(139 days)
Not Found
No
The device description and performance studies focus on the mechanical and physical properties of a nasal mask for CPAP/bilevel therapy. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device is a mask that connects to a positive airway pressure device (a therapeutic device) to deliver therapeutic gases, but it is not itself a therapeutic device.
No
The device is a nasal mask intended for delivering positive airway pressure therapy, not for diagnosing medical conditions.
No
The device description clearly outlines physical components like a mask, seal, headgear, and swivel adaptor, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "noninvasive positive airway pressure therapy such as CPAP or bilevel". This is a therapeutic application, not a diagnostic one.
- Device Description: The description details a mask that delivers pressurized gases to the airway. This is consistent with a respiratory therapy device, not a device used to examine specimens from the human body.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide information about a patient's health status based on such analysis.
- Performance Studies: The performance studies focus on the mechanical integrity, safety (CO2 rebreathing, exhaust flow, resistance), and equivalence to a predicate respiratory mask. These are not studies related to diagnostic accuracy or performance.
In summary, the F&P Evora Nasal Mask is a medical device used for delivering respiratory therapy, not for performing in vitro diagnostic tests.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
BZD
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nose (encloses the airway entrance of the nose)
Indicated Patient Age Range
Adults
Intended User / Care Setting
Physician-prescribed, single patient use in the home (A-Model), single patient use in the home and multiple patient use in the clinical setting (SL Model).
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)
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.
Testing included:
- 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 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
- 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)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Resistance to Flow:
Pressure drop through small 50l/min: 1.0 ± 0.1cmH2O
Pressure drop through medium 50l/min: 1.0 ± 0.1cmH2O
Pressure drop through large 50l/min: 1.0 ± 0.1cmH2O
Pressure drop through wide 50l/min: 1.0 ± 0.1cmH2O
Pressure drop through small 100l/min: 1.4 ± 0.25cmH2O
Pressure drop through medium 100l/min: 1.2 ± 0.25cmH2O
Pressure drop through large 100l/min: 1.2 ± 0.25cmH2O
Pressure drop through wide 100l/min: 1.3 ± 0.25cmH2O
Dead Space:
Small: 28 cc
Medium: 26 cc
Large: 28 cc
Wide: 34 cc
Sound:
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
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
F&P Brevida™ Nasal Pillows Mask (K161412)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
0
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
1
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
2
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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3
510(k) Summary
As Required by 21 CFR 807.92
| Date prepared | 02 June 2020 |
|---|---|
| Company Name and | |
| Address | Fisher & Paykel Healthcare Ltd. |
Address: 15 Maurice Paykel Place
East Tamaki
Auckland 2013, New Zealand
Telephone: +64 9 574 0100 |
| Prepared and Submitted by | Sylvia Wonner
Regulatory Affairs Associate |
| Contact Person | Reena Daken
Senior Regulatory Affairs Specialist
Telephone: +64 9 574 0100
Reena.Daken@fphcare.co.nz |
| Trade name | F&P Evora™ Nasal Mask |
| Common name | Nasal Mask |
| Classification name | Non Continuous Ventilator (IPPB)
Class II (21 CFR §868.5905)
Product code BZD (Anaesthesiology) |
| Predicate device | F&P Brevida™ Nasal Pillows Mask (K161412) |
4
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
5
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
6
- 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)
7
Technological Characteristics Comparison
Table 1: Comparison of Technological Characteristics with the Predicate Device
| Subject Device | Predicate | |||
|---|---|---|---|---|
| F&P Evora Nasal Mask | ||||
| (A model) | F&P Evora Nasal Mask | |||
| (SL model) | F&P Brevida Nasal Pillows Mask | Comments | ||
| Device Name | ||||
| Indications for use and intended use | ||||
| Indications for | ||||
| Use | 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. | 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. | 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 lbs (30 | ||||
| kg)) use in the home and for | ||||
| multiple patient adult use in the | ||||
| hospital or other | ||||
| clinical setting where proper | ||||
| disinfection of the device can | ||||
| occur between patient uses. | Substantially equivalent. |
Identical intended use, patient
population and operating
environment. |
| Patient
Population | Adult | | Adult | Identical |
| Operating
Environment | Home | Home, hospital or other clinical
setting | Home, hospital or other clinical
setting | Identical |
| | A model is intended for single patient use in the home while SL
model is intended for single patient use in the home and for multiple
patient use in the hospital or other clinical setting. | | | |
| Technical Specifications | | | | |
| Pressure
Range | | 4 to 25 cmH2O | 4 to 25 cmH2O | Identical |
| Resistance to
Flow | Pressure drop through small 50l/min: 1.0 ± 0.1cmH2O
Pressure drop through medium 50l/min: 1.0 ± 0.1cmH2O
Pressure drop through large 50l/min: 1.0 ± 0.1cmH2O | | Pressure drop through XS-S with
diffuser 50L/min: 1.7 cmH2O +/-
10 | Substantially equivalent. |
| | Subject Device | | Predicate | |
| | F&P Evora Nasal Mask
(A model) | F&P Evora Nasal Mask
(SL model) | F&P Brevida Nasal Pillows
Mask | |
| Device Name | | | | Comments |
| | Pressure drop through wide 50l/min: 1.0 ± 0.1cmH2O
Pressure drop through small 100l/min: 1.4 ± 0.25cmH2O
Pressure drop through medium 100l/min: 1.2 ± 0.25cmH2O
Pressure drop through large 100l/min: 1.2 ± 0.25cmH2O
Pressure drop through wide 100l/min: 1.3 ± 0.25cmH2O | | Pressure drop through M-L with
diffuser 50L/min: 1.0 cmH2O +/- 10
Pressure drop through XS-S with
diffuser 100L/min: 6.3 cmH2O +/- 10
Pressure drop through M-L with
diffuser 100L/min: 3.8 cmH2O +/- 10 | The pressure drop value of the
subject device is different to the
predicate device.
The subject device is in conformance
with ISO 17510:2015 and this
difference does not introduce any
additional risk to the user. |
| Dead Space | Small: 28 cc
Medium: 26 cc
Large: 28 cc
Wide: 34 cc | | XS-S: 29 cc
M-L: 33 cc | Substantially equivalent.
The dead space value of the subject
device is different to the predicate
device.
All seal sizes are in conformance
with ISO 17510:2015 and this
difference does not introduce any
additional risk to the user. |
| Sound | 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 | | Sound Power Level of the Mask
with diffuser is 25.4 dBA, with
uncertainty 2.5 dBA
Sound Pressure Level of the
Mask with diffuser is 17.5 dBA,
with uncertainty 2.5 dBA
Sound Power Level of the Mask
without diffuser is 30.6 dBA, with
uncertainty 2.5 dBA
Sound Pressure Level of the
Mask without diffuser is 22.6dBA,
with uncertainty 2.5 dBA | Substantially equivalent.
The average sound power and
pressure level of the subject device
is different to the predicate device.
The subject device is in conformance
with ISO 17510:2015 and this
difference does not introduce any
additional risk to the user. |
| | Subject Device | | Predicate | |
| | F&P Evora Nasal Mask
(A model) | F&P Evora Nasal Mask
(SL model) | F&P Brevida Nasal Pillows
Mask | Comments |
| Device Name | | | | |
| Shelf-Life | 1 year | | Shelf-life not claimed on labelling | Substantially equivalent.
The subject device claims a One-
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
Disinfection
Methods | N/A | Thermal Disinfection | Thermal Disinfection | Identical |
| Accessories | | | | |
| Accessory | Oxygen/Pressure Port
(900HC452)
Available as a separate part, not provided with device. | | Oxygen/Pressure Port
(900HC452)
Available as a separate part, not
provided with device. | Identical |
8
9
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).