(255 days)
WIZARD 210/220 Series CPAP Mask (K103174)
No
The description focuses on the physical components and function of a CPAP mask, with no mention of AI or ML capabilities.
No.
The device is a CPAP mask, which is an accessory to a therapeutic device (CPAP or bi-level system) and serves as an interface for therapy, rather than providing the therapy itself.
No
The device is a CPAP mask, intended to provide an interface for therapy, not to diagnose a condition.
No
The device description clearly details physical components like masks, headgear, vents, and tubing, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide an interface for delivering positive airway pressure (CPAP or bi-level therapy) to a patient. This is a therapeutic function, not a diagnostic one.
- Device Description: The description details a mask and headgear designed to deliver air to the patient's airways. It does not mention any components or processes related to analyzing biological samples (like blood, urine, tissue, etc.) to diagnose a condition.
- Lack of Diagnostic Function: The device's purpose is to facilitate a prescribed therapy, not to provide information about a patient's health status through in vitro examination.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This CPAP mask does not perform any such function.
N/A
Intended Use / Indications for 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.
Product codes
BZD
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nostril and mouth
Indicated Patient Age Range
patients greater than 30 kg (Adults with OSA)
Intended User / Care Setting
Home, Hospital
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)
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 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:
- IEC 62366-1:2015 Medical devices -- Part 1: Application of usability engineering to medical devices
Key Results: Non-clinical testing demonstrated that the new device has equivalent performance to the predicate device.
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.
WIZARD 210/220 Series CPAP Mask (K103174)
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.
AirFit F20 (K170924), AirFit N20 (K171212)
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 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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
Date Prepared: May. 17, 2019
| Company
Name/Owner | APEX Medical Corp.
No.9, Min Sheng St., Tu-Cheng, New Taipei City,
23679, Taiwan |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Prepared &
submitted by | Chieh Yang
Quality Engineering Manager
TEL: 886-2-2268-5568 #5102
FAX: 886-2-2268-9662
meow.yang@apexmedicalcorp.com |
| Official Contact | Frank Lin
Management Representative
APEX Medical Corp.
No.9, Min Sheng St., Tu-Cheng, New Taipei City,
23679, Taiwan
TEL: 886-2-2268-5568 #5001
FAX: 886-2-2268-9662
frank.lin@apexmedicalcorp.com |
| Classification
Reference | 21 CFR 868.5905 |
| Product Code | BZD non-continuous ventilator (Class II) |
| Common/Usual
Name | CPAP Mask |
| Proprietary Name | WIZARD 310/320 Series CPAP Mask |
| Legally Marketed
Predicate Device | WIZARD 210/220 Series CPAP Mask (K103174) |
| Reference Device | AirFit F20 (K170924)
AirFit N20 (K171212) |
| Intended
Use/Indications for | WIZARD 310/320 series CPAP Mask is intended to
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.
5
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
210/220 Series CPAP Mask
(K103174) | Subject Device
WIZARD 310/320 Series
CPAP Mask | | | | |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|-------|--------------------------------------------------|-------|--------|
| Principles of
Operation | To provide an interface such
that airflow from a positive
pressure source is directed to
the patient's nostril and mouth
and are held in place with
adjustable headgear that
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
home
Multi-patient multi-use for
hospital | Same as left | | | | |
| Patient Support
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
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
Cleaning | Warm water | | | Same as left | | |
| Validated
Disinfection | Thermal water/High level
chemical disinfectant | | | Same as left | | |
| Therapy
Pressure Range | 420 cmH2O | | | WIZARD 310: 430 cmH2O
WIZARD 320: 4~40 cmH2O | | |
| Exhalation holes
location | On the elbow assembly | | | On the cushion assembly | | |
| Hose
Connection | 22 mm hose | | | Same as left | | |
| CPAP Tubing
connection point | A port compliance to ISO
5356-1 is used to connect to
CPAP delivery hose | | | Same as left | | |
| Swivel
Connection | 360 degree rotation | | | Same as left | | |
| Secure and
Less-leak
Interface | Single layer cushion | | | Same as left | | |
| Operation Range | +5°C to +35°C (+41°F to +95
°F)
15% to 95% R.H
(non-condensing) | | | Same as left | | |
| Storage and | -15°C to +60°C (+5°F to
+140°F) | | | Same as left | | |
6
7
| Transport | 10% to 90% R.H
(non-condensing) | |
|-------------------------------------|------------------------------------------------------------------|----------------------------------------------------------------|
| Component | Material | Material |
| Mask Frame | PC | TPEE |
| Mask Cushion | 2 pcs design:
-1pc PC
-1pc Silicone (face contact
side) | 1pc design:
- Silicone (face contact
side) mounted on PC |
| Forehead
Support Pad | Silicone rubber | NA |
| Elbow | PC | Same as left |
| Elbow
Diaphragm | Silicone Rubber
(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
Connector | PP | Same as left |
| Quick Release
Button
(Buckle) | POM | Same as left |
| Headgear Strap | PU Foam/Nylon /Neoprene
(Color : Dark Grey/Black) | PU Foam/Nylon /Neoprene
(Color : Light Grey) |
| Noise (dB) |