HYPOTHERMX INTRAVENOUS FLUID WARMER

K103801 · Emit Corporation · LGZ · May 20, 2011 · General Hospital

Device Facts

• Record ID: K103801
• Device Name: HYPOTHERMX INTRAVENOUS FLUID WARMER
• Applicant: Emit Corporation
• Product Code: LGZ · General Hospital
• Decision Date: May 20, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

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 intended to be used by healthcare professionals in clinical and field environments.

Device Story

HypothermX® HX100 is a portable, battery-operated, disposable intravenous fluid and blood warmer. Device connects between standard IV infusion and extension sets. Fluid flows through a sterile stainless steel tube heated via flameless catalytic combustion. Microprocessor-controlled electronics monitor temperature using thermistors. Device operates at flow rates of 50-200 ml/min, delivering fluids at 38°C ± 3°C. Audio/visual LED indicators provide status updates (Blue <35°C; Yellow 42-46°C; Red >46°C). Safety ITCO switch terminates heating at 50°C. Used by healthcare professionals in clinical and field settings to prevent hypothermia during fluid administration.

Clinical Evidence

Bench testing only. Studies evaluated biocompatibility of the sterilized fluid pathway, temperature accuracy across specified flow rates, and hemolytic effects during flow, stop-flow, and high-flow conditions.

Technological Characteristics

Disposable unit with stainless steel fluid path. Heating principle: flameless catalytic combustion. Temperature control: thermistors. Power source: lithium battery. Form factor: inline IV set component. Microprocessor-controlled. Audio/visual LED alarm system. Safety: ITCO switch (50°C cutoff).

Indications for Use

Indicated for warming blood, blood products, and intravenous solutions prior to administration in patients requiring fluid therapy. Intended for use by healthcare professionals in clinical and field environments.

Regulatory Classification

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.

Predicate Devices

• eFlow™ Model 100 IV Fluid Warmer (K060537)
• Thermal Angel™ Blood/Fluid Warmer Model 200 (K012031)

Submission Summary (Full Text)

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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: [phone] Facsimile: [phone] 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®<br>Intravenous Fluid<br>and Blood Warmer | Thermal Angel | eFlow<br>Model 100 |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| K# | Not yet assigned | K012031 | K060537 |
| Heating Method | Stainless steel tube<br>heated by fuel<br>(flameless catalytic<br>combustion) | Heating blanket<br>covering stainless steel<br>tubing; heated by<br>electrical resistance | Electrical Resistance |
| Temperature<br>Control | Thermistors | Thermistors | Temperature Sensors |
| Alarm | Audio/Visual LED<br>Indicators | Visual, LED<br>Indicators | Audio/Visual LED<br>Indicators |
| Alarm<br>Conditions | Illumination:<br>Blue (<35°C)<br>Yellow (42-46°C)<br>Red (>46°C).<br>Audible alarm:<br>Every 10-20 seconds<br>(42-46°C)<br>Every 1-2 seconds<br>(>46°C).<br>Safety ITCO switch<br>turns off @ 50°C. | Illumination: Red<br>fading to dim or no<br>light = no power<br>Green fading to dim or<br>no light = decrease in<br>heat.<br>Safety switch turns off<br>@47°C | Illumination:<br>Blue Flashing (<33°C)<br>Blue (33-34°C)<br>Yellow (43-44°C)<br>Yellow/Red Flashing<br>(≥45°C)<br>ITCO switch turns off<br>at 50°C |
| Electronics | Microprocessor<br>controlled | Microprocessor<br>controlled | Microprocessor<br>controlled |
| Power Source | Lithium Battery | Rechargeable Battery | 115 or 230V AC; 12-30<br>V DC Battery |
| Flow | 50-200 ml/minute | up to and including<br>200 ml/min | 1-200ml/min |
| Optimum<br>Infusion Temp. | $38\pm3$ °C | $38\pm3$ °C | 35-42°C |
| Usage | Disposable | Disposable | Reusable device with<br>disposable 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 [phone] or [phone] 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 [phone] or [phone] 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:

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.

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/