(56 days)
No
The description details a system that automatically adjusts heat and current based on temperature probe feedback, which is a standard control loop mechanism, not indicative of AI/ML. There is no mention of learning, adaptation, or complex pattern recognition.
Yes.
The device warms and adds humidity to gases delivered to patients requiring mechanical ventilation or positive pressure breathing assistance to improve physiological function.
No
The device is a respiratory humidifier base, intended to warm and add humidity to gases delivered to patients. Its function is therapeutic (providing humidified gas) and operational (monitoring temperature to maintain set gas temperature), not diagnostic (identifying or characterizing a medical condition).
No
The device description clearly states it is a "non-sterile medical electrical device" with a "heater plate" and "temperature probe leads," indicating it is a hardware device with electrical and mechanical components, not software only.
Based on the provided information, the Flexicare FL-9000U Respiratory Humidifier Base is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to warm and add humidity to gases delivered to patients requiring mechanical ventilation or positive pressure breathing assistance. This is a therapeutic function, not a diagnostic one.
- Device Description: The device description details how it heats water and provides current to warm and humidify gases for patient delivery. It does not describe any function related to analyzing samples from the human body.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
- Using reagents or calibrators.
The device is clearly described as a medical device used in a hospital setting to support respiratory therapy.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
BTT
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained personnel only within a hospital/institutional environment.
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)
Verification tests were performed to establish the safety and efficacy of Flexicare's FL-9000U Respiratory Humidifier. These Non-clinical tests included Dimensions and weight measurement, power supply, heater plate capacity, heater wire power supply, display range, 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 each manufacturer's device are substantially equivalent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
1
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
2
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)
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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 Respiratory
Humidifier | Fisher & Paykel MR850 Respiratory Humidifier | |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510K | K: Unknown | K:073706 | |
| Device Description | FL-9000 is a Dual Servo Controlled
Heated Respiratory Humidifier,
controlling both Airway & Chamber
temp | MR850 is a Dual Servo Controlled Heated
Respiratory Humidifier,
controlling both Airway & Chamber temp | |
| 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. | The Fisher & Paykel Healthcare MR850
humidifier is intended to be used to warm and
add humidity to gases delivered to patients
requiring mechanical ventilation or positive
pressure breathing assistance or general medical
gases.
The heated-wire breathing circuits are intended
as conduits of breathing gas for ventilation of
patients, and to maintain the temperature of
humidified inspired gas, to reduce condensation.
They are accessories for the Fisher & Paykel
Healthcare MR850 Respiratory Gas Humidifier.
The RT130 is used for flow rates between 0.3 and
4 L/min, and the RT131 is for flow rates greater
than 4 L/min, for neonatal patients.
Source: Fisher & Paykel K073706 clearance letter. | |
| Principle of operation | The device has two heating control
units and two temperature sensors
respectively. Water within a
humidification chamber is heated
by the device's heating plate and
this temperature is controlled by
the device with the use of
temperature probes. Dry medical
gases passing through the chamber
gain increased humidity and heat.
The supplied Heated wire adaptors
supply current to heated wires
within breathing tubes that
maintain gas temperature
travelling to patient. Temperature
probes measurement temperature
and device controls chamber
temperature to achieve desired gas
warmth and humidify for patient. | The device has two heating control units and two
temperature sensors respectively. Water within a
humidification chamber is heated by the device's
heating plate and this temperature is controlled
by the device with the use of temperature
probes. Dry medical gases passing through the
chamber gain increased humidity and heat. The
supplied Heated wire adaptors supply current to
heated wires within breathing tubes that
maintain gas temperature travelling to patient.
Temperature probes measurement temperature
and device controls chamber temperature to
achieve desired gas warmth and humidify for
patient. | |
| Structure and operation | The product consists of FL-9000U
Respiratory humidifier, Heated
wire adaptor leads (single & dual)
and Temperature sensor leads. | The product consists of MR850 Respiratory
humidifier, 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 lightning
protection | | 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 heated
wire 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 over
temperature 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°C
Range: 36-40°C | Default: 40°C
Range: 35-40°C
(Versions 7.22) |
| | Non-invasive | Default: 34°C
Range: 31-35°C | Default: 34°C
Range:28-34°C
(Versions 7.22) |
| Chamber
outlet | 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 |
| Chamber
outlet | 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 mm
14 segment LED | | 3 digit 14 mm
7 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 alarm
Chamber: High alarm / Low alarm | | High Humidity Alarm | | |
| | | | Low Humidity Alarm | | |
| Display temperature of
41°C | Yes | | Yes | | |
| Airway Temperature
exceeds 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 ambient
Temperature 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 60601-1
EN 60601-1 | | |
| | EN 60601-1-2:2007 | | IEC 60601-1-2 | | |
| | EN ISO 8185:2009 | | EN 60601-1-2 | | |
| | EN ISO 10993-1,3,5,6,10
EN 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 weight
measurement, power supply, heater plate capacity, heater wire power supply, display
range, 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 each
manufacturer's device are substantially equivalent. | | | | |
| Conclusion | Flexicare's FL-9000U Respiratory Humidifier Base is considered to be substantially
equivalent to the Fisher & Paykel MR850 Respiratory Humidifier. The comparison of
features, performance, materials and intended use demonstrate that Flexicare's FL-
9000U Respiratory Humidifier Base is as safe and effective as the predicate device for
its 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-type | |
| 2 pin clover-type | 2 pin S-type | |
| 2 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-Determined
Acceptance 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. | 10993-10:2010
10993-5:2009
10993-3:2014
10993-6:2009 | Pass |
| Requirements for respiratory
humidification systems | ISO 8185:2009 | Pass |
| 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 |
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.