Who is the manufacturer of Fluido Compact Blood and Fluid Warming System?

The Surgical Company International B.V. filed the 510(k) submission for Fluido Compact Blood and Fluid Warming System (K211618).

What is the FDA product code for Fluido Compact Blood and Fluid Warming System?

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 Fluido Compact Blood and Fluid Warming System?

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

What are the predicate devices for Fluido Compact Blood and Fluid Warming System?

Vital Signs, Inc. enFlow Model IV Fluid Warmer (K112902).

Who can help prepare an FDA 510(k) submission like Fluido Compact Blood and Fluid Warming System?

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.

Fluido Compact Blood and Fluid Warming System

K211618 · The Surgical Company International B.V. · LGZ · Jun 5, 2023 · General Hospital

Device Facts

Record ID	K211618
Device Name	Fluido Compact Blood and Fluid Warming System
Applicant	The Surgical Company International B.V.
Product Code	LGZ · General Hospital
Decision Date	Jun 5, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.5725
Device Class	Class 2
Attributes	Therapeutic

Intended Use

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 Story

Fluido Compact System warms blood, blood products, and IV fluids to 39°C; utilizes conduction warming technology via a disposable cassette with a biocompatible coated aluminum heater plate. System comprises a reusable warming module, control module, and sterile disposable set. Operated by healthcare professionals (nurses, doctors) in hospital settings; requires physician order. Control module powers warming module; closed-loop software monitors fluid temperature via sensors. Redundant safety module provides over-temperature shutoff. Output is warmed fluid delivered to patient line. Benefits include prevention of hypothermia during infusion/transfusion.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via bench testing, including temperature control, flow rate verification, alarm functionality, usability, heater safety (ASTM F2172-02), and electrical/EMC testing (IEC 60601-1, IEC 60601-1-2).

Technological Characteristics

Conduction warming technology; biocompatible coated aluminum heater plate; closed-loop temperature control; redundant over-temperature shutoff. Power: 100-240V AC. Standards: ASTM F2172-02, IEC 60601-1, IEC 60601-1-2, ISO 10993. Disposable set sterilized via ethylene oxide. Connectivity: Standalone system.

Indications for Use

Indicated for adult patients requiring fluid warming prior to administration of blood, blood products, and IV fluids to prevent hypothermia. Contraindications not specified.

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

Vital Signs, Inc. enFlow Model IV Fluid Warmer (K112902)

Related Devices

K252636 — Fluido Compact System · The Surgical Company International B.V. · Nov 18, 2025
K112902 — ENFLOW IV FLUID WARMER · Vital Signs, Inc. · Mar 14, 2012
K150404 — QiF Blood and Fluid Warmer · Quality IN Flow , Ltd. · Jun 23, 2016
K171215 — QiF Blood and Fluid Warmer · Quality IN Flow , Ltd. · Sep 27, 2017
K180154 — QiF Blood and Fluid Warmer · Quality IN Flow , Ltd. · Apr 27, 2018

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {2}------------------------------------------------ # 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) | | |------------------------------------------------------------|---------------------------------------------| | <div></div> | | | 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 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." {3}------------------------------------------------ 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. | |-------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |-------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| {4}------------------------------------------------ | | 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 | {5}------------------------------------------------ {6}------------------------------------------------ ### 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.