(288 days)
Not Found
No
The device description and performance studies focus on the physical components and basic functionality of a nasal mask for CPAP/Bi-level therapy, with no mention of AI or ML.
No
The device is a nasal mask, which is a patient interface for CPAP or Bi-level therapy. It doesn't provide the therapy itself but connects to a therapeutic device (CPAP or Bi-level device).
No
Explanation: The device is a nasal mask used for delivering CPAP or Bi-level therapy. Its purpose is to facilitate the delivery of prescribed treatment, not to diagnose a condition. The diagnostic activity happens prior to the use of this device, by a physician.
No
The device description clearly outlines physical components like a silicone seal, headgear straps, a breathing tube connection, and exhaust holes, indicating it is a hardware device, not software-only.
Based on the provided information, the F&P Eson™ 2 Nasal Mask is not an In Vitro Diagnostic (IVD) 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 diagnosed with sleep apnea or similar conditions. This is a therapeutic purpose, not a diagnostic one.
- Device Description: The description details a physical mask and its components for delivering air, not for analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: There is no mention of the device being used with biological samples (blood, urine, tissue, etc.), performing tests on these samples, or providing diagnostic results.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The F&P Eson™ 2 Nasal Mask is used in vivo (on the body) to deliver therapy.
N/A
Intended Use / Indications for Use
The F&P Eson™ 2 Nasal 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 Eson™ 2 Nasal Mask is intended for single patient adult (≥ 66lb (30kg)) use in the home and for multiple patient adult use in the clinical setting where proper disinfection of the device can occur between patient uses.
Product codes (comma separated list FDA assigned to the subject device)
BZD
Device Description
The F&P Eson™ 2 Nasal Mask is a non-invasive patient interface with a silicone seal which covers around the nose of a patient held in place by adjustable headgear straps.
The mask connects to a single breathing tube via 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 Eson™ 2 Nasal Mask is a prescription only device, provided in a non-sterile state.
An oxygen pressure port accessory is available to be used with the device for oxygen therapy and/or gas monitoring (previously covered by K121597 F&P Eson Nasal Mask).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Around the nose
Indicated Patient Age Range
adult (≥ 66lb (30kg))
Intended User / Care Setting
single patient adult use in the home and for multiple patient adult use in the hospital or other clinical setting where proper disinfection of the device can occur between patient uses.
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)
Non-Clinical Tests:
- Transportation and storage testing: product had no visible deformations, sufficiently removed CO2 through the exhaust vents, had no visible lint on the seal, had no offensive odour, and packaging was still intact.
- Automatic High-Level Disinfection: mask was able to achieve the minimum 6 log reduction.
- Thermal Disinfection: mask was able to be thermally disinfected through the predetermined cycles of 75°C for 30min, 80°C for 10min and 90°C for 1min.
- Sound Emissions: mask was able to achieve a sound pressure level of less than 25dBA with the diffuser system.
- Carbon Dioxide Flushing: mask was able to sufficiently flush carbon dioxide at a suitable rate under worst case scenario.
- Shelf Life Assessment: mask's materials have well known properties, are very stable and present a very remote risk of degradation within a shelf life of 10 years.
Clinical Tests:
Not applicable - no clinical testing was performed with respect to the Eson™ 2 nasal mask.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Pressure drop through mask @ 50L/min: 0.19 ± 0.1cmH2O (with diffuser)
- Pressure drop through mask @ 100L/min: 0.80 ± 0.1cmH2O (with diffuser)
- Pressure drop through mask @ 50L/min: 0.17 ± 0.1cmH2O (without diffuser)
- Pressure drop through mask @ 100L/min: 0.73 ± 0.1cmH2O (without diffuser)
- Dead Space: Small: 69 cc, Medium: 86 cc, Large: 98 cc
- Sound power level: 21.3 dBA with uncertainty 2.5 dBA (with diffuser)
- Sound pressure level: 13.3 dBA with uncertainty 2.5 dBA (with diffuser)
- Sound power level: 31.4 dBA with uncertainty 2.5 dBA (without diffuser)
- Sound pressure level: 23.4 dBA with uncertainty 2.5 dBA (without diffuser)
- The mask was able to achieve the minimum 6 log reduction for automatic high-level disinfection.
- The mask was able to be thermally disinfected through cycles of 75°C for 30min, 80°C for 10min and 90°C for 1min.
- The mask was able to achieve a sound pressure level of less than 25dBA with the diffuser system.
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.
Eson™ Nasal Mask (K121597)
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.
Not Found
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
§ 868.5905 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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 20, 2016
Fisher&Paykel Amelia Ortiz Regulatory Affairs Specialist 15 Maurice Paykel Place, EastTamaki P O Box 14 348. Panmure Auckland 2013, New Zealand
Re: K153505
Trade/Device Name: F&P Eson™ 2 Nasal Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: Class II Product Code: BZD Dated: August 17, 2016 Received: August 22, 2016
Dear Ms. Ortiz:
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 801and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements
1
as set forth in 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 vou desire specific advice for your device on our labeling regulation (21 CFR Part 801 and Part 809), 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,
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
Indications for Use
510(k) Number (if known) K153505
Device Name F&P Eson™ 2 Nasal Mask
Indications for Use (Describe)
The F&P Eson™ 2 Nasal 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 Eson™ 2 Nasal Mask is intended for single patient adult (≥ 661b (30kg)) use in the home and for 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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary
Image /page/3/Picture/4 description: The image shows the logo for Fisher & Paykel Healthcare. The words "Fisher & Paykel" are on the top line, and the word "Healthcare" is on the bottom line. A horizontal line separates the two lines of text. The text is in a dark blue font.
15 Maurice Paykel Place, East Tamaki P O Box 14 348, Panmure Auckland, New Zealand Telephone: +64 9 574 0100 Facsimile: +64 9 574 0158 Website: www.fphcare.com
| Contact person/Author | Amelia Ortiz |
|---|---|
| Co-Author/Reviewer | Sue Cho, Ryan Bormann |
| Date prepared | 21 September 2016 |
| Contact details | Address: 15 Maurice Paykel Place |
| Paykel Building | |
| East Tamaki | |
| Auckland 2013, New Zealand |
Telephone: +64 9 574 0100
Fax: +64 9 574 0158 |
| Trade name | F&P Eson™ 2 Nasal Mask |
| Common name | Nasal Mask |
| Classification name | Non Continuous Ventilator (IPPB)
Class II (21 CFR §868.5905)
Product code BZD (Anaesthesiology) |
| Predicate device | Eson™ Nasal Mask (K121597) |
4
Device Description
The F&P Eson™ 2 Nasal Mask is a non-invasive patient interface with a silicone seal which covers around the nose of a patient held in place by adjustable headgear straps.
The mask connects to a single breathing tube via 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 Eson™ 2 Nasal Mask is a prescription only device, provided in a non-sterile state.
An oxygen pressure port accessory is available to be used with the device for oxygen therapy and/or gas monitoring (previously covered by K121597 F&P Eson Nasal Mask).
Indications for Use
The F&P Eson™ 2 Nasal 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 Eson™ 2 Nasal Mask is intended for single patient adult (≥ 66lb (30kg)) use in the home and for 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
The F&P Eson™ 2 Nasal Mask has the following similarities to the previously cleared predicate Eson™ Nasal Mask (K121597):
- -Substantially equivalent intended use with same patient population and operating environment.
- -Same mode of operation whereby both masks deliver gases through the nose.
- -Same breathing tube connection mechanism via a 22mm connector.
- -Same RollFit™ seal mechanism where the silicone seal rolls back and forward on the bridge of the nose.
- -Both new and the predicate device headgear are designed to attach at the same four points on the mask frame.
The key differences to the predicate device are that the F&P Eson™ 2 Nasal Mask:
- Has colour cues (VisiBlue™) added to swivel, frame, seal, and headgear components to aid in reassembly and orientation of the mask.
- Provide a simpler diffuser system whereby the diffuser mat and the cover have been integrated into a single component and is washable.
- -Has a detachable elbow to aid in mask cleaning and disinfection.
- -Has a headgear which allows over the head fitting of the mask.
- -Has a notch mechanism for crown strap headgear adjustment, removing the need of a headgear buckle piece for adjustment.
5
| Feature | F&P Eson™ 2
Nasal Mask | Predicate Device:
Eson™ Nasal
Mask (K121597) | Comment |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification
Regulation | 868.5905 | 868.5905 | Identical |
| Product Code | BZD | BZD | Identical |
| Indications for Use | The F&P Eson 2
Nasal 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 Eson 2
Nasal Mask is
intended for single
patient adult ( $≥$ 66lb
(30kg)) use in the
home and for
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 Eson
Nasal Mask is
intended to be
used by individuals
who have been
diagnosed by a
physician as
requiring CPAP or
Bi-Level Ventilator
treatment. The
F&P Eson Nasal
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. | The indications for use
between F&P Eson 2 Nasal
Mask and Eson Nasal Mask
are identical, with the
addition of a weight
specification for adult
patients $≥$ 66lb (30kg). |
| Patient Population | Adult | Adult | Identical |
| Operating
Environment | Home, hospital or
other clinical
setting | Home, hospital or
other clinical
setting | Identical |
| Mask Availability | Prescription only | Prescription only | Identical |
| Breathing Circuit | Single inspiratory
tube | Single inspiratory
tube | Identical |
| Exhalation Vent
(Exhaust holes) | Exhalation vent in
the form of cluster
of holes located on
the elbow. | Exhalation vent in
the form of cluster
of holes located on
the elbow. | Substantially equivalent |
| Feature | F&P Eson™ 2 Nasal Mask | Predicate Device:
Eson™ Nasal Mask (K121597) | Comment |
| Reusability between multiple patients | Reusable (Multi-Patient Use) – validated high-level thermal disinfection method available for cleaning between patient use | Reusable (Multi-Patient Use) – validated high-level thermal disinfection method available for cleaning between patient use | Identical |
| Face Coverage | Seal around the nose | Seal around the nose | Identical |
| Number of Seal Sizes | 3 sizes – small, medium, and large. | 3 sizes – small, medium, and large. | Identical |
| Accessories | Oxygen / Pressure Port Adaptor (900HC452) | Oxygen / Pressure Port Adaptor (900HC452) | Identical |
| Breathing Tube connection to Mask | 22mm conical connector | 22mm conical connector | Identical |
| Facial Seal Design | RollFit™ seal design which self-adjusts by rolling back and forward on the bridge of the nose. | RollFit™ seal design which self-adjusts by rolling back and forward on the bridge of the nose. | Identical |
| Diffuser | Washable one piece design with integrated diffuser mat and cover. | Two piece design consisting of diffuser cover and replacement only diffuser mat/filter. | Substantially equivalent.
Function and mechanism of the diffuser component are identical.
F&P Eson™ 2 Nasal Mask diffuser was modified to be washable and the number of components were reduced. |
| Elbow Design | Removable elbow | Permanently attached elbow | F&P Eson™ 2 Nasal Mask elbow modified to be removable for ease of cleaning. |
| Feature | F&P Eson™ 2
Nasal Mask | Predicate Device:
Eson™ Nasal
Mask (K121597) | Comment |
| Headgear Design | Six headgear straps. Four attachment points on the mask frame. Notch mechanism for crown headgear strap adjustment. | Six headgear straps. Four attachment points on mask frame. Buckle adjustment mechanism for crown headgear straps. | Different in design - crown headgear strap modified to eliminate the need of a buckle piece for adjustment.
The modification has not significantly altered the way in which the headgear interacts with the patient or the connection points on the mask. The adjustment points on the headgear for the patient remain the same as the predicate. |
| Mask Fitting | Using headgear clips located on the bottom headgear strap. By loosening of bottom headgear straps. Over the head | Using headgear clips located on the bottom headgear strap. By loosening of bottom headgear straps. | F&P Eson™ 2 Nasal Mask provides an additional method of fitting the mask to the predicate – over the head. |
| Mask Elbow
Design
(ball elbow) | Removable | Non-removable | F&P Eson™ 2 Nasal Mask elbow modified to be removable to aid in cleaning and disinfection of the mask. |
6
7
8
| Feature | F&P Eson™ 2
Nasal Mask | Predicate Device:
Eson™ Nasal
Mask (K121597) | Comment |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| Resistance to
Flow | With diffuser:
Pressure drop through mask @ 50L/min:
0.19 ± 0.1cmH2O Pressure drop through mask @ 100L/min:
0.80 ± 0.1cmH2O Without diffuser: Pressure drop through mask @ 50L/min:
0.17 ± 0.1cmH2O Pressure drop through mask @ 100L/min:
0.73 ± 0.1cmH2O | With diffuser:
Pressure drop through mask @ 50L/min:
0.14 ± 0.1cmH2O Pressure drop through mask @ 100L/min:
0.65 ± 0.1cmH2O Without diffuser: Pressure drop through mask @ 100L/min:
0.15 ± 0.1cmH2O Pressure drop through mask @ 100L/min:
0.62 ± 0.1cmH2O | F&P Eson™ 2 Nasal Mask has a higher pressure drop and is in conformance with ISO 17510-2. |
| Dead Space | Small: 69 cc
Medium: 86 cc
Large: 98 cc | Small: 61 cc
Medium: 67 cc
Large: 79 cc | F&P Eson™ 2 Nasal Mask has more dead space and is in conformance with ISO 17510-2 |
| Pressure Range | 4 to 30 cmH2O | 4 to 25cmH2O | F&P Eson 2 has a higher allowable pressure rating |
9
7
| Feature | F&P Eson™ 2 Nasal Mask | Predicate Device:
Eson™ Nasal Mask (K121597) | Comment |
|---------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|
| Sound | With diffuser:
Sound power level: 21.3 dBA with uncertainty 2.5 dBA.Sound pressure level: 13.3 dBA with uncertainty 2.5 dBA.Without diffuser:
Sound power level: 31.4 dBA with uncertainty 2.5 dBA.Sound pressure level: 23.4 dBA with uncertainty 2.5 dBA. | With diffuser:
Sound power level: 30 dBA with uncertainty 2.5 dBA.Sound pressure level: 22 dBA with uncertainty 2.5 dBA.Without diffuser:
Sound power level: 32 dBA with uncertainty 2.5 dBA.Sound pressure level: 24 dBA with uncertainty 2.5 dBA. | F&P Eson™ 2 Nasal Mask is quieter than the predicate. |
10
| Feature | F&P Eson™ 2
Nasal Mask | Predicate Device:
Eson™ Nasal
Mask (K121597) | Comment |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Materials of
Construction | Swivel:
polycarbonate,
ink pad print. Elbow:
polycarbonate. Diffuser assembly:
polycarbonate,
polyethylene
phthalate with
pigment. Frame assembly:
polycarbonate,
ink pad print,
blue colorant. Seal assembly:
polycarbonate,
silicone, ink
pad print. Headgear:
nylon/spandex,
polyurethane
foam, nylon,
grey and blue
colorant. Headgear
clips: acetal. | Swivel:
polycarbonate,
grey colourant. Elbow:
polycarbonate. Diffuser assembly:
polycarbonate,
polyester fibre. Frame:
Polycarbonate. Seal assembly:
polycarbonate,
silicone. Headgear:
nylon/spandex,
polyurethane
foam. Headgear
clips: acetal. Headgear
buckle: nylon,
grey colorant. | F&P Eson™ 2 Nasal Mask
and Eson™ Nasal Mask are
constructed from similar
materials.
Differences in materials from
the predicate underwent
cytotoxicity, sensitization
and extractables and
leachables testing to
demonstrate that the device
is biocompatible as per ISO
10993. |
Non-Clinical Tests
Testing of the F&P Eson™ 2 Nasal Mask was compared to the predicate K121597 Eson Nasal Mask for performance and biocompatibility. These tests demonstrate substantial equivalence of the F&P Eson™ 2 Nasal Mask to the predicate device.
The F&P Eson™ 2 Nasal Mask has been tested to the following standards:
- . ISO 17510-2:2007 Sleep Apnoea Breathing Therapy - Part 2: Masks and Applications Accessories
- . ISO 10993-1:2009 Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process
Specific tests used to show conformance to these standards include:
- . Transportation and storage testing to provide evidence that the mask will perform as intended once it arrives to the prescribed user. Results were that the product had no
11
visible deformations, sufficiently removed CO2 through the exhaust vents, had no visible lint on the seal, had no offensive odour, that the packaging was still intact.
- . Automatic High-Level Disinfection to provide evidence that the mask can effectively be disinfected in a certified washer disinfector. The mask was able to achieve the minimum 6 log reduction.
- Thermal Disinfection to provide evidence that the mask can effectively be disinfected through thermal disinfection cycles of 75°C for 30min, 80°C for 10min and 90°C for 1min. The mask was able to be thermally disinfected through the predetermined cycles.
- . Sound Emissions to provide evidence that the sound pressure level is less than 25 dBA. Mask was able to achieve a sound pressure level of less than 25dBA with the diffuser system.
- . Carbon Dioxide Flushing to determine if the mask is able to meet the minimum carbon dioxide flush rate. Under the worst case scenario, the mask was able to sufficiently flush carbon dioxide at a suitable rate.
- Shelf Life Assessment to show that the materials used in the mask have the ability to . retain their structural integrity during storage. It was determined that the mask's materials have well known properties, are very stable and present a very remote risk of degradation within a shelf life of 10 years.
Clinical Tests
Not applicable - no clinical testing was performed with respect to the Eson™ 2 nasal mask.
Conclusion
The comparison of features, performance, and intended use demonstrate that the F&P Eson™ 2 Nasal Mask is substantially equivalent to the predicate K121597 Eson Nasal Mask.