DM-EMG

K072513 · Gvp Elettronica Srl · DWJ · Dec 7, 2007 · Cardiovascular

Device Facts

• Record ID: K072513
• Device Name: DM-EMG
• Applicant: Gvp Elettronica Srl
• Product Code: DWJ · Cardiovascular
• Decision Date: Dec 7, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5900
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

DM-EMG is a portable thermal regulation system for patient warming during emergency transport or medical procedures. System components include a heating mattress (polyester textile with micro carbon fibers and biocompatible PVC), a 12Vdc connection cable, a rechargeable battery pack, an electronic converter, and a carrying case. Device operates via thermal conduction; heating mattress warms patient body or infusion bags. Operated by emergency rescue personnel or clinicians. Safety features include two thermal cut-offs (91.4°F and 104°F) and fuse protection. Provides active warming to counteract hypothermia; improves patient comfort and core temperature stability.

Clinical Evidence

Field study conducted by Regional Helicopter Rescue Service (Bergamo, Italy) on 25 trauma patients. Comparison of active warming (DM-EMG, n=12) vs. passive warming (thermal reflective blanket, n=13). Active warming group showed mean core temperature increase of +0.6°C compared to +0.3°C for passive group. Subjective improvement in well-being and reduction in shivering noted in active warming group. No complications reported. Bench testing verified thermal cut-off functionality and temperature stabilization across various power sources.

Technological Characteristics

Heating mattress: polyester textile with micro carbon fibers, biocompatible PVC finish. Energy source: 12Vdc or 230Vac (via converter). Thermal regulation: conduction. Safety: dual thermal cut-offs (91.4°F/104°F), 8A fuse. Standards: EN 60601-1, EN 60601-1-2, EN 60601-2-35, EN 60601-2-38, EN 20366, CAN/CSA-C22.2 No.601.1M90, UL 60601-1. Connectivity: standalone. Sterilization: N/A (wipeable).

Indications for Use

Indicated for accident victims and patients experiencing or at risk of hypothermia during emergency rescue, transport, or surgical procedures/medical crises.

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

• Chill Buster 8001 Portable Electric Blanket (Thermo Gear, Inc)

Submission Summary (Full Text)

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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

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.

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Technological Comparison

### Submitted Device

Predicate Device

| Features | DM-EMG System | Model 8001 System |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|
| Indications For Use | Counteract Hypothermia<br>Low -level heat distributed to<br>patient | Counteract Hypothermia<br>Low -level heat distributed to<br>patient |
| Function | Conduction | Conduction |
| Heat Delivery Mechanism | Conduction | Conduction |
| Heat Source | Thermal Carbon Fibers and<br>Copper<br>Wires 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 upon<br>power source | about 40 W |
| Max Heat Presented to<br>Patient | 110F | 105F |
| User Heat Output Control | Continuous supply from battery<br>pack<br>converter and DC - DC cable | Uncelebrated continuous 20 W -<br>40W |
| Thermal Temperature Cut Off | 2 Thermal Cutoffs (91.4F and 104<br>F) | 105F @ blanket wire surface |
| Alarms | None | None |
| Circuit Protection | Battery electronic protection UL<br>File<br>0209833. - electronic converter<br>and<br>DC -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- Contamination<br>Protection | Single Use Blanket Cover | Sterile Single Use Blanket Cover |
| Blanket Material | Biocompatible PVC | Oxford Nylon and Nylon Acrylic<br>Flame Retardant Polycarbonate |
| Control Unit Construction | Converter<br>Latene 7 T -VO UL94 -VO-V2<br>Battery<br>UL File 0209833 | |
| Blanket Cleaning | Wipe with alcohol based<br>disinfectant | machine washable and dryable |
| System Weight | 1.65 lbs blanket with converter<br>3.13 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.

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Public Health Service

Image /page/5/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized caduceus or a representation of human figures. The symbol is composed of three curved lines that converge at the bottom, creating a sense of movement or flow.

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 [phone]. 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 [phone] or [phone] 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. |

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