FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASE

K161314 · Flexicare Medical Limited. · BTT · Jul 6, 2016 · Anesthesiology

Device Facts

• Record ID: K161314
• Device Name: FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASE
• Applicant: Flexicare Medical Limited.
• Product Code: BTT · Anesthesiology
• Decision Date: Jul 6, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5450
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

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.

Device Story

The Flexicare FL-9000U is a dual servo-controlled respiratory humidifier base used in hospital settings by trained personnel. It functions as part of a system including a humidification chamber and a heated wire breathing circuit. The device features a heater plate that warms water in the chamber; temperature probe leads monitor gas temperature at the chamber and patient end. These probes provide feedback to the device, which automatically adjusts heater plate and heated wire current to maintain set gas temperature and humidity levels. The device includes an LCD display for monitoring and alarm indicators for fault conditions. It does not contact the patient directly; only the temperature probe tip contacts the breathing gas. By providing warmed, humidified gas, the device helps maintain airway conditions for ventilated patients.

Clinical Evidence

Bench testing only. No clinical data provided. Performance evaluated against ISO 8185:2009 and IEC 60601 series standards. Testing included dimensions, power supply, heater plate capacity, display accuracy, alarm parameters, sound pressure levels, and humidification output. Biocompatibility testing performed per ISO 10993-1, 3, 5, 6, and 10. Results demonstrate substantial equivalence to the predicate device.

Technological Characteristics

Mains-powered (115V) medical electrical device. Polycarbonate housing. Dual servo-controlled heating (heater plate + heated wire circuit). YSI temperature sensing. IPX1 rated. Connectivity via proprietary leads for heated wire breathing systems. Non-sterile. Software-controlled temperature regulation. Complies with EN 60601-1, EN 60601-1-2, EN ISO 8185, and EN ISO 10993.

Indications for Use

Indicated for patients requiring mechanical ventilation or positive pressure breathing assistance via endotracheal tube or face mask in hospital/institutional settings. For use by trained personnel only.

Regulatory Classification

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.

Predicate Devices

• Fisher & Paykel MR850 Respiratory Humidifier (K073706)

Reference Devices

• Flexicare Heated Wire Breathing Systems (K150900)
• Flexicare Autofill Humidification Chambers (K150900)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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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: [phone] Fax: [phone]

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<br>Humidifier | Fisher & Paykel MR850 Respiratory Humidifier | |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510K | K: Unknown | K:073706 | |
| Device Description | FL-9000 is a Dual Servo Controlled<br>Heated Respiratory Humidifier,<br>controlling both Airway & Chamber<br>temp | MR850 is a Dual Servo Controlled Heated<br>Respiratory Humidifier,<br>controlling both Airway & Chamber temp | |
| Intended use | The Flexicare FL-9000U Respiratory<br>Humidifier Base is intended to<br>warm and add humidity to gases<br>delivered to patients requiring<br>mechanical ventilation or positive<br>pressure breathing assistance via<br>an endotracheal tube or face mask.<br>For use by trained personnel only<br>within a hospital/institutional<br>environment. This device is<br>intended to be used only with the<br>Flexicare Heated Wire Breathing<br>System and Flexicare Autofill<br>Humidification Chamber. | The Fisher & Paykel Healthcare MR850<br>humidifier is intended to be used to warm and<br>add humidity to gases delivered to patients<br>requiring mechanical ventilation or positive<br>pressure breathing assistance or general medical<br>gases.<br>The heated-wire breathing circuits are intended<br>as conduits of breathing gas for ventilation of<br>patients, and to maintain the temperature of<br>humidified inspired gas, to reduce condensation.<br>They are accessories for the Fisher & Paykel<br>Healthcare MR850 Respiratory Gas Humidifier.<br>The RT130 is used for flow rates between 0.3 and<br>4 L/min, and the RT131 is for flow rates greater<br>than 4 L/min, for neonatal patients.<br>Source: Fisher & Paykel K073706 clearance letter. | |
| Principle of operation | The device has two heating control<br>units and two temperature sensors<br>respectively. Water within a<br>humidification chamber is heated<br>by the device's heating plate and<br>this temperature is controlled by<br>the device with the use of<br>temperature probes. Dry medical<br>gases passing through the chamber<br>gain increased humidity and heat.<br>The supplied Heated wire adaptors<br>supply current to heated wires<br>within breathing tubes that<br>maintain gas temperature<br>travelling to patient. Temperature<br>probes measurement temperature<br>and device controls chamber<br>temperature to achieve desired gas<br>warmth and humidify for patient. | The device has two heating control units and two<br>temperature sensors respectively. Water within a<br>humidification chamber is heated by the device's<br>heating plate and this temperature is controlled<br>by the device with the use of temperature<br>probes. Dry medical gases passing through the<br>chamber gain increased humidity and heat. The<br>supplied Heated wire adaptors supply current to<br>heated wires within breathing tubes that<br>maintain gas temperature travelling to patient.<br>Temperature probes measurement temperature<br>and device controls chamber temperature to<br>achieve desired gas warmth and humidify for<br>patient. | |
| Structure and operation | The product consists of FL-9000U<br>Respiratory humidifier, Heated<br>wire adaptor leads (single & dual)<br>and Temperature sensor leads. | The product consists of MR850 Respiratory<br>humidifier, Heated wire adaptor leads (single &<br>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<br>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<br>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<br>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<br>Range: 36-40°C | Default: 40°C<br>Range: 35-40°C<br>(Versions 7.22) |
| | Non-invasive | Default: 34°C<br>Range: 31-35°C | Default: 34°C<br>Range:28-34°C<br>(Versions 7.22) |
| Chamber<br>outlet | Invasive | Default:<br>Range: 34-40°C | Default:<br>Range: 35.5-42°C<br>(Versions 7.22) |
| | Non-invasive | Default:<br>Range: 31-35°C | Default:<br>Range: 31-36°C<br>(Versions 7.22) |
| | | Temperature control settings (non-heater wire) | |
| Airway | Invasive | 37°C (Range 36-38°C) | 37°C |
| Chamber<br>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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| Display | 4 digit 14 mm<br>14 segment LED | | 3 digit 14 mm<br>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<br>Chamber: High alarm / Low alarm | | High Humidity Alarm | | |
| | | | Low Humidity Alarm | | |
| Display temperature of<br>41°C | Yes | | Yes | | |
| Airway Temperature<br>exceeds 43°C | Yes…