°M Warmer System

K232107 · Mequ A/S · LGZ · May 31, 2024 · General Hospital

Device Facts

• Record ID: K232107
• Device Name: °M Warmer System
• Applicant: Mequ A/S
• Product Code: LGZ · General Hospital
• Decision Date: May 31, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The °M Warmer System is indicated for use to warm blood, blood products, colloids and crystalloid solutions prior to parenteral administration. It is intended to be used by healthcare professionals in hospital, clinical and field environments to help prevent hypothermia. The field environment includes road, rotary and fixed-wing ambulances.

Device Story

The °M Warmer System is an in-line infusion fluid warmer designed to prevent hypothermia during parenteral administration of blood, blood products, and fluids. The system comprises a single-patient-use disposable warmer unit, a reusable rechargeable battery pack, and a charger. The disposable unit features a sterile fluid path with a parylene-coated aluminum heating chamber. Resistive heating elements, powered by the battery, heat the fluid as it passes through the chamber. The device is operated by healthcare professionals (paramedics, nurses, doctors) in hospitals, clinics, and field environments (ambulances). Software controls the heating process and monitors outflow temperature via redundant sensors. Visual LED indicators provide status updates on temperature (overheat/underheat) and battery levels. By maintaining normothermic fluid temperatures, the device helps prevent patient hypothermia during medical emergencies or surgeries.

Clinical Evidence

No clinical data. Substantial equivalence is based on non-clinical bench testing, including sterilization and shelf-life validation (ISO 11137-1, ASTM F1980-16), software verification/validation (IEC 62304), electrical safety and EMC (IEC 60601 series), heater safety (ASTM F2172-02), flow rate testing (ISO 8536-4), and biocompatibility (ISO 10993-1).

Technological Characteristics

Components: disposable warmer with integrated fluid path, rechargeable battery, charger. Materials: parylene-coated anodized aluminum fluid path, silicone gasket, plastic tubing. Heating: software-controlled resistive heating. Connectivity: standalone. Sterilization: provided sterile. Standards: ASTM F2172-02, ISO 10993-1, IEC 60601-1, IEC 62304.

Indications for Use

Indicated for warming blood, blood products, colloids, and crystalloid solutions prior to parenteral administration in patients requiring normothermic fluid to prevent hypothermia. Intended for use by healthcare professionals in hospital, clinical, and field (ambulance) settings.

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

• enFlow IV Fluid Warmer (K112902)

Submission Summary (Full Text)

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May 31, 2024

Mequ A/S Ulrik Andersen CEO Ole Maaløes Vej 3 2200 København Denmark

Re: K232107

Trade/Device Name: °M Warmer System Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: LGZ, BSB Dated: May 3, 2024 Received: May 3, 2024

Dear Ulrik Andersen:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

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Sincerely, Jake K. Lindstrom -S

Jake Lindstrom, Ph.D. Assistant Director, Infusion Devices DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K232107

Device Name °M Warmer System

#### Indications for Use (Describe)

The °M Warmer System is indicated for use to warm blood, blood products, colloids and crystalloid solutions prior to parenteral administration. It is intended to be used by healthcare professionals in hospital, clinical and field environments to help prevent hypothermia. The field environment includes road, rotary and fixed-wing ambulances.

| 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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# K232107 510(k) Summary

| Submitter: | MEQU A/S |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | Ole Maaløes Vej 3<br>København<br>2200<br>Denmark |
| Phone number: | [phone] |
| Fax number: | MEQU A/S does not have a fax number |
| Contact person: | Ulrik Krogh Andersen |
| Date prepared: | 07/14/2023 |
| Trade name: | °M Warmer System |
| Common name: | In-line infusion fluid warmer |
| Classification name: | Warmer, Thermal Infusion Liquid<br>(21 CFR 880.5725, product code LGZ)<br>Warmer, Blood, Non-Electromagnetic Radiation<br>(21 CFR, 864.9205, product code BSB) |
| Substantial equivalence is claimed to: | enFlow IV Fluid Warmer<br>(K112902) |

# Indications for use

The °M Warmer System is indicated for use to warm blood, blood products, colloids and crystalloid solutions prior to parenteral administration. It is intended to be used by healthcare professionals in hospital, clinical and field environments to help prevent hypothermia.

The field environment includes road, rotary and fixed-wing ambulances.

### Description

The °MEQU °M Warmer System consists of three components:

- a single-patient use, disposable warmer unit
- a multi-patient, reusable, rechargeable battery pack for powering the warmer
- a reusable charger for recharging the battery pack.

The warmer contains a sterile fluid path with standard Luer lock connectors allowing it to be connected in the infusion fluid line. The fluid path includes a parylene coated aluminium heating chamber in which fluids passing through the warmer are heated. Heat is generated using resistive heating elements, using power supplied by the rechargeable battery pack.

The warmer contains the electronics and software to control the temperature of the chamber and thus the temperature of the outgoing fluid.

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Remaining power in the battery pack is indicated to the user during use. When depleted, the battery pack can be re-charged using the charger.

#### Substantial equivalence

The °M Warmer System is substantially equivalent to the cleared enFlow IV Fluid Warmer. The °M Warmer System has the same intended use.

The technological characteristics and principles of operation are substantially similar, both the °M Warmer System and the enFlow IV Fluid Warmers are composed of a reusable power source and a sterile, disposable, single patient use cartridge.

The enFlow IV Fluid Warmer has a reusable warminq unit and the °M Warmer System has a disposable warming unit.

Both the subject and predicate devices control the operation of the system and the outflow temperature of the infuscate and contains software, hardware and the power source.

The subject and predicate device use the same heating method, i.e., resistive heating. The disposable cartridge of both the subject and predicate devices contains a fluid path that serves as a heat exchanger. The heat exchanger of the subject and predicate devices contains metal that heat the blood, blood product or parenteral/intravenous fluid by resistive heating.

The only main technological differences between the °M Warmer System and its predicate are: The °M Warmer System has a disposable warming unit, it does not have AC-mains power inlet, it has no audio warninqs, the material composition of the heat exchanger fluid path and maximum output temperature.

The Alarm function in °M Warmer is constructed to have a low thermal delay to alarm sensor and has the lowest activation threshold for the Alarm.

These differences do not raise any concerns to safety and effectiveness and equivalent performance has been demonstrated. Thus, °M Warmer System is substantially equivalent.

Detailed comparison between the predicate and the subject device is provided in the table below:

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# °MEQU

| | °M Warmer System<br>(Subject device) | enFlow IV Fluid<br>Warmer<br>(K112902) | Comparison |
|----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The °M Warmer System is indicated for use to warm blood, blood products, colloids and crystalloid solutions prior to parenteral administration. It is intended to be used by healthcare professionals in hospital, clinical and field environments to help prevent hypothermia. The field environment includes road, rotary and fixed-wing ambulances. | Indicated for warming blood, blood products and intravenous solutions prior to administration. It is intended to be used by healthcare professionals in hospital, clinical and field environments to help prevent hypothermia. | Difference: Similar °M Warmer is more specific in the indication for use. |
| Intended use | Medical emergencies or surgeries where warm fluid administration is required to treat the patient. Whenever parenteral introduction of normothermic fluid is desired or indicated | Medical emergencies or surgeries where warm fluid administration is required to treat the patient. Whenever parenteral introduction of normothermic fluid is desired or indicated | Same |
| User population | Healthcare professional (i.e. paramedic, nurse doctor etc.) | Healthcare professional (i.e. paramedic, nurse doctor etc.) | Same |
| User Interface<br>/ Notifications | Visual (LED) | Visual (LED) and audio | Difference: The M warmer does not have an audible alarm or a configurable audible alarm. This difference does not raise a new question on safety and effectiveness. |
| Notification Types | Overheat<br>Under heat<br>Low battery | Overheat<br>Under heat<br>Low battery | Same |
| Alarm Sensor | Two redundant temperature sensors. | Two redundant temperature sensors. | Same |
| Alarm Condition / Alarm indicators | Visual (RED LED) instantaneous activated from 43 °C. | Visual (RED LED) and Audible alarm activated from 45 °C with 20 seconds delay and instantaneous activated at 50 °C. | Difference: The enFlow activates RED LED later at the higher temperatures and have audible alarm. |
| Usage Environment | Clinic and Field. The field environment includes road, rotary and fixed-wing ambulances. | Clinic and Field | Same |
| Components | - Disposable warmer with integrated fluid path<br>- Power source (rechargeable battery pack)<br>- Charger | - Warmer<br>- Disposable fluid path cartridges<br>- Power source (rechargeable battery pack or AC mains power) | Difference: enFlow has fluid path cartridges and AC mains power while the subject device has integrated fluid path. |
| Infusion temperature | $39±3°C$ @ 150ml/min at 5°C input temperature | $40±2°C$ @ 200ml/min at 20°C input temperature | Similar, within the physiological range |
| Flow Rate | Up to 150ml/min at 5°C input temperature | Up to 200 ml/min at 20°C input temperature | Similar, within the physiological range |
| Operation Environment | 15 % RH to 95 % RH (relative humidity). Temperature range of 0°C to +40°C; non-condensing. | 10 % RH to 90 % RH (relative humidity). Temperature range of -5°C to +50°C. | Similar, RH and Temperature ranges slightly different and °M Warmer indicate non-condensing. |
| Heating technology | Software-controlled resistive heating | Software-controlled resistive heating | Same |
| Fluid path | Sterile fluid path consisting of plastic tubing, silicone gasket and biocompatible parylene coated anodized aluminium. | Sterile fluid path consisting of plastic tubing and biocompatible coated aluminium. | Same |
| Warmer type | Inline | Inline | Same |
| Power Source | Rechargeable battery | Rechargeable battery and 110-120 or 220-240 VAC | Difference: In addition to rechargeable battery, enFlow has additional 110-120 or 220-240 VAC. |
| Biocompatibility | The fluid path is made of biocompatible parylene coated anodized aluminum. | The fluid path is made of biocompatible coated aluminum (natural) extrusion | Similar. Both devices are biocompatible. |
| Software | The software control the heating process and the operation of the device. | The software control the heating process and the operation of the device. | Same |
| Sterility | The disposable unit is | The disposable unit is | Same |
| Product specific Standard with which the Device Complies | ASTM 2172:2002, Standard specification for blood/ Intravenous Fluid Irrigation Fluid Warmers | ASTM 2172:2002, Standard specification for blood/ Intravenous Fluid Irrigation Fluid Warmers | Same |

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# °MEQU

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provided sterile for

single patient use.

provided sterile for

single patient use.

°MEQU

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# Performance data from non-clinical studies

The following non-clinical testing was conducted:

Sterilization and shelf-life validation were conducted in accordance with

- ISO 11137-1:2006/Amd.:1 2013, ASTM F1980-16

- FDA Shelf Life of Medical Devices quidance, issued April 1991
Software verification and validation was performed in accordance with

- IEC 62304:2006/A1:2015
- FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, issued on May 11, 2005

Electrical Safety and EMC testing was performed in accordance with - IEC 60601-1:2005/A1:2012, IEC 60601-1-2:2014, IEC 60601-1-12:2014.

Aluminum leaching testing

Heater safety testing was performed in accordance with

- - ASTM F2172-02: 2011
Flow rate testing was performed in accordance with - ISO 8536-4: 2019

Biocompatibility testing was performed in accordance with

- ISO 10993-1 Fifth edition 2018-08

- Use of International Standard ISO 10993-1, "Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process", issued on September 4, 2020

Biological safety has been evaluated according to the ISO 10993-series in order to verify that the level of leaching substances and metals are below the specified limits for daily intake.

# Clinical studies

The claim of substantial equivalence is not based on an assessment of clinical performance data.

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# Conclusion

The °M Warmer System has similar technological characteristics to the enFlow IV Fluid Warmer, and has the same intended use.The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The °M Warmer System is substantially equivalent to the enFlow IV Fluid Warmer cleared under K112902 with respect to the indications for use, target populations, treatment method, and technological characteristics.