(255 days)
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.
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.
The provided text describes a CPAP mask and its FDA 510(k) clearance, which focuses on demonstrating substantial equivalence to a predicate device, not on presenting novel acceptance criteria or a study proving a device's performance against specific clinical acceptance criteria.
Therefore, I cannot create a table of acceptance criteria and reported device performance because the provided document does not contain this information in the context of a new study proving performance. The document primarily highlights:
- Comparison to a predicate device: The core of the submission is to show the WiZARD 310/320 series CPAP Mask is substantially equivalent to the WiZARD 210/220 Series CPAP Mask (K103174) and reference devices AirFit F20 (K170924) and AirFit N20 (K171212).
- Safety and Performance Testing: Non-clinical testing was performed to demonstrate equivalent performance to the predicate device, focusing on biocompatibility and reliability.
Here's a breakdown of the information that can be extracted based on the provided text, and what information is not available within this document:
1. Table of Acceptance Criteria and Reported Device Performance:
- Not explicitly provided as a set of clinical performance acceptance criteria with corresponding study results. The document focuses on demonstrating substantial equivalence through comparison to a predicate device and non-clinical testing.
- Instead, the document lists "performance characteristics" that are deemed similar to the predicate device. These are not acceptance criteria in the sense of demonstrating a certain level of efficacy or diagnostic accuracy. They are design and functional specifications.
Summary of "Similar Performance Characteristics" to Predicate Device:
| Item | Predicate Device (WiZARD 210/220 Series CPAP Mask, K103174) | Subject Device (WiZARD 310/320 Series CPAP Mask) | Remarks |
|---|---|---|---|
| Principles of Operation | Interface for airflow from positive pressure source | Same | Substantially equivalent |
| Patient Use Type | Adult >30 Kg | Same | Substantially equivalent |
| Indication | Obstructive sleep apnea | Same | Substantially equivalent |
| Environment | Home, Hospital | Same | Substantially equivalent |
| Reuse | Single patient multi-use for home; Multi-patient multi-use for hospital | Same | Substantially equivalent |
| Patient Support System | CPAP or bi-level system | Same | Substantially equivalent |
| Shelf Life | 5 years | Same | Substantially equivalent |
| Use of Life | 6 months | Same | Substantially equivalent |
| Mask Size | L/M/S | Same | Substantially equivalent |
| Sterility | Clean, non-sterile | Same | Substantially equivalent |
| Validated Cleaning | Warm water | Same | Substantially equivalent |
| Validated Disinfection | Thermal water/High level chemical disinfectant | Same | Substantially equivalent |
| Therapy Pressure Range | 4~20 cmH2O | WiZARD 310: 4 | Difference noted, but deemed not to raise new questions of safety/effectiveness. |
| Hose Connection | 22 mm hose | Same | Substantially equivalent |
| CPAP Tubing Connection Point | Port compliance to ISO 5356-1 | Same | Substantially equivalent |
| Swivel Connection | 360 degree rotation | Same | Substantially equivalent |
| Secure and Less-leak Interface | Single layer cushion | Same | Substantially equivalent |
| Operation Range | +5°C to +35°C, 15% to 95% R.H | Same | Substantially equivalent |
| Storage and Transport | -15°C to +60°C, 10% to 90% R.H | Same | Substantially equivalent |
| Noise (dB) | <40dB | <30dB | Improvement noted in subject device. |
| Biocompatibility Test | ISO 10993-1, -5, -10 | ISO 10993-1, -5, -10, -17, -18; ISO 18562-1, -2 | Subject device tested to additional standards. |
Note on Differences: While some differences are noted (Therapy Pressure Range, Noise, Biocompatibility Standards), the overall conclusion is that these "do not affect the substantial equivalence claim... because non-clinical testing demonstrated that the new device has equivalent performance to the predicate device."
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not provided. The document refers to "non-clinical testing" but does not detail sample sizes for any test sets or data provenance (e.g., country, retrospective/prospective nature).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This information is typically relevant for studies involving human interpretation or clinical endpoints. The provided document details a 510(k) submission for a CPAP mask, relying on bench testing and comparison to a predicate device, not expert-adjudicated ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. As above, this is not relevant for the type of submission described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is not an AI/algorithm-based diagnostic device. The submission is for a medical device (CPAP mask).
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an algorithmic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. For this CPAP mask submission, "ground truth" would relate to engineering specifications, performance against standards, and biocompatibility, rather than clinical ground truth like pathology or outcomes data in the context of diagnostic accuracy. The non-clinical tests (biocompatibility, reliability, risk assessment, usability) serve as the evidence base.
8. The sample size for the training set:
- Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established:
- Not applicable. As above, no training set is relevant here.
In summary, the provided FDA 510(k) clearance letter and summary detail a substantial equivalence submission for a CPAP mask. This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device through engineering comparisons and non-clinical testing, rather than through clinical studies with acceptance criteria for diagnostic performance or outcomes data.
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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 (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
| CompanyName/Owner | APEX Medical Corp.No.9, Min Sheng St., Tu-Cheng, New Taipei City,23679, Taiwan |
|---|---|
| Prepared &submitted by | Chieh YangQuality Engineering ManagerTEL: 886-2-2268-5568 #5102FAX: 886-2-2268-9662meow.yang@apexmedicalcorp.com |
| Official Contact | Frank LinManagement RepresentativeAPEX Medical Corp.No.9, Min Sheng St., Tu-Cheng, New Taipei City,23679, TaiwanTEL: 886-2-2268-5568 #5001FAX: 886-2-2268-9662frank.lin@apexmedicalcorp.com |
| ClassificationReference | 21 CFR 868.5905 |
| Product Code | BZD non-continuous ventilator (Class II) |
| Common/UsualName | CPAP Mask |
| Proprietary Name | WIZARD 310/320 Series CPAP Mask |
| Legally MarketedPredicate Device | WIZARD 210/220 Series CPAP Mask (K103174) |
| Reference Device | AirFit F20 (K170924)AirFit N20 (K171212) |
| IntendedUse/Indications for | WIZARD 310/320 series CPAP Mask is intended toprovide 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 WIZARD210/220 Series CPAP Mask(K103174) | Subject DeviceWIZARD 310/320 SeriesCPAP Mask | ||||
|---|---|---|---|---|---|---|
| Principles ofOperation | To provide an interface suchthat airflow from a positivepressure source is directed tothe patient's nostril and mouthand are held in place withadjustable headgear thatstraps 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 forhomeMulti-patient multi-use forhospital | Same as left | ||||
| Patient SupportSystem | 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 DeadSpace | 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 | ||||
| ValidatedCleaning | Warm water | Same as left | ||||
| ValidatedDisinfection | Thermal water/High levelchemical disinfectant | Same as left | ||||
| TherapyPressure Range | 4~20 cmH2O | WIZARD 310: 4 | ||||
| Exhalation holeslocation | On the elbow assembly | On the cushion assembly | ||||
| HoseConnection | 22 mm hose | Same as left | ||||
| CPAP Tubingconnection point | A port compliance to ISO5356-1 is used to connect toCPAP delivery hose | Same as left | ||||
| SwivelConnection | 360 degree rotation | Same as left | ||||
| Secure andLess-leakInterface | 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 |
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| 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 contactside) | 1pc design:- Silicone (face contactside) mounted on PC |
| ForeheadSupport Pad | Silicone rubber | NA |
| Elbow | PC | Same as left |
| ElbowDiaphragm | 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 |
| TubingConnector | PP | Same as left |
| Quick ReleaseButton(Buckle) | POM | Same as left |
| Headgear Strap | PU Foam/Nylon /Neoprene(Color : Dark Grey/Black) | PU Foam/Nylon /Neoprene(Color : Light Grey) |
| Noise (dB) | <40dB | <30dB |
| BiocompatibilityTest | ISO 10993-1ISO 10993-5ISO 10993-10 | ISO 10993-1ISO 10993-5ISO 10993-10 |
| ISO 10993-17 | ||
| ISO 10993-18ISO 18562-1ISO 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
§ 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).