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

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

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

Device Description

The QinFlow Blood and Fluid Warmer (Warrior / Warrior lite) is a portable sterile fluid path, inline blood and fluid warmer intended for warming blood, blood products, and intravenous fluids prior to administration. The device is composed of the following main components:

Disposable Unit (DU) / Compact Disposable Unit (CDU)
Base Unit (BU)
Power source
Connecting Cable (CC)
The CDU can be connected directly onto the Warrior Lite BU or using an Extension cable accessory. The DU can be connected to the Warrior Lite using the Extension cable only.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the QinFlow Blood and Fluid Warmer (Warrior, Warrior EXTREME, and Warrior Lite). This document asserts that the new device is substantially equivalent to a previously cleared predicate device (K180154).

The information provided focuses on the device's technical characteristics and performance testing to demonstrate substantial equivalence to a predicate device, rather than a study validating a new acceptance criterion for an AI/ML algorithm or a typical clinical efficacy study. Therefore, many of the requested items related to AI/ML specific studies (e.g., sample size for training set, number of experts for ground truth, MRMC studies, effect size of AI assistance) are not applicable in this context.

However, I can extract the relevant information regarding performance criteria and the testing performed for this medical device submision.

1. A table of acceptance criteria and the reported device performance:

The document doesn't explicitly list "acceptance criteria" in a separate table, but rather describes the performance testing requirements and states that the device meets them. The comparison to the predicate device serves as the primary means to demonstrate substantial equivalence.

Acceptance Criteria (Implied by comparison and testing)	Reported Device Performance (Summary from comparison table and performance data)
Intended Use	Warming blood, blood products, and intravenous fluids prior to administration in adults and pediatric patients in hospital, clinics, field and transport environments to help prevent hypothermia. (Matches predicate, with clarified patient population and transport environment)
Operating Principle	Resistive heating; Software-controlled electromechanical system with in-line resistive heating at a constant outlet temperature of 100.4 ± 3.6 °F (38 ± 2°C). (Same as predicate)
Intended Fluid(s) to be Warmed	IV Fluids, Blood, Blood Products, Plasma. (Same as predicate)
Intended Route of Administration	IV. (Same as predicate)
Temperature Set Point & Measurement Accuracy	100.4 ± 3.6 °F (38 ± 2 °C); ± 2°C ( ± 3.6°F). (Same as predicate)
Input Temperature Requirements	At least 4°C (39.2°F). (Same as predicate)
Warm-up Time	Up to 30 seconds. (Same as predicate)
Flow Rate	Based on gravity or fluid pump, up to 180 ml/min (Warrior/Warrior EXTREME), up to 170 ml/min (Warrior Lite). (Within specified range of predicate's 160 – 180 ml/min; differences do not raise new questions of safety/effectiveness).
Warmed Volume Capacity	2.8 - 5L (Warrior/Warrior EXTREME), 1.25 - 2.4L (Warrior Lite). (Warrior Lite capacity is smaller due to smaller battery, but does not raise new safety/effectiveness concerns).
Material Compatibility	Biocompatibility testing demonstrates tubing/fluid path to be biocompatible. (Same as predicate).
Sterilization Method	Ethylene Oxide (ETO) for Disposable Unit. (Same as predicate).
Shelf Life (Disposable Unit/CDU)	3 years. (Same as predicate).
Base Unit Service Life	5 years. (Same as predicate).
Ingress Protection (Water & Particles)	Warrior EXTREME: IP56, Warrior: IP33, Warrior Lite: IP56. (Different from predicate's IP22, but tested successfully per IEC 60601-1-12).
Storage Conditions	Warrior/Warrior EXTREME: -4°F to 140°F & 93% RH; Warrior Lite: -20 °C to 70 °C & 93% RH. (Wider range for Warrior Lite successfully tested).
Operation Temperature & Humidity	Warrior/Warrior EXTREME: 41°F & 15%RH to 104°F & 90% RH; Warrior Lite: 23°F to 122°F& 90%RH. (Wider range for Warrior Lite successfully tested).
Transient Operating Conditions	-4°F & 15%RH to 122°F & 90%RH. (Tested per IEC 60601-1-12).
Atmospheric Pressure/Altitude	-400 to 4572 meters (-1312 to 15,000 ft). (Same as predicate).
Nominal Input Voltage	100-240 VAC, 18-25.2 DC. (Same as predicate).
Safety Testing (Electrical, EMC, EMS)	Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-12 demonstrated.
Software Verification & Validation	Conducted per IEC 62304 and FDA guidance for Major level concern.
Usability	Simulated use testing in accordance with IEC 62366:2007 and FDA guidance demonstrated safe and effective use.

2. Sample size used for the test set and the data provenance:

The document describes "Performance Data" which includes various types of engineering and laboratory testing (functional, electrical safety, EMC, software V&V, hemocompatibility, usability, shelf-life, sterilization).

Sample Size: The specific sample sizes for each type of functional or safety test are not provided in this summary. It states "Testing to verify that the device functions as intended, and all design and functional specifications are met for all models/system configurations" and "shelf-life testing and Sterilization assessment... was conducted with acceptable results."
Data Provenance: This is not a data-driven clinical study in the sense of patient data. The data provenance is from laboratory and engineering testing of the devices themselves. There is no mention of country of origin of data, or if it was retrospective or prospective in the context of clinical patient data, because this is about device performance characteristics, not clinical trial data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This submission focuses on the engineering and functional performance of a fluid warming device, not on diagnostic accuracy based on expert interpretation of medical images or data. Ground truth here refers to objective measurements against engineering specifications and industry standards, not expert medical consensus.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. See point 3.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is not an AI/ML diagnostic or assistive device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. While the device does contain software, the submission reviews its performance as an integrated medical device for fluid warming, not as a standalone AI algorithm for analysis or decision-making without a human in the loop. The software V&V ensures the software functions correctly within the device.

7. The type of ground truth used:

The "ground truth" for this device's performance evaluation comes from established engineering specifications, recognized industry standards (e.g., IEC 60601 series, ISO 11135, IEC 62304, IEC 62366), and direct physical/electrical measurements. For example, the "ground truth" for temperature accuracy is the target temperature, measured by calibrated instruments. For hemocompatibility, the "ground truth" is the absence of adverse interactions with blood products, demonstrated through specific testing.

8. The sample size for the training set:

Not applicable. This refers to a traditional medical device submission, not an AI/ML algorithm development. There is no "training set" in the context of machine learning. The device's software is developed and validated through traditional software engineering V&V processes.

9. How the ground truth for the training set was established:

Not applicable. See point 8.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".

December 8, 2022

Quality in Flow Ltd. Omer Pechter Director of RA and QA 11 Ha'avoda st. Rosh Ha'ayin, 4801761 Israel

Re: K211800

Trade/Device Name: Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite Blood and Fluid Warmer Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion pump Regulatory Class: Class II Product Code: LGZ, BSB Dated: December 2, 2022

Received: December 5, 2022

Dear Omer Pechter:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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/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 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/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 (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerelv.

Courtney H. Lias -S

Courtney H. Lias, Ph.D. Office Director OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K211800

Device Name

OinFlow Blood and Fluid Warmer (Warrior/Warrior EXTREME / Warrior Lite)

Indications for Use (Describe)

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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Image /page/3/Picture/0 description: The image shows the logo for QinFlow. The logo consists of the text "QinFLOW" in a sans-serif font. The "Qin" part of the text is in a dark gray color, while the "FLOW" part of the text is in a gradient of red and pink. To the right of the text is a stylized water droplet, which is also in a gradient of blue, pink, and red.

K211800 510(K) SUMMARY

This 510(k) Summary is submitted in accordance with the requirements of 21 CFR 807.87 and 807.92.

Submitter

Name:	Quality In Flow Ltd.
Address:	23 Ha-Yetsira St.,Petah Tikva, Israel
Phone:	+972506492360
Email:	omer.pechter@qinflow.com
Contact Person:	Omer Pechter
	Director of RA & QA
Date Prepared:	December 8, 2022
Device Trade Name	QinFlow Blood and Fluid Warmer (Warrior /Warrior EXTREME / Warrior Lite)
Device Common or Usual Name	Warmer, Thermal, Infusion Fluid
Regulation Name	Infusion Pump
Regulation Number	21 C.F.R. 880.5725
Product Code	LGZ
Regulation Name	Blood and plasma warming device
Regulation Number	21 C.F.R. 864.9205
Product Code	BSB
Device Class	Class II
Classification Panel	General Hospital

Predicate Device

Predicate Name and 510(k) Number:

K180154; OiF Blood and Fluid Warmer

Device Description

1. Disposable Unit (DU) / Compact Disposable Unit (CDU) The DU/CDU is a single-use, sterile disposable unit located between the fluid container (intravenous solution or blood product) and the treated patient, outside of the patient body. The disposable unit is made of an Expanded Polypropylene (EPP) encasing a spiral Stainless Steel (SS) heat exchanger tube to warm the inlet fluid. The DU/CDU has a standard intravenous tube extension and luer connections that can be used with any standard IV/blood set.

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Image /page/4/Picture/0 description: The image contains the logo for QinFlow. The logo consists of the text "QinFLOW" in a simple, sans-serif font. To the right of the text is a stylized water droplet icon, which is horizontally striped with a gradient of colors, transitioning from blue at the top to red at the bottom. The overall design is clean and modern.

Base Unit (BU) The BU controls the system outflow fluid temperature and provide information signals to 2. the user through an LCD (for Warrior and Warrior EXTREME) and LED indication panel (for Warrior Lite). The Bu contains firmware (SW) and electronics (HW).
1. Power source The power source is a rechargeable detachable battery located within the BU (Lite Battery for Warrior Lite and Enhanced Battery for Warrior EXTREME or an AC power supply module (for Warrior and Warrior EXTREME.)
Connecting Cable (CC) a cable consisting, and power wires connects between the Warrior and Warior 4. EXTREME BU and the DU/CDU to facilitate the transfer of data and electrical current. The DU /can be connected to the Warrior / Warrior EXTREME BU using the CC only or with an additional Extension cable accessory.
1. The CDU can be connected directly onto the Warrior Lite BU or using an Extension cable accessory. The DU can be connected to the Warrior Lite using the Extension cable only.

Indications for Use

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

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

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

Technological Characteristics

The technological characteristics of the OinFlow Blood and Fluid Warmer remain the same as the previously cleared device under K180154.

The table below compares technological features of the proposed and the predicate. The similarities or differences do not alter the intended therapeutic use of the device, nor do they affectiveness of the device relative to the predicate. As shown in the device comparison table below, both the subject and predicate devices have the same intended use for warming blood, blood products, and intravenous fluids prior to administration. Like the predicate device, the proposed device is a portable, software controlled in-line fluid warmer located between the fluid container (intravenous solution or blood / blood product) and the treated patient, outside of the Warrior lite Base Unit technological characteristic and principle of operation are the OiF predicate device. It is simply a smaller size device. The Warrior Lite battery is also smaller than the predicate device battery and contain less cells; as such its fluid warming capacity of the Warrior Lite is smaller than the predicate device. Any other differences were supported by acceptable results of safety and/or performance testing.

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Image /page/5/Picture/0 description: The image shows the logo for QinFlow. The logo consists of the text "QinFLOW" in a sans-serif font. To the right of the text is a stylized image of a water droplet, with horizontal lines of color ranging from blue at the top to red at the bottom. The text is in a dark gray color.

In summary, proposed device has the following technological characteristics which are comparable to the predicate device:

1. Intended use/Indications for Use: Warning blood, blood products, and intravenous fluids prior the addition of pediatic population and transport environment. Both the predicate and proposed device flow rates can support both and pediation The change in indications for use statement is intended to clarify the patient population and no new risks were identified.
Environment of Use: The environment of use remains the predicate except for the addition of the transport environment. 2.
1. Technology (Operating Principle): Software-controlled electromechanical system with in-line resistive heating at a constant outlet temperature of 100.4 ± 3.6 °F (38 ± 2°C). The fluid flows through a spiral heat exchange tube in sterile, single- use Disposable Unit and heated to the required physiological temperature while flowing inside the tube.
1. Design Configuration: The device is comprised of a Base Unit (BU) and a sterile disposable Unit (DU) or Compact Disposable Unit (CDU)). The DU / CDU is composed of an EPP encasing a spiral stainless-steel heat exchanger tube. The Base (software) and electronics. The Base Unit controls 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"; for Warrior EXTREME). The DU / CDU has a standard intravenous tube extension.
1. Materials Compatibility: Fluid-contacting and patient contacting materials are the same
User Interface: Warrior EXTREME Base unit with visual display and button controls on the front panel and Warrior Lite Base unit with Parel 6. LED indication and on/off button.

Device Comparison
	Subject Devices		Predicate
Technological Features	QinFlow Blood and Fluid Warmer(Warrior/Warrior EXTREME)	QinFlow Blood and Fluid Warmer(Warrior Lite)	QiF Blood and Fluid Warmer(Warrior, K180154)	Summary
Indications for Use	The Warrior Blood and FluidWarmer device is intended forwarming blood, blood products,and intravenous fluids prior toadministration in adults andpediatric patients. It is intended tobe used by healthcareprofessionals in hospital, clinics,field and transport environmentsto help prevent hypothermia.The Warrior EXTREME Bloodand Fluid Warmer device isintended for warming blood,blood products, and intravenous	The Warrior Lite Blood and FluidWarmer device is intended forwarming blood, blood products, andintravenous fluids prior toadministration in adults and pediatricpatients. It is intended to be used byhealthcare professionals in hospital,clinics, field and transportenvironments to help preventhypothermia.	The QiF Blood and Fluid Warmerdevice is intended for warming blood,blood products, and intravenous fluidsprior to administration. It is intended tobe used by healthcare professionals inhospital, clinics, and field environments,to help prevent hypothermia.	Both the subject and predicate devicehave essentially the same intended use.The change was made to specify theintended user population and thetransport environment in accordancewith 21 CFR 814.20(b)(3)(i).The change does not raise differentquestions of safety and effectiveness.
Device Comparison
	Subject Devices		Predicate
Technological Features	QinFlow Blood and Fluid Warmer(Warrior/Warrior EXTREME)	QinFlow Blood and Fluid Warmer(Warrior Lite)	QiF Blood and Fluid Warmer(Warrior, K180154)	Summary
Intended Use	fluids prior to administration inadults and pediatric patients. It isintended to be used by healthcareprofessionals in hospital, clinics,field and transport environmentsto help prevent hypothermia.
Intended Use	Intended for warming blood,blood products and intravenoussolutions in adults and pediatricpatients during medicalemergencies whenever parenteralintroduction of normothermicfluid are desired or indicated. Itis intended to be used byhealthcare professionals in hospital,clinical, field and transportenvironments to help preventhypothermia.	Intended for warming blood, bloodproducts and intravenous solutions inadults and pediatric patients duringmedical emergencies wheneverparenteral introduction ofnormothermic fluid are desired orindicated. It is intended to be used byhealthcare professionals in hospital,clinical, field and transportenvironments to help preventhypothermia	Intended for warming blood, bloodproducts and intravenous solutionsprior to administration. It is intended tobe used by healthcare professionals inhospital, clinical and fieldenvironments to help preventhypothermia.	Both the subject and predicate deviceshave essentially the same intended use.The change was made to specify theintended user population and thetransport environment in accordancewith 21 CFR 814.20(b)(3)(i).The change does not raise differentquestions of safety and effectiveness.
Intended Users	Healthcare professionals (e.g.,physicians, registered nurses,mid-level practitioners,EMT/Paramedic, military medics)	Healthcare professionals (e.g.,physicians, registered nurses, mid-level practitioners, EMT/Paramedic,military medics)	Healthcare professionals (e.g.,physicians, registered nurses, mid-levelpractitioners, EMT/Paramedic, militarymedics)	Same
Use Environment	Hospital, Clinic, Field andTransport	Hospital, Clinic, Field and Transport	Hospital, Clinic, Field and Transport	Same
Operating Principle	Resistive heating	Resistive heating	Resistive heating	Same
Intended fluid(s) to bewarmed	IV Fluids, Blood, Blood	IV Fluids, Blood, Blood	IV Fluids, Blood, Blood Products,Plasma	Same
		Device Comparison
	Subject Devices		Predicate
Technological Features	QinFlow Blood and Fluid Warmer(Warrior/Warrior EXTREME)	QinFlow Blood and Fluid Warmer(Warrior Lite)	QiF Blood and Fluid Warmer(Warrior, K180154)	Summary
Intendedroute(s)of administration	IV	IV	IV	Same
System Components	1. Base Unit2. Disposable Unit (Sterile,Heat exchanger)3. Connecting Cable4. Compact Disposable Unit(optional)Extension Cable Accessory(optional)	1. Base Unit2. Disposable Unit (Sterile,Heat exchanger)3. Compact Disposable Unit(optional, New)Extension Cable Accessory (optionalwhen using CDU)	1. Base Unit2. Disposable Unit (Sterile,Heat exchanger)Connecting Cable	Optional use of the followingcomponents:1. Compact Disposable Unit (CDU)2. Extension CableThe change does not raise differentquestions of safety and effectiveness.
Power Source	Rechargeable Battery or AC powersupply module	Rechargeable Lite Battery	Rechargeable Battery or AC powersupply module	The Warrior Lite can only be operatedwith the rechargeable Lite Battery.The change does not raise differentquestions of safety and effectiveness.
User Interface	1. Visual (LCD display) andaudio2. Self-test/mute buttonOn/off switch	1. Visual (LED panel)On/off button	1. Visual (LCD display) and audio2. Self-test/mute buttonOn/off switch	Warrior Lite provides informationsignals through LED panel instead ofLCD display.The change does not raise differentquestions of safety and effectiveness.
Heating Method	Resistive Heating	Resistive Heating	Resistive Heating	Same
Heating Control	software controls the heatingprocess and the operation of thedevice	software controls the heating processand the operation of the device	software controls the heating processand the operation of the device	Same
Warmer Type	Same as predicate	Same as predicate	In-line	Same
Device Comparison
	Subject Devices		Predicate
Technological Features	QinFlow Blood and Fluid Warmer(Warrior/Warrior EXTREME)	QinFlow Blood and Fluid Warmer(Warrior Lite)	QiF Blood and Fluid Warmer(Warrior, K180154)	Summary
Flow Rate	Based on gravity or fluid pump, upto 180 ml/min	Based on gravity or fluid pump, up to170 ml/min	Based on gravity or fluid pump, up to160 – 180 ml/min	The flow rates are within thespecified range of the predicatedevice.The differences do not raise differentquestions of safety and effectiveness
Materials/Biocompatibility	Biocompatibility testingdemonstrates tubing/fluid path tobe biocompatible.	Biocompatibility testing demonstratestubing/fluid path to be biocompatible.	Biocompatibility testing demonstratestubing/fluid path to be biocompatible.	Same
Sterilization	ETO	ETO	ETO	Same
Storage conditions	-4°F to 140°F & 93% RH(-20oC to 60oC & 93% RH)	-20 °C to 70 °C & 93% RH(-4 °F to 158 °F & 93% RH)	-4°F to 140°F & 93% RH(-20oC to 60oC & 93% RH)	A wider range of storage conditionswas successfully tested per IEC60601-1-12 for Warrior lite.
Operation Temperature &Humidity	41°F & 15%RH to 104°F &90% RH(5°C & 15%RH to 40°C & 90%RH	23°F to 122°F& 90%RH (-5°C to 50°C& 90%RH)	41°F & 15%RH to 104°F & 93% RH(5°C & 15%RH to 40°C & 93%RH)	A wider range of operatingtemperatures was successfully testedfor per IEC 60601-1-12 for WarriorLite.The change does not raise differentquestions of safety and effectiveness.
Transient OperatingConditions	-4°F & 15%RH to 122°F &90%RH(-20°C & 15%RH to 50°C &90%RH)	-4°F & 15%RH to 122°F & 90%RH(-20°C & 15%RH to 50°C & 90%RH)	41°F & 15%RH to 104°F & 93% RH(5°C & 15%RH to 40°C & 93%RH)	The change does not raise differentquestions of safety and effectivenessas demonstrated by additional testingof transient operating conditions perIEC 60601-1-12.
AtmosphericPressure/(Altitude)	-400 to 4572 meters(-1312 to 15,000 ft)Operated with AC power supplymodule	Operated with lite battery:-400 to 4572 meters(-1312 to 15,000 ft)	Operated with battery-400 to 4572 meters(-1312 to 15,000 ft)	Same
	Subject Devices		Predicate
	QinFlow Blood and Fluid Warmer	QinFlow Blood and Fluid Warmer	QiF Blood and Fluid Warmer
Technological Features	(Warrior/Warrior EXTREME)	(Warrior Lite)	(Warrior, K180154)	Summary
	-400 to 3200 meters(-1312 to 10,499 ft)		Operated with AC power supplymodule
Nominal Input Voltage	100-240 VAC18-25.2 DC	100-240 VAC18-25.2 DC	-400 to 2000 meters(-1312 to 10,499 ft)100-240 VAC15-21 DC	Same
Temperature set point	$100.4 \pm 3.6$ °F (38 $\pm$ 2 °C)	$100.4 \pm 3.6$ °F (38 $\pm$ 2 °C)	$100.4 \pm 3.6$ °F (38 $\pm$ 2 °C)	Same
Measurement Accuracy	$\pm$ 2°C ( $\pm$ 3.6°F)	$\pm$ 2°C ( $\pm$ 3.6°F)	$\pm$ 2°C ( $\pm$ 3.6°F)	Same
Input TemperatureRequirements	At least 4°C (39.2°F)	At least 4°C (39.2°F)	At least 4°C (39.2°F)	Same
Warm-up time	Up to 30 seconds	Up to 30 seconds	Up to 30 seconds	Same
Warmed Volume Capacity	2.8 - 5L	1.25 - 2.4L	Operated with battery:2.8 - 5L	The Warrior Lite battery is alsosmaller than the predicate devicebattery and contain less cells; as suchits fluid warming capacity of theWarrior Lite is smaller than thepredicate device.The change does not raise differentquestions of safety and effectiveness.
Device Comparison
	Subject Devices		Predicate
Technological Features	QinFlow Blood and Fluid Warmer(Warrior/Warrior EXTREME)	QinFlow Blood and Fluid Warmer(Warrior Lite)	QiF Blood and Fluid Warmer(Warrior, K180154)	Summary
Disposable Unit /Compact Disposable UnitShelf Life	DU Shelf Life is 3 years CDUShelf Life is 3 years	DU Shelf Life is 3 years CDU ShelfLife is 3 years	DU Shelf Life is 3 years	Same
Base Unit Service Life	5 years	5 years	5 years	Same
Water and particlesIngress rate	Warrior EXTREME: IP56Warrior: IP33	IP56	IP22	Warrior EXTREME, Warrior lite IPIP56 is different and testedsuccessfully per IEC 60601-1-12.The change does not raise differentquestions of safety and effectiveness.
Physical Dimensions ofcomponents	Dimensions of Base Unit withbattery H xW x L millimeter (inch)232x156x78 mm (9.13x6.14x3.07in)	Dimensions of Base Unit with battery HxW x L millimeter (inch) 136×82×83mm (5.35×3.23×3.27 in)	Operated with battery:Dimensions of Base Unit with batteryH xW x L millimeter (inch)232x156x78 mm (9.13x6.14x3.07 in)Operated with AC module:Approximately 300×190×180 mm(11.8×7.5×7.1 in)	Warrior Lite BU dimensions with LiteBattery was designed to be smaller.The change does not raise differentquestions of safety and effectiveness
Weight of components	Approximately1720g(3.79lb)	Approximately790g(1.541b)	Operated with batteryApproximately1720g(3.79lb)Operated With AC module:Approximately 3700 g (~8 lb)	Warrior Lite BU weight with liteBattery was designed to be lower.The change does not raise differentquestions of safety and effectiveness
BU Display (LED/LCD)	LCD	LED	LCD	Warrior Lite provides informationsignals through LED panel instead ofLCD display.The change does not raise differentquestions of safety and effectiveness.
Device Comparison
Technological Features	Subject Devices		Predicate
	QinFlow Blood and Fluid Warmer(Warrior/Warrior EXTREME)	QinFlow Blood and Fluid Warmer(Warrior Lite)	QiF Blood and Fluid Warmer(Warrior, K180154)	Summary
Alarm ConditionsIndicators	Visual (LCD display) andaudioSelf-test/mute button On/off switch	Visual (LED panel) On/off button	Visual (LCD display) andaudioSelf-test/mute button On/off switch	Warrior Lite provides informationsignals through LED panel instead ofLCD display.The Warrior Lite does not have:1. audible information signals2. self-test/mute button
				The change does not raise differentquestions of safety and effectiveness.

Sterility: Using Ethylene Oxide (ETO) sterilization method 7.

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Image /page/6/Picture/0 description: The image shows the logo for QinFlow. The logo consists of the text "QinFL" in a dark gray sans-serif font, followed by a stylized water droplet icon that transitions from blue at the top to red at the bottom. To the right of the droplet is the letter "W" in the same dark gray font as "QinFL".

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Image /page/7/Picture/0 description: The image shows the logo for QinFlow. The logo consists of the text "QinFL" in a gray sans-serif font, followed by a stylized water droplet icon with horizontal bands of color ranging from blue at the top to red at the bottom. The letter "W" in the same gray sans-serif font as the rest of the text is to the right of the water droplet.

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Image /page/8/Picture/0 description: The image shows the logo for QinFlow. The logo consists of the text "QinFL" in a gray sans-serif font, followed by a stylized water droplet icon with horizontal bands of color ranging from blue at the top to red at the bottom. The letter "W" in the same gray sans-serif font as the rest of the text is to the right of the water droplet.

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Image /page/9/Picture/0 description: The image contains the logo for QinFlow. The logo consists of the text "QinFLOW" in a simple, sans-serif font. To the right of the text is a stylized water droplet graphic, which is colored with a gradient from blue at the top to red at the bottom, giving it a layered appearance.

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Image /page/10/Picture/0 description: The image shows the logo for QinFlow. The logo consists of the text "QinFL" in a gray sans-serif font, followed by a stylized water droplet icon with horizontal bands of color ranging from blue at the top to red at the bottom. The logo is completed with the letter "W" in a gray sans-serif font.

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Image /page/11/Picture/0 description: The image shows the logo for QinFlow. The logo consists of the text "QinFL" in a dark gray sans-serif font, followed by a stylized water droplet icon. The water droplet is colored with horizontal bands of blue at the top, transitioning to red at the bottom. The letter "W" in a dark gray sans-serif font is placed to the right of the water droplet.

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Image /page/12/Picture/0 description: The image shows the logo for QinFlow. The logo consists of the text "QinFLOW" in a simple, sans-serif font. To the right of the text, there is a stylized graphic of a drop of liquid, colored with a gradient from blue at the top to red at the bottom, suggesting a flow or temperature change.

Pre-market Submission: Traditional 510(k)

Performance Data

Performance testing requirements were determined through the arisk management process, applicable FDA guidance documents and performance standards (21 CFR §880.5725). Performance testing in support of substantial equivalence determination included:

Functional: Testing to verify that the device functions as intended, and all design and functional specifications are met for all models/system configurations.
Software Verification and Validation: Software verification testing were conducted and documentation is provided for a Major level concern per IEC 62304 and as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
Safety Testing ●
- a. Electrical: Testing per IEC 60601-1:2005 to demonstrate compliance with applicable electrical safety requirements.
- Electromagnetic Compatibility: Testing per IEC 60601-1-2:2014 to demonstrate compliance b. with applicable electromagnetic interference requirements.
- EMS Equipment Safety: Testing per IEC 60601-1-12:2014 to demonstrate compliance with c. applicable emergency medical equipment requirements.
Hemocompatibility Testing: Testing to demonstrate safe use with blood products
Usability Assessment: Simulated use testing in accordance with IEC 62366:2007 and FDA's Medical Use-Safety: Incorporating Human Factors Engineering into Risk Management Guidance to demonstrate that the Warrior Lite can be used safely and effectively by intended users.
Shelf-life and Sterilization Validation: Shelf-life testing and Sterilization assessment per ISO 11135: ● 2014 for sterilization validation was conducted with acceptable results.

Conclusions

The QinFlow Blood and Fluid Warmer (Warrior, Warrior EXTREME and Warior Lite) is as safe and as effective as previously cleared predicate device (K180154), as demonstrated by performance data and risk assessment. The intended use, technological characteristics and principle of operation are substantially equivalent to the predicate device and do not raise any new concerns with regard to safety or effectiveness. Thus, the QinFlow Blood and Fluid Warmer is substantially equivalent to the predicate device.

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).