(740 days)
Not Found
No
The description focuses on standard heat exchange technology with closed-loop software control and safety features, without mentioning AI or ML.
Yes
The device is described as a 'Blood and Fluid Warming System' specifically designed to warm blood, blood products, and IV fluids prior to administration to help prevent hypothermia, which is a therapeutic intervention.
No
The device description indicates it is a fluid warming system designed to warm blood, blood products, and IV fluids to prevent hypothermia. Its function is to deliver warm fluids, not to diagnose medical conditions or analyze patient data.
No
The device description clearly outlines hardware components including a Warming Module, Control Module, and a disposable set with a plastic housing and aluminum heater plate. While software is mentioned for temperature control, it is part of a larger hardware system.
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, blood products, and IV fluids prior to administration to a patient to prevent hypothermia. This is a therapeutic intervention performed on the patient, not a diagnostic test performed on a sample from the patient.
- Device Description: The device description details a system for heating fluids that are being infused into a patient. It describes a warming module, control module, and a disposable set that connects to the fluid source and the patient line. This is consistent with a medical device used for patient treatment.
- Lack of Diagnostic Elements: There is no mention of analyzing samples, detecting substances, or providing diagnostic information about the patient's condition.
IVD devices are used to examine specimens derived from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not perform any such function.
N/A
Intended Use / Indications for Use
The Fluido Compact Blood and Fluid Warming System can be used in adult patients that need fluid warming prior to administration of blood, blood products and IV fluids to help prevent hypothermia. The system is intended to be used by healthcare professionals, e.g., nurses, medical specialists, doctors. Only medical professionals shall interact with the system. The devices must only be used on the order of a physician.
Product codes
LGZ
Device Description
The Fluido® Compact System consists of Fluido Compact Warming Module, Fluido Compact Control Module and Fluido Compact Standard Set (disposable).
The Fluido Compact system is designed to supply warm fluids at 39°C set point with flow rates from 5 to 100 ml/min. The sterile disposable set consist of a plastic housing and biocompatible coated aluminum heater plate. Heat from the warming module is transferred through the heat transfer part into the fluids that is circulating through the inner part of the cassette. The disposable is connected to the blood or fluid source (infusate reservoir) and the patient line on the other end. The disposable has standard luer lock fittings on both ends. The Control Module serves as the power supply for the Warming module.
Fluid and blood are warmed during infusion or transfusion. The delivery of heat is done by heat exchange. A warming module exchanges heat to a disposable set, which is connected to the fluid reservoir and the patient line via conduction warming technology The fluid temperature is controlled by closed loop software and guarded by sensors and has a redundant safety module for fluid overtemperature shutoff.
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
Adult
Intended User / Care Setting
hospital by healthcare professionals, e.g., nurses, medical specialists, doctors.
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)
Non-clinical testing:
- Performance testing according to applicable testing met all acceptance criteria.
- Comparative bench performance testing:
- Temperature: PASS
- Flow rates: PASS
- Alarms: PASS
- Useability: PASS
- Performance testing heater safety
- ASTM F2172-02 (Reapproved 2011): PASS
- Electrical/EMC testing:
- IEC 60601-1: PASS
- IEC 60601-1-2: PASS
- Clinical testing: Clinical testing was not necessary to demonstrate substantial equivalence.
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).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
June 5, 2023
The Surgical Company International B.V. Inette Nieveen RAQA Director Beeldschermweg 6F Amersfoort, Utrecht 3821 AH Netherlands
Re: K211618
Trade/Device Name: Fluido Compact Blood and Fluid Warming System Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion pump Regulatory Class: Class II Product Code: LGZ Dated: June 2, 2023 Received: June 2, 2023
Dear Inette Nieveen:
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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 (OS) 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 mediation-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).
Sincerely,
Digitally signed by Jake K. Jake K. Lindstrom -S Lindstrom -S Date: 2023.06.05 16:41:56 -04'00'
Jake Lindstrom, Ph.D. Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices. and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K211618
Device Name
Fluido Compact Blood and Fluid Warming System
Indications for Use (Describe)
The Fluido Compact Blood and Fluid Warming System can be used in adult patients that need fluid warming pror to administration of blood, blood products and IV fluids to help prevent hypothermia. The system is intended to be used by healthcare professionals, e.g., nurses, medical specialists, doctors. Only medical professionals shall interact with the system. The devices must only be used on the order of a physician.
| 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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The Surgical Company International B.V.
FLUIDO COMPACT SYSTEM TRADITIONAL 510(K) PREMARKET NOTIFICATION
510(k) Summary
This 510(k) summary is in accordance with the requirements of 21 CFR 807.92
| SUBMITTER 807.92(a)(1) | |
|---|---|
| Submitter Name: | The Surgical Company International B.V. |
| Submitter Address: | Beeldschermweg 6F |
| 3821 AH Amersfoort, The Netherlands | |
| Phone Number: | +31 (0) 33 4507250 |
| Contact Person: | F (Federica) Federici |
| Date Prepared: | October 25, 2022 |
| DEVICE 807.92(a)(2) | |
| Device Trade Name: | Fluido® Compact System |
| Common Name | Infusion Pump |
| Classification | 21 CFR 880.5725 |
| Product Code: | LGZ |
| Review Panel: | General Hospital |
| Device Class: | Class II |
| PREDICATE DEVICE | |
| 807.92(a)(3) | Vital Signs, Inc. enFlow Model IV Fluid Warmer |
| (K112902) (a GE Healthcare Company) |
DEVICE DESCRIPTION 807.92(a)(4):
The Fluido® Compact System consists of Fluido Compact Warming Module, Fluido Compact Control Module and Fluido Compact Standard Set (disposable).
The Fluido Compact system is designed to supply warm fluids at 39°C set point with flow rates from 5 to 100 ml/min. The sterile disposable set consist of a plastic housing and biocompatible coated aluminum heater plate. Heat from the warming module is transferred through the heat transfer part into the fluids that is circulating through the inner part of the cassette. The disposable is connected to the blood or fluid source (infusate reservoir) and the patient line on the other end. The disposable has standard luer lock fittings on both ends. The Control Module serves as the power supply for the Warming module.
Fluid and blood are warmed during infusion or transfusion. The delivery of heat is done by heat exchange. A warming module exchanges heat to a disposable set, which is connected to the fluid reservoir and the patient line via conduction warming technology The fluid temperature is controlled by closed loop software and guarded by sensors and has a redundant safety module for fluid overtemperature shutoff.
| INTENDED USE /
INDICATION FOR USE
807.92(a)(5): | The Fluido Compact System can be used in adult patients
that need fluid warming prior to administration of blood,
blood products and IV fluids to help prevent hypothermia. |
| ------------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
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| The system is intended to be used in hospital by healthcare professionals, e.g., nurses, medical specialists, doctors. Only medical professionals shall interact with the system. The devices must only be used on the order of a physician. | |
|---|---|
| -- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
SUMMARY OF TECHNOLOGICAL CHARCHTERISTICS COMPARISON 807.92(a)(6):
Fluido® Compact Blood And Fluid Warming System device has the same fundamental technological characteristics as the predicate device. Similarities and differences are listed in the table below.
| Use
Characteristics | Fluido® Compact Blood
And Fluid Warming System | Predicate enFlow IV
Fluid Warmer | Equivalence |
|--------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|
| Patient
Population | Adult | Not defined | Similar |
| User | Healthcare professionals | Healthcare
professionals | Same |
| Use
Environment | Hospital | Hospital, clinical and
field environments | Similar |
| Operating
Principle | Reusable Warmer
Reusable Controller
Disposable sterile | Reusable Warmer
Reusable Controller
Disposable sterile | Same |
| Prescription
Use/
Over-The-
Counter use | Prescription Use | Prescription Use | Same |
| Technological Characteristics | | | Same/different
technological
characteristics |
| Administered
Fluids | IV Fluids,
Blood Products | IV Fluids,
Blood,
Blood Products | Similar |
| Fluid Path | Sterile Fluid Path | Sterile Fluid Path | Same |
| System
Components | Reusable Warmer
Reusable Controller
Disposable sterile Set | Reusable Warmer
Reusable Controller
Disposable sterile
Cartridge | Same |
| Safety Features | Reusable Warmer
Reusable Controller
Disposable sterile Set
Closed-loop
temperature controlOver-temperature
control and cut off
(ASTM F2172-02)Audible and Visual
alarms | Reusable Warmer
Reusable Controller
Disposable sterile
Cartridge
Closed-loop
temperature controlOver temperature
control and cut off
(ASTM F2172-02)Audible and Visual
alarms | Same |
| | heater temperature
monitoring circuit | • Independent heater
temperature
monitoring circuit | |
| Warming
technology | Conduction | Conduction | Same |
| Heat exchange | Inline disposable | Inline disposable | Same |
| Temperature
control | Closed Loop temperature
control | Closed Loop
temperature control | Same |
| Fluid
Temperature
Output | 39°C ± 2°C | 40°C ± 2°C | Similar,
within the
physiological
range |
| Safety cut off
Temperature | 49°C | 45°C | Similar, still
within the
safety margins |
| Flow Rate
Range | Standard Set:
5 - 100 ml/min | Keep Vein Open (KVO)
to 200 ml/min | Similar |
| Storage
Conditions/
Specifications | Warmer and Controller:
-40°C - 50°C at 10% to
90% relative humidity
Disposable Set:
-20°C - 40°C at 10% to
90% relative humidity | -30°C – 70°C at 10% to
90% relative humidity | Similar |
| Power Source | AC power supply
100-240 V ~ 50/60Hz)
1.6A | AC power supply
110-120 or 220-240 V
5A | Similar |
| Dimensions | Warmer:
16.5 cm x 7.5 cm x 5.0 cm
Controller:
28.5 cm x 12.0 cm x 19.5
cm
Disposable Set:
14.6 cm x 3.5 cm x 1.1 cm | Warmer:
12.7 cm x 6.6 cm x 3.0
cm
Controller:
23.6 cm x 16.8 cm x 3.8
cm
Disposable cartridge:
11.4 cm x 3.8 cm x 1.0
cm | Similar |
| Weight | Warmer (without
disposable): 450g
Controller: 1.7kg
Disposable Set: 24g | Warmer (without
disposable): 279g
Controller: 1.8kg
Disposable Cartridge:
33g | Similar |
| Performance
standards | IEC 60601-1
IEC 60601-1-2 | IEC 60601-1
IEC 60601-1-2 | Same |
| Sterilization | Disposable Set:
Ethylene oxide sterilized | Disposable Cartridge:
Gamma sterilized | Similar |
| Biocompatibility | ISO 10993 | ISO 10993 | Same |
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FLUIDO COMPACT SYSTEM TRADITIONAL 510(K) PREMARKET NOTIFICATION
Non-clinical testing 807.92(b)(1):
Performance testing according to applicable testing met all acceptance criteria.
Comparative bench performance testing:
- . Temperature: PASS
- . Flow rates: PASS
- Alarms: PASS ●
- . Useability: PASS
Performance testing heater safety
- . ASTM F2172-02 (Reapproved 2011): PASS
Electrical/EMC testing: IEC 60601-1: PASS IEC 60601-1-2: PASS
Clinical testing 807.92(b)(2): Clinical testing was not necessary to demonstrate substantial equivalence.
CONCLUSION OF SUBSTANTIAL EQUIVALENCE 807.92(b)(3):
Performance testing to FDA recognized standards and FDA guidance demonstrates substantial equivalence to the predicate device. The predicate comparison table and performance testing provided in this 510(k) is sufficient to demonstrate that the Fluido® Compact Blood and Fluid Warming System is substantially equivalent to the legally marketed predicate device, Vital Signs, Inc. enFlow Model IV Fluid Warmer cleared under 510(k) K112902.