(206 days)
Not Found
No
The device description and performance studies focus on the mechanical and functional aspects of a CPAP mask, with no mention of AI or ML technologies.
No.
The device is a mask that connects to a CPAP or Bi-Level therapy device, which delivers the therapy. Therefore, the mask itself is not a therapeutic device.
No
Explanation: The F&P Vitera Full Face mask is a patient interface for CPAP or Bi-Level therapy, designed to deliver pressurized gases from a continuous airway pressure device. It does not perform any diagnostic functions or analyze patient data to determine a medical condition.
No
The device description clearly describes a physical mask with hardware components (seal, headgear, swivel adaptor, exhaust holes) and does not mention any software functionality.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections.
- Device Function: The F&P Vitera Full Face Mask is a patient interface used to deliver pressurized air for CPAP or Bi-Level therapy. It is a physical device that connects to a breathing machine and is worn on the face. It does not perform any tests on bodily samples.
- Intended Use: The intended use clearly states it's for delivering CPAP or Bi-Level therapy to individuals diagnosed with conditions requiring such treatment. It does not mention any diagnostic purpose.
- Device Description: The description details its physical components and how it functions as a mask for delivering air, not for analyzing samples.
The information provided consistently describes a device used for treatment (delivering therapy) rather than diagnosis (testing samples).
N/A
Intended Use / Indications for Use
A Model: The F&P Vitera Full Face mask is intended to be used by adults weighing ≥ 66lbs (30kgs) who have been diagnosed by a physician as requiring CPAP or Bi-Level therapy. The F&P Vitera Full Face mask is intended for single patient use in the home.
SL Model: The F&P Vitera Full Face mask is intended to be used by adults weighing ≥ 66lbs (30kgs) who have been diagnosed by a physician as requiring CPAP or Bi-Level therapy. The F&P Vitera Full Face mask is intended for single patient use in the home and for multiple patient use in the hospital or other clinical setting where proper disinfection of the device can occur between patient uses.
Product codes
BZD
Device Description
The F&P Vitera Full Face Mask is a non-invasive patient interface with a seal that encloses the oral and nasal airway. The mask is held on the face with a headgear. The mask connects to a single breathing tube by a 22mm male swivel adaptor to receive pressurized gases from a continuous airway pressure device (CPAP or Bi-Level). The exhaust holes on the seal of the mask allow exhaled gases to be flushed out while the system is in operation.
The F&P Vitera Full Face 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
oral and nasal airway
Indicated Patient Age Range
Adults weighing ≥ 66lbs (30kgs)
Intended User / Care Setting
Home, hospital or other 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing of the F&P Vitera Full Face Mask was completed to determine that device design changes, compared to F&P Simplus Full Face Mask (K130328) do not raise questions of safety or effectiveness. These tests demonstrate substantial equivalence of the F&P Vitera Full Face Mask to the predicate device.
Testing included:
- Shelf life simulation based on ASTM F1980-07 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices.
- Transportation simulation based on ISTA 2A Packaged-Products weighing 150lb (68kg) or less.
- Performance testing to confirm the F&P Vitera Full Face Mask does not adversely affect safety and effectiveness, including:
- CO2 rebreathing during normal use and single fault conditions
- Non-rebreathing valve (NRV) activation / deactivation pressure
- Total mask exhaust flow
- Resistance to flow and pressure drop
- Mechanical integrity and performance verification after normal and reasonable abuse scenarios, including simulations of home use/cleaning; multi-patient use/reprocessing; accelerated ageing (shelf life) and simulated transportation and storage.
The results of the comparative bench testing do not raise any new or different questions of safety or effectiveness for the F&P Vitera Full Face Mask.
Clinical study was not required to demonstrate Substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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/0 description: The image shows 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, which is a blue square with the letters "FDA" in white. To the right of the square are the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" below it.
October 11, 2019
Fisher & Paykel Healthcare Ltd. Masar Mohammad Senior Regulatory Affairs Specialist 15 Maurice Paykel Place, East Tamaki Auckland, 2013 New Zealand
Re: K190713
Trade/Device Name: F&P Vitera Full Face Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous ventilator (IPPB) Regulatory Class: Class II Product Code: BZD Dated: September 18, 2019 Received: September 20, 2019
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. 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
1
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 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 medical devices and radiation-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,
for
Michael Ryan Division 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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K190713
Device Name F&P Vitera Full Face Mask
Indications for Use (Describe)
A Model: The F&P Vitera Full Face mask is intended to be used by adults weighing ≥ 66lbs (30kgs) who have been diagnosed by a physician as requiring CPAP or Bi-Level therapy. The F&P Vitera Full Face mask is intended for single patient use in the home.
SL Model: The F&P Vitera Full Face mask is intended to be used by adults weighing ≥ 661bs (30kgs) who have been diagnosed by a physician as requiring CPAP or Bi-Level therapy. The F&P Vitera Full Face mask is intended for single patient use in the home and for multiple patient use in the hospital or other clinical setting where proper disinfection of the device can occur between patient uses.
X 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 in a bold, sans-serif font, with the "&" symbol connecting the two names. Below the names is a horizontal line, and below that is the word "HEALTHCARE" in a similar font, but slightly smaller than the names above.
510(k) Summary 5
As Required by 21 CFR 807.92 (c)
| Contact person/submitter | Masar Mohammad |
|---|---|
| Date prepared | 11 October 2019 |
| Contact details | Address: 15 Maurice Paykel Place |
| East Tamaki | |
| Auckland 2013, New Zealand | |
| Telephone: +64 9 574 0100 | |
| Trade name | F&P Vitera Full Face Mask |
| Common name | Full Face Mask |
| Classification name | Non Continuous Ventilator (IPPB) |
| Class II (21 CFR §868.5905) | |
| Product code BZD (Anaesthesiology) | |
| Predicate device | F&P Simplus™ Full Face Mask (K130328) |
5.1 Device Description
The F&P Vitera Full Face Mask is a non-invasive patient interface with a seal that encloses the oral and nasal airway. The mask is held on the face with a headgear. The mask connects to a single breathing tube by a 22mm male swivel adaptor to receive pressurized gases from a continuous airway pressure device (CPAP or Bi-Level). The exhaust holes on the seal of the mask allow exhaled gases to be flushed out while the system is in operation.
The F&P Vitera Full Face Mask is a prescription only device, provided in a non-sterile state.
Refer below to Vitera Full Face Mask part numbers that are used to differentiate the mask sizes and models.
| Sizes | A model | SL model |
|---|---|---|
| Small | VIT1SA | |
| Vitera Mask Full Face Small A | ||
| VIT1SSA Vitera Mask Seal / Small A | VIT1SSL Vitera Mask Full Face Small | |
| Sleep Lab | ||
| Medium | VIT1MA | |
| Vitera Mask Full Face Medium A | ||
| VIT1MMA Vitera Mask Seal Medium / | ||
| Medium A | VIT1MSL Vitera Mask Full Face | |
| Medium Sleep Lab | ||
| Large | VIT1LA | |
| Vitera Mask Full Face Large A | ||
| VIT1LLA Vitera Mask Seal / Large A | VIT1LSL Vitera Mask Full Face Large | |
| Sleep Lab |
4
Intended Use / Indications for Use 5.2
A Model: The F&P Vitera Full Face mask is intended to be used by adults weighing ≥ 66lbs (30kgs) who have been diagnosed by a physician as requiring CPAP or Bi-Level therapy. The F&P Vitera Full Face mask is intended for single patient use in the home.
SL Model: The F&P Vitera Full Face mask is intended to be used by adults weighing ≥ 66lbs (30kgs) who have been diagnosed by a physician as requiring CPAP or Bi-Level therapy. The F&P Vitera Full Face mask is intended for single patient use in the home and for multiple patient use in the hospital or other clinical setting where proper disinfection of the device can occur between patient uses.
5
Technological Characteristics Comparison 5.3
5.3.1 Similarities between the subject and predicate devices:
The F&P Vitera Full Face mask has the following similarities to the previously cleared predicate Simplus Full Face Mask.
- Same intended use with same patient population and operating environment.
- Same product code, device classification and classification panel.
- Same breathing circuit which is a single inspiratory tube with the connection ● mechanism via a 22mm male connector.
- Same mode of operation whereby masks deliver gases through the nose and mouth.
- Same seal and headgear size category. ●
- Same exhaust system consisting of a series of holes on the facial seal. ●
- . Both have a single non-rebreathing valve (NRV) flap design on the elbow.
- Same axis rotation between the elbow and the tube.
- Both are prescription devices only that can be reprocessed. ●
- Same mask components and accessory.
5.3.2 Differences between the subject and predicate devices:
The key differences to the predicate device are that the F&P Vitera Full Face mask:
- . Has colour cues (VisiBlue™) added to swivel, frame, and headgear components to aid the user in the reassembly and orientation of the mask.
- The headgear been modified:
- Materials: o
- The headgear been modified:
●
- 트 VentiCool™: has a new mesh fabric designed to improve breathability by allowing air and moisture to escape.
- . Soft tab: has a new tab material to assist the user during headgear adjustments.
- . Headgear clips: has a new clip material to assist the user during the assembly and disassembly of the headgear to the mask.
- Headgear Release and Clips: the headgear has only 3 connection points to the O frame due to the introduction of a new forehead clip. The buckle on the crown strap of the predicate headgear has been removed as its functions have been integrated into the subject device headgear.
- Has a detachable elbow to aid in mask cleaning and disinfection during multi-patient use.
- The NRV flap that has a sealing bead along with a curved hinge. Also, it features two locating prongs with the Elbow Lower component.
- Has "RollFit™ XT" that adapts to the face and allows for a greater range of motion. ●
6
Non-Clinical Performance Data 5.4
Performance testing of the F&P Vitera Full Face Mask was completed to determine that device design changes, compared to F&P Simplus Full Face Mask (K130328) do not raise questions of safety or effectiveness. These tests demonstrate substantial equivalence of the F&P Vitera Full Face Mask to the predicate device. A summary of the testing conducted for the F&P Vitera Full Face Mask device is provided below.
- Shelf life simulation was based on ASTM F1980-07 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices.
- Transportation simulation was based on ISTA 2A Packaged-Products weighing 150lb ● (68kg) or less.
- . Performance testing was completed to confirm the F&P Vitera Full Face Mask does not adversely affect safety and effectiveness.
- CO2 rebreathing during normal use and single fault conditions o
- Non-rebreathing valve (NRV) activation / deactivation pressure o
- Total mask exhaust flow o
- Resistance to flow and pressure drop o
- Mechanical integrity and performance of the new device was also verified after normal ● and reasonable abuse scenarios. This included simulations of home use/cleaning; multipatient use/reprocessing; accelerated ageing (shelf life) and simulated transportation and storage.
7
Testing of the F&P Vitera Full Face Mask was compared to the predicate F&P Simplus Full Face Mask (K130328) for performance. These tests demonstrate substantial equivalence of the F&P Vitera Full Face Mask to the predicate device. The results of the comparative bench testing do not raise any new or different questions of safety or effectiveness for the F&P Vitera Full Face Mask.
The F&P Vitera Full Face Mask has been tested to the following standards:
- ISO 17510:2015 Sleep Apnoea Breathing Therapy- Masks and Application Accessories
- ISO 5356-1:2015 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 10993-10:2010, 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
- . 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)
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Image /page/8/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, there is a blue line, and then the word "HEALTHCARE" is in a smaller, bold, dark blue font.
| Subject Device | Predicate | Comments | ||
|---|---|---|---|---|
| Device Name | F&P Vitera Full Face Mask | |||
| (A model) | F&P Vitera Full Face Mask | |||
| (SL model) | F&P Simplus Full Face Mask | |||
| Indications for use and intended use | ||||
| Intended Use | The F&P Vitera Full Face | |||
| mask is intended to be used by | ||||
| adults weighing ≥ 66lbs | ||||
| (30kgs) who have been | ||||
| diagnosed by a physician as | ||||
| requiring CPAP or Bi-Level | ||||
| therapy. The F&P Vitera Full | ||||
| Face mask is intended for | ||||
| single patient use in the home. | The F&P Vitera Full Face mask | |||
| is intended to be used by | ||||
| adults weighing ≥ 66lbs | ||||
| (30kgs) who have been | ||||
| diagnosed by a physician as | ||||
| requiring CPAP or Bi-Level | ||||
| therapy. The F&P Vitera Full | ||||
| Face mask is intended for | ||||
| single patient use in the home | ||||
| and for multiple patient use in | ||||
| the hospital or other clinical | ||||
| setting where proper | ||||
| disinfection of the device can | ||||
| occur between patient uses. | The F&P Simplus Full Face | |||
| 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 | ||||
| Simplus Full Face 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 patients. | Substantially equivalent. |
Identical intended use, patient
population and operating
environment.
The Intended Use of the F&P Vitera
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 only | | Prescription use only | Identical |
| Patient
Population | Adult | | Adult | Identical |
| Classification | | | | |
| Product Code | BZD | | BZD | Identical |
| Device
classification | 868.5905 | | 868.5905 | Identical |
| Classification
panel | Anaesthesiology | | Anaesthesiology | Identical |
| | Subject Device | | Predicate | Comments |
| Device Name | F&P Vitera Full Face Mask
(A model) | F&P Vitera Full Face Mask
(SL model) | F&P Simplus Full Face Mask | |
| Operating
Environment | Home | Home, hospital or other clinical
setting
A model is intended for single patient use in the home while SL
model is intended for single patient use in the home and for
multiple patient use in the hospital or other clinical setting. | Home, hospital or other clinical
setting | Identical |
| Technical Specifications | | | | |
| Pressure
Range | 4 to 30 cmH2O | | 4 to 25 cmH2O | Substantially equivalent.
The upper pressure limit has been
increased on the subject device
mask allowing the mask to be used
at higher pressures if required.
The subject device is in
conformance with ISO 17510:2015
and the change to the upper
pressure limit does not introduce
any additional risk to the user. |
| Resistance to
Flow | • Pressure drop through the mask at 50 L/min: 0.24 cmH2O
• Pressure drop through the mask at 100 L/min: 0.47 cmH2O | | • Pressure drop through the
mask at 50 L/min: 0.17 cmH2O
• Pressure drop through the
mask at 100 L/min: 0.64 cmH20 | Substantially equivalent.
The subject device is in
conformance with ISO 17510:2015
and this difference does not
introduce any additional risk to the
user. |
| Inspiratory &
Expiratory
Resistance | • Inspiratory Resistance: 1.05 cmH2O
• Expiratory Resistance: 0.80 cmH2O | | • Inspiratory Resistance: 0.67
cmH2O
• Expiratory Resistance: 0.12
cmH2O | Substantially equivalent.
The subject device is in
conformance with ISO 17510:2015
and this difference does not
introduce any additional risk to the
user. |
| | Subject Device | | Predicate | Comments |
| Device Name | F&P Vitera Full Face Mask
(A model) | F&P Vitera Full Face Mask
(SL model) | F&P Simplus Full Face Mask | |
| Dead Space | | Small: 245.8 cc Medium: 274.1 cc Large: 321.8 cc | Small: 251 cc Medium: 278 cc Large: 310 cc | Substantially equivalent.
All seal sizes are in conformance
with ISO 17510:2015 and this
difference does not introduce any
additional risk to the user. |
| Sound | | Sound Power Level of the Mask: 29.8 dBA, with uncertainty 2.5 dBA Sound Pressure Level of the Mask: 21.8 dBA, with uncertainty 2.5 dBA | Sound Power Level of the Mask: 28.8 dBA, with uncertainty 2.5 dBA Sound Pressure Level of the Mask: 17.8 dBA, with uncertainty 2.5 dBA | Substantially equivalent.
The subject device is in
conformance with ISO 17510:2015
and this difference does not
introduce any additional risk to the
user. |
| Shelf-Life | 5 years | | Shelf-life not claimed on
labelling | Substantially equivalent.
The subject device claims a 5-year
shelf life with supporting data. |
| Cleaning and High-Level Disinfection | | | | |
| Sterility | Device not provided sterile | | Device not provided sterile | Identical |
| Reusability | Single Patient Use | Reusable - Multi Patient Use | Reusable - Multi Patient Use | Identical |
| High Level
Disinfection
Methods | N/A | Thermal Disinfection:
80°C for 10 mins
75°C for 30 mins
90°C for 1 min | Thermal Disinfection:
80°C for 10 mins | Substantially equivalent.
The parameters used for the
thermal disinfection are identical.
Additional temp/time configurations
have been validated for the subject
device (75°C for 30 mins and 90°C
for 1 min) |
| | Subject Device | | Predicate | Comments |
| Device Name | F&P Vitera Full Face Mask
(A model) | F&P Vitera Full Face Mask
(SL model) | F&P Simplus Full Face Mask | |
| Accessories | | | | |
| Accessory | Oxygen/Pressure Port
(900HC452)
Available as a separate part, not provided with device. | | Oxygen/Pressure Port
(900HC452)
Available as a separate part, not provided with device. | Identical |
Table 1: Comparison of Technological Characteristics with the Predicate Device
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F&P Vitera Full Face Mask – Traditional 510(k)
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F&P Vitera Full Face Mask – Traditional 510(k)
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F&P Vitera Full Face Mask – Traditional 510(k)
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Clinical Performance Data 5.5
Clinical study was not required to demonstrate Substantial equivalence.
Biocompatibility 5.6
The F&P Vitera Full Face Mask is classified as an externally communicating device, tissue contact, permanent duration (>30 days). Cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, genotoxicity, and extractables evaluations were conducted based on applicable ISO 10993 test standards and particulate and volatile organic compound (VOC) emissions were evaluated based on ISO 18562. Additionally, a biological risk assessment was conducted on the biocompatibility results and concluded the F&P Vitera Full Face Mask is considered safe for use with patients ≥ 30 kg.
Accessories and Spare Parts 5.7
F&P Vitera Full Face Mask has one accessory and multiple spare parts.
-
Accessory:
F&P Vitera Full Face Mask has the below accessory that is packaged and sold separately. -
o Oxygen Pressure Port Connector
Spare Parts: .
F&P Vitera Full Face Mask has the below device components which are available for purchase as spare parts:
- Vitera Seal Small o
- Vitera Seal Medium O
- Vitera Seal Large O
- Vitera Headgear Medium / Large Vitera Clips and Forehead Clip o (clips are assembled with the headgear and sold together)
- Vitera Headgear Small Vitera Clips and Forehead Clip O (clips are already assembled with the headgear and sold together)
- Vitera Clips and Forehead Clip O (Clips can be purchased separately from the headgear)
- O Vitera Elbow
- o Swivel
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Image /page/13/Picture/1 description: The image shows the logo for Fisher & Paykel Healthcare. The words "Fisher & Paykel" are in a large, bold, blue font on the top line. Below that, the word "HEALTHCARE" is in a smaller, bold, blue font. There is a blue line above the word "HEALTHCARE".
5.8 Mask Models
Two proposed model variants of Vitera will be made available for sale in the United States:
- Vitera A model is intended for single patient use in the home. ●
- Vitera SL model is intended for single patient use in the home and for multiple patient use in the hospital or other clinical setting where proper disinfection of the device can occur between patient uses.
Mask Models Sizes 5.8.1
Both models are available in 3 sizes, Small, Medium and Large.
Mask Models Similarities 5.8.2
The F&P Vitera Full Face Mask design is identical in A and SL models.
5.8.3 Mask Models Differences
The only differences between F&P Vitera Full Face Mask A and SL models are in the labelling content. Differences include: product labels, user instructions, disinfection quide, product direct marking and packaging (product bag) and content.
Conclusions 5.9
The comparison of features, performance, and intended use demonstrate that the F&P Vitera Full Face Mask is substantially equivalent to the predicate F&P Simplus Full Face Mask (K130328).