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:

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.
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).
Connecting Cable (CC) - a cable that connect between the BU and the DU to facilitate the transfer of data and electrical current.

AI/ML Overview

The provided text concerns a 510(k) premarket notification for a medical device (QiF Blood and Fluid Warmer), focusing on its substantial equivalence to a predicate device. This type of document is for regulatory approval and does not describe a clinical study comparing AI performance. Therefore, many of the requested elements for describing an AI study will not be present.

Instead, the document details performance testing of the device itself to demonstrate its safety and effectiveness, particularly after adding an AC power supply module.

Here's a breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Parameter / Acceptance Criteria	Reported Device Performance
Infusion Temperature	$38 \pm 2^\circ C$
Heating Method	Resistive heating
Flow Rate	Up to 160 – 180 ml/min (based on gravity or fluid pump)
Safety Features	System self-test, Overheat notification, Overheat cut-off, Battery under-voltage protection (cut-off)
Notification Types	Overheat, Under heat, Low battery, Flow irregularity
Environmental Conditions	Operating and storage conditions certified within acceptable ranges (specific ranges for AC power supply module detailed in comparison table sections for operating/storage conditions are: Storage: -4°F to 140°F & 93% RH; Operating: 41°F &15%RH to 104°F & 93% RH; Altitude: -1312 to 10,499 ft.)
Electrical Safety	Compliance with IEC-60601-1:2005 and IEC 60601-1-2:2010
Usability	Compliance with IEC 60601-1-6:2013
Risk Management	Risk analysis in accordance with ISO 14971:2012

Key Finding: The subject device demonstrated equivalent performance to the predicate device in all performance tests, including heating fluid to set-point temperature from various inlet temperatures in various flow rates and system performance through flow rate irregularities.

Regarding AI-specific questions (2-9):

The provided text does not describe an AI medical device or an AI performance study. It describes a physical medical device (blood and fluid warmer) and its regulatory submission for a modification (adding an AC power supply). Therefore, information related to AI model acceptance criteria, sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance are not applicable and not present in this document.

The "Conclusions" section clearly states: "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." This confirms the focus is on the equivalence of the hardware device, not an AI algorithm.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

Type of Use (Select one or both, as applicable)	Production Use (Part 21 CFR 601 Subpart D) 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)
Production Use (Part 21 CFR 601 Subpart D)		Production Use (Part 21 CFR 601 Subpart D)	Same as Contract Use (21 CFR 601 Subpart E)	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.Kibutz Einat; P.O.B. 29; Israel 4880500
Corresponding Official:	Neta ShermanVP Product Realization; RA & QA Manager
Telephone Number:	(972) (54) 660 0146
Email:	neta.sherman@qinflow.com
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

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.
1. 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).
1. 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:

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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.

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).

	Quality in Flow - QiFBlood and FluidWarmer [Subjectdevice; K180154]	Quality in Flow - QiFBlood and FluidWarmer [K171215]	Comparison
Intended Use	Intended for warmingblood, blood productsand intravenoussolutions prior toadministration. It isintended to be used byhealthcare professionalsin hospital, clinical andfield environments tohelp preventhypothermia.	Intended for warmingblood, blood productsand intravenoussolutions prior toadministration. It isintended to be used byhealthcare professionalsin hospital, clinical andfield environments tohelp preventhypothermia.	Same
Indications for Use	Medical emergencies or surgeries where warm fluid administration is required to treat the patient.Whenever parenteral introduction of normothermic fluid are desired or indicated	Medical emergencies or surgeries where warm fluid administration is required to treat the patient.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	DifferentAC 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 BUBU is inserted into the AC power supply module casing	A Rechargeable Battery connected to the bottom of the BU	DifferentAC 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).Spiral stainless steel tube and a short segment of a PVC tubeThe tube serves as the conductor of electrical current.	Located within the sterile disposable cartridges (DU).Spiral stainless steel tube and a short segment of a PVC tubeThe 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% RHcompliance to -22°F to 158°F	DifferentThe 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& 93% RH	41°F &15%RH to 104°F& 93% RH compliancewith 23°F to 104°F	DifferentThe QiF deviceoperated withbattery andoperated with ACpower supplymodule are bothcertified for thesame operatingconditions; theQiF deviceoperated withbattery was alsovalidated forbroader operatingconditions
Altitude	-1312 to 10,499 ft	-1312 to 15,000 ft	DifferentThe QiF deviceoperated withbattery andoperated with ACpower supplymodule are bothcertified for thesame altitudeconditions; theQiF deviceoperated withbattery was alsovalidated forbroader altitudeconditions
Dimensions of BaseUnit with Battery	Approximately235x160x75 mm(9.25x6.5x2.9 in)	Approximately235x160x75 mm(9.25x6.5x2.9 in)	Same
Dimensions of BaseUnit with AC powersupply module	Approximately300×190×180 mm(11.8x7.5x7.1 in)	N/A	N/A
Dimensions ofDisposable Unit insterile bag	Approximately210x160x45mm(8.3x 6.5x1.8 in)	Approximately210x160x45mm(8.3x 6.5x1.8 in)	Same
Warmer Type	Inline warmer	Inline warmer	Same
Heat Insulation	Yes: the heat exchangeris encased within anexpanded polypropylene(EPP) oval box toprevent any contactbetween the user andwarm tube intended toprovide thermal andelectrical isolationbetween the device andthe user.	Yes: the heat exchangeris encased within anexpanded polypropylene(EPP) oval box toprevent any contactbetween the user andwarm tube intended toprovide thermal andelectrical isolationbetween the device andthe user.	Same