(75 days)
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No
The document describes a physical warming device and does not mention any AI or ML components or functionalities.
Yes
The device is described as treating hypothermic patients by warming their body core through local application, indicating a therapeutic function.
No
The device is described as a thermal warming device for treating hypothermic patients, which is a therapeutic function, not a diagnostic one. It applies heat and negative pressure, but there is no mention of it collecting or analyzing data to identify a medical condition.
No
The device description explicitly states it is a "compact, thermal warming device" that utilizes a "heating element" and "sub-atmospheric pressure," indicating it is a hardware device with physical components.
Based on the provided information, the VitalHeat™ is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "Non-Invasively treat hypothermic patients by warming their body core." This describes a therapeutic intervention applied directly to the patient's body, not a test performed on a sample taken from the body.
- Device Description: The device description details a "thermal warming device" that uses "sub-atmospheric pressure (SAP) and a heating element" applied to a "distal appendage (hand)." This is a physical treatment method.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The VitalHeat™'s function is to directly apply heat to the patient's body for therapeutic warming.
N/A
Intended Use / Indications for Use
The VitalHeat™ is designed to Non-Invasively treat hypothermic patients by warming with local application of negative pressure and thermal load (heat) to a distal appendage.
Product codes
DWJ
Device Description
The Dynatherm Medical, Inc. VitalHeat™ consists of a Warming Mitt and a Control Unit.
The VitalHeat™ is a compact, thermal warming device for use in health care facilities to help patients recover from the discomfort and consequences of lowered core temperature. The device utilizes a technology, which combines sub-atmospheric pressure (SAP) and a heating element on one heat technology, which cornent design is to be utilized on a hand). The combination of sub-atmospheric pressure and a heating element allow for the maximum transfer of heat through the heat exchange prosoulature. The compact design allows for minimum coverage of the patient (hand), which should not impede standard patient care and/o full body access.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Hand, distal appendage, distal limb
Indicated Patient Age Range
18 years of age and older.
Intended User / Care Setting
Healthcare facilities.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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§ 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
VitalHeat™
Premarket Notification 510(k) Section 2 - Certifications and Summaries
2.1 Summary of Safety and Effectiveness | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Dynatherm Medical, Inc. 819 Mitten Road, Suite 42 Burlingame, CA 94010 Non-Confidential Summary of Safety and Effectiveness Page 1 of 3
Dynatherm Medical, Inc.
Official Contact: Proprietary or Trade Name: Commom/Usual Name: Classification Name: Predicate Device:
Phone: (650) 777-4361 (650) 777-4370 Fax: Nathan Hamilton VitalHeat™ VitalHeat™ Thermal Regulating System Aquarius Medical Corporation Thermo-STAT - K970367 Aquarius Medical Corporation AcroTherm - K003368
Device Description:
The Dynatherm Medical, Inc. VitalHeat™
- Warming Mitt �
- Control Unit �
The VitalHeat™ is a compact, thermal warming device for use in health care facilities to help patients recover from the discomfort and consequences of lowered core temperature. The device utilizes a technology, which combines sub-atmospheric pressure (SAP) and a heating element on one heat tooknology, which cornent design is to be utilized on a hand). The combination of sub-atmospheric pressure and a heating element allow for the maximum transfer of heat through the heat exchange prosoulature. The compact design allows for minimum coverage of the patient (hand), which should not impede standard patient care and/o full body access.
1
2.1 Summary of Safety and Effectiveness
Indicated Used:
The VitalHeat™ designed to non-invasively treat hypothermic patients by rewarming their body core. This is The Vital loat - reseign application of negative pressure and thermal load (heat) to hand.
Dynatherm Medical, Inc. 819 Mitten Road, Suite 42 Burlingame, CA 94010 Non-Confidential Summary of Safety and Effectiveness Page 2 of 3
Patient Population:
The system is for use with patients experiencing cold who are 18 years of age and older.
Environments of Use:
The device is intended for use throughout healthcare facilities.
Contraindications:
The VitalHeat™ is contraindicated for patients under the age of 18 and for patients with peripheral vascular disease.
2
VitalHeat™
Premarket Notification 510(k) Section 2 - Certifications and Summaries
2.1 Summary of Safety and Effectiveness - - - - - - - - - -
Page 3 of 3 510 (k) COMPARATIVE TABLE
| COMPANY | DYNATHERM | AMC | AMC |
|---|---|---|---|
| PRODUCTS | VitalHeat™ | ACROTHERM | |
| K003368 | THERMO-STAT | ||
| K970367 | |||
| Intended use | Patient Temperature | ||
| Control and Maintain | Patient Temperature | ||
| Control and Maintain | Patient Temperature | ||
| Control | |||
| Intended | |||
| Environment of use | Healthcare | ||
| Facilities | Healthcare | ||
| Facilities | PACU | ||
| Contraindications | Patients 1000 ml/Min. |