(231 days)
No
The summary describes a physical mask component for CPAP/Bi-Level therapy and does not mention any software, algorithms, or data processing capabilities indicative of AI/ML.
No.
The document describes the F&P Evora Full Face mask as an accessory that connects to a CPAP or Bi-level device, which is the therapeutic device. The mask itself delivers pressurized air but does not provide the therapy.
No
The device is a full-face mask designed to deliver CPAP or Bi-Level therapy, not to diagnose medical conditions. Its intended use is for patients already diagnosed with a need for such therapy.
No
The device description clearly states it is a "non-invasive compact full-face mask" and details its physical components and connection to a CPAP/Bi-level device. The performance studies also focus on physical and material properties of the mask.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the mask is for delivering CPAP or Bi-Level therapy to patients diagnosed with requiring such treatment. This is a therapeutic application, not a diagnostic one.
- Device Description: The description details a mask that connects to a breathing tube to receive pressurized air. This is consistent with a device used for respiratory support, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
The device is a medical device used for treatment, specifically for delivering respiratory therapy.
N/A
Intended Use / Indications for Use
The F&P Evora™ 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 Evora 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 (comma separated list FDA assigned to the subject device)
BZD
Device Description
The F&P Evora™ Full Face Mask (hereafter named "Evora Full") is a non-invasive compact full-face mask that seals underneath the patient's nose and lips. The mask connects to a single breathing tube by a 22mm male swivel adaptor to receive pressurised air from a continuous positive airway pressure device (CPAP or Bi-level). The exhaust holes on the seal of the mask allow exhaled air to be flushed out while the system is in operation. The Evora Full mask is a prescription only device, provided in non-sterile 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
Adults weighing ≥ 66lbs (30kgs)
Intended User / Care Setting
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.
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)
Summary of Non-Clinical Tests:
- Cleaning Validation
- High-Level Disinfection Validation
- Leak
- Dead Space Analysis
- Human Factors/Usability Engineering
- Mechanical Integrity
- Shelf-Life and Storage
- ISO 17510:2015 Sleep apnoea breathing therapy Masks and application accessories
- CO2 Rebreathing
- Pressure-Flow Curve
- Exhaust Flow
- Resistance to Flow (pressure drop)
- Inspiratory and Expiratory Resistance
- Open-to-Atmosphere and Closed-to-Atmosphere Pressures
- Anti-Asphyxia Valve Pressures
- Vibration and Noise
- ASTM 1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
- ISTA 2A International Safety Transit Association Guidelines Procedure 2A: Packaged-Products weighing 150 lb (68 kg) or less.
- ISO 5356-1:2015 Anaesthetic and respiratory equipment - Conical connectors: Part 1: Cones and sockets
- ISO 10993-1:2018 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
- 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
- SIO 10993-11:2017 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 materials (available in English only)
- ISO 10993-17:2002 Biological evaluation of medical devices Part 17: Establishment of allowable limits for leachable substances
- ISO 10993-18:2020 Biological evaluation of medical devices Part 18: Chemical characterization of medical device materials within a risk management process
- ISO 10993-33:2015 Biological evaluation of medical devices Part 33: Guidance on tests to evaluate genotoxicity - Supplement to ISO 10993-3
- 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 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter
- ISO 18562-3 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic compounds (VOCs)
- ISO 18562-4 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
F&P Vitera™ Full Face Mask, K190713
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.
F&P Evora™ Nasal Mask, K200089
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/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 18, 2022
Fisher & Paykel Healthcare Ltd Reena Daken Regulatory Affairs Market Manager 15 Maurice Paykel Place, East Tamaki Auckland. 2013 New Zealand
Re: K212371
Trade/Device Name: F&P Evora Full Face Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous ventilator (IPPB) Regulatory Class: Class II Product Code: BZD Dated: February 18, 2022 Received: February 18, 2022
Dear Reena Daken:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) 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 mediation-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,
Rachana Visaria, Ph.D. Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212371
Device Name F&P Evora™ Full Face Mask
Indications for Use (Describe)
The F&P Evora 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 Evora 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.
| 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
510(k) Summary
As Required by 21 CFR 807.92
I. SUBMITTER
| Company Name and
Address | Fisher & Paykel Healthcare Limited
15 Maurice Paykel Place
East Tamaki
Auckland 2013, New Zealand
Telephone: +64 9 574 0100 |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Prepared and Submitted by | Nicholas Yap
Regulatory Affairs Specialist |
| Contact Person | Reena Daken
Regulatory Affairs Manager
Telephone: +64 9 574 0100
Email: reena.daken@fphcare.co.nz |
| Date Prepared | 18 March 2022 |
II. DEVICE
| Name of Device | F&P Evora™ Full Face Mask |
|---|---|
| Common/Usual Name | Full Face Mask |
| Classification Name | Non Continuous Ventilator (IPPB) |
| Regulatory Class | Class II (21 CFR §868.5905) |
| Product Code | BZD |
PREDICATE DEVICE lll.
- Predicate device:
- F&P Vitera™ Full Face Mask, K190713
- . Reference devices:
- o F&P Evora™ Nasal Mask, K200089
- Used to support claims of substantial equivalence with respect to design and performance
- o F&P Evora™ Nasal Mask, K200089
4
DEVICE DESCRIPTION IV.
The F&P Evora™ Full Face Mask (hereafter named "Evora Full") is a non-invasive compact full-face mask that seals underneath the patient's nose and lips. The mask connects to a single breathing tube by a 22mm male swivel adaptor to receive pressurised air from a continuous positive airway pressure device (CPAP or Bi-level). The exhaust holes on the seal of the mask allow exhaled air to be flushed out while the system is in operation. The Evora Full mask is a prescription only device, provided in non-sterile state
| Model | Product Code | Product Description |
|---|---|---|
| A-Model | EVF1XA | Evora Full Face Mask Extra Small A Model |
| EVF1MA | Evora Full Face Mask Small-Medium Model | |
| EVF1LA | Evora Full Face Mask Large A Model | |
| EVF1XXA | Evora Full Face Mask Double Seal XS/XS A Model | |
| EVF1MMA | Evora Full Face Mask Double Seal S-M/S-M A Model | |
| EVF1LLA | Evora Full Face Mask Double Seal Lrg/Lrg A Model | |
| Fit Pack A-Model | EVF1XMLA | Evora Full Face Mask Fit Pack A Model |
| SL A-Model | EVF1XSLA | Evora Full Mask Extra Small Sleep Lab A |
| EVF1MSLA | Evora Full Mask Small-Medium Sleep Lab A | |
| EVF1LSLA | Evora Full Mask Large Sleep Lab A | |
| Fit Pack SL A-Model | EVF1XMLSLA | Evora Full Mask Fit Pack Sleep Lab A |
A list of the subject device product codes can be found below:
INDICATIONS FOR USE V.
The F&P Evora 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 Evora 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
COMPARISON OF TECHNOLOGICAL CHARATCERISTICS WITH THE PREDICATE DEVICE VI.
The comparison of features, performance data and intended use demonstrate that the F&P Evora™ Full Face Mask is substantially equivalent to the predicate device, F&P Vitera™ Full Face Mask (K190713). Please see the table below.
| Design /
Technological
| Characteristic | Subject Device | Predicate Device | Comments |
|---|---|---|---|
| F&P Evora™ Full Face Mask | F&P Vitera™ Full Face Mask (K190713) | ||
| Classification | |||
| Legal | |||
| Manufacturer | Fisher & Paykel Healthcare Ltd. | Fisher & Paykel Healthcare Ltd. | |
| Product Code | BZD | BZD | |
| Device | |||
| Classification | 21 CFR §868.5905 | 21 CFR §868.5905 | Identical |
| Classification | |||
| panel | Anaesthesiology | Anaesthesiology | |
| Intended Use/Indications for Use | |||
| Intended Use/ | |||
| Indications for | |||
| Use | The F&P Evora 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 | |||
| Evora 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 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. | Identical | ||
| Availability | Prescription use only | ||
| (Part 21 CFR 801 Subpart D) | Prescription use only | ||
| (Part 21 CFR 801 Subpart D) | Identical | ||
| Design / | |||
| Technological | |||
| Characteristic | Subject Device | Predicate Device | Comments |
| F&P Evora™ Full Face Mask | F&P Vitera™ Full Face Mask (K190713) | ||
| Patient | |||
| Population | Adult (> 30kg) | Adult (> 30kg) | Identical |
| Application | CPAP or Bi-Level therapy | CPAP or Bi-Level therapy | Identical |
| Operating | |||
| Environment | Home, hospital or other clinical setting | Home, hospital or other clinical setting | Identical |
| Technical Specifications and Features | |||
| Pressure | |||
| Range | 4 to 30 cmH2O | 4 to 30 cmH2O | Identical. |
| Resistance to | |||
| Flow | Pressure drop through the mask at 50 L/min: 0.9 ± 0.3 cmH2O Pressure drop through the mask at 100 L/min: 2.2 ± 0.3cmH2O | Pressure drop through the mask at 50 L/min: 0.24 ± 0.15 cmH2O Pressure drop through the mask at 100 L/min: 0.47 ± 0.15 cmH2O | This difference does not raise new |
| questions of safety and | |||
| effectiveness. | |||
| Dead Space | XS: 165.2 cm3 S-M: 162.6 cm3 L: 164.1 cm3 | Small: 245.8 cc Medium: 274.1 cc Large: 321.8 cc | This difference does not raise new |
| questions of safety and | |||
| effectiveness. | |||
| Sound Power | |||
| Level | Sound Power Level of the Mask: | ||
| 28.2 dBA, with uncertainty 2.5 dBA Sound Pressure Level of the Mask: | |||
| 20.2 dBA, with uncertainty 2.5 dBA | 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 | Substantially equivalent | ||
| Shelf-Life | 2 years | 5 years | This difference does not raise new |
| questions of safety and | |||
| effectiveness. | |||
| Breathing | |||
| Circuit | Single Inspiratory Tube | Single Inspiratory Tube | Identical |
| Design / | |||
| Technological | |||
| Characteristic | Subject Device | Predicate Device | Comments |
| F&P Evora™ Full Face Mask | F&P Vitera™ Full Face Mask (K190713) | ||
| (PAP system – | |||
| external to the | |||
| "mask") | |||
| Operating and | |||
| Storage | |||
| Conditions | Operating Temperature: 5 to 40°C | ||
| Storage Temperature: -20 to 50°C | Operating Temperature: 5 to 40°C | ||
| Storage Temperature: -20 to 50°C | Identical | ||
| Design | |||
| Swivel [4] | 22mm ISO conical connector | 22mm ISO conical connector | Identical. |
| Cleaning and High-Level Disinfection | |||
| 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: | ||
| 90°C for 1 min | Thermal Disinfection: | ||
| 80°C for 10 mins | |||
| 75°C for 30 mins | |||
| 90°C for 1 min | Equivalent. | ||
| The subject device contains a | |||
| subset of the high-level | |||
| disinfection methods compared to | |||
| the predicate. | |||
| 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. | ||
| The Oxygen/Pressure Port was | |||
| cleared under K023559. |
6
7
F&P Evora™ Full Face Mask – Traditional 510(k)
8
VII. PERFORMANCE DATA
Summary of Non-Clinical Tests
- . Cleaning Validation
- High-Level Disinfection Validation ●
- Leak
- Dead Space Analysis
- Human Factors/Usability Engineering
- Mechanical Integrity
- Shelf-Life and Storage ●
- ISO 17510:2015 Sleep apnoea breathing therapy Masks and application ● accessories
- o CO2 Rebreathing
- Pressure-Flow Curve O
- o Exhaust Flow
- Resistance to Flow (pressure drop) O
- Inspiratory and Expiratory Resistance O
- Open-to-Atmosphere and Closed-to-Atmosphere Pressures о
- O Anti-Asphyxia Valve Pressures
- o Vibration and Noise
- ASTM 1980-16 Standard Guide for Accelerated Aging of Sterile Barrier ● Systems for Medical Devices
- ISTA 2A International Safety Transit Association Guidelines Procedure 2A: ● Packaged-Products weighing 150 lb (68 kg) or less.
- . ISO 5356-1:2015 Anaesthetic and respiratory equipment - Conical connectors: Part 1: Cones and sockets
- ISO 10993-1:2018 Biological evaluation of medical devices Part 1: Evaluation ● and testing within a risk management process
- . 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
- SIO 10993-11:2017 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 materials (available in English only)
- . ISO 10993-17:2002 Biological evaluation of medical devices Part 17: Establishment of allowable limits for leachable substances
- ISO 10993-18:2020 Biological evaluation of medical devices Part 18: Chemical ● characterization of medical device materials within a risk management process
9
- . ISO 10993-33:2015 Biological evaluation of medical devices Part 33: Guidance on tests to evaluate genotoxicity - Supplement to ISO 10993-3
- 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 Biocompatibility evaluation of breathing gas pathways in ● healthcare applications - Part 2: Tests for emissions of particulate matter
- ISO 18562-3 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic compounds (VOCs)
- ISO 18562-4 Biocompatibility evaluation of breathing gas pathways in . healthcare applications - Part 4: Tests for leachables in condensate
CONCLUSIONS VIII.
The F&P Evora™ Full Face Mask is substantially equivalent to the predicate based on patient population, intended uses, comparison of the technological characteristics and performance. In addition, the conclusions drawn from the non-clinical tests demonstrate that the device is substantially equivalent to the legally marketed predicate device.