F&P Visairo NIV Mask Range

K203449 · Fisher & Paykel Healthcare, Ltd. · CBK · Apr 14, 2021 · Anesthesiology

Device Facts

• Record ID: K203449
• Device Name: F&P Visairo NIV Mask Range
• Applicant: Fisher & Paykel Healthcare, Ltd.
• Product Code: CBK · Anesthesiology
• Decision Date: Apr 14, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Fisher & Paykel Healthcare Visairo masks are single patient use masks intended for use as an accessory to ventilators to enable non-invasive positive pressure ventilation (NPPV) therapy (CPAP or bi-level) to be delivered to spontaneously breathing adult patients (> 30 kg) with respiratory insufficiency or respiratory failure who have been prescribed NPPV. The masks are to be fitted and therapy maintained by trained medical practitioners in a hospital/institutional environment with patient monitoring in place.

Device Story

Oro-nasal full face masks; accessory to ventilators for non-invasive positive pressure ventilation (NPPV). Input: pressurized air from ventilator; Output: delivery of CPAP or bi-level therapy to patient airway. Used in hospital/institutional environments; fitted and maintained by trained medical practitioners. Device provides interface for therapy delivery; helps maintain seal for respiratory support. Benefits patient by enabling non-invasive respiratory assistance. Models include non-vented (with/without anti-asphyxiation valve) and vented versions. Single patient use; 14-day usage limit.

Clinical Evidence

Bench testing only. Compliance with ISO 17510:2020 (sleep apnea breathing therapy masks), ISO 5356-1:2015 (conical connectors), ISO 10993-1:2018 (biocompatibility), and ISO 18562-1:2017 (biocompatibility of breathing gas pathways).

Technological Characteristics

Oro-nasal full face mask; single patient use; non-sterile. Features ISO 5356-1 conical connectors (22mm). Operating pressure range 4-40 cmH2O. Dead space < 200 cm3. Includes anti-asphyxiation valve models. Biocompatible materials per ISO 10993-1 and ISO 18562-1. 14-day usage limit; 3-year shelf life.

Indications for Use

Indicated for spontaneously breathing adult patients (>30 kg) with respiratory insufficiency or respiratory failure requiring non-invasive positive pressure ventilation (CPAP or bi-level) in hospital/institutional settings.

Regulatory Classification

Identification

A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.

Predicate Devices

• F&P Nivairo™ RT046 Non-Vented Full Face Hospital Mask Standard Elbow Version (K173060)

Reference Devices

• F&P Nivairo™ RT045 Non-Vented Full Face Hospital Mask Anti-Asphyxiation Valve Version (K170367)
• F&P Nivairo™ RT047 Vented Full Face Hospital Mask Standard Elbow Version (K191624)
• F&P Eson™ Nasal Mask (K121597)
• F&P Vitera™ Full Face Mask (K190713)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Fisher & Paykel Healthcare Ltd Reena Daken Regulatory Affairs Market Manager 15 Maurice Paykel Place, East Tamaki Auckland, 2013 New Zealand

Re: K203449

Trade/Device Name: F&P Visairo NIV Mask Range Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: Class II Product Code: CBK Dated: March 12, 2021 Received: March 15, 2021

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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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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 medical devices and radiation-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,

Brandon Blakely, PhD Acting Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K203449

Device Name F&P Visairo NIV Masks

### Indications for Use (Describe)

The Fisher & Paykel Healthcare Visairo masks are single patient use masks intended for use as an accessory to ventilators to enable non-invasive positive pressure ventilation (NPPV) therapy (CPAP or bi-level) to be delivered to spontaneously breathing adult patients (> 30 kg) with respiratory insufficiency or respiratory failure who have been prescribed NPPV. The masks are to be fitted and therapy maintained by trained medical practitioners in a hospital/institutional environment with patient monitoring in place.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

> Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/1 description: The image shows the logo for Fisher & Paykel Healthcare. The words "Fisher & Paykel" are on the top line, with the "&" symbol between the two words. The word "Healthcare" is on the second line, and there is a line above and below the word. All of the text is in blue.

# 510(k) Summary

As Required by 21 CFR 807.92

#### I. SUBMITTER

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

#### II. DEVICE

| Name of Device | F&P Visairo™ NIV Masks |
|---------------------|--------------------------------------|
| Common/Usual Name | Full Face Mask |
| Classification Name | Ventilator, Continuous, Facility Use |
| Regulatory Class | Class II (21 CFR §868.5895) |
| Product Code | CBK |

#### lll. PREDICATE DEVICE

- . Predicate device:
- o F&P Nivairo™ RT046 Non-Vented Full Face Hospital Mask Standard Elbow Version, K173060
- . Reference devices:
- o F&P Nivairo™ RT045 Non-Vented Full Face Hospital Mask Anti-Asphyxiation Valve Version, K170367
- o F&P Nivairo™ RT047 Vented Full Face Hospital Mask Standard Elbow Version, K191624
- o F&P Eson™ Nasal Mask, K121597
- o F&P Vitera™ Full Face Mask, K190713

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Image /page/4/Picture/1 description: The image shows the logo for Fisher & Paykel Healthcare. The words "Fisher & Paykel" are in a bold, sans-serif font on the top line. Below that is a horizontal line, and below that is the word "HEALTHCARE" in a smaller, sans-serif font. The logo is in a dark blue color.

#### DEVICE DESCRIPTION IV.

The F&P Visairo™ NIV Masks ("Visairo Masks") are oro-nasal full face masks that are intended for use as an accessory to deliver non-invasive positive pressure ventilation (NPPV) to a patient as part of a non-invasive ventilation system. The Visairo Masks are prescription only, provided in a non-sterile state.

A list of the subject device product codes can be found below:

| Model | Product Code | Description |
|-------|--------------|-------------------------------------------------------------------------------|
| RT075 | RT075A | Non-Vented Hospital Under Nose Mask, Anti-Asphyxiation Valve Version – Size A |
| | RT075B | Non-Vented Hospital Under Nose Mask, Anti-Asphyxiation Valve Version – Size B |
| | RT075C | Non-Vented Hospital Under Nose Mask, Anti-Asphyxiation Valve Version – Size C |
| RT076 | RT076A | Non-Vented Hospital Under Nose Mask, Standard Elbow Version – Size A |
| | RT076B | Non-Vented Hospital Under Nose Mask, Standard Elbow Version – Size B |
| | RT076C | Non-Vented Hospital Under Nose Mask, Standard Elbow Version – Size C |
| RT077 | RT077A | Vented Hospital Under Nose Mask, Anti-Asphyxiation Valve Version – Size A |
| | RT077B | Vented Hospital Under Nose Mask, Anti-Asphyxiation Valve Version – Size B |
| | RT077C | Vented Hospital Under Nose Mask, Anti-Asphyxiation Valve Version – Size C |

#### INDICATIONS FOR USE V.

The Fisher & Paykel Healthcare Visairo masks are single patient use masks intended for use as an accessory to ventilators to enable non-invasive positive pressure ventilation (NPPV) therapy (CPAP or bi-level) to be delivered to spontaneously breathing adult patients (> 30 kg) with respiratory insufficiency or respiratory failure who have been prescribed NPPV. The masks are to be fitted and therapy maintained by trained medical practitioners in a hospital/institutional environment with patient monitoring in place.

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#### COMPARISON OF TECHNOLOGICAL CHARATCERISTICS WITH THE PREDICATE DEVICE VI.

The comparison of features, performance data and intention NIV Masks are substantially equivalent to the predicate device, F&P Nivairo™ RT046 Mask (K173060). Please see the table below.

| Design / Technological<br>Characteristic | Subject Device<br>F&P Visairo Masks | Predicate Device<br>F&P Nivairo RT046 Mask (K173060) | Comments |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | | | |
| Legal manufacturer | Fisher & Paykel Healthcare Ltd | Fisher & Paykel Healthcare Ltd | Identical |
| Regulation Number | 21 CFR §868.5895 | 21 CFR §868.5895 | |
| Product Code | CBK | CBK | |
| Classification Panel | Anaesthesiology | Anaesthesiology | |
| Intended Use / Indications for Use | | | |
| Indications for Use | The Fisher & Paykel Healthcare single<br>patient use masks are intended for use as<br>an accessory to ventilators to enable<br>noninvasive positive pressure ventilation<br>(NPPV) therapy (CPAP or bi-level) to be<br>delivered to spontaneously breathing adult<br>patients (>30 kg) with respiratory<br>insufficiency or respiratory failure who<br>have been prescribed NPPV. The masks<br>are to be fitted and therapy maintained by<br>trained medical practitioners in a<br>hospital/institutional environment. | The Fisher & Paykel Healthcare single<br>patient use masks are intended for use as<br>an accessory to ventilators to enable<br>noninvasive positive pressure ventilation<br>(NPPV) therapy (CPAP or bi-level) to be<br>delivered to spontaneously breathing adult<br>patients (>30 kg) with respiratory<br>insufficiency or respiratory failure who have<br>been prescribed NPPV. The masks are to<br>be fitted and therapy maintained by trained<br>medical practitioners in a<br>hospital/institutional environment. | Identical |
| Availability | Prescription use<br>(Part 21 CFR 801 Subpart D) | Prescription use<br>(Part 21 CFR 801 Subpart D) | Identical |
| Patient Population | Adult (>30 kg) | Adult (>30 kg) | Identical |
| Patient Consciousness | Responsive and able to remove mask | Responsive and able to remove mask | Identical |
| Design / Technological<br>Characteristic | Subject Device<br>F&P Visairo Masks | Predicate Device<br>F&P Nivairo RT046 Mask (K173060) | Comments |
| Patient Monitoring | Appropriate patient monitoring | Appropriate patient monitoring | Identical |
| Operating Environment | Hospital/institutional environments | Hospital/institutional environments | Identical |
| Application | CPAP or Bi-level positive pressure<br>ventilation | CPAP or Bi-level positive pressure<br>ventilation | Identical |
| Reusability | Single use | Single use | Identical |
| Technical Specifications and Features | | | |
| Operating Pressure<br>Range | 4 - 40 cmH₂O | 4 - 25 cmH₂O | The subject device was designed to<br>achieve a seal and deliver therapy at<br>higher operating pressures. This is<br>consistent with other under the nose NIV<br>masks on the market. |
| Compatibility with F&P<br>Systems | F&P 850 ™ | F&P 850 ™ | Identical |
| Interface Connections | ISO 5356-1 Conical Connectors<br>• RT075 and RT076: 22mm female ISO<br>medical taper<br>• RT077: 22mm male ISO medical<br>taper | ISO 5356-1 Conical Connectors<br>• RT045 and RT046: 22mm female ISO<br>medical taper<br>• RT047: 22mm male ISO medical taper | Identical<br>The RT075 and RT076 are identical to<br>the RT046 predicate device (K173060).<br>The RT077 is identical to the RT047<br>reference device (K191624). |
| Mask Dead Space | All models: < 200 cm³ | < 325 cm³ | All Visairo Mask models were calculated<br>to have a dead space of 191cm³ or less.<br>This is consistent with other NIV masks<br>with an under the nose seal on the<br>market. |
| Anti-Asphyxiation Valve<br>Operation | RT075<br>• Open to Atmospheric Pressure<br>0.41 cmH₂O | RT045<br>• Open to Atmospheric Pressure<br>0.41 cmH₂O | Identical<br>The RT075 is identical to the RT045<br>reference device (K170367) |
| Design / Technological<br>Characteristic | Subject Device<br>F&P Visairo Masks | Predicate Device<br>F&P Nivairo RT046 Mask (K173060) | Comments |
| | • Closed to Atmospheric Pressure<br>0.92 cmH2O | • Closed to Atmospheric Pressure<br>0.92 cmH2O | The RT076 is identical to the RT046<br>predicate device (K173060) |
| | RT076<br>• N/A (No Anti-Asphyxiation Valve) | RT046<br>• N/A (No Anti-Asphyxiation Valve) | The RT077 is identical to the RT047<br>reference device (K191624) |
| | RT077 | RT047 | |
| | • Open to Atmospheric Pressure<br>0.24 cmH2O | • Open to Atmospheric Pressure:<br>0.24 cmH2O | |
| | • Closed to Atmospheric Pressure<br>0.80 cmH2O | • Closed to Atmospheric Pressure:<br>0.80 cmH2O | |
| | | | |
| Resistance to Flow<br>through mask | RT075 | RT045 | Identical |
| | • 0.23 cmH2O @ 50 L/min | • 0.23 cmH2O @ 50 L/min | The RT075 is identical to the RT045<br>reference device (K170367) |
| | • 0.51 cmH2O @ 100 L/min | • 0.51 cmH2O @ 100 L/min | The RT076 is identical to the RT046<br>predicate device (K173060) |
| | RT076 | RT046 | The RT077 is identical to the RT047 |
| | • 0.07 cmH2O @ 50 L/min | • 0.07 cmH2O @ 50 L/min | reference device (K191624) |
| | • 0.33 cmH2O @ 100 L/min | • 0.33 cmH2O @ 100 L/min | |
| | | | |
| | RT077 | RT047 | |
| | • 0.26 cmH2O @ 50 L/min<br>• 0.63 cmH2O @ 100 L/min | • 0.26 cmH2O @ 50 L/min<br>• 0.63 cmH2O @ 100 L/min | |
| Breathing Circuit | • RT075 - Single limb with an<br>exhalation port | • RT045 - Single limb with an exhalation<br>port | Identical |
| Design / Technological<br>Characteristic | Subject Device<br>F&P Visairo Masks | Predicate Device<br>F&P Nivairo RT046 Mask (K173060) | Comments |
| | RT076 – Dual limb RT077 – Single limb, exhalation port optional | RT046 – Dual limb RT047 – Single limb, exhalation port optional | The RT075 is identical to the RT045<br>reference device (K170367)<br>The RT076 is identical to the RT046<br>predicate device (K173060)<br>The RT077 is identical to the RT047<br>reference device (K191624) |
| Sterility | Device not provided sterile | Device not provided sterile | Identical |
| Maximum number of<br>days in use | 14-day usage | 14-day usage | Identical |
| Shelf life | 3-year shelf life | 3-year shelf life | Identical |
| Sizes | Available in three sizes – A, B, and C | Available in four sizes – XS, S, M, L | The naming convention has been<br>changed due to the Seal fit. The subject<br>device patient population is identical to<br>that of the predicate device. |

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Image /page/6/Picture/1 description: The image shows the logo for Fisher & Paykel Healthcare. The words "Fisher & Paykel" are in a bold, sans-serif font, with the "&" symbol connecting the two names. Below this, the word "HEALTHCARE" is written in a similar font, with a line above it.

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Image /page/7/Picture/1 description: The image shows the logo for Fisher & Paykel Healthcare. The words "Fisher & Paykel" are on the top line in a bold, sans-serif font. Below that is a horizontal line, and below that is the word "HEALTHCARE" in a larger, bold, sans-serif font.

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Image /page/8/Picture/1 description: The image shows the logo for Fisher & Paykel Healthcare. The words "Fisher & Paykel" are on the top line in a bold, blue font. Below that is a blue line, and below that is the word "HEALTHCARE" in a bold, blue font.

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Image /page/9/Picture/1 description: The image shows the logo for Fisher & Paykel Healthcare. The words "Fisher & Paykel" are on the top line, with a stylized ampersand between them. The word "Healthcare" is on the second line, in all caps. All of the text is in a dark blue color.

#### PERFORMANCE DATA VII.

## Summary of non-clinical tests

The F&P Visairo NIV Masks have been tested to applicable requirements to the following standards:

- . ISO 17510:2020 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 18562-1:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process

#### CONCLUSIONS VIII.

The F&P Visairo NIV Masks are 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.