(56 days)
The Flexicare FL-9000U Respiratory Humidifier Base is intended to warm and add humidity to gases delivered to patients requiring mechanical ventilation or positive pressure breathing assistance via an endotracheal tube or face mask. For use by trained personnel only within a hospital/institutional environment. This device is intended to be used only with the Flexicare Heated Wire Breathing System and Flexicare Autofill Humidification Chamber.
The Flexicare FL-9000U Respiratory Humidifier Base is for use as part of a complete system to provide warmed and humidified inspired respiratory gases to ventilated adult patients and those receiving respiratory support, as part of a complete system including a Humidification Chamber and either a heated wire breathing circuit or limb, or a non-heated breathing circuit or limb.
The Flexicare FL-9000U Respiratory Humidifier Base is a non-sterile medical electrical device which when in use forms part of an actively humidified respiratory humidification system. The Flexicare FL-9000U features a heater plate that allows a humidification chamber containing a volume of water to secure in place above it. The Flexicare FL-9000U heats the water within a humidification chamber and provides current to heated wires within Heated Wire Breathing System (if using a heated system) to warm and humidify gases to be administered to the patient. The Flexicare FL-9000U Respiratory Humidifier Base is provided with temperature probe leads that connect to the patient end and humidification chamber end of a breathing system. These probes feedback to the FL-9000U which automatically adjusts heat and current accordingly to maintain the set gas temperature.
When in use the Flexicare FL-9000U Respiratory Humidifier Base has no contact with the patient. The probe tip of the temperature probe lead accessory contacts breathing gases that are to be delivered to the patient and is the only component of the device/its accessories with contact of this nature.
The Flexicare FL-9000U Respiratory Humidifier Base is mains powered (115V), intended for use within a hospital environment and intended for any patient population where active humidification is required.
The Flexicare FL-9000U Respiratory Humidifier Base is a respiratory gas humidifier designed to warm and add humidity to gases delivered to patients requiring mechanical ventilation or positive pressure breathing assistance. The device's performance was evaluated against a predicate device, the Fisher & Paykel MR850 Respiratory Humidifier, to establish substantial equivalence.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria were primarily established through a "comparison test" against the predicate device, the Fisher & Paykel MR850 Respiratory Humidifier (K073706), and adherence to various recognized standards. The reported device performance is presented as "Substantially equivalent" or "Pass" based on these comparisons and tests.
| Characteristic Compared / Test | Predetermined Acceptance Criteria / Standard | Reported Device Performance |
|---|---|---|
| Device Characteristics (Comparison to Predicate) | ||
| Dimensions & weight | Comparison test (to K073706) | Substantially equivalent |
| Power Supply voltage | Comparison test (to K073706) | Substantially equivalent |
| Power Supply frequency | Comparison test (to K073706) | Substantially equivalent |
| Power Supply current | Comparison test (to K073706) | Substantially equivalent |
| Heater plate capacity | Comparison test (to K073706) | Substantially equivalent |
| Heater Wire Supply Voltage | Comparison test (to K073706) | Substantially equivalent |
| Heater Wire Supply current | Comparison test (to K073706) | Substantially equivalent |
| Heater Wire Supply resistance | Comparison test (to K073706) | Substantially equivalent |
| Heater Wire Supply power | Comparison test (to K073706) | Substantially equivalent |
| Display range | Comparison test (to K073706) | Substantially equivalent |
| Display accuracy | Comparison test (to K073706) | Substantially equivalent |
| High humidity alarm parameters | Comparison test (to K073706) | Substantially equivalent |
| Low humidity alarm parameters | Comparison test (to K073706) | Substantially equivalent |
| Sound pressure level | Comparison test (to K073706) | Substantially equivalent |
| Biocompatibility Testing | ||
| Cytotoxicity, Irritation, Sensitization, Systemic Toxicity, Genotoxicity, Implantation & Sub-Acute Toxicity (referring to probe tip) | ISO 10993-10:2010, 10993-5:2009, 10993-3:2014, 10993-6:2009 | Pass |
| Performance Standards | ||
| Requirements for respiratory humidification systems | ISO 8185:2009 | Pass |
| Humidity performance (Invasive) | >33mg/L (Refer to Humidity Test Report NO. HSO-VH-2600A-2015-01,1) | >33mg/L (Substantially equivalent to predicate) |
| Humidity performance (Non-invasive) | >10mg/L (Refer to Humidity Test Report NO. HSO-VH-2600A-2015-01,1) | >10mg/L (Substantially equivalent to predicate) |
| Warm-up time | Less than 30 minutes (Substantially equivalent to predicate) | Less than 30 minutes (Substantially equivalent to predicate) |
| Recommended ambient Temperature range | 18 - 26°C (Substantially equivalent to predicate) | 18 - 26°C (Substantially equivalent to predicate) |
| Recommended Flow range (Invasive) | Up to 60 L/min (Substantially equivalent to predicate) | Up to 60 L/min (Substantially equivalent to predicate) |
| Recommended Flow range (Non-invasive) | Up to 120 L/min (Substantially equivalent to predicate) | Up to 120 L/min (Substantially equivalent to predicate) |
| Heater plate over temperature cutout | 115 ± 3°C (Flexicare) vs 118 ± 6°C (Predicate) - considered substantially equivalent | 115 ± 3°C (Reported for Flexicare) |
| Safety cutoff software | 110°C (Substantially equivalent to predicate) | 110°C (Substantially equivalent to predicate) |
| Safety and Electrical Standards | ||
| Electromagnetic capability & Electrical safety testing | BS EN 60601-1:2006, BS EN 60601-1-2:2007, IEC 60601-1:2005 +CORR.1:2006 CORR. 2:2007 | Pass |
| Enclosure testing - IP rating (IPX1) | IEC 60529 Edition 2.2: 2013 | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of a dataset for AI/ML performance evaluation. Instead, performance was evaluated through non-clinical testing on the physical device and its accessories. This involved:
- Comparison testing: Directly comparing the Flexicare FL-9000U with the predicate device (Fisher & Paykel MR850).
- Adherence to recognized standards: Testing the device against specific criteria outlined in various international standards (e.g., ISO, IEC, EN).
The provenance of this testing data would be from Flexicare's own testing facilities or accredited third-party laboratories performing these tests on the physical device. The information does not state the country of origin of the data explicitly, but Flexicare Medical Limited is based in the United Kingdom.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable in the context of this 510(k) summary. The device is a physical medical device, not an AI/ML diagnostic tool that requires expert-established ground truth from images or clinical data for performance evaluation in the same way. The "ground truth" for this device's performance is derived from physical measurements, electrical tests, and compliance with established engineering and medical device standards, as well as direct comparison to a predicate device.
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as point 3. The evaluation of this physical medical device does not involve human readers or a consensus-based adjudication method for a test set of data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (especially those using AI) where human reader performance is being evaluated, often with and without AI assistance. This device is a respiratory humidifier, a therapeutic device, and its performance evaluation does not involve such studies.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
No, a standalone (algorithm only) performance evaluation was not done. This concept is specific to AI/ML software devices. The Flexicare FL-9000U is a hardware device with embedded software, and its evaluation focuses on its physical and electrical performance in delivering warmed and humidified gases, not standalone algorithm performance.
7. The Type of Ground Truth Used
The "ground truth" for the performance of the Flexicare FL-9000U Respiratory Humidifier Base is primarily established through:
- Engineering specifications and measurements: Direct measurement of physical characteristics (dimensions, weight), electrical parameters (voltage, current, power), temperature control, and sound levels.
- Compliance with international standards: Verification that the device meets the requirements outlined in standards like ISO 8185 for respiratory humidifiers, ISO 10993 series for biocompatibility, IEC 60601 series for electrical safety and EMC, and IEC 60529 for IP rating.
- Comparative performance to a legally marketed predicate device: Demonstrating that its performance in function is substantially equivalent to the Fisher & Paykel MR850 Respiratory Humidifier, which has an established safety and effectiveness profile. For humidity performance, a specific "Humidity Test Report (NO. HSO-VH-2600A-2015-01,1)" is referenced, implying data derived from specific testing protocols.
There is no "expert consensus," "pathology," or "outcomes data" ground truth in the sense typically used for diagnostic or predictive AI/ML devices.
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical medical device and is not an AI/ML algorithm that requires a "training set" for model development.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 6, 2016
Dave Yungvirt Third Party Review Group, LLC (TPRG) The Old Station House 24 Lackawanna Place Millburn, NJ 07041
Re: K161314
Trade/Device Name: Flexicare FL-9000U Respiratory Humidifier Base Regulation Number: 21 CFR 868.5450 Regulation Name: Respiratory gas humidifier Regulatory Class: Class II Product Code: BTT Dated: June 16, 2016 Received: June 17, 2016
Dear Dave Yungvirt:
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.
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 (reporting of medical device
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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K161314
Device Name
Flexicare FL-9000U Respiratory Humidifier Base
Indications for Use (Describe)
The Flexicare FL-9000U Respiratory Humidifier Base is intended to warm and add humidity to gases delivered to patients requiring mechanical ventilation or positive pressure breathing assistance via an endotracheal tube or face mask. For use by trained personnel only within a hospital/institutional environment. This device is intended to be used only with the Flexicare Heated Wire Breathing System and Flexicare Autofill Humidification Chamber.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Image /page/3/Picture/0 description: The image is a logo for Flexicare. The word "Flexicare" is written in a stylized font, with the "F" in red and the rest of the letters in blue. Below the word "Flexicare" is the phrase "TOTAL QUALITY - TOTAL CARE" in red. The logo is simple and modern, and it conveys a sense of quality and care.
510(k) Summary
510(k) Sponsor, Contact Person and Date Summary Prepared:
Flexicare Medical Limited Cynon Valley Business Park Mountain Ash, Mid. Glamorgan CF45 4ER. United Kingdom
Joel Biddle Compliance Engineer Telephone: 00 44 1443 474 647 Fax: 00 44 1443 474 222
Summary prepared on: July 4th, 2016
Device Name:
Trade Name: Flexicare FL-9000U Respiratory Humidifier Base
Common/Usual Name: Respiratory Gas Humidifier
Classification Name: Respiratory Gas Humidifier: 21 CFR 868.5450
Product Codes: BTT (Respiratory Gas Humidifier)
There have been no prior submissions for the device included within this submission.
Legally Marketed Equivalent Device:
FL-9000U Respiratory Humidifier Base is substantially equivalent to Fisher & Paykel's MR850 Respiratory Humidifier cleared under K073706.
Device Description:
The Flexicare FL-9000U Respiratory Humidifier Base is for use as part of a complete system to provide warmed and humidified inspired respiratory gases to ventilated adult patients and those receiving respiratory support, as part of a complete system including a Humidification Chamber and either a heated wire breathing circuit or limb, or a non-heated breathing circuit or limb.
The Flexicare FL-9000U Respiratory Humidifier Base is a non-sterile medical electrical device which when in use forms part of an actively humidified respiratory humidification system. The Flexicare FL-9000U features a heater plate that allows a humidification chamber containing a volume of water to secure in place above it. The Flexicare FL-9000U heats the water within a humidification chamber and provides current to heated wires within Heated Wire Breathing System (if using a heated system) to warm and humidify gases to be administered to the patient. The Flexicare FL-9000U Respiratory Humidifier Base is provided with temperature probe leads that connect to the patient end and humidification chamber end of a breathing system. These probes feedback to the FL-9000U which automatically adjusts heat and current accordingly to maintain the set gas temperature.
When in use the Flexicare FL-9000U Respiratory Humidifier Base has no contact with the patient. The probe tip of the temperature probe lead accessory contacts breathing gases that
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Image /page/4/Picture/0 description: The image is a logo for "flexicare". The word "flexi" is in blue, and the word "care" is in red. Above the word "flexicare" is a red and blue design that looks like two intertwined check marks. Below the word "flexicare" is the phrase "TOTAL QUALITY - TOTAL CARE".
are to be delivered to the patient and is the only component of the device/its accessories with contact of this nature.
The Flexicare FL-9000U Respiratory Humidifier Base is mains powered (115V), intended for use within a hospital environment and intended for any patient population where active humidification is required.
Intended Use:
The Flexicare FL-9000U Respiratory Humidifier Base is intended to warm and add humidity to gases delivered to patients requiring mechanical ventilation or positive pressure breathing assistance via an endotracheal tube or face mask. For use by trained personnel only within a hospital/institutional environment. This device is intended to be used only with the Flexicare Heated Wire Breathing System and Flexicare Autofill Humidification Chamber.
Substantial Equivalence:
Flexicare's FL-9000U Respiratory Humidifier Base has the same intended use as the predicate device, Fisher & Paykel's MR850 Respiratory Humidifier. Flexicare's FL-9000U Respiratory Humidifier Base and the predicate device are reusable medical electrical devices. Supplied in one variation for all patient populations.
Neither manufacturer's devices are life supporting or life sustaining.
Patient Contact: – FL-9000U Respiratory Humidifier Base has no contact with the patient, The Temperature probe lead accessory contacts breathing gases that are to be delivered to the patient (externally communicating). The material of this component has been subject to biocompatibility testing, and amounts to only 0.02% of total surface area when used in conjunction with an Adult Heated Wire Breathing System.
Flexicare's FL-9000U Respiratory Humidifier Base and the predicate devices by Fisher & Paykel both include one component that has gas pathway contact – the temperature probe present on supplied temperature probe lead.
Flexicare's FL-9000U Respiratory Humidifier Base and the predicate devices by Fisher & Paykel both require software to operate/function.
Flexicare's FL-9000U Respiratory Humidifier Base and the predicate devices by Fisher & Paykel are both electronically powered devices (115V).
Flexicare's FL-9000U Respiratory Humidifier Base and the predicate devices by Fisher & Paykel are both supplied non-sterile.
Both manufacturers' devices are able to be used with industry standard devices such as humidification chambers and breathing systems.
Flexicare's FL-9000U Respiratory Humidifier Base and the predicate devices by Fisher & Paykel are both are designed for the same intended use in the same intended conditions. During comparison testing it was determined that there were no invasive components in either of the manufacturer's devices.
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Image /page/5/Picture/0 description: The image is a logo for "flexicare". The word "flexicare" is written in a stylized font, with the "f" and "care" in red and the "lexi" in blue. Above the word "flexicare" are two curved lines, one red and one blue, that mirror each other. Below the word "flexicare" is the phrase "TOTAL QUALITY - TOTAL CARE" in smaller, blue font.
Both manufacturers' device's feature an LCD display, depressible front lip to secure a humidification chamber, invasive mode selecting button, are mains powered (115v) and are supplied with cables to connect to a Heated Wire Breathing System. Both manufacturers' device's feature a polycarbonate based rigid housing.
Both manufacturers' device's feature a fixed US mains (115V) power cable and plug.
The housing of Flexicare's FL-9000U Respiratory Humidifier Base is beige, with remaining components being white or grev. Labelling on device housing is blue and white in-line with Flexicare branding.
Any differences in color between the Flexicare device and the predicate device is by manufacturer's aesthetics choice/ branding, and is not related to intended use or performance of device.
Both manufacturer's devices are supplied with a mains power cable, single heated wire adaptor lead, dual heated wire adaptor cable and a temperature probe lead to connect to a single or dual Heated Wire Breathing System.
Both Flexicare's FL-9000U Respiratory Humidifier Base and the predicate device can be used with Dual Heated Wire Breathing Systems, Single Heated Wire Breathing Systems and Non- Heated Wire Breathing Systems in both invasive and non-invasive modes.
Neither manufacturer's devices are in vitro diagnostic devices.
Accessories
Flexicare's FL-9000U Respiratory Humidifier Base is supplied with the following compatible accessories:
- FL9000-01U Single Heated Wire Adaptor Lead; the Single Heated Wire Adaptor . Lead is used to supply electrical current from the FL-9000U Respiratory Humidifier Base to a Single Heated Wire Breathing System (if a heated breathing system is used).
- FL9000-02U Dual Heated Wire Adaptor Lead; the Dual Heated Wire Adaptor Lead is ● used to supply electrical current from the FL-9000U Respiratory Humidifier Base to a Dual Heated Wire Breathing System (if a heated breathing system is used).
- . FL9000-03U - Temperature Probe Lead: the Temperature Probe Lead is used to monitor the temperature at the chamber and at the patient end of the breathing system. Temperature measurements are fed back to the FL-9000U Respiratory Humidifier Base which automatically adjusts output accordingly to maintain the temperature within the breathing system at the set parameters.
Flexicare's FL-9000U Respiratory Humidifier Base is compatible with, yet not supplied with, the following accessories:
- Flexicare Heated Wire Breathing Systems. Cleared under K150900 .
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Image /page/6/Picture/0 description: The image is a logo for "flexicare". The logo has the word "flexicare" in blue and red, with the "flexi" part in blue and the "care" part in red. Above the word "flexicare" is a stylized "f" in red and blue. Below the word "flexicare" is the phrase "TOTAL QUALITY - TOTAL CARE".
Flexicare Autofill Humidification Chambers. Cleared under K150900 . Substantial equivalence comparison table - Respiratory Humidifier
Flexicare's FL-9000U Respiratory Humidifier Base is substantially equivalent to MR850 Respiratory Humidifier manufactured by Fisher & Paykel (510(k) K073706).
The Table below shows the similarities and differences between Flexicare's FL-9000U Respiratory Humidifier Base and the predicate device manufactured by Fisher & Paykel.
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Image /page/7/Picture/0 description: The image is a logo for Flexicare. The logo has the word "flexicare" in blue and red, with the "f" being a stylized red and blue line. Below the word is the phrase "TOTAL QUALITY - TOTAL CARE" in red.
| Characteristic compared | Flexicare's FL-9000U RespiratoryHumidifier | Fisher & Paykel MR850 Respiratory Humidifier | |
|---|---|---|---|
| 510K | K: Unknown | K:073706 | |
| Device Description | FL-9000 is a Dual Servo ControlledHeated Respiratory Humidifier,controlling both Airway & Chambertemp | MR850 is a Dual Servo Controlled HeatedRespiratory Humidifier,controlling both Airway & Chamber temp | |
| Intended use | The Flexicare FL-9000U RespiratoryHumidifier Base is intended towarm and add humidity to gasesdelivered to patients requiringmechanical ventilation or positivepressure breathing assistance viaan endotracheal tube or face mask.For use by trained personnel onlywithin a hospital/institutionalenvironment. This device isintended to be used only with theFlexicare Heated Wire BreathingSystem and Flexicare AutofillHumidification Chamber. | The Fisher & Paykel Healthcare MR850humidifier is intended to be used to warm andadd humidity to gases delivered to patientsrequiring mechanical ventilation or positivepressure breathing assistance or general medicalgases.The heated-wire breathing circuits are intendedas conduits of breathing gas for ventilation ofpatients, and to maintain the temperature ofhumidified inspired gas, to reduce condensation.They are accessories for the Fisher & PaykelHealthcare MR850 Respiratory Gas Humidifier.The RT130 is used for flow rates between 0.3 and4 L/min, and the RT131 is for flow rates greaterthan 4 L/min, for neonatal patients.Source: Fisher & Paykel K073706 clearance letter. | |
| Principle of operation | The device has two heating controlunits and two temperature sensorsrespectively. Water within ahumidification chamber is heatedby the device's heating plate andthis temperature is controlled bythe device with the use oftemperature probes. Dry medicalgases passing through the chambergain increased humidity and heat.The supplied Heated wire adaptorssupply current to heated wireswithin breathing tubes thatmaintain gas temperaturetravelling to patient. Temperatureprobes measurement temperatureand device controls chambertemperature to achieve desired gaswarmth and humidify for patient. | The device has two heating control units and twotemperature sensors respectively. Water within ahumidification chamber is heated by the device'sheating plate and this temperature is controlledby the device with the use of temperatureprobes. Dry medical gases passing through thechamber gain increased humidity and heat. Thesupplied Heated wire adaptors supply current toheated wires within breathing tubes thatmaintain gas temperature travelling to patient.Temperature probes measurement temperatureand device controls chamber temperature toachieve desired gas warmth and humidify forpatient. | |
| Structure and operation | The product consists of FL-9000URespiratory humidifier, Heatedwire adaptor leads (single & dual)and Temperature sensor leads. | The product consists of MR850 Respiratoryhumidifier, Heated wire adaptor leads (single &dual) and Temperature sensor leads. | |
| Mode of operation | Device does not have patient contact. During use it is located between the ventilator and breathing system (between ventilator and patient). | Device does not have patient contact. During use it is located between the ventilator and breathing system (between ventilator and patient). | |
| Scope of patient | Device intended for patients requiring mechanical ventilation, positive pressure breathing support or other respiratory support requiring controlled heat and humidity | Device intended for patients requiring mechanical ventilation, positive pressure breathing support or other respiratory support requiring controlled heat and humidity | |
| Electric lightningprotection | Class I | Class I | |
| Applied part | Type B | Type B | |
| Drip proof | IPX 1 | IPX 1 | |
| Target population | Any patient requiring active humidification | Any patient requiring active humidification | |
| Housing material | Polycarbonate | Polycarbonate | |
| Temp sensing | YSI | YSI | |
| Heating Method | Pass over | Pass over | |
| Heated Wire control on/off | Yes | Yes | |
| Single/dual/non heatedwire compatible | Yes | Yes | |
| Dimensions | 156mm × 170mm × 130mm | 140mm × 173mm × 135mm | |
| Weight | 2.9kg | 2.8kg | |
| Supply frequency | 50/60 Hz | 50/60 Hz | |
| Supply voltage | 115V~ | 115V~ | |
| Supply current | 2.0 A max at 115V~ | 2.0 A max at 115V~ | |
| Heater plate | 150 W | 150 W | |
| Heater plate overtemperature cutout | 115 ± 3°C | 118 ± 6°C | |
| Safety cutoff software | 110°C | 110°C | |
| Heater Wire | 22V~, 2.73A, 60W, 50/60Hz | 22V~, 2.73A, 60W, 50/60Hz | |
| Temperature control settings (heater wire) | |||
| Airway | Invasive | Default: 40°CRange: 36-40°C | Default: 40°CRange: 35-40°C(Versions 7.22) |
| Non-invasive | Default: 34°CRange: 31-35°C | Default: 34°CRange:28-34°C(Versions 7.22) | |
| Chamberoutlet | Invasive | Default:Range: 34-40°C | Default:Range: 35.5-42°C(Versions 7.22) |
| Non-invasive | Default:Range: 31-35°C | Default:Range: 31-36°C(Versions 7.22) | |
| Temperature control settings (non-heater wire) | |||
| Airway | Invasive | 37°C (Range 36-38°C) | 37°C |
| Chamberoutlet | Non-invasive | 31°C (Range 30-32°C) | 31°C |
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Image /page/8/Picture/0 description: The image contains the logo for "flexicare". The logo is a stylized "J" in red and blue, followed by the word "flexicare" in blue and red. Below the word "flexicare" is the phrase "TOTAL QUALITY - TOTAL CARE" in a smaller font.
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Image /page/9/Picture/0 description: The image is a logo for a company called "flexicare". The logo is made up of the word "flexicare" in blue and red letters, with the first letter "f" stylized with a red and blue line. Below the word "flexicare" is the phrase "TOTAL QUALITY - TOTAL CARE" in smaller, red letters. The logo is simple and modern, and the colors are bright and eye-catching.
| Display | 4 digit 14 mm14 segment LED | 3 digit 14 mm7 segment LED | |||
|---|---|---|---|---|---|
| Display range | 05 - 80°C | 10 - 70°C | |||
| Accuracy | ± 0.3°C | ± 0.3°C | |||
| Alarm Parameters | |||||
| High Humidity Alarm | |||||
| Alarm parameter | Airway: High alarm / Low alarmChamber: High alarm / Low alarm | High Humidity Alarm | |||
| Low Humidity Alarm | |||||
| Display temperature of41°C | Yes | Yes | |||
| Airway Temperatureexceeds 43°C | Yes | Yes | |||
| Low Humidity Alarm | |||||
| 60 minutes @ 34.5 °C | Yes | Yes | |||
| 10 minutes @ 29.5 °C | Yes | Yes | |||
| Sound Pressure Level | Alarms exceed 50 dBA @ 1m | Alarms exceed 50 dBA @ 1m | |||
| Performance | |||||
| Recommended ambientTemperature range | 18 - 26°C | 18 - 26°C | |||
| Recommended Flow range | Invasive | Non-invasive | Invasive | Non-invasive | |
| Up to 60 L/min | Up to 120 L/min | Up to 60 L/min | Up to 120 L/min | ||
| Refer to Humidity Test Report (NO. HSO-VH-2600A-2015-01,1) | |||||
| Humidity performance | Invasive | Non-invasive | Invasive | Non-invasive | |
| >33mg/L | >10mg/L | >33mg/L | >10mg/L | ||
| Warm-up time | Less than 30 minutes | ||||
| Standard and Approvals | EN 60601-1:2006 | IEC 60601-1EN 60601-1 | |||
| EN 60601-1-2:2007 | IEC 60601-1-2 | ||||
| EN ISO 8185:2009 | EN 60601-1-2 | ||||
| EN ISO 10993-1,3,5,6,10EN 62366:2008 | EN ISO 8185:2009 | ||||
| EN 62304:2006 | |||||
| ISO 3744:2010 | |||||
| BS EN 60529:1992+A2:2013 | |||||
| Non-clinical Test Results | Verification tests were performed to establish the safety and efficacy of Flexicare's FL-9000U Respiratory Humidifier. These Non-clinical tests included Dimensions and weightmeasurement, power supply, heater plate capacity, heater wire power supply, displayrange, display accuracy, alarm parameters, sound pressure level, humidification output,Electromagnetic Capability, Electrical Safety and IPX 1 testing.Testing demonstrated that the relevant features, design and performance of eachmanufacturer's device are substantially equivalent. | ||||
| Conclusion | Flexicare's FL-9000U Respiratory Humidifier Base is considered to be substantiallyequivalent to the Fisher & Paykel MR850 Respiratory Humidifier. The comparison offeatures, performance, materials and intended use demonstrate that Flexicare's FL-9000U Respiratory Humidifier Base is as safe and effective as the predicate device forits intended purpose. | ||||
| Accessories | |||||
| Single Heated Wire Adaptor Lead | |||||
| Connector (Machine end) | 4-Pin Connector | 4-Pin Connector | |||
| Connector (Patient end) | 2 pin S-type | 2 pin S-type | |||
| Type/configuration | Single | Single |
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Image /page/10/Picture/0 description: The image is a logo for "Flexicare". The logo has the word "Flexicare" in blue, with the first letter "f" stylized with a red line above it. Below the word "Flexicare" is the phrase "TOTAL QUALITY - TOTAL CARE" in smaller letters. The logo is simple and professional, and it conveys a sense of quality and care.
| Supplied | Yes | Yes |
|---|---|---|
| Dual Heated Wire Adaptor Lead | ||
| Connector (Machine end) | 4-Pin Connector | 4-Pin Connector |
| Connector (Patient end) | 2 pin S-type2 pin clover-type | 2 pin S-type2 pin clover-type |
| Type/configuration | Dual | Dual |
| Supplied | Yes | Yes |
| Temperature Probe Lead | ||
| Length | 192 cm | 207 cm |
| Number of probes | 2 | 2 |
| Probe location | Chamber, Patient end | Chamber, Patient end |
| Function | Airway Temp./ Chamber Temp.Measure | Airway Temp./ Chamber Temp. Measure |
| Supplied | Yes | Yes |
Summary of performance Testing: Flexicare's FL-9000U Respiratory Humidifier Base has been evaluated in accordance with standards listed in table:
| Test | Standard / Pre-DeterminedAcceptance Criteria | Outcome |
|---|---|---|
| Dimensions & weight | Comparison test | Substantially equivalent |
| Power Supply voltage | Comparison test | Substantially equivalent |
| Power Supply frequency | Comparison test | Substantially equivalent |
| Power Supply current | Comparison test | Substantially equivalent |
| Heater plate capacity | Comparison test | Substantially equivalent |
| Heater Wire Supply Voltage | Comparison test | Substantially equivalent |
| Heater Wire Supply current | Comparison test | Substantially equivalent |
| Heater Wire Supply resistance | Comparison test | Substantially equivalent |
| Heater Wire Supply power | Comparison test | Substantially equivalent |
| Display range | Comparison test | Substantially equivalent |
| Display accuracy | Comparison test | Substantially equivalent |
| High humidity alarm parameters | Comparison test | Substantially equivalent |
| Low humidity alarm parameters | Comparison test | Substantially equivalent |
| Sound pressure level | Comparison test | Substantially equivalent |
| Cytotoxicity, Irritation, Sensitization,Systemic Toxicity, Genotoxicity,Implantation & Sub-Acute Toxicity. | 10993-10:201010993-5:200910993-3:201410993-6:2009 | Pass |
| Requirements for respiratoryhumidification systems | ISO 8185:2009 | Pass |
| Electromagnetic capability &Electrical safety testing | BS EN 60601-1:2006BS EN 60601-1-2:2007IEC 60601-1:2005+CORR.1:2006 CORR. 2:2007 | Pass |
| Enclosure testing - IP rating (IPX1) | IEC 60529 Edition 2.2: 2013 | Pass |
Flexicare's FL-9000U Respiratory Humidifier Base has been evaluated for performance within K161314 with the compatible accessories noted in this 510(k) summary, including those supplied with the FL-9000 and those not supplied, cleared under K150900.
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Image /page/11/Picture/0 description: The image is a logo for Flexicare. The logo has the word "flexicare" in blue and red letters. Above the word is a red and blue design that looks like a stylized letter "f". Below the word "flexicare" is the phrase "TOTAL QUALITY - TOTAL CARE".
Consensus Standards
ISO 8185 and ISO 5356-1 are recognized consensus standards for devices classified through FDA product code BTT.
However, ISO 5356 (and its associated quidance documents) is not applicable to Flexicare's FL-9000U Respiratory Humidifier. ISO 5356 is the internationally recognized standard for conical connectors present within anesthetic and respiratory medical devices.
Neither Flexicare's FL-9000U Respiratory Humidifier, its supplied accessories nor the predicate device manufactured by Fisher & Paykel have conical connectors included within their designs.
Conical connectors are present on related equipment devices such as Humidification Chambers and Heated Wire Breathing Systems. However, in Flexicare's case these devices have been cleared separately under K150900, and are not supplied with the FL-9000U Respiratory Humidifier.
The MR850 predicate device manufactured by Fisher & Paykel is also not supplied with any related equipment that include conical connectors.
The Flexicare FL-9000U Respiratory Humidifier Base passed the performance testing when tested against methods and criteria from relevant FDA Recognized standards. The results of this testing show that The Flexicare FL-9000U Respiratory Humidifier Base passes all performance & safety tests and performs at least as well as the marketed predicate device.
Although very similar in design and function there are some differences, as described below, between the Flexicare FL-9000U Respiratory Humidifier Base and the predicate device from Fisher & Paykel.
Differences:
- . The Flexicare FL-9000U Respiratory Humidifier Base has a 4 digit 14 segment LED display whilst the Fisher and Paykel device has a 3 digit 7 segment LED display. This does not cause an advantage in performance for Flexicare's device, but allows for more versatile/detailed display.
- . The Flexicare FL-9000U Respiratory Humidifier Base has text definitions adjacent to LED warning lights that illuminate during fault conditions. This allows user to immediately understand the reason for alarm. The Fisher & Paykel MR850 does not have this text.
- . The Flexicare FL-9000U Respiratory Humidifier Base also has an LED indicator with a symbol for "Refer to instructions for use" adjacent to it which illuminates also during fault conditions.
- . Another difference between Flexicare's device and its predicate device from Fisher & Paykel is the color of the humidification chamber securing area at the top of the device, where Flexicare's is white in color and F&P's is light blue in color. However, these differences in color do not affect the safety and/or effectiveness of either manufacturer's devices and are due to individual company branding/marketing.
Conclusion: The overall conclusion from the comparison testing is that Flexicare's FL-900U Respiratory Humidifier Base is considered to be substantially equivalent to that of the predicate device.
§ 868.5450 Respiratory gas humidifier.
(a)
Identification. A respiratory gas humidifier is a device that is intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient. Cascade, gas, heated, and prefilled humidifiers are included in this generic type of device.(b)
Classification. Class II (performance standards).