MAC Medical D-Series Blanket and Solution Warming Cabinets

K180842 · Mac Medical, Inc. · LGZ · Mar 5, 2019 · General Hospital

Device Facts

• Record ID: K180842
• Device Name: MAC Medical D-Series Blanket and Solution Warming Cabinets
• Applicant: Mac Medical, Inc.
• Product Code: LGZ · General Hospital
• Decision Date: Mar 5, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2

Intended Use

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 Story

Device is a stainless steel, double-walled, insulated warming cabinet for hospital/surgical use. It stores and warms blankets, linens, and sterile fluids (irrigation/injection). Operation involves convection electric heating with a circulating fan, controlled by an electronic temperature controller with an LED display. Users set temperatures based on manufacturer guidelines for the specific items. The device includes an over-temperature alarm (audible/visual) that triggers if the chamber exceeds 5°C above the set point, and an internal sensor that shuts off heating elements during over-temperature conditions. Shelves and baskets are removable for cleaning. The device is intended to maintain items at safe, recommended temperatures for clinical use, potentially improving patient comfort and safety during procedures.

Clinical Evidence

No clinical data. Substantial equivalence is supported by non-clinical bench testing, including electrical safety (IEC 61010-1), electromagnetic compatibility (IEC 61326), empty chamber and product-loaded temperature range qualification, and over-temperature alarm verification.

Technological Characteristics

Stainless steel interior/exterior; double-walled insulated construction; convection electric heating with circulating fan; electronic temperature controller with LED display; temperature range 90°F–160°F (blankets), 90°F–149°F (irrigation), 90°F–103°F (injection); audible/visual over-temperature alarm; IEC 61010-1 and IEC 61326 compliant.

Indications for Use

Indicated for hospital and surgical outpatient center use to store and warm blankets, hospital linens, irrigation fluids, and injection fluids.

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

• Enthermics Medical Systems Fluid Warming Cabinets (K993797)
• Imperial Surgical Blanket and Solution Warming Cabinets (K112702)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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 ([e-mail]) or phone [phone] 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)

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.

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

| <div> <span style="font-size: 10pt;">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> </div> |
|---------------------------------------------------------------------------------------------------|
| <div> <span style="font-size: 10pt;">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> |

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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: [phone] ext. 318 |
| | Fax Number: [phone] |
| | Email: [e-mail] |
| 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 Cabinets<br>K112702 - Imperial Surgical Blanket and Solution Warming Cabinets |

#### 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.

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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.

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.

#### Intended Use/ Indications for Use:

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.

| Technical<br>Characteristics | MAC Medical D-Series<br>Warming Cabinet –<br>K180842 | Enthermics Medical<br>Systems Fluid Warming<br>Cabinet -K993797 | Imperial Surgical<br>Blanket and Solution<br>Warming Cabinet –<br>K112702 |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use/<br>Indications for<br>Use | The MAC Medical D-<br>Series Blanket and Solution<br>Warming Cabinets are<br>designed to store and warm<br>blankets, hospital linens,<br>irrigation fluids, and/ or<br>injection fluids in<br>accordance with the<br>recommended warming<br>temperatures and storage<br>guidelines provided by the<br>manufacturers of such | The Enthermics Medical<br>Systems Fluid Warming<br>Cabinet is designed to safely<br>store and warm irrigation, or<br>injection fluids in<br>accordance with the<br>recommended warming<br>temperatures and storage<br>time guidelines provided by<br>the manufacturers of such<br>products. | The Imperial Surgical<br>Blanket and Solution<br>Warming Cabinet is<br>designed to safely store<br>and warm blankets,<br>hospital lines, irrigation,<br>and/ or injection fluids in<br>accordance with the<br>recommended warming<br>temperatures and storage<br>time guidelines provided<br>by the manufacturers of<br>such products. |
| Heating System | products.<br>Convection electric heating<br>with circulating fan. | Electrothermal heating array. | such products.<br>Convection electric heating<br>with circulating fan. |
| User Interface | Digital Display | Digital Display | Digital Display |
| Software | Not applicable | Not applicable | Not Applicable |
| Construction | Stainless Steel interior and<br>exterior | Stainless Steel interior and<br>exterior | Stainless steel interior and<br>exterior<br>Counter top model made<br>with baked on powder<br>coated steel outer shell<br>with Stainless Steel interior |
| Electrical Safety<br>Testing | IEC 61010-1<br>IEC 61326 | IEC 61010-1 | IEC 61010-1 (CSAC22.2) |
| Over<br>Temperature<br>Alarm | Audible and visual if<br>chamber temperature<br>exceeds 5° C (10° F) above<br>set temperature. Internal<br>sensor shuts off heating<br>elements when over | Audible and visual if<br>chamber temperature<br>exceeds 5° C (10° F) above<br>set temperature and an over<br>temperature indicator will<br>blink indicating an over | Audible and visual if<br>chamber temperature<br>exceeds 6°C above set<br>temperature. Internal<br>sensor shuts off heating<br>elements when over |
| Technical<br>Characteristics | MAC Medical D-Series<br>Warming Cabinet -<br>K180842 | Enthermics Medical<br>Systems Fluid Warming<br>Cabinet -K993797 | Imperial Surgical<br>Blanket and Solution<br>Warming Cabinet -<br>K112702 |
| Temperature Range | temperature occurs<br>Blankets = 90° F - 160° F<br>Irrigation Fluids = 90° F - 149° F<br>Injection Fluids = 90° F - 103° F | temperature condition.<br>Blankets = 86° F - 160° F<br>Irrigation Fluids = 86° F - 150° F<br>Injection Fluids = 86° F - 104° F | temperature occurs<br>Blankets = N/A<br>Irrigation Fluids = 98° F - 150° F<br>Injection Fluids = 98° F - 104° F |
| Temperature<br>Lock | Settings are factory set and<br>keyed locked. The cabinet<br>can be unlocked with a key<br>in the field and the user can<br>revise the setting based on<br>the specific need. | N/A | Settings are factory set.<br>The cabinet can be<br>unlocked in the field and<br>the user can revise the<br>setting based on the<br>specific need. |
| Temperature<br>accuracy | Upper Chamber - ± 1° F<br>Middle Chamber - ± 1° F<br>Lower Chamber - ± 1° F | + 0/ - 2° F - For settings 98°<br>F to 104° F<br>+ 0/ - 3° F - For settings<br>110° F to 150° F | +0/ - 2.7° F |
| Installation | Free Standing or Recessed | Free Standing (Mobile) or<br>Recessed | Free Standing or Recessed |
| Controls | Electronic temperature<br>controller with LED<br>display. Element on the red<br>neon indicator display. | Electronic control consists of<br>4 digit LED display, on/off<br>keys, integrated lock feature<br>and a series of prompt<br>sequence indicators. | Electronic temperature<br>controller with LED<br>display. Illuminated power<br>switch/ breaker (red).<br>Amber neon indicator for<br>element on red neon<br>indicator for trouble. |
| Unit<br>Configuration | Single/ Dual/ Triple | Single | Single/ Dual |
| Unit Depth | Inside Cavity 18" or 24"<br>Overall 20.5" or 26.5" | 34.9" | 22" or 28" for table top<br>and full-size cabinets. 1 |
| Cabinet Volume | Triple compartment<br>capacity - 14.01 cu ft<br>overall<br>Upper - 3.89 cu ft<br>Middle - 3.73 cu ft<br>Lower - 6.4 cu ft | Single compartment - 7.8 cu<br>ft | Dual compartment<br>capacity - 18.1 cu ft overall<br>4.3 cu ft upper<br>13.8 cu ft lower |
| Voltage<br>Requirements | 120 VAC 50/60 HZ or<br>240 VAC 50/60 HZ | 120 VAC 50/60 HZ or<br>230 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".