(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.
§ 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).