QiF Blood and Fluid Warmer

K180154 · Quality IN Flow , Ltd. · LGZ · Apr 27, 2018 · General Hospital

Device Facts

• Record ID: K180154
• Device Name: QiF Blood and Fluid Warmer
• Applicant: Quality IN Flow , Ltd.
• Product Code: LGZ · General Hospital
• Decision Date: Apr 27, 2018
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The QiF Blood and Fluid Warmer device is intended for warming blood, blood products, and intravenous fluids prior to administration. It is intended to be used by healthcare professionals in hospital, clinics, and field environments, to help prevent hypothermia.

Device Story

Portable, inline blood and fluid warmer; warms IV fluids, blood, and blood products prior to administration. System consists of a Base Unit (BU), a sterile Disposable Unit (DU) with a spiral stainless steel heat exchanger, and a connecting cable. Operates via resistive heating; controlled by BU firmware/electronics. Powered by rechargeable battery or AC power supply module. Used by healthcare professionals in hospitals, clinics, and field environments. BU monitors outflow temperature; provides visual/audio notifications for overheat, under-heat, low battery, and flow irregularities. Prevents hypothermia by maintaining fluid at 38±2°C. Heat exchanger encased in expanded polypropylene (EPP) box for thermal/electrical isolation. Output affects clinical decision-making by ensuring normothermic fluid delivery during critical care.

Clinical Evidence

Bench testing only. Performance testing validated heating accuracy across various inlet temperatures and flow rates, and system response to flow irregularities. Environmental and electrical safety testing conducted per IEC 60601-1, IEC 60601-1-2, and IEC 60601-1-6. Risk management performed per ISO 14971:2012.

Technological Characteristics

Inline resistive heating system. Fluid path: stainless steel heat exchanger, PVC tubing, luer connections. Base Unit: firmware-controlled electronics. Power: rechargeable battery or AC power supply module. EPP housing for thermal/electrical insulation. Dimensions: BU with AC module ~300x190x180 mm. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, ISO 14971.

Indications for Use

Indicated for medical emergencies or surgeries requiring warm fluid administration to treat patients, or whenever parenteral introduction of normothermic fluid is desired.

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

• QiF Blood and Fluid Warmer (K171215)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 27, 2018

Quality In Flow Ltd. Neta Sherman VP Product Realization; RA & QA Manager Kibutz Einat POB 29 Kibutz Einat, 4880500 ISRAEL

Re: K180154

Trade/Device Name: OiF Blood and Fluid Warmer Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: LGZ, BSB Dated: March 25, 2018 Received: March 28, 2018

Dear Neta Sherman:

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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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 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.

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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-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, Tina Kiang

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) K180154

Device Name QiF Blood and Fluid Warmer

Indications for Use (Describe)

The QiF Blood and Fluid Warmer device is intended for warming blood, blood products, and intravenous fluids prior to administration. It is intended to be used by healthcare professionals in hospital, clinics, and field environments, to help prevent hypothermia.

| Type of Use (Select one or both, as applicable) | <table border="0"><tr><td><table border="0"><tr><td></td><td> Production Use (Part 21 CFR 601 Subpart D) </td></tr></table></td><td><table border="0"><tr><td></td><td> Same as Contract Use (21 CFR 601 Subpart E) </td></tr></table></td></tr></table> | <table border="0"><tr><td></td><td> Production Use (Part 21 CFR 601 Subpart D) </td></tr></table> | | Production Use (Part 21 CFR 601 Subpart D) | <table border="0"><tr><td></td><td> Same as Contract Use (21 CFR 601 Subpart E) </td></tr></table> | | Same as Contract Use (21 CFR 601 Subpart E) |
|------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------|--|---------------------------------------------|
| <table border="0"><tr><td></td><td> Production Use (Part 21 CFR 601 Subpart D) </td></tr></table> | | Production Use (Part 21 CFR 601 Subpart D) | <table border="0"><tr><td></td><td> Same as Contract Use (21 CFR 601 Subpart E) </td></tr></table> | | Same as Contract Use (21 CFR 601 Subpart E) | | |
| | Production Use (Part 21 CFR 601 Subpart D) | | | | | | |
| | Same as Contract Use (21 CFR 601 Subpart E) | | | | | | |

> Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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### K180154 510(k) SUMMARY

| Manufacturer's Name: | Quality In Flow Ltd.<br>Kibutz Einat; P.O.B. 29; Israel 4880500 |
|------------------------------|-----------------------------------------------------------------|
| Corresponding Official: | Neta Sherman<br>VP Product Realization; RA & QA Manager |
| Telephone Number: | (972) (54) 660 0146 |
| Email: | [e-mail] |
| Preparation Date: | April 11, 2018 |
| Device Trade Name: | QiF Blood and Fluid Warmer |
| Device Common or Usual Name: | Infusion Pump, blood and plasma warming device |
| Regulation Name: | Infusion Pump |
| Regulation Number: | 21 C.F.R 880.5725 |
| Product Code: | LGZ, BSB |
| Device Class: | Class II |
| Classification Panel: | General Hospital |

### Purpose of 510(k)

The purpose of this 510(k) is to add the AC power supply module as an additional power source to the rechargeable detachable battery of the QiF blood and fluid warmer.

#### Indications for Use

The QiF Blood and Fluid Warmer device is intended for warming blood, blood products, and intravenous fluids prior to administration. It is intended to be used by healthcare professionals in hospital, clinics, and field environments, to help prevent hypothermia.

#### Device Description

The Quality in Flow QiF Blood and Fluid Warmer is a portable sterile Fluid Path, in-line Blood and Fluid Warmer.

The QiF device is composed of the following main components:

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- 1. Disposable Unit (DU) - The disposable cartridge is made of a plastic oval box encasing a spiral Stainless Steel (SS) heat exchanger tube. The DU is located between the fluid container (intravenous solution or blood product) and the treated patient, outside of the patient body. The DU has a standard intravenous tube extension. The DU comprises the temperature sensors.
- 2. Base Unit (BU) – The BU controls the performance of the system and the outflow fluid temperature. The power source is a rechargeable detachable battery located within the BU or an AC power supply module; the BU contains firmware (SW) and electronics (HW).
- 3. Connecting Cable (CC) - a cable that connect between the BU and the DU to facilitate the transfer of data and electrical current.

# Substantial Equivalence Discussion

Both the cleared device and the modified QiF Blood and Fluid Warmer are a portable, inline Blood and Fluid Warmer located between the fluid container (intravenous solution or blood product) and the treated patient, outside of the patient body. The device is comprised of a Base Unit (BU) and a sterile disposable cartridge (Disposable Unit). The Disposable Unit (DU) is composed of a plastic oval box encasing a spiral stainless steel heat exchanger tube. The Base Unit contains Firmware (software) and electronics (HW). The Base Unit controls the performance of the system and the fluid outflow temperature. The power source is either a rechargeable detachable battery located within the Base Unit or an AC power supply module (also referred as "AC unit"). The DU has a standard intravenous tube extension.

The QiF modified device has the same indications for use as its predicate device. A Substantial Equivalence Comparison table between the subject device and the predicate device is presented below:

| | Quality in Flow - QiF<br>Blood and Fluid<br>Warmer [Subject<br>device; K180154] | Quality in Flow - QiF<br>Blood and Fluid<br>Warmer [K171215] | Comparison |
|-----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Intended for warming<br>blood, blood products<br>and intravenous<br>solutions prior to<br>administration. It is<br>intended to be used by<br>healthcare professionals<br>in hospital, clinical and<br>field environments to<br>help prevent<br>hypothermia. | Intended for warming<br>blood, blood products<br>and intravenous<br>solutions prior to<br>administration. It is<br>intended to be used by<br>healthcare professionals<br>in hospital, clinical and<br>field environments to<br>help prevent<br>hypothermia. | Same |
| Indications for Use | Medical emergencies or surgeries where warm fluid administration is required to treat the patient.<br><br>Whenever parenteral introduction of normothermic fluid are desired or indicated | Medical emergencies or surgeries where warm fluid administration is required to treat the patient.<br><br>Whenever parenteral introduction of normothermic fluid are desired or indicated | Same |
| Fluids that Can be Warmed | IV Fluids, Blood, Blood Products | IV Fluids, Blood, Blood Products | Same |
| Components | Warmer with display and a sterile, disposable heat exchanger | Warmer with display and a sterile, disposable heat exchanger | Same |
| Safety Features | System self-test Overheat notification Overheat cut-off Battery under-voltage protection (cut-off) | System self-test Overheat notification Overheat cut-off Battery under-voltage protection (cut-off) | Same |
| Notification Types | Overheat Under heat Low battery Flow irregularity | Overheat Under heat Low battery Flow irregularity | Same |
| User Interface / Notifications | Visual (LCD display) and audio Self-test/mute button On/off switch | Visual (LCD display) and audio Self-test/mute button On/off switch | Same |
| Power Source | Rechargeable Battery or AC power supply module | Rechargeable Battery | Different<br>AC power supply module was added as an additional power source |
| Power source case and attachment to Base Unit (BU) | A Rechargeable Battery connected to the bottom of the BU<br><br>BU is inserted into the AC power supply module casing | A Rechargeable Battery connected to the bottom of the BU | Different<br>AC power supply module was added as an additional power source |
| Infusion temp. | $38±2°C$ | $38±2°C$ | Same |
| Heating Method | Resistive heating | Resistive heating | Same |
| | | | |
| Fluid Path | Located within the sterile disposable cartridges (DU).<br>Spiral stainless steel tube and a short segment of a PVC tube<br>The tube serves as the conductor of electrical current. | Located within the sterile disposable cartridges (DU).<br>Spiral stainless steel tube and a short segment of a PVC tube<br>The tube serves as the conductor of electrical current. | Same |
| Flow Rate | Based on gravity or fluid pump, up to 160 – 180 ml/min | Based on gravity or fluid pump, up to 160 – 180 ml/min | Same |
| 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 |
| Biocompatibility | The fluid path is made of biocompatible Stainless Steel, PVC and luer connections | The fluid path is made of biocompatible Stainless Steel, PVC and luer connections | Same |
| Sterility | The disposable unit is provided sterile for single patient use | The disposable unit is provided sterile for single patient use | Same |
| Single Use or Reusable | Single Use | Single Use | Same |
| Shelf Life | DU shelf life - 3 years | DU shelf life - 3 years | Same |
| Storage conditions | -4°F to 140°F & 93% RH | -4°F to 140°F & 93% RH<br>compliance to -22°F to 158°F | Different<br>The QiF device operated with battery and operated with AC power supply module are both certified for the same storage conditions; the QiF device operated with battery was also validated for broader storage conditions |
| Operating conditions | 41°F &15%RH to 104°F<br>& 93% RH | 41°F &15%RH to 104°F<br>& 93% RH compliance<br>with 23°F to 104°F | Different<br>The QiF device<br>operated with<br>battery and<br>operated with AC<br>power supply<br>module are both<br>certified for the<br>same operating<br>conditions; the<br>QiF device<br>operated with<br>battery was also<br>validated for<br>broader operating<br>conditions |
| Altitude | -1312 to 10,499 ft | -1312 to 15,000 ft | Different<br>The QiF device<br>operated with<br>battery and<br>operated with AC<br>power supply<br>module are both<br>certified for the<br>same altitude<br>conditions; the<br>QiF device<br>operated with<br>battery was also<br>validated for<br>broader altitude<br>conditions |
| Dimensions of Base<br>Unit with Battery | Approximately<br>235x160x75 mm<br>(9.25x6.5x2.9 in) | Approximately<br>235x160x75 mm<br>(9.25x6.5x2.9 in) | Same |
| Dimensions of Base<br>Unit with AC power<br>supply module | Approximately<br>300×190×180 mm<br>(11.8x7.5x7.1 in) | N/A | N/A |
| Dimensions of<br>Disposable Unit in<br>sterile bag | Approximately<br>210x160x45mm<br>(8.3x 6.5x1.8 in) | Approximately<br>210x160x45mm<br>(8.3x 6.5x1.8 in) | Same |
| Warmer Type | Inline warmer | Inline warmer | Same |
| Heat Insulation | Yes: the heat exchanger<br>is encased within an<br>expanded polypropylene<br>(EPP) oval box to<br>prevent any contact<br>between the user and<br>warm tube intended to<br>provide thermal and<br>electrical isolation<br>between the device and<br>the user. | Yes: the heat exchanger<br>is encased within an<br>expanded polypropylene<br>(EPP) oval box to<br>prevent any contact<br>between the user and<br>warm tube intended to<br>provide thermal and<br>electrical isolation<br>between the device and<br>the user. | Same |

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The differences between the subject device and the predicate device are the addition of the AC power supply, AC power supply casing, narrowing of the storage, operating, and altitude conditions of use.

The operating and storage conditions and the altitude of use of the AC power supply module are within the ranges of the QiF cleared predicate device; The labeling of the QiF device operated with the AC power supply module specifically indicates the storage and operating conditions and this difference does not raise different questions of safety and effectiveness.

Based on the aforementioned modifications to the subject device, the subject device does not raise different types of safety and effectiveness questions when compared to the predicate device.

## Performance Testing Summary

Based on a risk analysis of the changes, the following testing was conducted to demonstrate substantial equivalence to the predicate device:

- . Performance testing, including heating fluid to set-point temperature from various inlet temperatures in various flow rates and system performance through flow rate irregularities, demonstrated that the subject device has equivalent performance to the predicate device.
- Validation of the subject device included performance testing, environmental testing ● and electrical safety testing per:
- O IEC-60601-1:2005: General Requirements For Basic Safety And Essential Performance
- IEC 60601-1-2:2010 Medical Electrical Equipment. General Requirements o For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic compatibility
- IEC 60601-1-6:2013 Medical Electrical Equipment Part 1-6: General o Requirements For Basic Safety And Essential Performance - Collateral Standard: Usability

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- . A risk analysis was completed in accordance with ISO 14971:2012, Medical Devices - Applications of Risk Management to Medical Devices
In all instances, the subject device functioned as intended and demonstrated equivalent performance to the predicate device.

## Conclusions

The modifications to the device do not raise different questions of safety and effectiveness and are supported by risk management activities. The QiF Blood and Fluid Warmer is substantially equivalent to the QiF Blood and Fluid Warmer, cleared under K171215.