Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2)

K163464 · Bmc Medical., Ltd. · BZD · Sep 5, 2017 · Anesthesiology

Device Facts

• Record ID: K163464
• Device Name: Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2)
• Applicant: Bmc Medical., Ltd.
• Product Code: BZD · Anesthesiology
• Decision Date: Sep 5, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Viva Nasal Mask channels airflow noninvasively to a patient from a positive airway pressure device such as a continuous positive airway pressure (CPAP) or bi-level system. The Viva Nasal Mask is: To be used by adult patients (>66lbs />30kg) for whom positive airway pressure has been prescribed. Intended for single-patient reuse. The Numa Full Face Mask channels airflow noninvasively to a patient from a positive airway pressure device such as a continuous positive airway pressure (CPAP) or Bi-level system. The Numa Full Face Mask is: To be used by adult patients (>66lbs />30kg) for whom positive airway pressure has been prescribed. Intended for single-patient reuse.

Device Story

Viva Nasal Mask and Numa Full Face Mask serve as patient interfaces for positive airway pressure (CPAP/bi-level) therapy; devices channel airflow to patient's nose (Viva) or nose and mouth (Numa). Masks consist of plastic body, silicone seal, and adjustable headgear; include 22mm entrainment valve elbow for circuit connection. Used in home environments by adult patients; operated by patient. Output is delivery of prescribed pressurized air; device design facilitates CO2 exhalation via passive port and provides anti-asphyxia functionality if airflow is impeded. Clinical benefit includes noninvasive delivery of respiratory therapy for prescribed conditions. No software or electronic components; purely mechanical interface.

Clinical Evidence

No clinical data. Bench testing only, including passive exhalation port flow, resistance to flow, anti-asphyxia valve performance, dead space, CO2 rebreathing, mechanical integrity, and environmental stress testing (temperature/humidity/transportation) per ISO 17510-2.

Technological Characteristics

Materials: Polycarbonate, silicone, nylon, spandex, polypropylene. Interface: Nasal (Viva) or full-face (Numa) mask with headgear. Connection: 22mm entrainment valve elbow. Non-sterile. Mechanical design; no energy source or software.

Indications for Use

Indicated for adult patients (>30kg) prescribed positive airway pressure therapy (CPAP or bi-level) via noninvasive nasal (Viva) or full-face (Numa) mask interface.

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

• BMC-NM2 Nasal Mask (K133009)
• Quattro™ Air (K123979)

Reference Devices

• BMC Willow Mask (K112277)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 5, 2017

BMC Medical.,Ltd. % Alex Lucio Executive Vice President 3B Medical Inc. 799 Overlook Drive. Winter Haven, F1 33884

Re: K163464

Trade/Device Name: Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2) Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: Class II Product Code: BZD Dated: July 19, 2017 Received: July 24, 2017

Dear Alex Lucio:

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 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

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the quality systems (OS) 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 [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" (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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

# Michael J. Ryan -S

for Lori A. Wiggins, MPT, CLT Acting 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

#### Indications for Use

510(k) Number (if known) K163464

#### Device Name

Viva Nasal Mask (Model: NM4) Numa Full Face Mask (Model: BMC-FM2)

Indications for Use (Describe)

The Viva Nasal Mask channels airflow noninvasively to a patient from a positive airway pressure device such as a continuous positive airway pressure (CPAP) or bi-level system.

The Viva Nasal Mask is:

[]To be used by adult patients (>661bs />30kg) for whom positive airway pressure has been prescribed. □Intended for single-patient reuse.

The Numa Full Face Mask channels airflow noninvasively to a patient from a positive airway pressure device such as a continuous positive airway pressure (CPAP) or Bi-level system.

The Numa Full Face Mask is:

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

□ Intended for single-patient reuse.

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)

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# 510(k) Summary

## 510(k) Owner:

| Name: | BMC Medical Co., Ltd. |
|------------------|-----------------------------------------------------------------------------------------------------------------|
| Address: | Room 110 Tower A Fengyu Building, No. 115<br>Fucheng Road Haidian, Beijing100036,<br>PEOPLE'S REPUBLIC OF CHINA |
| Phone: | 0086-010-51663880-705 |
| Fax: | 0086-010-51663880-810 |
| Contact Person: | Jiang Huiqi |
| Submission Date: | November 15, 2016 |

## Submission Correspondent:

| Name: | Alex Lucio<br>Executive Vice President |
|----------|------------------------------------------------------------------|
| Address: | 3B Medical, Inc.<br>799 Overlook Drive<br>Winter Haven, FL 33884 |
| Phone: | 863-226-6284 |
| Email: | [e-mail] |

## Applicant Device Information:

| Trade Name: | Viva Nasal Mask (Model: NM4)<br>Numa Full Face Mask (Model: BMC-FM2) |
|----------------------|----------------------------------------------------------------------|
| Common Name: | Vented Face Mask |
| Name/Classification: | Accessory to Non-Continuous<br>Ventilator |
| Product Code: | BZD |
| Regulation Number: | 21CFR 868.5905 |
| Device Class: | II |
| Predicate Device(s) | |
| | Predicate Device of Viva Nasal Mask: BMC-NM2 Nasal<br>Mask (K133009) |
| | Predicate Device of Numa Full Face Mask: Quattro™ Air<br>(K123979) |

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#### Reference Device

BMC Willow Mask, K112277

## Device Description

#### Viva Nasal Mask

Viva Nasal Mask provides an interface 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. Viva Nasal Mask has plastic body and silicone seal that touches the face and includes a pad that rests on the forehead.

The Viva Nasal Mask is a prescription device supplied non-sterile.

#### Numa Full Face Mask

Numa Full Face Mask provides an interface 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. Numa Full Face Mask has plastic body and silicone seal that touches the face and include an adjustable pad that rests on the forehead.

Numa Full Face Mask is a prescription device supplied non-sterile.

### Indications for Use

The Viva Nasal Mask channels airflow noninvasively to a patient from a positive airway pressure device such as a continuous positive airway pressure (CPAP) or bi-level system.

The Viva Nasal Mask is:

- . To be used by adult patients (>66lbs />30kg) for whom positive airway pressure has been prescribed.
- Intended for single-patient reuse.

The Numa Full Face Mask channels airflow noninvasively to a patient from a positive airway pressure device such as a continuous positive airway pressure (CPAP) or Bi-level system.

The Numa Full Face Mask is:

- To be used by adult patients (>66lbs / >30kg) for whom positive airway ● pressure has been prescribed.
- Intended for single-patient reuse. ●

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## Table 1: Technical Comparison to the Predicate Device 1.1 Comparison Table1 (Viva (Model: NM4) K163464to BMC-NM2 Nasal Mask (K133009))

| Comparison Elements | Applicant Device | Predicate Device | Comparison Statement | |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Viva (Model: NM4)K163464 | BMC-NM2 (K133009) | | |
| Device name | Nasal Mask | Nasal Mask | | |
| Classification name | Accessory to Non-Continuous Ventilator | Accessory to Non-Continuous Ventilator | Same classification information | |
| Product code | BZD | BZD | | |
| Indications for Use | The Viva Nasal Mask channels airflow<br>noninvasively to a patient from a positive<br>airway pressure device such as a continuous<br>positive airway pressure (CPAP) or bi-level<br>system.<br>The Viva Nasal Mask is:<br>To be used by adult patients (>66lbs<br>/ >30kg) for whom positive airway pressure<br>has been prescribed.<br>Intended for single-patient reuse. | The BMC-NM2 Nasal Mask channels airflow<br>noninvasively to a patient from a positive<br>airway pressure device such as a continuous<br>positive airway pressure (CPAP) or Bi-level<br>system.<br>The BMC-NM2 Nasal Mask is:<br>To be used by adult patients (>30 kg) for whom<br>positive airway pressure has been prescribed.<br>Intended for single-patient re-use in home<br>environment and multi-patient reuse in the<br>hospital/institutional environment. | Different.<br>The inclusion of "single-patient reuse" is<br>a narrower indication to the "multi-<br>patient, multi-use" in the hospital /<br>institutional environment<br>and does not alter the intended<br>use of the device. | |
| Target population | Adult (>66lbs / >30kg) | Adult (>66lbs/30kg) | Same | |
| Patient usage type | Single-patient reuse | Single-patient reuse in home environment and<br>multi-patient reuse in the hospital/institutional<br>environment. | Different.<br>The inclusion of "single-patient reuse" is<br>a narrower indication to the "multi-<br>patient, multi-use" in the hospital /<br>institutional environment<br>and does not alter the intended<br>use of the device. | |
| Anatomical site | Nose | Nose | Same | |
| Provided sterile or non-sterile | Not sterile | Not sterile | Same | |
| Design | Nasal interface and headgear | Nasal interface and headgear | Same | |
| Number of mask size | Three sizes (small, medium, and large) | Three size (small, medium, and large) | Same | |
| Patient circuit connection | 22mm entrainment valve elbow | 22mm entrainment valve elbow | Same | |
| Therapy Pressure range | 4 to 25 hPa | 4 to 30 hPa | Different.<br>This difference will not raise new risks,<br>as pressure range is within subset o<br>predicate. | |
| Device<br>Specifica<br>tions | | | | |
| | Comparison Elements | Applicant Device<br>Viva (Model: NM4)K163464 | Predicate Device<br>BMC-NM2 (K133009) | Comparison Statement |
| | Intentional leak(Passive<br>Exhalation Port Flow) | 4hPa=19 L/min<br>8hPa=28L/min<br>12hPa=35L/min<br>16hPa=41L/min<br>20hPa=46L/min<br>25hPa=51L/min | 4hPa=20L/min<br>12hPa=40L/min<br>20hPa=51L/min<br>30hPa=72L/min | Different.<br>International leak is actually to exhale CO2. Under the same pressure, subject<br>device's intentional leak is slightly<br>smaller than that of predicate device. This<br>difference has little impact on CO2<br>rebreathing. The subject device has<br>passed CO2 rebreathing testing according<br>to ISO 17510-2:2007. Please refer to<br>"Appendix E_CO2 Rebreathing Testing".<br>Hence, this difference will not introduce<br>any additional risk to the user. |
| | Dead space | S Size: 76ml<br>M Size: 83ml<br>Large Size: 92ml | S Size: 124ml<br>M Size: 129ml<br>Large Size: 135ml | Different.<br>The dead space of three sizes is less than<br>that of the predicate.<br>All seal sizes are in conformance with<br>ISO 17510-2:2007 and this difference<br>does not introduce any additional risk to<br>the user. |
| | Resistance/<br>Pressure Drop | at 50L/min: 0.2 hPa<br>at 100L/min: 0.8 hPa | at 50 L/min: 0.2 hPa<br>at 100 L/min: 0.5 hPa | Same. |
| | Operating environment | 5 to 40°C<br>10% to 93% relative humidity, non-condensing | 5 to 40°C<br>10% to 93% relative humidity, non-condensing | Same. |
| | Storage environment | -20 to +55°C<br>10% to 93% relative humidity, non-condensing | -20 to +55°C<br>10% to 93% relative humidity, non-condensing | Same. |
| | Materials | Polycarbonate<br>Silicon | Polycarbonate<br>Silicon | Same materials for BMC's Willow Nasal<br>Mask (K112271) Cleared previously for<br>substantially equivalent intended use. |
| Comparison Elements | Applicant Device | Predicate Device | Comparison Statement | |
| | Viva (Model: NM4)K163464 | BMC-NM2 (K133009) | | |
| | Nylon & Spandex Fabric | Nylon & Spandex Fabric | | |
| | Polypropylene | — | | |

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# 1.2 Comparison Table 2 (Numa (Model: BMC-FM2) K163464 to Quattro™Air(K123979))

| Comparison Elements | Applicant Device | Predicated Device | Conclusion | |
|-------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device name | Numa (Model: BMC-FM2)K163464<br>Full Face Mask | QuattroTMAir(K123979)<br>Full Face Mask | | |
| Classification name | Accessory to Non-Continuous Ventilator | Accessory to Non-Continuous Ventilator | Same classification information | |
| Product code | BZD | BZD | | |
| Indications for Use | The Numa Full Face Mask channels airflow<br>noninvasively to a patient from a positive<br>airway pressure device such as a continuous<br>positive airway pressure (CPAP) or Bi-level<br>system.<br>The Numa Full Face Mask is:<br>To be used by adult patients (>66lbs / >30kg)<br>for whom positive airway pressure has been<br>prescribed.<br>Intended for single-patient reuse. | The Quattro Air is a noninvasive accessory used<br>for channeling airflow (with or without<br>supplemental oxygen) to a patient from a positive<br>airway pressure (PAP) device such as a<br>continuous positive airway pressure (CPAP) or<br>bilevel system.<br>The Quattro Air is:<br>to be used by patients (weighing >30 kg) for<br>whom positive airway pressure therapy has been<br>prescribed<br>intended for single-patient reuse in the home<br>environment and multipatient reuse in the<br>hospital/institutional environment.. | Different.<br>The inclusion of "single-patient<br>reuse" is a narrower indication to<br>the "multi-patient, multi-use" in the<br>hospital / institutional environment<br>and does not alter the intended<br>use of the device. | |
| Target population | Adult (>66lbs / >30kg) | Adult (>66lbs/30kg) | Same | |
| Patient usage type | Single-patient reuse | Single-patient re-use in the home environment and<br>multi-patient re-use in the hospital/institutional<br>environment | Different.<br>The inclusion of "single-patient<br>reuse" is a narrower indication to<br>the "multi-patient, multi-use" in the<br>hospital / institutional environment<br>and does not alter the intended<br>use of the device. | |
| Anatomical site | Nose and mouth | Nose and mouth | Same | |
| Comparison Elements | | Applicant Device | Predicated Device | Conclusion |
| | | Numa (Model: BMC-FM2)K163464 | Quattro™Air(K123979) | |
| | Provided sterile or non-sterile | Not sterile | Not sterile | Same |
| Design | | face interface and headgear | face interface and headgear | Same |
| | Number of mask size | Three sizes (small, medium, and large) | Four sizes (extra small, small, medium, and large) | Similar. The predicate is available<br>in an additional extra small size.<br>The additional size is an optional<br>sizing option. That has no<br>correlation to safety or<br>effectiveness. |
| | Patient circuit connection | 22mm entrainment valve elbow | 22mm entrainment valve elbow | Same |
| | Therapy Pressure range | 3 to 40hPa…