The MAC Medical D-Series Blanket and Solution Warming Cabinets are designed to store and warm blankets, hospital linens, irrigation fluids, and/ or injection fluids in accordance with the recommended warming temperatures and storage guidelines provided by the manufacturers of such products.

Device Description

The MAC Medical D-Series Blanket and Solution Warming Cabinets are designed to store and warm sterile IV solutions, surgical irrigation solutions, linens and/ or blankets to an acceptable level for hospital and surgical outpatient center applications.

The MAC Medical D-Series Warming Cabinets are constructed with stainless steel panels, headers and doors. The Warming Cabinets are doubled walled constructed and are fully insulated to provide uniform heating. Optional glass doors are double paned tempered glass with aluminum.

A pull-out shelf inside the top of the cabinet contains the heating element, fan, thermostat, and temperature sensor. The electronics are located on the outside of the cabinet and the power cable is connected in the back of the cabinet. The wheeled baskets run on mounted rails and automatically stop when they reach the full out position. The shelves and baskets can be removed for cleaning and repositioning.

AI/ML Overview

This document describes the premarket notification (510(k)) for the MAC Medical D-Series Blanket and Solution Warming Cabinets. It focuses on demonstrating substantial equivalence to predicate devices rather than proving novel clinical effectiveness with detailed AI or human reader studies. Therefore, many of the requested elements for an AI/MRMC study are not applicable or not present in this type of submission.

Here's a breakdown based on the provided document:

Acceptance Criteria and Device Performance

The acceptance criteria for this device are based on demonstrating substantial equivalence to legally marketed predicate devices, primarily regarding safety and performance specifications related to warming and temperature control. The performance is assessed through non-clinical bench testing.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a warming cabinet and not an AI-driven diagnostic device, the "acceptance criteria" are primarily based on meeting safety standards and functional specifications similar to predicate devices. The document compares technical characteristics.

Feature / Acceptance Criteria	MAC Medical D-Series Warming Cabinet (K180842) - Reported Performance	Enthermics Medical Systems Fluid Warming Cabinet (Predicate K993797)	Imperial Surgical Blanket and Solution Warming Cabinet (Predicate K112702)
Intended Use/Indications for Use	To store and warm blankets, hospital linens, irrigation fluids, and/or injection fluids in accordance with recommended warming temperatures and storage guidelines.	To safely store and warm irrigation, or injection fluids in accordance with recommended warming temperatures and storage time guidelines.	To safely store and warm blankets, hospital lines, irrigation, and/ or injection fluids in accordance with recommended warming temperatures and storage time guidelines.
Heating System	Convection electric heating with circulating fan.	Electrothermal heating array.	Convection electric heating with circulating fan.
User Interface	Digital Display	Digital Display	Digital Display
Software	Not applicable	Not applicable	Not Applicable
Construction	Stainless Steel interior and exterior	Stainless Steel interior and exterior	Stainless steel interior and exterior; Counter top model made with baked on powder coated steel outer shell with Stainless Steel interior
Electrical Safety Testing	IEC 61010-1, IEC 61326	IEC 61010-1	IEC 61010-1 (CSAC22.2)
Over Temperature Alarm	Audible and visual if chamber temperature exceeds 5° C (10° F) above set temperature. Internal sensor shuts off heating elements when over temperature occurs.	Audible and visual if chamber temperature exceeds 5° C (10° F) above set temperature and an over temperature indicator will blink.	Audible and visual if chamber temperature exceeds 6°C above set temperature. Internal sensor shuts off heating elements when over temperature occurs.
Temperature Range (Blankets)	90° F - 160° F	86° F - 160° F	N/A (for blankets)
Temperature Range (Irrigation Fluids)	90° F - 149° F	86° F - 150° F	98° F - 150° F
Temperature Range (Injection Fluids)	90° F - 103° F	86° F - 104° F	98° F - 104° F
Temperature Lock	Settings are factory set and keyed locked. Can be unlocked with a key in the field for user revision.	N/A	Settings are factory set. Can be unlocked in the field for user revision.
Temperature Accuracy	Upper Chamber - ± 1° FMiddle Chamber - ± 1° FLower Chamber - ± 1° F	+ 0/ - 2° F - For settings 98° F to 104° F+ 0/ - 3° F - For settings 110° F to 150° F	+0/ - 2.7° F
Installation	Free Standing or Recessed	Free Standing (Mobile) or Recessed	Free Standing or Recessed
Controls	Electronic temperature controller with LED display. Element on the red neon indicator display.	Electronic control consists of 4 digit LED display, on/off keys, integrated lock feature and a series of prompt sequence indicators.	Electronic temperature controller with LED display. Illuminated power switch/ breaker (red). Amber neon indicator for element on red neon indicator for trouble.
Unit Configuration	Single/ Dual/ Triple	Single	Single/ Dual
Unit Depth	Inside Cavity 18" or 24"Overall 20.5" or 26.5"	34.9"	22" or 28" for table top and full-size cabinets.
Cabinet Volume	Triple compartment capacity - 14.01 cu ft overallUpper - 3.89 cu ftMiddle - 3.73 cu ftLower - 6.4 cu ft	Single compartment - 7.8 cu ft	Dual compartment capacity - 18.1 cu ft overall4.3 cu ft upper13.8 cu ft lower
Voltage Requirements	120 VAC 50/60 HZ or 240 VAC 50/60 HZ	120 VAC 50/60 HZ or 230 VAC 50/60 HZ	120 VAC 60 HZ
Expected Life	10 years	Not available	Not available

2. Sample Size for Test Set and Data Provenance

This is a warming cabinet, not a device processing patient data. The "test set" refers to the specific warming cabinet units manufactured by MAC Medical that underwent non-clinical bench testing.

Sample Size: Not explicitly stated as a number of units, but implies that the tests were performed on representative units of the D-Series.
Data Provenance: Not applicable in the context of patient data. The provenance is from internal testing performed by MAC Medical. The document does not specify the country of origin of the testing, but the company is based in Illinois, USA. The testing is prospective for the purpose of this submission.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. This device does not generate diagnostic interpretations requiring expert ground truth in the way AI algorithms do. Ground truth here refers to metrological standards for temperature measurement and adherence to electrical safety standards.

4. Adjudication Method for Test Set

Not applicable. This is not a study involving human interpretation. The "adjudication" is through engineering and quality control procedures confirming the device meets specified performance criteria and safety standards.

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

Not applicable. This device is a warming cabinet, not an AI-assisted diagnostic tool for medical imagery or patient interpretation. There is no human reader component that would be "assisted" by this device.

6. Standalone Performance (Algorithm Only)

Not applicable. There is no AI algorithm in this device. Its performance is measured directly through its physical function (heating, temperature control, safety).

7. Type of Ground Truth Used

The "ground truth" for the non-clinical bench testing is based on:

Engineering specifications and design requirements.
International safety standards (e.g., IEC 61010-1 for electrical safety, IEC 61326 for EMC).
Metrological accuracy for temperature measurements (e.g., using calibrated temperature probes).
Functional verification against specified temperature ranges and alarm conditions.

8. Sample Size for Training Set

Not applicable. This is not an AI/machine learning device. There is no "training set" in the context of data for an algorithm. The design and manufacturing processes are refined through engineering, quality control, and adherence to established medical device manufacturing practices.

9. How Ground Truth for Training Set Was Established

Not applicable, as there is no training set for an AI algorithm. The device's design is based on established engineering principles for warming cabinets and safety standards.

Summary

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March 5, 2019

MAC Medical Inc. Garv Oliveros Director Quality Compliance 820 South Mulberry Street Millstadt, Illinois 62260

Re: K180842

Trade/Device Name: MAC Medical D-Series Blanket and Solution Warming Cabinets Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: LGZ Dated: January 28, 2019 Received: January 29, 2019

Dear Gary Oliveros:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Sapana Patel -S

for Tina Kiang, Ph.D. Acting 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) K180842

Device Name

MAC Medical D-Series Blanket and Solution Warming Cabinets

Indications for Use (Describe)

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)

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Image /page/3/Picture/0 description: The image shows the logo for MAC Medical. The logo is in blue and white. The word "mac" is in large, cursive letters, and the word "MEDICAL" is in smaller, block letters below it.

510 (k) Summary K180842 MAC Medical D-Series Blanket and Solution Warming Cabinets Submitted in accordance with the requirements of 21 CFR 807.92

Applicant's Name:	MAC Medical, Inc.
Address:	820 South Mulberry Street
	Millstadt, IL 62260
Contact Person:	Gary Oliveros
	MAC Medical
	Director of Quality Compliance
	Telephone Number: (618) 476-3550 ext. 318
	Fax Number: (618) 476-3337
	Email: goliveros@macmedical.com
510 (k) Number:	K180842
Date Prepared:	March 4, 2019
Device Trade Name:	MAC Medical D-Series Blanket and Solution Warming Cabinets
Common Name:	Blanket and Solution Warming Cabinet
Device Classification:	Class II
Regulation Number:	21 CFR § 880.5725
Classification Name:	Warmer, Thermal Infusion Fluid Product
Product Code:	LGZ
FDA Panel:	General Hospital
Predicate Device:	K993797 - Entheremics Medical Systems Fluid Warming CabinetsK112702 - Imperial Surgical Blanket and Solution Warming Cabinets

Device Description:

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Image /page/4/Picture/0 description: The image shows the logo for MAC Medical. The word "mac" is written in a stylized, cursive font in blue. Below the word "mac" is the word "MEDICAL" in a smaller, sans-serif font. The logo has a white and gray swoosh design behind the text.

Intended Use/ Indications for Use:

TechnicalCharacteristics	MAC Medical D-SeriesWarming Cabinet –K180842	Enthermics MedicalSystems Fluid WarmingCabinet -K993797	Imperial SurgicalBlanket and SolutionWarming Cabinet –K112702
Intended Use/Indications forUse	The MAC Medical D-Series Blanket and SolutionWarming Cabinets aredesigned to store and warmblankets, hospital linens,irrigation fluids, and/ orinjection fluids inaccordance with therecommended warmingtemperatures and storageguidelines provided by themanufacturers of such	The Enthermics MedicalSystems Fluid WarmingCabinet is designed to safelystore and warm irrigation, orinjection fluids inaccordance with therecommended warmingtemperatures and storagetime guidelines provided bythe manufacturers of suchproducts.	The Imperial SurgicalBlanket and SolutionWarming Cabinet isdesigned to safely storeand warm blankets,hospital lines, irrigation,and/ or injection fluids inaccordance with therecommended warmingtemperatures and storagetime guidelines providedby the manufacturers ofsuch products.
Heating System	products.Convection electric heatingwith circulating fan.	Electrothermal heating array.	such products.Convection electric heatingwith circulating fan.
User Interface	Digital Display	Digital Display	Digital Display
Software	Not applicable	Not applicable	Not Applicable
Construction	Stainless Steel interior andexterior	Stainless Steel interior andexterior	Stainless steel interior andexteriorCounter top model madewith baked on powdercoated steel outer shellwith Stainless Steel interior
Electrical SafetyTesting	IEC 61010-1IEC 61326	IEC 61010-1	IEC 61010-1 (CSAC22.2)
OverTemperatureAlarm	Audible and visual ifchamber temperatureexceeds 5° C (10° F) aboveset temperature. Internalsensor shuts off heatingelements when over	Audible and visual ifchamber temperatureexceeds 5° C (10° F) aboveset temperature and an overtemperature indicator willblink indicating an over	Audible and visual ifchamber temperatureexceeds 6°C above settemperature. Internalsensor shuts off heatingelements when over
TechnicalCharacteristics	MAC Medical D-SeriesWarming Cabinet -K180842	Enthermics MedicalSystems Fluid WarmingCabinet -K993797	Imperial SurgicalBlanket and SolutionWarming Cabinet -K112702
Temperature Range	temperature occursBlankets = 90° F - 160° FIrrigation Fluids = 90° F - 149° FInjection Fluids = 90° F - 103° F	temperature condition.Blankets = 86° F - 160° FIrrigation Fluids = 86° F - 150° FInjection Fluids = 86° F - 104° F	temperature occursBlankets = N/AIrrigation Fluids = 98° F - 150° FInjection Fluids = 98° F - 104° F
TemperatureLock	Settings are factory set andkeyed locked. The cabinetcan be unlocked with a keyin the field and the user canrevise the setting based onthe specific need.	N/A	Settings are factory set.The cabinet can beunlocked in the field andthe user can revise thesetting based on thespecific need.
Temperatureaccuracy	Upper Chamber - ± 1° FMiddle Chamber - ± 1° FLower Chamber - ± 1° F	+ 0/ - 2° F - For settings 98°F to 104° F+ 0/ - 3° F - For settings110° F to 150° F	+0/ - 2.7° F
Installation	Free Standing or Recessed	Free Standing (Mobile) orRecessed	Free Standing or Recessed
Controls	Electronic temperaturecontroller with LEDdisplay. Element on the redneon indicator display.	Electronic control consists of4 digit LED display, on/offkeys, integrated lock featureand a series of promptsequence indicators.	Electronic temperaturecontroller with LEDdisplay. Illuminated powerswitch/ breaker (red).Amber neon indicator forelement on red neonindicator for trouble.
UnitConfiguration	Single/ Dual/ Triple	Single	Single/ Dual
Unit Depth	Inside Cavity 18" or 24"Overall 20.5" or 26.5"	34.9"	22" or 28" for table topand full-size cabinets. 1
Cabinet Volume	Triple compartmentcapacity - 14.01 cu ftoverallUpper - 3.89 cu ftMiddle - 3.73 cu ftLower - 6.4 cu ft	Single compartment - 7.8 cuft	Dual compartmentcapacity - 18.1 cu ft overall4.3 cu ft upper13.8 cu ft lower
VoltageRequirements	120 VAC 50/60 HZ or240 VAC 50/60 HZ	120 VAC 50/60 HZ or230 VAC 50/60 HZ	120 VAC 60 HZ
Expected Life	10 years	Not available	Not available

Comparison of Technical Characteristics:

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Image /page/5/Picture/0 description: The image shows the logo for MAC Medical. The word "mac" is written in a stylized, cursive font in a dark blue color. Below the word "mac" is the word "MEDICAL" in a smaller, sans-serif font. There is a black line separating the two words.

Risk Management:

Risk Management has been implemented for the MAC Medical D-Series Blanket and Solution Warming Cabinets and complies with ISO 14971, Medical Devices - Application of Risk Management to Medical Devices. The MAC Medical D-Series Blanket and Solution Warming Cabinets are as safe and effective as the predicate devices when used as intended.

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Image /page/6/Picture/0 description: The image shows the logo for MAC Medical. The logo features the word "mac" in a stylized, italicized font, with a shadow effect that gives it a three-dimensional appearance. Below the word "mac" is the word "MEDICAL" in a smaller, sans-serif font.

Summary of Non-Clinical Bench Testing:

Non-Clinical bench testing was performed on the MAC Medical D-Series Warming Cabinet. The Non-Clinical Bench Testing included:

o Electrical Safety testing in accordance with IEC 61010-1 Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use - Part 1: General requirements;
Electrical-magnetic Compatibility Testing in accordance with IEC 61326, Electrical equipment for o measurement, control and laboratory use - EMC requirements - Part 1 : General requirements;
Temperature Range Heating Specification Testing Empty Chamber Qualification:
Temperature Range Heating Specification Testing Product in Chamber Qualification; and
. Over Temperature Alarm Testing.

Conclusion:

The Non-Clinical testing indicates the device performance is substantially equivalent to the predicate devices. MAC Medical has demonstrated through the non-clinical bench test results the MAC Medical D-Series Warming Cabinet is as safe and effective as the predicate devices. Non-Clinical Bench Testing indicates the Warming Cabinet functions throughout the expected life of the device. Furthermore, the non-clinical bench test results clearly establish objective evidence to substantiate compliance to the documented intended use/ indications for use of the device which states, "The MAC Medical D-Series Blanket and Solution Warming Cabinets are designed to store and warm blankets, hospital linens, irrigation fluids, and/ or injection fluids in accordance with the recommended warming temperatures and storage guidelines provided by the manufacturers of such products".

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).