(92 days)
Not Found
No
The 510(k) summary describes a portable heating blanket with electronic components for temperature control. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML. The performance studies focus on temperature regulation and patient warming outcomes, not algorithmic performance.
Yes
The device is intended to raise and maintain body temperature to counteract hypothermia, which is a therapeutic intervention.
No
This device is a portable warming blanket designed to prevent and treat hypothermia by actively warming patients. Its function is therapeutic, not diagnostic.
No
The device description explicitly lists multiple hardware components (heating mattress, cables, battery pack, electronic converter, carrying case).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to warm patients and prevent hypothermia. This is a therapeutic and supportive function, not a diagnostic one.
- Device Description: The device is a heating blanket system. It does not involve the examination of specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or compatibility testing.
- Performance Studies: The performance studies focus on the device's ability to increase core body temperature and maintain surface temperature, which are related to its warming function, not diagnostic capabilities.
IVD devices are used to perform tests on samples like blood, urine, or tissue to diagnose diseases or conditions. This device does not perform any such tests.
N/A
Intended Use / 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.
Product codes
DWJ
Device Description
The DM --EMG portable warming device is made up of 5 major components
- 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 the standards. Device construction ensures a soft, light and manageable device, comfortable for the patient. Warming is provided to patient's body by thermal conduction.
- 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.
- 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.
- 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.
- 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).
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
Emergency rescue / transport (helicopter, ambulance, automobile, sea and other rescue means), during a surgical procedure or medical crisis.
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)
Non Clinical Performance Studies:
Formal Studies: 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 tests were performed by GVP Elettronica srl Caronna P LLA Italy to verify 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. 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. This test also demonstrated that with maximum power supply from a new and maximum charged battery pack the maximum temperature reached was 40°C.
Independent Study:
- Study Type: On-field comparison between active warming with the DM-EMG and passive warming using a thermal reflective blanket.
- Sample Size: 25 patients (12 active warming, 13 passive warming).
- Data Source: Regional Helicopter Rescue Service, Bergamo in Orio al Serio Italy.
- Key Results: 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.
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 handwritten sequence of characters. The sequence starts with a capital letter 'K', followed by the number '0', then the number '7', the number '2', the number '5', the number '1', and finally the number '3'. The characters are written in a slightly irregular style, typical of handwriting.
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.
1
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.
2
Technological Comparison
Submitted Device
Predicate Device
| Features | DM-EMG System | Model 8001 System |
|---|---|---|
| Indications For Use | Counteract Hypothermia | |
| Low -level heat distributed to | ||
| patient | Counteract Hypothermia | |
| Low -level heat distributed to | ||
| patient | ||
| Function | Conduction | Conduction |
| Heat Delivery Mechanism | Conduction | Conduction |
| Heat Source | Thermal Carbon Fibers and | |
| Copper | ||
| 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 | |
| power source | about 40 W | |
| Max Heat Presented to | ||
| Patient | 110F | 105F |
| User Heat Output Control | Continuous supply from battery | |
| pack | ||
| converter and DC - DC cable | Uncelebrated continuous 20 W - | |
| 40W | ||
| Thermal Temperature Cut Off | 2 Thermal Cutoffs (91.4F and 104 | |
| F) | 105F @ blanket wire surface | |
| Alarms | None | None |
| Circuit Protection | Battery electronic protection UL | |
| File |
-
- electronic converter
and
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
Protection | Single Use Blanket Cover | Sterile Single Use Blanket Cover |
| Blanket Material | Biocompatible PVC | Oxford Nylon and Nylon Acrylic
Flame Retardant Polycarbonate |
| Control Unit Construction | Converter
Latene 7 T -VO UL94 -VO-V2
Battery
UL File 0209833 | |
| Blanket Cleaning | Wipe with alcohol based
disinfectant | machine washable and dryable |
| System Weight | 1.65 lbs blanket with converter
3.13 Ibs blanket with battery | 8 lbs |
- electronic converter
3
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
4
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