Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite Blood and Fluid Warmer

Q: Who is the manufacturer of Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite Blood and Fluid Warmer?

Quality IN Flow , Ltd. filed the 510(k) submission for Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite Blood and Fluid Warmer (K211800).

Q: What is the FDA product code for Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite Blood and Fluid Warmer?

LGZ. It is classified under 21 CFR 880.5725 as a Class 2 device in the General Hospital panel.

Q: What is the regulatory pathway for Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite Blood and Fluid Warmer?

510(k) clearance (submission type: Traditional).

Q: What are the predicate devices for Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite Blood and Fluid Warmer?

OiF Blood and Fluid Warmer (K180154).

Q: Who can help prepare an FDA 510(k) submission like Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite Blood and Fluid Warmer?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K211800 · Quality IN Flow , Ltd. · LGZ · Dec 8, 2022 · General Hospital

Device Facts

Record ID	K211800
Device Name	Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite Blood and Fluid Warmer
Applicant	Quality IN Flow , Ltd.
Product Code	LGZ · General Hospital
Decision Date	Dec 8, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.5725
Device Class	Class 2
Attributes	Therapeutic, Pediatric

Intended 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.

Device Story

Portable, in-line fluid warmer for blood, blood products, and IV fluids. System comprises a Base Unit (BU) and a sterile, single-use Disposable Unit (DU/CDU). DU contains a spiral stainless steel heat exchanger encased in Expanded Polypropylene (EPP). BU uses resistive heating to maintain a constant outlet temperature of 38 ± 2°C. Operated by healthcare professionals (physicians, nurses, medics) in hospitals, clinics, field, and transport settings. BU controls heating process via firmware and electronics; provides status via LCD (Warrior/Warrior EXTREME) or LED panel (Warrior Lite). Powered by rechargeable battery or AC module. Warmed fluid flows through the heat exchanger to the patient. Benefits include prevention of hypothermia during fluid administration. Warrior Lite is a smaller, lighter version of the predicate with reduced warming capacity and LED-only interface.

Clinical Evidence

Bench testing only. Included functional verification, software V&V (Major level of concern), electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), EMS equipment safety (IEC 60601-1-12), hemocompatibility, usability assessment (IEC 62366), and shelf-life/sterilization validation (ISO 11135).

Technological Characteristics

Software-controlled electromechanical system; resistive heating; constant outlet temperature 38 ± 2°C. Materials: EPP, stainless steel heat exchanger. Connectivity: Standalone. Power: Rechargeable battery or AC module. Sterilization: ETO. Software: Major level of concern per IEC 62304.

Indications for Use

Indicated for warming blood, blood products, and intravenous fluids prior to administration in adult and pediatric patients to prevent hypothermia. Used by healthcare professionals in hospital, clinic, field, and transport environments.

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

OiF Blood and Fluid Warmer (K180154)

Related Devices

K180154 — QiF Blood and Fluid Warmer · Quality IN Flow , Ltd. · Apr 27, 2018
K163708 — QiF Blood and Fluid Warmer · Quality IN Flow , Ltd. · Apr 20, 2017
K171215 — QiF Blood and Fluid Warmer · Quality IN Flow , Ltd. · Sep 27, 2017
K150404 — QiF Blood and Fluid Warmer · Quality IN Flow , Ltd. · Jun 23, 2016
K232107 — °M Warmer System · Mequ A/S · May 31, 2024

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ # 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) 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. Type of Use (Select one or both, as applicable) | <div> Prescription Use (Part 21 CFR 801 Subpart D) </div> | |---------------------------------------------------------------------------------------------------------------------------------------------------------------| | <div> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | ## 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.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ 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 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: - 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. {4}------------------------------------------------ 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). - 3. 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. - 5. 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. {5}------------------------------------------------ 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. - 3. 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. - 4. 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. - 5. 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 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 | 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. | 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. | Both the subject and predicate device have essentially the same intended use. The change was made to specify the intended user population and the transport environment in accordance with 21 CFR 814.20(b)(3)(i). The change does not raise different questions 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 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. | | | | | Intended Use | Intended for warming blood, blood products and intravenous solutions in adults and pediatric patients during medical emergencies whenever parenteral introduction of normothermic fluid are desired or indicated. It is intended to be used by healthcare professionals in hospital, clinical, field and transport environments to help prevent hypothermia. | Intended for warming blood, blood products and intravenous solutions in adults and pediatric patients during medical emergencies whenever parenteral introduction of normothermic fluid are desired or indicated. It is intended to be used by healthcare professionals in hospital, clinical, field and transport environments to help prevent hypothermia | Intended for warming blood, blood products and intravenous solutions prior to administration. It is intended to be used by healthcare professionals in hospital, clinical and field environments to help prevent hypothermia. | Both the subject and predicate devices have essentially the same intended use. The change was made to specify the intended user population and the transport environment in accordance with 21 CFR 814.20(b)(3)(i). The change does not raise different questions 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-level practitioners, EMT/Paramedic, military medics) | Same | | Use Environment | Hospital, Clinic, Field and Transport | Hospital, Clinic, Field and Transport | Hospital, Clinic, Field and Transport | Same | | Operating Principle | Resistive heating | Resistive heating | Resistive heating | Same | | Intended fluid(s) to be warmed | 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 | | Intended route(s) of administration | IV | IV | IV | Same | | System Components | 1. Base Unit 2. Disposable Unit (Sterile, Heat exchanger) 3. Connecting Cable 4. Compact Disposable Unit (optional) Extension Cable Accessory (optional) | 1. Base Unit 2. Disposable Unit (Sterile, Heat exchanger) 3. Compact Disposable Unit (optional, New) Extension Cable Accessory (optional when using CDU) | 1. Base Unit 2. Disposable Unit (Sterile, Heat exchanger) Connecting Cable | Optional use of the following components: 1. Compact Disposable Unit (CDU) 2. Extension Cable The change does not raise different questions of safety and effectiveness. | | Power Source | Rechargeable Battery or AC power supply module | Rechargeable Lite Battery | Rechargeable Battery or AC power supply module | The Warrior Lite can only be operated with the rechargeable Lite Battery. The change does not raise different questions of safety and effectiveness. | | User Interface | 1. Visual (LCD display) and audio 2. Self-test/mute button On/off switch | 1. Visual (LED panel) On/off button | 1. Visual (LCD display) and audio 2. Self-test/mute button On/off switch | Warrior Lite provides information signals through LED panel instead of LCD display. The change does not raise different questions of safety and effectiveness. | | Heating Method | Resistive Heating | Resistive Heating | Resistive Heating | Same | | Heating Control | software controls the heating process and the operation of the device | software controls the heating process and the operation of the device | software controls the heating process and 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, up to 180 ml/min | Based on gravity or fluid pump, up to 170 ml/min | Based on gravity or fluid pump, up to 160 – 180 ml/min | The flow rates are within the specified range of the predicate device. The differences do not raise different questions of safety and effectiveness | | Materials/ Biocompatibility | Biocompatibility testing demonstrates tubing/fluid path to be biocompatible. | Biocompatibility testing demonstrates tubing/fluid path to be biocompatible. | Biocompatibility testing demonstrates tubing/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 conditions was successfully tested per IEC 60601-1-12 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 operating temperatures was successfully tested for per IEC 60601-1-12 for Warrior Lite. The change does not raise different questions of safety and effectiveness. | | Transient Operating Conditions | -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 different questions of safety and effectiveness as demonstrated by additional testing of transient operating conditions per IEC 60601-1-12. | | Atmospheric Pressure/(Altitude) | -400 to 4572 meters (-1312 to 15,000 ft) Operated with AC power supply module | 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 supply module | | | Nominal Input Voltage | 100-240 VAC 18-25.2 DC | 100-240 VAC 18-25.2 DC | -400 to 2000 meters (-1312 to 10,499 ft) 100-240 VAC 15-21 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 Temperature Requirements | 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…