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.

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.

AI/ML Overview

Here's an analysis of the provided text regarding the HypothermX® HX100 Intravenous Fluid and Blood Warmer, focusing on acceptance criteria and study details.

It's important to note that the provided text is a 510(k) summary, which is a regulatory document. As such, it often focuses on demonstrating substantial equivalence to predicate devices rather than providing exhaustive details of every study conducted with the same level of detail as a peer-reviewed clinical trial.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the HypothermX® HX100 are primarily derived from its intended use and comparison to predicate devices, particularly regarding temperature output and flow rates.

Acceptance Criteria Aspect	Description / Target	Reported Device Performance (HypothermX® HX100)
Intended Output Temp.	Optimal infusion temperature for warming blood/fluids.	$38 \pm 3$ °C
Flow Rate Range	Range of flow rates the device can effectively warm fluids.	50-200 ml/minute
Alarm Condition: <35°C	Illumination to indicate cold temperature.	Blue Illumination
Alarm Condition: 42-46°C	Illumination and audible alarm for elevated temperature.	Yellow Illumination; Audible alarm (every 10-20 seconds)
Alarm Condition: >46°C	Illumination and audible alarm for high temperature.	Red Illumination; Audible alarm (every 1-2 seconds)
Safety Cut-off Temp.	Automatic shut-off to prevent overheating.	Safety ITCO switch turns off @ 50°C
Biocompatibility	Materials in fluid pathway must be biocompatible.	Sterilized fluid pathway materials demonstrated to be biocompatible.
Hemolytic Effect	Minimal or no hemolytic effect during operation.	Laboratory evaluations conducted; presumed to meet acceptance criteria (details not specified).
Sterility	Fluid path must be sterile.	Fluid path is sterile.

Study Details

Based on the provided 510(k) summary, the studies conducted were primarily non-clinical evaluations to support substantial equivalence. Information on human clinical trials (MRMC studies, standalone AI performance) is not part of this submission, as the device is a fluid warmer and not an AI/diagnostic device.

Sample Size used for the Test Set and the Data Provenance:
- The document describes "laboratory evaluations" and "studies conducted on the sterilized fluid pathway" and "performance data."
- Test Set Sample Size: Not explicitly stated regarding the number of runs, volumes of fluid, or specific test conditions. The context implies bench testing rather than a clinical dataset.
- Data Provenance: The studies were internal laboratory evaluations. There is no indication of country of origin of data as it's not a data-driven AI device. These would be prospective bench tests conducted for the purpose of this submission.
- Retrospective/Prospective: The tests described (performance, biocompatibility, hemolytic effect) would be prospective bench tests.
Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
- This question is not applicable in the context of this device. A fluid warmer's performance (temperature accuracy, flow rate, safety cut-offs) is typically measured using calibrated laboratory equipment, not human expert interpretation to establish "ground truth." The "truth" is objective physical measurements.
Adjudication Method for the Test Set:
- Not applicable. As the "ground truth" is objective measurement by calibrated sensors and instruments, there is no need for human adjudication of results.
If a Multi Reader Multi Case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC study was not done. This type of study is relevant for AI-powered diagnostic or interpretive tools, not for a medical device like an intravenous fluid warmer. The device's function is to warm fluid; it does not involve human interpretation of images or data that AI would assist with.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable in the AI sense. The HypothermX is a standalone device in that it performs its function (warming fluid) automatically. It does not have an "algorithm" in the typical AI sense that would have a standalone performance measured against a human-in-the-loop. Its performance is measured directly by its physical output (temperature, flow).
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance is established through objective physical measurements using calibrated instruments (e.g., thermometers, flow meters) under controlled laboratory conditions. For biocompatibility, it would be established by validated test methods according to relevant ISO standards.
The sample size for the training set:
- Not applicable. This device is hardware-based with embedded electronics for control. It does not utilize machine learning or AI algorithms that require a "training set" of data in the typical sense. Its control parameters are engineered and calibrated, not learned from a dataset.
How the ground truth for the training set was established:
- Not applicable. As there is no "training set" for AI/ML, there is no ground truth established for one. The device's operational parameters are based on engineering design and validation.

Summary

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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

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EMIT Corporation HypothermX® HX100 Intravenous Fluid and Blood Warmer

Features	HypothermX®Intravenous Fluidand Blood Warmer	Thermal Angel	eFlowModel 100
K#	Not yet assigned	K012031	K060537
Heating Method	Stainless steel tubeheated by fuel(flameless catalyticcombustion)	Heating blanketcovering stainless steeltubing; heated byelectrical resistance	Electrical Resistance
TemperatureControl	Thermistors	Thermistors	Temperature Sensors
Alarm	Audio/Visual LEDIndicators	Visual, LEDIndicators	Audio/Visual LEDIndicators
AlarmConditions	Illumination:Blue (<35°C)Yellow (42-46°C)Red (>46°C).Audible alarm:Every 10-20 seconds(42-46°C)Every 1-2 seconds(>46°C).Safety ITCO switchturns off @ 50°C.	Illumination: Redfading to dim or nolight = no powerGreen fading to dim orno light = decrease inheat.Safety switch turns off@47°C	Illumination:Blue Flashing (<33°C)Blue (33-34°C)Yellow (43-44°C)Yellow/Red Flashing(≥45°C)ITCO switch turns offat 50°C
Electronics	Microprocessorcontrolled	Microprocessorcontrolled	Microprocessorcontrolled
Power Source	Lithium Battery	Rechargeable Battery	115 or 230V AC; 12-30V DC Battery
Flow	50-200 ml/minute	up to and including200 ml/min	1-200ml/min
OptimumInfusion Temp.	$38\pm3$ °C	$38\pm3$ °C	35-42°C
Usage	Disposable	Disposable	Reusable device withdisposable set

Comparison of the Technological Characteristics of the New Device and Predicate Devices:

Discussion of Nonclinical Studies and Clinical Tests

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.

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EMIT Corporation HypothermX® HX100 Intravenous Fluid and Blood Warmer

Rationale for Substantial Equivalence

The HypothermX® shares the same indication for use and the same or similar device operation and overall technical and functional capabilities and therefore is substantially equivalent to the predicate device. Any differences between the HypothermX and the equivalent device have no significant influence on safety or effectiveness of the HypothermX® product.

Conclusion

The HypothermX® was found to be substantially equivalent to the predicate device as it shares the same intended use and the same or similar technological characteristics and thus is substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the symbol. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

JAN 1 0 2017

EMIT Corporation C/O Ms. Darla J. Elkin President Elkin Regulatory Consulting, LLC 42 North Chantsong Circle Woodlands, Texas 77382

Re: K103801

Trade/Device Name: HypothermX® HX100 Intravenous Fluid and Blood Warmer Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: LGZ Dated: May 12, 2011 Received: May 13, 2011

Dear Ms. Elkin:

This letter corrects our substantially equivalent letter of May 20, 2011.

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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

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Page 2 - Ms. Darla J. Elkin

CFR Part 807); labeling (21 CFR Parts 801 and 809 ); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Erin I. Keith -S

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: HypothermX® HX 100 Intravenous Fluid Warmer

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Indications for Use:

Prescription Use X________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off

Jivision of Anesthesiolog: General Hospital infection Control, Dental Levices

510(K) Number. K/ 0380/

Regulation Number and Section

§ 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).