(191 days)
Not Found
No
The description focuses on the physical components and function of a CPAP mask, with no mention of software, algorithms, or data processing that would indicate AI/ML. The performance studies are related to material biocompatibility, general performance standards, and safety, not algorithmic performance.
No
A CPAP mask acts as an interface for CPAP or bi-level therapy, which are forms of continuous positive airway pressure. While the therapy itself is therapeutic, the mask merely facilitates the delivery of the therapy, connecting the patient to the CPAP or bi-level system.
No
The device is a CPAP mask, which is used for therapeutic purposes (delivering positive airway pressure), not for diagnosing medical conditions.
No
The device description clearly outlines physical components like a frame, cushion seal, forehead support pad, vents, and a quick-release mechanism. The performance studies focus on biocompatibility, overall performance (likely related to airflow and fit), safety (including cleaning/disinfection and CO2 rebreathing), and shelf life, all of which are characteristic of a physical medical device. There is no mention of software as a component or its function.
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 CPAP or bi-level therapy, which is a treatment for respiratory conditions. This involves delivering air pressure to the patient's airway.
- Device Description: The description details a mask that fits on the face and connects to a CPAP machine. It describes physical components and their function in delivering air and managing exhaled breath.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to obtain information about a physiological state, health, or disease. IVDs are typically used for diagnosis, monitoring, or screening based on analysis of biological samples.
The device described is a medical device used for therapy, specifically respiratory support, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The WIZARD series 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. Adults with OSA.
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.
Product codes
BZD
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Face
Indicated Patient Age Range
Patients greater than 30 kg, Adult
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)
Biocompatibility: Requirement: All materials used in the construction of the mask shall be compliant with ISO 10993-1. Parameter: All material which may contact the patient or the clinician must be biocompatible. Result: PASS.
Performance: Requirement: Overall performance shall be compliant to ISO 17510-2. Parameter: Test items compliance to ISO 17510-2. Result: PASS.
Safety: Requirement: Overall safety shall be compliant to ISO 17510-2. Parameter: Test items including cleaning/disinfection and CO2 rebreathing (normal and single fault condition). Result: PASS.
Shelf Life: Requirement: Should be compliant to product specification. Parameter: 5 years shelf life. Result: PASS.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K000705, K991648, K002465, K961915
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K103174
510k Summary
MAY - 6 2011
Date Prepared: March 09, 2011
General Information
| Official Contact : | Alan Chang
Director of Regulatory & Quality Division
APEX 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 Mask
WiZARD 220 Full Face Mask |
| Predicate Device : | Respironics ComfortSelect Nasal CPAP
Mask (K000705, K991648)
Respironics ComfortFull 2 Full Face CPAP
Mask (K002465, K961915) |
| Reason for submission : | New device |
Intended Use/Indications for use
| Indications for Use : | The WIZARD series 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.
Adults with OSA |
| ----------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
Patient Population :
1
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
2
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 |
3
| | Nasal CPAP Mask
(K000705, K991648) | Nasal Mask |
|---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Indications for Use | The ComfortSelect Nasal
Mask is intended to provide
an interface for adult
patients when used with
CPAP 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 Testing
for Safety and
Efficacy | Compliance to ISO 17510-2 | Same |
| Features | Predicated Device | Proposed Device |
|---|---|---|
| Trade Name | Respironics ComfortFull 2 | |
| Full Face CPAP Mask | ||
| (K002465, K961915) | WIZARD 220 Full | |
| Face Mask | ||
| Indications for Use | The ComfortFull 2 Full Face | |
| Mask is intended to provide | ||
| an interface for adult | ||
| patients when used with | ||
| CPAP 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 Testing | ||
| for Safety and | ||
| Efficacy | Compliance to ISO 17510-2 | Same |
Summary of Test:
| Attribute | Requirement | Parameter | Result |
|---|---|---|---|
| Biocompatibility | All materials used in | ||
| the construction of | All material which | ||
| may contact the | PASS |
4
| | the mask shall be
compliant with ISO
10993-1 | patient or the clinician
must be
biocompatible | |
|-------------|-------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|------|
| Performance | Overall performance
shall be compliant to
ISO 17510-2 | Test items
compliance to ISO
17510-2 | PASS |
| Safety | Overall safety shall be
compliant to ISO
17510-2 | Test items including
cleaning/disinfection
and CO2 rebreathing
(normal and single
fault condition) | PASS |
| Shelf Life | Should be compliant
to product
specification | 5 years shelf life | PASS |
:
:
5
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.
6
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
7
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: _______________________________________________________________________________________________________________________________________________________________