(191 days)
WiZARD 210/220 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.
WiZARD series mask consists of a frame with a cushion seal on the face. Different height forehead support pad are offer to user allow fitting forehead better. Series of vents are feature on the elbow 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. There is no whistling or whooshing sound from the exhalation vent and no jet of air blowing on the bed partner. WiZARD serous mask is 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 provided 510(k) summary for the WiZARD 210/220 Series CPAP Mask is for a medical device that does not involve AI. Therefore, many of the requested categories related to AI models and their evaluation (such as sample sizes for test/training sets, ground truth establishment methods, number/qualifications of experts, adjudication, MRMC studies, and standalone performance) are not applicable.
The submission focuses on demonstrating substantial equivalence to predicate devices through compliance with established international standards for non-continuous ventilators.
Here's a breakdown of the available information based on your request:
1. Acceptance Criteria and Reported Device Performance
| Attribute | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | All materials used in the construction of the mask shall be compliant with ISO 10993-1. | PASS |
| Performance | Overall performance shall be compliant to ISO 17510-2. (Specifically for Exhaust Flow, Resistance to Flow, Anti-asphyxia Valve Pressure, Inspiration Resistance, Expiration Resistance, Noise) | PASS |
| Safety | Overall safety shall be compliant to ISO 17510-2. (Including cleaning/disinfection and CO2 rebreathing under normal and single fault conditions) | PASS |
| Shelf Life | Should be compliant to product specification. | PASS (5 years) |
2. Sample size used for the test set and the data provenance
Not applicable. The "test set" in this context refers to physical testing performed on the device to ensure compliance with specified standards, not a data-based test set for an algorithm. The 510(k) summary does not specify the number of units tested for each criterion.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device does not involve expert-labeled ground truth as it is a physical medical device, not an AI/ML system. The "ground truth" for the performance and safety criteria is defined by the requirements of the ISO standards themselves.
4. Adjudication method for the test set
Not applicable. As this is not an AI/ML system, there is no adjudication process for conflicting interpretations of data. Compliance is assessed against objective engineering and safety standards.
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
Not applicable. This is a physical medical device (CPAP mask) and does not involve AI or human "readers" interacting with an AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device does not include an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the device's performance and safety is defined by compliance with international standards: ISO 10993-1 for biocompatibility and ISO 17510-2 for performance and safety. These standards specify objective measurement methods and acceptable limits.
8. The sample size for the training set
Not applicable. No training set is involved as this is not an AI/ML system.
9. How the ground truth for the training set was established
Not applicable. No training set is involved.
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K103174
510k Summary
MAY - 6 2011
Date Prepared: March 09, 2011
General Information
| Official Contact : | Alan ChangDirector of Regulatory & Quality DivisionAPEX Medical Corp.9, Min Sheng St., Tu-Cheng, Taipei County ,236, Taiwan, |
|---|---|
| Classification Reference : | 21 CFR 868.5905 |
| Product Code : | BZD-noncontinuous ventilator |
| Common/Usual Name : | CPAP Mask |
| Proprietary Name : | WiZARD 210 Nasal MaskWiZARD 220 Full Face Mask |
| Predicate Device : | Respironics ComfortSelect Nasal CPAPMask (K000705, K991648)Respironics ComfortFull 2 Full Face CPAPMask (K002465, K961915) |
| Reason for submission : | New device |
Intended Use/Indications for use
| Indications for Use : | The WIZARD series mask is intended toprovide an interface for Continuous PositiveAirway Pressure (CPAP) or bi-level therapy.These masks are intended for single patientreuse in the home and multi-patient,multi-use in the hospital environment. Thesemasks are to be used on patients greaterthan 30 kg for whom positive airway pressure(CPAP or bi-level system) has beenprescribed.Adults with OSA |
|---|---|
| ----------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
Patient Population :
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Hospital, home
Environment of Use :
The masks will not remain sterile between Contraindications : repeated single-patient uses and should not be placed over open
Device Description
WiZARD series mask consists of a frame with a cushion seal on the face. Different height forehead support pad are offer to user allow fitting forehead better. Series of vents are feature on the elbow 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. There is no whistling or whooshing sound from the exhalation vent and no jet of air blowing on the bed partner. WiZARD serous mask is 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
Device Feature
Wizard 210 Nasal Mask
Image /page/1/Picture/7 description: The image shows an exploded diagram of a device with multiple parts labeled with numbers. Parts 1 through 5 are located on the right side of the image, while parts 8 through 10 are on the left. Part 11 is located at the bottom of the image.
Wizard 220 Full Face Mask
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Image /page/2/Picture/0 description: The image shows a diagram of a mask with various numbered parts. Part 1 is a small clip, while part 2 is the mask's seal. The frame of the mask is labeled as part 3, and another clip is labeled as part 4. Parts 5 through 10 appear to be components of a tube, and part 11 is a strap.
Constitute accessories
| 1 | Forehead Support Pad | 2 | Cushion | 3 | Plastic Frame |
|---|---|---|---|---|---|
| 4 | Buckle | 5 | Elbow | 6 | Port Cap |
| 7 | Anti-asphyxia valve | 8 | Swivel hose | 9 | Silicon Tubing |
| 10 | Silicon Tubing Connector | 11 | Headgear |
Technological Characteristics
The WiZARD series mask not only provides a comfortable and secure interface on the patient's face, it also offer a reliable mechanism of connection to a CPAP or bi-level positive air pressure source for the treatment of Obstructive Sleep Apnea. WiZARD series mask is connected to the CPAP or bi-level system standard 22 mm breathing tube via swivel hose, silicon tubing and silicon tubing connector.
Performance properties are described as below;
| Exhaust Flow | Compliance to ISO 17510-2 |
|---|---|
| Resistance to Flow | Compliance to ISO 17510-2 |
| Anti-asphyxia Valve Pressure | Compliance to ISO 17510-2 |
| Inspiration Resistance | Compliance to ISO 17510-2 |
| Expiration Resistance | Compliance to ISO 17510-2 |
| Noise | Compliance to ISO 17510-2 |
SE Comparative Table
| Features | Predicated Device | Proposed Device |
|---|---|---|
| Trade Name | Respironics ComfortSelect | WiZARD 210 |
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| Nasal CPAP Mask(K000705, K991648) | Nasal Mask | |
|---|---|---|
| Indications for Use | The ComfortSelect NasalMask is intended to providean interface for adultpatients when used withCPAP or bi-level therapy. | Identical |
| Environment of Use | Hospital, home | Same |
| Patient Population | Adult | Identical |
| Single patient,Multi-use | Single patient multi-use | Same |
| Components | Frame 、cushion、headgear | Same |
| Materials | Polycarbonate、silicon、nylone/neoprene | Same |
| Comparative Testingfor Safety andEfficacy | Compliance to ISO 17510-2 | Same |
| Features | Predicated Device | Proposed Device |
|---|---|---|
| Trade Name | Respironics ComfortFull 2Full Face CPAP Mask(K002465, K961915) | WIZARD 220 FullFace Mask |
| Indications for Use | The ComfortFull 2 Full FaceMask is intended to providean interface for adultpatients when used withCPAP or bi-level therapy. | Identical |
| Environment of Use | Hospital, home | Same |
| Patient Population | Adult | Identical |
| Single patient,Multi-use | Single patient multi-use | Same |
| Components | Frame, cushion,anti-asphyxia valve,headgear | Same |
| Materials | Polycarbonate, silicon,nylone/neoprene | Same |
| Comparative Testingfor Safety andEfficacy | Compliance to ISO 17510-2 | Same |
Summary of Test:
| Attribute | Requirement | Parameter | Result |
|---|---|---|---|
| Biocompatibility | All materials used inthe construction of | All material whichmay contact the | PASS |
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| the mask shall becompliant with ISO10993-1 | patient or the clinicianmust bebiocompatible | ||
|---|---|---|---|
| Performance | Overall performanceshall be compliant toISO 17510-2 | Test itemscompliance to ISO17510-2 | PASS |
| Safety | Overall safety shall becompliant to ISO17510-2 | Test items includingcleaning/disinfectionand CO2 rebreathing(normal and singlefault condition) | PASS |
| Shelf Life | Should be compliantto productspecification | 5 years shelf life | PASS |
:
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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or feathers. The bird is positioned to the right of a circular text element. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" and is arranged around the circumference of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAY - 6 2011
Mr. Alan Chang Director of Regulatory & Quality Division APEX Medical Corporation 9, Min Sheng St. Tu-Cheng, Taipei Country, 236 Taiwan
Re: K103174
Trade/Device Name: Wizard 210/220 Series CPAP Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: April 29. 2011 Received: May 2, 2011
Dear Mr. Chang:
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. 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.
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Page 2- Mr. Chang
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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices m/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
h foo
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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1. INDICATIONS FOR USE STATEMENT
Indications for Use
510(k) Number (if known): Device Name: Wizard 210/220 series CPAP Mask Indications for Use:
WiZARD 210/220 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.
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 807 Subpart C)
(Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
L. Schull
(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page 1 of 1
10374 510(k) Number: _______________________________________________________________________________________________________________________________________________________________
§ 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).