A Model: The F&P Vitera Full Face mask is intended to be used by adults weighing ≥ 66lbs (30kgs) who have been diagnosed by a physician as requiring CPAP or Bi-Level therapy. The F&P Vitera Full Face mask is intended for single patient use in the home.

SL Model: The F&P Vitera Full Face mask is intended to be used by adults weighing ≥ 66lbs (30kgs) who have been diagnosed by a physician as requiring CPAP or Bi-Level therapy. The F&P Vitera Full Face 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.

Device Description

The F&P Vitera Full Face Mask is a non-invasive patient interface with a seal that encloses the oral and nasal airway. 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 continuous 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 Vitera Full Face Mask is a prescription only device, provided in a non-sterile state.

AI/ML Overview

This document is a 510(k) Premarket Notification for the F&P Vitera Full Face Mask. It primarily focuses on demonstrating substantial equivalence to a predicate device, the F&P Simplus Full Face Mask (K130328), rather than detailing an acceptance criteria study for a novel AI/Machine Learning (ML) enabled medical device.

Therefore, most of the requested information regarding AI/ML device acceptance criteria and study particulars (like AI performance metrics, sample sizes for test/training sets, expert consensus, MRMC studies, ground truth establishment) is not present in this document.

However, I can extract the relevant information regarding the device's performance testing and general acceptance criteria that are mentioned to support its substantial equivalence claim.

Based on the provided document, here's what can be gathered regarding acceptance criteria and performance studies for the F&P Vitera Full Face Mask:

The document aims to demonstrate that the F&P Vitera Full Face Mask is substantially equivalent to a legally marketed predicate device (F&P Simplus Full Face Mask). This means the acceptance criteria are primarily focused on showing that the new device performs comparably to the predicate and does not introduce new questions of safety or effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance (Comparative):

The acceptance criteria here are implicitly defined by compliance with relevant ISO standards and comparison to the predicate device's performance. The "Comments" column indicates whether the differences are considered acceptable or "substantially equivalent."

Characteristic / Test	Acceptance Criteria (Implicit)	Reported Device Performance (F&P Vitera Full Face Mask)	Predicate Device Performance (F&P Simplus Full Face Mask)	Substantial Equivalence Comment
Intended Use	Identical to predicate	Adults ≥ 66lbs (30kgs), CPAP/Bi-Level therapy. A model: single patient home. SL model: single patient home + multi-patient hospital/clinical.	Individuals (adults), CPAP/Bi-Level Ventilator treatment. Single-patient home + multi-patient hospital/clinical.	Substantially equivalent. Minimum weight specified in Vitera, but no new risks.
Availability	Prescription Use Only	Prescription Use Only	Prescription Use Only	Identical
Patient Population	Adult	Adult	Adult	Identical
Pressure Range	Conformance to ISO 17510:2015, no new risks	4 to 30 cmH2O	4 to 25 cmH2O	Substantially equivalent. Higher upper limit, but conforms to ISO 17510:2015, no new risk.
Resistance to Flow	Conformance to ISO 17510:2015, no new risks	• 50 L/min: 0.24 cmH2O• 100 L/min: 0.47 cmH2O	• 50 L/min: 0.17 cmH2O• 100 L/min: 0.64 cmH2O	Substantially equivalent. Conforms to ISO 17510:2015, no new risk.
Inspiratory & Expiratory Resistance	Conformance to ISO 17510:2015, no new risks	• Inspiratory: 1.05 cmH2O• Expiratory: 0.80 cmH2O	• Inspiratory: 0.67 cmH2O• Expiratory: 0.12 cmH2O	Substantially equivalent. Conforms to ISO 17510:2015, no new risk.
Dead Space	Conformance to ISO 17510:2015, no new risks	Small: 245.8 cc, Medium: 274.1 cc, Large: 321.8 cc	Small: 251 cc, Medium: 278 cc, Large: 310 cc	Substantially equivalent. Conforms to ISO 17510:2015, no new risk.
Sound	Conformance to ISO 17510:2015, no new risks	Power: 29.8 dBA, Pressure: 21.8 dBA	Power: 28.8 dBA, Pressure: 17.8 dBA	Substantially equivalent. Conforms to ISO 17510:2015, no new risk.
Shelf-Life	Supported by data	5 years	Not claimed on labeling	Substantially equivalent. Supported by data for Vitera.
Sterility	Not provided sterile	Device not provided sterile	Device not provided sterile	Identical
Reusability	Single/Multi-patient use	A model: Single Patient UseSL model: Multi Patient Use	Multi Patient Use	Identical (for SL model comparative)
High Level Disinfection Methods	Acceptable thermal disinfection parameters	Thermal: 80°C for 10 mins; 75°C for 30 mins; 90°C for 1 min	Thermal: 80°C for 10 mins	Substantially equivalent. Validated additional temp/time configurations.
CO2 Rebreathing	Not adversely affected	Data available * (tested to confirm no adverse effect)	N/A (implied acceptable for predicate)	Performance testing completed to confirm no adverse effect.
NRV Activation/Deactivation Pressure	Not adversely affected	Data available * (tested to confirm no adverse effect)	N/A (implied acceptable for predicate)	Performance testing completed to confirm no adverse effect.
Total Mask Exhaust Flow	Not adversely affected	Data available * (tested to confirm no adverse effect)	N/A (implied acceptable for predicate)	Performance testing completed to confirm no adverse effect.
Mechanical Integrity/Performance	Verified after normal/abuse scenarios	Data available * (incl. home/cleaning, multi-patient reprocessing, accelerated aging, transport/storage)	N/A (implied acceptable for predicate)	Verified after normal and reasonable abuse scenarios.
Biocompatibility	Safe for use, conform to ISO 10993/18562	Classified as externally communicating device, tissue contact, permanent duration. Tested for cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, genotoxicity, extractables, particulate/VOC emissions. Concluded safe for use with patients ≥ 30 kg.	N/A (implied acceptable for predicate)	Biological risk assessment concluded safe for use.

Note: The document states "Performance testing was completed to confirm the F&P Vitera Full Face Mask does not adversely affect safety and effectiveness" for CO2 rebreathing, NRV, and total exhaust flow. Specific numerical data for these tests are not provided in this summary, but the conclusion of non-adverse effect implies meeting an internal acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not specified in terms of number of masks or test runs for each performance criterion. The document broadly states "Performance testing... was completed to determine that device design changes... do not raise questions of safety or effectiveness."
Data Provenance: Implied to be bench testing conducted by the manufacturer, Fisher & Paykel Healthcare Ltd. The address provided is in Auckland, New Zealand, suggesting the testing likely occurred there. The data is retrospective in the sense that it supports a premarket notification for a finalized device. No clinical (human subject) test data is required or provided for this device application.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not Applicable. This document describes bench testing and comparison to a predicate device, not an AI/ML enabled device requiring human expert ground truth for image interpretation or similar tasks. The "ground truth" for performance is based on physical measurements and compliance with engineering standards.

4. Adjudication Method for the Test Set:

Not Applicable. As no human experts were involved in establishing ground truth for a test set (as in AI/ML performance evaluation), no adjudication method was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. This is not an AI/ML device, and no MRMC study was conducted or required. The study described is bench testing for mechanical and physiological characteristics, not a human reader study.

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

Not Applicable. This is a hardware medical device (a mask for CPAP/Bi-Level therapy), not an algorithm or AI/ML product.

7. The Type of Ground Truth Used:

For the performance testing, the "ground truth" is derived from:
- Engineering specifications and measurements: e.g., pressure drop, resistance, dead space, sound levels.
- Compliance with international standards: Specifically, ISO 17510:2015, ISO 5356-1:2015, ISO 10993 series (biological evaluation), and ISO 18562 series (biocompatibility of breathing gas pathways).
- Benchmarking against a predicate device: Comparisons are made to the F&P Simplus Full Face Mask.

8. The Sample Size for the Training Set:

Not Applicable. This is not an AI/ML device; therefore, there is no "training set."

9. How the Ground Truth for the Training Set was Established:

Not Applicable. As no training set exists, no ground truth needed to be established for it.

Summary

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Image /page/0/Picture/0 description: The image shows 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 square are the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" below it.

October 11, 2019

Fisher & Paykel Healthcare Ltd. Masar Mohammad Senior Regulatory Affairs Specialist 15 Maurice Paykel Place, East Tamaki Auckland, 2013 New Zealand

Re: K190713

Trade/Device Name: F&P Vitera Full Face Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous ventilator (IPPB) Regulatory Class: Class II Product Code: BZD Dated: September 18, 2019 Received: September 20, 2019

Dear Masar Mohammad:

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,

for

Michael Ryan Division 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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K190713

Device Name F&P Vitera Full Face Mask

Indications for Use (Describe)

SL Model: The F&P Vitera Full Face mask is intended to be used by adults weighing ≥ 661bs (30kgs) who have been diagnosed by a physician as requiring CPAP or Bi-Level therapy. The F&P Vitera Full Face 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.

X 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/1 description: The image shows the logo for Fisher & Paykel Healthcare. The words "Fisher & Paykel" are in a bold, sans-serif font, with the "&" symbol connecting the two names. Below the names is a horizontal line, and below that is the word "HEALTHCARE" in a similar font, but slightly smaller than the names above.

510(k) Summary 5

As Required by 21 CFR 807.92 (c)

Contact person/submitter	Masar Mohammad
Date prepared	11 October 2019
Contact details	Address: 15 Maurice Paykel PlaceEast TamakiAuckland 2013, New ZealandTelephone: +64 9 574 0100
Trade name	F&P Vitera Full Face Mask
Common name	Full Face Mask
Classification name	Non Continuous Ventilator (IPPB)Class II (21 CFR §868.5905)Product code BZD (Anaesthesiology)
Predicate device	F&P Simplus™ Full Face Mask (K130328)

5.1 Device Description

The F&P Vitera Full Face Mask is a prescription only device, provided in a non-sterile state.

Refer below to Vitera Full Face Mask part numbers that are used to differentiate the mask sizes and models.

Sizes	A model	SL model
Small	VIT1SAVitera Mask Full Face Small AVIT1SSA Vitera Mask Seal / Small A	VIT1SSL Vitera Mask Full Face SmallSleep Lab
Medium	VIT1MAVitera Mask Full Face Medium AVIT1MMA Vitera Mask Seal Medium /Medium A	VIT1MSL Vitera Mask Full FaceMedium Sleep Lab
Large	VIT1LAVitera Mask Full Face Large AVIT1LLA Vitera Mask Seal / Large A	VIT1LSL Vitera Mask Full Face LargeSleep Lab

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Intended Use / Indications for Use 5.2

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Technological Characteristics Comparison 5.3

5.3.1 Similarities between the subject and predicate devices:

The F&P Vitera Full Face mask has the following similarities to the previously cleared predicate Simplus Full Face Mask.

Same intended use with same patient population and operating environment.
Same product code, device classification and classification panel.
Same breathing circuit which is a single inspiratory tube with the connection ● mechanism via a 22mm male connector.
Same mode of operation whereby masks deliver gases through the nose and mouth.
Same seal and headgear size category. ●
Same exhaust system consisting of a series of holes on the facial seal. ●
. Both have a single non-rebreathing valve (NRV) flap design on the elbow.
Same axis rotation between the elbow and the tube.
Both are prescription devices only that can be reprocessed. ●
Same mask components and accessory.

5.3.2 Differences between the subject and predicate devices:

The key differences to the predicate device are that the F&P Vitera Full Face mask:

. Has colour cues (VisiBlue™) added to swivel, frame, and headgear components to aid the user in the reassembly and orientation of the mask.
- The headgear been modified:
  - Materials: o

●

트 VentiCool™: has a new mesh fabric designed to improve breathability by allowing air and moisture to escape.
. Soft tab: has a new tab material to assist the user during headgear adjustments.
. Headgear clips: has a new clip material to assist the user during the assembly and disassembly of the headgear to the mask.
Headgear Release and Clips: the headgear has only 3 connection points to the O frame due to the introduction of a new forehead clip. The buckle on the crown strap of the predicate headgear has been removed as its functions have been integrated into the subject device headgear.
Has a detachable elbow to aid in mask cleaning and disinfection during multi-patient use.
The NRV flap that has a sealing bead along with a curved hinge. Also, it features two locating prongs with the Elbow Lower component.
Has "RollFit™ XT" that adapts to the face and allows for a greater range of motion. ●

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Non-Clinical Performance Data 5.4

Performance testing of the F&P Vitera Full Face Mask was completed to determine that device design changes, compared to F&P Simplus Full Face Mask (K130328) do not raise questions of safety or effectiveness. These tests demonstrate substantial equivalence of the F&P Vitera Full Face Mask to the predicate device. A summary of the testing conducted for the F&P Vitera Full Face 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 Vitera Full Face Mask does not adversely affect safety and effectiveness.
- CO2 rebreathing during normal use and single fault conditions o
- Non-rebreathing valve (NRV) activation / deactivation pressure o
- Total mask exhaust flow o
- 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; multipatient use/reprocessing; accelerated ageing (shelf life) and simulated transportation and storage.

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Testing of the F&P Vitera Full Face Mask was compared to the predicate F&P Simplus Full Face Mask (K130328) for performance. These tests demonstrate substantial equivalence of the F&P Vitera Full Face Mask to the predicate device. The results of the comparative bench testing do not raise any new or different questions of safety or effectiveness for the F&P Vitera Full Face Mask.

The F&P Vitera Full Face 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 10993-1:2009, 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
. 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 10993-11:2006, 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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Image /page/8/Picture/1 description: The image shows the logo for Fisher & Paykel Healthcare. The words "Fisher & Paykel" are in a bold, dark blue font on the top line. Underneath, there is a blue line, and then the word "HEALTHCARE" is in a smaller, bold, dark blue font.

	Subject Device		Predicate	Comments
Device Name	F&P Vitera Full Face Mask(A model)	F&P Vitera Full Face Mask(SL model)	F&P Simplus Full Face Mask

	Indications for use and intended use
Intended Use	The F&P Vitera Full Facemask is intended to be used byadults weighing ≥ 66lbs(30kgs) who have beendiagnosed by a physician asrequiring CPAP or Bi-Leveltherapy. The F&P Vitera FullFace mask is intended forsingle patient use in the home.	The F&P Vitera Full Face maskis intended to be used byadults weighing ≥ 66lbs(30kgs) who have beendiagnosed by a physician asrequiring CPAP or Bi-Leveltherapy. The F&P Vitera FullFace mask is intended forsingle patient use in the homeand for multiple patient use inthe hospital or other clinicalsetting where properdisinfection of the device canoccur between patient uses.	The F&P Simplus Full FaceMask is intended to be used byindividuals who have beendiagnosed by a physician asrequiring CPAP or Bi-LevelVentilator treatment. The F&PSimplus Full Face Mask isintended for single-patient adultuse in the home and multiple-patient adult use in the hospitalor other clinical setting whereproper disinfection of the devicecan occur between patients.	Substantially equivalent.Identical intended use, patientpopulation and operatingenvironment.The Intended Use of the F&P Viteraspecifies the minimum weight of anadult patient. Specifying the weightof an adult patient was not found tointroduce any new risks to thedevice and does not alter theintended use of the device.
Availability	Prescription use only		Prescription use only	Identical
PatientPopulation	Adult		Adult	Identical
Classification
Product Code	BZD		BZD	Identical
Deviceclassification	868.5905		868.5905	Identical
Classificationpanel	Anaesthesiology		Anaesthesiology	Identical
	Subject Device		Predicate	Comments
Device Name	F&P Vitera Full Face Mask(A model)	F&P Vitera Full Face Mask(SL model)	F&P Simplus Full Face Mask
OperatingEnvironment	Home	Home, hospital or other clinicalsettingA model is intended for single patient use in the home while SLmodel is intended for single patient use in the home and formultiple patient use in the hospital or other clinical setting.	Home, hospital or other clinicalsetting	Identical
Technical Specifications
PressureRange	4 to 30 cmH2O		4 to 25 cmH2O	Substantially equivalent.The upper pressure limit has beenincreased on the subject devicemask allowing the mask to be usedat higher pressures if required.The subject device is inconformance with ISO 17510:2015and the change to the upperpressure limit does not introduceany additional risk to the user.
Resistance toFlow	• Pressure drop through the mask at 50 L/min: 0.24 cmH2O• Pressure drop through the mask at 100 L/min: 0.47 cmH2O		• Pressure drop through themask at 50 L/min: 0.17 cmH2O• Pressure drop through themask at 100 L/min: 0.64 cmH20	Substantially equivalent.The subject device is inconformance with ISO 17510:2015and this difference does notintroduce any additional risk to theuser.
Inspiratory &ExpiratoryResistance	• Inspiratory Resistance: 1.05 cmH2O• Expiratory Resistance: 0.80 cmH2O		• Inspiratory Resistance: 0.67cmH2O• Expiratory Resistance: 0.12cmH2O	Substantially equivalent.The subject device is inconformance with ISO 17510:2015and this difference does notintroduce any additional risk to theuser.
	Subject Device		Predicate	Comments
Device Name	F&P Vitera Full Face Mask(A model)	F&P Vitera Full Face Mask(SL model)	F&P Simplus Full Face Mask
Dead Space		Small: 245.8 cc Medium: 274.1 cc Large: 321.8 cc	Small: 251 cc Medium: 278 cc Large: 310 cc	Substantially equivalent.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: 29.8 dBA, with uncertainty 2.5 dBA Sound Pressure Level of the Mask: 21.8 dBA, with uncertainty 2.5 dBA	Sound Power Level of the Mask: 28.8 dBA, with uncertainty 2.5 dBA Sound Pressure Level of the Mask: 17.8 dBA, with uncertainty 2.5 dBA	Substantially equivalent.The subject device is inconformance with ISO 17510:2015and this difference does notintroduce any additional risk to theuser.
Shelf-Life	5 years		Shelf-life not claimed onlabelling	Substantially equivalent.The subject device claims a 5-yearshelf 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:80°C for 10 mins75°C for 30 mins90°C for 1 min	Thermal Disinfection:80°C for 10 mins	Substantially equivalent.The parameters used for thethermal disinfection are identical.Additional temp/time configurationshave been validated for the subjectdevice (75°C for 30 mins and 90°Cfor 1 min)
	Subject Device		Predicate	Comments
Device Name	F&P Vitera Full Face Mask(A model)	F&P Vitera Full Face Mask(SL model)	F&P Simplus Full Face Mask
Accessories
Accessory	Oxygen/Pressure Port(900HC452)Available as a separate part, not provided with device.		Oxygen/Pressure Port(900HC452)Available as a separate part, not provided with device.	Identical

Table 1: Comparison of Technological Characteristics with the Predicate Device

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Image /page/9/Picture/0 description: The image shows the logo for Fisher & Paykel Healthcare. The words "Fisher&Paykel" are in a large, bold, blue font on the top line. Below that is a blue line, and below that is the word "HEALTHCARE" in a smaller, bold, blue font.

F&P Vitera Full Face Mask – Traditional 510(k)

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Image /page/10/Picture/0 description: The image shows the logo for Fisher & Paykel Healthcare. The words "Fisher&Paykel" are in a bold, blue font. Below that, the word "HEALTHCARE" is also in a bold, blue font and underlined with a blue line.

F&P Vitera Full Face Mask – Traditional 510(k)

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Image /page/11/Picture/0 description: The image shows the logo for Fisher & Paykel Healthcare. The words "Fisher&Paykel" are on the top line in a bold, sans-serif font. Below that is a horizontal line, and below that is the word "HEALTHCARE" in a similar font.

F&P Vitera Full Face Mask – Traditional 510(k)

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Image /page/12/Picture/1 description: The image shows the logo for Fisher & Paykel Healthcare. The words "Fisher & Paykel" are in a large, bold, blue font on the top line. Below that is a blue line, and below that is the word "HEALTHCARE" in a smaller, bold, blue font.

Clinical Performance Data 5.5

Clinical study was not required to demonstrate Substantial equivalence.

Biocompatibility 5.6

The F&P Vitera Full Face Mask is classified as an externally communicating device, tissue contact, permanent duration (>30 days). Cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, genotoxicity, and extractables evaluations were conducted based on applicable ISO 10993 test standards and particulate and volatile organic compound (VOC) emissions were evaluated based on ISO 18562. Additionally, a biological risk assessment was conducted on the biocompatibility results and concluded the F&P Vitera Full Face Mask is considered safe for use with patients ≥ 30 kg.

Accessories and Spare Parts 5.7

F&P Vitera Full Face Mask has one accessory and multiple spare parts.

Accessory:
F&P Vitera Full Face Mask has the below accessory that is packaged and sold separately.
o Oxygen Pressure Port Connector

Spare Parts: .

F&P Vitera Full Face Mask has the below device components which are available for purchase as spare parts:

Vitera Seal Small o
Vitera Seal Medium O
Vitera Seal Large O
Vitera Headgear Medium / Large Vitera Clips and Forehead Clip o (clips are assembled with the headgear and sold together)
Vitera Headgear Small Vitera Clips and Forehead Clip O (clips are already assembled with the headgear and sold together)
Vitera Clips and Forehead Clip O (Clips can be purchased separately from the headgear)
O Vitera Elbow
o Swivel

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Image /page/13/Picture/1 description: The image shows the logo for Fisher & Paykel Healthcare. The words "Fisher & Paykel" are in a large, bold, blue font on the top line. Below that, the word "HEALTHCARE" is in a smaller, bold, blue font. There is a blue line above the word "HEALTHCARE".

5.8 Mask Models

Two proposed model variants of Vitera will be made available for sale in the United States:

Vitera A model is intended for single patient use in the home. ●
Vitera SL model 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.

Mask Models Sizes 5.8.1

Both models are available in 3 sizes, Small, Medium and Large.

Mask Models Similarities 5.8.2

The F&P Vitera Full Face Mask design is identical in A and SL models.

5.8.3 Mask Models Differences

The only differences between F&P Vitera Full Face Mask A and SL models are in the labelling content. Differences include: product labels, user instructions, disinfection quide, product direct marking and packaging (product bag) and content.

Conclusions 5.9

The comparison of features, performance, and intended use demonstrate that the F&P Vitera Full Face Mask is substantially equivalent to the predicate F&P Simplus Full Face Mask (K130328).

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).