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 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.

AI/ML Overview

The provided document describes the acceptance criteria and the study that proves the WiZARD 230 Nasal Pillow Mask meets these criteria. This is a 510(k) premarket notification for a medical device seeking substantial equivalence to a predicate device.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Attribute	Requirement	Reported Device Performance
Biocompatibility	All materials used in the construction of the mask shall be compliant with ISO 10993-1	PASS (All material which may contact the patient or the clinician must be biocompatible)
Performance	Overall performance shall be compliant to ISO17510-2	PASS (Test items described in ISO 17510-2)
Safety	Overall performance shall be compliant to ISO17510-2	PASS (Test items including cleaning/disinfection and CO2 rebreathing (normal and single fault condition))
Shelf Life	Should be compliant to product specification	PASS (5 years shelf life)

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for the test set or the data provenance (country of origin, retrospective/prospective). The testing appears to be conducted in a laboratory or controlled environment to meet international standards (ISO 10993-1, ISO 17510-2) rather than using patient-specific data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

The document does not mention the use of experts to establish ground truth for a test set. The evaluation seems to be based on compliance with established international standards for medical devices and their materials.

4. Adjudication Method

The document does not describe an adjudication method. The "testing" referred to is compliance testing against ISO standards for performance, safety, and biocompatibility, which typically involves objective measurements and pass/fail criteria rather than expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

There is no indication of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study being performed. This is a device for delivering CPAP therapy, and the evaluation is primarily focused on its physical and functional compliance with safety and performance standards, not on interpretation of medical images or diagnostic accuracy.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This question is not applicable. The WiZARD 230 Nasal Pillow Mask is a physical medical device, not an algorithm or AI system. Its performance is evaluated based on its physical characteristics, material safety, and functional capabilities in delivering airflow, as per ISO standards.

7. Type of Ground Truth Used

The "ground truth" for the acceptance criteria is based on international standards for medical devices:

ISO 10993-1: For biocompatibility of materials.
ISO 17510-2: For the performance and safety of respiratory protective devices.

8. Sample Size for the Training Set

This question is not applicable. As the device is a physical product and not an AI or machine learning model, there is no "training set."

9. How the Ground Truth for the Training Set Was Established

This question is not applicable for the same reason as above.

Summary

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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: +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 intendedto provide an interface for ContinuousPositive Airway Pressure (CPAP) or bi-leveltherapy. This mask is intended for single-patient reuse in the home and multi-patient,multi-use in the hospital environment. Thismask only can be used on patients greaterthan 30 kg for whom positive airwaypressure (CPAP or bi-level system) hasbeen prescribed.
Patient Population :	Adults with OSA
Environment of Use :	Hospital, home
Contraindications :	The masks should not be placed over openwounds that are prone to infection.

Device Description

WiZARD 230 Nasal Pillow Mask is safe when used under the conditions and

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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 Fixedbase

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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. .

SE Comparative Table

Features	Predicated Device	Proposed Device
Trade Name	ResMed Swift™ FX Nasal PillowMask	WIZARD 230 NasalPillow Mask
Indications for Use	The Swift™ FX channels airflownoninvasively to a patient from apositive airway pressure (PAP)device such as a continuouspositive airway pressure (CPAP)or bilevel system.The Swift™ FX is:• To be used by adult patients (>66 lb/30 kg) for whom positiveairway pressure has beenprescribed• Intended for single-patient re-use in the home environmentand multipatient re-use in thehospital/institutionalenvironment.	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
ComparativeTesting for Safetyand Efficacy	Compliance to ISO 17510-2	Same

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Summary of Test:

Attribute	Requirement	Parameter	Result
Biocompatibility	All materials used inthe construction ofthe mask shall becompliant with ISO10993-1	All material which maycontact the patient orthe clinician must bebiocompatible	PASS
Performance	Overall performanceshall be compliant toISO17510-2	Test items described inISO 17510-2	PASS
Safety	Overall performanceshall be compliant toISO17510-2	Test items includingcleaning/disinfectionand CO2 rebreathing(normal and single faultcondition)	PASS
Shelf Life	Should be compliantto productspecification	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. .

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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.

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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

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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:

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
FDA Logo

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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Page 1 of 1

Regulation Number and Section

§ 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).