(546 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description and performance studies focus on standard medical device functionalities and testing.
Yes.
The device is intended for warming blood products and intravenous fluids to prevent hypothermia, which is a therapeutic intervention aimed at maintaining or restoring a patient's body temperature for medical purposes.
No
The device is described as a blood and fluid warmer intended for warming bodily fluids, not for diagnosing medical conditions.
No
The device description explicitly lists multiple hardware components (Disposable Unit, Base Unit, Power source, Connecting Cable) and the performance studies include hardware-specific testing (Electrical, Electromagnetic Compatibility, EMS Equipment Safety, Hemocompatibility).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to warm blood products and intravenous fluids prior to administration to patients. This is a therapeutic or supportive function, not a diagnostic one.
- Device Description: The device description focuses on the components and how it warms fluids for administration. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device is clearly intended to prepare fluids for infusion into the patient, which falls under the category of medical devices used for treatment or support, not diagnosis.
N/A
Intended Use / Indications for Use
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.
Product codes
LGZ, BSB
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) 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.
- Base Unit (BU) The BU controls the system outflow fluid temperature and provide information signals to 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).
-
- 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 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.
-
- 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adults and pediatric patients
Intended User / Care Setting
healthcare professionals in hospital, clinics, field and transport environments
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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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:
-
- 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).
-
- 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.
-
- 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:
-
- 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.
-
- 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.
-
- 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.
-
- 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:
- Compact Disposable Unit (CDU)
- 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 - Self-test/mute button
On/off switch | 1. Visual (LED panel)
On/off button | 1. Visual (LCD display) and audio - 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 | 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 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.
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 |
| Disposable Unit /
Compact Disposable Unit
Shelf Life | DU Shelf Life is 3 years CDU
Shelf Life is 3 years | DU Shelf Life is 3 years CDU Shelf
Life is 3 years | DU Shelf Life is 3 years | Same |
| Base Unit Service Life | 5 years | 5 years | 5 years | Same |
| Water and particles
Ingress rate | Warrior EXTREME: IP56
Warrior: IP33 | IP56 | IP22 | Warrior EXTREME, Warrior lite IP
IP56 is different and tested
successfully per IEC 60601-1-12.
The change does not raise different
questions of safety and effectiveness. |
| Physical Dimensions of
components | Dimensions of Base Unit with
battery H xW x L millimeter (inch)
232x156x78 mm (9.13x6.14x3.07
in) | Dimensions of Base Unit with battery H
xW x L millimeter (inch) 136×82×83
mm (5.35×3.23×3.27 in) | Operated with battery:
Dimensions of Base Unit with battery
H 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 Lite
Battery was designed to be smaller.
The change does not raise different
questions of safety and effectiveness |
| Weight of components | Approximately
1720g
(3.79lb) | Approximately
790g
(1.541b) | Operated with battery
Approximately
1720g
(3.79lb)
Operated With AC module:
Approximately 3700 g (~8 lb) | Warrior Lite BU weight with lite
Battery was designed to be lower.
The change does not raise different
questions of safety and effectiveness |
| BU Display (LED/LCD) | LCD | LED | LCD | Warrior Lite provides information
signals through LED panel instead of
LCD display.
The change does not raise different
questions 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 Conditions
Indicators | Visual (LCD display) and
audio
Self-test/mute button On/off switch | Visual (LED panel) On/off button | Visual (LCD display) and
audio
Self-test/mute button On/off switch | Warrior Lite provides information
signals through LED panel instead of
LCD display.
The Warrior Lite does not have:
- audible information signals
- self-test/mute button |
| | | | | The change does not raise different
questions of safety and effectiveness. |
- Sterility: Using Ethylene Oxide (ETO) sterilization method 7.
6
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".
7
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.
8
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.
9
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.
10
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.
11
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.
12
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.