A-Model: The F&P Evora Nasal Mask is intended to be used by adults weighing ≥661bs (30kgs) who have been prescribed noninvasive positive airway pressure therapy such as CPAP or bilevel by a physician. The F&P Evora Nasal Mask is intended for single patient use in the home.

SL Model: The F&P Evora Nasal Mask is intended to be used by adults weighing ≥66lbs (30kgs) who have been prescribed noninvasive positive airway pressure therapy such as CPAP or bilevel by a physician. The F&P Evora Nasal Mask is intended for single patient use in the home and for multiple patient use in the clinical setting where proper disinfection of the device can occur between patient uses.

Device Description

The F&P Evora Nasal Mask is a non-invasive patient interface with a seal that encloses the airway entrance of the nose. The mask is held on the face with a headgear. The mask connects to a single breathing tube by a 22mm male swivel adaptor to receive pressurized gases from a Positive Airway Pressure device (CPAP or Bi-Level). The exhaust holes on the seal of the mask allow exhaled gases to be flushed out while the system is in operation.

The F&P Evora Nasal Mask is a prescription only device, provided in a non-sterile state. The mask will be available in 2 different main models: A-Model, and Sleeplab (SL)-Model. Both models are identical except for Intended Use, Operating Environment; Reusability and High Level Disinfection Methods. This is because the A model is used only by single patients in the home while the SL model is used both by single patients in the home and multiple patients use in the hospital or other clinical setting where proper disinfection of the device can occur between patient uses.

A Model: Offered in 4 different sizes (Small, Medium, Large, Wide), the packaging contains a single mask and a single size seal, intended for single patient use. In addition, to the 4 sizes, a so-called Fit Pack model (EVO1SMLA) is offered which contains a single mask with 3 seal sizes (Small, Medium and Large).

Sleeplab (SL)-Model: Offered in 4 different sizes (Small, Medium, Large, Wide) contains a single mask and a single size seal, intended for single patient use and multi-patient use. In addition, to the 4 sizes, a so-called Fit Pack model (EVO1SMLSL) is offered which contains a single mask with 3 seal sizes (Small, Medium and Large).

Besides the main models, an accessory and spare parts will be made available.

-Accessory: The only accessory available for the F&P Evora Nasal Mask will be an Oxygen / Pressure Port Connector, which will be packaged and sold separately.
-Spare parts: F&P Evora Nasal has the below components which are available for purchase as spare parts:
- Evora Nasal Seal Spare (Small, Medium, Large and Wide) o
- Evora Nasal Headgear Spare O
- Evora Nasal Backstrap Spare о
- O F&P Swivel White
- O Evora Nasal Tube & Frame Spare
- Evora Nasal Mask No H/G (Small, Medium, Large and Wide) o

AI/ML Overview

The provided document is an FDA 510(k) K200089 submission for the F&P Evora Nasal Mask. This document describes the device, its intended use, and provides non-clinical performance data to demonstrate substantial equivalence to a predicate device.

Crucially, this document does not contain information about acceptance criteria and reported device performance in the context of a clinical study or a study directly addressing a diagnostic or therapeutic performance metric for which acceptance criteria typically apply (e.g., sensitivity, specificity, accuracy).

Instead, the "performance" data presented here is related to engineering and safety standards for medical devices, such as:

Shelf life simulation: Based on ASTM F1980-07.
Transportation simulation: Based on ISTA 2A.
Performance testing to confirm non-adverse effects on safety and effectiveness: CO2 rebreathing, total mask exhaust flow, resistance to flow and pressure drop.
Mechanical integrity and performance: Verified after normal and reasonable abuse scenarios (home use/cleaning, multi-patient use/reprocessing, accelerated aging, simulated transportation and storage).
Compliance with various ISO standards: Including ISO 17510:2015 (Sleep Apnoea Breathing Therapy- Masks and Application Accessories) and a series of ISO 10993 standards for biological evaluation of medical devices.

The "Technological Characteristics Comparison" table (Table 1) compares specific technical parameters like pressure range, resistance to flow, dead space, and sound levels between the F&P Evora Nasal Mask (subject device) and the F&P Brevida Nasal Pillows Mask (predicate device).

Therefore, many of the requested items (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, type of ground truth, training set sample size, ground truth for training set) are not applicable to the information contained in this 510(k) summary. These items are typically relevant for AI/ML-based diagnostic devices or devices that produce a measurable "result" requiring human interpretation or comparison to a definitive reference standard.

However, I can extract the closest analogous information available from the document:

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

Since this is a non-clinical, substantial equivalence submission for a nasal mask, the "acceptance criteria" are primarily established by conformity to recognized standards and comparative performance with a predicate device. The "reported device performance" refers to the measurements taken on the F&P Evora Nasal Mask.

Performance Metric	Acceptance Criteria (Implied by Standards/Predicate)	Reported Device Performance (F&P Evora Nasal Mask)
Indications for Use	Substantially equivalent to predicate, adult patients ≥66 lbs (30kgs) needing CPAP/bilevel therapy.	A-Model: Intended for single patient use in the home. SL-Model: Intended for single patient use in the home and for multiple patient use in the hospital or other clinical setting where proper disinfection can occur. (Determined to be "Substantially equivalent. Identical intended use, patient population and operating environment" for the respective models compared to predicate).
Patient Population	Adult (≥66 lbs / 30 kg)	Adult (≥66 lbs / 30 kg). ("Identical")
Operating Environment	Home (A-model) / Home, hospital, clinical setting (SL-model)	A-Model: Home. SL-Model: Home, hospital or other clinical setting. ("Identical" to predicate for respective models).
Pressure Range	4 to 25 cmH2O (matching predicate)	4 to 25 cmH2O. ("Identical")
Resistance to Flow (Pressure Drop)	Conformance with ISO 17510:2015.	Small (50L/min): 1.0 ± 0.1 cmH2O Medium (50L/min): 1.0 ± 0.1 cmH2O Large (50L/min): 1.0 ± 0.1 cmH2O Wide (50L/min): 1.0 ± 0.1 cmH2O Small (100L/min): 1.4 ± 0.25 cmH2O Medium (100L/min): 1.2 ± 0.25 cmH2O Large (100L/min): 1.2 ± 0.25 cmH2O Wide (100L/min): 1.3 ± 0.25 cmH2O (Comment: "The subject device is in conformance with ISO 17510:2015 and this difference does not introduce any additional risk to the user.")
Dead Space	Conformance with ISO 17510:2015.	Small: 28 cc Medium: 26 cc Large: 28 cc Wide: 34 cc (Comment: "All seal sizes are in conformance with ISO 17510:2015 and this difference does not introduce any additional risk to the user.")
Sound	Conformance with ISO 17510:2015.	Sound Power Level: 26.8 dBA (uncertainty 2.5 dBA) Sound Pressure Level: 18.8 dBA (uncertainty 2.5 dBA) (Comment: "The subject device is in conformance with ISO 17510:2015 and this difference does not introduce any additional risk to the user.")
Shelf-Life	Not explicitly claimed on predicate, but supported by data for subject device.	1 year. ("The subject device claims a One-year shelf life with supporting data.")
Sterility	Not provided sterile (matching predicate).	Device not provided sterile. ("Identical")
Reusability	Single Patient Use (A-model) / Reusable - Multi Patient Use (SL-model) (matching predicate).	A-Model: Single Patient Use. SL-Model: Reusable – Multi Patient Use. ("Identical")
High Level Disinfection Methods	Thermal Disinfection (for SL-model, matching predicate).	SL-Model: Thermal Disinfection. ("Identical")
Accessory (Oxygen/Pressure Port)	Available as separate part (matching predicate).	Oxygen/Pressure Port (900HC452) Available as a separate part, not provided with device. ("Identical")
Other Non-Clinical Tests	Demonstrates substantial equivalence, confirms safety/effectiveness, meets relevant standards.	- Shelf life simulation based on ASTM F1980-07. - Transportation simulation based on ISTA 2A. - Confirmed non-adverse effects on safety and effectiveness for CO2 rebreathing, total mask exhaust flow, resistance to flow/pressure drop. - Mechanical integrity/performance verified after abuse scenarios (home use/cleaning, multi-patient use/reprocessing, accelerated aging, transport/storage). - Tested to ISO 17510:2015, ISO 5356-1:2015, ISO 10993 series (1, 2, 3, 5, 10, 11, 12, 17, 18), ISO 18562 series (1, 2, 3).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample size for test set: Not applicable in the context of clinical study data or a specific "test set" as understood for AI/ML performance evaluation. The data presented are from non-clinical engineering and safety tests on the device itself.
Data provenance: Not explicitly stated as "country of origin" for each test. The submitting company is Fisher & Paykel Healthcare Ltd., located in Auckland, New Zealand. The tests are non-clinical, conducted in a laboratory setting. There is no indication of retrospective or prospective data in the clinical sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable as the document describes non-clinical engineering and performance testing of a physical medical device (nasal mask), not an AI/ML diagnostic algorithm requiring expert "ground truth."

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

This information is not applicable as there is no human adjudication process involved in these non-clinical tests.

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

This information is not applicable. No MRMC study was performed as this is not an AI/ML diagnostic or assistive device.

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

This information is not applicable. This is not an AI/ML algorithm.

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

The "ground truth" for the non-clinical tests is represented by established engineering standards, regulatory requirements, and measurements against the predicate device's known characteristics. For example, CO2 rebreathing tests would measure actual CO2 levels, and resistance to flow tests would measure physical pressure drops, compared against specified limits or predicate performance.

8. The sample size for the training set

This information is not applicable as there is no AI/ML training set involved.

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

This information is not applicable as there is no AI/ML training set involved.

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, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.

June 2, 2020

Fisher & Paykel Healthcare Ltd. Reena Daken Senior Regulatory Affairs Specialist 15 Maurice Paykel Place. East Tamaki Auckland 2013 New Zealand

Re: K200089

Trade/Device Name: F&P Evora Nasal Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: Class II Product Code: BZD Dated: April 23, 2020 Received: April 30, 2020

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 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

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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 mediation-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,

for Michael Ryan Director DHT1C: Division of ENT, 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)

Device Name F&P Evora Nasal Mask

Indications for Use (Describe)

A-Model:

The F&P Evora Nasal Mask is intended to be used by adults weighing ≥661bs (30kgs) who have been prescribed noninvasive positive airway pressure therapy such as CPAP or bilevel by a physician. The F&P Evora Nasal Mask is intended for single patient use in the home.

SL Model:

The F&P Evora Nasal Mask is intended to be used by adults weighing ≥66lbs (30kgs) who have been prescribed noninvasive positive airway pressure therapy such as CPAP or bilevel by a physician. The F&P Evora Nasal Mask is intended for single patient use in the home and for multiple patient use in the clinical setting where proper disinfection of the device can occur between patient uses.

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)

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510(k) Summary

As Required by 21 CFR 807.92

Date prepared	02 June 2020
Company Name andAddress	Fisher & Paykel Healthcare Ltd.Address: 15 Maurice Paykel PlaceEast TamakiAuckland 2013, New ZealandTelephone: +64 9 574 0100
Prepared and Submitted by	Sylvia WonnerRegulatory Affairs Associate
Contact Person	Reena DakenSenior Regulatory Affairs SpecialistTelephone: +64 9 574 0100Reena.Daken@fphcare.co.nz
Trade name	F&P Evora™ Nasal Mask
Common name	Nasal Mask
Classification name	Non Continuous Ventilator (IPPB)Class II (21 CFR §868.5905)Product code BZD (Anaesthesiology)
Predicate device	F&P Brevida™ Nasal Pillows Mask (K161412)

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Device Description

Besides the main models, an accessory and spare parts will be made available.

-Accessory: The only accessory available for the F&P Evora Nasal Mask will be an Oxygen / Pressure Port Connector, which will be packaged and sold separately.
-Spare parts: F&P Evora Nasal has the below components which are available for purchase as spare parts:
- Evora Nasal Seal Spare (Small, Medium, Large and Wide) o
- Evora Nasal Headgear Spare O
- Evora Nasal Backstrap Spare о
- O F&P Swivel White
- O Evora Nasal Tube & Frame Spare
- Evora Nasal Mask No H/G (Small, Medium, Large and Wide) o

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Intended Use / Indication for Use

A-Model:

SL Model:

The F&P Evora Nasal Mask is intended to be used by adults weighing ≥66lbs (30kgs) who have been prescribed non-invasive positive airway pressure therapy such as CPAP or bilevel by a physician. The F&P Evora Nasal Mask is intended for single patient use in the home and for multiple patient use in the hospital or other clinical setting where proper disinfection of the device can occur between patient uses.

Non-Clinical Performance Data

Performance testing of the F&P Evora Nasal Mask was completed to determine that device design changes compared to F&P Brevida Nasal Pillows Nasal Mask (K161412) do not raise different questions of safety or effectiveness. These tests demonstrate substantial equivalence of the F&P Evora Nasal Mask to the predicate device. A summary of the testing conducted for the F&P Evora Nasal Mask device is provided below.

Shelf life simulation was based on ASTM F1980-07 Standard Guide for Accelerated . Aging of Sterile Barrier Systems for Medical Devices.
. Transportation simulation was based on ISTA 2A Packaged-Products weighing 150lb (68kg) or less.
Performance testing was completed to confirm the F&P Evora Nasal Mask does not adversely affect safety and effectiveness.
- CO2 rebreathing during normal use o
- o Total mask exhaust flow
- Resistance to flow and pressure drop O
. Mechanical integrity and performance of the new device was also verified after normal and reasonable abuse scenarios. This included simulations of home use/cleaning; multi-patient use/reprocessing; accelerated ageing (shelf life) and simulated transportation and storage.

The F&P Evora Nasal Mask has been tested to the following standards:

. ISO 17510:2015 Sleep Apnoea Breathing Therapy- Masks and Application Accessories
. ISO 5356-1:2015 Anaesthetic and respiratory equipment- Conical connectors: Part 1: Cones and sockets
. ISO 10993-1:2018, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
. ISO 10993-2:2006, Biological evaluation of medical devices - Part 2: Animal Welfare requirements

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ISO 10993-3:2014, Biological evaluation of medical devices Part 3: Tests for . Genotoxicity Carcinogenicity and reproductive toxicity
. ISO 10993-5:2009, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
. ISO 10993-10:2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
. ISO 10993-11:2017, Biological evaluation of medical devices – Part 11: Tests for systemic Toxicity
. ISO 10993-12:2012, Biological evaluation of medical devices - Part 12: Sample preparation and reference material
. ISO 10993-17:2002, Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances
. ISO 10993-18:2005, Biological evaluation of medical devices - Part 18: chemical characterization of materials
. ISO 18562-1:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications, Part 1: Evaluation and testing within a risk management process
ISO 18562-2:2017 Biocompatibility evaluation of breathing gas pathways in healthcare . applications, Part 2: Tests for emissions of particulate matter
. ISO 18562-3:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications, Part 3: Tests for emissions of volatile organic compounds (VOCs)

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Technological Characteristics Comparison

Table 1: Comparison of Technological Characteristics with the Predicate Device

	Subject Device		Predicate
	F&P Evora Nasal Mask(A model)	F&P Evora Nasal Mask(SL model)	F&P Brevida Nasal Pillows Mask	Comments
Device Name
	Indications for use and intended use
Indications forUse	The F&P Evora Nasal Mask isintended to be used by adultsweighing ≥66lbs (30kgs) whohave been prescribed non-invasive positive airwaypressure therapy such as CPAPor bilevel by a physician. TheF&P Evora Nasal Mask isintended for single patient use inthe home.	The F&P Evora Nasal Mask isintended to be used by adultsweighing ≥66lbs (30kgs) whohave been prescribed non-invasive positive airwaypressure therapy such as CPAPor bilevel by a physician. TheF&P Evora Nasal Mask isintended for single patient use inthe home and for multiple patientuse in the hospital or otherclinical setting where properdisinfection of the device canoccur between patient uses.	The F&P Brevida Nasal PillowsMask is intended to be used byindividuals who have beendiagnosed by a physician asrequiring CPAP or Bi-Leveltherapy. The F&P Brevida NasalPillows Mask is intended forsingle patient adult (≥66 lbs (30kg)) use in the home and formultiple patient adult use in thehospital or otherclinical setting where properdisinfection of the device canoccur between patient uses.	Substantially equivalent.Identical intended use, patientpopulation and operatingenvironment.
PatientPopulation	Adult		Adult	Identical
OperatingEnvironment	Home	Home, hospital or other clinicalsetting	Home, hospital or other clinicalsetting	Identical
	A model is intended for single patient use in the home while SLmodel is intended for single patient use in the home and for multiplepatient use in the hospital or other clinical setting.
Technical Specifications
PressureRange		4 to 25 cmH2O	4 to 25 cmH2O	Identical
Resistance toFlow	Pressure drop through small 50l/min: 1.0 ± 0.1cmH2OPressure drop through medium 50l/min: 1.0 ± 0.1cmH2OPressure drop through large 50l/min: 1.0 ± 0.1cmH2O		Pressure drop through XS-S withdiffuser 50L/min: 1.7 cmH2O +/-10	Substantially equivalent.
	Subject Device		Predicate
	F&P Evora Nasal Mask(A model)	F&P Evora Nasal Mask(SL model)	F&P Brevida Nasal PillowsMask
Device Name				Comments
	Pressure drop through wide 50l/min: 1.0 ± 0.1cmH2OPressure drop through small 100l/min: 1.4 ± 0.25cmH2OPressure drop through medium 100l/min: 1.2 ± 0.25cmH2OPressure drop through large 100l/min: 1.2 ± 0.25cmH2OPressure drop through wide 100l/min: 1.3 ± 0.25cmH2O		Pressure drop through M-L withdiffuser 50L/min: 1.0 cmH2O +/- 10Pressure drop through XS-S withdiffuser 100L/min: 6.3 cmH2O +/- 10Pressure drop through M-L withdiffuser 100L/min: 3.8 cmH2O +/- 10	The pressure drop value of thesubject device is different to thepredicate device.The subject device is in conformancewith ISO 17510:2015 and thisdifference does not introduce anyadditional risk to the user.
Dead Space	Small: 28 ccMedium: 26 ccLarge: 28 ccWide: 34 cc		XS-S: 29 ccM-L: 33 cc	Substantially equivalent.The dead space value of the subjectdevice is different to the predicatedevice.All seal sizes are in conformancewith ISO 17510:2015 and thisdifference does not introduce anyadditional risk to the user.
Sound	Sound Power Level of the Mask is 26.8 dBA, with uncertainty 2.5 dBASound Pressure Level of the Mask 18.8 dBA, with uncertainty 2.5 dBA		Sound Power Level of the Maskwith diffuser is 25.4 dBA, withuncertainty 2.5 dBASound Pressure Level of theMask with diffuser is 17.5 dBA,with uncertainty 2.5 dBASound Power Level of the Maskwithout diffuser is 30.6 dBA, withuncertainty 2.5 dBASound Pressure Level of theMask without diffuser is 22.6dBA,with uncertainty 2.5 dBA	Substantially equivalent.The average sound power andpressure level of the subject deviceis different to the predicate device.The subject device is in conformancewith ISO 17510:2015 and thisdifference does not introduce anyadditional risk to the user.
	Subject Device		Predicate
	F&P Evora Nasal Mask(A model)	F&P Evora Nasal Mask(SL model)	F&P Brevida Nasal PillowsMask	Comments
Device Name
Shelf-Life	1 year		Shelf-life not claimed on labelling	Substantially equivalent.The subject device claims a One-year shelf life with supporting data.
Cleaning and High-Level Disinfection
Sterility	Device not provided sterile		Device not provided sterile	Identical
Reusability	Single Patient Use	Reusable – Multi Patient Use	Reusable – Multi Patient Use	Identical
High LevelDisinfectionMethods	N/A	Thermal Disinfection	Thermal Disinfection	Identical
Accessories
Accessory	Oxygen/Pressure Port(900HC452)Available as a separate part, not provided with device.		Oxygen/Pressure Port(900HC452)Available as a separate part, notprovided with device.	Identical

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Conclusions

The comparison of features, performance, and intended use demonstrate that the F&P Evora Nasal Mask is the predicate F&P Brevida Nasal Pillows Mask (K161412).

Regulation Number and Section

§ 868.5905 Noncontinuous ventilator (IPPB).

(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).