(270 days)
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.
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 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.
The provided document is a 510(k) Summary for medical devices, specifically the Viva Nasal Mask (Model: NM4) and Numa Full Face Mask (Model: BMC-FM2). It describes the devices and compares them to predicate devices to demonstrate substantial equivalence, rather than providing a detailed study of acceptance criteria and performance as typically found in clinical trials for new AI/diagnostic devices.
Therefore, much of the requested information (such as sample sizes for test and training sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) is not present in this type of regulatory submission for these specific devices, which are mechanical masks and not AI/diagnostic tools.
However, I can extract the available information regarding their performance and acceptance criteria based on the comparison to predicate devices and non-clinical testing.
Here's the breakdown of what can be inferred or directly stated from the document:
1. Table of Acceptance Criteria and Reported Device Performance
For these devices, "acceptance criteria" are not explicitly listed in a quantitative fashion as pass/fail thresholds for specific metrics. Instead, the acceptance is based on demonstrating "substantial equivalence" to predicate devices through technical comparisons and non-clinical performance data. The device performance is reported as being "substantially equivalent" to the predicate devices for various parameters.
| Comparison Element | Viva Nasal Mask (Model: NM4) Reported Performance (Applicant Device K163464) | Predicate Device (BMC-NM2 Nasal Mask K133009) Performance | Numa Full Face Mask (Model: BMC-FM2) Reported Performance (Applicant Device K163464) | Predicate Device (Quattro™ Air K123979) Performance |
|---|---|---|---|---|
| Indications for Use | Channels airflow noninvasively for adult patients (>66lbs / >30kg) prescribed positive airway pressure, intended for single-patient reuse. | Channels airflow noninvasively for adult patients (>30kg) prescribed positive airway pressure, intended for single-patient reuse in home and multi-patient reuse in hospital/institutional environment. | Channels airflow noninvasively for adult patients (>66lbs / >30kg) prescribed positive airway pressure, intended for single-patient reuse. | Channels airflow noninvasively for adult patients (>30 kg) prescribed positive airway pressure, intended for single-patient reuse in home and multi-patient reuse in hospital/institutional environment. |
| Target Population | Adult (>66lbs / >30kg) | Adult (>66lbs/30kg) | Adult (>66lbs / >30kg) | Adult (>66lbs/30kg) |
| Patient Usage Type | Single-patient reuse (narrower indication than predicate) | Single-patient reuse in home & multi-patient in institution. | Single-patient reuse (narrower indication than predicate) | Single-patient reuse in home & multi-patient in institution. |
| Anatomical Site | Nose | Nose | Nose and mouth | Nose and mouth |
| Provided Sterile | Not sterile | Not sterile | Not sterile | Not sterile |
| Design | Nasal interface and headgear | Nasal interface and headgear | Face interface and headgear | Face interface and headgear |
| Number of Mask Sizes | Three sizes (small, medium, large) | Three sizes (small, medium, large) | Three sizes (small, medium, large) | Four sizes (extra small, small, medium, large) |
| Patient Circuit Connection | 22mm entrainment valve elbow | 22mm entrainment valve elbow | 22mm entrainment valve elbow | 22mm entrainment valve elbow |
| Therapy Pressure Range | 4 to 25 hPa | 4 to 30 hPa | 3 to 40 hPa | 3 to 40 hPa |
| Intentional Leak (Passive Exhalation Port Flow) | Slightly smaller than predicate but passed CO2 rebreathing testing (ISO 17510-2:2007). | Example: 4hPa=20L/min, 12hPa=40L/min, 20hPa=51L/min | Slightly smaller than predicate but passed CO2 rebreathing testing (ISO 17510-2:2007). | Example: 3 cm H2O =19 L/min, 12 cm H2O =41 L/min, 20 cm H2O =54 L/min |
| Dead Space | S Size: 76ml, M Size: 83ml, Large Size: 92ml (less than predicate, conforms to ISO 17510-2:2007). | S Size: 124ml, M Size: 129ml, Large Size: 135ml | S Size: 171ml, M Size: 192ml, Large Size: 218mL (less than predicate, conforms to ISO 17510-2:2007). | S Size: 176ml, M Size: 198ml, Large Size: 222mL |
| Resistance/Pressure Drop | at 50L/min: 0.2 hPa, at 100L/min: 0.8 hPa (Same as predicate) | at 50 L/min: 0.2 hPa, at 100 L/min: 0.5 hPa | at 50L/min: 0.15 cm H2O, at 100L/min: 0.5 cm H2O | at 50 L/min: 0.1 cm H2O, at 100 L/min: 0.4 cm H2O |
| Inspiratory/Expiratory Resistance (AAV open) | Inspiration at 50 L/min: 1.8 cm H2O, Expiration at 50 L/min: 2.0 cm H2O (Less than 10cmH2O required by ISO 17510-2:2007) | Inspiration at 50 L/min: 0.2cm H2O, Expiration at 50 L/min: 0.9 cm H2O | N/A (Viva Nasal Mask does not have AAV) | N/A |
| Operating Environment | 5 to 40°C, 10% to 93% relative humidity, non-condensing | 5 to 40°C, 10% to 93% relative humidity, non-condensing | 5 to 40°C, 10% to 93% relative humidity, non-condensing | 5°C to 40°C, 15% to 95% relative humidity, non-condensing |
| Storage Environment | -20 to +55°C, 10% to 93% relative humidity, non-condensing | -20 to +55°C, 10% to 93% relative humidity, non-condensing | -20 to +55°C, 10% to 93% relative humidity, non-condensing | -20 to +60°C, 0% to 95% relative humidity, non-condensing |
Study Details:
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify a "test set" in the context of patient data. Performance testing was "non-clinical" (bench testing). No patient data samples are mentioned.
- Data Provenance: Not applicable as no patient data was used.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable as no "ground truth" based on expert review of patient data was established for these non-clinical tests. The standard (ISO 17510-2:2007) serves as the benchmark for many parameters.
4. Adjudication method for the test set
- Not applicable as no expert adjudication of patient data was performed.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. These are mechanical masks, not AI/diagnostic devices that involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. These are mechanical masks, not algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the non-clinical performance tests (like CO2 rebreathing, dead space, resistance), the "ground truth" or acceptance criteria are derived from international standards, specifically ISO 17510-2:2007. The goal was to show that the device performs within acceptable limits set by this standard and is substantially equivalent to predicate devices.
8. The sample size for the training set
- Not applicable as no "training set" in the context of machine learning or patient data was used.
9. How the ground truth for the training set was established
- Not applicable as no "training set" was used.
In summary, this 510(k) submission relies on non-clinical bench testing and comparison to legally marketed predicate devices to demonstrate substantial equivalence, rather than clinical trials with patient data, expert review, or AI performance metrics.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a series of human profiles facing to the right.
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 (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.
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. 115Fucheng Road Haidian, Beijing100036,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 LucioExecutive Vice President |
|---|---|
| Address: | 3B Medical, Inc.799 Overlook DriveWinter Haven, FL 33884 |
| Phone: | 863-226-6284 |
| Email: | alucio@3Bproducts.com |
Applicant Device Information:
| Trade Name: | Viva Nasal Mask (Model: NM4)Numa Full Face Mask (Model: BMC-FM2) |
|---|---|
| Common Name: | Vented Face Mask |
| Name/Classification: | Accessory to Non-ContinuousVentilator |
| Product Code: | BZD |
| Regulation Number: | 21CFR 868.5905 |
| Device Class: | II |
| Predicate Device(s) | |
| Predicate Device of Viva Nasal Mask: BMC-NM2 NasalMask (K133009) | |
| Predicate Device of Numa Full Face Mask: Quattro™ Air(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 airflownoninvasively to a patient from a positiveairway pressure device such as a continuouspositive airway pressure (CPAP) or bi-levelsystem.The Viva Nasal Mask is:To be used by adult patients (>66lbs/ >30kg) for whom positive airway pressurehas been prescribed.Intended for single-patient reuse. | The BMC-NM2 Nasal Mask channels airflownoninvasively to a patient from a positiveairway pressure device such as a continuouspositive airway pressure (CPAP) or Bi-levelsystem.The BMC-NM2 Nasal Mask is:To be used by adult patients (>30 kg) for whompositive airway pressure has been prescribed.Intended for single-patient re-use in homeenvironment and multi-patient reuse in thehospital/institutional environment. | Different.The inclusion of "single-patient reuse" isa narrower indication to the "multi-patient, multi-use" in the hospital /institutional environmentand does not alter the intendeduse of the device. | |
| Target population | Adult (>66lbs / >30kg) | Adult (>66lbs/30kg) | Same | |
| Patient usage type | Single-patient reuse | Single-patient reuse in home environment andmulti-patient reuse in the hospital/institutionalenvironment. | Different.The inclusion of "single-patient reuse" isa narrower indication to the "multi-patient, multi-use" in the hospital /institutional environmentand does not alter the intendeduse 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.This difference will not raise new risks,as pressure range is within subset opredicate. | |
| DeviceSpecifications | ||||
| Comparison Elements | Applicant DeviceViva (Model: NM4)K163464 | Predicate DeviceBMC-NM2 (K133009) | Comparison Statement | |
| Intentional leak(PassiveExhalation Port Flow) | 4hPa=19 L/min8hPa=28L/min12hPa=35L/min16hPa=41L/min20hPa=46L/min25hPa=51L/min | 4hPa=20L/min12hPa=40L/min20hPa=51L/min30hPa=72L/min | Different.International leak is actually to exhale CO2. Under the same pressure, subjectdevice's intentional leak is slightlysmaller than that of predicate device. Thisdifference has little impact on CO2rebreathing. The subject device haspassed CO2 rebreathing testing accordingto ISO 17510-2:2007. Please refer to"Appendix E_CO2 Rebreathing Testing".Hence, this difference will not introduceany additional risk to the user. | |
| Dead space | S Size: 76mlM Size: 83mlLarge Size: 92ml | S Size: 124mlM Size: 129mlLarge Size: 135ml | Different.The dead space of three sizes is less thanthat of the predicate.All seal sizes are in conformance withISO 17510-2:2007 and this differencedoes not introduce any additional risk tothe user. | |
| Resistance/Pressure Drop | at 50L/min: 0.2 hPaat 100L/min: 0.8 hPa | at 50 L/min: 0.2 hPaat 100 L/min: 0.5 hPa | Same. | |
| Operating environment | 5 to 40°C10% to 93% relative humidity, non-condensing | 5 to 40°C10% to 93% relative humidity, non-condensing | Same. | |
| Storage environment | -20 to +55°C10% to 93% relative humidity, non-condensing | -20 to +55°C10% to 93% relative humidity, non-condensing | Same. | |
| Materials | PolycarbonateSilicon | PolycarbonateSilicon | Same materials for BMC's Willow NasalMask (K112271) Cleared previously forsubstantially 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)K163464Full Face Mask | QuattroTMAir(K123979)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 airflownoninvasively to a patient from a positiveairway pressure device such as a continuouspositive airway pressure (CPAP) or Bi-levelsystem.The Numa Full Face Mask is:To be used by adult patients (>66lbs / >30kg)for whom positive airway pressure has beenprescribed.Intended for single-patient reuse. | The Quattro Air is a noninvasive accessory usedfor channeling airflow (with or withoutsupplemental oxygen) to a patient from a positiveairway pressure (PAP) device such as acontinuous positive airway pressure (CPAP) orbilevel system.The Quattro Air is:to be used by patients (weighing >30 kg) forwhom positive airway pressure therapy has beenprescribedintended for single-patient reuse in the homeenvironment and multipatient reuse in thehospital/institutional environment.. | Different.The inclusion of "single-patientreuse" is a narrower indication tothe "multi-patient, multi-use" in thehospital / institutional environmentand does not alter the intendeduse 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 andmulti-patient re-use in the hospital/institutionalenvironment | Different.The inclusion of "single-patientreuse" is a narrower indication tothe "multi-patient, multi-use" in thehospital / institutional environmentand does not alter the intendeduse 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 availablein an additional extra small size.The additional size is an optionalsizing option. That has nocorrelation to safety oreffectiveness. | |
| Patient circuit connection | 22mm entrainment valve elbow | 22mm entrainment valve elbow | Same | |
| Therapy Pressure range | 3 to 40hPa | 3 to 40 hPa | Same | |
| Device Specifications | Intentional leak(PassiveExhalation Port Flow) | 3 cm H2O =18L/min4 cm H2O =22 L/min8 cm H2O =32 L/min10 cm H2O=36 L/min12 cm H2O =40L/min16 cm H2O =47 L/min20 cm H2O =53 L/min25 cm H2O =60 L/min30 cm H2O =65 L/min35 cm H2O =71L/min40 cm H2O =78 L/min | 3 cm H2O =19 L/min4 cm H2O =22 L/min8 cm H2O =32 L/min12 cm H2O =41 L/min16 cm H2O =48 L/min20 cm H2O =54 L/min24cm H2O =60L/min28cm H2O =66L/min30 cm H2O =69 L/min32cm H2O =72L/min36cm H2O =72L/min38cm H2O =77L/min40cm H2O =82 L/min | Different.International leak is actually toexhale CO2. Under the samepressure, subject device'sintentional leak is slightly smallerthan that of predicate device. Thisdifference has little impact onCO2rebreathing. The subject devicehas passed CO2rebreathing testingaccording to ISO 17510-2:2007.Please refer to "Appendix E_CO2Rebreathing Testing". Hence, thisdifference will not introduce anyadditional risk to the user. |
| Dead space | S Size: 171mlM Size: 192mlLarge Size: 218mL | S Size: 176mlM Size: 198mlLarge Size: 222mL | Different. The dead space of threesizes is less than that of thepredicate. All seal sizes are inconformance with ISO 17510-2(2007) and this difference does notintroduce any additional risk to the | |
| Comparison Elements | Applicant DeviceNuma (Model: BMC-FM2)K163464 | Predicated DeviceQuattro™Air(K123979) | Conclusion | |
| user. | ||||
| Resistance/Pressure Drop | at 50L/min: 0.15 cm H2Oat 100L/min: 0.5 cm H2O | at 50 L/min: 0.1 cm H2Oat 100 L/min: 0.4 cm H2O | Testing is performed and resultsfrom this testing concluded that theverification testing raises no newissues of safety or effectiveness. | |
| Inspiratory and expiratoryresistance (with Anti AsphyxiaValve open to atmosphere) | Inspiration at 50 L/min: 1.8 cm H2OExpiration at 50 L/min: 2.0 cm H2O | Inspiration at 50 L/min: 0.2cm H2OExpiration at 50 L/min: 0.9 cm H2O | Different. Testing is performedaccording to ISO 17510-2:2007 andresults are all less than 10cmH2Orequired in Clause 5.5 of ISO17510-2:2007. Hence, testingshows inspiratory and expiratoryresistance are substantiallyequivalent . | |
| Operating environment | 5 to 40°C10% to 93 % relative humidity non-condensing | 5°C to 40°C15% to 95% relative humidity non-condensing | Similar. This difference will notraise new risks. | |
| Storage andtransportenvironment | -20 to +55°C10% to 93% relative humidity, non-condensing | -20 to +60°C0% to 95% relative humidity, non-condensing | Different. The labeled maximumfor storage and transportenvironment is a few degrees at theoutside maximum. This differencewill not raise new risks. | |
| Materials | Silicon | Silicon | As predicate device is manufactured | |
| Nylon & spandex Fabric | "Breathoprene" Fabric | by a different manufacturer,formulations are unknown. | ||
| Polycarbonate | Molded Plastic | Leveraging K112271, alsomanufactured by BMC Medical, for | ||
| Polypropylene | — | biocompatibility. The materialsused in K112271 are identical to thematerials used in the proposeddevice. |
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K163464 - 510(k) Summary Doc No.: BMC-TF (FDA)- NM4-FM2
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K163464 - 510(k) Summary Doc No.: BMC-TF (FDA)- NM4-FM2
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Performance Data
Non-Clinical Testing
Performance testing has been carried out in conformance with ISO 17510-2 to verify the performance of the Viva Nasal Mask and Numa Full Face Mask. The results of performance data show that the Viva Nasal Mask is substantially equivalent to its predicate mask -- BMC-NM2 Nasal Mask (K133009), and the Numa Full Face Mask is substantially equivalent to its predicate mask -- Quattro™ Air (K123979)
The performance bench testing includes:
Passive exhalation port flow, the resistance to flow, anti-asphyxia valve related testing, dead space, CO2 rebreathing, ISO 17510-2 testing, transportation, and accelerated aging and shelf life.
The CO2 performance of the new device was tested to ensure the mask design provides adequate venting to flush out the expired CO2. The testing included physical and functional dead-space, measurements. The device was shown to be substantially equivalent to the predicate devices. The Anti-Asphyxia Valve (AAV) performance was tested to ensure the patient can continue to breathe fresh air if ever the airflow from the flow generator is impeded. The device was shown to be substantially equivalent to the predicate devices.
The pressure-flow characteristics and through impedance of the mask were tested to ensure clinicians are able to prescribe the appropriate therapy using the new device. The device was shown to be substantially equivalent to the predicate devices. The mechanical integrity and performance of the new device was tested during normal use and reasonable abuse scenarios. The device was also tested to demonstrate that the mask can withstand the effects of storage temperature, humidity and transportation shock & vibration.
All the materials used in the manufacturing of the Viva Nasal Mask and Numa Full Face Mask are identical to the materials used in BMC's legally marketed Willow Mask (K112271) under same conditions.
In conclusion, the test reports demonstrate that the Viva Nasal Mask and Numa Full Face Mask are substantially equivalent to the predicate devices.
Clinical Test
No clinical testing was performed; use of full face mask and nasal mask with CPAP or bilevel therapy is proven technology and is well accepted by the medical community.
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Conclusion
Substantial Equivalence Conclusion
The Viva Nasal Mask and Numa Full Face Mask are substantially equivalent to the predicate devices:
-they have similar indications for use;
- -they have similar technological characteristics to the predicate devices;
-they do not raise any new questions of safety or effectiveness;
-they are substantially equivalent to the predicate devices.
§ 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).