APEX MEDICAL WIZARD SERIES CPAP MASK

K103174 · Apex Medical Corp. · BZD · May 6, 2011 · Anesthesiology

Device Facts

• Record ID: K103174
• Device Name: APEX MEDICAL WIZARD SERIES CPAP MASK
• Applicant: Apex Medical Corp.
• Product Code: BZD · Anesthesiology
• Decision Date: May 6, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended 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.

Device Story

WiZARD 210 (nasal) and 220 (full face) masks serve as patient interfaces for CPAP or bi-level therapy; connect to pressure source via standard 22 mm tubing. Device consists of frame, cushion seal, forehead support, and headgear; includes exhalation vents for CO2 purging and anti-asphyxia valve (on 220). Quick-release mechanism allows rapid removal. Used in home or hospital settings; operated by patients or clinicians. Provides secure, comfortable seal to deliver prescribed airway pressure; benefits patients by facilitating effective treatment of obstructive sleep apnea.

Clinical Evidence

Bench testing only. Compliance with ISO 17510-2 standards for exhaust flow, resistance to flow, anti-asphyxia valve pressure, inspiration/expiration resistance, and noise. Biocompatibility testing per ISO 10993-1. Safety testing included cleaning/disinfection and CO2 rebreathing under normal and single-fault conditions. All tests passed.

Technological Characteristics

Interface for CPAP/bi-level systems; connects via 22 mm tubing. Materials: polycarbonate, silicon, nylon/neoprene. Features: cushion seal, forehead support, exhalation vents, anti-asphyxia valve (220 model), quick-release mechanism. Compliant with ISO 17510-2 for performance and ISO 10993-1 for biocompatibility. Non-sterile.

Indications for Use

Indicated for patients >30 kg requiring CPAP or bi-level positive airway pressure therapy for conditions such as OSA. Intended for single-patient home use or multi-patient hospital use.

Regulatory Classification

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.

Predicate Devices

• Respironics ComfortSelect Nasal CPAP Mask (K000705, K991648)
• Respironics ComfortFull 2 Full Face CPAP Mask (K002465, K961915)

Submission Summary (Full Text)

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# K103174

## 510k Summary

MAY - 6 2011

Date Prepared: March 09, 2011

## General Information

| Official Contact : | Alan Chang<br>Director of Regulatory & Quality Division<br>APEX Medical Corp.<br>9, Min Sheng St., Tu-Cheng, Taipei County ,<br>236, Taiwan, |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| Classification Reference : | 21 CFR 868.5905 |
| Product Code : | BZD-noncontinuous ventilator |
| Common/Usual Name : | CPAP Mask |
| Proprietary Name : | WiZARD 210 Nasal Mask<br>WiZARD 220 Full Face Mask |
| Predicate Device : | Respironics ComfortSelect Nasal CPAP<br>Mask (K000705, K991648)<br>Respironics ComfortFull 2 Full Face CPAP<br>Mask (K002465, K961915) |
| Reason for submission : | New device |

## Intended Use/Indications for use

| Indications for Use : | The WIZARD series mask is intended to<br>provide an interface for Continuous Positive<br>Airway Pressure (CPAP) or bi-level therapy.<br>These masks are intended for single patient<br>reuse in the home and multi-patient,<br>multi-use in the hospital environment. These<br>masks are to be used on patients greater<br>than 30 kg for whom positive airway pressure<br>(CPAP or bi-level system) has been<br>prescribed.<br>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<br>(K000705, K991648) | Nasal Mask |
|---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Indications for Use | The ComfortSelect Nasal<br>Mask is intended to provide<br>an interface for adult<br>patients when used with<br>CPAP or bi-level therapy. | Identical |
| Environment of Use | Hospital, home | Same |
| Patient Population | Adult | Identical |
| Single patient,<br>Multi-use | Single patient multi-use | Same |
| Components | Frame 、cushion、headgear | Same |
| Materials | Polycarbonate、silicon、<br>nylone/neoprene | Same |
| Comparative Testing<br>for Safety and<br>Efficacy | Compliance to ISO 17510-2 | Same |

| Features | Predicated Device | Proposed Device |
|---------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| Trade Name | Respironics ComfortFull 2<br>Full Face CPAP Mask<br>(K002465, K961915) | WIZARD 220 Full<br>Face Mask |
| Indications for Use | The ComfortFull 2 Full Face<br>Mask is intended to provide<br>an interface for adult<br>patients when used with<br>CPAP or bi-level therapy. | Identical |
| Environment of Use | Hospital, home | Same |
| Patient Population | Adult | Identical |
| Single patient,<br>Multi-use | Single patient multi-use | Same |
| Components | Frame, cushion,<br>anti-asphyxia valve,<br>headgear | Same |
| Materials | Polycarbonate, silicon,<br>nylone/neoprene | Same |
| Comparative Testing<br>for Safety and<br>Efficacy | Compliance to ISO 17510-2 | Same |

### Summary of Test:

| Attribute | Requirement | Parameter | Result |
|------------------|----------------------------------------------|---------------------------------------|--------|
| Biocompatibility | All materials used in<br>the construction of | All material which<br>may contact the | PASS |

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| | the mask shall be<br>compliant with ISO<br>10993-1 | patient or the clinician<br>must be<br>biocompatible | |
|-------------|-------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|------|
| Performance | Overall performance<br>shall be compliant to<br>ISO 17510-2 | Test items<br>compliance to ISO<br>17510-2 | PASS |
| Safety | Overall safety shall be<br>compliant to ISO<br>17510-2 | Test items including<br>cleaning/disinfection<br>and CO2 rebreathing<br>(normal and single<br>fault condition) | PASS |
| Shelf Life | Should be compliant<br>to product<br>specification | 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 [phone] or [phone] 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

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10374 510(k) Number: _______________________________________________________________________________________________________________________________________________________________