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 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.

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.

Device Description

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).

AI/ML Overview

The provided text is a 510(k) Summary for the F&P 820 Humidification System. It describes the device, its intended use, comparison with predicate devices, and the non-clinical testing performed to demonstrate substantial equivalence.

However, the information requested in your prompt regarding acceptance criteria and a study that proves the device meets the acceptance criteria with specific details like sample size, expert ground truth establishment, adjudication methods, MRMC studies, and separate training/test sets with their ground truth establishment for an AI/ML powered device is not present in this document.

This document pertains to a traditional medical device (a respiratory humidifier system), not an AI/ML-powered diagnostic or therapeutic device. Therefore, the detailed acceptance criteria and study design elements typically associated with AI/ML device validation (like sensitivity, specificity, AUC, human reader improvement with AI assistance, sample sizes for training/test sets, and expert consensus for ground truth) are not applicable to this submission and are consequently not described.

The "Performance Data" section (Section VII) focuses on demonstrating compliance with relevant international standards for medical devices (e.g., electrical safety, EMC, biocompatibility, software verification/validation, human factors, and bench/performance testing for humidification output, thermal overshoot, resistance to flow, etc.). These are the "acceptance criteria" for this type of device, and the summary states that the device "meets the applicable requirements" and "demonstrates an appropriate profile."

To directly answer your prompt, based only on the provided text:

1. A table of acceptance criteria and the reported device performance:

The document doesn't present "acceptance criteria" in the format of a table as you might expect for an AI/ML study (e.g., minimum sensitivity). Instead, it states that the device was tested to "applicable requirements" of various standards, and the performance described is primarily via comparison to the predicate device in Table 1, where the subject device's performance characteristics are presented as meeting or being equivalent to those of the predicate and relevant standards.

Here's an extraction of relevant performance characteristics from Table 1, framed as criteria and performance. Note: These are not explicit "acceptance criteria" numbers as you would see for predictive models, but rather technical specifications and compliance claims.

Acceptance Criteria (Derived from Standards/Predicate)	Reported Device Performance (F&P 820 Humidification System)
Humidity Performance
Setting 1, 2, or 3 (Flow Range 5-70 L/min)	≥ 12 mg/L
Setting 4 (Flow Range 5-40 L/min)	≥ 33 mg/L
Gas temperature at patient end of breathing tube for flow range
Setting 1	26-30 °C
Setting 2	29-37 °C
Setting 3	32-40 °C
Setting 4 (Flow Range 5-40 L/min)	35-43 °C
Time to reach set temperature	<60 mins
Ambient Temperature Range	18 – 26 °C
Alarms	Alarms exceed 45 dbA @1m; Auditory alarm pause: 120 seconds (Different from predicate, but conforms to IEC 60601-1-8:2006 + A1:2012)
Transport Conditions	-25 to 70 °C (Broader range than predicate, but equivalent as it encompasses predicate's range)
Service Life	7 Years
IEC 60601-1 Classification	CLASS II (Different from predicate CLASS I, but conforms to AAMI/IEC 60601-1:2005 + AMD1:2012)
Biocompatibility	Meets ISO 10993-1:2018 and ISO 18562-1:2017: "demonstrates an appropriate biocompatibility profile for the device."
Electrical Safety, EMC, Alarms	Complies with ANSI AAMI ES 60601-1:2005/(R)2012 and A1:2012, IEC 60601-1-2:2014 + AMD1:2020 Ed 4.1, AIM Standard 7351731 Rev. 2.00 2017-02-23. Alarms testing in accordance with IEC 60601-1-8:2006 and A1:2012. "demonstrated the appropriate electrical safety and electromagnetic compatibility profile."
Software Verification & Validation	Conducted and documented as recommended by FDA guidance.
Human Factors	Study conducted and documented as recommended by FDA guidance. "demonstrated that the human factors assessment had been sufficiently evaluated and was safe and effective for the intended users, uses, and use environments."
Resistance to flow, compliance, and gas leak testing	In line with ISO 5367:2014.

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified. For a non-AI/ML device, performance testing usually involves a defined number of units tested to ensure design specifications are met, but this is not typically expressed as a "test set sample size" in the context of clinical data used for AI/ML performance evaluation.
Data Provenance: Not applicable/specified. The testing performed is bench/laboratory testing of the physical device, not analysis of clinical data from patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable. Ground truth as established by human experts is not relevant for the type of bench and performance testing conducted for this device. Ground truth, in this context, refers to measurements from calibrated equipment and adherence to standard specifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. Adjudication methods are used to resolve discrepancies in human expert labeling of data, which is not part of this device's testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No. An MRMC study is relevant for AI/ML diagnostic aids. This is a respiratory humidifier system, not a diagnostic imaging AI.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is not an algorithm-only device. Its performance is inherent to its physical design and functionality.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

The "ground truth" for this device's performance is based on measurements from calibrated test equipment and adherence to established engineering and medical device standards (e.g., ISO, IEC). For instance, humidity output is measured by the device itself and validated against a standard, not derived from expert consensus on patient outcomes.

8. The sample size for the training set:

Not applicable. This device does not employ machine learning that would require a "training set."

9. How the ground truth for the training set was established:

Not applicable. No training set is used for this device.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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:

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 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.

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 Limited15 Maurice Paykel PlaceEast TamakiAuckland 2013, New ZealandTelephone: +64 9 574 0100
Prepared and Submitted by	Arisha SamadRegulatory Affairs Specialist
Contact Person	Reena DakenRegulatory Affairs ManagerTelephone: +64 9 574 0100Email: reena.daken@fphcare.co.nz
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)Number	Device Name	Reason for secondary predicate
K983112	Adult breathing circuit (RT102)	Used as a predicate for the F&P 820A10Jaccessory breathing circuit kits.
K003973	F&P humidification chamber(HC325)	Used as a predicate for the F&P MR325accessory humidification chamber.

. Reference device(s):

510(k)Number	Device Name	Reason for reference
K152029	Hamilton-BC4022- Adult singlelimb breathing set	Used to address the technological differencesbetween the subject and predicate device andsupport claims of safety and effectiveness withrespect to breathing circuit use in patientpopulation
K143646	F&P Adult breathing circuit(900MR810)	Used to address the technological differencesbetween the subject and predicate device.

DEVICE DESCRIPTION IV.

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:

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.

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.

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 /TechnologicalCharacteristics	Subject DeviceF&P 820 System - Humidifier Base	Predicate DeviceF&P MR810 Respiratory Humidifier (K143646)	Comments
Indications for usestatement	The Fisher & Paykel 820 System is intended to providetherapeutic levels of heat and humidity to a patient's inspiredrespiratory gases, when using a continuous or intermittentventilator system or a continuous gas flow.The 820 System is intended for both non-invasive andinvasive therapies. Addition of heat and humidity to thesupply of cold and dry respiratory gases provided throughnon-invasive or invasive ventilation is beneficial to preventdrying of the patient airways.The 820 System is for adult and pediatric (excludingNeonatal) patients requiring a flow range $≥5$ L/min. For use inhospitals, long term care facilities and homes under theprescription of a qualified medical professional.	The Fisher & Paykel MR810 System is intended to providetherapeutic levels of heat and humidity to a patient's inspiredrespiratory gases, when using a continuous or intermittentventilator system or a continuous gas flow system.The MR810 System is intended for both non-invasive andinvasive therapies. Addition of heat and humidity to the supplyof cold and dry respiratory gases provided through non-invasive or invasive ventilation is beneficial to prevent drying ofthe patient airways.The MR810 System is for use for adult and pediatric patientsrequiring a flow range $≥5$ L/min. The MR810 System isdesigned for use in hospitals, long term care facilities andhomes under the prescription of a qualified medicalprofessional.	Identical
Application	Non-invasiveInvasive	Non-invasiveInvasive	Identical
Use Environment	HospitalHome	HospitalHome	Identical
Patient Population	Adult and Paediatric (Excluding Neonatal)	Adult and Paediatric (Excluding Neonatal)	Identical
Intended User Group	Medical or clinical professionals.Technical healthcare professionals.Professional Care givers.Lay users.	Medical or clinical professionals.Technical healthcare professionals.Professional Care givers.Lay users.	Identical
Operating Principle	Provides heat and humidity to the respiratory gases bypassing the gas through a humidification chamber and heatedbreathing tube.	Provides heat and humidity to the respiratory gases by passingthe gas through a humidification chamber and heatedbreathing tube.	Identical
Design /TechnologicalCharacteristics	Subject DeviceF&P 820 System - Humidifier Base	Predicate DeviceF&P MR810 Respiratory Humidifier (K143646)	Comments
HumidityPerformance	≥ 12 mg/L in Settings 1, 2 or 3For 5 - 70 L/min Flow Range≥ 33 mg/L in Setting 4For 5 - 40 L/min Flow Range	≥ 10 mg/L in Setting Low, Med or High:For 5 - 60 L/min Flow Range≥ 33 mg/L in Setting HighFor 5 - 30 L/min Flow Range	EquivalentThe 820 System meets theapplicable requirements of ISO80601-2-74:2017
Gas temperature atpatient end ofbreathing tube forflow range	Setting 1: 26-30 °CSetting 2: 29-37 °CSetting 3: 32-40 °CFor 5 - 70 L/min Flow RangeSetting 4: 35-43 °CFor 5 - 40 L/min Flow Range	Setting Low: 28 - 29 °CSetting Medium: 28 - 31 °CFor 5 - 60 L/min Flow RangeSetting High: 33 - 36°CFor 5 - 30 L/min Flow Range	EquivalentThe 820 System meets theapplicable requirements of ISO80601-2-74:2017
Time to reach settemperature	<60 mins	<60 mins	Identical
Ambient TemperatureRange	18 – 26 °C	18 - 26 °C	Identical
Alarms	Alarms exceed 45 dbA @1mAuditory alarm pause: 120 seconds	No audio alarm functionality	DifferentThe subject device conforms to IEC60601-1-8:2006 + A1:2012
Transport Conditions	-25 to 70 Deg °C	-10 to +50 Dec °C	EquivalentThe subject device has broaderstorage conditions than the primarypredicate device.
Service Life	7 Years	7 Years	Identical
IEC 60601-1Classification	CLASS II	CLASS I	DifferentThe subject device conforms toAAMI/IEC 60601-1:2005 +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	condensation and maintain the desired temperature and level
	of humidity before being delivered to the patient interface.	of humidity before being delivered to the patient interface.
Patient Population	Adult and paediatric patients (excluding neonates) >10 kg	Adult patients	Different
			The subject device is compliant to
			the pneumatic requirements of
			ISO 5367 for the indicated patient
			populations.
Intended Interface	Non-invasive and invasive interfaces	Non-invasive and invasive interfaces	Identical

Duration of Use	14 Days	7 Days	Different
Shelf Life	3 years	5 years	Equivalent
			The subject device falls within the
			secondary predicate device shelf life
			duration.
Storage conditions	-10°C — 50°C	-10°C -- 50°C	Equivalent
			The subject device falls within the
			secondary predicate device storage
			condition range.
Characteristic forcomparison	Subject DeviceF&P MR325	Secondary Predicate DeviceF&P HC325 (K003973)	Comments
Intended Use	Holds water and adds heat and humidity to respiratorygases	Holds water and adds heat and humidity torespiratory gases	Identical
Indications for Use	The MR325 humidification chamber is an accessory to theF&P 820 System and compatible with F&P 820 serieshumidifiers. The F&P 820 System is intended to providetherapeutic levels of heat and humidity to a patient's inspiredrespiratory gases, when using a continuous or intermittentventilator system or a continuous gas flow.The 820 System is intended for both non-invasive and invasivetherapies. Addition of heat and humidity to the supply of cold anddry respiratory gases provided through non-invasive or invasiveventilation is beneficial to prevent drying of the patient airways.The 820 System is for adult and paediatric (excluding Neonatal)for use in hospitals, long term care facilities and homes underthe prescription of a qualified medical professional.	The HC325 humidification chamber is an accessory to theF&P HC150 Respiratory Humidifier.The HC150 respiratory humidifier is used to warm andhumidify gases delivered to patients requiring continuouspositive airway pressure (CPAP) therapy or maskventilation.The HC325 Humidification Chamber has been designed asa Passover humidifier for use with Nasal CPAP and NasalMask ventilation systems.	DifferentSubject device tested to ISO5367:2014, ISO 80601-2-74:2017,ISO 10993-1:2018 and ISO 18562-1:2017 and is equivalent to thesecondary predicate device.
Operating Principle	Water in the humidification chamber is heated to add watervapour and heat energy to the passing gas flow. The gas thenenters the breathing tube.	Water in the humidification chamber is heated to add watervapour and heat energy to the passing gas flow. The gasthen enters the breathing tube.	Identical
Patient Population	Adult and paediatric patients (excluding neonates)	Patients requiring positive pressure breathing therapy suchas CPAP	DifferentThe subject device is compliant tothe requirements of ISO 5367 forthe indicated patient populations.
Intended Interface	Non-invasive and invasive interfaces	Non-invasive and invasive interfaces	Identical
Duration of use	14 days	No-predefined duration of use	DifferentSubject device has a 14-dayDuration of use.
Reusability	Single Use	Single Patient Reusable. With cleaning instructions.	DifferentSubject device is for single use.
Shelf Life	3 years	No-predefined shelf-life	DifferentSubject device shelf-life is 3 years
Storage conditions	-10°C – 50°C	-10°C – 50°C	Identical

Table 1: Subject Device and Primary Predicate Comparison Table

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Table 2: F&P 820A10J – Circuit Heated Single Limb to Secondary Predicate Comparison Table

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Table 3: F&PMR325 – Chamber Manual Fill to Secondary Predicate Comparison Table

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PERFORMANCE DATA VII.

Summary of non-clinical tests

The F&P 820 Respiratory Humidifier has been tested to the applicable requirements* of the following standards:

Standards	Title
ISO 10993-1:2018	Biological evaluation of medical devices – Part 1: Evaluation and testing within arisk management process
ISO 18562-1:2017	Biocompatibility Evaluation of Breathing Gas Pathways in HealthcareApplications- Part 1: Evaluation and Testing Within a Risk Management Process
IEC 62304:2015Consolidated Version	Medical device software - software lifecycle processes
IEC 60601-1-2:2014 +AMD1:2020 Ed 4.1	Medical electrical equipment - Part 1-2: General requirements for basic safetyand essential performance - Collateral Standard: Electromagnetic compatibility- Requirements and tests.
Standard 7351731 Rev.2.00 2017-02-23	Medical Electrical Equipment and System Electromagnetic Immunity Test forExposure to Radio Frequency Identification Readers - An AIM Standard
ISO 5367:2014	Anaesthetic and respiratory equipment - Breathing sets and connectors
ISO 5356-1:2004	Anaesthetic and Respiratory Equipment - Conical Connectors - Part 1: Conesand Sockets.
ANSI AAMI ES60601-1:2005/(R)2012 andA1:2012, C1:2009/(R)2012and A2:2010/(R)2012	Medical electrical equipment - Part 1: General requirements for basic safety andessential performance (edition 3.1).
ISO 80601-2-74: 2017	Medical Electrical Equipment- Part 2-74: Particular Requirements For BasicSafety and Essential Performance Of Respiratory Humidifying Equipment.*excluding clause 201.12.1.102a
IEC 60601-1-6:2013	Medical electrical equipment - Part 1-6: General requirements for basic safetyand essential performance - Collateral standard: Usability
IEC 60601-1-8:2012	Medical electrical equipment: Part 1-8: General requirements for basic safetyand essential performance - Collateral Standard: General requirements, testsand guidance for alarm systems in medical electrical equipment and medicalelectrical systems.
IEC 60601-1-11:2015	Medical electrical equipment - Part 1-11: General requirements for basic safetyand essential performance - Collateral Standard: Requirements for medicalelectrical equipment and medical electrical systems used in the homehealthcare environment
IEC 62366-1:2015 +AMD:2020	Medical devices - Part 1: Application of usability engineering to medical devices

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Biocompatibility Testing:

The biocompatibility evaluation for the F&P 820 Humidification System was conducted in accordance with the International Standards ISO 10993-1:2018 "Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process," and ISO 18562--1:2017 "Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process" as recognized by the FDA. FDA's guidance document on Use of International Standard ISO 10993-1. "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process",2020. Testing of the F&P 820 Humidification System demonstrates an appropriate biocompatibility profile for the device.

Electrical Safety, Electromagnetic Compatibility (EMC), and Alarms:

Electrical safety and EMC testing were conducted on the F&P Humidification System. The system complies with ANSI AAMI ES 60601-1:2005/(R)2012 and A1:2012, IEC 60601-1-2:2014 + AMD1:2020 Ed 4.1 and AIM Standard 7351731 Rev. 2.00 2017-02-23. The testing demonstrated the appropriate electrical safety and electromagnetic compatibility profile for the device. Alarms testing was performed in accordance with IEC 60601-1-8:2006 and A1:2012.

Software Verification and Validation Testing:

Software verification and validation was conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."

Human Factors:

A human Factors and Usability Engineering study was conducted on the F&P820 Respiratory Humidifier and accessories, and documentation was updated and provided as recommended by FDA's guidance. The study demonstrated that the human factors assessment had been sufficiently evaluated and was safe and effective for the intended users, uses, and use environments.

Bench / Performance Testing:

Performance testing was conducted to demonstrate substantial equivalence including:

Humidification output, thermal overshoot, surface temperature of applied parts in line . with ISO 80601-2-74:2017
Resistance to flow, compliance, and gas leak testing in line with ISO 5367:2014 .

VIII. CONCLUSION

The F&P 820 Humidification System are substantially equivalent to the predicate devices based on intended uses, comparison of the technological characteristics and performance. In addition, the conclusions drawn from the non-clinical tests demonstrate that the devices are substantially equivalent to the legally marketed predicate devices.

Regulation Number and Section

§ 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).