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

AI/ML Overview

The provided text is a 510(k) summary for a medical device (QiF Blood and Fluid Warmer). It details modifications made to a previously cleared device and asserts substantial equivalence to its predicate. However, it does not contain the specific information required to answer your request about acceptance criteria and a study proving the device meets those criteria for characteristics typically evaluated in AI/ML medical devices.

The document focuses on the physical and functional aspects of the fluid warmer, such as battery upgrades, integrated disposable units, extended shelf life, and operating conditions, with performance data centering on these hardware and software changes.

Here's why the requested information isn't present in the document:

Type of Device: The QiF Blood and Fluid Warmer is a physical medical device (hardware with embedded software for control), not an AI/ML diagnostic or predictive algorithm. Therefore, the types of "performance data" and "acceptance criteria" discussed are related to its physical operation (e.g., heating to a set temperature, battery life, environmental robustness), rather than metrics like sensitivity, specificity, AUC, or the performance of human readers with/without AI assistance.
Acceptance Criteria & Reported Performance: While the document has a "Risk" and "Mitigation" table and discusses "Verification endpoints," these are not presented as typical acceptance criteria with reported performance values as would be expected for an AI/ML algorithm. For example, it confirms "Warming to set point temperature" and "Warming rates" were verified, but doesn't quantify them against specific pass/fail thresholds.
Study Design for AI/ML: The document does not describe a study involving a test set, ground truth established by experts, an adjudication method, or a multi-reader multi-case (MRMC) comparative effectiveness study, as these are methodologies relevant to AI/ML performance evaluation, not a fluid warmer.
Training Set Information: Since this is not an AI/ML algorithm that "learns" from data, there's no concept of a "training set" for the device's core functionality as described. The software validation mentioned is traditional software testing, not machine learning model training.

In summary, the provided document does not contain the specific information you requested because the device (QiF Blood and Fluid Warmer) is not an AI/ML medical device that would be evaluated with such criteria.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 20, 2017

Quality in Flow, Ltd. Neta Sherman Official Correspondent POB 29 Kibutz Einat, 4880500 ISRAEL

Re: K163708

Trade/Device Name: QiF Blood and Fluid Warmer Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: LGZ, BSB Dated: March 24, 2017 Received: March 24, 2017

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

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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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page

510(k) Number (if known) K163708

Device Name QiF Blood and Fluid warmer

Indications for Use (Describe)

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

区 Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

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FORM FDA 3881 (8/14)

Page 1 of 1 FDA

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510(k) SUMMARY Quality in Flow's QiF Blood and Fluid Warmer K163708

Manufacturer: Quality in Flow Ltd.

Phone: (972) (54) 6600146 Contact Person: Neta Sherman

Date Prepared: April 20, 2017

Subject Device

Name of Device - QiF Blood and Fluid Warmer Common Name – QiF Blood and Fluid Warmer Regulation Number - 21 C.F.R 880.5725 Requlation Name - Infusion Pump Requlatory class - class II Product Code - LGZ, BSB Classification Panel - General Hospital

Predicate Device

510(k) Number- K150404 Name of Device – QiF Blood and Fluid Warmer Common Name – QiF Blood and Fluid Warmer Regulation Number - 21 C.F.R 880.5725 Regulation Name - Infusion Pump Regulatory Class - class II Product Code - LGZ, BSB Classification Panel - General Hospital

Indications for Use

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:

1. Disposable Unit (DU) The disposable cartridge is made of a plastic oval box encasing a spiral Stainless Steel (SS) heat exchanger tube. The Disposable Unit is located between the fluid container (intravenous solution or blood product) and the treated patient, outside of the patient body. The Disposable Unit has a standard intravenous tube extension. The Disposable Unit comprises the temperature sensors.
1. Base Unit (BU) The Base Unit controls the performance of the system and the outflow fluid temperature. The power source is a rechargeable detachable battery

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located within the Base Unit; the Base Unit contains firmware (SW) and electronics (HW).

1. Connecting Cable (CC) - a cable consisting data and power wires connects between the Base Unit and the Disposable Unit to facilitate the transfer of data and electrical current.

Purpose of 510(k)

The purpose of this 510(k) is to modify the QiF Blood and Fluid Warmer in the following ways:

1. The rechargeable Battery pack was upgraded to an enhanced model with increased capacity with a new charger adaptor.
1. Integrated DU (a single DU for warming both blood, blood products and IV fluids, instead of two separate DUs, one for blood/blood products and one for IV fluids). The Blood DU was chosen for warming both blood, blood products and IV fluids. By doing so, the algorithm and precautions of blood warming, which are stricter than those of IV fluid warming, remain, and the fluids are warmed with the same DU as the blood/blood products.
1. Additional Testing: DU shelf life extended from 1 year to 3 years.
Additional testing and labeling change: storage temperature of -30°C to 70°C 4. (-22°F to 158°F), operating altitude (10,499 ft to 15,000 ft), and operating temperature of -5°C to 40°C (23°F to 104°F). Theses parameters were added to the device labeling.
1. Labeling change: due to the integrated DU, some changes were required in the labeling. In addition, one warning regarding usage of fluid pump was revised, and instructions regarding charger adapter correct orientation, and battery charging were added. The troubleshooting instructions were also revised for enhanced clarity.

Performance Data

Performance tests were performed in order to demonstrate that the modified device has equivalent performance to its predicate.

1. The rechargeable Battery pack upgrade: Risk analysis was performed and it was concluded that no additional risks were raised by the battery upgrade. Validation activities included electrical testing by certified labs.
1. Integrated Disposable Unit (DU) (same unit now warms both blood, blood products and IV fluids, instead of two separate DU's, one for blood/blood products and one for IV fluids).

The integrated DU does not include a change in technology or performance as it is the same as the predicate Blood DU (BDU). The modification is to the software only. Software validation was performed and showed the software functioned as intended without bugs.

The risk discussion showed there is a clear overall risk elimination, and all the potential risks from the change are reduced, validated and the residual risk is acceptable.

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1. DU shelf life extended from 1 year to 3 years. The cleared device IFU indicated shelf life of one (1) year, based on real time shelf life tests. The update of the DU shelf life is increased to three (3) years based on successful accelerated testing validation.
1. Operating and storage climate change: The operating altitude (10,499ft to 15,000ft) is verified per IEC 60601-1-11 section 4.2.2.C. Storage temperature of -30°C to 70°C (-22°F to 158°F), and operating temperature of -5°C to 40°C (23°F to 104°F) is verified through functional testing at boundary conditions by a certified lab. Device preconditioning included:
- a. Climate (temperature)
- b. Bump test
- c. Vibration

Verification endpoints included:

a. Visual inspection
b. Warming to set point temperature
c. Warming rates
d. Device functionality (Software and Hardware)

In all instances, the modified device functioned as intended and demonstrated equivalent performance.

Risk analysis identified the following risks and mitigations:

Risk	Mitigation
New battery overheats, affects	Battery testing per IEC62133:2012
electrical safety or EMC	Electrical safety testing per IEC 60601-
	1:2005 +CORR.1:2006 +
	CORR.2:2007 + AM1:2012 (or IEC
	60601-1:2012 reprint))and IEC60601-1-
	11:2010
	EMC testing per IEC60601-1-2:2007
Software does not recognize combined	Software validation testing to show
DU and does not work as intended	continued essential performance
Packaging does not maintain sterility	Packaging validation
for the extended shelf-life
Functionality after storage at low (-30	Tested per EN 1789:2007+A2:2014
°C) and high (70 °C) temperature	standard at a certified laboratory.
Functionality at low (0 ℃, -5 ℃) and	Tested per EN 1789:2007+A2:2014
high (40 °C ) temperature	standard at a certified laboratory.
Functionality at low pressures (altitude	Testing per IEC 60601-1-11 section
of 15,000 ft)	4.2.2.c
Warning modification for use with a	Performance testing to show outflow
pump allows increased flow rates	temperature achieved at high flow
where there is inadequate time for	rates.
heating or causes user notification	Validation testing under irregular flow
warnings to not be delivered as	scenarios to demonstrate continued
intended	proper functionality and user
	notification.

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Technological Characteristics

The modified QiF Blood and Fluid has the same technological characteristics as the predicate QiF Blood and Fluid Warmer, to which it is a modification.

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 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 a rechargeable detachable battery located within the Base Unit. The Disposable Unit has a standard intravenous tube extension.

Substantial Equivalence

An abbreviated SE Table is presented below:

	Quality in Flow - QiFBlood and FluidWarmer model 01[K163708]	Quality in Flow – QiFBlood and FluidWarmer model 01[K150404]	SE Justification
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 byhealthcareprofessionals inhospital, clinical andfield environments tohelp preventhypothermia.	Same
Indications forUse	Medical emergencies orsurgeries where warmfluid administration isrequired to treat thepatient.Whenever parenteralintroduction ofnormothermic fluid aredesired or indicated	Medical emergencies orsurgeries where warmfluid administration isrequired to treat thepatient.Whenever parenteralintroduction ofnormothermic fluid aredesired or indicated	Same
Components	Warmer with display anda sterile, disposableheat exchanger	Warmer with displayand a sterile,disposable heatexchanger	Same
	Quality in Flow - QiFBlood and FluidWarmer model 01[K163708]	Quality in Flow – QiFBlood and FluidWarmer model 01[K150404]	SE Justification
Safety Features	• System self-test• Overheat notification• Overheat cut-off• Battery under-voltage protection(cut-off)	• System self-test• Overheatnotification• Overheat cut-off• Battery under-voltage protection(cut-off)	Same
NotificationTypes	• 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 (LCDdisplay) and audio• Self-test/mutebutton• On/off switch	Same
Power Source	Rechargeable Battery	Rechargeable Battery	Same
Infusion temp.	$38±2°C$	$38±2°C$	Same
Heating Method	Resistive heating	Resistive heating	Same
Fluid Path	Located within the steriledisposable cartridges(DU).Spiral stainless steeltube and a shortsegment of a PVC tubeThe tube serves as theconductor of electricalcurrent.	Located within thesterile disposablecartridges (DU).Spiral stainless steeltube and a shortsegment of a PVC tubeThe tube serves as theconductor of electricalcurrent.	Same
Flow Rate	Based on gravity or fluidpump, up to 160 – 180ml/min	Based on gravity,Up to ~160 – 180ml/min	Similar. Fluid pumpcan be used withlimit of up to 180ml/min based ontesting up to 220ml/min
Software	The software control theheating process and theoperation of the device	The software control theheating process and theoperation of the device	Same
Biocompatibility	The fluid path is made ofbiocompatible StainlessSteel, PVC and luerconnections	The fluid path is madeof biocompatibleStainless Steel, PVCand luer connections	Same
Sterility	The disposable unit isprovided sterile for	The disposable unit isprovided sterile for	Same
	Quality in Flow - QiFBlood and FluidWarmer model 01[K163708]	Quality in Flow - QiFBlood and FluidWarmer model 01[K150404]	SE Justification
Single Use orReusable	Single Use	Single Use	Same
Shelf Life	DU shelf life – 3 years	DU shelf life - 1 year	Extended shelf lifewas validatedthrough bench toptesting
Storageconditions	-4°F to 140°F & 93% RHand compliance to -22°F RHto 158°F	-4°F to 140°F & 93% RH	Similar. Expandedoperating conditionswere validatedthroughperformance testingin a certified lab
Operatingconditions	41°F &15%RH to 104°F& 93% RH andcompliance with 23°F to104°F	41°F &15%RH to 104°F& 93% RH	Similar. Expandedoperating conditionswere validatedthroughperformance testingin a certified lab
Altitude	-1312 to 10,499 ft.	-1312 to 15,000 ft.	Similar. Expandedoperating conditionswere validatedthroughperformance testingin a certified lab
Dimensions ofBase Unit withBattery	Approximately235x160x75 mm(9.25x6.5x2.9 in)	Same	Same
Dimensions ofDisposable Unitin sterile bag	DU:Approximately210x160x45mm(8.3x 6.5x1.8 in)	Same	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 heatexchanger is encasedwithin an expandedpolypropylene (EPP)oval box to prevent anycontact between theuser and warm tubeintended to providethermal and electricalisolation between thedevice and the user.	Same

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Conclusion

The QiF modified device has the same indications and similar technological characteristics and principles of operation as its predicate device. The technological differences between the QiF Blood and Fluid Warmer modified and its predicate device do not raise different issues of safety or effectiveness. Performance data demonstrates that the modified QiF Blood and Fluid Warmer is substantially equivalent.

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).