(159 days)
No
The description focuses on the physical components and function of a mask for positive airway pressure therapy, with no mention of AI or ML.
No.
The device described is a mask (patient interface) that connects to a CPAP or Bi-level device, which are the actual therapeutic devices delivering positive airway pressure therapy. The mask itself does not deliver therapy but rather facilitates it.
No
The device is a non-invasive patient interface (mask) for positive airway pressure therapy (CPAP/Bi-Level), which is a treatment, not a diagnostic procedure. Its purpose is to deliver pressurized air, not to diagnose a condition.
No
The device description clearly states it is a "non-invasive patient interface with cushions that seal against the airway entrance of the nose" and is a physical mask with hardware components like a headgear and swivel adaptor.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states the mask is for delivering non-invasive positive airway pressure therapy (CPAP or Bi-Level) to treat conditions like sleep apnea. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a physical interface for delivering air, not a device for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. The device's function is purely mechanical and related to delivering pressurized air.
- Performance Studies: The performance studies focus on aspects like cleaning, disinfection, leak, dead space, mechanical integrity, and biocompatibility – all relevant to a respiratory therapy device, but not to an IVD.
In summary, the F&P Solo mask is a medical device used for treatment, not for diagnosing a condition by examining samples outside the body.
N/A
Intended Use / Indications for Use
A-Model
The F&P Solo mask is intended to be used by adults weighing ≥66lbs (30 kgs) who have been prescribed non-invasive positive airway pressure therapy such as CPAP or Bi-Level by a physician. The F&P Solo mask is intended for singlepatient use in the home.
SL A-Model
The F&P Solo mask is intended to be used by adults weighing ≥66lbs (30 kgs) who have been prescribed non-invasive positive airway pressure therapy such as CPAP or Bi-Level by a physician. The F&P Solo mask is intended for singlepatient use in the home and for multiple patient use in the hospital or other proper disinfection of the device can occur between patient uses.
Product codes (comma separated list FDA assigned to the subject device)
BZD, SLN1SA, SLN1MA, SLN1LA, SLN1WA, SLP1SA, SLP1MA, SLP1LA, SLNSMLA, SLPSMLA, SLN1SSLA, SLN1MSLA, SLN1LSLA, SLN1WSLA, SLP1SSLA, SLP1MSLA, SLP1LSLA, SLN1SMLSLA, SLP1SMLSLA
Device Description
The Solo Mask, is a non-invasive patient interface with cushions that seal against the airway entrance of the nose. The mask is held on the face with a headqear and connects to a single breathing tube by a 22mm male swivel adaptor to receive pressurized air from a continuous Positive Airway Pressure device (CPAP or Bi-level). The exhaust bias holes on the frame of the mask allow exhaled air to be flushed out while the system is in operation. The F&P Solo Mask is a prescription only device, provided in a non-sterile state.
A-Model: The A Model is intended for single- patient use in a home environment only. The mask is available in seven different configurations which differ only in the size and type of the cushions made available in the packaging (Nasal: S, M, L and W; Pillows: S, M and L).
SL A-Model: The 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 seven different configurations which differ only in the size and type of cushions made available in the packaging (Nasal: S, M, L and Wide; Pillows: S, M and L).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nose, Nares
Indicated Patient Age Range
Adults
Intended User / Care Setting
Used by adults prescribed non-invasive positive airway pressure therapy by a physician.
A-Model: single-patient use in the home.
SL A-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
- Dead Space Analysis
- Human Factors/Usability Engineering
- Mechanical Integrity
- Shelf-Life, Storage and Transportation
The F&P Solo Mask Range has been tested to applicable requirements to the following standards:
- ISO 17510:2015 Sleep apnoea breathing therapy Masks and application accessories (CO2 Rebreathing, Pressure-Flow Curve, Exhaust Flow, Resistance to Flow (Pressure Drop), Vibration and Noise)
- ISO 5356-1:2015 Anaesthetic 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 10993-17:2002 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 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 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 18562-4 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate
- ISO/TS 21726:2019 Biological evaluation of medical devices - Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Resistance to Flow:
Nasal Cushion:
Small 50 L/min: 0.84 cmH2O
Medium 50 L/min: 0.59 cmH2O
Large 50 L/min: 0.54 cmH2O
Wide 50 L/min: 0.58 cmH2O
Small 100 L/min: 3.63 cmH2O
Medium 100 L/min: 2.73 cmH2O
Large 100 L/min: 2.50 cmH2O
Wide 100 L/min: 2.65 cmH2O
Pillows Cushion:
Small 50 L/min: 2.17 cmH2O
Medium 50 L/min: 1.05 cmH2O
Large 50 L/min: 0.89 cmH2O
Small 100 L/min: 8.56 cmH2O
Medium 100 L/min: 4.42 cmH2O
Large 100 L/min: 3.83 cmH2O
Dead Space:
Nasal:
Small: 29.6 cc
Medium: 26.8 cc
Large: 31.1 cc
Wide: 36.9 cc
Pillows:
Small: 25.8 cc
Medium: 27.7 cc
Large: 30.5 cc
Sound:
Sound Power Level of the Mask is 31.5 dBA, with uncertainty 2.5 dBA
Sound Pressure Level of the Mask 23.6 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 Evora™ Nasal Mask, K200089
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.
F&P Brevida™ Nasal Mask, K161412
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
May 17, 2023
Fisher & Paykel Healthcare Ltd Reena Daken Regulatory Affairs Manager 15 Maurice Paykel Place, East Tamaki Auckland, 2013 New Zealand
Re: K223696
Trade/Device Name: F&P Solo Mask Range Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous ventilator (IPPB) Regulatory Class: Class II Product Code: BZD Dated: May 2, 2023 Received: May 2, 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 (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
1
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 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 (OS) 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,
Rachana Visaria -S
Rachana Visaria, Ph.D. Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K223696
Device Name F&P Solo Mask Range
Indications for Use (Describe)
A-Model
The F&P Solo mask is intended to be used by adults weighing ≥661bs (30 kgs) who have been prescribed non-invasive positive airway pressure therapy such as CPAP or Bi-Level by a physician. The F&P Solo mask is intended for singlepatient use in the home.
SL A-Model
The F&P Solo mask is intended to be used by adults weighing ≥661bs (30 kgs) who have been prescribed non-invasive positive airway pressure therapy such as CPAP or Bi-Level by a physician. The F&P Solo mask is intended for singlepatient use in the home and for multiple patient use in the hospital or other 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
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 | Alec O'Connell-Biddlecombe
Regulatory Affairs Associate |
| Contact Person | Reena Daken
Regulatory Affairs Manager
Telephone: +64 9 574 0100
Email: reena.daken@fphcare.co.nz |
| Date Prepared | 16 May 2023 |
== DEVICE
| Name of Device | F&P Solo Mask Range |
|---|---|
| Common/Usual Name | Nasal Mask |
| Classification Name | Non Continuous Ventilator (IPPB) |
| Regulatory Class | Class II (21 CFR §868.5905) |
| Product Code | BZD |
lll. PREDICATE DEVICE
- . Predicate device:
- o F&P Evora™ Nasal Mask, K200089
- . Reference devices:
- o F&P Brevida™ Nasal Mask, K161412
- Used to support claims of substantial equivalence with respect to design and performance
- o F&P Brevida™ Nasal Mask, K161412
4
IV. DEVICE DESCRIPTION
The Solo Mask, is a non-invasive patient interface with cushions that seal against the airway entrance of the nose. The mask is held on the face with a headqear and connects to a single breathing tube by a 22mm male swivel adaptor to receive pressurized air from a continuous Positive Airway Pressure device (CPAP or Bi-level). The exhaust bias holes on the frame of the mask allow exhaled air to be flushed out while the system is in operation. The F&P Solo Mask is a prescription only device, provided in a non-sterile state.
| Model | Product Code | Product Description |
|---|---|---|
| A-Model | SLN1SA | Solo Nasal Mask Small A Model |
| The A Model is intended for single- patient use in a | ||
| home environment only. The mask is available in | ||
| seven different configurations which differ only in | ||
| the size and type of the cushions made available in | ||
| the packaging (Nasal: S, M, L and W; Pillows: S, | ||
| M and L). | SLN1MA | Solo Nasal Mask Medium A Model |
| SLN1LA | Solo Nasal Mask Large A Model | |
| SLN1WA | Solo Nasal Mask Wide A Model | |
| SLP1SA | Solo Pillows Mask Small A Model | |
| SLP1MA | Solo Pillows Mask Medium A Model | |
| SLP1LA | Solo Pillows Mask Large A Model | |
| SLNSMLA | Solo Nasal Mask Fit Pack/SML A Model | |
| SLPSMLA | Solo Pillows Mask Fit Pack/SML A Model | |
| SL A-Model | ||
| The 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 seven different | ||
| configurations which differ only in the size and type | ||
| of cushions made available in the packaging | ||
| (Nasal: S, M, L and Wide; Pillows: S, M and L). | SLN1SSLA | |
| SLN1MSLA | Solo Nasal Mask Medium Sleep Lab A | |
| SLN1LSLA | Solo Nasal Mask Large Sleep Lab A | |
| SLN1WSLA | Solo Nasal Mask Wide Sleep Lab A | |
| SLP1SSLA | Solo Pillows Mask Small Sleep Lab A | |
| SLP1MSLA | Solo Pillows Mask Medium Sleep Lab A | |
| SLP1LSLA | Solo Pillows Mask Large Sleep Lab A | |
| SLN1SMLSLA | Solo Nasal Mask Fit Pack Sleep Lab A | |
| SLP1SMLSLA | Solo Pillows Mask Fit Pack Sleep Lab A |
A list of the subject device product codes can be found below:
IV. INDICATIONS FOR USE
A-Model
The F&P Solo mask is intended to be used by adults weighing ≥66lbs (30 kgs) who have been prescribed non-invasive positive airway pressure therapy such as CPAP or Bi-Level by a physician. The F&P Solo mask is intended for singlepatient use in the home.
SL A-Model
The F&P Solo mask is intended to be used by adults weighing ≥66lbs (30 kgs) who have been prescribed non-invasive positive airway pressure therapy such as CPAP or Bi-Level by a physician. The F&P Solo mask is intended for singlepatient 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.
5
V. COMPARISON OF TECHNOLOGICAL CHARATCERISTICS WITH THE PREDICATE DEVICE
The comparison of features, performance data and intended use demonstrate that the F&P Solo Mask Range is substantially equivalent to the predicate device, F&P Evora™ Nasal Mask (K200089). Please see the table below.
| Design/
Technological
Characteristics | Subject Device F&P
Solo Mask | Predicate Device
F&P Evora Nasal Mask (K200089) | Comments |
|--------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | | | |
| Legal Manufacturer | Fisher & Paykel Healthcare Ltd. | Fisher & Paykel Healthcare Ltd. | Identical |
| Product Code | BZD | BZD | |
| Device classification | 21 CFR 868.5905 | 21 CFR 868.5905 | |
| Classification panel | Anaesthesiology | Anaesthesiology | |
| Indications for Use | | | |
| | A-Model: | A-Model: | |
| | The F&P Solo mask is intended to be used by
adults weighing ≥ 66 lbs (30 kgs) who have been
prescribed non-invasive positive airway pressure
therapy such as CPAP or Bi-Level by a
physician. The F&P Solo mask is intended for
single- patient use in the home.
SL 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 | |
| Indications for Use | The F&P Solo mask is intended to be
used by adults weighing ≥ 66lbs (30 kgs) who
have been prescribed non-invasive positive
airway pressure therapy such as CPAP or Bi-
Level by a physician. The F&P Solo 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. | 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
uses. | Identical |
| Design/
Technological
Characteristics | Subject Device F&P
Solo Mask | Predicate Device
F&P Evora Nasal Mask
(K200089) | Comments |
| Availability | Prescription use only | Prescription use only | Identical |
| Patient Population | PAP Therapy | PAP Therapy | Identical |
| Patient Population | Adult (>30kg) | Adult (>30kg) | Identical |
| Patient Consciousness | Responsive and able to remove mask | Responsive and able to remove mask | Identical |
| Operating
Environment | Home, hospital or other clinical setting | Home, hospital or other clinical setting | Identical |
| Technical Specifications and Features | | | |
| Breathing Circuit | Single Inspiratory Tube | Single Inspiratory Tube | Identical |
| Breathing Tube
connection to mask | 22mm ISO Taper | 22mm ISO Taper | Identical |
| Seal sizes | Nasal Cushion: Available in four sizes:
Small, Medium, Large, Wide
Pillows Cushion:
Available in three sizes: Small, Medium, Large | Predicate:
Available in four sizes: Small, Medium, Large,
Wide | While the subject device's Nasal
cushions are identical, the Pillows
cushion offers three additional
sizes.
The subject device is designed to
be in conformance to ISO
17510:2015. |
| Headgear Sizes | One size | One size | Identical |
| Exhalation Vent | Numerous vent holes in Mask Frame | Numerous radial vent holes in Mask Frame | Identical.
The subject device vent holes are
located on the frame, whilst the
predicate has vent holes organized
in a radial pattern, also located on
the frame.
The subject device is designed to
be in conformance to ISO
17510:2015. |
| Design/
Technological
Characteristics | Subject Device F&P
Solo Mask | Predicate Device
F&P Evora Nasal Mask
(K200089) | Comments |
| Technical Specifications | | | |
| Pressure Range | 4 to 20 cm H2O | 4 to 25 cm H2O | The subject device is designed to be
in conformance with ISO 17510:2015 |
| Resistance to Flow | Pressure drop through Nasal Cushion: | Nasal (F&P Evora Nasal, predicate device):
Pressure drop through small 50 L/min: 1.0 ±
0.1cmH2O | The pressure drop for the subject
device is disclosed in labelling in |
| | Small 50 L/min: 0.84 cmH2O
Medium 50 L/min: 0.59 cmH2O | Pressure drop through medium 50 L/min: 1.0
± 0.1 cmH2O | accordance with ISO 17510:2015. |
| | Large 50 L/min: 0.54 cmH2O | Pressure drop through large 50 L/min: 1.0 ±
0.1 cmH2O | The reference device (Brevida,
K161412) has been used to support
claims of substantial equivalence for |
| | Wide 50 L/min: 0.58 cmH2O | Pressure drop through wide 50 L/min: 1.0 ±
0.1 cmH2O | pressure drop values with respect to
the 'Pillows Cushion'. |
| | Small 100 L/min: 3.63 cmH2O
Medium 100 L/min: 2.73 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 | |
| Large 100 L/min: 2.50 cmH2O
Wide 100 L/min: 2.65 cmH2O | | | |
| Pressure drop through Pillows Cushion:
Small 50 L/min: 2.17 cmH2O | | | |
| Medium 50 L/min: 1.05 cmH2O
Large 50 L/min: 0.89 cmH2O | | | |
| Small 100 L/min: 8.56 cmH2O
Medium 100 L/min: 4.42 cmH2O
Large 100 L/min: 3.83 cmH2O | | | |
| Dead Space | Nasal:
Small: 29.6 cc
Medium: 26.8 cc | Small: 28 cc
Medium: 26 cc
Large: 28 cc
Wide: 34 cc | Measured dead space is disclosed in
labelling in accordance with ISO
17510:2015. |
| | Large: 31.1 cc
Wide: 36.9 cc | | |
| | Pillows:
Small: 25.8 cc
Medium: 27.7 cc
Large: 30.5 cc | | |
| Sound | Sound Power Level of the Mask is 31.5 dBA, with
uncertainty 2.5 dBA
Sound Pressure Level of the Mask 23.6 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 | Measured sound power level is
disclosed in labelling in accordance
with ISO 17510:2015. |
| Shelf-Life | 2 year | 1 year | The subject device claims a 2-year
shelf life. |
| Design/
Technological
Characteristics | Subject Device F&P
Solo Mask | Predicate Device
F&P Evora Nasal Mask
(K200089) | Comments |
| Operating and Storage
Conditions | Operating Temperature: 5 to 40 °C
Storage Temperature: -20 to 50°C | Operating Temperature: 5 to 40 °C
Storage Temperature: -20 to 50°C | Identical |
| Cleaning and High-Level Disinfection | | | |
| Sterility | Device not provided sterile | Device not provided sterile | Identical |
| Reusability | Reusable - Multi Patient Use | Reusable - Multi Patient Use | Identical |
| High Level Disinfection
Methods | Thermal Disinfection: 75°C (167°F) for 30 mins
80°C (176°F) for 10 mins | 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 contains a subset
of the high-level disinfection
methods compared to the predicate. |
| Design / Components | | | |
| Mask Components | Cushion
Frame
Headgear
Tube
Swivel | Seal
Frame
Headgear
Tube
Swivel | Identical - name of seal changed to
cushion. |
| Cushion | Soft pliable cushion between mask base and nares
(nasal cushion).
Soft pliable cushion between mask base, extending
into the nares (pillows cushion). | Soft pliable seal between mask base and
nares, without any of the seal extending into
the nares. | The subject device has cushions
which seal under the nose (nasal)
and into the nares (pillows) when
compared
to the predicate device. |
| Frame | Connection for tube, cushion, and headgear. | Connection for tube, seal and headgear. | Identical - name of seal changed to
cushion. |
| Headgear | Adjustable headgear made up of stretch and non-
stretch portions. | Adjustable headgear made up of two
components:
• Moulded front and top straps that
are permanently joined together.
• Single backstrap | Both the subject and predicate
devices have stretch and non-stretch
sections.
The subject device headgear is one
assembly with adjustment built in. |
| Tube | Permanently attached to mask frame | Permanently attached to mask frame | Identical |
| Swivel | Permanently attached to the mask tube, while still
allowing rotation, with 22mm taper allowing
connection to industry-standard breathing tubes | Removable 22mm taper allowing connection
to industry-standard breathing tubes | The subject device has a
permanently attached swivel, while
still allowing rotation. |
| 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 |
6
7
8
9
VI. PERFORMANCE DATA
Summary of Non-Clinical Tests
- Cleaning Validation ●
- High-Level Disinfection Validation .
- Leak ●
- Dead Space Analysis ●
- Human Factors/Usability Engineering ●
- Mechanical Integrity
- Shelf-Life, Storage and Transportation ●
The F&P Solo Mask Range has been tested to applicable requirements to the following standards:
- ISO 17510:2015 Sleep apnoea breathing therapy Masks and application accessories .
- CO2 Rebreathing o
- Pressure-Flow Curve o
- Exhaust Flow о
- Resistance to Flow (Pressure Drop) O
- o Vibration and Noise
- ISO 5356-1:2015 Anaesthetic 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 10993-17:2002 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 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 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 18562-4 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate
- ISO/TS 21726:2019 Biological evaluation of medical devices - Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
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VII. CONCLUSIONS
The F&P Solo Mask Range 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.