The ivNow Modular Fluid Warmer is intended to warm injection / IV and irrigation fluid bags to a predetermined temperature, and once warm, to monitor and control the temperature of the fluid in the bags.

Device Description

Enthermics Medical Systems' ivNow Modular Fluid Warmer is designed to rapidly warm and maintain the temperature of injection / IV and irrigation fluid bags. Open on two sides with no cover or door, the device consists of a warming area module (alcove) in a "C" shape with a heating element that warms and maintains the temperature of the fluid. The basic device may be used as a single module or [pre]assembled in multiple configurations comprised of 1-6 modules with a common power switch and cord, fastened together by a unique rear mounting panel. The device is available in either 120v or 230v.

When an injection / IV or irrigation fluid bag is placed in the warming alcove, an optical sensor signals to the control that the alcove is occupied. The control then engages the heating element which warms the fluid in the bag. The temperature of the heating element and fluid is monitored by two sets of sensors contained within the device. When the desired temperature of the fluid is reached and confirmed, the real time temperature of the fluid is displayed on a panel at the front of the device (the control display). Internally, the heating element and fluid temperatures are monitored, and the heating element is regulated to raise the fluid to the desired temperature but never beyond that temperature. When the fluid reaches the desired temperature, the control displays the set temperature and a green indicator light next to the control display turns on. The control will continue to monitor the temperature of the heating element and fluid, and regulate the heating element to maintain the fluid at its set temperature indefinitely. The length of time that a particular bag has been warming in the alcove is also monitored and displayed (total residence time monitor display).

AI/ML Overview

The provided document describes the ivNow Modular Fluid Warmer, a medical device designed to warm and maintain the temperature of injection/IV and irrigation fluid bags.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Intended Use	Warm injection/IV and irrigation fluid bags to a predetermined temperature, and once warm, to monitor and control the temperature of the fluid in the bags.
Temperature Control & Display	Device warms and maintains fluid at a set temperature (factory preset: 40°C / 104°F). Real-time temperature of the fluid is displayed on a panel. A green indicator light turns on when the desired temperature is reached and confirmed.
Thermal Cutout Temperature	1°C (or 1°F for "Factor") over set point temperature.
Residence Time Monitor	Total residence time duration of the fluid in the compartment is internally measured and displayed.
Safety	Confirmed to be safe through testing (implies meeting safety standards related to warming medical fluids).
Effectiveness	Confirmed to be effective for its intended use through testing (implies successful warming and temperature maintenance).

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "Device testing included a Thermal Performance Test, Life Cycle Test and Control Failure Test." However, it does not specify the sample size used for these tests (e.g., number of devices tested, number of fluid bags used).

The data provenance is internal testing conducted by Enthermics Medical Systems, Inc. The document does not indicate data from external sources, country of origin of data beyond the manufacturer's location, or if the testing was retrospective or prospective. It's implied to be prospective testing conducted during device development/validation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not mention the use of experts to establish ground truth for the test set. The validation appears to be based on engineering tests (Thermal Performance, Life Cycle, Control Failure) rather than human interpretation or expert assessment.

4. Adjudication Method for the Test Set

As no experts were mentioned for establishing ground truth, and the tests were technical/engineering-based, there was no adjudication method described for a 'test set' in the context of expert review.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not describe an MRMC comparative effectiveness study. This type of study is typically used for diagnostic or screening devices where human readers interpret results, often with and without AI assistance, to assess the impact of AI on performance. The ivNow Modular Fluid Warmer is a therapeutic/supportive device, not a diagnostic one.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The studies mentioned ("Thermal Performance Test, Life Cycle Test and Control Failure Test") describe the standalone performance of the device itself. The device's primary function is automated temperature control, and these tests would evaluate the device's ability to perform this function independently, without human interaction during the warming process beyond initial setup. So, yes, the described tests are essentially standalone performance evaluations of the device's core functionalities.

7. Type of Ground Truth Used

The ground truth for the ivNow Modular Fluid Warmer's performance is based on objective, quantifiable physical parameters directly measured by the device and external instruments during testing. This includes:

Fluid temperature (measured against a known set point).
Heating element temperature.
Time (for residence time monitoring).
Operational integrity over time (for life cycle testing).
Response to failure conditions (for control failure testing).

This is a form of empirical ground truth established through direct physical measurement and engineering validation.

8. Sample Size for the Training Set

The concept of a "training set" is typically applicable to machine learning algorithms. The ivNow Modular Fluid Warmer is an electro-mechanical device with intelligent controls, but it is not described as utilizing machine learning or AI algorithms in a way that would require a distinct "training set" of data to learn from. Therefore, no sample size for a training set is mentioned or relevant in the context of this device description.

9. How the Ground Truth for the Training Set Was Established

Since there is no mention of a "training set" for a machine learning algorithm, this question is not applicable to the information provided in the document. The device's "programming" or operational parameters would have been set during its design and development, validated through the described testing.

Summary

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Section VI

09 1336ம்

510(k) NOTIFICATION SUMMARY

GENERAL INFORMATION I.

MAY - 7 2010

Submission Applicant and Correspondent: A.
Name:

Enthermics Medical Systems, Inc.

Address:

W164 N9221 Water Street Menomonee Falls, Wisconsin 53051-0443 Tel: 262-251-8356 Fax: 262-251-7067

Contact Person:

Emalee G. Murphy K&L Gates LLP 1601 K Street, NW Washington, DC 20006 Tel: 202-778-9428 Fax: 202-778-9100 email: emalee.murphy@klgates.com

B. Name of Device Warmer, Thermal, Infusion Fluid

Trade Name:

ivNow Modular Fluid Warmer

Common Name:

ivNow, Injection / IV & Irrigation Fluid Bag Warming Module

Regulatory Information: C.
Classification: Unclassified (Pre-Amendment Device)

LGZ

Product Codes:

Panel:

General Hospital

Performance Standard: No performance standards have been officially adopted by FDA.

Device Est. Reg. No:

2131400

Devices to Which the New Device is Substantially Equivalent: D.
TEMP 3 Fluid Warming System (K012276) EC-770I Fluid Warming Cabinet (K993797)

DC-1255287 v1

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DEVICE DESCRIPTION: II.

III. INDICATIONS FOR USE

IV. SUMMARY OF TECHNICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICES

The Enthermics Medical Systems' ivNow Modular Fluid Warmer is substantially equivalent to the FDA-cleared Medical Solutions' Temp 3 Warming Cabinet (K012276) and to Enthermics Medical Systems, Inc.'s EC-7701 Fluid Warming Cabinet (K993797). (See Section X)

All three devices are intended to safely store, warm and monitor the temperature of injection / IV and irrigation fluid bags prior to use.

All three devices possess electronic control elements that display the real time fluid temperature and that automatically maintain the desired fluid temperature.

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The applicant device is similar to the Medical Solutions' Temp 3 Warmer, in that the ivNow Modular Fluid Warmer also includes an electronic control feature that shows the total time each bag has been warming in the device.

All three devices are "stackable" for ease of use. The Medical Solutions' Temp 3 Warming Cabinet (K012276) and Enthermics Medical Systems, Inc.'s EC-7701 Fluid Warming Cabinet (K993797) are both closed heating cabinets, whereas the ivNow Modular Fluid Warmer features open heating alcoves.

Although the three devices differ in physical design, these differences do not affect the substantial equivalence of Enthermics Medical Systems' ivNow Modular Fluid Warmer to the predicate devices.

Product Name	ivNow Modular FluidWarmer	TEMP 3 WarmingCabinet	EC-7701 Fluid WarmingCabinet
Manufacturer	Enthermics MedicalSystems, Inc.	Medical Solutions, Inc.	Enthermics MedicalSystems, Inc.
Product andRegulatoryStatus	K012276Warmer, Thermal, FluidInfusionUnclassified (Pre-Amendment)Product Code LGZ	K012276Warmer, Thermal, FluidInfusionUnclassified (Pre-Amendment)Product Code LGZ	K993797.Warmer, Thermal, FluidInfusionUnclassified (Pre-Amendment)Product Code LGZ
Intended Use	The ivNow ModularFluid Warmer isdesigned to store,rapidly warm andmaintain thetemperature of injection/ IV and irrigation fluidbags prior to their use.The residence timeduration of the fluid inthe compartment is alsointernally measured anddisplayed.	The TEMP 3 WarmingCabinet is designed tostore, rapidly warm andmaintain the temperatureof IV fluid bags andirrigation solution bagsprior to their use. Theresidence time duration ofthe medium in thecompartment is alsointernally measured anddisplayed.	The EC-7701 FluidWarming Cabinet isdesigned to safely storeand warm irrigationfluid or injection fluidsin accordance with therecommended warmingtemperatures and storagetimes stated in the fluidmanufacturers' labeling.
ConstructionMaterials andDesign	Anodized Aluminumwith an electric heatingelement and a siliconesubstrate heating pad	Powder Coat FinishedAluminum with anelectric heating element.Closed heating cabinet.	20 gauge stainless steelexterior casing and door.The cabinet is warmedusing a low-heat-density

Substantial Equivalence Comparison Chart:

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	element. Open heating"alcoves".The exposed exteriorpanels are constructed ofengineering plastics		electrothermal cablearray. Closed heatingcabinet.
	while the rear mountingpanel is of corrosionresistance cut andformed steel.
TemperatureControls	Setting Range: Ambientto 43°C	Setting Range:Ambient to 43°C
	Factory preset: 40°C(104° F)	Factory preset: 40°C(104° F)
	Thermal CutoutTemperature: 1°C overset point temperature	Thermal CutoutTemperature: 1°C overset point temperature
Factor	Total residence timemonitor display1°F over set point	Total residence timemonitor display1°F over set point
ComparableSizes and Forms	14" wide by 7" high by7" deep	21.355" high by 17.163"wide by 6.239" deep	40.7" high by 25.2"wideby 34.9" deep
Voltage	120 V or 230 V	120V	120 V or 230 V
Sterility	N/A	N/A	N/A
BiocompatibilityTesting	N/A	N/A	N/A.

TESTS AND CONCLUSIONS V.

The ivNow Modular Fluid Warmer has been tested to confirm it is safe and effective for its intended use. Device testing included a Thermal Performance Test, Life Cycle Test and Control Failure Test. (See Section XI) :

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or other bird with outstretched wings. The bird is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a sans-serif font. The text is arranged to follow the curve of the circle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Enthermics Medical Systems, Incorporated C/O Mr. Emalee G. Murphy K & L Gates LLP 1601 K Street, NW Washington, DC 20006

JAN 1 0 2017

Re: K091336

Trade/Device Name: ivNOW Modular Fluid Warmer Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: LGZ Dated: April 26, 2010 Received: April 27, 2010

Dear Mr. Murphy:

This letter corrects our substantially equivalent letter of May 7, 2010.

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. Iisting 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 CFR Part 807); labeling (21 CFR Parts 801 and 809 ); medical device reporting (reporting of

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Page 2 - Mr. Emalee G. Murphy

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 vours.

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): K091336

Device Name:	ivNOW Modular Fluid Warmer
Indications For Use:	The ivNow Modular Fluid Warmer is intended to warminjection / IV and irrigation fluid bags to a predeterminedtemperature, and once warm, to monitor and control the

temperature of the fluid in the bags.

Prescription Use _ × (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Susan

(Division Sign-Off) Division of Anesthesiology, General Hospital infection Control, Dental Devices

. and/or

510(k) Number: K091336

DC-1344851 vi

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).