NASAL MASK, NASAL MASK, FULL FACE MASK

K133009 · BMC Medical Co., Ltd. · BZD · Apr 23, 2014 · Anesthesiology

Device Facts

• Record ID: K133009
• Device Name: NASAL MASK, NASAL MASK, FULL FACE MASK
• Applicant: BMC Medical Co., Ltd.
• Product Code: BZD · Anesthesiology
• Decision Date: Apr 23, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The BMC-NM, BMC-NM2 Nasal Mask and BMC-FM full face mask channel airflow noninvasively to a patient from a positive airway pressure device such as a continuous positive airway pressure (CPAP) or Bi-level system. The BMC-NM, BMC-NM2 Nasal Mask and BMC-FM full face mask are: To be used by adult patients (>66lbs />30kg) for whom positive airway pressure has been prescribed. Intended for single-patient reuse in home environment and multi-patient re-use in the hospital/institutional environment.

Device Story

BMC-NM, BMC-NM2 (nasal) and BMC-FM (full face) masks serve as patient interfaces for non-invasive positive airway pressure (CPAP/bi-level) therapy. Devices consist of hard plastic body, silicone seal, and adjustable headgear; include 22mm entrainment valve elbow for circuit connection. Used in home or hospital settings by adult patients. Masks channel airflow to nose (nasal) or nose/mouth (full face). Seal design allows inflation upon machine activation to minimize strap tension. Healthcare providers prescribe therapy; patients or caregivers manage mask fit. Bench testing confirms performance equivalence to predicates regarding pressure-flow, dead space, and resistance. Devices are non-sterile, reusable, and support thermal/chemical disinfection.

Clinical Evidence

No clinical data provided. Substantial equivalence established via bench testing (ISO 17510-2) including pressure-flow characteristics, dead space (CO2 re-breathing), flow impedance, and disinfection validation (30 cycles).

Technological Characteristics

Materials: Polycarbonate, silicone, nylon/spandex fabric. Design: Nasal or full-face interface with adjustable headgear and 22mm entrainment valve elbow. Connectivity: Standalone interface for CPAP/bi-level systems. Sterilization: Supplied non-sterile; validated for thermal/chemical disinfection. Operating range: 4-30 hPa.

Indications for Use

Indicated for adult patients (>30kg/66lbs) prescribed CPAP or bi-level positive airway pressure therapy. Used in home or hospital/institutional environments. No specific contraindications listed.

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

• ComfortGel (K092835)
• Mirage Activa (K030798)
• Mirage Quattro (K113127)

Submission Summary (Full Text)

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### 510(k) Summary K133009

APR 2 3 2014

# 1. 510(k) Owner's Information:

| Name: | BMC Medical Co., Ltd. |
|-----------------|-------------------------------------------------------------------|
| Address: | Room 110 Tower A Fengyu Building, No. 115 Fucheng Road |
| | Haidian, Beijing 100036, PEOPLE'S REPUBLIC OF CHINA |
| Phone: | 0086-010-51663880-879 |
| Fax: | 0086-010-51663880-810 |
| Contact person: | Jinjing |
| | Date the summary was prepared [807.92(a)(1)]: September. 17, 2013 |

# 2. Applicant Device information:

| Trade name: | BMC-NM Nasal Mask, BMC-NM2 Nasal Mask<br>BMC-FM Full Face Mask |
|----------------------|----------------------------------------------------------------|
| Common name: | Vented Face Mask |
| Name/classification: | Accessory to Non-continuous Ventilator |
| Product code: | BZD |
| Regulation Number: | 21CFR 868.5905 |
| Device Class: | II |

# 3. Predicate Device

# 3.1 Predicate Device of Nasal Mask BMC-NM and BMC-NM2

Product name: ComfortGeI™ (K092835) Manufacturer: RESPIRONICS Mirage ActivaTM (K030798) Manufacturer: Resmed Product name: Product Code: BZD Intended Use:

- Mirage ActivaTM Mask (K030798): .
Mirage ActivaTM mask is an accessory to a non-continuous ventilator (respirator) intended for single-patient use for adult patients prescribed continuous positive airway pressure (CPAP) and bi-level therapy in hospital, clinic, and home environments.

- . ComfortGel™(K092835):

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The ComfortGel Blue 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.

# 3.2 Predicate Device of BMC-FM full face mask

Product name: Mirage Quattro (K113127) Manufacturer: Resmed

Product Code: BZD

# Intended Use:

The Mirage Quattro channels airflow noninvasively to a patient from a positive airway pressure device such as a continuous positive airway pressure (CPAP) or bilevel system.

The Mirage Quattro is to be used by adult patients (>66lbs />30kg) for whom positive airway pressure has been prescribed.

The Mirage Quattro is intended for single patient re-use in the home environment and/or multi-patient reuse in the hospital/ institutional environment.

# 4. Device Description

# 4.1 BMC-NM and BMC-NM2 Nasal Mask

BMC-NM and BMC-NM2 Nasal Masks are interfaces such that airflow from a positive pressure source is directed to the patient's nose. The masks are held in place with adjustable headgear that straps the mask to the face. BMC-NM and BMC-NM2 Nasal Masks have hard plastic body and softer silicone seal that touches the face and include a pad that rests on the forehead. The seal may inflate once the machine is turned on so the straps do not need to be too tight.

The BMC-NM and BMC-NM2 are safe when used under the conditions and purposes intended as indicated in the labeling provided with the product.

The BMC-NM and BMC-NM2 are prescription devices supplied non-sterile.

# 4.2 BMC-FM Full Face Mask

BMC-FM full face mask is interfaces such that airflow from a positive pressure source is directed to the patient's mouth and nose. The masks are held in place with adjustable headgear that straps the mask to the face. BMC-FM Full face Mask has plastic body and softer silicone seal that touches the face and include an adjustable pad that rests on the forehead. The seal may inflate once the machine is turned on so the straps do not need to be too tight.

The BMC-FM is safe when used under the conditions and purposes intended as indicated in the labeling provided with the product.

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The BMC-FM is prescription device supplied non-sterile.

# 5. Statement of intended use

The BMC-NM, BMC-NM2 Nasal Mask and BMC-FM full face mask channel airflow noninvasively to a patient from a positive airway pressure device such as a continuous positive airway pressure (CPAP) or Bi-level system.

The BMC-NM, BMC-NM2 Nasal Mask and BMC-FM full face mask are:

· To be used by adult patients (>661bs />30kg) for whom positive airway pressure has been prescribed.

· Intended for single-patient reuse in home environment and multi-patient re-use in the hospital/institutional environment.

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# Technical Comparison to the predicate device ﻧﺎ

6.1 Comparison table1 (Nasal mask to its predicate device

| Comparison Elements | Applicant Device | | Predicated Device | |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | BMC-NM | BMC-NM2 | ComfortGelTM<br>(K092835) | Mirage ActivaTM (K030798) |
| Device name | Nasal mask | Nasal mask | Nasal mask | Nasal mask |
| Classification name | Accessory to<br>Non-continuous<br>Ventilator | Accessory to<br>Non-continuous<br>Ventilator | Accessory to Non-continuous<br>Ventilator | Accessory to Non-continuous<br>Ventilator |
| Product code | BZD | BZD | BZD | BZD |
| Comparison statement: | The applicant devices are substantially equivalent to the predicate devices. | | | |
| Intended Use | The BMC-NM and BMC-NM2 Nasal Mask<br>channel airflow noninvasively to a patient<br>from a positive airway pressure device such<br>as a continuous positive airway pressure<br>(CPAP) or Bi-level system.<br>The BMC-NM and BMC-NM2 Nasal Mask<br>are:<br>To be used by adult patients (>66lbs /<br>>30kg) for whom positive airway pressure<br>has been prescribed. Intended for single-patient reuse in<br>home environment and multi-patient re-use<br>in the hospital/institutional environment. | | The ComfortGel Blue Nasal Mask<br>is intended to provide an interface<br>for application of CPAP or bi-level<br>therapy to patients. The mask is for<br>single patient use in the home or<br>multi-patient use in the<br>hospital/institutional environment.<br>The mask is to be used by patients<br>(>66lbs/30kg) for whom CPAP or<br>bi-level therapy has been<br>prescribed. | Mirage ActivaTM mask is an<br>accessory to a<br>non-continuous ventilator<br>(respirator) intended for<br>single-patient use for adult<br>patients prescribed<br>continuous positive airway<br>pressure (CPAP) and<br>bi-level therapy in hospital,<br>clinic, and home<br>environments. |
| Indications for use | The BMC-NM and BMC-NM2 Nasal Mask<br>channel airflow noninvasively to a patient | | The ComfortGel Blue Nasal Mask<br>is intended to provide an interface | Mirage ActivaTM mask is an<br>accessory to a |
| | Applicant Device | | Predicated Device | |
| Comparison Elements | BMC-NM | BMC-NM2 | ComfortGel™<br>(K092835) | Nasal Mask<br>Mirage Activa™ (K030798) |
| | from a positive airway pressure device such as a continuous positive airway pressure (CPAP) or Bi-level system. The BMC-NM and BMC-NM2 Nasal Mask are: To be used by adult patients (>66lbs / >30kg) for whom positive airway pressure has been prescribed.Intended for single-patient reuse in home environment and multi-patient re-use in the hospital/institutional environment. | | 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. | non-continuous ventilator (respirator) intended for single-patient use for adult patients prescribed continuous positive airway pressure (CPAP) and bi-level therapy in hospital, clinic, and home environments. |
| Target population | Adult (>66lbs / >30kg) | Adult (>66lbs / >30kg) | Adult (>66lbs/30kg) | Adult |
| Environment of use | home or hospital/institutional environment | home or hospital/institutional environment | home or hospital/institutional environment | hospital/clinic and home environment |
| Patient usage type | Single-patient reuse in home environment and multi-patient re-use in the hospital/institutional environment. | Single-patient reuse in home environment and multi-patient re-use in the hospital/institutional environment. | Single-patient reuse in home environment and multi-patient re-use in the hospital/institutional environment. | Single patient reuse |
| Anatomical site | Nose | Nose | Nose | Nose |
| Provided sterile or non-sterile | Not sterile | Not sterile | Not sterile | Not sterile |
| Comparison Statement | The applicant devices are substantially equivalent to the predicate devices. | | | |
| Design | Nasal interface and headgear | Nasal interface and headgear | Nasal interface and headgear | Nasal interface and headgear |
| Number of mask size | Three-small, medium, and large | Three-small, medium, and large | Three-small, medium, and large | Four-small, medium, large, |
| Comparison Elements | Applicant Device | | Predicated Device | |
| | BMC-NM | BMC-NM2 | ComfortGelTM Nasal<br>(K092835) | Mirage ActivaTM (K030798)<br>large and wide |
| Patient circuit connection | 22mm entrainment valve elbow | 22mm entrainment valve elbow | 22mm entrainment valve elbow | 22mm entrainment valve elbow |
| Comparison Statement | The applicant devices are substantially equivalent to the predicate devices. | | | |
| Therapy Pressure range | 4 to 30 hPa | 4 to 30 hPa | 4 to 30 hPa | 4-20hPa |
| Intentional leak | 4hPa=19L/min<br>12hPa=34/min<br>20hPa=50L/min<br>30hPa=68L/min | 4hPa=20L/min<br>12hPa=40/min<br>20hPa=51L/min<br>30hPa=72L/min | 4hPa=15L/min<br>12hPa=31/min<br>20hPa=34L/min<br>30hPa=46L/min | 4hPa=19L/min<br>12hPa=34L/min<br>20hPa=45L/min |
| Dead space (large size) | 145ml | 135ml | 142.6ml | 145ml |
| Resistance/ Pressure Drop | 0.2 hPa at 50L/min<br>0.7 hPa at 100L/min | 0.2 hPa at 50 L/min<br>0.5 hPa at 100 L/min | 0.1 hPa at 50L/min<br>0.25 hPa at 100L/min. | 0.3 hPa at 50L/min<br>0.9 hPa at 100L/min |
| Operating environment | 5 to 40°C<br>10% to 93% relative humidity, non-condensing | 5 to 40°C<br>relative humidity, non-condensing | 5 to 40°C<br>15% to 95% relative humidity, non-condensing | 5 to 40°C<br>15% to 95% relative humidity, non-condensing |

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| | | Applicant Device | | Predicated Device | | |
|----------------|----------------------|----------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|---------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|---------------------------|
| | Comparison Elements | BMC-NM | BMC-NM2 | ComfortGelTM<br>(K092835) | Nasal Mask | Mirage ActivaTM (K030798) |
| | Storage environment | -20 to +55°C<br>10% to 93% relative humidity, non-condensing | -20 to +60°C<br>up to 95% relative humidity, non-condensing | -20 to +60°C<br>up to 95% relative humidity, non-condensing | | |
| | Comparison Statement | The applicant devices have similar specifications as the predicate devices. | | | | |
| | | Polycarbonate<br>Silicon | Polycarbonate<br>Silicon | Polycarbonate<br>Silicon | | |
| | Main materials | Nylon & spandex Fabric | | GUrethane gel/EVA<br>Urethane film | | "Breathoprene" fabric |
| | | | | UBL, Urethane Foam, and Lycra | | |
| | Comparison Statement | The applicants devices have similar materials with the predicate devices. | | | | |
| Safety element | Performance testing | Tested to determine the pressure-flow characteristic, dead space (CO2 re-breathing), and flow impedance. | | Intentional leak, pressure drop, dead space CO2 rebreathing, dead space testing test. | Tested to determine the pressure-flow characteristic, (CO2 re-breathing), and flow impedance. | |
| | Clinical testing | None clinical testing needed | | None clinical testing needed | | |
| | Human factors | Compliance with FDA guidance | | Compliance with FDA guidance | | |
| | Comparison Statement | The applicant devices are substantially equivalent to the predicate devices. | | | | |
| | Label and Labeling | Compliance with FDA guidance | | Compliance with FDA guidance | | |

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| Comparison Elements | Applicant Device | Predicated Device |
|----------------------|------------------------------------------------------------------------------|---------------------------|
| | BMC-NM | ComfortGelTM<br>(K092835) |
| | BMC-NM2 | Nasal Mask |
| | | Mirage ActivaTM (K030798) |
| Comparison Statement | The applicant devices are substantially equivalent to the predicate devices. | |

# 6.2 Comparison table 2 (Full face mask to Mirage Quattro (K113127)

| Comparison Elements | Applicant Device | Predicated Device |
|-------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device name | BMC-FM | Mirage QuattroTM (K113127) |
| Classification name | Full Face Mask | Full Face Mask |
| Product code | Accessory to Non-continuous Ventilator | Accessory to Non-continuous Ventilator |
| | BZD | BZD |
| Comparison statement: The applicant device is substantially equivalent to the predicate device. | | |
| Intended Use | The BMC-FM full face mask channel airflow<br>noninvasively to a patient from a positive airway<br>pressure device such as a continuous positive<br>airway pressure (CPAP) or Bi-level system.<br>The BMC-FM full face mask are:<br>The full face mask is:<br>To be used by adult patients (>66lbs /<br>>30kg) for whom positive airway<br>pressure has been prescribed.Intended for single-patient reuse in home<br>environment and multi-patient re-use in<br>the hospital/institutional environment. | The Mirage Quattro channels airflow noninvasively<br>to a patient from a positive airway pressure device<br>such as a continuous positive airway pressure (CPAP)<br>or bilevel system.<br>The Mirage Quattro is to be used by adult patients<br>(>66 lb / 30 kg) for whom positive airway pressure has<br>been prescribed.<br>The Mirage Quattro is intended for single-patient<br>re-use in the home environment and multipatient<br>re-use in the hospital/institutional environment. |
| | | |
| Comparison Elements | Applicant Device<br>BMC-FM | Predicated Device<br>Mirage QuattroTM(K113127) |
| Indications for use | The BMC-FM full face mask channels airflow<br>noninvasively to a patient from a positive airway<br>pressure device such as a continuous positive<br>airway pressure (CPAP) or Bi-level system.<br>The BMC-FM full face mask are:<br>The full face mask is:<br>•To be used by adult patients (>66lbs /<br>>30kg) for whom positive airway<br>pressure has been prescribed.<br>• Intended for single-patient reuse in home<br>environment and multi-patient re-use in the<br>hospital/institutional environment. | The Mirage Quattro channels airflow noninvasively to<br>a patient from a positive airway pressure device such<br>as a continuous positive airway pressure (CPAP) or<br>bilevel system.<br>The Mirage Quattro is to be used by adult patients<br>(>66 lb / 30 kg) for whom positive airway pressure has<br>been prescribed.<br>The Mirage Quattro is intended for single-patient<br>re-use in the home environment and multipatient<br>re-use in the hospital/institutional environment. |
| Target population | Adult (>66lbs />30kg) | Adult (>66lbs/30kg) |
| Environment of use | Home environment and the hospital/institutional<br>environment | Home environment and the hospital/institutional<br>environment |
| Patient usage type | single-patient reuse in home environment and<br>multi-patient re-use in the hospital/institutional<br>environment | single-patient re-use in the home<br>environment and multi-patient re-use in the<br>hospital/institutional environment |
| Anatomical site | Nose and mouth | Nose and mouth |
| Provided sterile or non-sterile | Not sterile | Not sterile |
| Comparison Statement | The applicant device is substantially equivalent to the predicate device. | |
| Design | face interface and headgear | face interface and headgear |
| Number of mask size | Three-small, medium, and large | Four -Extra small, small, medium, and large |

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| Port No.: BMC-TF (FDA)-STA | | | |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|
| Comparison Elements | Applicant Device | Predicated Device | |
| Patient circuit connection | BMC-FM<br>22mm entrainment valve elbow | Mirage QuattroTM (K113127)<br>22mm entrainment valve elbow | |
| Comparison Statement | The applicant device is substantially equivalent to the predicate device. | | |
| Therapy Pressure range | 4 to 30 hPa | 4 to 40 hPa | |
| Intentional leak | 4 cm H2O =23 L/min<br>8 cm H2O =33 L/min<br>12 cm H2O =43 L/min<br>16 cm H2O =49 L/min<br>20 cm H2O =54 L/min<br>25 cm H2O =63 L/min<br>30 cm H2O =69 L/min | 4 cm H2O =22 L/min<br>8 cm H2O =32 L/min<br>12 cm H2O =41 L/min<br>16 cm H2O =48 L/min<br>20 cm H2O =54 L/min<br>24cm H2O =60L/min<br>28cm H2O =66L/min<br>32cm H2O =72L/min<br>36cm H2O =72L/min<br>38cm H2O =77L/min<br>40cm H2O =82 L/min | |
| Device Specifications | Dead space (large size) | 246mL | 242 mL |
| | Resistance/ Pressure Drop | at 50L/min: 0.2 cm H2O<br>at 100L/min: 0.3 cm H2O | at 50 L/min: 0.1 cm H2O<br>at 100 L/min: 0.4 cm H2O |
| | Inspiratory and expiratory resistance (with Anti Asphyxia Valve open to atmosphere) | Inspiration at 50 L/min 1.0 cm H2O<br>Expiration at 50 L/min 1.2 cm H2O | Inspiration at 50 L/min 0.8 cm H2O<br>Expiration at 50 L/min 0.8 cm H2O |
| | Operating environment | 5 to 40°C<br>10% to 93 % relative humidity non-condensing | 5°C to 40°C<br>15% to 95% relative humidity non-condensing |

| Report No.: | |
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| | Premarket Notification 510(k) Submission-510(k) Summary<br>Report No.: BMC-TF (FDA)-STA | | | | | |
|-------------------|-----------------------------------------------------------------------------------------|---------------------------------------------------------------------------|----------------------------------------------|---------------------------|--|--|
| | Comparison Elements | | Applicant Device | Predicated Device | | |
| | | | BMC-FM | Mirage QuattroTM(K113127) | | |
| | Storage and<br>environment | -20 to +55°C | -20 to +60°C | | | |
| | | 10% to 93% relative humidity, non-condensing | 10% to 95% relative humidity, non-condensing | | | |
| | Comparison Statement | The applicant device has similar specifications as the predicate device. | | | | |
| | | Polycarbonate | Polycarbonate | | | |
| | | Silicon | Silicon | | | |
| | Materials | Nylon &spandex Fabric | Fabric/Nylon | | | |
| | Comparison Statement | The applicants device has similar materials with the predicate devices. | | | | |
| Safety<br>element | Performance testing | Testing according to ISO 17510-2 | Testing according to ISO 17510-2 | | | |
| | Clinical testing | None clinical testing needed | None clinical testing needed | | | |
| | Comparison Statement | The applicant device is substantially equivalent to the predicate device. | | | | |
| | Label and Labeling | Compliance with FDA guidance | Compliance with FDA guidance | | | |
| | Comparison Statement | The applicant device is substantially equivalent to the predicate device. | | | | |

Premarket Notification 510(k) Submission-510(k) Summary

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