(142 days)
No
The summary describes a physical mask accessory for ventilators and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is described as an accessory to ventilators used to deliver non-invasive positive pressure ventilation (NPPV) therapy, functioning as a mask rather than providing therapy itself.
No
The device is a mask accessory to ventilators for delivering non-invasive positive pressure ventilation (NPPV) therapy; it is not used for diagnosing medical conditions.
No
The device description clearly states it is an oro-nasal full face mask, which is a physical hardware component used for delivering ventilation. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to deliver non-invasive positive pressure ventilation (NPPV) to patients with respiratory insufficiency or failure. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is an oro-nasal full face mask, an accessory for a ventilation system. This is a physical interface for delivering air, not a device designed to analyze biological samples.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.), chemical reactions, or any other processes typically associated with in vitro diagnostics.
In summary, the F&P Visairo masks are medical devices used for delivering therapy, not for diagnosing conditions by testing samples outside the body.
N/A
Intended Use / Indications for 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.
Product codes
CBK
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oro-nasal
Indicated Patient Age Range
Adult (> 30 kg)
Intended User / Care Setting
Trained medical practitioners in a hospital/institutional environment with patient monitoring in place.
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)
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
The conclusions drawn from the non-clinical tests demonstrate that the device is substantially equivalent to the legally marketed predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K170367, K191624, K121597, K190713
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5895 Continuous ventilator.
(a)
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.(b)
Classification. Class II (performance standards).
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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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
Address | Fisher & Paykel Healthcare Limited
15 Maurice Paykel Place
East Tamaki
Auckland 2013, New Zealand
Telephone: +64 9 574 0100 |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Prepared and Submitted
by | Nicholas Yap
Regulatory Affairs Specialist |
| Contact Person | Reena Daken
Regulatory Affairs Market Manager
Telephone: +64 9 574 0100
Email: reena.daken@fphcare.co.nz |
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:
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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
Characteristic | Subject Device
F&P Visairo Masks | Predicate Device
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
patient use masks are intended for use as
an accessory to ventilators to enable
noninvasive 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. | The Fisher & Paykel Healthcare single
patient use masks are intended for use as
an accessory to ventilators to enable
noninvasive 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. | Identical |
| Availability | Prescription use
(Part 21 CFR 801 Subpart D) | Prescription use
(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
Characteristic | Subject Device
F&P Visairo Masks | Predicate Device
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
ventilation | CPAP or Bi-level positive pressure
ventilation | Identical |
| Reusability | Single use | Single use | Identical |
| Technical Specifications and Features | | | |
| Operating Pressure
Range | 4 - 40 cmH₂O | 4 - 25 cmH₂O | The subject device was designed to
achieve a seal and deliver therapy at
higher operating pressures. This is
consistent with other under the nose NIV
masks on the market. |
| Compatibility with F&P
Systems | F&P 850 ™ | F&P 850 ™ | Identical |
| Interface Connections | ISO 5356-1 Conical Connectors
• RT075 and RT076: 22mm female ISO
medical taper
• RT077: 22mm male ISO medical
taper | ISO 5356-1 Conical Connectors
• RT045 and RT046: 22mm female ISO
medical taper
• RT047: 22mm male ISO medical taper | Identical
The RT075 and RT076 are identical to
the RT046 predicate device (K173060).
The RT077 is identical to the RT047
reference device (K191624). |
| Mask Dead Space | All models: