(210 days)
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.
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.
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.
The BMC-FM is prescription device supplied non-sterile.
Here's an analysis of the acceptance criteria and supporting studies for the BMC Medical Co., Ltd. Nasal Mask (BMC-NM, BMC-NM2) and Full Face Mask (BMC-FM) based on the provided 510(k) summary (K133009):
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated in a quantitative "acceptance limit" vs. "result" format as might be seen for a new technology with novel performance targets. Instead, the acceptance criteria are implicitly defined by demonstrating "substantial equivalence" to predicate devices through a series of performance tests. The reported device performance is presented in comparison tables against the predicate devices for various specifications.
Here's a table summarizing the implicit acceptance criteria (similarity to predicate) and the reported device performance from the provided document:
Table of Acceptance Criteria (Implicit) and Reported Device Performance
| Comparison Element | Predicate Device Performance (Acceptance Benchmark) | Applicant Device Performance (Reported) | Acceptance Outcome (Implicit) |
|---|---|---|---|
| Nasal Masks (BMC-NM, BMC-NM2) | |||
| Therapy Pressure Range | ComfortGel™: 4 to 30 hPa; Mirage Activa™: 4-20 hPa | BMC-NM: 4 to 30 hPa; BMC-NM2: 4 to 30 hPa | Met (within range or similar) |
| Intentional Leak (4hPa) | ComfortGel™: 15 L/min; Mirage Activa™: 19 L/min | BMC-NM: 19 L/min; BMC-NM2: 20 L/min | Met (similar) |
| Intentional Leak (12hPa) | ComfortGel™: 31 L/min; Mirage Activa™: 34 L/min | BMC-NM: 34 L/min; BMC-NM2: 40 L/min | Met (similar) |
| Intentional Leak (20hPa) | ComfortGel™: 34 L/min; Mirage Activa™: 45 L/min | BMC-NM: 50 L/min; BMC-NM2: 51 L/min | Met (similar) |
| Intentional Leak (30hPa) | ComfortGel™: 46 L/min; Mirage Activa™: N/A (max 20hPa) | BMC-NM: 68 L/min; BMC-NM2: 72 L/min | Met (similar to available) |
| Dead Space (large size) | ComfortGel™: 142.6 ml; Mirage Activa™: 145 ml | BMC-NM: 145 ml; BMC-NM2: 135 ml | Met (similar) |
| Resistance/Pressure Drop (50L/min) | ComfortGel™: 0.1 hPa; Mirage Activa™: 0.3 hPa | BMC-NM: 0.2 hPa; BMC-NM2: 0.2 hPa | Met (similar) |
| Resistance/Pressure Drop (100L/min) | ComfortGel™: 0.25 hPa; Mirage Activa™: 0.9 hPa | BMC-NM: 0.7 hPa; BMC-NM2: 0.5 hPa | Met (similar) |
| Operating Environment (Temp) | ComfortGel™: 5 to 40°C; Mirage Activa™: 5 to 40°C | BMC-NM: 5 to 40°C; BMC-NM2: 5 to 40°C | Met (identical) |
| Operating Environment (Humidity) | ComfortGel™: 15%-95%; Mirage Activa™: 15%-95% | BMC-NM: 10%-93%; BMC-NM2: relative humidity (non-condensing) | Met (similar range) |
| Storage Environment (Temp) | ComfortGel™: -20 to +60°C; Mirage Activa™: N/A (listed under operating for predicate) | BMC-NM: -20 to +55°C; BMC-NM2: -20 to +60°C | Met (similar) |
| Storage Environment (Humidity) | ComfortGel™: up to 95%; Mirage Activa™: N/A | BMC-NM: 10%-93%; BMC-NM2: up to 95% | Met (similar range) |
| Materials | Polycarbonate, Silicon, Urethane, Nylon, Spandex | Polycarbonate, Silicon, Nylon & Spandex Fabric | Met (similar) |
| Performance Testing | Intentional leak, pressure drop, dead space CO2 rebreathing | Pressure-flow characteristic, dead space (CO2 re-breathing), flow impedance. | Met (similar scope) |
| Full Face Mask (BMC-FM) | |||
| Therapy Pressure Range | Mirage Quattro™: 4 to 40 hPa | BMC-FM: 4 to 30 hPa | Met (within range) |
| Intentional Leak (4 cm H2O) | Mirage Quattro™: 22 L/min | BMC-FM: 23 L/min | Met (similar) |
| Intentional Leak (8 cm H2O) | Mirage Quattro™: 32 L/min | BMC-FM: 33 L/min | Met (similar) |
| Intentional Leak (12 cm H2O) | Mirage Quattro™: 41 L/min | BMC-FM: 43 L/min | Met (similar) |
| Intentional Leak (16 cm H2O) | Mirage Quattro™: 48 L/min | BMC-FM: 49 L/min | Met (similar) |
| Intentional Leak (20 cm H2O) | Mirage Quattro™: 54 L/min | BMC-FM: 54 L/min | Met (identical) |
| Intentional Leak (30 cm H2O) | Mirage Quattro™: 66L/min (extrapolated) | BMC-FM: 69 L/min | Met (similar) |
| Dead Space (large size) | Mirage Quattro™: 242 mL | BMC-FM: 246 mL | Met (similar) |
| Resistance/Pressure Drop (50L/min) | Mirage Quattro™: 0.1 cm H2O | BMC-FM: 0.2 cm H2O | Met (similar) |
| Resistance/Pressure Drop (100L/min) | Mirage Quattro™: 0.4 cm H2O | BMC-FM: 0.3 cm H2O | Met (similar) |
| Inspiratory Resistance (50L/min) | Mirage Quattro™: 0.8 cm H2O | BMC-FM: 1.0 cm H2O | Met (similar) |
| Expiratory Resistance (50L/min) | Mirage Quattro™: 0.8 cm H2O | BMC-FM: 1.2 cm H2O | Met (similar) |
| Operating Environment (Temp) | Mirage Quattro™: 5°C to 40°C | BMC-FM: 5 to 40°C | Met (identical) |
| Operating Environment (Humidity) | Mirage Quattro™: 15% to 95% | BMC-FM: 10% to 93% | Met (similar range) |
| Storage Environment (Temp) | Mirage Quattro™: -20 to +60°C | BMC-FM: -20 to +55°C | Met (similar) |
| Storage Environment (Humidity) | Mirage Quattro™: 10% to 95% (assumed from operating temp) | BMC-FM: 10% to 93% | Met (similar range) |
| Materials | Polycarbonate, Silicon, Fabric/Nylon | Polycarbonate, Silicon, Nylon & Spandex Fabric | Met (similar) |
| Performance Testing | Testing according to ISO 17510-2 | Testing according to ISO 17510-2 | Met (identical standard) |
2. Sample Size Used for the Test Set and Data Provenance
The document describes "performance bench testing" and "nonclinical tests." These tests are typically conducted on physical samples of the device in a laboratory setting, not with patient data.
- Sample Size: The exact number of samples used for these bench tests (e.g., number of masks tested for resistance, dead space, leak) is not specified in the provided summary.
- Data Provenance: The tests are explicitly described as "bench tests" and "nonclinical tests." This implies the data is generated in a laboratory setting. No information on country of origin for the data or whether it's retrospective or prospective is relevant or provided, as these are not human subject studies.
3. Number of Experts and Their Qualifications for Ground Truth
- Number of Experts: Not applicable. This submission relies on objective engineering and performance data derived from bench testing, not expert interpretation of clinical data.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where human interpretation or ground truth establishment is subjective and requires consensus. This is a technical performance study based on objective measurements against standards and predicate device specifications. Therefore, an adjudication method is not applicable and not mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study was done. This type of study involves human readers interpreting cases (e.g., medical images) with and without AI assistance. The device in question is a physical medical mask, not an AI diagnostic tool.
6. Standalone (Algorithm Only) Performance Study
- No standalone performance study of an algorithm was done. This device is a physical medical mask, not an algorithm or software.
7. Type of Ground Truth Used
The "ground truth" for demonstrating substantial equivalence is based on:
- Objective Technical Specifications: Measurements of physical properties and performance characteristics (e.g., intentional leak, dead space, resistance, operating/storage conditions, materials) derived from international standards (like ISO 17510-2 for the full face mask) and comparison against the technical specifications of the legally marketed predicate devices.
- Bench Testing Results: The results of the laboratory tests (pressure-flow characteristics, CO2 re-breathing, flow impedance, damp heat, disinfection validation) serve as the evidence to support the claim of similarity to predicates.
8. Sample Size for the Training Set
- Training Set: Not applicable. This is not a machine learning or AI device that requires training data. The devices are physical medical accessories.
9. How Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.
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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 MaskBMC-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(K092835) | Mirage ActivaTM (K030798) | |
| Device name | Nasal mask | Nasal mask | Nasal mask | Nasal mask |
| Classification name | Accessory toNon-continuousVentilator | Accessory toNon-continuousVentilator | Accessory to Non-continuousVentilator | Accessory to Non-continuousVentilator |
| 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 Maskchannel airflow noninvasively to a patientfrom a positive airway pressure device suchas a continuous positive airway pressure(CPAP) or Bi-level system.The BMC-NM and BMC-NM2 Nasal Maskare:To be used by adult patients (>66lbs />30kg) for whom positive airway pressurehas been prescribed. Intended for single-patient reuse inhome environment and multi-patient re-usein the hospital/institutional environment. | The ComfortGel Blue Nasal Maskis intended to provide an interfacefor application of CPAP or bi-leveltherapy to patients. The mask is forsingle patient use in the home ormulti-patient use in thehospital/institutional environment.The mask is to be used by patients(>66lbs/30kg) for whom CPAP orbi-level therapy has beenprescribed. | Mirage ActivaTM mask is anaccessory to anon-continuous ventilator(respirator) intended forsingle-patient use for adultpatients prescribedcontinuous positive airwaypressure (CPAP) andbi-level therapy in hospital,clinic, and homeenvironments. | |
| Indications for use | The BMC-NM and BMC-NM2 Nasal Maskchannel airflow noninvasively to a patient | The ComfortGel Blue Nasal Maskis intended to provide an interface | Mirage ActivaTM mask is anaccessory to a | |
| Applicant Device | Predicated Device | |||
| Comparison Elements | BMC-NM | BMC-NM2 | ComfortGel™(K092835) | Nasal MaskMirage 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(K092835) | Mirage ActivaTM (K030798)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/min12hPa=34/min20hPa=50L/min30hPa=68L/min | 4hPa=20L/min12hPa=40/min20hPa=51L/min30hPa=72L/min | 4hPa=15L/min12hPa=31/min20hPa=34L/min30hPa=46L/min | 4hPa=19L/min12hPa=34L/min20hPa=45L/min |
| Dead space (large size) | 145ml | 135ml | 142.6ml | 145ml |
| Resistance/ Pressure Drop | 0.2 hPa at 50L/min0.7 hPa at 100L/min | 0.2 hPa at 50 L/min0.5 hPa at 100 L/min | 0.1 hPa at 50L/min0.25 hPa at 100L/min. | 0.3 hPa at 50L/min0.9 hPa at 100L/min |
| Operating environment | 5 to 40°C10% to 93% relative humidity, non-condensing | 5 to 40°Crelative humidity, non-condensing | 5 to 40°C15% to 95% relative humidity, non-condensing | 5 to 40°C15% to 95% relative humidity, non-condensing |
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.
.
·
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.
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| Applicant Device | Predicated Device | |||||
|---|---|---|---|---|---|---|
| Comparison Elements | BMC-NM | BMC-NM2 | ComfortGelTM(K092835) | Nasal Mask | Mirage ActivaTM (K030798) | |
| Storage environment | -20 to +55°C10% to 93% relative humidity, non-condensing | -20 to +60°Cup to 95% relative humidity, non-condensing | -20 to +60°Cup to 95% relative humidity, non-condensing | |||
| Comparison Statement | The applicant devices have similar specifications as the predicate devices. | |||||
| PolycarbonateSilicon | PolycarbonateSilicon | PolycarbonateSilicon | ||||
| Main materials | Nylon & spandex Fabric | GUrethane gel/EVAUrethane 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(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 airflownoninvasively to a patient from a positive airwaypressure device such as a continuous positiveairway pressure (CPAP) or Bi-level system.The BMC-FM full face mask are:The full face mask is:To be used by adult patients (>66lbs />30kg) for whom positive airwaypressure has been prescribed.Intended for single-patient reuse in homeenvironment and multi-patient re-use inthe hospital/institutional environment. | The Mirage Quattro channels airflow noninvasivelyto a patient from a positive airway pressure devicesuch as a continuous positive airway pressure (CPAP)or bilevel system.The Mirage Quattro is to be used by adult patients(>66 lb / 30 kg) for whom positive airway pressure hasbeen prescribed.The Mirage Quattro is intended for single-patientre-use in the home environment and multipatientre-use in the hospital/institutional environment. |
| Comparison Elements | Applicant DeviceBMC-FM | Predicated DeviceMirage QuattroTM(K113127) |
| Indications for use | The BMC-FM full face mask channels airflownoninvasively to a patient from a positive airwaypressure device such as a continuous positiveairway pressure (CPAP) or Bi-level system.The BMC-FM full face mask are:The full face mask is:•To be used by adult patients (>66lbs />30kg) for whom positive airwaypressure has been prescribed.• Intended for single-patient reuse in homeenvironment and multi-patient re-use in thehospital/institutional environment. | The Mirage Quattro channels airflow noninvasively toa patient from a positive airway pressure device suchas a continuous positive airway pressure (CPAP) orbilevel system.The Mirage Quattro is to be used by adult patients(>66 lb / 30 kg) for whom positive airway pressure hasbeen prescribed.The Mirage Quattro is intended for single-patientre-use in the home environment and multipatientre-use in the hospital/institutional environment. |
| Target population | Adult (>66lbs />30kg) | Adult (>66lbs/30kg) |
| Environment of use | Home environment and the hospital/institutionalenvironment | Home environment and the hospital/institutionalenvironment |
| Patient usage type | single-patient reuse in home environment andmulti-patient re-use in the hospital/institutionalenvironment | single-patient re-use in the homeenvironment and multi-patient re-use in thehospital/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-FM22mm entrainment valve elbow | Mirage QuattroTM (K113127)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/min8 cm H2O =33 L/min12 cm H2O =43 L/min16 cm H2O =49 L/min20 cm H2O =54 L/min25 cm H2O =63 L/min30 cm H2O =69 L/min | 4 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/min32cm H2O =72L/min36cm H2O =72L/min38cm H2O =77L/min40cm H2O =82 L/min | |
| Device Specifications | Dead space (large size) | 246mL | 242 mL |
| Resistance/ Pressure Drop | at 50L/min: 0.2 cm H2Oat 100L/min: 0.3 cm H2O | at 50 L/min: 0.1 cm H2Oat 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 H2OExpiration at 50 L/min 1.2 cm H2O | Inspiration at 50 L/min 0.8 cm H2OExpiration at 50 L/min 0.8 cm H2O | |
| Operating environment | 5 to 40°C10% to 93 % relative humidity non-condensing | 5°C to 40°C15% to 95% relative humidity non-condensing |
| Report No.: |
|---|
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| Premarket Notification 510(k) Submission-510(k) SummaryReport No.: BMC-TF (FDA)-STA | ||||||
|---|---|---|---|---|---|---|
| Comparison Elements | Applicant Device | Predicated Device | ||||
| BMC-FM | Mirage QuattroTM(K113127) | |||||
| Storage andenvironment | -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. | |||||
| Safetyelement | 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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Safety elemer
Biocompatibility t
| Model | BMC-NM------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------BMC-NM2 | BMC-FM | Nasal pillow mask(K112271LEAR - SEA - A - A - A - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - |
|---|---|---|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | Polycarbonate | Polycarbonate | Polycarbonat | |
| Materials | Silicon | Silicon------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | Silicon | |
| Nylon &spandex Fabric | Nylon &spandex Fabricמשפחת משמעות משמעות מורי ויווי את העיריון וויינור ויידי מרצות ה | Nylon &spandex Fabric |
rials used in BMC-NM, BMC-NM2 and BMC-FM in this submission are exactly the same as those materials used in nasal in nasa
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Model | BMC-NM | BMC-N | CARD AND CHARGE CONNUMBER LA . COLLEGION . LABMC-FAll and and the first of the different of |
|---|---|---|---|
| STERE THE STORE THE CONSTITUTION OF THE CONTRACT PERFECT PERFECT PERFECT PERFECT PERFECT PERFECT PERFECT PERFECT PERFECT PERFECT PERFECT PERFECT PERFECT PERFECT PERFECT PERFEContact | E | issue contacting | issue contactingA A B A B A Ff |
| The state of the state of the state of the status anduration of contact | Permanent contact | Permanent contact |
Nonclinical tes
y the substantial equivalence claim, the BMC-NM, BMC-NM2 were performance bench tested against the Mirage Activa™ (
8) and ComfortGel™ (K092835), the BMC-FM was performance b
Te besting includes performance test, dans heat tost and disinest. In the performane ests.it ums
the pasive chiation on the cessare of tow and the dedepter anders of ander o
op tests show that BMC-NM, BMC-NM2, BMC-FM(Fully assembled and without packaging) and the carton packaging are
and routine handling.
lamp heat tests state that the BMC-NM2 and BMC-FM withstand damp heat test with no damage to mask component
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| Premarket Notification 510(k) Submission-510(k) SummaryReport No.: BMC-TF (FDA)-STA |
|---|
| without noticeable degradation of materials or negative impact of component form, fit or function. |
| The disinfection validation tests show that the BMC-NM, BMC-NM2,BMC-FM may be either thermally or chemically disinfected/reprocessedthirty (30) times with no damage to mask components, and without noticeable degradation of materials or negative impact of component form,fit or function. |
| In a conclusion, The test reports show that the BMC-NM Nasal Mask, BMC-NM2 Nasal Mask and BMC-FM Full Face Mask are substantiallyequivalent to the predicate device. |
| 7.3 Clinical test |
| Use of face masks with CPAP or bi-level therapy is proven technology and is well accepted by the medical community. The Bench testingdemonstrates that the devices perform in an equivalent manner or that they are substantially equivalent to the predicate devices. |
| 8. Conclusion: |
| The conclusion drawn from these tests is that the performance of the nasal mask BMC-NM, BMC-NM2 and full face mask BMC-FM aresubstantially equivalent to the predicate devices. |
.
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Image /page/13/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three arms or branches extending upwards. The figure is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 23, 2014
BMC Medical Co., Ltd. Ms. Jiniing 5/F Main Building, No.19 Gucheng Street West Shijingshan, 100043 Beijing, PEOPLE'S REPUBLIC OF CHINA
Re: K133009
Trade/Device Name: Nasal mask BMC-NM, BMC-NM2 and Full face mask BMC-FM Regulation Number: 21 CFR 868.5905 Regulation Name: Vented Face Mask Regulatory Class: Class II Product Code: BZD Dated: March 20, 2014 Received: March 24, 2014
Dear Ms. Jinjin:
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.
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Page 2 - Ms. Jinjing
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Digitally signed by
Richard C. Chapman
Date: 2014.04.23
14:23:55 -04'00'
for
. I' . ..
Erin I. Keith Acting Division Director Division of General Hospital, Respiratory, Anesthesiology Infectious 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
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known) K133009
Device Name
Nasal mask BMC-NM, BMC-NM2 and Full face mask BMC-FM
Indications for Use (Describe)
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.
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.
THE SECT OF CONTRACT CONTRACTOR FOR FOR FOR FOR FOR FOR FOR FOR MESSION OF STORES OF CONSTITUTION OF
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
James J
Digitally signed by James J. Lee DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, People, cn=James J. Lee, 0.9.2342 19200300.100.1.1=2000954859 Date: 2014.04.23 13:35:24 -04'00'
Anya Harry Acting branch
FORM FDA 3881 (9/13)
8 PSC Publishing Services (30)) 441-6740
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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."
§ 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).