Who is the manufacturer of Skynector CPAP Mask?

Sky Wise Medical Instrument (Shen Zhen) Co., Ltd. filed the 510(k) submission for Skynector CPAP Mask (K150685).

What is the FDA product code for Skynector CPAP Mask?

BZD. It is classified under 21 CFR 868.5905 as a Class 2 device in the Anesthesiology panel.

What is the regulatory pathway for Skynector CPAP Mask?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Skynector CPAP Mask?

Mirage Quattro Full Face Mask (K113127); ComfortGel Nasal Mask (K092835).

Who can help prepare an FDA 510(k) submission like Skynector CPAP Mask?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Skynector CPAP Mask

K150685 · Sky Wise Medical Instrument (Shen Zhen) Co., Ltd. · BZD · Aug 24, 2015 · Anesthesiology

Device Facts

Record ID	K150685
Device Name	Skynector CPAP Mask
Applicant	Sky Wise Medical Instrument (Shen Zhen) Co., Ltd.
Product Code	BZD · Anesthesiology
Decision Date	Aug 24, 2015
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.5905
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Skynector CPAP Mask channels airflow non-invasively to a patient from a positive airway pressure device such as a continuous positive airway pressure (CPAP) or bi-level system. The Skynector CPAP Mask is to be used by adult patients (>66lb />30kg) for whom positive airway pressure has been prescribed. The Skynector CPAP Mask is intended for single patient re-use in the home environment and/or multi-patient reuse in the hospital /institutional environment.

Device Story

Skynector CPAP masks (full-face and nasal models) serve as patient interfaces for CPAP or bi-level ventilation. Devices consist of hard polycarbonate frames and soft silicone cushions/pads, secured by nylon/polyester headgear. Masks channel airflow from a flow generator to the patient's nose and/or mouth. Full-face models include an anti-asphyxia valve and intentional vent holes to minimize CO2 re-breathing. Used in home or hospital settings by patients under prescription. Healthcare providers use the mask to facilitate prescribed pressure therapy; the interface ensures a seal to maintain required pressure levels (4-20 cmH2O). Benefits include non-invasive delivery of respiratory support for sleep apnea or related conditions.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including ISO 17510-2 performance testing (leak rate, pressure drop, anti-asphyxia valve function, CO2 re-breathing, inspiratory/expiratory resistance) and biocompatibility testing (ISO 10993 series).

Technological Characteristics

Materials: Polycarbonate (bracket, swivel, connector, elbow), silicone rubber (cushion, pad, valve), PVC (pick off port), nylon/polyester (headgear). Design: Face interface with headgear. Connectivity: None (mechanical interface). Sterilization: Provided non-sterile. Standards: ISO 5356-1, ISO 10993-3/5/6/10, ISO 17510-2, ASTM D3045-92.

Indications for Use

Indicated for adult patients (>30kg) prescribed positive airway pressure therapy via CPAP or bi-level systems. Used for non-invasive delivery of airflow. Contraindications not specified.

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

Mirage Quattro Full Face Mask (K113127)
ComfortGel Nasal Mask (K092835)

Related Devices

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K060273 — SLEEPNET MOJO FULL FACE MASK -SMALL, MODEL NO. 53835, MEDIUM ,MODEL NO.53836,LARGE,MODEL NO. 53837 · Sleepnet Corporation · May 2, 2006
K251847 — Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask · Sleepnet Corporation · Jan 15, 2026
K070321 — TWILIGHT FULL FACE MASK · Invacare Corp. · Apr 30, 2007
K140580 — REVOLUTION FULLFACE MASK · Respironics Inc. (Dba Philips Respironics) · Jan 16, 2015

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus-like symbol with three human profiles facing right, representing health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 August 24, 2015 Sky Wise Medical Instrument (Shenzhen) Co., Ltd. C/O Field Fu Official Correspondent Shenzen Joyantech Consulting Co., Ltd. 4th Floor, Jinhui Building Nanhai BLVD. Nanshan District Shenzhen, Guang Dong, 518000 CHINA Re: K150685 Trade/Device Name: Skynector CPAP Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator Regulatory Class: Class II Product Code: BZD Dated: July 17, 2015 Received: July 23, 2015 #### Dear Mr. Fu: 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. 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 {1}------------------------------------------------ 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 devicerelated 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 Industry and Consumer Education 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" (21 CFR 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 Industry and Consumer Education 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, *Tejashri Purohit-Sheth, M.D.* Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR Erin I. Keith M.S. Director Division of Anesthesiology, General Hospital. Respiratory. Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K150685 Device Name Skynector CPAP Mask #### Indications for Use (Describe) The Skynector CPAP Mask channels airflow non-invasively to a patient from a positive arway pressure device such as a continuous positive airway pressure (CPAP) or bi-level system. The Skynector CPAP Mask is to be used by adult patients (>661b />30kg) for whom positive airway pressure has been prescribed. The Skynector CPAP Mask is intended for single patient re-use in the home environment and/or multi-patient reuse in the hospital / institutional environment. Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. #### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) {3}------------------------------------------------ This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ # SECTION 05 510(k) Summary This summary of 510(K) safety and effectiveness information is submitted as Required by requirements of SMDA and 21 CFR §807.92. ## 1 Administrative Information | Date of Summary prepared | Feb, 28, 2014 | |--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer information | Company title: Sky Wise Medical Instrument (Shenzhen) Co. Ltd. Company address: No 12 South Ping Xi Road Xinsheng Community, Longgang Street, Longgang District, Shenzhen, Guangdnog, China Phone: +86-755-28491103 Fax: +86-755-28494339 Contact Person: Hu hanhan E-mail: 942526346@qq.com | | Submission Correspondent | Shenzhen Joyantech Consulting Co., Ltd. 4th Floor, Jinhui Building, Nanhai BLVD, Nanshan District, Shenzhen, Guangdong, China. Contact person: Mr. Field.Fu E-Mail: cefda13485@163.com QQ: 670312758 Website: www.cefda.com | | Image: Joyantech logo | | | Establishment registration number | No. | ### 2 Device Information | Type of 510(k) submission: | Traditional | |-------------------------------|---------------------| | Trade Name: | Skynector CPAP Mask | | Model: | FM-02, NM-03 | {5}------------------------------------------------ Version:A/0 | Product: Skynector CPAP Mask | | |------------------------------|--| Ventilator, Non-Continuous (Respirator). Classification name: Anesthesiology Review Panel: BZD Product Code: Device Class: ll 868.5905 Regulation Number: | ### 3 Predicate Device Information | Sponsor: | ResMed Limited; Respironics, Incorporated. | |----------------|----------------------------------------------------------| | Device: | Mirage Quattro Full Face Mask; ComfortGel Nasal Mask. | | 510(K) Number: | K113127, K092835 | ### 4 Device Description The Skynector CPAP masks are designed based on human facial shape and structure, and the operating characteristics during application, they are injection mold of hard PC plastic and soft silicone rubber materials, with high level of air tightness, convenient operation and comfortable to wear, etc. They are used for the interfacing devices that are used to provide users with Continuous Positive Airway Pressure (CPAP) ventilation or biphasic positive airway pressure (BiPAP) ventilation treatment. ### 5 Intended Use The Skynector CPAP Mask channels airflow non-invasively to a patient from a positive airway pressure device such as a continuous positive airway pressure (CPAP) or bi-level system. The Skynector CPAP Mask is to be used by adult patients (>661b />30kg) for whom positive airway pressure has been prescribed. The Skynector CPAP Mask is intended for single patient re-use in the home environment and/or multi-patient reuse in the hospital /institutional environment. ### 6 Indications for Use {6}------------------------------------------------ The Skynector CPAP Mask channels airflow non-invasively to a patient from a positive airway pressure device such as a continuous positive airway pressure (CPAP) or bi-level system. The Skynector CPAP Mask is to be used by adult patients (>661b />30kg) for whom positive airway pressure has been prescribed. The Skynector CPAP Mask is intended for single patient re-use in the home environment and/or multi-patient reuse in the hospital /institutional environment. # 7 Technological characteristics of the proposed device compared to the predicate device The proposed device and the Predicate device have the same intended use, design principle, and similar material composition. The differences don't impact safety and effectiveness of the device. The proposed device is substantially equivalent to the predicate devices. The compared details are listed in tables below: | | Subject Device: | Predicate Device: | Remarks: | | |---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Device: Skynector CPAP Full-face Mask Manufacturer: Sky Wise Medical Instrument(Shenzhen) Co.,Ltd. | Device: Mirage Quattro Full FaceMask Manufacturer: ResMed LTD. | | | | | 510(k) Number: To be determined | 510(k) Number: K113127 | | | | Intended Use | The Skynector CPAP Mask channels airflow non- invasively to a patient from a positive airway pressure device such as a continuous positive airway pressure (CPAP) or bi-level system. The Skynector CPAP Mask is to be used by adult patients (>66lb / >30kg) for whom positive airway pressure has been prescribed. | The Mirage Quattro channels airflow non-invasively to a patient from a positive airway pressure device such as a continuous positive airway pressure (CPAP) or bi-level system. The Mirage Quattro is to be used by adult patients (>30 kg) for whom positive airway pressure has been prescribed. | Both masks are noninvasive and the meanings of intended use are same. | | | | Subject Device: | Predicate Device: | Remarks: | | | | intended for single patient re- use in the home environment and/or multi-patient reuse in the hospital /institutional environment. | single-patient re-use in the home environment and multi-patient re-use in the hospital/institutional environment. | | | | Patient Population | Patients(>30 kg) | Patients > 66 lbs/30 kg | Same | | | Environment of use | Home or Hospital/institutional Environment | Home or Hospital/institutional Environment | Same | | | Product Code | BZD | BZD | Same | | | Provided Sterile or Non-Sterile | Provided Non-Sterile | Provided Non-Sterile | Same | | | Patient Usage Type | Single Patient Use in the home or multi-patient use in the hospital/institutional environment. | Single Patient Use in the home or multi-patient use in the hospital/institutional environment. | Same | | | Design | Face interface and headgear | Face interface and headgear | Same | | | Material | FM-02: bracket, swivel, connector, elbow: Polycarbonate; forehead pad, cushion, valve: Silicone Rubber; pick off port: Polyvinylchloride; faceplate: Polypropylene; headgear: nylon, polyester. FM-03: bracket, faceplate, swivel, connector, support arm assembly, elbow: Polycarbonate: forehead pad, cushion, valve: Silicone Rubber; pick off port: Polyvinylchloride; headgear: nylon, polyester. FM-05: | Moulded plastic and silicone components and fabric / nylon headgear. | All the materials composed the Skynector CPAP masks were evaluated per ISO 10993- 1. Based on the testing performed, the differences will not affect the safety or effectiveness of the device. | | | | Subject Device: | Predicate Device: | Remarks: | | | | bracket, faceplate, swivel, connector, support arm assembly, cushion clip, elbow: Polycarbonate; forehead pad, cushion, valve: Silicone Rubber; pick off port: Polyvinylchloride; headgear: nylon, polyester. | | | | | Number of Pick off ports: | One | Two | The design difference will not affect the safety or effectiveness of the device. | | | Shape and size of faceplate | The shape of the faceplate follows the contours of the face allowing clearance of facial features, covering the mouth and nose for therapy. The faceplate attaches to a silicone cushion via a retaining ring. | The shape of the faceplate and cushion clip offered in various sizes to ensure adequate fit over the extended patient population. | The design difference will not affect the safety or effectiveness of the device. | | | Shape and size of cushion | The cushions of the FM-02 and FM-05 are made of single layer silicone with damping groove to increase the comfort. The cushion of the FM-03 is made of double layer silicone to increase the comfortable fit. | The previously cleared mask provides characteristics seal via silicone interface. The previously cleared mask offered in various sizes to ensure adequate fit over the extended patient population. | Base on the testing of leakage, the design modification will not affects the safety or effectiveness of the device. | | | Safety Valve | Contain an anti-asphyxia valve (AAV) to enable the patient to breathe fresh air in the event that airflow from the flow generator is impeded. | Contain an anti-asphyxia valve (AAV) to enable the patient to breathe fresh air in the event that airflow from the flow generator is impeded. | Same | | | Exhalation device | No accessory exhalation device is required. The full- face masks incorporate intentional vent holes to | No accessory exhalation device is required. The masks incorporate vents to provide continuous air flow to flush out and minimize the amount of CO2 | Same | | | | Subject Device: | Predicate Device: | Remarks: | | | | reduce carbon dioxide re- breathing. | re-breathed by the patient. | | | | Anatomical Sites | Mouth and nose | Mouth and nose | Same | | | Patient Circuit Connection | 22 mm entrainment valve elbow | 22 mm entrainment valve elbow | Same | | | Pressure Range | 4-20 cmH2O | 4-40 cmH2O | Verification testing of the modified device did not raise any new questions of safety and efficacy. | | | Number of Mask Sizes | FM-02: Three- small, medium, and large FM-03: Three- small, medium, and large FM-05: Three- small, medium, and large | Four- extra small, small, medium, and large | The difference will not affect its function and effectiveness. | | | Mask Deadspace | size | FM-02 Full- face mask | Mirage Quattro Full Face Mask | The dead space is calculated by the identical methods. The dead space has no pass/fail criteria, reportable value only. It appears a little larger than the predicate device, but it will not affect its function and effectiveness. | | | L | 358 | 242 | | | | M | 311 | No information available | | | | S | 280 | No information available | | ### Table 1: Device Comparison Table to K113127 {7}------------------------------------------------ Product: Skynector CPAP Mask {8}------------------------------------------------ SEC_005:001_510K Summary Product: Skynector CPAP Mask {9}------------------------------------------------ Product: Skynector CPAP Mask {10}------------------------------------------------ | Version:A/0 | |-------------| | | | | Subject Device: | | Predicate Device: | Remarks: | | | |--------------------------------|----------------------------------|--------|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Leak rate | | | | This leak rate is provided for the healthcare professional to determine if it is compatible with CPAP or bi- level therapy device. It appears the leak rates of CPAP mask is similar with the Mirage Quattro Full Face Mask, leak rate increases stably when air pressure increases. | | | | Pressure Drop | Specifications and models | | Flow (L/min) | Drop in Pressure (cmH2O) | Mirage Quattro Full Face Mask | drop is measured by the same test configuration. It appears the pressure drop of the CPAP Full- face mask is a little larger than | | | Full-Face mask | FM-02L | 100L/min | 1.5 | 50L/min | face mask is a little larger than | | | | FM-02M | 50L/min | 0.5 | 0.1cmH2O | the Mirage Quattro Full | | | | FM-02S | 50L/min | 0.5 | 0.4cmH2O | Face Mask. The pressure | | Valve Open to Atmosphere | FM-02 Full-Face mask:0.5cmH2O | | | | Mirage Quattro Full Face Mask:1.1cmH2O | drop is nominal and it will not affect its function and effectiveness. The valve will fully open to atmosphere when the mask pressure reaches the opening | {11}------------------------------------------------ ## SEC_005:001_510K Summary Product: Skynector CPAP Mask Version:A/0 | | Subject Device: | Predicate Device: | Remarks: | |---------------------------------|----------------------------------|-------------------------------------------|-------------------------------------------------------------------------------------------------------------| | | | | pressure and remains fully open as the patient inhales and exhales. | | Valve Close to Atmosphere | FM-02 Full-Face mask:0.8cmH2O | Mirage Quattro Full Face Mask:1.6cmH2O | The valve will fully close to atmosphere when the activation pressure is met or exceeded. | ### Table 2: Device Comparison Table to K092835 | Table 2: Device Comparison Table to K092835 | | | | |---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------| | | Subject Device: | Predicate Device: | Remarks: | | | Device: Skynector CPAP Nasal Mask Manufacturer: Sky Wise Medical Instrument(Shenzhen) Co.,Ltd. 510(k) Number: To be determined | Device: ComfortGel Nasal Mask Manufacturer: Respironics, Inc. 510(k) Number: K092835 | | | Intended Use | The reusable CPAP masks with headgear are intended for use as patient interface for a CPAP or bi-level system by adult patients(>30 kg) for whom CPAP or bi-level therapy has been prescribed. The nasal mask covers the nose, and it is to be for single- patient re-use in the home and multi-patient re-use in the hospital/institutional environment. | The ComfortGel Nasal Mask is intended to provide an interface for application of CPAP or bi-level therapy to patients. The mask is for single patient use in the home or multi-patient use in the hospital/institutional environment. The mask is to be used by patients (>66lbs/30kg) for whom CPAP or bi-level therapy has been prescribed using a CPAP or bi-level system. | Both masks are noninvasive and the meanings of intended use are same. | | Patient Population | Patients(>30 kg) | Patients > 66 lbs/30 kg | Same | | Environment of use | Home or Hospital/institutional Environment | Home or Hospital/institutional Environment | Same | | Product Code | BZD | BZD | Same | {12}------------------------------------------------ SEC_005:001_510K Summary Product: Skynector CPAP Mask | | Subject Device: | Predicate Device: | Remarks: | |---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Provided Sterile or Non-Sterile | Provided Non-Sterile | Provided Non-Sterile | Same | | Patient Usage Type | Single Patient Use in the home or multi-patient use in the hospital/institutional environment. | Single Patient Use in the home or multi-patient use in the hospital/institutional environment. | Same | | Design | Nasal interface and headgear | Nasal interface and headgear | Same | | Material | NM-01 : bracket, faceplate, swivel, support arm assembly, quick clip, elbow: Polycarbonate; forehead pad, cushion: Silicone Rubber; headgear: nylon, polyester; pick off port: Polyvinylchloride. NM-03: bracket, faceplate, swivel, support arm assembly, cushion clip, elbow: Polycarbonate; forehead pad, cushion: Silicone Rubber; headgear: nylon, polyester; pick off port: Polyvinylchloride. | Faceplate: Polycarbonate Face seal: Gel cushion with polyester overlay Cushion Flap: Silicone Exhalation Elbow: Polycarbonate Exhalation Port: Delrin Forehead Pad: Silicone Headgear: UBL, Urethane Foam, and Lycra | All the materials composed the Skynector CPAP masks were evaluated per ISO 10993-1. Based on the testing performed, the modification will not affect the safety or effectiveness of the device. | | Number of Pick off ports: | One | None | The design difference will not affect the safety or effectiveness of the device. | | Shape and size of faceplate | The shape of the faceplate follows the contours of the face allowing clearance of facial features, covering the nose only for therapy. The faceplate attaches to a silicone cushion via a retaining ring. | The shape of the faceplate follows the contours of the face allowing clearance of facial features, covering the nose only for therapy. The faceplate attaches to a silicone sealing flap via a retaining ring. | Same | {13}------------------------------------------------ SEC_005:001_510K Summary Product: Skynector CPAP Mask | | Subject Device: | Predicate Device: | Remarks: | | | |----------------------------------|-----------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|--|-------------------------------------------------------------------------------------------------------------| | Shape and size of cushion | The cushions of the NM-01 and NM-03 are made of double layer silicone to increase the comfortable fit. | Gel cushion to allow for a more comfortable fit and improved mask performance (fewer leaks). | The materials of cushion are different. The design modification will not affect the safety or effectiveness of the device. | | | | Safety Valve | N/A- nasal mask | N/A- nasal mask | Same | | | | Exhalation device | No accessory exhalation device is required. An exhalation vent is integrated. | No accessory exhalation device is required. 54 pin holes exhalation ports are integrated. | Based on the testing performed, the design difference will not affect the safety or effectiveness of the device. | | | | Anatomical Sites | Nose | Nose | Same | | | | Patient Circuit Connection | 22 mm exhalation elbow | 22 mm exhalation elbow | Same | | | | Pressure Range | 4-20 cmH2O | 4-30 cmH2O | Verification testing of the modified device did not raise any new questions of safety and efficacy. | | | | Number of Mask Sizes | NM-01: Four- petite, small, medium, and large; NM-03: Three- small, medium, and large. | Four- petite, small, medium, and large | The difference will not affect its function and effectiveness. | | | | Mask Dea…

Skynector CPAP Mask

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Related Devices

Submission Summary (Full Text)

Panel 1

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Skynector CPAP Mask

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

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Submission Summary (Full Text)

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