(159 days)
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.
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.
This document is a 510(k) Premarket Notification from the FDA regarding the F&P Solo Mask Range, a non-invasive patient interface for CPAP or Bi-Level therapy. The document asserts that the device is substantially equivalent to a predicate device, as required by FDA regulations.
Based on the provided information, the request appears to be asking for a description of acceptance criteria and the study that proves the device meets those criteria, specifically concerning an AI/ML medical device. However, this document is NOT about an AI/ML medical device. It's about a physical medical device (a CPAP mask).
Therefore, I cannot extract the information requested in points 1 through 9 because the provided text does not contain any information about AI/ML acceptance criteria, ground truth, expert adjudication, or MRMC studies.
The document primarily focuses on:
- Device Description: What the F&P Solo Mask is, its models (A-Model, SL A-Model), and its intended use (CPAP/Bi-Level therapy for adults).
- Predicate Device Comparison: A detailed table comparing the F&P Solo Mask with a legally marketed predicate device (F&P Evora™ Nasal Mask, K200089) based on design features, technical specifications (pressure range, resistance to flow, dead space, sound, shelf-life, operating conditions), and components.
- Non-Clinical Tests: A summary of various non-clinical tests performed on the device to demonstrate conformance to applicable standards (e.g., ISO 17510:2015 for CO2 rebreathing, pressure-flow curve, exhaust flow, resistance to flow, vibration and noise; ISO 10993 series for biological evaluation). These are physical and performance tests specific to a respiratory mask, not AI/ML performance metrics.
In summary, none of the requested AI/ML specific information (acceptance criteria for AI, data provenance, expert ground truth, MRMC studies, standalone AI performance data, training set details) is present in this 510(k) submission for a non-AI/ML device.
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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
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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 (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
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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 Limited15 Maurice Paykel PlaceEast TamakiAuckland 2013, New ZealandTelephone: +64 9 574 0100 |
|---|---|
| Prepared and Submitted by | Alec O'Connell-BiddlecombeRegulatory Affairs Associate |
| Contact Person | Reena DakenRegulatory Affairs ManagerTelephone: +64 9 574 0100Email: 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
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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 ahome environment only. The mask is available inseven different configurations which differ only inthe size and type of the cushions made available inthe 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-ModelThe Sleep Lab A Model is intended for singlepatient use in a home environment as well as formulti-patient use in the hospital or other clinicalsetting. The mask is available in seven differentconfigurations which differ only in the size and typeof 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.
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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/TechnologicalCharacteristics | Subject Device F&PSolo Mask | Predicate DeviceF&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 byadults weighing ≥ 66 lbs (30 kgs) who have beenprescribed non-invasive positive airway pressuretherapy such as CPAP or Bi-Level by aphysician. The F&P Solo mask is intended forsingle- patient use in the home.SL A-Model: | The F&P Evora™ Nasal Mask is intended to beused by adults weighing≥66lbs (30kgs) who have been prescribed non-invasive positive airway pressure therapy suchas CPAP or bilevel by a physician. The F&PEvora Nasal Mask is intended for single patientuse in the home | ||
| Indications for Use | The F&P Solo mask is intended to beused by adults weighing ≥ 66lbs (30 kgs) whohave been prescribed non-invasive positiveairway pressure therapy such as CPAP or Bi-Level by a physician. The F&P Solo mask isintended for single-patient use in the home and formultiple patient use in the hospital or other clinicalsetting where proper disinfection of the device canoccur between patient uses. | SL Model:The F&P Evora Nasal Mask is intended to beused by adults weighing ≥66lbs (30kgs) whohave been prescribed non-invasive positiveairway pressure therapy such as CPAP orbilevel by a physician. The F&P Evora NasalMask is intended for single patient use in thehome and for multiple patient use in the hospitalor other clinical setting where properdisinfection of the device can occur betweenuses. | Identical |
| Design/TechnologicalCharacteristics | Subject Device F&PSolo Mask | Predicate DeviceF&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 |
| OperatingEnvironment | 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 Tubeconnection to mask | 22mm ISO Taper | 22mm ISO Taper | Identical |
| Seal sizes | Nasal Cushion: Available in four sizes:Small, Medium, Large, WidePillows Cushion:Available in three sizes: Small, Medium, Large | Predicate:Available in four sizes: Small, Medium, Large,Wide | While the subject device's Nasalcushions are identical, the Pillowscushion offers three additionalsizes.The subject device is designed tobe in conformance to ISO17510:2015. |
| 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 arelocated on the frame, whilst thepredicate has vent holes organizedin a radial pattern, also located onthe frame.The subject device is designed tobe in conformance to ISO17510:2015. |
| Design/TechnologicalCharacteristics | Subject Device F&PSolo Mask | Predicate DeviceF&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 bein 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 subjectdevice is disclosed in labelling in |
| Small 50 L/min: 0.84 cmH2OMedium 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 supportclaims 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 tothe 'Pillows Cushion'. | |
| Small 100 L/min: 3.63 cmH2OMedium 100 L/min: 2.73 cmH2O | Pressure drop through small 100 L/min: 1.4 ±0.25 cmH2OPressure drop through medium 100 L/min: 1.2± 0.25 cmH2OPressure drop through large 100 L/min: 1.2 ±0.25 cmH2OPressure drop through wide 100 L/min: 1.3 ±0.25 cmH2O | ||
| Large 100 L/min: 2.50 cmH2OWide 100 L/min: 2.65 cmH2O | |||
| Pressure drop through Pillows Cushion:Small 50 L/min: 2.17 cmH2O | |||
| Medium 50 L/min: 1.05 cmH2OLarge 50 L/min: 0.89 cmH2O | |||
| Small 100 L/min: 8.56 cmH2OMedium 100 L/min: 4.42 cmH2OLarge 100 L/min: 3.83 cmH2O | |||
| Dead Space | Nasal:Small: 29.6 ccMedium: 26.8 cc | Small: 28 ccMedium: 26 ccLarge: 28 ccWide: 34 cc | Measured dead space is disclosed inlabelling in accordance with ISO17510:2015. |
| Large: 31.1 ccWide: 36.9 cc | |||
| Pillows:Small: 25.8 ccMedium: 27.7 ccLarge: 30.5 cc | |||
| Sound | Sound Power Level of the Mask is 31.5 dBA, withuncertainty 2.5 dBASound Pressure Level of the Mask 23.6 dBA, withuncertainty 2.5 dBA | Sound Power Level of the Mask is 26.8 dBA,with uncertainty 2.5 dBASound Pressure Level of the Mask 18.8 dBA,with uncertainty 2.5 dBA | Measured sound power level isdisclosed in labelling in accordancewith ISO 17510:2015. |
| Shelf-Life | 2 year | 1 year | The subject device claims a 2-yearshelf life. |
| Design/TechnologicalCharacteristics | Subject Device F&PSolo Mask | Predicate DeviceF&P Evora Nasal Mask(K200089) | Comments |
| Operating and StorageConditions | Operating Temperature: 5 to 40 °CStorage Temperature: -20 to 50°C | Operating Temperature: 5 to 40 °CStorage 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 DisinfectionMethods | Thermal Disinfection: 75°C (167°F) for 30 mins80°C (176°F) for 10 mins | Thermal Disinfection: 75°C (167°F) for 30mins 80°C (176°F) for 10 mins 90°C (194°F)for 1 min | The subject device contains a subsetof the high-level disinfectionmethods compared to the predicate. |
| Design / Components | |||
| Mask Components | CushionFrameHeadgearTubeSwivel | SealFrameHeadgearTubeSwivel | Identical - name of seal changed tocushion. |
| Cushion | Soft pliable cushion between mask base and nares(nasal cushion).Soft pliable cushion between mask base, extendinginto the nares (pillows cushion). | Soft pliable seal between mask base andnares, without any of the seal extending intothe nares. | The subject device has cushionswhich seal under the nose (nasal)and into the nares (pillows) whencomparedto the predicate device. |
| Frame | Connection for tube, cushion, and headgear. | Connection for tube, seal and headgear. | Identical - name of seal changed tocushion. |
| Headgear | Adjustable headgear made up of stretch and non-stretch portions. | Adjustable headgear made up of twocomponents:• Moulded front and top straps thatare permanently joined together.• Single backstrap | Both the subject and predicatedevices have stretch and non-stretchsections.The subject device headgear is oneassembly with adjustment built in. |
| Tube | Permanently attached to mask frame | Permanently attached to mask frame | Identical |
| Swivel | Permanently attached to the mask tube, while stillallowing rotation, with 22mm taper allowingconnection to industry-standard breathing tubes | Removable 22mm taper allowing connectionto industry-standard breathing tubes | The subject device has apermanently attached swivel, whilestill allowing rotation. |
| Accessories | |||
| Accessory | Oxygen/Pressure Port(900HC452)Available as a separate part, not providedwith device. | Oxygen/PressurePort (900HC452)Available as a separate part, not providedwith device. | Identical |
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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.
§ 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).