F&P Evora Nasal Mask Nasal A Model (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack/ SML (Small/Medium/Large) A Model, F&P Evora Nasal Mask Nasal Sleep Lab (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack / SML (Small/Medium/Large) Sleep Lab Model
Device Facts
| Record ID | K200089 |
|---|---|
| Device Name | F&P Evora Nasal Mask Nasal A Model (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack/ SML (Small/Medium/Large) A Model, F&P Evora Nasal Mask Nasal Sleep Lab (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack / SML (Small/Medium/Large) Sleep Lab Model |
| Applicant | Fisher & Paykel Healthcare, Ltd. |
| Product Code | BZD · Anesthesiology |
| Decision Date | Jun 2, 2020 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5905 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
A-Model: The F&P Evora Nasal Mask is intended to be used by adults weighing ≥66lbs (30kgs) who have been prescribed non-invasive positive airway pressure therapy such as CPAP or bilevel by a physician. The F&P Evora Nasal Mask is intended for single patient use in the home. SL Model: The F&P Evora Nasal Mask is intended to be used by adults weighing ≥66lbs (30kgs) who have been prescribed non-invasive positive airway pressure therapy such as CPAP or bilevel by a physician. The F&P Evora Nasal Mask is intended for single patient use in the home and for multiple patient use in the hospital or other clinical setting where proper disinfection of the device can occur between patient uses.
Device Story
Non-invasive nasal mask interface for CPAP/bilevel therapy; encloses airway entrance of nose; secured via headgear. Connects to breathing tube via 22mm male swivel adaptor; exhaust holes on seal flush exhaled gases. Used in home (A-Model) or home/clinical settings (SL-Model). Operated by patient or clinician. Provides interface for pressurized gas delivery; facilitates therapy compliance and airway support. Available in multiple sizes; optional oxygen/pressure port connector. Non-sterile, prescription-only.
Clinical Evidence
Bench testing only. Performance verified via CO2 rebreathing, exhaust flow, resistance to flow, pressure drop, mechanical integrity, and accelerated aging (ASTM F1980-07). Biocompatibility testing performed per ISO 10993 series and ISO 18562 series. No clinical data presented.
Technological Characteristics
Non-invasive nasal mask; 22mm male swivel connector; silicone seal; headgear. Pressure range 4-25 cmH2O. Conforms to ISO 17510:2015, ISO 5356-1:2015, ISO 10993, and ISO 18562. Non-sterile; SL model supports thermal disinfection for multi-patient use.
Indications for Use
Indicated for adults ≥66lbs (30kgs) prescribed non-invasive positive airway pressure therapy (CPAP or bilevel) by a physician.
Regulatory Classification
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.
Predicate Devices
- F&P Brevida Nasal Pillows Mask (K161412)
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
June 2, 2020
Fisher & Paykel Healthcare Ltd. Reena Daken Senior Regulatory Affairs Specialist 15 Maurice Paykel Place. East Tamaki Auckland 2013 New Zealand
Re: K200089
Trade/Device Name: F&P Evora Nasal Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: Class II Product Code: BZD Dated: April 23, 2020 Received: April 30, 2020
#### Dear Reena Daken:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Michael Ryan Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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### Indications for Use
510(k) Number (if known)
Device Name F&P Evora Nasal Mask
# Indications for Use (Describe)
A-Model:
The F&P Evora Nasal Mask is intended to be used by adults weighing ≥661bs (30kgs) who have been prescribed noninvasive positive airway pressure therapy such as CPAP or bilevel by a physician. The F&P Evora Nasal Mask is intended for single patient use in the home.
SL Model:
The F&P Evora Nasal Mask is intended to be used by adults weighing ≥66lbs (30kgs) who have been prescribed noninvasive positive airway pressure therapy such as CPAP or bilevel by a physician. The F&P Evora Nasal Mask is intended for single patient use in the home and for multiple patient use in the clinical setting where proper disinfection of the device can occur between patient uses.
| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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# 510(k) Summary
## As Required by 21 CFR 807.92
| Date prepared | 02 June 2020 |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Name and<br>Address | Fisher & Paykel Healthcare Ltd.<br><br>Address: 15 Maurice Paykel Place<br>East Tamaki<br>Auckland 2013, New Zealand<br>Telephone: +64 9 574 0100 |
| Prepared and Submitted by | Sylvia Wonner<br>Regulatory Affairs Associate |
| Contact Person | Reena Daken<br>Senior Regulatory Affairs Specialist<br>Telephone: +64 9 574 0100<br>Reena.Daken@fphcare.co.nz |
| Trade name | F&P Evora™ Nasal Mask |
| Common name | Nasal Mask |
| Classification name | Non Continuous Ventilator (IPPB)<br>Class II (21 CFR §868.5905)<br>Product code BZD (Anaesthesiology) |
| Predicate device | F&P Brevida™ Nasal Pillows Mask (K161412) |
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#### Device Description
The F&P Evora Nasal Mask is a non-invasive patient interface with a seal that encloses the airway entrance of the nose. The mask is held on the face with a headgear. The mask connects to a single breathing tube by a 22mm male swivel adaptor to receive pressurized gases from a Positive Airway Pressure device (CPAP or Bi-Level). The exhaust holes on the seal of the mask allow exhaled gases to be flushed out while the system is in operation.
The F&P Evora Nasal Mask is a prescription only device, provided in a non-sterile state. The mask will be available in 2 different main models: A-Model, and Sleeplab (SL)-Model. Both models are identical except for Intended Use, Operating Environment; Reusability and High Level Disinfection Methods. This is because the A model is used only by single patients in the home while the SL model is used both by single patients in the home and multiple patients use in the hospital or other clinical setting where proper disinfection of the device can occur between patient uses.
A Model: Offered in 4 different sizes (Small, Medium, Large, Wide), the packaging contains a single mask and a single size seal, intended for single patient use. In addition, to the 4 sizes, a so-called Fit Pack model (EVO1SMLA) is offered which contains a single mask with 3 seal sizes (Small, Medium and Large).
Sleeplab (SL)-Model: Offered in 4 different sizes (Small, Medium, Large, Wide) contains a single mask and a single size seal, intended for single patient use and multi-patient use. In addition, to the 4 sizes, a so-called Fit Pack model (EVO1SMLSL) is offered which contains a single mask with 3 seal sizes (Small, Medium and Large).
Besides the main models, an accessory and spare parts will be made available.
- -Accessory: The only accessory available for the F&P Evora Nasal Mask will be an Oxygen / Pressure Port Connector, which will be packaged and sold separately.
- -Spare parts: F&P Evora Nasal has the below components which are available for purchase as spare parts:
- Evora Nasal Seal Spare (Small, Medium, Large and Wide) o
- Evora Nasal Headgear Spare O
- Evora Nasal Backstrap Spare о
- O F&P Swivel White
- O Evora Nasal Tube & Frame Spare
- Evora Nasal Mask No H/G (Small, Medium, Large and Wide) o
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#### Intended Use / Indication for Use
#### A-Model:
The F&P Evora Nasal Mask is intended to be used by adults weighing ≥66lbs (30kgs) who have been prescribed non-invasive positive airway pressure therapy such as CPAP or bilevel by a physician. The F&P Evora Nasal Mask is intended for single patient use in the home.
#### SL Model:
The F&P Evora Nasal Mask is intended to be used by adults weighing ≥66lbs (30kgs) who have been prescribed non-invasive positive airway pressure therapy such as CPAP or bilevel by a physician. The F&P Evora Nasal Mask is intended for single patient use in the home and for multiple patient use in the hospital or other clinical setting where proper disinfection of the device can occur between patient uses.
#### Non-Clinical Performance Data
Performance testing of the F&P Evora Nasal Mask was completed to determine that device design changes compared to F&P Brevida Nasal Pillows Nasal Mask (K161412) do not raise different questions of safety or effectiveness. These tests demonstrate substantial equivalence of the F&P Evora Nasal Mask to the predicate device. A summary of the testing conducted for the F&P Evora Nasal Mask device is provided below.
- Shelf life simulation was based on ASTM F1980-07 Standard Guide for Accelerated . Aging of Sterile Barrier Systems for Medical Devices.
- . Transportation simulation was based on ISTA 2A Packaged-Products weighing 150lb (68kg) or less.
- Performance testing was completed to confirm the F&P Evora Nasal Mask does not adversely affect safety and effectiveness.
- CO2 rebreathing during normal use o
- o Total mask exhaust flow
- Resistance to flow and pressure drop O
- . Mechanical integrity and performance of the new device was also verified after normal and reasonable abuse scenarios. This included simulations of home use/cleaning; multi-patient use/reprocessing; accelerated ageing (shelf life) and simulated transportation and storage.
The F&P Evora Nasal Mask has been tested to the following standards:
- . ISO 17510:2015 Sleep Apnoea Breathing Therapy- Masks and Application Accessories
- . ISO 5356-1:2015 Anaesthetic and respiratory equipment- Conical connectors: Part 1: Cones and sockets
- . ISO 10993-1:2018, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- . ISO 10993-2:2006, Biological evaluation of medical devices - Part 2: Animal Welfare requirements
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- ISO 10993-3:2014, Biological evaluation of medical devices Part 3: Tests for . Genotoxicity Carcinogenicity and reproductive toxicity
- . ISO 10993-5:2009, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- . ISO 10993-10:2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
- . ISO 10993-11:2017, Biological evaluation of medical devices – Part 11: Tests for systemic Toxicity
- . ISO 10993-12:2012, Biological evaluation of medical devices - Part 12: Sample preparation and reference material
- . ISO 10993-17:2002, Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances
- . ISO 10993-18:2005, Biological evaluation of medical devices - Part 18: chemical characterization of materials
- . ISO 18562-1:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications, Part 1: Evaluation and testing within a risk management process
- ISO 18562-2:2017 Biocompatibility evaluation of breathing gas pathways in healthcare . applications, Part 2: Tests for emissions of particulate matter
- . ISO 18562-3:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications, Part 3: Tests for emissions of volatile organic compounds (VOCs)
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## Technological Characteristics Comparison
Table 1: Comparison of Technological Characteristics with the Predicate Device
| | Subject Device | | Predicate | |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | F&P Evora Nasal Mask<br>(A model) | F&P Evora Nasal Mask<br>(SL model) | F&P Brevida Nasal Pillows Mask | Comments |
| Device Name | | | | |
| | Indications for use and intended use | | | |
| Indications for<br>Use | The F&P Evora Nasal Mask is<br>intended to be used by adults<br>weighing ≥66lbs (30kgs) who<br>have been prescribed non-<br>invasive positive airway<br>pressure therapy such as CPAP<br>or bilevel by a physician. The<br>F&P Evora Nasal Mask is<br>intended for single patient use in<br>the home. | The F&P Evora Nasal Mask is<br>intended to be used by adults<br>weighing ≥66lbs (30kgs) who<br>have been prescribed non-<br>invasive positive airway<br>pressure therapy such as CPAP<br>or bilevel by a physician. The<br>F&P Evora Nasal Mask is<br>intended for single patient use in<br>the home and for multiple patient<br>use in the hospital or other<br>clinical setting where proper<br>disinfection of the device can<br>occur between patient uses. | The F&P Brevida Nasal Pillows<br>Mask is intended to be used by<br>individuals who have been<br>diagnosed by a physician as<br>requiring CPAP or Bi-Level<br>therapy. The F&P Brevida Nasal<br>Pillows Mask is intended for<br>single patient adult (≥66 lbs (30<br>kg)) use in the home and for<br>multiple patient adult use in the<br>hospital or other<br>clinical setting where proper<br>disinfection of the device can<br>occur between patient uses. | Substantially equivalent.<br><br>Identical intended use, patient<br>population and operating<br>environment. |
| Patient<br>Population | Adult | | Adult | Identical |
| Operating<br>Environment | Home | Home, hospital or other clinical<br>setting | Home, hospital or other clinical<br>setting | Identical |
| | A model is intended for single patient use in the home while SL<br>model is intended for single patient use in the home and for multiple<br>patient use in the hospital or other clinical setting. | | | |
| Technical Specifications | | | | |
| Pressure<br>Range | | 4 to 25 cmH2O | 4 to 25 cmH2O | Identical |
| Resistance to<br>Flow | Pressure drop through small 50l/min: 1.0 ± 0.1cmH2O<br>Pressure drop through medium 50l/min: 1.0 ± 0.1cmH2O<br>Pressure drop through large 50l/min: 1.0 ± 0.1cmH2O | | Pressure drop through XS-S with<br>diffuser 50L/min: 1.7 cmH2O +/-<br>10 | Substantially equivalent. |
| | Subject Device | | Predicate | |
| | F&P Evora Nasal Mask<br>(A model) | F&P Evora Nasal Mask<br>(SL model) | F&P Brevida Nasal Pillows<br>Mask | |
| Device Name | | | | Comments |
| | Pressure drop through wide 50l/min: 1.0 ± 0.1cmH2O<br>Pressure drop through small 100l/min: 1.4 ± 0.25cmH2O<br>Pressure drop through medium 100l/min: 1.2 ± 0.25cmH2O<br>Pressure drop through large 100l/min: 1.2 ± 0.25cmH2O<br>Pressure drop through wide 100l/min: 1.3 ± 0.25cmH2O | | Pressure drop through M-L with<br>diffuser 50L/min: 1.0 cmH2O +/- 10<br>Pressure drop through XS-S with<br>diffuser 100L/min: 6.3 cmH2O +/- 10<br>Pressure drop through M-L with<br>diffuser 100L/min: 3.8 cmH2O +/- 10 | The pressure drop value of the<br>subject device is different to the<br>predicate device.<br>The subject device is in conformance<br>with ISO 17510:2015 and this<br>difference does not introduce any<br>additional risk to the user. |
| Dead Space | Small: 28 cc<br>Medium: 26 cc<br>Large: 28 cc<br>Wide: 34 cc | | XS-S: 29 cc<br>M-L: 33 cc | Substantially equivalent.<br>The dead space value of the subject<br>device is different to the predicate<br>device.<br>All seal sizes are in conformance<br>with ISO 17510:2015 and this<br>difference does not introduce any<br>additional risk to the user. |
| Sound | Sound Power Level of the Mask is 26.8 dBA, with uncertainty 2.5 dBA<br>Sound Pressure Level of the Mask 18.8 dBA, with uncertainty 2.5 dBA | | Sound Power Level of the Mask<br>with diffuser is 25.4 dBA, with<br>uncertainty 2.5 dBA<br>Sound Pressure Level of the<br>Mask with diffuser is 17.5 dBA,<br>with uncertainty 2.5 dBA<br>Sound Power Level of the Mask<br>without diffuser is 30.6 dBA, with<br>uncertainty 2.5 dBA<br>Sound Pressure Level of the<br>Mask without diffuser is 22.6dBA,<br>with uncertainty 2.5 dBA | Substantially equivalent.<br>The average sound power and<br>pressure level of the subject device<br>is different to the predicate device.<br>The subject device is in conformance<br>with ISO 17510:2015 and this<br>difference does not introduce any<br>additional risk to the user. |
| | Subject Device | | Predicate | |
| | F&P Evora Nasal Mask<br>(A model) | F&P Evora Nasal Mask<br>(SL model) | F&P Brevida Nasal Pillows<br>Mask | Comments |
| Device Name | | | | |
| Shelf-Life | 1 year | | Shelf-life not claimed on labelling | Substantially equivalent.<br>The subject device claims a One-<br>year shelf life with supporting data. |
| Cleaning and High-Level Disinfection | | | | |
| Sterility | Device not provided sterile | | Device not provided sterile | Identical |
| Reusability | Single Patient Use | Reusable – Multi Patient Use | Reusable – Multi Patient Use | Identical |
| High Level<br>Disinfection<br>Methods | N/A | Thermal Disinfection | Thermal Disinfection | Identical |
| Accessories | | | | |
| Accessory | Oxygen/Pressure Port<br>(900HC452)<br>Available as a separate part, not provided with device. | | Oxygen/Pressure Port<br>(900HC452)<br>Available as a separate part, not<br>provided with device. | Identical |
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#### Conclusions
The comparison of features, performance, and intended use demonstrate that the F&P Evora Nasal Mask is the predicate F&P Brevida Nasal Pillows Mask (K161412).
