(265 days)
No
The summary describes a physical mask accessory for ventilation and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is a mask accessory to ventilators for NPPV therapy; it does not independently provide therapy.
No
The device is a mask accessory for ventilators used to deliver noninvasive positive pressure ventilation, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a "vented hospital full face mask with an anti-asphyxiation valve" and describes physical components and performance testing related to hardware, not software.
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 noninvasive 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 a mask used as an accessory to a ventilator. It facilitates the delivery of air/oxygen to the patient's respiratory system.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition based on in vitro testing.
The device is clearly intended for use in a clinical setting to support a patient's breathing, which falls under the category of a medical device used for treatment or support, not diagnosis.
N/A
Intended 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 with patient monitoring in place.
Product codes
MNT
Device Description
The Nivairo™ RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version (referred as RT047) is a vented hospital full face mask with an anti-asphyxiation valve for use with single limb circuits. The RT047 is a single use device intended for use as an accessory to deliver non-invasive positive pressure ventilation (NPPV) to a patient as passively vented non-invasive ventilation system.
The RT047 is a prescription only device, 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
Not Found
Indicated Patient Age Range
adult patients (> 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)
Performance testing of the RT047 was completed to determine that device design changes, compared to the predicate do not raise new questions of safety or effectiveness. The following tests demonstrate substantial equivalence of the RT047 to the predicate device.
- Dead Space Testing
- Pressure Drop and Resistance to Flow Testing
- CO2 Testing
- Non-rebreathing valve (NRV) Flap Operation and Leak Testing
- Venting Leak Rate and Product Leak Testing
- Pressure Port Testing
- Humidity Delivery Performance
- Simulated Transport, Storage Testing in accordance with ASTM-D4169-16
- Condensate Testing for Biocompatibility Assessment
- Exhaustive Extractables Testing
- Biocompatibility testing as per ISO 10993 and ISO 18562 standards listed above
Clinical performance testing was not required to demonstrate substantial equivalence for the RT047. The comparison of features, performance, technological characteristics, and intended use demonstrate that the RT047 is substantially equivalent to the predicate RT045 (K170367).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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 shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol is a stylized representation of a human figure, while the FDA name is written in blue and includes the words "U.S. Food & Drug Administration".
March 9, 2020
Fisher & Paykel Healthcare Limited Nicholas Yap Regulatory Affairs Associate 15 Maurice Paykel Place Auckland, 2013 NZ
Re: K191624
Trade/Device Name: F&P Nivairo™ RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: Class II Product Code: MNT Dated: February 3, 2020 Received: February 7, 2020
Dear Nicholas Yap:
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
1
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 (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 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,
James J. Lee Ph.D. 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K191624
Device Name
Nivairo™ RT047 vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version
Indications for Use (Describe)
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 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 a large ampersand between the two words. The word "HEALTHCARE" is on the second line, and it is directly below the first line. A blue line separates the two lines of text.
510(k) Summary ട
| Official Contact | Reena Daken |
|---|---|
| Submitter | Nicholas Yap |
| Date prepared | March 09, 2020 |
| Contact details | Address: 15 Maurice Paykel Place |
| East Tamaki | |
| Auckland 2013, New Zealand | |
| Telephone: +64 9 574 0100 | |
| Fax: +64 9 574 0158 | |
| Trade name | F&P Nivairo™ RT047 Vented Hospital Full Face Mask, Anti- |
| Asphyxiation Valve Version | |
| Common name | Full Face Mask |
| Classification name | Continuous Ventilator (accessory to) |
| Class II, 21 CFR 868.5895 | |
| Product code MNT (Anesthesiology) | |
| Predicate device | K170367 RT045 Non-Vented Hospital Full Face Mask, Anti- |
| Asphyxiation Valve | |
| Reference devices: | K130328 F&P Simplus Full Face Mask |
| K173060 F&P Nivairo™ RT046 Non-Vented Full Face Mask | |
| Standard Elbow Version | |
| K060044 F&P RT040 Acute Care Face Mask |
Device Description 5.1
The Nivairo™ RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version (referred as RT047) is a vented hospital full face mask with an anti-asphyxiation valve for use with single limb circuits. The RT047 is a single use device intended for use as an accessory to deliver non-invasive positive pressure ventilation (NPPV) to a patient as passively vented non-invasive ventilation system.
The RT047 is a prescription only device, provided in a non-sterile state.
5.2 Intended Use / Indications for Use
The Fisher & Paykel Healthcare single use masks are intended for use as an accessory to ventilators to enable non-invasive pressure ventilation (NPPV) therapy (CPAP or bi-level) to be delivered to spontaneously breathing adult patients (>30kg) with respiratory insufficiency or respiratory failure who have been prescribed NPPV. The masks are to be fitted and therapy
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Image /page/4/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 similar font. The logo is in blue.
maintained by trained medical practitioners in a hospital/institutional environment with patient monitoring in place.
Technological Characteristics Comparison 5.3
5.3.1 Similarities between the subject and predicate devices
The RT047 has the following key similarities to the previously cleared predicate Nivairo™ RT045 Hospital Full Face Mask Non-Vented, Anti-Asphyxiation Version (referred as RT045):
- Identical intended use with same patient population and operating environment .
- Same mode of operation both masks deliver gases oro-nasally .
- . Same Headgear
5.3.2 Differences between the subject and predicate devices
The key differences between the RT047 and the RT045 are:
- RT047 Elbow is vented. RT045 elbow is not vented. .
- · RT047 Swivel is a 22mm male ISO taper. RT045 Swivel is a 22mm female ISO taper.
- RT047 Swivel has a Pressure Port with a Pressure Port Cap. RT045 Swivel does not have a . Pressure Port and thus, no Pressure Port Cap.
- · Elbow color: RT047 is orange while RT045 is clear/colourless.
5.4 Non-Clinical Performance Data
The RT047 has been tested to applicable clauses of the following standards:
- ISO 17510:2015 Sleep apnoea breathing therapy Masks and application accessories ●
- . ISO 5356-1:2015 Anesthetic 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 10993-2:2006 Biological evaluation of medical devices - Part 2: Animal welfare requirements
- 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 10993-10:2010 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
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Image /page/5/Picture/1 description: The image shows the logo for Fisher & Paykel Healthcare. The logo is in blue and consists of the words "Fisher & Paykel" on the top line and "Healthcare" on the bottom line. There is a horizontal line separating the two lines of text. The ampersand symbol is between the two names on the top line.
- . ISO 10993-12:2012 Biological evaluation of medical devices - Part 12: Sample preparation and reference material
- . ISO 10993-17:2002 Biological evaluation of medical devices – Part 17: Establishment of allowable limits for leachable substances
- ISO 10993-18:2005 Biological evaluation of medical devices Part 18: Chemical . characterization of materials
- . ISO 18562-1:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 1: Evaluation and testing within a risk management process
- ISO 18562-2:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter
- . ISO 18562-3:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic compounds (VOCs)
Performance testing of the RT047 was completed to determine that device design changes, compared to the predicate do not raise new questions of safety or effectiveness. The following tests demonstrate substantial equivalence of the RT047 to the predicate device.
- . Dead Space Testing
- Pressure Drop and Resistance to Flow Testing
- CO2 Testing ●
- Non-rebreathing valve (NRV) Flap Operation and Leak Testing
- . Venting Leak Rate and Product Leak Testing
- . Pressure Port Testing
- Humidity Delivery Performance
- Simulated Transport, Storage Testing in accordance with ASTM-D4169-16
- Condensate Testing for Biocompatibility Assessment
- . Exhaustive Extractables Testing
- . Biocompatibility testing as per ISO 10993 and ISO 18562 standards listed above
Clinical Performance Data 5.5
Clinical performance testing was not required to demonstrate substantial equivalence for the RT047.
5.6 Conclusions
The comparison of features, performance, technological characteristics, and intended use demonstrate that the RT047 is substantially equivalent to the predicate RT045 (K170367).