The F&P Brevida™ Nasal Pillows Mask is intended to be used by individuals who have been diagnosed by a physician as requiring CPAP or Bi-Level Therapy. The F&P Brevida™ Nasal Pillows Mask is intended for single patient adult (> 66 los (30kgs)) use in the home and multiple patient adult use in the clinical setting where proper disinfection of the device can occur between patient uses.

Device Description

The F&P Brevida™ Nasal Pillows Mask is a non-invasive patient interface with a silicone seal that encloses the nasal airway entrance. The mask is held on the face with a headgear.

The mask connects to a single breathing tube by a 22mm swivel adaptor to receive pressurized gases from a continuous airway pressure device (CPAP or Bi-Level). The exhaust holes on the elbow of the mask allow exhaled gases to be flushed out while the system is in operation.

The F&P Brevida™ Nasal Pillows Mask is a prescription only device, provided in a nonsterile state.

AI/ML Overview

The provided text does not contain information about the acceptance criteria or a study proving the device meets those criteria, as typically found for complex AI/ML devices in regulatory documents. Instead, it describes a medical device, the F&P Brevida™ Nasal Pillows Mask, and its substantial equivalence to a predicate device (F&P Pilairo™ Nasal Pillows Mask) based on non-clinical performance data.

Therefore, for your request, I must state that the information asked is largely absent from the document. The document focuses on establishing "substantial equivalence" to a predicate device, a pathway that often relies on demonstrating similar technical characteristics and performance without requiring new, extensive clinical trials or specific acceptance criteria studies in the AI/ML sense.

However, I can extract the following based on the provided text's approach to "performance" and "equivalence," which are proxies for meeting certain expectations for a medical device:

A table of acceptance criteria and the reported device performance
- The document does not list explicit acceptance criteria with numerical targets for performance metrics in the way a study for a novel AI/ML diagnostic device might.
- Instead, for most characteristics, the "performance" is reported as being "Identical" to the predicate device, or in cases of differences, it is stated that the difference "does not introduce any additional risk to the user" or that it "does not introduce any new risk to the patient."
- For Dynamic Dead Space, the document provides specific values: "29.27cc (XS-S)" and "33.14cc (M-L)" for the F&P Brevida™. It states that "Both seal sizes are in conformance with ISO 17510-2 (2007)." This ISO standard would implicitly define the "acceptance criteria" for dead space, but the specific numerical limit from the standard is not provided in the text.
- For High Level Disinfection Methods, the "performance" refers to the parameters used: "Thermal Disinfection (80°C for 10 mins and 75°C for 30 mins)" and states that "The parameters used for the thermal disinfection are identical" to the predicate for thermal disinfection. It also notes "Please see Section 14 for testing of both sets of parameters," implying that testing confirmed efficacy at these parameters.
- For Seal sizes, it states that "Both seal sizes have undergone product verification and meet all product requirements." This indicates an internal set of acceptance criteria, but they are not detailed.
- For Material changes, it states that "The new materials have been assessed for biocompatibility and no additional risk to the patient was found to have been introduced due to the new materials." This implies acceptance based on passing biocompatibility assessments per ISO standards.
Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- The document states: "Substantial equivalence was not based on an assessment of clinical performance data."
- It lists non-clinical performance data which refers to bench testing against various ISO standards.
- No sample sizes for test sets are mentioned, as this is not a study assessing clinical performance on patient data.
- Data provenance is not applicable, as the "data" consists of engineering test results (e.g., dead space measurements, material biocompatibility tests, disinfection efficacy).
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. This device is a physical nasal pillows mask, not an AI/ML diagnostic or prognostic system requiring expert-established ground truth from medical images or clinical data.
Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. There is no adjudication method described because there's no diagnostic or interpretive data requiring expert consensus or review.
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
- Not applicable. This is a physical medical device (nasal mask), not an AI system, so no MRMC study with human readers or AI assistance would be relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI algorithm; it's a physical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable in the typical sense. For the technical characteristics described, "ground truth" would be established by physical measurements, chemical analyses, and adherence to engineering standards (e.g., ISO 17510-2 for dead space, ISO 10993 for biocompatibility).
The sample size for the training set
- Not applicable. This is not an AI/ML device that requires a training set.
How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device that requires a training set with established ground truth.

In summary, the provided document describes a regulatory submission for a physical medical device, not an AI/ML product. The "acceptance criteria" are implied by adherence to ISO standards and demonstrating "substantial equivalence" to a predicate device through non-clinical bench testing. The information requested, particularly concerning expert ground truth, sample sizes for test/training sets, and AI performance metrics, is not present because it's not relevant to the type of device and regulatory pathway described.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing right, stacked on top of each other, with flowing lines beneath them.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 18, 2017

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

Re: K161412

Trade/Device Name: F&P Brevida™ Nasal Pillows Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: Class II Product Code: BZD Dated: December 19, 2016 Received: December 22, 2016

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. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

{1}------------------------------------------------

the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital. Respiratory. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K161412

Device Name F&P Brevida Nasal Pillows Mask

Indications for Use (Describe)

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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for Fisher & Paykel Healthcare. The words "Fisher & Paykel" are in a large, bold, sans-serif font, with the "&" symbol in between. Below this, there is a horizontal line, and below that, the word "HEALTHCARE" is in a smaller, bold, sans-serif font. The entire logo is in a dark blue color.

5. 510(k) Summary

Contact person/submitter	Masar Mohammad
Date prepared	17 Jan 2017
Contact details	Address: 15 Maurice Paykel Place
	East Tamaki
	Auckland 2013, New Zealand
	Telephone: +64 9 574 0100
	Fax: +64 9 574 0158
Trade name	F&P Brevida™ Nasal Pillows Mask
Common name	Nasal Pillows Mask
Classification name	Non Continuous Ventilator (IPPB)
	Class II (21 CFR §868.5905)
	Product code BZD (Anaesthesiology)
Predicate device	K120027 F&P Pilairo™ Nasal Pillows Mask

Device Description 5.1.

The F&P Brevida™ Nasal Pillows Mask is a non-invasive patient interface with a silicone seal that encloses the nasal airway entrance. The mask is held on the face with a headgear.

The F&P Brevida™ Nasal Pillows Mask is a prescription only device, provided in a nonsterile state.

5.2. Intended Use

The F&P Brevida™ Nasal Pillows Mask is intended to be used by individuals who have been diagnosed by a physician as requiring CPAP or Bi-Level Therapy. The F&P Brevida™ Nasal Pillows Mask is intended for single patient adult (≥ 66lbs (30kgs)) use in the home and multiple patient adult use in the hospital or other clinical setting where proper disinfection of the device can occur between patient uses.

Technological Characteristics Comparison 5.3.

The F&P Brevida™ Nasal Pillows Mask has the following similarities to the previously cleared predicate Pilairo™ Nasal Pillows Mask (K120027).

Substantially equivalent intended use with same patient population and operating environment.
. Same mode of operation whereby both masks deliver gases through the nose.

{4}------------------------------------------------

Image /page/4/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. A horizontal line runs beneath the company name. Below the line, the word "HEALTHCARE" is written in a similar bold, sans-serif font, but slightly smaller than the company name.

Same breathing tube connection mechanism via a 22mm male connector. ●
. Same silicone seal mechanism where mask seals on the entrance of the nostrils as well as around the nose.
. Both new and predicate device headgear are designed to attach at the same two point on the mask frame.

The key differences to the predicate device are that the F&P Brevida™ Nasal Pillows Mask:

. Has colour cues (VisiBlue™) added to swivel, frame, seal, and headgear components to aid the user in the reassembly and orientation of the mask.
. Provide a diffuser system in which the diffuser mat and the cover have been integrated into a single component. This component is washable.
. Has a detachable elbow to aid in mask cleaning and disinfection during multi-patient use.
. Has an adjustable headgear.

The below table provides a side-by-side comparison of the subject and predicate devices.

Table 1: Device Comparison Table

	F&P Brevida™ NasalPillows Mask	F&P Pilairo™ NasalPillows Mask	Comments
	Indications for use and intended use
Intended use	The F&P Brevida™ NasalPillows Mask is intendedto be used by individualswho have been diagnosedby a physician asrequiring CPAP or Bi-Level Therapy. The F&PBrevida™ Nasal PillowsMask is intended forsingle patient adult (≥66lbs (30kgs)) use in thehome and multiple patientadult use in the hospital orother clinical settingwhere proper disinfectionof the device can occurbetween patient uses.	The F&P Pilairo™ NasalPillows Mask is intendedto be used by individualswho have beendiagnosed by a physicianas requiring CPAP or Bi-Level Ventilator Therapy.The F&P Pilairo™ NasalPillows Mask is intendedfor single-patient adultuse in the home andmultiple-patient adult usein the hospital or otherclinical setting whereproper disinfection of thedevice can occur betweenpatient uses.	Identical intended use and patientpopulation. The Intended Use of theF&P Brevida specifies the minimumweight of an adult patient.Specifying the weight of an adultpatient was not found to introduceany new risks to the device anddoes not alter the intended use ofthe device.
Availability	Prescription use(Part 21 CFR 801 SubpartD)	Prescription use(Part 21 CFR 801 SubpartD)	Identical
PatientPopulation	Adult	Adult	Identical
Classification
ProductCode	BZD	BZD	Identical
Deviceclassification	868.5905	868.5905	Identical
	F&P Brevida™ NasalPillows Mask	F&P Pilairo™ NasalPillows Mask	Comments
Classificationpanel	Anaesthesiology	Anaesthesiology	Identical
	Operation and safety features
OperatingEnvironment	Home, hospital or otherclinical setting	Home, hospital or otherclinical setting	Identical
BreathingCircuit	Single Inspiratory Tube	Single Inspiratory Tube	Identical
ExhalationVent	Numerous tiny vent holesin Elbow	Numerous tiny vent holesin Elbow	Identical
BreathingTubeconnection tomask	22mm ISO Taper	22mm ISO Taper	Identical
Fixation	Headgear with 2attachment points	Headgear with 2attachment points	Identical
HeadgearRelease	One hook connection perside to the mask frame	One hook connection perside to the mask frame	Identical
FaceCoverage	Direct Nasal	Direct Nasal	Identical
Dead Space	Dynamic29.27cc (XS-S)33.14cc (M-L)	Dynamic32cc (Single size)	The dead space of the small seal isless than that of the predicate,while the larger seal has more deadspace. Both seal sizes are inconformance with ISO 17510-2(2007) and this difference does notintroduce any additional risk to theuser. For additional informationplease refer to Test Report TR-27521 Attached in Appendix I.
PatientConsciousness	Responsive and able toremove mask	Responsive and able toremove mask	Identical
PressureRange	4 to 25 cm H20	4 to 25 cm H20	Identical
	Components and materials
Sterility	Device not providedsterile	Device not providedsterile	Identical
Reusability	Reusable –Multi Patient Use	Reusable –Multi Patient Use	Identical
High LevelDisinfectionMethods	Thermal Disinfection(80°C for 10 mins and75°C for 30 mins)	Sterrad 100S, Cidex OPA,Thermal Disinfection	The parameters used for thethermal disinfection are identical.Please see Section 14 for testing ofboth sets of parameters.
Facial Seal	Soft pliable seal betweenmask base and nares	Soft pliable seal betweenmask base and nares	Identical
Seal sizes	Available in two differentsizes (XS-S, and M-L)	1 size	The subject device has two seal
	F&P Brevida™ NasalPillows Mask	F&P Pilairo™ NasalPillows Mask	Comments
			not been found to introduce anyadditional risk to the patient. Bothseal sizes have undergone productverification and meet all productrequirements. Please see Section18 for details on performancetesting.
Mask Frame	Two piece coloured/clearpolycarbonate withconnection for elbow,silicone seal, andheadgear	Two piece coloured / clearpolycarbonate withconnection for siliconeseal, and headgear	The components and structure ofthe mask frame is identical,however, there have been somechanges in the materials used. Thenew materials have been assessedfor biocompatibility and noadditional risk to the patient wasfound to have been introduced dueto the new materials. Please referto Section 15 for Biocompatibilityassessment.
Mask ElbowDesign	Removable	Non-removable	The F&P Brevida™ Nasal PillowsMask has a removable elbow to aidthe user in the cleaning anddisinfection of the mask duringmulti-patient reuse.
Headgear	Adjustable headgearmade up of one strap,elastic.	Non-adjustable headgear.Headgear is elastic.	The design of the subject deviceheadgear consists of two parts. Atthe back of the headgear, twostraps form a halo which is thenconnected to a single strap oneither side. This is different to thesingle strap of the predicate device.Additionally, the headgear used inthe predicate would stretch to fit thepatient, while the subject device'sheadgear is adjustable. Thesedifferences are intended to better fita larger percentage of the patientpopulation and have not beenfound to introduce any new risk tothe patient.
Accessories
Oxygen/Pressure Port(900HC452)	Available as a separatepart, not provided withdevice.	Available as a separatepart, not provided withdevice.	Identical - The Oxygen/Pressureport is the same accessory usedwith the predicate device. Thisaccessory was cleared underK023559 and has not beenmodified.

{5}------------------------------------------------

Image /page/5/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. Underneath that, there is a blue line, and then the word "HEALTHCARE" is in a smaller, bold, blue font.

{6}------------------------------------------------

F&P Brevida™ Nasal Pillows Mask – Traditional 510(k)

Image /page/6/Picture/1 description: The image shows the logo for Fisher & Paykel Healthcare. The words "Fisher & Paykel" are in a large, bold, blue font. Below that, the word "HEALTHCARE" is in a smaller, bold, blue font. There is a blue line above the word "HEALTHCARE".

{7}------------------------------------------------

5.4. Non-Clinical Performance Data

Testing of the Brevida™ Nasal Pillows Mask was compared to the predicate K120027 F&P Pilairo™ Nasal Pillows Mask for performance. These tests demonstrate substantial equivalence of the Brevida™ Nasal Pillows Mask to the predicate device. The results of the comparative bench testing do not raise any new questions of safety or effectiveness for the F&P Brevida™ Nasal Pillows Mask.

The Brevida™ Nasal Pillows Mask has been tested to the following standards:

ISO 17510-2:2007, Sleep Apnoea Breathing Therapy- Part 2: Masks and Application . Accessories
ISO 5356-1:2004, 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 10993-6:2007, Biological evaluation of medical devices – Part 6: Tests for local effects after implantation.
. 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.

5.5. Clinical Performance Data

Substantial equivalence was not based on an assessment of clinical performance data

5.6. Conclusions

The comparison of features, performance, and intended use demonstrate that the Brevida™ Nasal Pillows Mask is substantially equivalent to the predicate K120027 F&P Pilairo™ Nasal Pillows Mask.

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).