(210 days)
F&P Eson 2 Nasal Mask, K153505
No.
The document describes a nasal mask for PAP therapy and mentions no AI, ML, or DNN.
No.
The device is a mask that aids in the delivery of Positive Airway Pressure (PAP) therapy, but it is not the therapeutic device itself. The mask provides an interface between the flow generator (therapeutic device) and the patient.
No
Explanation: The device is a nasal mask used to deliver positive airway pressure therapy, not to diagnose a condition. Its function is to provide an interface for delivering therapy, not to measure or identify a medical condition.
No
The device description clearly states it is a "non-invasive, Positive Airway Pressure (PAP) therapy nasal mask that features an over-the-nose cushion", which entails physical components and not just software. The non-clinical tests and applicable standards listed also focus on hardware-related aspects like cleaning validation, mechanical integrity, and biocompatibility, further confirming it is a physical medical device.
No.
The device is a nasal mask used for delivering non-invasive positive airway pressure therapy. It does not perform in vitro examination of specimens derived from the human body.
N/A
Intended Use / Indications for Use
A-Model: The F&P Nova Nasal Mask is intended to be used by adults aged 22 years and older weighing ≥ 66 lb (30 ks) who have been prescribed non-invasive positive airway pressure therapy such as CPAP or Bi-Level by a physician. The Nova Nasal mask is intended for single-patient use in the home.
SLA-Model: The F&P Nova Nasal mask is intended to be used by adults aged 22 years and older weighing ≥ 66 lb (30 kg) who have been prescribed non-invasive positive airway pressure therapy such as CPAP or Bi-Level by a physician. The Nova 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.
Product codes
BZD
Device Description
The F&P Nova Nasal Mask is a non-invasive, Positive Airway Pressure (PAP) therapy nasal mask that features an over-the-nose cushion that seals the patient's nose, held in place by adjustable headgear straps. The mask is designed to aid in the delivery of PAP by providing an interface between the flow generator and tubing, and the patient. The F&P Nova Nasal Mask is a prescription-only device, provided in a non-sterile state.
The Nova Nasal Mask range is available in three cushion sizes – Small, Medium, and Large.
The mask has two models: A-Model and Sleeplab (SL) A-Model. Both 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.
A list of product codes in the scope of this submission includes:
A-Model: The A-Model is intended for single-patient use in a home environment only. The mask is available in three different sizes (S, M, L).
NVN1SA: Nova Nasal Mask Small A-Model
NVN1MA: Nova Nasal Mask Medium A-Model
NVN1LA: Nova Nasal Mask Large A-Model
Fit Pack A-Model: The A-Model Fit Pack is intended for single-patient use in a home environment only.
NVN1SMLA: Nova Nasal Mask Fit Pack/SML A-Model
SLA-Model: The Sleep Lab A-Model is intended for single-patient use in a home environment as well a for multi-patient use in the hospital or other clinical setting. The mask is available in three different sizes (S, M, L).
NVN1SSLA: Nova Nasal Mask Small Sleep Lab A-Model
NVN1MSLA: Nova Nasal Mask Medium Sleep Lab A-Model
NVN1LSLA: Nova Nasal Mask Large Sleep Lab A-Model
Fit Pack SLA-Model: The 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.
NVN1SMLSLA: Nova Nasal Mask Fit Pack Sleep Lab A-Model
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:
Nova Nasal Cushion Spare (available in Small, Medium, Large)
Nova Nasal Mask Headgear Spare (available in Small, and Medium-Large)
Nova Nasal Mask (without Headgear) Spare (available in Small, Medium, Large)
Nova Nasal Mask Frame Assembly Spare
Nova Nasal Tube Clip Spare
Nova Nasal Diffuser Spare
Nova Nasal Headgear Pad Spare
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nasal
Indicated Patient Age Range
Adults aged 22 years and older
Intended User / Care Setting
Prescription use only.
A-model: Single-patient use in the home.
SLA-model: 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.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Summary of Non-Clinical Tests:
- Cleaning Validation
- High-Level Disinfection Validation
- Leak
- CO2 rebreathing during normal use
- Resistance to flow and Pressure Drop
- Total mask exhaust flow
- Vibration and Noise Testing
- Dead Space Analysis
- Human Factors/Usability Engineering
- Mechanical Integrity
- Shelf-Life, Storage and Transportation
The F&P Nova Nasal 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
- ISTA 2A:2011 Procedure 2A: Packaged-Products weighing 150 lb (68 kg) or less. Basic requirements: Atmospheric conditioning, compression, fixed displacement or random vibration, and shock vibration
- ASTM F1980-16 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 skin sensitization
- ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
- ISO 10993-17:2002 Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances
- 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
- ISO 18652-2:2017 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
- ISO 17664-1:2021 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices
- ISO 17664-2:2021 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices.
The F&P Nova Nasal Mask is substantially equivalent to the predicate device 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
F&P Evora Nasal Mask, K200089
Reference Device(s)
F&P Eson 2 Nasal Mask, K153505
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
U.S. Food & Drug Administration 510(k) Clearance Letter
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
June 18, 2025
Fisher & Paykel Healthcare Limited
Reena Daken
Regulatory Affairs Manager
15 Maurice Paykel Place, East Tamaki
Auckland, 2013
New Zealand
Re: K243583
Trade/Device Name: F&P Nova Nasal Mask
Regulation Number: 21 CFR 868.5905
Regulation Name: Noncontinuous Ventilator (IPPB)
Regulatory Class: Class II
Product Code: BZD
Dated: May 19, 2025
Received: May 19, 2025
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"
Page 2
K243583 - Reena Daken Page 2
(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).
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 (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-reporting-combination-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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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).
Page 3
K243583 - Reena Daken Page 3
Sincerely,
Rachana Visaria -S
Rachana Visaria, Ph.D.
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
Enclosure
Page 4
FORM FDA 3881 (8/23) Page 1 of 1
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known): K243583
Device Name: F&P Nova Nasal Mask
Indications for Use (Describe)
A-Model
The F&P Nova Nasal Mask is intended to be used by adults aged 22 years and older weighing ≥ 66 lb (30 ks) who have been prescribed non-invasive positive airway pressure therapy such as CPAP or Bi-Level by a physician. The Nova Nasal mask is intended for single-patient use in the home.
SLA-Model
The F&P Nova Nasal mask is intended to be used by adults aged 22 years and older weighing ≥ 66 lb (30 kg) who have been prescribed non-invasive positive airway pressure therapy such as CPAP or Bi-Level by a physician. The Nova 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.
Type of Use (Select one or both, as applicable)
☒ 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
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Paperwork Reduction Act (PRA) Staff
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"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."
Page 5
510(k) Summary
As Required by 21 CFR 807.92
Page 1 of 7
K243583
I. SUBMITTER
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 Specialist
Contact Person: Reena Daken
Regulatory Affairs Manager
Telephone: +64 9 574 0100
Email: reena.daken@fphcare.co.nz
Date Prepared: 19 May 2025
II. DEVICE
Name of Device: F&P Nova Nasal Mask
Common/Usual Name: Nasal Mask
Classification Name: Non Continuous Ventilator (IPPB)
Regulatory Class: Class II (21 CFR §868.5905)
Product Code: BZD (Anaesthesiology)
III. PREDICATE DEVICE
Predicate device: F&P Evora Nasal Mask, K200089.
Reference device: F&P Eson 2 Nasal Mask, K153505.
IV. DEVICE DESCRIPTION
The F&P Nova Nasal Mask is a non-invasive, Positive Airway Pressure (PAP) therapy nasal mask that features an over-the-nose cushion that seals the patient's nose, held in place by adjustable headgear straps. The mask is designed to aid in the delivery of PAP by providing an interface between the flow generator and tubing, and the patient. The F&P Nova Nasal Mask is a prescription-only device, provided in a non-sterile state.
The Nova Nasal Mask range is available in three cushion sizes – Small, Medium, and Large.
Page 6
The mask has two models: A-Model and Sleeplab (SL) A-Model. Both 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.
A list of product codes in the scope of this submission includes:
| Model | Product Code | Product Description |
|---|---|---|
| A-Model | The A-Model is intended for single-patient use in a home environment only. The mask is available in three different sizes (S, M, L). | |
| NVN1SA | Nova Nasal Mask Small A-Model | |
| NVN1MA | Nova Nasal Mask Medium A-Model | |
| NVN1LA | Nova Nasal Mask Large A-Model | |
| Fit Pack A-Model | The A-Model Fit Pack is intended for single-patient use in a home environment only. | |
| NVN1SMLA | Nova Nasal Mask Fit Pack/SML A-Model | |
| SLA-Model | The Sleep Lab A-Model is intended for single-patient use in a home environment as well a for multi-patient use in the hospital or other clinical setting. The mask is available in three different sizes (S, M, L). | |
| NVN1SSLA | Nova Nasal Mask Small Sleep Lab A-Model | |
| NVN1MSLA | Nova Nasal Mask Medium Sleep Lab A-Model | |
| NVN1LSLA | Nova Nasal Mask Large Sleep Lab A-Model | |
| Fit Pack SLA-Model | The 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. | |
| NVN1SMLSLA | Nova Nasal Mask Fit Pack Sleep Lab A-Model |
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:
- Nova Nasal Cushion Spare (available in Small, Medium, Large)
- Nova Nasal Mask Headgear Spare (available in Small, and Medium-Large)
- Nova Nasal Mask (without Headgear) Spare (available in Small, Medium, Large)
- Nova Nasal Mask Frame Assembly Spare
- Nova Nasal Tube Clip Spare
- Nova Nasal Diffuser Spare
- Nova Nasal Headgear Pad Spare
Page 2 of 7
Page 7
V. INDICATIONS FOR USE
A-Model
The F&P Nova Nasal Mask is intended to be used by adults aged 22 years and older weighing ≥ 66 lb (30 ks) who have been prescribed non-invasive positive airway pressure therapy such as CPAP or Bi-Level by a physician. The Nova Nasal mask is intended for single-patient use in the home.
SLA-Model
The F&P Nova Nasal mask is intended to be used by adults aged 22 years and older weighing ≥ 66 lb (30 kg) who have been prescribed non-invasive positive airway pressure therapy such as CPAP or Bi-Level by a physician. The Nova 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.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
| Design/Technological Characteristic | Subject Device F&P Nova Nasal Mask | Predicate Device F&P Evora Nasal Mask (K200089) | 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 | Anaesthesiology | Anaesthesiology | |
| Indications for Use/Intended Use | |||
| Indications for Use/Intended Use | A-model: The F&P Nova Nasal Mask is intended to be used by adults aged 22 years and older weighing ≥ 66 lb (30 ks) who have been prescribed non-invasive positive airway pressure therapy such as CPAP or Bi-Level by a physician. The Nova Nasal mask is intended for single-patient use in the home. |
SLA-model: The F&P Nova Nasal mask is intended to be used by adults aged 22 years and older weighing ≥ 66 lb (30 kg) who have been prescribed non-invasive positive airway pressure therapy such as CPAP or Bi-Level by a physician. The Nova 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. | A-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.
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 hospital or other clinical setting where proper disinfection of the device can occur between patient uses. | Identical. |
| Availability | Prescription use only | Prescription use only | |
| Patient Population | Adults aged 22 years and older weighing ≥ 66lbs (30kgs) | Adults weighing ≥ 66lbs (30kgs) | |
Page 3 of 7
Page 8
| Design/Technological Characteristic | Subject Device F&P Nova Nasal Mask | Predicate Device F&P Evora Nasal Mask (K200089) | Comments |
|---|---|---|---|
| Patient Consciousness | Responsive and able to remove mask | Responsive and able to remove mask | |
| Operation and Features | |||
| Operating Environment | A-model: Home | ||
| SLA-model: Home, hospital or other clinical setting | A-model: Home | ||
| SL-model: Home, hospital or other clinical setting | Identical. | ||
| Face Coverage | Nasal | Nasal | |
| Operating Temperature Range | 5 to 40 °C (41 to 104 °F). | 5 to 40 °C (41 to 104 °F). | |
| Breathing Circuit | Single Inspiratory Tube | Single Inspiratory Tube | |
| Breathing Tube Connection to Mask | 22mm ISO Taper | 22mm ISO Taper | |
| Cushion Sizes | Available in three sizes: | ||
| • Small | |||
| • Medium | |||
| • Large | Available in four sizes: | ||
| • Small | |||
| • Medium | |||
| • Large | |||
| • Wide | Equivalent. | ||
| Headgear Sizes | Two sizes | One size | Equivalent. |
| Exhalation Vent | Vent hole array in Mask Frame | Numerous radial vent holes in Mask Frame | Equivalent. |
| Technical Specifications | |||
| Pressure Range | 4 to 30 cm H2O | 4 to 25 cm H2O | Equivalent. |
| Resistance to Flow | Pressure drop through the mask with Diffuser at 50 L/min: 0.3 ± 0.1 cmH2O |
Pressure drop through the mask without Diffuser at 50 L/min: 0.3 ± 0.1 cmH2O
Pressure drop through the mask with Diffuser at 100 L/min: 1.5 ± 0.3 cmH2O
Pressure drop through the mask without Diffuser at 100 L/min: 1.5 ± 0.3 cmH2O | Pressure drop through small 50 L/min: 1.0 ± 0.1cmH2O
Pressure drop through medium 50 L/min: 1.0 ± 0.1 cmH2O
Pressure drop through large 50 L/min: 1.0 ± 0.1 cmH2O
Pressure drop through wide 50 L/min: 1.0 ± 0.1 cmH2O
Pressure drop through small 100 L/min: 1.4 ± 0.25 cmH2O
Pressure drop through medium 100 L/min: 1.2 ± 0.25 cmH2O
Pressure drop through large 100 L/min: 1.2 ± 0.25 cmH2O
Pressure drop through wide 100 L/min: 1.3 ± 0.25 cmH2O | The subject device is designed to be in conformance with ISO 17510:2015 and the pressure drop is disclosed in labeling in accordance with ISO 17510:2015. |
| Dead Space | Small: 68.6 cc
Medium: 75.0 cc
Large: 86.8 cc | Small: 28 cc
Medium: 26 cc
Large: 28 cc
Wide: 34 cc
Reference device (K153505):
Small: 69 cc
Medium: 86 cc
Large 98 cc | Measured dead space is disclosed in labeling in accordance with ISO 17510:2015. |
Page 4 of 7
Page 9
| Design/Technological Characteristic | Subject Device F&P Nova Nasal Mask | Predicate Device F&P Evora Nasal Mask (K200089) | Comments |
|---|---|---|---|
| Sound | With Diffuser: | ||
| Sound Power Level of the mask is 25.5 dBA, with uncertainty 2.5 dBA. |
Sound Pressure Level of the mask is 17.5 dBA, with uncertainty 2.5 dBA.
Without Diffuser:
Sound Power Level of the mask is 30.0 dBA, with uncertainty 2.5 dBA.
Sound Pressure Level of the mask is 22.0 dBA, with uncertainty 2.5 dBA. | Sound Power Level of the Mask is 26.8 dBA, with uncertainty 2.5 dBA.
Sound Pressure Level of the Mask 18.8 dBA, with uncertainty 2.5 dBA.
Reference device (K153505):
With Diffuser:
Sound power level: 21.3 dBA with uncertainty 2.5 dBA.
Sound pressure level: 13.3 dBA with uncertainty 2.5 dBA.
Without Diffuser:
Sound power level: 31.4 dBA with uncertainty 2.5 dBA.
Sound pressure level: 23.4 dBA with uncertainty 2.5 dBA. | Measured sound power level is disclosed in labeling in accordance with ISO 17510:2015. |
| Shelf-Life | 5 years | 1 year | The subject device claims a 5-year shelf life. |
| Cleaning and High-Level Disinfection | | | |
| Sterility | Device not provided sterile | Device not provided sterile | Identical. |
| Reusability | A-model: Single patient reuse
SLA-model: Reusable – Multi patient use | A-model: Single Patient reuse
SL-model: Reusable – Multi patient use | |
| High Level Disinfection Methods | Applies to multi patient use only
Thermal Disinfection:
75°C (167°F) for 30 mins
80°C (176°F) for 10 mins
90°C (194°F) for 1 min
Chemical Disinfection:
CIDEX OPA
12-minute soak at 20°C.
Headgear is excluded from reprocessing. | Applies to multi patient use only
Thermal Disinfection:
75°C (167°F) for 30 mins
80°C (176°F) for 10 mins
90°C (194°F) for 1 min | The subject device has identical disinfection methods and has additional chemical disinfection method. |
| Design/Components | | | |
| High-level Mask Components | Cushion
Frame
Headgear
Tube
Swivel
Diffuser clip
Tube clip
Headgear pad | Seal
Frame
Headgear
Tube
Swivel
Reference device (K153505):
Seal
Frame
Headgear
Tube
Swivel
Diffuser | The subject device includes optional components – diffuser clip, tube clip and headgear pad. |
Page 5 of 7
Page 10
VII. PERFORMANCE DATA
Summary of Non-Clinical Tests
- Cleaning Validation
- High-Level Disinfection Validation
- Leak
- CO2 rebreathing during normal use
- Resistance to flow and Pressure Drop
- Total mask exhaust flow
- Vibration and Noise Testing
- Dead Space Analysis
- Human Factors/Usability Engineering
- Mechanical Integrity
- Shelf-Life, Storage and Transportation
The F&P Nova Nasal 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
- ISTA 2A:2011 Procedure 2A: Packaged-Products weighing 150 lb (68 kg) or less. Basic requirements: Atmospheric conditioning, compression, fixed displacement or random vibration, and shock vibration
- ASTM F1980-16 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 skin sensitization
- ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
- ISO 10993-17:2002 Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances
- 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
- ISO 18652-2:2017 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
- ISO 17664-1:2021 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices
- ISO 17664-2:2021 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices.
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VIII. CONCLUSION
The F&P Nova Nasal Mask is substantially equivalent to the predicate device 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.
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