(367 days)
Not Found
No
The 510(k) summary describes a physical medical device (a nasal pillow mask) and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies focus on physical properties and safety, not algorithmic performance.
Yes
The device is described as an interface for CPAP or bi-level therapy, which are forms of positive airway pressure therapy used to treat conditions like sleep apnea. While the mask itself is not the therapy, it is an essential component that delivers the therapeutic airflow to the patient, making it a critical part of a therapeutic system.
No
This device, a nasal pillow mask, is an interface for providing therapy (CPAP or bi-level therapy), not for diagnosing medical conditions.
No
The device description clearly indicates it is a physical mask with headgear, designed to provide an interface for airflow, which are hardware components.
Based on the provided information, the WiZARD 230 Nasal Pillow Mask is not an IVD (In Vitro Diagnostic) device.
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 airways.
- Device Description: The device description focuses on the physical components and how it delivers airflow to the patient's nostrils.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a disease or condition, or to examine specimens derived from the human body. IVD devices are specifically designed for these purposes.
- Anatomical Site: The anatomical site is the nostril, which is an external interface for delivering air, not for collecting or analyzing biological samples.
IVD devices typically involve analyzing biological samples (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The WiZARD 230 Nasal Pillow Mask is a therapeutic device used to deliver treatment, not to perform diagnostic tests.
N/A
Intended Use / Indications for Use
WiZARD 230 Nasal Pillow Mask is intended to provide an interface for Continuous Positive Airway Pressure (CPAP) or bi-level therapy. This mask is intended for single patient reuse in the home and multi-patient, multi-use in the hospital environment. This mask only can be used on patients greater than 30 kg for whom positive airway pressure (CPAP or bi-level system) has been prescribed.
Product codes (comma separated list FDA assigned to the subject device)
BZD
Device Description
The WiZARD 230 Nasal Pillow Mask provides an interface such that airflow from a positive pressure source is directed to the patient's nostril. The mask is held in place with adjustable headgear that straps the mask to the face.
WiZARD 230 Nasal Pillow Mask is safe when used under the conditions and purposes intended as indicated in the labeling provided with the product.
WiZARD 230 Nasal Pillow Mask is a prescription device supplied nonsterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nostril
Indicated Patient Age Range
Adults with OSA / patients greater than 30 kg
Intended User / Care Setting
Home and hospital environment
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)
| Attribute | Requirement | Parameter | Result |
|---|---|---|---|
| Biocompatibility | All materials used in the construction of the mask shall be compliant with ISO 10993-1 | All material which may contact the patient or the clinician must be biocompatible | PASS |
| Performance | Overall performance shall be compliant to ISO17510-2 | Test items described in ISO 17510-2 | PASS |
| Safety | Overall performance shall be compliant to ISO17510-2 | 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 |
Conclusion: these differences do not affect the safety or effectiveness of the WiZARD 230 Nasal Pillow Mask.
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.
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.
Not Found
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
JUN
6 2013
WiZARD 230 Nasa I Pillow Mask 510(k) Rev.003
2. 510 (K) SUMMARY
Date Prepared: May 31, 2012 (Revised on Jun 4, 2013)
Official Contact Frank Lin
QA Manager
APEX Medical Corp.
No.9, Min Sheng St., Tu-Cheng, New Taipei City , 23679, Taiwan
Tel: +886-2-22685568
Fax:+886-2-22686525
Classification Reference 21 CFR 868.590 Product Code BZD non-continuous ventilator
Common/Usual Name CPAP Mask
Proprietary Name WiZARD 230 Nasal Pillow Mask
ResMed Swift™ FX Nasal Pillow Mask Predicate Device (K090244)
Reason for submission New device
Intended Use/Indications for use
| Indications for Use : | WiZARD 230 Nasal Pillow Mask is intended
to provide an interface for Continuous
Positive Airway Pressure (CPAP) or bi-level
therapy. This mask is intended for single-
patient reuse in the home and multi-patient,
multi-use in the hospital environment. This
mask only can 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 |
| Environment of Use : | Hospital, home |
| Contraindications : | The masks should not be placed over open
wounds that are prone to infection. |
Device Description
The WiZARD 230 Nasal Pillow Mask provides an interface such that airflow from a positive pressure source is directed to the patient's nostril. The mask is held in place with adjustable headgear that straps the mask to the face.
WiZARD 230 Nasal Pillow Mask is safe when used under the conditions and
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1
purposes intended as indicated in the labeling provided with the product.
WiZARD 230 Nasal Pillow Mask is a prescription device supplied nonsterile.
Device Feature
Image /page/1/Picture/5 description: The image shows a diagram of a device with multiple numbered parts. The device includes a main body labeled as '9', with other components attached to it. A hose, labeled '5', connects to the main body via a series of smaller parts, including a connector labeled '4'. The diagram also highlights other parts such as '1', '2', '3', '6', '7', '8', '10', '11', and '12', indicating a detailed breakdown of the device's assembly.
| Accessory | Accessory | ||
|---|---|---|---|
| 1 | Mask Frame | 7 | Quick Release Button |
| 2 | Mask Cushion | 8 | Swivel Hose |
| 3 | Cushion Fixed Base | 9 | Side Strap |
| 4 | Elbow | 10 | Back Strap |
| 5 | Short Tube | 11 | Tube Retainer |
| 6 | Tubing Connector | 12 | Tube Retainer Fixed |
| base |
Technological Characteristics
WiZARD 230 Nasal Pillow Mask provides a secure interface via mask frame and cushion. This mask incorporate vent holes on elbow to provide continuous air leak to flush out and minimize the amount of CO2 rebreathed by the patient. The incorporation of these vent holes does not interfere with the intended performance of the mask.
WiZARD 230 Nasal Pillow Mask connects to an air delivery tube between the mask and the positive pressure source via standard conical connectors. The tube has a quick release structure makes it can easily connect/disconnect from positive pressure source.
Strap of WiZARD 230 Nasal Pillow Mask is constructed by using molded plastic and PU foam/fabric/nylon headgear. All the components are fabricated using materials deemed safe. Tube retain structure includes in strap to keep the air delivery tube at fix position.
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2
. .
SE Comparative Table
,
.
| Features | Predicated Device | Proposed Device |
|---|---|---|
| Trade Name | ResMed Swift™ FX Nasal Pillow | |
| Mask | WIZARD 230 Nasal | |
| Pillow Mask | ||
| Indications for Use | The Swift™ FX channels airflow | |
| noninvasively to a patient from a | ||
| positive airway pressure (PAP) | ||
| device such as a continuous | ||
| positive airway pressure (CPAP) | ||
| or bilevel system. | ||
| The Swift™ FX is: | ||
| • To be used by adult patients (> | ||
| 66 lb/30 kg) for whom positive | ||
| airway pressure has been | ||
| prescribed | ||
| • Intended for single-patient re- | ||
| use in the home environment | ||
| and multipatient re-use in the | ||
| hospital/institutional | ||
| environment. | Identical | |
| Environment of Use | Hospital, home | Same |
| Patient Population | Adult | Identical |
| Single patient, | ||
| Multi-use | Single patient multi-use | Same |
| Components | Cushion 、Elbow 、Breath Tube、 | |
| Strap(back/side) | Similar | |
| Materials | Silicon 、PC、PP、 | |
| nylone/neoprene | Similar | |
| Comparative | ||
| Testing for Safety | ||
| and Efficacy | Compliance to ISO 17510-2 | Same |
.
.
.
3
Summary of Test:
| Attribute | Requirement | Parameter | Result |
|---|---|---|---|
| Biocompatibility | All materials used in | ||
| the construction of | |||
| the mask shall be | |||
| compliant with ISO | |||
| 10993-1 | All material which may | ||
| contact the patient or | |||
| the clinician must be | |||
| biocompatible | PASS | ||
| Performance | Overall performance | ||
| shall be compliant to | |||
| ISO17510-2 | Test items described in | ||
| ISO 17510-2 | PASS | ||
| Safety | Overall performance | ||
| shall be compliant to | |||
| ISO17510-2 | 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 |
Substantial equivalence
This premarket notification section 510(k) shows WiZARD 230 Nasal Pillow Mask substantially equivalent to ResMed Swift™ FX Nasal Pillow Mask.
The characteristics of the WiZARD 230 Nasal Pillow Mask (shown as below) are similar to the predicates device, ResMed Swift™ FX Nasal Pillow Mask. Both masks have the same intended use, environment of use and patient population. Based on verification testing, we conclude that although few minor differences in technological characteristics (e.g. sealing, side strape, mask assembly) of these two masks, but these differences do not affect the safety or effectiveness of the WiZARD 230 Nasal Pillow Mask. .
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with outstretched wings.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 6, 2013
Apex Medical Corporation Mr. Frank Lin Quality Assurance Manager No. 9, Min Sheng Street Tu-Cheng City New Taipei City, Taiwan 23679
Re: K121642
Trade/Device Name: WiZARD 230 Nasal Pillow Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: May 24, 2013 Received: May 28, 2013
Dear Mr. 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 todevices 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.
5
Page 2 – Mr. Lin
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 contact 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. 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.
Image /page/5/Picture/6 description: The image shows a signature above the text "Tejashri Purohit-Sheth, M.D., Clinical Deputy Director, DAGRID, FOR, Sincerely yours". The signature is illegible. The text is likely part of a letter or document.
Kwame Ulmer, M.S. Acting Division Director · Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
1. INDICATIONS FOR USE STATEMENT
Indications for Use
510(k) Number (if known): _ K | 2| 642
Device Name: WiZARD 230 Nasal Pillow Mask
Indications for Use:
WiZARD 230 Nasal Pillow Mask is intended to provide an interface for Continuous Positive Airway Pressure (CPAP) or bi-level therapy. This mask is intended for single-patient reuse in the home and multi-patient, multi-use in the hospital environment. This mask only can be used on patients greater than 30 kg for whom positive airway pressure (CPAP or bi-level system) has been prescribed.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use
(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)
Anya C. Harry
| Digitally signed by | Anya C. Harry |
|---|---|
| DN: | C=US, O=U.S. Government, OU=HHS, OU=FDA, OU=People, CN=Anya C. Harry, 0.9.2342.19200300.100.1.1=0011315590 |
| Date: | 2013.06.05 17:03:18 -04'00' |
(Division Sign-Off) (Division of Anestheslology, General Hospital Infection Control, Dental Devices
510(k) Number: K121642
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