WiZARD 310/320 Series CPAP Mask

K182394 · Apex Medical Corp. · BZD · May 17, 2019 · Anesthesiology

Device Facts

• Record ID: K182394
• Device Name: WiZARD 310/320 Series CPAP Mask
• Applicant: Apex Medical Corp.
• Product Code: BZD · Anesthesiology
• Decision Date: May 17, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended 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, 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.

Device Story

The WiZARD 310 (nasal) and 320 (full face) masks serve as patient interfaces for CPAP or bi-level therapy. The device directs airflow from a positive pressure source to the patient's nose and/or mouth via adjustable headgear. Integrated exhalation vents on the cushion assembly purge exhaled CO2. The device connects to standard 22 mm breathing tubing and includes a quick-release mechanism. Used in home or hospital settings by patients >30 kg. The mask provides a secure, low-leak interface to facilitate prescribed airway pressure therapy, potentially improving patient compliance and treatment efficacy for sleep-disordered breathing.

Clinical Evidence

Bench testing only. Performance validated via ISO 17510 (mechanical integrity, environmental exposure, drop/sit tests), ISO 10993 series (biocompatibility), ISO 18562 series (breathing gas pathway safety), and IEC 62366-1 (usability). No clinical data presented.

Technological Characteristics

Materials: TPEE frame, silicone cushion, PU foam/nylon/neoprene headgear, PC elbow/swivel, PP tubing connector, POM quick-release. Interface: Nasal (310) or Full Face (320). Connectivity: Standard 22 mm ISO 5356-1 port. Sterilization: Supplied non-sterile; validated for thermal water/high-level chemical disinfection. Standards: ISO 10993-1/5/10/17/18, ISO 18562-1/2/3, ISO 17510, ISO 14971, IEC 62366-1.

Indications for Use

Indicated for patients >30 kg requiring CPAP or bi-level positive airway pressure therapy for conditions such as obstructive sleep apnea. Contraindicated for patients with recent eye surgery, dry eyes, hiatal hernia, excessive reflux, impaired cough reflex, impaired cardiac sphincter function, dependence on mechanical life support, use of emetic prescription drugs, or those who are uncooperative, unresponsive, or unable to remove the mask independently. Not for use over open wounds or skin prone to decubitus ulcers.

Regulatory Classification

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.

Predicate Devices

• WIZARD 210/220 Series CPAP Mask (K103174)

Reference Devices

• AirFit F20 (K170924)
• AirFit N20 (K171212)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 17, 2019

Apex Medical Corp. Frank Lin Management Representative No. 9 Min Sheng St. Tu-Cheng New Taipei City, 23679 Taiwan

Re: K182394

Trade/Device Name: WiZARD 310/320 Series CPAP Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: Class II Product Code: BZD Dated: April 17, 2019 Received: April 18, 2019

Dear Frank Lin:

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

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

for Michael Ryan 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 Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K182394

Device Name WiZARD 310/320 Series CPAP Mask

#### Indications for Use (Describe)

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, 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.

| 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> |

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# 510(k) Summary

Date Prepared: May. 17, 2019

| 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: [phone] #5102<br>FAX: [phone]<br>[e-mail] |
| Official Contact | Frank Lin<br>Management Representative<br>APEX Medical Corp.<br>No.9, Min Sheng St., Tu-Cheng, New Taipei City,<br>23679, Taiwan<br>TEL: [phone] #5001<br>FAX: [phone]<br>[e-mail] |
| Classification<br>Reference | 21 CFR 868.5905 |
| Product Code | BZD non-continuous ventilator (Class II) |
| Common/Usual<br>Name | CPAP Mask |
| Proprietary Name | WIZARD 310/320 Series CPAP Mask |
| Legally Marketed<br>Predicate Device | WIZARD 210/220 Series CPAP Mask (K103174) |
| Reference Device | AirFit F20 (K170924)<br>AirFit N20 (K171212) |
| Intended<br>Use/Indications for | WIZARD 310/320 series CPAP Mask is intended to<br>provide an interface for Continuous Positive Airway |

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Pressure (CPAP) or bi-level therapy. These masks use are intended for single-patient reuse in the home and multi-patient, 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.

- Patient Population Adults with OSA
Hospital, home Environment of Use

Contraindication This mask is not for use on patients with the following conditions: recent eye surgery or dry eyes, hiatal hernia, excessive reflux, impaired cough reflex, and impaired cardiac sphincter function. This mask is not for use on patients who are dependent on mechanical ventilation for their life support. This mask is not for use on patient who are taking a prescription drug that induces vomiting, or on patients who are uncooperative, unresponsive or unable to remove the mask by themselves. This mask should not be placed over open wound or skin under risk of decubitus ulcers that are prone to infection.

Device Description The WiZARD 310 Nasal Mask and WiZARD 320 Full Face Mask provide an interface such that airflow from a positive pressure source is directed to the patient's nostril and mouth. The masks are held in place with adjustable headgear that straps the mask to the face. Series of vent are feature on the cushion that serves as an exhalation vent to purge the exhaled carbon dioxide from the mask. Air coming out from these holes is very diffuse and quiet. WiZARD 310/320 series CPAP mask are connected to the CPAP or bi-level system via standard 22 mm breathing tubing. A quickly-release mechanism also includes which allow the mask can be removed quickly.

> The WiZARD 310 Nasal Mask and WiZARD 320 Full Face Mask are appropriate when used under the conditions and purposes intended as indicated in the labeling provided with the product. The WiZARD 310 Nasal Mask and WiZARD 320 Full Face Mask are the prescription device supplied non-sterile.

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# Comparison of device to predicate device:

- a. Product Specification Comparison Table of Subject Device WiZARD 310/320 Series CPAP Mask, and Predicate Device WiZARD 210/220 Series CPAP Mask (K103174).

| Item | Predicate Device WIZARD<br>210/220 Series CPAP Mask<br>(K103174) | Subject Device<br>WIZARD 310/320 Series<br>CPAP Mask | | | | |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|-------|--------------------------------------------------|-------|--------|
| Principles of<br>Operation | To provide an interface such<br>that airflow from a positive<br>pressure source is directed to<br>the patient's nostril and mouth<br>and are held in place with<br>adjustable headgear that<br>straps the mask to the face. | Same as left | | | | |
| Patient Use Type | Adult >30 Kg | Same as left | | | | |
| Indication | Obstructive sleep apnea | Same as left | | | | |
| Environment | Home, Hospital | Same as left | | | | |
| Reuse | Single patient multi-use for<br>home<br>Multi-patient multi-use for<br>hospital | Same as left | | | | |
| Patient Support<br>System | CPAP or bi-level system | Same as left | | | | |
| Shelf Life | 5 years | Same as left | | | | |
| Use of Life | 6 months | Same as left | | | | |
| Mask Size | L/M/S | Same as left | | | | |
| Mask Weight | (g) | 210 | 220 | (g) | 310 | 320 |
| | L | 117.3 | 160.1 | L | 88.57 | 119.6 |
| | M | 115.1 | 153.7 | M | 87.41 | 112.55 |
| | S | 113.2 | 148.5 | S | 85.83 | 108.06 |
| | (ml) | 210 | 220 | (ml) | 310 | 320 |
| Mask Dead<br>Space | L | 118 | 212 | L | 112.2 | 328 |
| | M | 107 | 197 | M | 96.6 | 284 |
| | S | 89 | 164 | S | 76.6 | 224.8 |
| Sterility | Clean, non-sterile | | | Same as left | | |
| Validated<br>Cleaning | Warm water | | | Same as left | | |
| Validated<br>Disinfection | Thermal water/High level<br>chemical disinfectant | | | Same as left | | |
| Therapy<br>Pressure Range | 4~20 cmH2O | | | WIZARD 310: 4~30 cmH2O<br>WIZARD 320: 4~40 cmH2O | | |
| Exhalation holes<br>location | On the elbow assembly | | | On the cushion assembly | | |
| Hose<br>Connection | 22 mm hose | | | Same as left | | |
| CPAP Tubing<br>connection point | A port compliance to ISO<br>5356-1 is used to connect to<br>CPAP delivery hose | | | Same as left | | |
| Swivel<br>Connection | 360 degree rotation | | | Same as left | | |
| Secure and<br>Less-leak<br>Interface | Single layer cushion | | | Same as left | | |
| Operation Range | +5°C to +35°C (+41°F to +95<br>°F)<br>15% to 95% R.H<br>(non-condensing) | | | Same as left | | |
| Storage and | -15°C to +60°C (+5°F to<br>+140°F) | | | Same as left | | |

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| Transport | 10% to 90% R.H<br>(non-condensing) | |
|-------------------------------------|------------------------------------------------------------------|----------------------------------------------------------------|
| Component | Material | Material |
| Mask Frame | PC | TPEE |
| Mask Cushion | 2 pcs design:<br>-1pc PC<br>-1pc Silicone (face contact<br>side) | 1pc design:<br>- Silicone (face contact<br>side) mounted on PC |
| Forehead<br>Support Pad | Silicone rubber | NA |
| Elbow | PC | Same as left |
| Elbow<br>Diaphragm | Silicone Rubber<br>(WiZARD 210 without) | Same as left |
| Port Cap | Silicone rubber | NA |
| Swivel Hose | PC | Same as left |
| Silicon Tubing | Silicon Rubber | Same as left |
| Tubing<br>Connector | PP | Same as left |
| Quick Release<br>Button<br>(Buckle) | POM | Same as left |
| Headgear Strap | PU Foam/Nylon /Neoprene<br>(Color : Dark Grey/Black) | PU Foam/Nylon /Neoprene<br>(Color : Light Grey) |
| Noise (dB) | <40dB | <30dB |
| Biocompatibility<br>Test | ISO 10993-1<br>ISO 10993-5<br>ISO 10993-10 | ISO 10993-1<br>ISO 10993-5<br>ISO 10993-10 |
| | | ISO 10993-17 |
| | | ISO 10993-18<br>ISO 18562-1<br>ISO 18562-2 |

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# Changes from the predicate devices WiZARD 210/220 Series CPAP Mask (K103174):

- Chang the material of the mask frame.
- Change the colour and shape of the headgear strap.
- Delete the design of the forehead support pad.

As the table list above shows WiZARD 310/320 Series CPAP Mask incorporates features from predicate device, the subject and predicate device have an identical intended use, patient population, principle of operation, employ same technology with similar performance and made of similar materials.

The main differences between the subject device and the previously cleared predicate device WiZARD 210/220 Series CPAP Mask (K103174) do not affect the substantial equivalence claim to the predicate device because non-clinical testing demonstrated that the new device has equivalent performance to the predicate device.

#### 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

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- 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 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:

- ISO 14971:2007 Second Edition, Medical devices Application of risk । management to medical devices
## d. Usability Validation:

- i IEC 62366-1:2015 Medical devices -- Part 1: Application of usability engineering to medical devices
## Substantial Equivalence Conclusion

The subject device WiZARD 310/320 series CPAP mask is substantially equivalent to the predicate device WiZARD 210/220 series CPAP mask (K103174):

- It has the same intended use
- It has similar technological characteristics
- It has similar performance characteristics
- The difference do not raise any new questions of safety or effectiveness