(112 days)
Not Found
No
The description focuses on standard hardware and software control for temperature regulation, with no mention of AI/ML terms or capabilities.
Yes
The device is intended for warming blood, blood products, and intravenous fluids prior to administration to help prevent hypothermia, which is a therapeutic purpose.
No
The device is a blood and fluid warmer intended to prevent hypothermia by warming blood and fluids prior to administration, not to diagnose a medical condition.
No
The device description clearly outlines hardware components (Disposable Unit with heat exchanger, Base Unit with electronics and battery, Connecting Cable) in addition to firmware (SW). The performance studies also include hardware verification and validation.
Based on the provided information, the QiF Blood and Fluid Warmer device is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to warm blood, blood products, and intravenous fluids prior to administration to a patient. This is a therapeutic or supportive function, not a diagnostic one.
- Device Description: The device warms fluids that will be introduced into the patient's body. It does not analyze or test biological samples in vitro (outside the living body) to provide information about a patient's health status.
- Lack of Diagnostic Elements: There is no mention of the device being used to detect, measure, or analyze any substances or characteristics in the blood or fluids for diagnostic purposes.
IVD devices are specifically designed to perform tests on samples taken from the human body (like blood, urine, tissue) to diagnose diseases, monitor conditions, or screen for health issues. The QiF Blood and Fluid Warmer's function is purely to modify the temperature of fluids before they enter the body.
N/A
Intended Use / 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.
Product codes
LGZ, BSB
Device 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:
- 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.
- 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 located within the Base Unit; the Base Unit contains firmware (SW) and electronics (HW).
- 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.
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
Not Found
Intended User / Care Setting
healthcare professionals in hospital, clinics and field 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 tests were performed in order to demonstrate that the modified device has equivalent performance to its predicate.
- 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.
- 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. - 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.
- 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.
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/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 (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 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,
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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.
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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."
FORM FDA 3881 (8/14)
Page 1 of 1 FDA
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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:
-
- 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.
-
- 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).
-
- 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:
-
- The rechargeable Battery pack was upgraded to an enhanced model with increased capacity with a new charger adaptor.
-
- 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.
-
- 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.
-
- 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.
-
- 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.
-
- 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
-
- 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.
-
- 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. |
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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
Blood and Fluid
Warmer model 01
[K163708] | Quality in Flow – QiF
Blood and Fluid
Warmer model 01
[K150404] | SE Justification |
|----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|
| Intended Use | 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. | 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. | Same |
| Indications for
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 |
| Components | Warmer with display and
a sterile, disposable
heat exchanger | Warmer with display
and a sterile,
disposable heat
exchanger | Same |
| | Quality in Flow - QiF
Blood and Fluid
Warmer model 01
[K163708] | Quality in Flow – QiF
Blood and Fluid
Warmer model 01
[K150404] | SE Justification |
| 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 |
| 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,
Up to ~160 – 180
ml/min | Similar. Fluid pump
can be used with
limit of up to 180
ml/min based on
testing up to 220
ml/min |
| 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 | The disposable unit is
provided sterile for | Same |
| | Quality in Flow - QiF
Blood and Fluid
Warmer model 01
[K163708] | Quality in Flow - QiF
Blood and Fluid
Warmer model 01
[K150404] | SE Justification |
| Single Use or
Reusable | Single Use | Single Use | Same |
| Shelf Life | DU shelf life – 3 years | DU shelf life - 1 year | Extended shelf life
was validated
through bench top
testing |
| Storage
conditions | -4°F to 140°F & 93% RH
and compliance to -22°F RH
to 158°F | -4°F to 140°F & 93% RH | Similar. Expanded
operating conditions
were validated
through
performance testing
in a certified lab |
| 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 | Similar. Expanded
operating conditions
were validated
through
performance testing
in a certified lab |
| Altitude | -1312 to 10,499 ft. | -1312 to 15,000 ft. | Similar. Expanded
operating conditions
were validated
through
performance testing
in a certified lab |
| Dimensions of
Base Unit with
Battery | Approximately
235x160x75 mm
(9.25x6.5x2.9 in) | Same | Same |
| Dimensions of
Disposable Unit
in sterile bag | DU:
Approximately
210x160x45mm
(8.3x 6.5x1.8 in) | Same | Same |
| Warmer Type | Inline warmer | Inline warmer | Same |
| 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 |
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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.