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

Device Description

The F&P Nova Micro Pillows Mask is a non-invasive, Positive Airway Pressure (PAP) therapy nasal pillows mask with a silicone seal that seals the nasal airway entrance of the Nova Micro Pillows Mask is designed to aid in the delivery of PAP by providing an interface between the flow generator and tubing, and the patient. The Nova Micro Pillows Mask features a pillows cushion with prongs that extrance of the patient's nasal nares, held in place by adjustable headgear straps. The Nova Micro Pillows Mask is a prescription-only device, provided in a non- sterile state. The F&P Nova Micro Pillows Maskrange is available in three cushion sizes – Small, Medium, and Large. The mask has two models: A-Model and Sleeplab (SL) A-Models are identical except for their Indications for Use, Operating Environment, and Reusability. The A-Model is intended to be single-patient use in the home, while the SL A-Model is intended to be used on multiple patients in a hospital or other clinical setting where proper disinfection of the device can occur between patient uses.

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA regarding the F&P Nova Micro Pillows Mask. It primarily focuses on demonstrating substantial equivalence to a predicate device based on indications for use, technological characteristics, and non-clinical performance data.

However, the provided text does not contain the specific information requested about acceptance criteria and a study proving a device meets these criteria in the context of AI/ML performance. This document describes a medical device (a CPAP mask) that is not an AI/ML device according to the information provided. Therefore, there is no discussion of performance metrics like accuracy, specificity, sensitivity, or the methodology of an AI/ML study (e.g., sample size for AI training/test sets, expert adjudication methods, MRMC studies, or ground truth establishment).

The "Performance Data" section (Section VII) lists various non-clinical tests performed on the mask, such as Cleaning Validation, Leak, Dead Space Analysis, CO2 Rebreathing, Pressure-Flow Curve, Resistance to Flow, Vibration and Noise, Human Factors/Usability Engineering, Mechanical Integrity, and Shelf-Life. These are standard engineering and safety tests for a physical medical device, not performance evaluations for an AI/ML algorithm.

Therefore, I cannot provide the requested table or details about an AI/ML study from the given text. The information is simply not present because the device described is not an AI/ML device.

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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 23, 2024

Fisher and Paykel Healthcare Limited Reena Daken Regulatory Affairs Manager 15 Maurice Paykel Place, East Tamaki Auckland, 2013 New Zealand

Re: K233829

Trade/Device Name: F&P Nova Micro Pillows Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: Class II Product Code: BZD Dated: November 30, 2023 Received: December 1, 2023

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Digitally signed by Binov J. Binoy J. Mathews -S Mathews -S Date: 2024.08.23 12:36:10 -04'00

For Rachana Visaria Assistant Director DHT1C: Division of Anesthesia, Respiratory, and Sleep Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K233829

Device Name F&P Nova Micro Pillows Mask

Indications for Use (Describe)

A-Model

SLA-Model

The F&P Nova Micro Pillows Mask is intended to be used by adults weighing ≥ 66 lbs (30kgs) who have been prescribed non-invasive positive airway pressure therapy such as CPAP or bi-level by a physician. The F&P Nova Micro Pillows Mask is intended for single-patient use in the home and for multiple-patient use in the hospital or other clinical settings 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

SUBMITTER I.

Company Name and Address	Fisher & Paykel Healthcare Limited
	15 Maurice Paykel Place
	East Tamaki
	Auckland 2013, New Zealand
	Telephone: +64 9 574 0100
Prepared and Submitted by	Jung Yun Lee
	Regulatory Affairs Associate
Contact Person	Reena Daken
	Regulatory Affairs Manager
	Telephone: +64 9 574 0100
	Email: reena.daken@fphcare.co.nz
Date Prepared	01 December 2023

II. DEVICE

Name of Device	F&P Nova Micro Pillows Mask
Common/Usual Name	Pillows Mask
Classification Name	Non Continuous Ventilator (IPPB)
Regulatory Class	Class II (21 CFR §868.5905)
Product Code	BZD

III. PREDICATE DEVICE

Predicate device: F&P Solo Mask Range, K223696

DEVICE DESCRIPTION IV.

The Nova Micro Pillows Maskrange is available in three cushion sizes – Small, Medium, and Large.

The mask has two models: A-Model and Sleeplab (SL) A-Models are identical except for their Indications for Use, Operating Environment, and Reusability. The A-Model is intended to be single-patient use in the home, while the SL A-Model is intended to be used on multiple patients in a hospital or other clinical setting where proper disinfection of the device can occur between patient uses.

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A list of products codes in the scope of this submission is provided in table below:

Model	Product Code	Product Description
A-ModelThe A-Model is intended for single-patient use in a home environment only. The mask is available in three different sizes (S, M, L).	NVP1SA	Nova Micro Pillows Mask Small A Model
	NVP1MA	Nova Micro Pillows Mask Medium A Model
	NVP1LA	Nova Micro Pillows Mask Large A Model
Fit Pack A-ModelThe A-Model Fit Pack is intended for single-patient use in a home environment only.	NVP1SMLA	Nova Micro Pillows Mask Fit Pack/SML A Model
SL A-ModelThe Sleep Lab A-Model is intended for single-patient use in a home environment as well as for multi-patient use in the hospital or other clinical setting. The mask is available in three different sizes (S, M, L).	NVP1SSLA	Nova Micro Pillows Mask Small Sleep Lab A
	NVP1MSLA	Nova Micro Pillows Mask Medium Sleep Lab A
	NVP1LSLA	Nova Micro Pillows Mask Large Sleep Lab A
Fit Pack SL A-ModelThe Sleep Lab A-Model Fit Pack is intended for single-patient use in a home environment as well as for multi-patient use in the hospital or other clinical setting.	NVP1SMLSLA	Nova Micro Pillows Mask Fit Pack Sleep Lab A

In addition to the main models, the following accessory and spare parts will be available:

· Accessory: Oxygen / Pressure Port Connector (900HC452), which will be packaged and sold separately.

· Spare components: The following spare components will be packaged and sold separately:

o Nova Micro Pillows Cushion Spare (available in Small, Medium, Large)

o Nova Micro Pillows Headgear Spare

o Nova Micro Pillows Mask (without Headgear) Spare (available in Small, Medium, Large)

o Nova Micro Pillows Frame Assembly Spare

INDICATIONS FOR USE V.

A-Model

The F&P Nova Micro Pillows Mask is intended to be used by adults weighing ≥ 66 lbs (30kgs) who have been prescribed non-invasive positive arrway pressure therapy such as CPAP or bi-level by a physician. The F&P Nova Micro Pillows Mask is intended for single-patient use in the home.

SLA-Model

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

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COMPARISON OF TECHNOLOGICAL CHARATCERISTICS WITH THE PREDICATE DEVICE VI.

Design/TechnologicalCharacteristic	Subject DeviceF&P Nova Micro Pillows Mask	Predicate DeviceF&P Solo (Pillows) Mask (K223696)	Comments
Classification
Legal Manufacturer	Fisher & Paykel Healthcare Limited	Fisher & Paykel Healthcare Limited
Product Code	BZD	BZD	Identical
Device Classification	21 CFR §868.5905	21 CFR §868.5905
Classification Panel	Anesthesiology	Anesthesiology
	Indications for Use/Intended Use
Indications for Use/Intended Use	For mask models intended for singlepatient use only:The F&P Nova Micro Mask is intended tobe used by adults weighing ≥ 66 lbs (30kgs) who have been prescribed non-invasive positive airway pressure therapysuch as CPAP or Bi-Level by a physician.The Solo PAP mask is intended for single-patient use in the home.	For mask models intended for singlepatient use only:The F&P Solo Mask is intended to be usedby adults weighing ≥ 66 lbs (30 kgs) whohave been prescribed non-invasive positiveairway pressure therapy such as CPAP orBi-Level by a physician. The Solo PAPmask is intended for single-patient use inthe home.	Identical
	For mask models intended for singlepatient and multi-patient use:The F&P Nova Micro Mask is intended tobe used by adults weighing ≥ 66lbs (30kgs) who have been prescribed non-invasive positive airway pressure therapysuch as CPAP or Bi-Level by a physician.	For mask models intended for singlepatient and multi-patient use:The F&P Solo Mask is intended to be usedby adults weighing ≥ 66 lbs (30 kgs) whohave been prescribed non-invasive positiveairway pressure therapy such as CPAP orBi-Level by a physician. The F&P Solo
Design/TechnologicalCharacteristic	Subject DeviceF&P Nova Micro Pillows Mask	Predicate DeviceF&P Solo (Pillows) Mask (K223696)	Comments
	The F&P Nova Micro Pillows Mask isintended for single-patient use in the homeand for multiple patient use in the hospitalor other clinical setting where properdisinfection of the device can occurbetween patient uses.	Mask is intended for single-patient use inthe home and for multiple patient use in thehospital or other clinical setting whereproper disinfection of the device can occurbetween patient uses.
Availability	Prescription use only	Prescription use only	Identical
Patient Population	Adults weighing ≥ 66lbs (30 kgs)	Adults weighing ≥ 66lbs (30 kgs)	Identical
Patient Consciousness	Responsive and able to remove mask	Responsive and able to remove mask	Identical
Operation and features
Operating Environment	Home, hospital or other clinical setting	Home, hospital or other clinical setting	Identical
Face Coverage	Nasal Pillows	Nasal Pillows	Identical
Operating TemperatureRange	5 to 40 °C (41 to 104 °F).	5 to 40 °C (41 to 104 °F).	Identical
Breathing Circuit	Single Inspiratory Tube	Single Inspiratory Tube	Identical
Breathing Tubeconnection to mask	22mm ISO Taper	22mm ISO Taper	Identical
Cushion sizes	Available in three sizes:Small, Medium, Large	Available in three sizes:Small, Medium, Large	Identical
Headgear Sizes	One size	One size	Identical
Exhalation Vent	Numerous vent holes in mask frame	Numerous vent holes in mask frame	Identical
Technical Specifications
Pressure Range	4 to 25 cm H2O	4 to 20 cm H2O	The subject device is designed to be i
Design/TechnologicalCharacteristic	Subject DeviceF&P Nova Micro Pillows Mask	Predicate DeviceF&P Solo (Pillows) Mask (K223696)	Comments
Resistance to Flow	Pressure drop through the mask at 50 L/min:Small cushion: 2.0 ± 0.2 cmH2OMedium cushion: 0.9 ± 0.2 cmH2OLarge cushion: 0.7 ± 0.2 cmH2O	Pressure drop through the Pillows mask at 50 L/min:Small cushion: 2.17 cmH2OMedium cushion: 1.05 cmH2OLarge cushion: 0.89 cmH2O	The subject device is designed to be inconformance with ISO 17510:2015 andthe pressure drop is disclosed in labellingin accordance with ISO 17510:2015.
	Pressure drop through the mask at 100L/min:Small cushion: 7.9 ± 1.0 cmH2OMedium cushion: 3.8 ± 1.0 cmH2OLarge cushion: 3.1 ± 1.0 cmH2O	Pressure drop through the Pillows mask at100 L/min:Small cushion: 8.56 cmH2OMedium cushion: 4.42 cmH2OLarge cushion: 3.83 cmH2O
Dead Space	Small: 14.1 ccMedium: 14.2 ccLarge: 18.2 cc	Small: 25.8 ccMedium: 27.7 ccLarge: 30.5 cc	Measured dead space is disclosed inlabelling in accordance with ISO17510:2015.
Sound	The sound power level of the mask is 21.4dBA, with uncertainty 2.5 dBA.	The sound power level of the mask is 31.5dBA, with uncertainty 2.5 dBA	Measured sound power level is disclosedin labelling in accordance with ISO17510:2015.
	The sound pressure level of the mask is13.45 dBA, with uncertainty 2.5 dBA.	The sound pressure level of the mask 23.6dBA, with uncertainty 2.5 dBA
Shelf-Life	3 years	2 years	The subject device claims a 3-year shelflife.
Cleaning and High-Level Disinfection
Design/TechnologicalCharacteristic	Subject DeviceF&P Nova Micro Pillows Mask	Predicate DeviceF&P Solo (Pillows) Mask (K223696)	Comments
Sterility	Device not provided sterile	Device not provided sterile	Identical
Reusability	Reusable - Multi Patient Use	Reusable - Multi Patient use	Identical
High-Level DisinfectionMethods	Thermal Disinfection:75°C (167°F) for 30 mins80°C (176°F) for 10 mins90°C (194°F) for 1 minChemical Disinfection:CIDEX OPA, MetriCide OPA Plus andRapicide OPA/28.12-minute soak at 20°C.Mask assembly only – headgear is excludedfrom reprocessing by chemical disinfection.	Thermal Disinfection:75°C (167°F) for 30 mins80°C (176°F) for 10 mins	The subject device has identicaldisinfection methods, except for theadditional thermal disinfection method at90°C, and chemical disinfection method.
Design / ComponentsMask Components	• Cushion• Frame• Headgear• Tube• Swivel	• Cushion• Frame• Headgear• Tube• Swivel	Identical

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VII. PERFORMANCE DATA

Summary of Non-Clinical Tests

· Cleaning Validation
· High-Level Disinfection Validation
· Leak
· Dead Space Analysis
CO2 Rebreathing .
· Pressure-Flow Curve
Exhaust Flow .
Resistance to Flow (Pressure Drop) .
· Vibration and Noise
Human Factors/Usability Engineering
· Mechanical Integrity
· Shelf-Life, Storage and Transportation

The F&P Nova Micro Mask has been tested to applicable requirements to the following standards:

· ISO 17510:2015 Sleep apnoea breathing therapy Masks and application accessories.
· ISO 5356-1:2015 Anesthetic and respiratory equipment Conical connectors: Part 1: Cones and sockets
· ASTM F1980-21 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
· ISO 10993-1:2018 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
· 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 10993-10:2021 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 10993-17:2023 Biological evaluation of medical devices Part 17: Toxicological risk assessment of medical device constituents
· ISO 10993-18:2020 Biological evaluation of medical devices Part 18: Chemical characterization of medical device materials within a risk management process
· ISO 10993-23:2021 Biological evaluation of medical devices Part 23: Tests for irritation
· ISO 18562-1:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process

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· ISO 18562-2 Biocompatibility evaluation of breathing gas pathways in healthcare applications -Part 2: Tests for emissions of particulate matter
· ISO 18562-3 Biocompatibility evaluation of breathing gas pathways in healthcare applications -Part 3: Tests for emissions of volatile organic compounds (VOCs)
ISO/TS 21726:2019 Biological evaluation of medical devices Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
ISTA 2A Packaged-Products 150 lb (68 kg) or less

VIII. CONCLUSION

The F&P Nova Micro Pillows Mask is substantially equivalent to the predicate based on patient population, intended uses, comparison of the technological characteristics and performance. In addition, the conclusions drawn from the non-clinical tests demonstrate that the device is substantially equivalent to the legally marketed predicate device.

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).