WIZARD 230 NASAL PILOW MASK

K121642 · Apex Medical Corp. · BZD · Jun 6, 2013 · Anesthesiology

Device Facts

• Record ID: K121642
• Device Name: WIZARD 230 NASAL PILOW MASK
• Applicant: Apex Medical Corp.
• Product Code: BZD · Anesthesiology
• Decision Date: Jun 6, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

The WiZARD 230 Nasal Pillow Mask is a non-invasive patient interface for CPAP or bi-level therapy. It directs airflow from a positive pressure source to the patient's nostrils via a nasal pillow cushion. The device consists of a mask frame, cushion, elbow with integrated vent holes for CO2 flushing, and adjustable headgear (straps). It connects to standard air delivery tubing via a quick-release swivel connector. Used in home or hospital settings, the mask is secured to the patient's face by the user or a clinician. The vent holes ensure continuous air leak to minimize CO2 rebreathing. By providing a secure, comfortable seal, the device facilitates effective delivery of prescribed positive airway pressure, supporting treatment for patients with OSA.

Clinical Evidence

Bench testing only. The device underwent performance testing in compliance with ISO 17510-2, including CO2 rebreathing (normal and single fault conditions) and cleaning/disinfection protocols. Biocompatibility of all patient-contacting materials was verified per ISO 10993-1. No clinical data was required or provided.

Technological Characteristics

Materials: molded plastic, PU foam, fabric, nylon. Interface: nasal pillow cushion with frame. Energy: passive (pneumatic). Connectivity: standard conical connectors for air delivery tubing. Sterilization: supplied non-sterile. Standards: ISO 10993-1 (biocompatibility), ISO 17510-2 (performance/safety). Features: integrated vent holes on elbow for CO2 flushing, quick-release tube connector.

Indications for Use

Indicated for adult patients (>30 kg) with obstructive sleep apnea (OSA) requiring CPAP or bi-level positive airway pressure therapy. Contraindicated for use over open wounds prone to infection.

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

• ResMed Swift™ FX Nasal Pillow Mask (K090244)

Submission Summary (Full Text)

{0}------------------------------------------------

K121642

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: [phone]

Fax:[phone]

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<br>to provide an interface for Continuous<br>Positive Airway Pressure (CPAP) or bi-level<br>therapy. This mask is intended for single-<br>patient reuse in the home and multi-patient,<br>multi-use in the hospital environment. This<br>mask only can be used on patients greater<br>than 30 kg for whom positive airway<br>pressure (CPAP or bi-level system) has<br>been prescribed. |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Patient Population : | Adults with OSA |
| Environment of Use : | Hospital, home |
| Contraindications : | The masks should not be placed over open<br>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

Page 9 of 54

{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<br>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.

Page 10 of 54

{2}------------------------------------------------

. .

## SE Comparative Table

,

.

| Features | Predicated Device | Proposed Device |
|---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|
| Trade Name | ResMed Swift™ FX Nasal Pillow<br>Mask | WIZARD 230 Nasal<br>Pillow Mask |
| Indications for Use | The Swift™ FX channels airflow<br>noninvasively to a patient from a<br>positive airway pressure (PAP)<br>device such as a continuous<br>positive airway pressure (CPAP)<br>or bilevel system.<br>The Swift™ FX is:<br>• To be used by adult patients (><br>66 lb/30 kg) for whom positive<br>airway pressure has been<br>prescribed<br>• Intended for single-patient re-<br>use in the home environment<br>and multipatient re-use in the<br>hospital/institutional<br>environment. | Identical |
| Environment of Use | Hospital, home | Same |
| Patient Population | Adult | Identical |
| Single patient,<br>Multi-use | Single patient multi-use | Same |
| Components | Cushion 、Elbow 、Breath Tube、<br>Strap(back/side) | Similar |
| Materials | Silicon 、PC、PP、<br>nylone/neoprene | Similar |
| Comparative<br>Testing for Safety<br>and Efficacy | Compliance to ISO 17510-2 | Same |

.

.

.

{3}------------------------------------------------

#### Summary of Test:

| Attribute | Requirement | Parameter | Result |
|------------------|----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|--------|
| Biocompatibility | All materials used in<br>the construction of<br>the mask shall be<br>compliant with ISO<br>10993-1 | All material which may<br>contact the patient or<br>the clinician must be<br>biocompatible | PASS |
| Performance | Overall performance<br>shall be compliant to<br>ISO17510-2 | Test items described in<br>ISO 17510-2 | PASS |
| Safety | Overall performance<br>shall be compliant to<br>ISO17510-2 | Test items including<br>cleaning/disinfection<br>and CO2 rebreathing<br>(normal and single fault<br>condition) | PASS |
| Shelf Life | Should be compliant<br>to product<br>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 [phone] or [phone] 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 [phone] or [phone] 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

Page 8 of 54

Page 1 of 1