QiF Blood and Fluid Warmer

K163708 · Quality IN Flow , Ltd. · LGZ · Apr 20, 2017 · General Hospital

Device Facts

• Record ID: K163708
• Device Name: QiF Blood and Fluid Warmer
• Applicant: Quality IN Flow , Ltd.
• Product Code: LGZ · General Hospital
• Decision Date: Apr 20, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 hospital, clinics and field environments, to help prevent hypothermia.

Device Story

Portable, in-line 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 Disposable Unit (DU) containing a spiral stainless steel heat exchanger; and a connecting cable. The DU is placed between the fluid container and the patient. The BU controls fluid outflow temperature via resistive heating. The device monitors temperature and flow; provides visual/audio notifications for overheat, under-heat, low battery, or flow irregularities. The system helps prevent hypothermia during fluid administration. Modifications include an upgraded battery, an integrated DU for both blood and IV fluids, and expanded operating/storage environmental specifications.

Clinical Evidence

Bench testing only. No clinical data presented. Verification included electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), battery testing (IEC 62133), and functional testing at extreme temperature/altitude conditions per EN 1789 and IEC 60601-1-11. Software validation confirmed performance of the integrated DU.

Technological Characteristics

Portable, in-line resistive heater. Components: Base Unit (rechargeable battery, electronics, firmware) and sterile Disposable Unit (plastic oval box, spiral stainless steel heat exchanger, PVC tubing). Thermal/electrical isolation provided by expanded polypropylene (EPP) housing. Connectivity: wired cable between BU and DU. Dimensions: BU ~235x160x75 mm; DU ~210x160x45 mm. Sterilization: Disposable unit provided sterile.

Indications for Use

Indicated for medical emergencies or surgeries requiring warm fluid administration to treat patients; indicated whenever parenteral introduction of normothermic fluid is desired.

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 (K150404)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

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

April 20, 2017

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

Re: K163708

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

Dear Neta Sherman:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

{1}------------------------------------------------

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801): medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely,

Image /page/1/Picture/8 description: The image contains a signature of "Tina Kiang -s". The signature is written in black ink and is on a white background. The signature is stylized and includes a loop on the left side.

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

{2}------------------------------------------------

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

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

510(k) Number (if known) K163708

Device Name QiF Blood and Fluid warmer

Indications for Use (Describe)

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.

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

区 Prescription Use (Part 21 CFR 801 Subpart D)

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

# CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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

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 [e-mail]

"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."

FORM FDA 3881 (8/14)

Page 1 of 1 FDA

{3}------------------------------------------------

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

Manufacturer: Quality in Flow Ltd.

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

Date Prepared: April 20, 2017

#### Subject Device

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

### Predicate Device

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

#### Indications for Use

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.

### Description

The Quality in Flow QiF Blood and Fluid Warmer is a portable sterile Fluid Path, in-line Blood and Fluid Warmer.

The QiF device is composed of the following main components:

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

{4}------------------------------------------------

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

- 3. Connecting Cable (CC) - a cable consisting data and power wires connects between the Base Unit and the Disposable Unit to facilitate the transfer of data and electrical current.
## Purpose of 510(k)

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

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

# Performance Data

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

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

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

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

{5}------------------------------------------------

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

Verification endpoints included:

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

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

Risk analysis identified the following risks and mitigations:

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

{6}------------------------------------------------

# Technological Characteristics

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

Both the cleared device and the modified QiF Blood and Fluid Warmer are a portable, inline Blood and Fluid Warmer located between the fluid container (intravenous solution or blood product) and the treated patient, outside of the patient body. The device is comprised of a Base Unit (BU) and a sterile disposable cartridge (Disposable Unit). The Disposable Unit is composed of a plastic oval box encasing a spiral stainless steel heat exchanger tube. The Base Unit contains Firmware (software) and electronics (HW). The Base Unit controls the performance of the system and the fluid outflow temperature. The power source is a rechargeable detachable battery located within the Base Unit. The Disposable Unit has a standard intravenous tube extension.

### Substantial Equivalence

An abbreviated SE Table is presented below:

| | Quality in Flow - QiF<br>Blood and Fluid<br>Warmer model 01<br>[K163708] | Quality in Flow – QiF<br>Blood and Fluid<br>Warmer model 01<br>[K150404] | SE Justification |
|----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|
| Intended Use | Intended for warming<br>blood, blood products<br>and intravenous<br>solutions prior to<br>administration. It is<br>intended to be used by<br>healthcare professionals<br>in hospital, clinical and<br>field environments to<br>help prevent<br>hypothermia. | Intended for warming<br>blood, blood products<br>and intravenous<br>solutions prior to<br>administration. It is<br>intended to be used by<br>healthcare<br>professionals in<br>hospital, clinical and<br>field environments to<br>help prevent<br>hypothermia. | Same |
| Indications for<br>Use | Medical emergencies or<br>surgeries where warm<br>fluid administration is<br>required to treat the<br>patient.<br><br>Whenever parenteral<br>introduction of<br>normothermic fluid are<br>desired or indicated | Medical emergencies or<br>surgeries where warm<br>fluid administration is<br>required to treat the<br>patient.<br><br>Whenever parenteral<br>introduction of<br>normothermic fluid are<br>desired or indicated | Same |
| Components | Warmer with display and<br>a sterile, disposable<br>heat exchanger | Warmer with display<br>and a sterile,<br>disposable heat<br>exchanger | Same |
| | Quality in Flow - QiF<br>Blood and Fluid<br>Warmer model 01<br>[K163708] | Quality in Flow – QiF<br>Blood and Fluid<br>Warmer model 01<br>[K150404] | SE Justification |
| Safety Features | • System self-test<br>• Overheat notification<br>• Overheat cut-off<br>• Battery under-<br>voltage protection<br>(cut-off) | • System self-test<br>• Overheat<br>notification<br>• Overheat cut-off<br>• Battery under-<br>voltage protection<br>(cut-off) | Same |
| Notification<br>Types | • Overheat<br>• Under heat<br>• Low battery<br>• Flow irregularity | • Overheat<br>• Under heat<br>• Low battery<br>• Flow irregularity | Same |
| User Interface /<br>Notifications | • Visual (LCD display)<br>and audio<br>• Self-test/mute button<br>• On/off switch | • Visual (LCD<br>display) and audio<br>• Self-test/mute<br>button<br>• On/off switch | Same |
| Power Source | Rechargeable Battery | Rechargeable Battery | Same |
| Infusion temp. | $38±2°C$ | $38±2°C$ | Same |
| Heating Method | Resistive heating | Resistive heating | Same |
| Fluid Path | Located within the sterile<br>disposable cartridges<br>(DU).<br>Spiral stainless steel<br>tube and a short<br>segment of a PVC tube<br>The tube serves as the<br>conductor of electrical<br>current. | Located within the<br>sterile disposable<br>cartridges (DU).<br>Spiral stainless steel<br>tube and a short<br>segment of a PVC tube<br>The tube serves as the<br>conductor of electrical<br>current. | Same |
| Flow Rate | Based on gravity or fluid<br>pump, up to 160 – 180<br>ml/min | Based on gravity,<br>Up to ~160 – 180<br>ml/min | Similar. Fluid pump<br>can be used with<br>limit of up to 180<br>ml/min based on<br>testing up to 220<br>ml/min |
| Software | The software control the<br>heating process and the<br>operation of the device | The software control the<br>heating process and the<br>operation of the device | Same |
| Biocompatibility | The fluid path is made of<br>biocompatible Stainless<br>Steel, PVC and luer<br>connections | The fluid path is made<br>of biocompatible<br>Stainless Steel, PVC<br>and luer connections | Same |
| Sterility | The disposable unit is<br>provided sterile for | The disposable unit is<br>provided sterile for | Same |
| | Quality in Flow - QiF<br>Blood and Fluid<br>Warmer model 01<br>[K163708] | Quality in Flow - QiF<br>Blood and Fluid<br>Warmer model 01<br>[K150404] | SE Justification |
| Single Use or<br>Reusable | Single Use | Single Use | Same |
| Shelf Life | DU shelf life – 3 years | DU shelf life - 1 year | Extended shelf life<br>was validated<br>through bench top<br>testing |
| Storage<br>conditions | -4°F to 140°F & 93% RH<br>and compliance to -22°F RH<br>to 158°F | -4°F to 140°F & 93% RH | Similar. Expanded<br>operating conditions<br>were validated<br>through<br>performance testing<br>in a certified lab |
| Operating<br>conditions | 41°F &15%RH to 104°F<br>& 93% RH and<br>compliance with 23°F to<br>104°F | 41°F &15%RH to 104°F<br>& 93% RH | Similar. Expanded<br>operating conditions<br>were validated<br>through<br>performance testing<br>in a certified lab |
| Altitude | -1312 to 10,499 ft. | -1312 to 15,000 ft. | Similar. Expanded<br>operating conditions<br>were validated<br>through<br>performance testing<br>in a certified lab |
| Dimensions of<br>Base Unit with<br>Battery | Approximately<br>235x160x75 mm<br>(9.25x6.5x2.9 in) | Same | Same |
| Dimensions of<br>Disposable Unit<br>in sterile bag | DU:<br>Approximately<br>210x160x45mm<br>(8.3x 6.5x1.8 in) | Same | Same |
| Warmer Type | Inline warmer | Inline warmer | Same |
| Heat Insulation | Yes: the heat exchanger<br>is encased within an<br>expanded polypropylene<br>(EPP) oval box to<br>prevent any contact<br>between the user and<br>warm tube intended to<br>provide thermal and<br>electrical isolation<br>between the device and<br>the user. | Yes: the heat<br>exchanger is encased<br>within an expanded<br>polypropylene (EPP)<br>oval box to prevent any<br>contact between the<br>user and warm tube<br>intended to provide<br>thermal and electrical<br>isolation between the<br>device and the user. | Same |

{7}------------------------------------------------

{8}------------------------------------------------

{9}------------------------------------------------

# Conclusion

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