(119 days)
No
The description focuses on the physical components and intended use of a non-vented full face mask for non-invasive ventilation. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities. The performance studies compare the new mask to a predicate mask based on physical performance, not algorithmic performance.
No.
The device is described as an accessory to ventilators for delivering non-invasive positive pressure ventilation (NPPV) therapy, rather than being a therapeutic device itself.
No
The device is a non-vented full face mask intended to be an accessory to ventilators for delivering non-invasive positive pressure ventilation (NPPV) therapy. Its purpose is therapeutic delivery, not diagnosis.
No
The device description clearly states it is a physical mask, a hardware component, intended for use with ventilators. It is not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the device is a mask used as an accessory to ventilators to deliver non-invasive positive pressure ventilation (NPPV) to a patient. It is a physical interface for delivering breathing gases.
- Intended Use: The intended use is to facilitate the delivery of respiratory therapy, not to analyze biological samples.
The device is a medical device, specifically a respiratory support accessory, but it does not fit the definition of an In Vitro Diagnostic device.
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 (NPV) 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 maintained by trained medical practitioners in a hospital/institutional environment with patient monitoring in place.
Product codes (comma separated list FDA assigned to the subject device)
CBK
Device Description
The Nivairo™ RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version (herein referred to as RT046) is a non-vented hospital full face mask with a standard elbow for use with dual limb circuits. The RT046 is a single use device intended for use as an accessory to deliver non-invasive positive pressure ventilation (NPPV) to a patient as part of a passively vented non-invasive ventilation system.
The RT046 is an oronasal full face mask intended to be used in a hospital/institutional environment by trained medical staff with patient monitoring systems in place. It connects to a dual limb breathing circuit via a 22mm female swivel adaptor to receive pressurized breathing gases from an external flow source or ventilator (CPAP or Bi-Level).
The RT046 mask 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
oronasal
Indicated Patient Age Range
adult patients (>30kg)
Intended User / Care Setting
trained medical practitioners in a hospital/institutional environment
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 RT046 (subject) was conducted and data were compared to the performance data for the RT041 (predicate) for performance. The data demonstrate substantial equivalence of the RT046 to the RT041. The results of the comparative bench testing do not raise any new questions regarding safety or effectiveness for the RT046.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
0
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, with the words "U.S. FOOD & DRUG" on the first line and "ADMINISTRATION" on the second line. The FDA logo is in blue.
January 25, 2018
Fisher and Paykel Healthcare Limited Ashley Nguyen Regulatory Affairs Specialist 15 Maurice Paykel Place Auckland, 2013 NZ
Re: K173060
Trade/Device Name: F&P NivairoTM RT046 Non-Vented Full Face Mask, Standard Elbow Version Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: Class II Product Code: CBK Dated: December 20, 2017 Received: December 22, 2017
Dear Ashley Nguyen:
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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Image /page/1/Figure/5 description: This image shows a formal letter closing. The letter is signed by Tara A. Ryan -S, with a digital signature including the date 2018.01.25. The letter is for Tina Kiang, Ph.D., who is the Acting Director of the Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices, Office of Device Evaluation, Center for Devices and Radiological Health.
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMS No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (ifknown)
Device Name
F&P Nivairo™ RT046 Non-Vented Hospital Full Face Mask, Standard Elbow 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 (NPV) 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 maintained by trained medical practitioners in a hospital/institutional environment with patient monitoring in place.
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
510(k) Summary 5
| Contact person/submitter | Ashley Nguyen |
|---|---|
| Date prepared | January 25, 2018 |
| 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™ RT046 Non-Vented Hospital Full Face Mask, |
| Standard Elbow Version | |
| Common name | Full Face Mask |
| Classification name | Non Continuous Ventilator IPPB (accessory to) |
| Class II, 21 CFR 868.5895 | |
| Product code CBK (Anesthesiology) | |
| Predicate device | K083122 RT041 Hospital Full Face Mask Non-Vented |
| Reference devices: | K130328 F&P Simplus Full Face Mask |
| K170367 F&P Nivairo™ RT045 Full Face Mask | |
| K023135 PerformaTrak SE (Image3 SE) Disposable Face Mask |
5.1 Device Description
The Nivairo™ RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version (herein referred to as RT046) is a non-vented hospital full face mask with a standard elbow for use with dual limb circuits. The RT046 is a single use device intended for use as an accessory to deliver non-invasive positive pressure ventilation (NPPV) to a patient as part of a passively vented non-invasive ventilation system.
The RT046 is an oronasal full face mask intended to be used in a hospital/institutional environment by trained medical staff with patient monitoring systems in place. It connects to a dual limb breathing circuit via a 22mm female swivel adaptor to receive pressurized breathing gases from an external flow source or ventilator (CPAP or Bi-Level).
The RT046 mask is a prescription only device, provided in a non-sterile state.
5.2 Intended Use
The Fisher & Paykel Healthcare single use masks are intended for use as an accessory to ventilators to enable non-invasive positive pressure ventilation (NPPV) therapy (CPAP or bilevel) 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 maintained by trained medical practitioners in a hospital/institutional environment with patient monitoring in place.
4
Technological Characteristics Comparison 5.3
The RT046 (subject) contains the following key similarities to the previously cleared predicate RT041 Hospital Full Face Mask Non Vented (herein referred to as RT041):
- Substantially equivalent intended use with same patient population and operating . environment.
- · Same mode of operation whereby both masks deliver gases are oronasal.
The key differences between the RT046 are that the RT041:
- · Headgear color is grey and light blue
- · Has a new addition of a crown strap to the head gear
- Uses headgear clips instead of a push button clip
- Uses new headgear materials .
- · Facial Seal includes two new features a rolling bridge (RollFit™) and two TubeFir"™ zones
- . Facial Seal sits under the lip, on the chin
- Does not include a silicone forehead padding ●
- Change in dead space volume ●
- . Has a pressure range of 4-25 cmH2O
- Is available in four sizes extra small, small, medium and large .
The RT046 (subject) contains the following key similarities to the reference devices:
- · F&P Simplus Full Face Mask (K130328)
- Headgear release design ●
- . Face coverage of seal
- Seal (RollFit™) ●
- Materials and components ●
- · F&P Nivairo™ RT045 Full Face Mask (K170367)
- Headgear color is grey and light blue ●
- Has a new addition of a crown strap to the head gear ●
- Uses headgear clips instead of a push button clip ●
- Uses new headgear materials
- Facial Seal includes two new features a rolling bridge (RollFit™) and two ● TubeFit™ zones
- Facial Seal sits under the lip, on the chin ●
- Identical dead space volume
- Has a pressure range of 4-25 cmH2O ●
- Is available in four sizes extra small, small, medium and large ●
- · Image3 SE Disposable Face Mask (K023135)
- Similar dead space ●
5
5.4 Non-Clinical Performance Data
Performance testing of the RT046 (subject) was conducted and data were compared to the performance data for the RT041 (predicate) for performance. The data demonstrate substantial equivalence of the RT046 to the RT041. The results of the comparative bench testing do not raise any new questions regarding safety or effectiveness for the RT046.
Where applicable the RT046 has been evaluated to:
- . ISO 5356-1:2004 Anaesthetic and respiratory equipment - Conical connectors -Part 1: Cones and sockets.
- ISO 10993-1:2009 Biological Evaluation of medical devices Part 1: Evaluation and ● testing within a risk management process.
- . Clauses 5.3 and 5.5 of ISO 17510-2:2007 Sleep Apnoea Breathing Therapy – Part 2: Masks and Application Accessories
The following biocompatibility testing was performed. The materials passed all parameters:
- Irritation ●
- . Sensitization
- Cytotoxicity .
- Genotoxicity
- . Muscle Implantation
- Acute Systemic Toxicity
- . Particulate Matter
- . Chemical Characterization
- . Volatile Organic Compounds
5.5 Clinical Performance Data
Clinical performance testing was not required to demonstrate substantial equivalence for the RT046.
5.6 Conclusions
The comparison of features, performance, technological characteristics, and intended use demonstrate that the RT046 (subject) is substantially equivalent to the RT041 (predicate).