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.

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.

AI/ML Overview

This describes the Fluido Compact Blood and Fluid Warming System, a medical device for warming fluids prior to administration, and outlines the testing performed to demonstrate its substantial equivalence to a predicate device.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Performance)	Reported Device Performance
Temperature (Accuracy)	PASS
Flow rates (Accuracy)	PASS
Alarms (Functionality)	PASS
Usability	PASS
Heater Safety (per ASTM F2172-02)	PASS
Electrical/EMC (per IEC 60601-1)	PASS
Electrical/EMC (per IEC 60601-1-2)	PASS

2. Sample size used for the test set and the data provenance

The document does not specify the sample size for the individual non-clinical performance tests (Temperature, Flow rates, Alarms, Usability, Heater Safety, Electrical/EMC). Only "Performance testing according to applicable testing met all acceptance criteria" is stated.

The data provenance is from non-clinical bench testing, conducted for the purpose of demonstrating substantial equivalence to a predicate device. No country of origin is explicitly mentioned for the testing itself, but the submitter is based in the Netherlands. The testing is retrospective in the sense that it was conducted after the device design was finalized to meet established standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable as the provided document describes performance testing of a physical medical device (fluid warming system) against technical standards and specified operational parameters, not an AI device requiring expert ground truth for classification or diagnostic accuracy.

4. Adjudication method for the test set

This information is not applicable for the same reason as point 3. The device's performance was measured directly against objective technical criteria and operational specifications, not against human interpretation or a consensus of experts.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable as the device is not an AI-assisted diagnostic or classification tool for human readers. It is a physical medical device designed to warm fluids.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable as the device is not an AI algorithm. It is a physical medical device.

7. The type of ground truth used

The "ground truth" for this device's performance is established by objective technical standards and predefined operational specifications. For example:

Temperature accuracy is measured against a set point (e.g., 39°C ± 2°C).
Flow rates are measured against a specified range (e.g., 5 to 100 ml/min).
Heater safety is assessed against the requirements of ASTM F2172-02.
Electrical/EMC performance is assessed against IEC 60601-1 and IEC 60601-1-2.

8. The sample size for the training set

This information is not applicable as the device is a physical medical device, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established

This information is not applicable for the same reason as point 8.

Summary

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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

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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)

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 6F3821 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 DEVICE807.92(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).

INTENDED USE /INDICATION FOR USE807.92(a)(5):	The Fluido Compact System can be used in adult patientsthat 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.
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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.

UseCharacteristics	Fluido® Compact BloodAnd Fluid Warming System	Predicate enFlow IVFluid Warmer	Equivalence
PatientPopulation	Adult	Not defined	Similar
User	Healthcare professionals	Healthcareprofessionals	Same
UseEnvironment	Hospital	Hospital, clinical andfield environments	Similar
OperatingPrinciple	Reusable WarmerReusable ControllerDisposable sterile	Reusable WarmerReusable ControllerDisposable sterile	Same
PrescriptionUse/Over-The-Counter use	Prescription Use	Prescription Use	Same
Technological Characteristics			Same/differenttechnologicalcharacteristics
AdministeredFluids	IV Fluids,Blood Products	IV Fluids,Blood,Blood Products	Similar
Fluid Path	Sterile Fluid Path	Sterile Fluid Path	Same
SystemComponents	Reusable WarmerReusable ControllerDisposable sterile Set	Reusable WarmerReusable ControllerDisposable sterileCartridge	Same
Safety Features	Reusable WarmerReusable ControllerDisposable sterile SetClosed-looptemperature controlOver-temperaturecontrol and cut off(ASTM F2172-02)Audible and Visualalarms	Reusable WarmerReusable ControllerDisposable sterileCartridgeClosed-looptemperature controlOver temperaturecontrol and cut off(ASTM F2172-02)Audible and Visualalarms	Same
	heater temperaturemonitoring circuit	• Independent heatertemperaturemonitoring circuit
Warmingtechnology	Conduction	Conduction	Same
Heat exchange	Inline disposable	Inline disposable	Same
Temperaturecontrol	Closed Loop temperaturecontrol	Closed Looptemperature control	Same
FluidTemperatureOutput	39°C ± 2°C	40°C ± 2°C	Similar,within thephysiologicalrange
Safety cut offTemperature	49°C	45°C	Similar, stillwithin thesafety margins
Flow RateRange	Standard Set:5 - 100 ml/min	Keep Vein Open (KVO)to 200 ml/min	Similar
StorageConditions/Specifications	Warmer and Controller:-40°C - 50°C at 10% to90% relative humidityDisposable Set:-20°C - 40°C at 10% to90% relative humidity	-30°C – 70°C at 10% to90% relative humidity	Similar
Power Source	AC power supply100-240 V ~ 50/60Hz)1.6A	AC power supply110-120 or 220-240 V5A	Similar
Dimensions	Warmer:16.5 cm x 7.5 cm x 5.0 cmController:28.5 cm x 12.0 cm x 19.5cmDisposable Set:14.6 cm x 3.5 cm x 1.1 cm	Warmer:12.7 cm x 6.6 cm x 3.0cmController:23.6 cm x 16.8 cm x 3.8cmDisposable cartridge:11.4 cm x 3.8 cm x 1.0cm	Similar
Weight	Warmer (withoutdisposable): 450gController: 1.7kgDisposable Set: 24g	Warmer (withoutdisposable): 279gController: 1.8kgDisposable Cartridge:33g	Similar
Performancestandards	IEC 60601-1IEC 60601-1-2	IEC 60601-1IEC 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.

Regulation Number and Section

§ 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).