F&P 820 Humidification System

K223684 · Fisher & Paykel Healthcare, Ltd. · BTT · Sep 5, 2023 · Anesthesiology

Device Facts

• Record ID: K223684
• Device Name: F&P 820 Humidification System
• Applicant: Fisher & Paykel Healthcare, Ltd.
• Product Code: BTT · Anesthesiology
• Decision Date: Sep 5, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5450
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The F&P 820 System is intended to provide therapeutic levels of heat and humidity to a patient's inspired respiratory gases when using a continuous or intermittent ventilator system or a continuous gas flow. This system is intended for both noninvasive and invasive therapies. The addition of heat and humidity to the supply of cold and dry respiratory gases provided through noninvasive ventilation is beneficial to prevent drying of the patient's airways. The F&P 820 System is designed for adult and pediatric patients (excluding neonate), requiring a flow range ≥ 5 L/min. It is designed for use in hospitals, long term care facilities and homes, under the prescription of qualified medical professionals.

Device Story

F&P 820 Humidification System provides heated, humidified respiratory gases to patients via ventilator systems or continuous gas flow. Device consists of a humidifier base, F&P 820A10 breathing tubes, and MR325 humidification chamber. Operation involves passing gas through a heated chamber and heated breathing tube to add moisture and heat, preventing airway drying. Used in hospitals, long-term care facilities, and homes by clinicians or lay users under prescription. Output is conditioned gas delivered to patient interface (invasive or non-invasive). System includes auditory alarms for safety. Benefits include maintenance of airway hydration and patient comfort during respiratory therapy.

Clinical Evidence

Bench testing only. No clinical data. Testing included humidification output, thermal overshoot, surface temperature (ISO 80601-2-74), resistance to flow, compliance, and gas leak testing (ISO 5367). Biocompatibility evaluated per ISO 10993-1 and ISO 18562-1. Electrical safety and EMC testing performed per ANSI AAMI ES 60601-1 and IEC 60601-1-2. Human factors and usability engineering study confirmed safety and effectiveness for intended users.

Technological Characteristics

Respiratory gas humidifier; provides heat/humidity via heated chamber and heated breathing tube. Class II electrical device. Complies with ISO 80601-2-74, ISO 5367, IEC 60601-1, and IEC 60601-1-2. Features auditory alarms (>45 dbA). Operating temperature range 18–26°C. Service life 7 years. Software-controlled temperature regulation.

Indications for Use

Indicated for adult and pediatric patients (excluding neonates) requiring a flow range ≥ 5 L/min who need heated and humidified respiratory gases during continuous or intermittent ventilation or continuous gas flow therapy. Used in hospital, long-term care, and home settings under prescription.

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

• F&P MR810 Respiratory Humidifier (K143646)
• Adult breathing circuit (RT102) (K983112)
• F&P humidification chamber (HC325) (K003973)

Reference Devices

• Hamilton-BC4022- Adult single limb breathing set (K152029)
• F&P Adult breathing circuit (900MR810) (K143646)

Submission Summary (Full Text)

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September 5, 2023

Fisher & Paykel Healthcare Ltd Reena Daken Regulatory Affairs Manager - North America 15 Maurice Paykel Place, East Tamaki Auckland. 2013 New Zealand

Re: K223684

Trade/Device Name: F&P 820 Humidification System Regulation Number: 21 CFR 868.5450 Regulation Name: Respiratory Gas Humidifier Regulatory Class: Class II Product Code: BTT Dated: December 8, 2022 Received: December 8, 2022

Dear Reena Daken:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Ethan L. Nyberg -S

Ethan Nyberg, Ph.D. Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K223684

Device Name F&P 820 Humidification System

### Indications for Use (Describe)

F&P 820 System Humidifier Base:

The F&P 820 System is intended to provide therapeutic levels of heat and humidity to a patient's inspired respiratory gases when using a continuous or intermittent ventilator system or a continuous gas flow.

This system is intended for both noninvasive and invasive therapies. The addition of heat and humidity to the supply of cold and dry respiratory gases provided through noninvasive ventilation is beneficial to prevent drying of the patient's airways.

The F&P 820 System is designed for adult and pediatric patients (excluding neonate), requiring a flow range ≥ 5 L/min. It is designed for use in hospitals, long term care facilities and homes, under the prescription of qualified medical professionals.

F&P 820A10 Breathing Tubes:

The F&P 820 series breathing tubes are an accessory to the F&P 820 System and are compatible with F&P 820 series humidifiers.

The F&P 820 System is intended to provide therapeutic levels of heat and humidity to a patient's inspiratory gases when using a continuous or intermittent ventilator system or a continuous gas flow.

This system is intended for both noninvasive and invasive therapies. The addition of heat and humidity to the supply of cold and dry respiratory gases provided through noninvasive ventilation is beneficial to prevent drying of the patient's airways.

This system is designed for adult and pediatric (excluding neonate) use in hospitals, long term care facilities and homes, under the prescription of qualified medical professionals.

F&P MR325 Humidification Chamber:

The MR325 humidification chamber is an accessory to the F&P 820 System and is compatible with F&P 820 series humidifiers.

The F&P 820 System is intended to provide therapeutic levels of heat and humidity to a patient's inspired respiratory gases when using a continuous or intermittent ventilator system or a continuous gas flow.

This system is intended for both noninvasive and invasive therapies. The addition of heat and humidity to the supply of cold and dry respiratory gases provided through noninvasive ventilation is beneficial to prevent drying of the patient's airways.

This system is designed for adult and pediatric (excluding neonate) use in hospitals, long term care facilities and homes, under the prescription of qualified medical professionals.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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## 510(k) Summary

As required by 21 CFR 807.92

# I. SUBMITTER

| Company Name and Address | Fisher & Paykel Healthcare Limited<br>15 Maurice Paykel Place<br>East Tamaki<br>Auckland 2013, New Zealand<br>Telephone: [phone] |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Prepared and Submitted by | Arisha Samad<br>Regulatory Affairs Specialist |
| Contact Person | Reena Daken<br>Regulatory Affairs Manager<br>Telephone: [phone]<br>Email: [e-mail] |
| Date Prepared | 05 September 2023 |

# II. DEVICE

| Name of Device | F&P 820 Humidification System |
|------------------------|-------------------------------|
| Common/Usual Name | Respiratory Humidifier |
| Classification Name | Respiratory Gas Humidifier |
| Regulatory Class | Class II |
| Primary Classification | BTT (21 CFR §868.5450) |
| Product Code | |

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#### PREDICATE DEVICE III.

- Primary Predicate device: .

| 510(k) Number | Device Name |
|---------------|----------------------------------|
| K143646 | F&P MR810 Respiratory Humidifier |

- Secondary Predicate devices: .

| 510(k)<br>Number | Device Name | Reason for secondary predicate |
|------------------|---------------------------------------|------------------------------------------------------------------------------|
| K983112 | Adult breathing circuit (RT102) | Used as a predicate for the F&P 820A10J<br>accessory breathing circuit kits. |
| K003973 | F&P humidification chamber<br>(HC325) | Used as a predicate for the F&P MR325<br>accessory humidification chamber. |

- . Reference device(s):

| 510(k)<br>Number | Device Name | Reason for reference |
|------------------|-----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K152029 | Hamilton-BC4022- Adult single<br>limb breathing set | Used to address the technological differences<br>between the subject and predicate device and<br>support claims of safety and effectiveness with<br>respect to breathing circuit use in patient<br>population |
| K143646 | F&P Adult breathing circuit<br>(900MR810) | Used to address the technological differences<br>between the subject and predicate device. |

#### DEVICE DESCRIPTION IV.

The Fisher & Paykel 820 Humidification (also referred to as F&P 820 System) is designed to provide respiratory humidification by providing heat, humidity, and delivering respiratory gases to patients.

The F&P 820 System is a revision of the predicate device platform, the Fisher & Paykel MR810 Respiratory Humidifier (K143646).

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## V. INDICATIONS FOR USE STATEMENT

### F&P 820 System Humidifier Base:

The F&P 820 System is intended to provide therapeutic levels of heat and humidity to a patient's inspired respiratory gases when using a continuous or intermittent ventilator system or a continuous gas flow.

This system is intended for both noninvasive and invasive therapies. The addition of heat and humidity to the supply of cold and dry respiratory gases provided through noninvasive or invasive ventilation is beneficial to prevent drying of the patient's airways.

The F&P 820 System is designed for adult and pediatric (excluding neonate), requiring a flow range ≥ 5 L/min. It is designed for use in hospitals, long term care facilities and homes, under the prescription of qualified medical professionals.

### F&P 820A10 Breathing Tubes:

The F&P 820 series breathing tubes are an accessory to the F&P 820 System and are compatible with F&P 820 series humidifiers.

The F&P 820 System is intended to provide therapeutic levels of heat and humidity to a patient's inspired respiratory gases when using a continuous or intermittent ventilator system or a continuous gas flow.

This system is intended for both noninvasive and invasive therapies. The addition of heat and humidity to the supply of cold and dry respiratory gases provided through noninvasive or invasive ventilation is beneficial to prevent drying of the patient's airways.

This system is designed for adult and pediatric (excluding neonate) use in hospitals, long term care facilities and homes, under the prescription of qualified medical professionals.

### F&P MR325 Humidification Chamber:

The MR325 humidification chamber is an accessory to the F&P 820 System and is compatible with F&P 820 series humidifiers.

The F&P 820 System is intended to provide therapeutic levels of heat and humidity to a patient's inspired respiratory gases when using a continuous or intermittent ventilator system or a continuous gas flow.

This system is intended for both noninvasive and invasive therapies. The addition of heat and humidity to the supply of cold and dry respiratory gases provided through noninvasive or invasive ventilation is beneficial to prevent drying of the patient's airways.

This system is designed for adult and pediatric (excluding neonate) use in hospitals, long term care facilities and homes, under the prescription of qualified medical professionals.

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# VI.COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

| Design /<br>Technological<br>Characteristics | Subject Device<br>F&P 820 System - Humidifier Base | Predicate Device<br>F&P MR810 Respiratory Humidifier (K143646) | Comments |
|--------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use<br>statement | The Fisher & Paykel 820 System is intended to provide<br>therapeutic levels of heat and humidity to a patient's inspired<br>respiratory gases, when using a continuous or intermittent<br>ventilator system or a continuous gas flow.<br>The 820 System is intended for both non-invasive and<br>invasive therapies. Addition of heat and humidity to the<br>supply of cold and dry respiratory gases provided through<br>non-invasive or invasive ventilation is beneficial to prevent<br>drying of the patient airways.<br>The 820 System is for adult and pediatric (excluding<br>Neonatal) patients requiring a flow range $≥5$ L/min. For use in<br>hospitals, long term care facilities and homes under the<br>prescription of a qualified medical professional. | The Fisher & Paykel MR810 System is intended to provide<br>therapeutic levels of heat and humidity to a patient's inspired<br>respiratory gases, when using a continuous or intermittent<br>ventilator system or a continuous gas flow system.<br>The MR810 System is intended for both non-invasive and<br>invasive therapies. Addition of heat and humidity to the supply<br>of cold and dry respiratory gases provided through non-<br>invasive or invasive ventilation is beneficial to prevent drying of<br>the patient airways.<br>The MR810 System is for use for adult and pediatric patients<br>requiring a flow range $≥5$ L/min. The MR810 System is<br>designed for use in hospitals, long term care facilities and<br>homes under the prescription of a qualified medical<br>professional. | Identical |
| Application | Non-invasive<br>Invasive | Non-invasive<br>Invasive | Identical |
| Use Environment | Hospital<br>Home | Hospital<br>Home | Identical |
| Patient Population | Adult and Paediatric (Excluding Neonatal) | Adult and Paediatric (Excluding Neonatal) | Identical |
| Intended User Group | Medical or clinical professionals.<br>Technical healthcare professionals.<br>Professional Care givers.<br>Lay users. | Medical or clinical professionals.<br>Technical healthcare professionals.<br>Professional Care givers.<br>Lay users. | Identical |
| Operating Principle | Provides heat and humidity to the respiratory gases by<br>passing the gas through a humidification chamber and heated<br>breathing tube. | Provides heat and humidity to the respiratory gases by passing<br>the gas through a humidification chamber and heated<br>breathing tube. | Identical |
| Design /<br>Technological<br>Characteristics | Subject Device<br>F&P 820 System - Humidifier Base | Predicate Device<br>F&P MR810 Respiratory Humidifier (K143646) | Comments |
| Humidity<br>Performance | ≥ 12 mg/L in Settings 1, 2 or 3<br>For 5 - 70 L/min Flow Range<br>≥ 33 mg/L in Setting 4<br>For 5 - 40 L/min Flow Range | ≥ 10 mg/L in Setting Low, Med or High:<br>For 5 - 60 L/min Flow Range<br>≥ 33 mg/L in Setting High<br>For 5 - 30 L/min Flow Range | Equivalent<br>The 820 System meets the<br>applicable requirements of ISO<br>80601-2-74:2017 |
| Gas temperature at<br>patient end of<br>breathing tube for<br>flow range | Setting 1: 26-30 °C<br>Setting 2: 29-37 °C<br>Setting 3: 32-40 °C<br>For 5 - 70 L/min Flow Range<br>Setting 4: 35-43 °C<br>For 5 - 40 L/min Flow Range | Setting Low: 28 - 29 °C<br>Setting Medium: 28 - 31 °C<br>For 5 - 60 L/min Flow Range<br>Setting High: 33 - 36°C<br>For 5 - 30 L/min Flow Range | Equivalent<br>The 820 System meets the<br>applicable requirements of ISO<br>80601-2-74:2017 |
| Time to reach set<br>temperature | <60 mins | <60 mins | Identical |
| Ambient Temperature<br>Range | 18 – 26 °C | 18 - 26 °C | Identical |
| Alarms | Alarms exceed 45 dbA @1m<br>Auditory alarm pause: 120 seconds | No audio alarm functionality | Different<br>The subject device conforms to IEC<br>60601-1-8:2006 + A1:2012 |
| Transport Conditions | -25 to 70 Deg °C | -10 to +50 Dec °C | Equivalent<br>The subject device has broader<br>storage conditions than the primary<br>predicate device. |
| Service Life | 7 Years | 7 Years | Identical |
| IEC 60601-1<br>Classification | CLASS II | CLASS I | Different<br>The subject device conforms to<br>AAMI/IEC 60601-1:2005 +<br>AMD1:2012 |
| Characteristic for | Subject Device | Secondary Predicate Device | Comments |
| comparison | F&P 820A10J | F&P RT102 (K983112) | |
| Intended Use | Deliver heated and humidified respiratory gases. | Deliver heated and humidified respiratory gases. | Identical |
| Indications for Use | The breathing set is an accessory to the F&P 820 System. The | The heated-wire breathing circuits are intended as conduits of | Equivalent |
| | F&P 820 System is intended to provide therapeutic levels of | breathing gas for ventilation of patients, and to maintain the | Both the subject and secondary |
| | heat and humidity to a patient's inspired respiratory gases, | temperature of humidified inspired gas, to reduce | predicate device are indicated to |
| | when using a continuous or intermittent ventilator system or a | condensation. They are accessories for the Fisher & Paykel | provide heat and humidity to |
| | continuous gas flow. | MR850 Respiratory Gas Humidifier. | respiratory gases delivered to |
| | The 820 System is intended for both non-invasive and invasive | | patients. |
| | therapies. Addition of heat and humidity to the supply of cold | | |
| | and dry respiratory gases provided through non-invasive or | | |
| | invasive ventilation is beneficial to prevent drying of the patient | | |
| | airways. | | |
| | The 820 System is for adult and pediatric (excluding Neonatal) | | |
| | for use in hospitals, long term care facilities and homes under | | |
| | the prescription of a qualified medical professional. | | |
| Operating Principle | The heated breathing tube is kept warm by the heater wire | The heated breathing tube is kept warm by the heater wire | Identical |
| | (controlled by the Humidification Base) to minimize | (controlled by the Humidification Base) to minimize | |
| | condensation and maintain the desired temperature and level…