WiZARD 510 Nasal Mask

{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 in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" in blue as well. The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products. October 29, 2020 Apex Medical Corp. Chieh Yang Quality Engineering Manager No. 9, Min Sheng St. Tu-Cheng. New Taipei City, 23679 Taiwan Re: K193206 Trade/Device Name: WiZARD 510 Nasal Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: Class II Product Code: BZD Dated: September 28, 2020 Received: September 30, 2020 Dear Chieh Yang: 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 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 Malvina B. Eydelman, M.D. Director 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) K193206 Device Name WiZARD 510 Nasal Mask #### Indications for Use (Describe) WIZARD 510 Nasal Mask is intended to provide an interface for Continuous Positive Airway Pressure (CPAP) or bi-level therapy. The nasal mask is intended for single-patient reuse in the home and multi-use in the hospital environment. The nasal mask is to be used on patients greater than 30 kg for whom positive airway pressure (CPAP or bilevel system) has been prescribed. | Type of Use (Select one or both, as applicable) | | |--------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------| | <div> <span> <span style="font-size:16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size:16px;">□</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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 Date Prepared: Oct. 24, 2020 | Company<br>Name/Owner | APEX Medical Corp.<br>No.9, Min Sheng St., Tu-Cheng, New Taipei City ,<br>23679, Taiwan | | |--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | Prepared &<br>submitted by | Chieh Yang<br>Quality Engineering Manager<br>TEL: 886-2-2268-5568 #5102<br>FAX: 886-2-2268-9662<br>meow.yang@apexmedicalcorp.com | | | Official Contact | Alan Chang<br>Management Representative<br>APEX Medical Corp.<br>No.9, Min Sheng St., Tu-Cheng, New Taipei City ,<br>23679, Taiwan<br>TEL: 886-2-2268-5568 #6100<br>FAX: 886-2-2268-9662<br>alan.chang@apexmedicalcorp.com | | | Classification<br>Reference | 21 CFR 868.5905 | | | Product Code | BZD non-continuous ventilator (Class II) | | | Common/Usual<br>Name | CPAP Nasal Mask | | | Proprietary Name | WIZARD 510 Nasal Mask | | | Legally Marketed<br>Predicate Device | WIZARD 210 Nasal Mask of WIZARD 210/220 Series<br>CPAP Mask (K103174) | | | Reference Device | WIZARD 310 Nasal Mask of WIZARD 310/320<br>(K182394) | | | Indications for use | WIZARD 510 Nasal Mask is intended to provide an<br>interface for Continuous Positive Airway Pressure<br>(CPAP) or bi-level therapy. The nasal mask is | | {4}------------------------------------------------ intended for single-patient reuse in the home and multi-patient, multi-use in the hospital environment. The nasal mask is to be used on patients greater than 30 kg for whom positive airway pressure (CPAP or bi-level system) has been prescribed. - Device Description The WiZARD 510 Nasal Mask provides an interface to direct airflow from a positive pressure source to the patient's nostril. The mask is held in place with adjustable headgear that straps the mask to the face. The elbow connector is designed with a series of vent holes to exhale air from the mask. WiZARD 510 nasal mask is connected to a CPAP or bi-level system via a standard 22 mm breathing tube. A quick release mechanism allows users to quickly remove the mask from the face. WiZARD 510 Nasal Mask is safe when used under the conditions and purposes as indicated in the labeling provided with the product. WiZARD 510 Nasal Mask is a prescription device supplied in non-sterile condition. Comparison of subject device to predicate device: | ltem | Predicate Device WiZARD 210<br>Nasal Mask of WiZARD<br>210/220 Series CPAP Mask<br>(K103174) | Subject Device<br>WiZARD 510 Nasal<br>Mask | |--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------| | Principles of<br>Operation | To provide an interface such that<br>airflow from a positive pressure<br>source is directed to the patient's<br>nostril and is held in place with<br>adjustable headgear that straps<br>the mask to the face. | Same as predicate | | Patient Use Type | Adult >30 Kg | Same as predicate | | | | | | Indication | Obstructive sleep apnea | Same as predicate | | Environment | Home, Hospital | Same as predicate | | Reuse | Single patient multi-use for<br>home<br>Multi-patient multi-use for<br>hospital | Same as predicate | | Patient Support<br>System | CPAP or bi-level system | Same as predicate | | Shelf Life | 5 years | Same as predicate | | Useful Life | 6 months | Same as predicate | | Mask Size | L/M/S | L/M | | Mask Weight | L: 117.3g/M: 115.1g/ S:113.2g | L: 93.5 g/ M: 91.5 g | | Mask Dead<br>Space | L: 118ml/ M:107ml/S:89ml | L:93.6ml/ M: 75.3ml | | Sterility | Clean, non-sterile | Same as predicate | | Validated<br>Cleaning | Warm water | Same as predicate | | Validated<br>Disinfection | Thermal water/High level<br>chemical disinfectant | Same as predicate | | Therapy<br>Pressure Range | 4~20 cmH2O | 4~30 cmH2O | | Exhalation holes<br>location | On the elbow assembly | Same as predicate | | Hose<br>Connection | 22 mm hose | Same as predicate | | CPAP Tubing<br>connection point | A port compliance to ISO 5356-1<br>is used to connect to CPAP<br>delivery hose | Same as predicate | | Swivel<br>Connection | 360 degree rotation | Same as predicate | | Secure and<br>Less-leak<br>Interface | Single layer cushion | Same as predicate | | Operation Range | +5°C to +35°C (+41°F to +95°F)<br>15% to 95% R.H<br>(non-condensing) | Same as predicate | | Storage and<br>Transport | -15°C to +60°C (+5°F to +140°F)<br>10% to 90% R.H<br>(non-condensing) | Same as predicate | | Component | Material | Material | | Mask Frame | Polycarbonate(PC) | Polycarbonate(PC) | | Mask Cushion | 2 pcs design:<br>-1pc Polycarbonate(PC)<br>-1pc Silicone (face contact side) | 1pc design:<br>- Silicone (face contact<br>side) mounted on<br>Polycarbonate(PC) | | Forehead<br>Support Pad | Silicone rubber | NA | | Elbow | Polycarbonate(PC) | Same as predicate | | Swivel Hose | Polycarbonate(PC) | Same as predicate | | Flexible Tube | Silicon Rubber | Low Density<br>Polyethylene (LDPE)<br>Helix / Thermoplastic<br>Elastomer (TPE)<br>FlexFilm™ | | Tubing<br>Connector | Polypropylene(PP) | Polycarbonate(PC) | | Quick Release<br>Button<br>(Buckle) | Polyoxymethylene (POM) | Same as predicate | | Headgear Strap | PU Foam/Nylon /Neoprene | PU<br>Foam/Nylon/Polyester | | | | and humidifier ) /<br>≤28 dBA (with CPAP) | | Biocompatibility<br>Test | ISO 10993-1 | ISO 10993-1 | | | ISO 10993-5 | ISO 10993-5 | | | ISO 10993-10 | ISO 10993-10 | | | | ISO 10993-17 | | | | ISO 10993-18 | | | | ISO 18562-1 | | | | ISO 18562-2 | | | | ISO 18562-3 | {5}------------------------------------------------ {6}------------------------------------------------ {7}------------------------------------------------ # Comparison of subject device to reference device: The therapy pressure range of the subject device WiZARD 510 Nasal Mask is expanded to 4~30 cmH2O and is substantially equivalent to the reference device WiZARD 310 Nasal Mask of WiZARD 310/320 (K182394). Please refer to the following Product Specification Comparison Table: | No | Item | Reference Device | Subject Device | | | | | | | |----|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|--------------------------------------------------------------------------|---------------------------|------------|-------|--------------------------------------| | 1 | Trade Name | APEX Medical , WIZARD 310 Nasal Mask (K182394) | APEX Medical, WiZARD 510 Nasal Mask | | | | | | | | 2 | Product Code | BZD | same as reference<br>devices | | | | | | | | 3 | Regulation<br>Number | 868.5905 | same as reference<br>devices | | | | | | | | 4 | Regulation Name | CPAP Mask | same as reference<br>devices | | | | | | | | 5 | Indications for<br>use | WIZARD 310/320 series CPAP Mask is intended to provide an interface for Continuous Positive Airway Pressure (CPAP) or bi-level therapy. These masks are intended for single-patient reuse in the home and multi-patient | WIZARD 510 Nasal Mask is intended to provide an interface for Continuous Positive Airway Pressure (CPAP) or bi-level therapy. The mask is intended for single-patient reuse in the home and | | | | | | | | | | multi-use in the hospital environment. These masks are to be used on patients greater than 30 kg for whom positive airway pressure (CPAP or bi-level system) has been prescribed. | multi-patient, multi-use in the hospital environment. The mask is to be used on adult patients greater than 30 kg for whom positive airway pressure (CPAP or bi-level system) has been prescribed. | | | | | | | | 6 | Patient Use Type | Adult >30 Kg | same as reference devices | | | | | | | | 7 | Indication | Obstructive sleep apnea | same as reference devices | | | | | | | | 8 | Environment | home, hospital | same as reference devices | | | | | | | | 9 | Reuse | Single patient multi-use for home<br>Multi-patient multi-use for hospital | same as reference devices | | | | | | | | 10 | Patient Support System | CPAP or bi-level system | same as reference devices | | | | | | | | 11 | Principle of Operation | Mask provides an interface such that airflow from a positive pressure source is directed to the patient's nostril and is held in place with adjustable headgear that straps the mask to the face. | same as reference devices | | | | | | | | 12 | Shelf Life | 5 years | same as reference devices | | | | | | | | 13 | Useful Life | 6 months | same as reference devices | | | | | | | | 14 | Sterility | Clean, non-sterile | same as reference devices | | | | | | | | 15 | Therapy Pressure Range | 4~30 cmH2O | same as reference devices | | | | | | | | 16 | Exhalation Hole | Yes | same as reference devices | | | | | | | | 17 | Hose Connection | 22 mm hose | same as reference devices | | | | | | | | 18 | Operation Range | +5°C to +35°C<br>(+41°F to +95°F)<br>15% to 95% R.H<br>(non-condensing) | same as reference devices | | | | | | | | | | 19 | | Storage and<br>Transport | -15°C to +60°C<br>(+5°F to +140°F)<br>10% to 90% R.H<br>(non-condensing) | same as reference devices | | | | | | | | | | 20 | | Noise (dB) | ≤30dB | ≤26 dB (with CPAP and<br>Humidifier) | | | | | | | | | | | ≤28 dB (with CPAP) | {8}------------------------------------------------ {9}------------------------------------------------ # Changes from the predicate devices WiZARD 210 Nasal Mask of WiZARD 210/220 Series CPAP Mask (K103174): - mechanical design of the mask frame and removal of the forehead support pad. - materials of the flexible tube, tubing connector and headgear strap. ● - color, shape and length of the flexible tube and headgear strap. - Expansion of the therapy pressure range - mask size category ## Non-clinical data Non-clinical verification and validation testing completed for the subjected device demonstrated that the WiZARD 510 Nasal Mask met all intended performance requirements. These included: {10}------------------------------------------------ ## a. Biocompatibility Test: - ISO 10993-1:2009, Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process - ISO 10993-5:2009, Biological evaluation of medical devices-Part 5: Tests for In Vitro cytotoxicity - ISO 10993-10:2010, Third Edition Biological evaluation of medical devices-Part 10: Tests for irritation and skin sensitization - ISO 10993-17:2002 Biological evaluation of medical devices -- Part 17: Establishment of allowable limits for leachable substances - ISO 10993-18:2002 Biological evaluation of medical devices -- Part 18: Chemical characterization of medical device materials within a risk management process - 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) # b. Reliability Test: - ISO 17510: 2015 Medical devices -- Sleep apnoea breathing therapy --Masks and application accessories - Mechanical integrity performance following relevant environmental exposure: home cleaning, transportation and storage, operational temperature and humidity range, drop test, sit test and shelf life. ## c. Risk Assessment: - i ISO 14971:2007 Second Edition, Medical devices - Application of risk management to medical devices ## d. Reprocessing test Validation of reprocessing claims included a combination of cleaning {11}------------------------------------------------ efficacy, disinfection efficacy and mechanical integrity testing. The above testing confirmed that the WiZARD 510 Nasal Mask met the predetermined acceptance criteria and the performance is substantially equivalent to the previously cleared predicate WiZARD 210 Nasal Mask (K103174). # Conclusion The subject device WiZARD 510 Nasal mask is substantially equivalent to the predicate device WiZARD 210 Nasal mask of WiZARD 210/220 series CPAP mask (K103174).