Who is the manufacturer of QiF Blood and Fluid Warmer?

Quality IN Flow , Ltd. filed the 510(k) submission for QiF Blood and Fluid Warmer (K171215).

What is the FDA product code for QiF Blood and Fluid Warmer?

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

What is the regulatory pathway for QiF Blood and Fluid Warmer?

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

What are the predicate devices for QiF Blood and Fluid Warmer?

QiF Blood and Fluid Warmer (K163708).

Who can help prepare an FDA 510(k) submission like QiF 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.

QiF Blood and Fluid Warmer

K171215 · Quality IN Flow , Ltd. · LGZ · Sep 27, 2017 · General Hospital

Device Facts

Record ID	K171215
Device Name	QiF Blood and Fluid Warmer
Applicant	Quality IN Flow , Ltd.
Product Code	LGZ · General Hospital
Decision Date	Sep 27, 2017
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.5725
Device Class	Class 2
Attributes	Therapeutic

Indications for Use

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 hospitals, clinics and field environments, to help prevent hypothermia.

Device Story

Portable, inline blood and fluid warmer; used in hospitals, clinics, and field environments by healthcare professionals. System consists of a Base Unit (BU) with rechargeable battery, firmware, and electronics; a sterile, single-use Disposable Unit (DU) containing a spiral stainless steel heat exchanger; and a connecting cable. Device placed between fluid container and patient. BU controls heating process and outflow temperature (set point 38 ± 2 °C) via resistive heating. Provides visual/audio notifications for overheat, under-heat, low battery, and flow irregularities. Safety features include system self-test, overheat cut-off, and battery under-voltage protection. Prevents hypothermia by delivering normothermic fluids; helps maintain patient temperature during surgery or emergency care.

Clinical Evidence

Bench testing only. No clinical data provided. Performance testing verified the device warms plasma to the set point of 38 ± 2 °C. No studies were performed to evaluate the effects on clotting factors in plasma products.

Technological Characteristics

Portable inline warmer; resistive heating. Components: Base Unit (electronics, firmware, rechargeable battery) and sterile Disposable Unit (plastic oval box, spiral stainless steel heat exchanger, PVC tubing). Heat insulation via expanded polypropylene (EPP) box. Flow rate up to 160–180 ml/min. Dimensions: BU 235x160x75 mm; DU 210x160x45 mm. Operating conditions: 41°F–104°F, 15%–93% RH. Altitude: -1312 to 15,000 ft.

Indications for Use

Indicated for warming blood, blood products, and intravenous fluids prior to administration in patients requiring normothermic fluid introduction during medical emergencies or surgeries. Intended for use by healthcare professionals in hospitals, clinics, and field 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

QiF Blood and Fluid Warmer (K163708)

Submission Summary (Full Text)

{0}------------------------------------------------ ## 510(k) SUMMARY - K171215 Quality in Flow's QiF Blood and Fluid Warmer Manufacturer: Quality in Flow Ltd. Phone: (972) (54) 6600146 Contact Person: Neta Sherman Date Prepared: September 26, 2017 #### Subject Device Name of Device- QiF Blood and Fluid Warmer Common Name- QiF Blood and Fluid Warmer Regulation Number- 21 C.F.R 880.5725 Regulation Name- Infusion pump Regulatory class- class II Product Code LGZ, BSB Classification Panel- General Hospital #### Predicate Device 510(k) Number- K163708 Name of Device- QiF Blood and Fluid Warmer Common Name- QiF Blood and Fluid Warmer Regulation Number- 21 C.F.R 880.5725 Requlation Name- Infusion pump Regulatory class- class II Product Code LGZ, BSB Classification Panel- General Hospital #### Indications for Use 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 hospitals, clinics and field environments, to help prevent hypothermia. #### Description The Quality in Flow QiF Blood and Fluid Warmer is a portable sterile Fluid Path, in-line Blood and Fluid Warmer. The QiF device is composed of the following main components: - 1. Disposable Unit (DU) The disposable cartridge is made of a plastic oval box encasing a spiral Stainless Steel (SS) heat exchanger tube. The DU is located between the fluid container (intravenous solution or blood product) and the treated patient, outside of the {1}------------------------------------------------ patient body. The DU has a standard intravenous tube extension. The DU comprises the temperature sensors. - 2. Base Unit (BU) The BU controls the performance of the system and the outflow fluid temperature. The power source is a rechargeable detachable battery located within the BU: the BU contains firmware (SW) and electronics (HW). - 3. Connecting Cable (CC) a cable consisting of data and power wires connects between the BU and the DU to facilitate the transfer of data and electrical current. ## Purpose of 510(k) The purpose of this 510(k) is to replace the contraindication against plasma warming with the QiF device with a precaution statement. #### Performance Data Performance tests were performed in order to demonstrate that the device has equivalent performance to its predicate. Specifically, testing was conducted to verify that the QiF device will warm plasma to the device set point temperature (38 ± 2 °C; 98.6±3.6°F). In all instances, the device functioned as intended and demonstrated equivalent performance. Studies have not been performed to evaluate the effects on clotting factors in plasma products following warming with the QiF Blood and Fluid Warmer. #### Technological Characteristics The QiF Blood and Fluid is not changed, thus it has identical technological characteristics as the predicate QiF Blood and Fluid Warmer. The QiF Blood and Fluid Warmer is a portable, inline Blood and Fluid Warmer located between the fluid container (intravenous solution or blood product) and the treated patient, outside of the patient body. The device is comprised of a Base Unit (BU) and a sterile disposable cartridge (Disposable Unit). The Disposable Unit is composed of a plastic oval box encasing a spiral stainless steel heat exchanger tube. The Base Unit contains Firmware (software) and electronics (HW). The Base Unit controls the performance of the system and the fluid outflow temperature. The power source is a rechargeable detachable battery located within the Base Unit. The DU has a standard intravenous tube extension. #### Substantial Equivalence An SE Table is presented below: {2}------------------------------------------------ | | Quality in Flow – QiF Blood and Fluid Warmer model 01 [Subject] | Quality in Flow – QiF Blood and Fluid Warmer model 01 [K163708] | SE Justification | |----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------| | Indications for Use | Intended for warming blood, blood products, and intravenous fluids prior to administration. It is intended to be used by healthcare professionals in hospitals, clinics and field environments, to help prevent hypothermia. | 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. | Same | | Intended use | Medical emergencies or surgeries where warm fluid administration is required to treat the patient. Whenever parenteral introduction of normothermic fluid are desired or indicated | Medical emergencies or surgeries where warm fluid administration is required to treat the patient. Whenever parenteral introduction of normothermic fluid are desired or indicated | Same | | Fluids that Can be Warmed | IV Fluids, Blood, Blood Products | IV Fluids, Blood, Blood Products | Same | | Components | Warmer with display and a sterile, disposable heat exchanger | Warmer with display and a sterile, disposable heat exchanger | Same | | Safety Features | • System self-test • Overheat notification • Overheat cut-off • Battery under-voltage protection (cut-off) | • System self-test • Overheat notification • Overheat cut-off • Battery under-voltage protection (cut-off) | Same | | Notification Types | • Overheat • Under heat • Low battery • Flow irregularity | • Overheat • Under heat • Low battery • Flow irregularity | Same | | User Interface / Notifications | • Visual (LCD display) and audio • Self-test/mute button • On/off switch | • Visual (LCD display) and audio • Self-test/mute button • On/off switch | Same | | Power Source | Rechargeable Battery | Rechargeable Battery | Same | | Infusion temp. | $38±2°C$ | $38±2°C$ | Same | | Heating Method | Resistive heating | Resistive heating | Same | | | Quality in Flow – QiF Blood and Fluid Warmer model 01 [Subject] | Quality in Flow – QiF Blood and Fluid Warmer model 01 [K163708] | SE Justification | | Fluid Path | Located within the sterile disposable cartridges (DU). Spiral stainless steel tube and a short segment of a PVC tube The tube serves as the conductor of electrical current. | Located within the sterile disposable cartridges (DU). Spiral stainless steel tube and a short segment of a PVC tube The tube serves as the conductor of electrical current. | Same | | Flow Rate | Based on gravity or fluid pump, up to 160 – 180 ml/min | Based on gravity or fluid pump, up to 160 – 180 ml/min | Same | | Software | The software control the heating process and the operation of the device | The software control the heating process and the operation of the device | Same | | Biocompatibility | The fluid path is made of biocompatible Stainless Steel, PVC and luer connections | The fluid path is made of biocompatible Stainless Steel, PVC and luer connections | Same | | Sterility | The disposable unit is provided sterile for single patient use | The disposable unit is provided sterile for single patient use | Same | | Single Use or Reusable | Single Use | Single Use | Same | | Shelf Life | DU shelf life - 3 years | DU shelf life - 3 years | Same | | Storage conditions | -4°F to 140°F & 93% RH and compliance to -22°F to 158°F | -4°F to 140°F & 93% RH and compliance to -22°F to 158°F | Same | | Operating conditions | 41°F &15%RH to 104°F & 93% RH and compliance with 23°F to 104°F | 41°F &15%RH to 104°F & 93% RH and compliance with 23°F to 104°F | Same | | Altitude | -1312 to 15,000ft | -1312 to 15,000 ft | Same | | Dimensions of Base Unit with Battery | Approximately 235x160x75 mm (9.25x6.5x2.9 in) | Approximately 235x160x75 mm (9.25x6.5x2.9 in) | Same | | Dimensions of Disposable Unit in sterile bag | DU: Approximately 210x160x45mm (8.3x 6.5x1.8 in) | DU: Approximately 210x160x45mm (8.3x 6.5x1.8 in) | Same | | Warmer Type | Inline warmer | Inline warmer | Same | | | Quality in Flow – QiF Blood and Fluid Warmer model 01 [Subject] | Quality in Flow – QiF Blood and Fluid Warmer model 01 [K163708] | SE Justification | | Heat Insulation | Yes: the heat exchanger is encased within an expanded polypropylene (EPP) oval box to prevent any contact between the user and warm tube intended to provide thermal and electrical isolation between the device and the user. | Yes: the heat exchanger is encased within an expanded polypropylene (EPP) oval box to prevent any contact between the user and warm tube intended to provide thermal and electrical isolation between the device and the user. | Same | {3}------------------------------------------------ {4}------------------------------------------------ # Conclusions The QiF Blood and Fluid Warmer is substantially equivalent to the predicate device. {5}------------------------------------------------ Image /page/5/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two parts: a circular seal on the left and a symbol on the right. The seal contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion. The symbol on the right features a stylized depiction of three human profiles facing right, with the profiles overlapping each other. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 September 27, 2017 Quality In Flow Ltd. % John Smith Partner Hogan Lovells US LLP 555 Thirteenth St. NW Washington, District of Columbia 20004 Re: K171215 Trade/Device Name: QiF Blood and Fluid Warmer Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: LGZ, BSB Dated: April 25, 2017 Received: April 25, 2017 Dear John Smith: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {6}------------------------------------------------ Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely, Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ # Please wait... If this message is not eventually replaced by the proper contents of the document, your PDF viewer may not be able to display this type of document. You can upgrade to the latest version of Adobe Reader for Windows®, Mac, or Linux® by visiting http://www.adobe.com/go/reader_download. For more assistance with Adobe Reader visit http://www.adobe.com/go/acrreader. Windows is either a registered trademark of Microsoft Corporation in the United States and/or other countries. Mac is a trademark of Apple Inc., registered in the United States and other countries. Linux is the registered trademark of Linus Torvalds in the U.S. and other countries.

QiF Blood and Fluid Warmer

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

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QiF Blood and Fluid Warmer

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

Panel 1

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