(243 days)
Not Found
No
The device description and summary of performance studies focus on the physical components and function of a nasal pillows mask, with no mention of AI or ML.
No
This device is a mask that interfaces with a CPAP or Bi-Level therapy device, but it is not the therapeutic device itself.
No
The device is a mask for CPAP or Bi-Level therapy, a treatment delivery device, not one that identifies or diagnoses a condition. It is used by individuals already diagnosed by a physician.
No
The device description clearly states it is a "non-invasive patient interface with a silicone seal that encloses the nasal airway entrance" and is held on the face with a headgear, indicating it is a physical hardware device.
Based on the provided information, the F&P Brevida™ Nasal Pillows Mask is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to provide a non-invasive interface for delivering pressurized gases (CPAP or Bi-Level therapy) to individuals requiring such treatment. This is a therapeutic function, not a diagnostic one.
- Device Description: The description focuses on the physical components and how it connects to a CPAP/Bi-Level device to deliver air. It does not mention any components or processes related to analyzing biological samples (blood, urine, tissue, etc.) which is the core function of an IVD.
- No mention of diagnostic testing: There is no indication that this device is used to diagnose a condition or measure any biological markers.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The F&P Brevida™ Nasal Pillows Mask is a medical device used for treatment, not diagnosis.
N/A
Intended Use / Indications for Use
The F&P Brevida™ Nasal Pillows Mask is intended to be used by individuals who have been diagnosed by a physician as requiring CPAP or Bi-Level Therapy. The F&P Brevida™ Nasal Pillows Mask is intended for single patient adult (> 66 los (30kgs)) use in the home and multiple patient adult use in the clinical setting where proper disinfection of the device can occur between patient uses.
Product codes
BZD
Device Description
The F&P Brevida™ Nasal Pillows Mask is a non-invasive patient interface with a silicone seal that encloses the nasal airway entrance. The mask is held on the face with a headgear.
The mask connects to a single breathing tube by a 22mm swivel adaptor to receive pressurized gases from a continuous airway pressure device (CPAP or Bi-Level). The exhaust holes on the elbow of the mask allow exhaled gases to be flushed out while the system is in operation.
The F&P Brevida™ Nasal Pillows Mask is a prescription only device, provided in a nonsterile 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 (> 66 los (30kgs))
Intended User / Care Setting
single patient adult use in the home and multiple patient adult use in the clinical setting
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
Non-Clinical Performance Data: Testing of the Brevida™ Nasal Pillows Mask was compared to the predicate K120027 F&P Pilairo™ Nasal Pillows Mask for performance. These tests demonstrate substantial equivalence of the Brevida™ Nasal Pillows Mask to the predicate device. The results of the comparative bench testing do not raise any new questions of safety or effectiveness for the F&P Brevida™ Nasal Pillows Mask.
Clinical Performance Data: Substantial equivalence was not based on an assessment of clinical performance data
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 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 an abstract symbol that resembles three human profiles facing right, stacked on top of each other, with flowing lines beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 18, 2017
Fisher & Paykel Healthcare Ltd. Masar Mohammad Regulatory Affairs Specialist 15 Maurice Paykel Place, East Tamaki Auckland 2013 New Zealand
Re: K161412
Trade/Device Name: F&P Brevida™ Nasal Pillows Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: Class II Product Code: BZD Dated: December 19, 2016 Received: December 22, 2016
Dear Masar Mohammad:
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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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 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 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 yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Tina Kiang, Ph.D. 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K161412
Device Name F&P Brevida Nasal Pillows Mask
Indications for Use (Describe)
The F&P Brevida™ Nasal Pillows Mask is intended to be used by individuals who have been diagnosed by a physician as requiring CPAP or Bi-Level Therapy. The F&P Brevida™ Nasal Pillows Mask is intended for single patient adult (> 66 los (30kgs)) use in the home and multiple patient adult use in the clinical setting where proper disinfection of the device can occur between patient uses.
| 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.
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."
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Image /page/3/Picture/1 description: The image shows the logo for Fisher & Paykel Healthcare. The words "Fisher & Paykel" are in a large, bold, sans-serif font, with the "&" symbol in between. Below this, there is a horizontal line, and below that, the word "HEALTHCARE" is in a smaller, bold, sans-serif font. The entire logo is in a dark blue color.
5. 510(k) Summary
| Contact person/submitter | Masar Mohammad |
|---|---|
| Date prepared | 17 Jan 2017 |
| 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 Brevida™ Nasal Pillows Mask |
| Common name | Nasal Pillows Mask |
| Classification name | Non Continuous Ventilator (IPPB) |
| Class II (21 CFR §868.5905) | |
| Product code BZD (Anaesthesiology) | |
| Predicate device | K120027 F&P Pilairo™ Nasal Pillows Mask |
Device Description 5.1.
The F&P Brevida™ Nasal Pillows Mask is a non-invasive patient interface with a silicone seal that encloses the nasal airway entrance. The mask is held on the face with a headgear.
The mask connects to a single breathing tube by a 22mm swivel adaptor to receive pressurized gases from a continuous airway pressure device (CPAP or Bi-Level). The exhaust holes on the elbow of the mask allow exhaled gases to be flushed out while the system is in operation.
The F&P Brevida™ Nasal Pillows Mask is a prescription only device, provided in a nonsterile state.
5.2. Intended Use
The F&P Brevida™ Nasal Pillows Mask is intended to be used by individuals who have been diagnosed by a physician as requiring CPAP or Bi-Level Therapy. The F&P Brevida™ Nasal Pillows Mask is intended for single patient adult (≥ 66lbs (30kgs)) use in the home and multiple patient adult use in the hospital or other clinical setting where proper disinfection of the device can occur between patient uses.
Technological Characteristics Comparison 5.3.
The F&P Brevida™ Nasal Pillows Mask has the following similarities to the previously cleared predicate Pilairo™ Nasal Pillows Mask (K120027).
- Substantially equivalent intended use with same patient population and operating environment.
- . Same mode of operation whereby both masks deliver gases through the nose.
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- Same breathing tube connection mechanism via a 22mm male connector. ●
- . Same silicone seal mechanism where mask seals on the entrance of the nostrils as well as around the nose.
- . Both new and predicate device headgear are designed to attach at the same two point on the mask frame.
The key differences to the predicate device are that the F&P Brevida™ Nasal Pillows Mask:
- . Has colour cues (VisiBlue™) added to swivel, frame, seal, and headgear components to aid the user in the reassembly and orientation of the mask.
- . Provide a diffuser system in which the diffuser mat and the cover have been integrated into a single component. This component is washable.
- . Has a detachable elbow to aid in mask cleaning and disinfection during multi-patient use.
- . Has an adjustable headgear.
The below table provides a side-by-side comparison of the subject and predicate devices.
Table 1: Device Comparison Table
| | F&P Brevida™ Nasal
Pillows Mask | F&P Pilairo™ Nasal
Pillows Mask | Comments |
|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Indications for use and intended use | | |
| Intended use | The F&P Brevida™ Nasal
Pillows Mask is intended
to be used by individuals
who have been diagnosed
by a physician as
requiring CPAP or Bi-
Level Therapy. The F&P
Brevida™ Nasal Pillows
Mask is intended for
single patient adult (≥
66lbs (30kgs)) use in the
home and multiple patient
adult use in the hospital or
other clinical setting
where proper disinfection
of the device can occur
between patient uses. | The F&P Pilairo™ Nasal
Pillows Mask is intended
to be used by individuals
who have been
diagnosed by a physician
as requiring CPAP or Bi-
Level Ventilator Therapy.
The F&P Pilairo™ Nasal
Pillows Mask is intended
for single-patient adult
use in the home and
multiple-patient adult use
in the hospital or other
clinical setting where
proper disinfection of the
device can occur between
patient uses. | Identical intended use and patient
population. The Intended Use of the
F&P Brevida specifies the minimum
weight of an adult patient.
Specifying the weight of an adult
patient was not found to introduce
any new risks to the device and
does not alter the intended use of
the device. |
| Availability | Prescription use
(Part 21 CFR 801 Subpart
D) | Prescription use
(Part 21 CFR 801 Subpart
D) | Identical |
| Patient
Population | Adult | Adult | Identical |
| Classification | | | |
| Product
Code | BZD | BZD | Identical |
| Device
classification | 868.5905 | 868.5905 | Identical |
| | F&P Brevida™ Nasal
Pillows Mask | F&P Pilairo™ Nasal
Pillows Mask | Comments |
| Classification
panel | Anaesthesiology | Anaesthesiology | Identical |
| | Operation and safety features | | |
| Operating
Environment | Home, hospital or other
clinical setting | Home, hospital or other
clinical setting | Identical |
| Breathing
Circuit | Single Inspiratory Tube | Single Inspiratory Tube | Identical |
| Exhalation
Vent | Numerous tiny vent holes
in Elbow | Numerous tiny vent holes
in Elbow | Identical |
| Breathing
Tube
connection to
mask | 22mm ISO Taper | 22mm ISO Taper | Identical |
| Fixation | Headgear with 2
attachment points | Headgear with 2
attachment points | Identical |
| Headgear
Release | One hook connection per
side to the mask frame | One hook connection per
side to the mask frame | Identical |
| Face
Coverage | Direct Nasal | Direct Nasal | Identical |
| Dead Space | Dynamic
29.27cc (XS-S)
33.14cc (M-L) | Dynamic
32cc (Single size) | The dead space of the small seal is
less than that of the predicate,
while the larger seal has more dead
space. Both seal sizes are in
conformance with ISO 17510-2
(2007) and this difference does not
introduce any additional risk to the
user. For additional information
please refer to Test Report TR-
27521 Attached in Appendix I. |
| Patient
Consciousness | Responsive and able to
remove mask | Responsive and able to
remove mask | Identical |
| Pressure
Range | 4 to 25 cm H20 | 4 to 25 cm H20 | Identical |
| | Components and materials | | |
| Sterility | Device not provided
sterile | Device not provided
sterile | Identical |
| Reusability | Reusable –
Multi Patient Use | Reusable –
Multi Patient Use | Identical |
| High Level
Disinfection
Methods | Thermal Disinfection
(80°C for 10 mins and
75°C for 30 mins) | Sterrad 100S, Cidex OPA,
Thermal Disinfection | The parameters used for the
thermal disinfection are identical.
Please see Section 14 for testing of
both sets of parameters. |
| Facial Seal | Soft pliable seal between
mask base and nares | Soft pliable seal between
mask base and nares | Identical |
| Seal sizes | Available in two different
sizes (XS-S, and M-L) | 1 size | The subject device has two seal |
| | F&P Brevida™ Nasal
Pillows Mask | F&P Pilairo™ Nasal
Pillows Mask | Comments |
| | | | not been found to introduce any
additional risk to the patient. Both
seal sizes have undergone product
verification and meet all productrequirements. Please see Section
18 for details on performance
testing. |
| Mask Frame | Two piece coloured/clear
polycarbonate with
connection for elbow,
silicone seal, and
headgear | Two piece coloured / clear
polycarbonate with
connection for silicone
seal, and headgear | The components and structure of
the mask frame is identical,
however, there have been some
changes in the materials used. The
new materials have been assessed
for biocompatibility and no
additional risk to the patient was
found to have been introduced due
to the new materials. Please refer
to Section 15 for Biocompatibility
assessment. |
| Mask Elbow
Design | Removable | Non-removable | The F&P Brevida™ Nasal Pillows
Mask has a removable elbow to aid
the user in the cleaning and
disinfection of the mask during
multi-patient reuse. |
| Headgear | Adjustable headgear
made up of one strap,
elastic. | Non-adjustable headgear.
Headgear is elastic. | The design of the subject device
headgear consists of two parts. At
the back of the headgear, two
straps form a halo which is then
connected to a single strap on
either side. This is different to the
single strap of the predicate device.
Additionally, the headgear used in
the predicate would stretch to fit the
patient, while the subject device's
headgear is adjustable. These
differences are intended to better fit
a larger percentage of the patient
population and have not been
found to introduce any new risk to
the patient. |
| Accessories | | | |
| Oxygen/Pres
sure Port
(900HC452) | Available as a separate
part, not provided with
device. | Available as a separate
part, not provided with
device. | Identical - The Oxygen/Pressure
port is the same accessory used
with the predicate device. This
accessory was cleared under
K023559 and has not been
modified. |
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F&P Brevida™ Nasal Pillows Mask – Traditional 510(k)
Image /page/6/Picture/1 description: The image shows the logo for Fisher & Paykel Healthcare. The words "Fisher & Paykel" are in a large, bold, blue font. Below that, the word "HEALTHCARE" is in a smaller, bold, blue font. There is a blue line above the word "HEALTHCARE".
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5.4. Non-Clinical Performance Data
Testing of the Brevida™ Nasal Pillows Mask was compared to the predicate K120027 F&P Pilairo™ Nasal Pillows Mask for performance. These tests demonstrate substantial equivalence of the Brevida™ Nasal Pillows Mask to the predicate device. The results of the comparative bench testing do not raise any new questions of safety or effectiveness for the F&P Brevida™ Nasal Pillows Mask.
The Brevida™ Nasal Pillows Mask has been tested to the following standards:
- ISO 17510-2:2007, Sleep Apnoea Breathing Therapy- Part 2: Masks and Application . Accessories
- 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.
- . 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 10993-6:2007, Biological evaluation of medical devices – Part 6: Tests for local effects after implantation.
- . ISO 10993-10:2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
- ISO 10993-11:2006, Biological evaluation of medical devices – Part 11: Tests for systemic Toxicity.
- . 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.
5.5. Clinical Performance Data
Substantial equivalence was not based on an assessment of clinical performance data
5.6. Conclusions
The comparison of features, performance, and intended use demonstrate that the Brevida™ Nasal Pillows Mask is substantially equivalent to the predicate K120027 F&P Pilairo™ Nasal Pillows Mask.