F&P Solo Mask Range

K223696 · Fisher & Paykel Healthcare, Ltd. · BZD · May 17, 2023 · Anesthesiology

Device Facts

• Record ID: K223696
• Device Name: F&P Solo Mask Range
• Applicant: Fisher & Paykel Healthcare, Ltd.
• Product Code: BZD · Anesthesiology
• Decision Date: May 17, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 single-patient 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 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 patient interface; seals against nose via nasal or pillows cushions; held by headgear; connects to CPAP/Bi-Level device via 22mm male swivel adaptor. Delivers pressurized air to airway; exhaust bias holes on frame flush exhaled air. Used in home (A-Model) or home/hospital (SL A-Model) by patients; prescription only. Healthcare providers use device to deliver prescribed pressure therapy; patient benefits from improved compliance/comfort during sleep therapy. No electronic processing or software.

Clinical Evidence

Bench testing only. No clinical data presented. Testing included ISO 17510:2015 (CO2 rebreathing, pressure-flow, exhaust flow, resistance to flow, vibration/noise), ISO 5356-1:2015 (connectors), and extensive biocompatibility testing (ISO 10993 series and ISO 18562 series). Human factors/usability engineering and mechanical integrity testing were also performed.

Technological Characteristics

Non-invasive nasal mask; includes nasal and pillows cushion options. Materials evaluated per ISO 10993 and ISO 18562. Features 22mm ISO taper connection. Designed for 4-20 cm H2O pressure range. Reusable; supports thermal disinfection (75°C/30min or 80°C/10min). Conforms to ISO 17510:2015 and ISO 5356-1:2015. No software or electronic components.

Indications for Use

Indicated for adults ≥30kg prescribed non-invasive positive airway pressure therapy (CPAP or Bi-Level). Contraindicated for patients who are not responsive or unable to remove the mask.

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 Evora™ Nasal Mask (K200089)

Reference Devices

• F&P Brevida™ Nasal Mask (K161412)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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# 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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# 510(k) Summary

# As Required by 21 CFR 807.92

# I. SUBMITTER

| Company Name and Address | Fisher & Paykel Healthcare Limited<br>15 Maurice Paykel Place<br>East Tamaki<br>Auckland 2013, New Zealand<br>Telephone: [phone] |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Prepared and Submitted by | Alec O'Connell-Biddlecombe<br>Regulatory Affairs Associate |
| Contact Person | Reena Daken<br>Regulatory Affairs Manager<br>Telephone: [phone]<br>Email: [e-mail] |
| 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

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#### 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<br>home environment only. The mask is available in<br>seven different configurations which differ only in<br>the size and type of the cushions made available in<br>the packaging (Nasal: S, M, L and W; Pillows: S,<br>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<br>The Sleep Lab A Model is intended for single<br>patient use in a home environment as well as for<br>multi-patient use in the hospital or other clinical<br>setting. The mask is available in seven different<br>configurations which differ only in the size and type<br>of cushions made available in the packaging<br>(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.

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#### 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/<br>Technological<br>Characteristics | Subject Device F&P<br>Solo Mask | Predicate Device<br>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<br>adults weighing ≥ 66 lbs (30 kgs) who have been<br>prescribed non-invasive positive airway pressure<br>therapy such as CPAP or Bi-Level by a<br>physician. The F&P Solo mask is intended for<br>single- patient use in the home.<br>SL A-Model: | The F&P Evora™ Nasal Mask is intended to be<br>used by adults weighing<br>≥66lbs (30kgs) who have been prescribed non-<br>invasive positive airway pressure therapy such<br>as CPAP or bilevel by a physician. The F&P<br>Evora Nasal Mask is intended for single patient<br>use in the home | |
| Indications for Use | The F&P Solo mask is intended to be<br>used by adults weighing ≥ 66lbs (30 kgs) who<br>have been prescribed non-invasive positive<br>airway pressure therapy such as CPAP or Bi-<br>Level by a physician. The F&P Solo mask is<br>intended for single-patient use in the home and for<br>multiple patient use in the hospital or other clinical<br>setting where proper disinfection of the device can<br>occur between patient uses. | SL Model:<br>The F&P Evora Nasal Mask is intended to be<br>used by adults weighing ≥66lbs (30kgs) who<br>have been prescribed non-invasive positive<br>airway pressure therapy such as CPAP or<br>bilevel by a physician. The F&P Evora Nasal<br>Mask is intended for single patient use in the<br>home and for multiple patient use in the hospital<br>or other clinical setting where proper<br>disinfection of the device can occur between<br>uses. | Identical |
| Design/<br>Technological<br>Characteristics | Subject Device F&P<br>Solo Mask | Predicate Device<br>F&P Evora Nasal Mask<br>(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<br>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<br>connection to mask | 22mm ISO Taper | 22mm ISO Taper | Identical |
| Seal sizes | Nasal Cushion: Available in four sizes:<br>Small, Medium, Large, Wide<br>Pillows Cushion:<br>Available in three sizes: Small, Medium, Large | Predicate:<br>Available in four sizes: Small, Medium, Large,<br>Wide | While the subject device's Nasal<br>cushions are identical, the Pillows<br>cushion offers three additional<br>sizes.<br>The subject device is designed to<br>be in conformance to ISO<br>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.<br>The subject device vent holes are<br>located on the frame, whilst the<br>predicate has vent holes organized<br>in a radial pattern, also located on<br>the frame.<br>The subject device is designed to<br>be in conformance to ISO<br>17510:2015. |
| Design/<br>Technological<br>Characteristics | Subject Device F&P<br>Solo Mask | Predicate Device<br>F&P Evora Nasal Mask<br>(K200089) | Comments |
| Technical Specifications | | | |
| Pressure Range | 4 to 20 cm H2O | 4 to 25 cm H2O | The subject device is designed to be<br>in conformance with ISO 17510:2015 |
| Resistance to Flow | Pressure drop through Nasal Cushion: | Nasal (F&P Evora Nasal, predicate device):<br>Pressure drop through small 50 L/min: 1.0 ±<br>0.1cmH2O | The pressure drop for the subject<br>device is disclosed in labelling in |
| | Small 50 L/min: 0.84 cmH2O<br>Medium 50 L/min: 0.59 cmH2O | Pressure drop through medium 50 L/min: 1.0<br>± 0.1 cmH2O | accordance with ISO 17510:2015. |
| | Large 50 L/min: 0.54 cmH2O | Pressure drop through large 50 L/min: 1.0 ±<br>0.1 cmH2O | The reference device (Brevida,<br>K161412) has been used to support<br>claims of substantial equivalence for |
| | Wide 50 L/min: 0.58 cmH2O | Pressure drop through wide 50 L/min: 1.0 ±<br>0.1 cmH2O | pressure drop values with respect to<br>the 'Pillows Cushion'. |
| | Small 100 L/min: 3.63 cmH2O<br>Medium 100 L/min: 2.73 cmH2O | Pressure drop through small 100 L/min: 1.4 ±<br>0.25 cmH2O<br>Pressure drop through medium 100 L/min: 1.2<br>± 0.25 cmH2O<br>Pressure drop through large 100 L/min: 1.2 ±<br>0.25 cmH2O<br>Pressure drop through wide 100 L/min: 1.3 ±<br>0.25 cmH2O | |
| Large 100 L/min: 2.50 cmH2O<br>Wide 100 L/min: 2.65 cmH2O | | | |
| Pressure drop through Pillows Cushion:<br>Small 50 L/min: 2.17 cmH2O | | | |
| Medium 50 L/min: 1.05 cmH2O<br>Large 50 L/min: 0.89 cmH2O | | | |
| Small 100 L/min: 8.56 cmH2O<br>Medium 100 L/min: 4.42 cmH2O<br>Large 100 L/min: 3.83 cmH2O | | | |
| Dead Space | Nasal:<br>Small: 29.6 cc<br>Medium: 26.8 cc | Small: 28 cc<br>Medium: 26 cc<br>Large: 28 cc<br>Wide: 34 cc | Measured dead space is disclosed in<br>labelling in accordance with ISO<br>17510:2015. |
| | Large: 31.1 cc<br>Wide: 36.9 cc | | |
| | Pillows:<br>Small: 25.8 cc<br>Medium: 27.7 cc<br>Large: 30.5 cc | | |
| Sound | Sound Power Level of the Mask is 31.5 dBA, with<br>uncertainty 2.5 dBA<br>Sound Pressure Level of the Mask 23.6 dBA, with<br>uncertainty 2.5 dBA | Sound Power Level of the Mask is 26.8 dBA,<br>with uncertainty 2.5 dBA<br>Sound Pressure Level of the Mask 18.8 dBA,<br>with uncertainty 2.5 dBA | Measured sound power level is<br>disclosed in labelling in accordance<br>with ISO 17510:2015. |
| Shelf-Life | 2 year | 1 year | The subject device claims a 2-year<br>shelf life. |
| Design/<br>Technological<br>Characteristics | Subject Device F&P<br>Solo Mask | Predicate Device<br>F&P Evora Nasal Mask<br>(K200089) | Comments |
| Operating and Storage<br>Conditions | Operating Temperature: 5 to 40 °C<br>Storage Temperature: -20 to 50°C | Operating Temperature: 5 to 40 °C<br>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<br>Methods | Thermal Disinfection: 75°C (167°F) for 30 mins<br>80°C (176°F) for 10 mins | Thermal Disinfection: 75°C (167°F) for 30<br>mins 80°C (176°F) for 10 mins 90°C (194°F)<br>for 1 min…