(143 days)
Not Found
No
The summary does not mention any AI or ML terms, and the device description focuses on a physical warming mechanism controlled by standard electronics.
Yes
The device is intended to warm blood, blood products, and intravenous solutions prior to administration, which constitutes a direct medical intervention for the patient.
No
The device is described as warming blood, blood products, and intravenous solutions, and its function is to heat these substances to a specific temperature. It does not perform any diagnostic function such as identifying, detecting, or measuring a disease, condition, or other health parameters.
No
The device description clearly states it is a single unit with a fluid path, warming unit, and is battery operated, indicating it is a physical hardware device.
Based on the provided information, the HypothermX® is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to warm blood, blood products, and intravenous solutions prior to administration. This is a therapeutic or supportive function, not a diagnostic one. IVD devices are used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description focuses on the mechanism of warming fluids as they pass through the device. It doesn't mention any analysis or testing of biological samples.
- Lack of Diagnostic Language: The document does not use any language typically associated with IVD devices, such as "diagnosis," "screening," "monitoring," "analyzing," "detecting," or "measuring biomarkers."
- Performance Studies: The performance studies mentioned focus on biocompatibility and temperature accuracy, which are relevant to a fluid warming device, not an IVD.
- Predicate Devices: The predicate devices listed are also fluid warmers, further supporting that this device falls into the category of therapeutic/supportive medical devices, not IVDs.
In summary, the HypothermX® is a device used to prepare fluids for administration to a patient, which is a therapeutic action, not a diagnostic one.
N/A
Intended Use / Indications for Use
The HypothermX® Intravenous Fluid and Blood Warmer is intended to warm blood, blood products and intravenous fluids prior to administration. The HypoThermX® is
Indications for Use:
The HypothermX® is intended to warm blood, blood products and intravenous solutions prior to administration. The HypothermX® is intended to be used by healthcare professionals in clinical and field environments.
Product codes (comma separated list FDA assigned to the subject device)
LGZ
Device Description
The HypothermX® Intravenous Fluid and Blood Warmer consists of a single unit that is placed between a standard IV infusion set and a standard IV extension set.
HypothermX® is designed to warm blood, blood products and intravenous fluids at flow rates of up to and including 50-200 ml/min. HypothermXo will deliver temperatures of 38°C-3°C.
HypothermX's® fluid path is sterile and the entire warming unit is disposable after use. HypothermXo is battery operated. Blood, blood products and intravenous fluids travel through the sterile tubing and are heated by flameless catalytic combustion. The temperature of the device is accurately controlled by the device's electronics.
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
intended to be used by healthcare professionals in clinical and field environments.
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)
Results of studies conducted on the sterilized fluid pathway demonstrate the materials to be biocompatible for its intended use. In addition, performance data demonstrate the temperature accuracy of the device at different flow rates. Laboratory evaluations have been conducted to evaluate the hemolytic effect of the HypothermX during flow, stop flow, and high flow rates.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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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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§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).
0
K10380
MAY 2 0 2011
EMIT Corporation S10(k) Notification HypothermXo HX100 Intravenous Fluid and Blood Warmer 510(k) SUMMARY EMIT Corporation HypothermX® This 510(k) Summary is submitted in accordance with 21 CFR Part 807, section 807.92. Sponsor's Name and Address: EMIT Corporation 17225 El Camino Real. Suite 350 Houston, Texas 77058 Contact Person: Darla J. Elkin Elkin RC, LLC 42 North Chantsong Circle The Woodlands. TX 77382 Telephone: (281) 450-8163 Facsimile: (281) 298-7277 Device Trade Name: HypothermX® HX100 Intravenous Fluid and Blood Warmer Product Code: LGZ Classification: Unclassified Common Name: Fluid and Blood Warmer Predicate Devices: eFlow™ Model 100 IV Fluid Warmer (K060537) Thermal Angel™ Blood/Fluid Warmer Model 200 (K012031) Device Description:
The HypothermX® Intravenous Fluid and Blood Warmer consists of a single unit that is placed between a standard IV infusion set and a standard IV extension set.
HypothermX® is designed to warm blood, blood products and intravenous fluids at flow rates of up to and including 50-200 ml/min. HypothermXo will deliver temperatures of 38°C-3°C.
HypothermX's® fluid path is sterile and the entire warming unit is disposable after use. HypothermXo is battery operated. Blood, blood products and intravenous fluids travel through the sterile tubing and are heated by flameless catalytic combustion. The temperature of the device is accurately controlled by the device's electronics. Intended Use:
The HypothermX® Intravenous Fluid and Blood Warmer is intended to warm blood, blood products and intravenous fluids prior to administration. The HypoThermX® is
1
EMIT Corporation HypothermX® HX100 Intravenous Fluid and Blood Warmer
| Features | HypothermX®
Intravenous Fluid
and Blood Warmer | Thermal Angel | eFlow
Model 100 |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| K# | Not yet assigned | K012031 | K060537 |
| Heating Method | Stainless steel tube
heated by fuel
(flameless catalytic
combustion) | Heating blanket
covering stainless steel
tubing; heated by
electrical resistance | Electrical Resistance |
| Temperature
Control | Thermistors | Thermistors | Temperature Sensors |
| Alarm | Audio/Visual LED
Indicators | Visual, LED
Indicators | Audio/Visual LED
Indicators |
| Alarm
Conditions | Illumination:
Blue (46°C).
Audible alarm:
Every 10-20 seconds
(42-46°C)
Every 1-2 seconds
(>46°C).
Safety ITCO switch
turns off @ 50°C. | Illumination: Red
fading to dim or no
light = no power
Green fading to dim or
no light = decrease in
heat.
Safety switch turns off
@47°C | Illumination:
Blue Flashing (