponpower source	about 40 W
Max Heat Presented toPatient	110F	105F
User Heat Output Control	Continuous supply from batterypackconverter and DC - DC cable	Uncelebrated continuous 20 W -40W
Thermal Temperature Cut Off	2 Thermal Cutoffs (91.4F and 104F)	105F @ blanket wire surface
Alarms	None	None
Circuit Protection	Battery electronic protection ULFile0209833. - electronic converterandDC -DC Cable are fuse protected	Fused positive battery lead
Internal Diagnostics	None	None
Safety Agency Approvals	IMQ and cCSAus	TUV Rhineland
EMC Compatibility Testing	EN 60601-1-2 + EN 50366	IEC 601-1-2
Cross- ContaminationProtection	Single Use Blanket Cover	Sterile Single Use Blanket Cover
Blanket Material	Biocompatible PVC	Oxford Nylon and Nylon AcrylicFlame Retardant Polycarbonate
Control Unit Construction	ConverterLatene 7 T -VO UL94 -VO-V2BatteryUL File 0209833
Blanket Cleaning	Wipe with alcohol baseddisinfectant	machine washable and dryable
System Weight	1.65 lbs blanket with converter3.13 Ibs blanket with battery	8 lbs

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Non Clinical Performance Studies

Formal Studies

The studies reported in this subsection were conducted by the product safety group at IMQ Milan Italy, an Independent firm accredited to test and certify equipment on behalf of numerous worldwide agencies and the DM -EMG is now under CSA approval.

Standards: the DM -EMG has been tested to the following safety standards

EN60601-1 EN60601-1-2 EN60601-2-35 EN60601-2-38 EN20366

Requiation 10 Automotive CAN / CSA-C22.2 No.601.1M90 UL 60601-1,2nd edition cCSAus

DM -EMG Operation Verification

Four (4) separate and distinct lab test were performed by GVP Elettronica srl Caronna P LLA Italy to verify the following operational attributes

USA1. This test illustrates that the DM-EMG warms infusion bags when placed in the carrying case with heating mattress. The 1 liter bag absorbed more heat than a .5 liter bag therefore requires more time to reach 33°C. Warmed surface temperatures were maintained between 29°C and 35°C during the 2.5 hour test.
USA2. This 1 hour test demonstrated that the folded warming blanket stabilized around 32° C in the middle of the pad and in contact with the warmed surface. Additionally this test showed the maximum temperature (+33°C) after the first switch off of the thermal cut off and that a contact temperature over 33°C is reached at the very beginning of warming. It is important to note that this test was accomplished with the battery pack NL2024HD22
USA3. This 2 hour test maintained surface temperatures around 31 / 32°C and demonstrates the need to maintain the heating mattress insulated from the outside during application.
USA4. This 6 hour test demonstrated that the first thermal cutoff controls temperature and the second thermal cutoff will avoid dangerous temperatures in the event of a default by the first cut off.

In addition this test demonstrated that with maximum power supply from a new and maximum charged battery pack the maximum temperature reached was 40°C

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Independent Study

The DM-EMG was used on patients by the Regional Helicopter Rescue Service. Bergamo in Orio al Serio Italy. During Helicopter rescue operations, an on field comparison between active warming with the DM-EMG and passive warming using a thermal reflective blanket was accomplished on 25 patients.

The DM-EMG was used as per the instructions for use manual, and placed on the thorax of the patient

All 25 patients had a mean core temperature <36°C. Those presenting with shivering were actively warmed with DM-EMG. Those without shiver were passively warmed.

Group	# patients	Initial Mean Core Temp	Increase
Active Warming	12	34.6°C	+.6°C
Passive Warming	13	34.8°C	+.3°C

The average mean increase was +.6℃ for active warming

In all the Active warming cases a subjective feeling of well being was noted in a short time (5 minutes) and in one case the immediate disappearance of shiver (pediatric patient probably obtained a bigger contact area).

No Complications occurred during Active warming

Conclusions

The DM-EMG performed as intended according to specification against all formal tests completed by IMQ and internal lab tests. The Independent field tests demonstrated efficacy with trauma patients under rescue conditions. The comparison table of technological characteristics demonstrated a substantial technological equivalence compared to the Chillbuster. No issues of safety or effectiveness were found during the afore mentioned tests.

Page 5.5

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Public Health Service

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OEC - 7 2007

GVP Elettronica c/o Mr. John Romano Medvation Application Correspondent 6 Durham Boat Drive Washington Crossing, PA 18977

Re: K072513

DM-EMG Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal regulating system Regulatory Class: Class II (two) Product Code: DWJ Dated: September 05, 2007 Received: September 11, 2007

Dear Mr. Romano:

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. John Romano

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) I mo letter will and in your he FDA finding of substantial equivalence of your device to a legally premated nevice 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 entitled, "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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

er R. Vichner

~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 STATEMENT

510(k) Number:	K072513
Device Name:	DM-EMG
Indications for Use:	The DM-EMG portable heating blanket is intended to efficiently keep hypothermia under control and to counteract accidental hypothermia of accident victims and patients during emergency rescue / transport (helicopter, ambulance, automobile, sea and other rescue means). Additionally it can also be used during the routine transport and warming of patients to counteract hypothermia, encountered during a surgical procedure or medical crisis.

510(k) Number:

K072513

Device Name:

DM-EMG

Indications for Use:

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

D/OR
Over-T
(21 CF

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dma R. Vihines

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number K072513

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).