The Enthermics Medical Systems DC Series Fluid Warming Cabinets are designed to safely store and warm irrigation fluids and injection fluids in accordance with the recommended warming temperatures and storage times stated in the fluid manufacturers' labeling.

Device Description

The DC Series Fluid Warming Cabinets are single cavity warming cabinets intended to heat either irrigation fluids (set point range of 90°F to 150°F) or injection fluids (set point range of 90°F to 110°F). The cabinets consist of powder coated steel exterior panels, and stainless steel cavity panels. The exterior also consists of ABS plastic panels. The heating system of the device includes three or more independent, fully insulated, electrothermal arrays mounted on the outside of the cavity. The device includes an over temperature alarm which provides an audible and visual indication that the cavity temperature has exceeded the set temperature by 10°F. Additional thermal reset switches are present the shut off power to the heating array or unit in the event of an over temperature array or cavity respectively.

AI/ML Overview

The provided text describes a Premarket Notification (510(k)) for the Enthermics Medical Systems DC Series Fluid Warming Cabinets. This document focuses on the device's design and intended use, rather than its performance in diagnostic or clinical efficacy studies as typically seen with AI/ML-based medical devices.

Therefore, the information requested in the prompt, such as acceptance criteria, sample sizes, expert ground truth, MRMC studies, standalone performance, and training set details, are not applicable to this type of medical device submission. These questions are usually relevant for devices heavily relying on diagnostic accuracy, such as imaging analysis software or AI-driven detection systems.

The DC Series Fluid Warming Cabinets are a physical product designed to warm fluids to specific temperatures. The 510(k) submission primarily demonstrates substantial equivalence to a predicate device (Enthermics Medical Systems EC-770l Fluid Warming Cabinet K993797) based on its technological characteristics, intended use, and safety features (e.g., over-temperature alarms). The "study" mentioned in the prompt's title is implicitly the comparison of the new device to the predicate device to demonstrate substantial equivalence, rather than a clinical trial or performance evaluation against ground truth data.

Key points from the document regarding the device and its compliance:

Acceptance Criteria & Performance: Not explicitly stated in terms of diagnostic metrics. Acceptance is based on meeting safety standards and functional specifications (e.g., temperature ranges, over-temperature alarms) that are substantially equivalent to a predicate device.
Sample Size: Not applicable. The "test" is a design and feature comparison, not a data-driven validation study in the context of AI/ML.
Ground Truth: Not applicable. There's no diagnostic output for which ground truth would be established by experts or pathology.
Adjudication Method: Not applicable.
MRMC Comparative Effectiveness Study: Not applicable.
Standalone Performance: Not applicable as it's a physical warming device, not an algorithm.
Type of Ground Truth: Not applicable.
Training Set Sample Size & Ground Truth: Not applicable.

The submission is a declaration of substantial equivalence, asserting that the new device shares the same intended use and similar technological characteristics (electrothermal heating, operational modes, safety features) as the existing predicate device. The differences highlighted (smaller volume, materials, more heating arrays, more accurate temperature detection/control) are presented as design changes that do not alter the fundamental safety or effectiveness compared to the predicate.

Summary

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Premarket Notification 510(k) Summary Section VII:

A. General Information on Submitter

Name:	Enthermics Medical Systems
Address:	W164 N9221 Water StreetMenomonee Falls, WI 53051
Phone:	(262) 251-8356
Fax:	(262) 251-7067
Registered Number:	2131400
Name of contact person:	Adam Van Essen

B. General Information on the Device

Name:	DC Series Fluid Warming Cabinet
Class:	Unclassified
Product Code:	LGZ, Warmer, Thermal, Infusion Fluid

C. Predicate Device

Enthermics Medical Systems, EC-770l Fluid Warming Cabinet (K993797)

D. Device Description

E. Intended Use

F. Technological Characteristics of Device Compared to Predicate Device

The predicate device, the Enthermics Medical Systems EC-770l Fluid Warming Cabinet (K993797) and the new DC Series Fluid Warming Cabinets are intended for the same uses and indications and the technological features of the predicate and the new cabinets are

11 132202 DEC - 6 2013

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virtually identical. The predicate and new Cabinets share the same basic design (electrothermal heating array(s) applied to the exterior of the Cabinet cavity with forced air circulation within the cavity). They also share the same two operational mode specifications (for injection and irrigation mode temperature ranges), and use the same over-temperature alarm systems (audible and visual indicators if set point is exceeded by a designated temperature).

The chief differences between the predicate and the new cabinet models include a smaller volume capacity for the new cabinets, the use of powder coated stainless steel panels and interior baskets and of external ABS plastic panels for the new cabinet exterior; two more electrothermal arrays in the new cabinets; and more accurate temperature detection and control.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged in a circular fashion around the bird symbol.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002

December 6, 2013

Enthermics Medical Systems Mr. Adam Van Essen Project Coordinator W164 N9221 Water Street MENOMONEE FALLS Wisconsin 53051

Re: K132202

Trade/Device Name: DC Series Fluid Warming Cabinet (DC250L and DC400L) Regulation Number: Unclassified Regulation Name: Unclassified Regulatory Class: Unclassified Product Code: LGZ Dated: November 4, 2013 Received: November 4, 2013

Dear Mr. Van Essen:

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.

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Page 2 - Mr. Van Essen

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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 Part 801); 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 Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Kwame O. Ulmer

for

Erin I. Keith, M.S. Acting Division 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

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Indications for Use

510(k) Number (if known) K132202

Device Name

DC Series Fluid Warming Cabinets

Indications for Use (Describe)

The Enthermics Medical Systems DC Series Fluid Warming Cabinets are and warm irrigation fluids and injection fluids in accordance with the recommended warming temperatures and storage times stated in the fluid manufacturers' labeling.

Type of Use (Select one or both, as applicable)

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 A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Digitally signed by Richard C.
Chapman
Date: 2013.12.06 10:02:49 -05'00'

FORM FDA 3881 (9/13) Page 1 of 2 PSC Publishing Services (301) 443-6740 EF

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).