(199 days)
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.
The Nivairo™ RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve (herein referred to as RT045) is a non-vented hospital full face mask with anti-asphyxiation valve for use with single limb circuits. The RT045 is a single use device intended to deliver noninvasive positive pressure ventilation (NPPV) to a patient as part of a passively vented noninvasive ventilation system.
The RT045 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 single 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 RT045 mask is a prescription only device, provided in a non-sterile state.
I am sorry, but the provided text is a 510(k) premarket notification for a medical device (Nivairo™ RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve). This document primarily focuses on establishing substantial equivalence to a predicate device based on technological characteristics and non-clinical performance data.
The document states: "Clinical performance testing was not required to demonstrate substantial equivalence for the RT045."
Therefore, I cannot provide information on:
- Acceptance criteria and device performance based on a study of the device's effectiveness in clinical use. The document does not describe such a study.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method.
- Multi-reader multi-case (MRMC) comparative effectiveness study results.
- Standalone (algorithm-only) performance.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- Sample size for the training set.
- How the ground truth for the training set was established.
The document does mention that non-clinical performance data was conducted to demonstrate substantial equivalence. It refers to:
- Performance testing of the RT045 compared to the RT040 (predicate device).
- Evaluations against standards:
- 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.
However, the specific "acceptance criteria" and "reported device performance" in relation to these non-clinical tests are not detailed in the provided text in a way that would allow for a table similar to what you requested for clinical studies. The document only states that "These data demonstrates substantial equivalence of the RT045 to the RT040. The results of the comparative bench testing do not raise any new questions regarding safety or effectiveness for the RT045."
{0}------------------------------------------------
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 24, 2017
Fisher and Paykel Healthcare Limited Ms. Danica Tung Regulatory Affairs Specialist 15 Maurice Paykel Place Auckland, 2013 NZ
Re: K170367
Trade/Device Name: Nivairo™ RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous ventilator Regulatory Class: Class II Product Code: MNT Dated: July 17, 2017 Received: July 19, 2017
Dear Ms. Tung:
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
Image /page/0/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
{1}------------------------------------------------
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 (reporting of medical devicerelated 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Tara A. Ryan -S
for
Lori Wiggins, MPT, CLT Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K170367
Device Name
Nivairo™ RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for Fisher & Paykel Healthcare. The words "Fisher & Paykel" are in a bold, dark blue font on the top line. Underneath the top line is a horizontal line, and underneath that is the word "HEALTHCARE" in a bold, dark blue font.
510(k) Summary 5
| Contact person/submitter | Danica Tung |
|---|---|
| Date prepared | 3 February 2017 |
| Contact details | Address: 15 Maurice Paykel PlaceEast TamakiAuckland 2013, New ZealandTelephone: +64 9 574 0100Fax: +64 9 574 0158 |
| Trade name | F&P Nivairo™ RT045 Non-Vented Hospital Full Face MaskAnti-Asphyxiation Valve |
| Common name | Full Face Mask |
| Classification name | Non Continuous Ventilator IPPB (accessory to)Class II, 21 CFR 868.5895Product code MNT (Anaesthesiology) |
| Predicate device | K060044 RT040 Acute Care Face Mask |
| Reference devices: | K130328 F&P Simplus Full Face MaskK023135 Image3 SE Disposable Face Mask |
5.1 Device Description
The Nivairo™ RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve (herein referred to as RT045) is a non-vented hospital full face mask with anti-asphyxiation valve for use with single limb circuits. The RT045 is a single use device intended to deliver noninvasive positive pressure ventilation (NPPV) to a patient as part of a passively vented noninvasive ventilation system.
The RT045 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 single 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 RT045 mask is a prescription only device, provided in a non-sterile state.
5.2 Intended Use
The Fisher & Paykel Healthcare single patient use masks are 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 and 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}------------------------------------------------
Image /page/4/Picture/1 description: The image shows the logo for Fisher & Paykel Healthcare. The words "Fisher & Paykel" are in a larger font size on the top line, and the word "Healthcare" is in a smaller font size on the bottom line. A horizontal line separates the two lines of text. The text is in a dark blue color.
5.3 Technological Characteristics Comparison
The RT045 (subject) contains the following key similarities to the previously cleared predicate RT040 Acute Care Face Mask (herein referred to as RT040):
- · 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 RT040 are that the RT045:
- · Headgear colour is grey and light blue
- Has a new addition of a crown strap to the headgear .
- Uses headgear clips instead of a pushbutton clip .
- Uses new headgear materials .
- . Does not include exhalation vents on the mask housing
- . Includes an anti-asphyxiation/non-rebreathing valve
- Seal includes two new features a rolling bridge (RollFit™) and two TubeFit™ zones .
- 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 RT045 (subject) contains the following key similarities to the two reference devices:
- · F&P Simplus Full Face Mask
- Headgear release design
- Face coverage of the seal
- o Seal (RollFit™)
- Image3 SE Disposable Face Mask (K023135) .
- o Use of an exhalation port between the mask and breathing circuit.
- o Deadspace
Non-Clinical Performance Data 5.4
Performance testing of the RT045 (subject) was conducted and data were compared to the performance data for the RT040 (predicate) for performance. These data demonstrates substantial equivalence of the RT045 to the RT040. The results of the comparative bench testing do not raise any new questions regarding safety or effectiveness for the RT045.
Where applicable the RT045 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.
{5}------------------------------------------------
Image /page/5/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.
- Clauses 5.3 and 5.5 of ISO 17510-2:2007 Sleep Apnoea Breathing Therapy- Part 2: . Masks and Application Accessories
ર-ર Clinical Performance Data
Clinical performance testing was not required to demonstrate substantial equivalence for the RT045.
5.6 Conclusions
The comparison of features, performance, and intended use demonstrate that the RT045 (subject) is substantially equivalent to the RT040 (predicate).
§ 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).