(118 days)
The MetaNeb® System is indicated for mobilization of secretions, lung expansion therapy, the treatment and prevention of pulmonary atelectasis, and also has the ability to provide supplemental oxygen when used with compressed oxygen.
The MetaNeb® System is a therapeutic device that uses a systematic approach to enhance normal mucus clearance and resolve or prevent patchy atelectasis. The system has three modes: Aerosol, CHFO (Continuous High Frequency Oscillation), and CPEP (Continuous Positive Expiratory Pressure). There are three major components: Circuit, Controller, and Stand.
Here's an analysis of the MetaNeb® System (K124032) based on the provided 510(k) summary, structured to address your specific points:
Since this is a 510(k) submission for a non-continuous ventilator, the "acceptance criteria" are primarily established by demonstrating substantial equivalence to predicate devices, rather than meeting specific quantifiable performance targets like sensitivity or specificity for an AI device. The study performed is a "comparative effectiveness study" in the sense of comparing the new device's performance to the predicate devices through various bench tests.
Acceptance Criteria and Reported Device Performance
The acceptance criteria for the MetaNeb® System are implicitly derived from demonstrating substantial equivalence to its predicate devices (PowerNeb® CoMedica K051964 and IPV - Percussionaire Corp K895485). This means the device must perform comparably in its intended use, safety, and effectiveness.
Table 1: Acceptance Criteria (as demonstrated by substantial equivalence to predicates) and Reported Device Performance
| Category / Performance Metric | Acceptance Criteria (Implied by Predicate Performance) | MetaNeb® Reported Performance (Range or Value) |
|---|---|---|
| Indications for Use | Mobilization of secretions, lung expansion therapy, prevention of pulmonary atelectasis, ability to provide supplemental oxygen (identical to predicates). | Identical: Mobilization of secretions, lung expansion therapy, treatment and prevention of pulmonary atelectasis, ability to provide supplemental oxygen when used with compressed oxygen. |
| Technology | Pneumatically operated system with CPEP, CHFO, and aerosol only modes (identical to predicates in design and basic function). | Pneumatic system with CPEP, CHFO, and Aerosol Only modes. (Compared to predicates, MetaNeb® has a dedicated Aerosol Only mode, unlike PowerNeb which requires setting CPEP to minimum flow, and IPV which uses an in-line nebulizer without a specific aerosol-only setting). |
| Materials Biocompatibility | Materials in gas/fluid pathway are safe for intended use, as per ISO 10993-1. (Predicates were cleared with their respective materials). | All associated materials in the gas or fluid pathway tested per ISO 10993-1 (Cytotoxicity, Sensitization, Irritation/Intracutaneous reactivity, Genotoxicity, Implantation as applicable). VOC, PM2.5, CO, Ozone testing performed for controller. All found to pass applicable ISO 10993-1 test requirements. |
| Environment of Use | Hospital, sub-acute facilities (identical to predicates). | Identical: Hospitals, sub-acute facilities, physician offices, and clinics (Bird IPV also includes homecare, but MetaNeb®'s scope aligns with the common environment for both). |
| Patient Population | Broad patient population, including adults and children (PowerNeb for "all patients", Bird IPV for "neonates to adults"). | Adult and Child > 2 years old (considered equivalent to predicates, aligning more closely with PowerNeb's general indication). |
| CPEP Mode @ Max Flow | ||
| - Peak Pressure (cmH2O) | Comparable to PowerNeb (32.6 to 35.1) | 27.8 to 29.9 (Lower range than PowerNeb, but within clinically acceptable ranges and demonstrating therapeutic pressure delivery). |
| - Total Respirable Dose (0.5-5um) | Comparable to PowerNeb (Albuterol: 631.5-818.8; Ipratropium: 137.1-155.1; Cromolyn: 2362.1-2695.2) | Albuterol: 735.5 - 890.6 |
| Ipratropium: 149.2 - 187 | ||
| Cromolyn: 2567.6 - 3046.6 (Comparable or slightly higher doses, indicating effective aerosol delivery). | ||
| CHFO Mode @ MetaNeb "High" | ||
| - Peak Pressure (cmH2O) | Comparable to PowerNeb (9.7 to 10.3) and IPV (25.3 to 27.0). | 21.1 to 25.4 (Closer to IPV's pressure range, demonstrating effective oscillation mechanics). |
| - Frequency (BPM) | Comparable to PowerNeb (222 to 235) and IPV (214 to 235). | 226 (Consistent with predicates). |
| - Total Respirable Dose (0.5-5um) | Comparable to PowerNeb (Albuterol: 171.3-202.1; Ipratropium: 30.5-48.3; Cromolyn: 805.4-1002.7) and IPV (Albuterol: 243.7-349.5; Ipratropium: 90-112.7; Cromolyn: 900.1-1196.1). | Albuterol: 139.2 - 200.2 |
| Ipratropium: 27 - 54.6 | ||
| Cromolyn: 673.1 - 948.1 (Lower for PowerNeb comparison, but this is reported under CHFO "MetaNeb High", there is another set of higher values under MetaNeb for albuterol, ipratrompium and cromolyn which are 421.6-572.4, 124.5-204.6, and 1367.9-1903.9 respectively. This indicates a different setting or test condition leads to higher doses, which are comparable to or exceed predicates, showing effective aerosol delivery during CHFO). | ||
| CHFO Mode w/ Ventilator Conn. | ||
| - Peak Pressure (cmH2O) | Comparable to IPV (19.8 to 44.4). | 20.5 to 44.1 (Consistent with IPV). |
| - Frequency (BPM) | Comparable to IPV (226 to 235). | 226 to 231 (Consistent with IPV). |
| - Total Respirable Dose (0.5-5um) | Comparable to IPV (Albuterol: 91.1 ± 10.6; Ipratropium: 97.1 ± 3.4; Cromolyn: 88 ± 9.2). | Albuterol: 95.8 + 13.1 |
| Ipratropium: 110.8 + 8.6 | ||
| Cromolyn: 73.4 + 15.4 (Comparable, showing effective aerosol delivery during CHFO while connected to a ventilator). | ||
| Safety - Contraindications | Similar contraindications to predicates (e.g., untreated tension pneumothorax, pulmonary air leak, recent pneumonectomy, pulmonary hemorrhage, myocardial infarction, vomiting, untrained operator). | Largely identical list of contraindications to PowerNeb, and similar to IPV. |
| Patient Circuit | Disposable or reusable (predicates vary), connection for in-line nebulizer, draw in room air mix, expiratory resistance adjustment. | Disposable "hand-set" with connection for in-line nebulizer, draws in room air mix, expiratory resistance adjustment (similar to PowerNeb). |
| Controller Features | On/off, mode selection, pressure / frequency adjustment, manometer, connection for patient circuit (features vary slightly among predicates). | On/off, mode selection, frequency selection for CHFO mode, pressure adjustment for CPEP mode, pressure manometer, connection for patient circuit (similar and offers convenience features like dedicated Aerosol Only mode compared to predicates). |
Study Details Proving Acceptance Criteria:
The submission relies on a series of non-clinical bench tests to demonstrate substantial equivalence, rather than human clinical trials.
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Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a "sample size" in the context of patients. The "test set" consists of mechanical/bench testing of the device and its components. The specific number of devices or components tested for each experiment (e.g., how many circuits were tested for particulate characterization, or how many full systems for life cycle testing) is not detailed.
- Data Provenance: Retrospective, as it involves laboratory testing conducted by the manufacturer to support the 510(k) submission. Country of origin for the data is assumed to be Singapore where Hill-Rom Services Pte Ltd is located, or at a contracted testing facility.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For a device performance bench test comparing against predicate devices, "ground truth" is established by validated testing methodologies and standards (e.g., aerosol particle sizing, pressure measurements) and comparison against the specifications/performance of legally marketed predicate devices. It doesn't involve expert consensus on medical images or clinical outcomes. The experts involved would be engineers and technical specialists conducting and analyzing the tests.
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Adjudication method for the test set:
- Not Applicable. As this is bench testing for substantial equivalence, clinical adjudication by medical experts isn't part of the process. Test results are compared directly against established engineering parameters, predicate device specifications, and relevant standards (e.g., ISO 10993-1).
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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:
- No. This is not an AI-powered diagnostic device, so a MRMC study is not relevant or applicable.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, in essence. The "standalone performance" is represented by the non-clinical bench testing where the device's technical specifications and performance characteristics (e.g., pressure output, aerosol particle size, frequency of oscillation) are measured directly and compared against the established performance ranges of the predicate devices under controlled laboratory conditions, without human interaction beyond initiating the test.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Technical Specifications and Predicate Device Performance. The "ground truth" for this submission is based on:
- Validated engineering and physics principles (e.g., how pressure is measured, how aerosol particles are characterized).
- Internationally recognized standards (e.g., ISO 10993-1 for biocompatibility).
- The established and cleared performance characteristics of the legally marketed predicate devices.
- Technical Specifications and Predicate Device Performance. The "ground truth" for this submission is based on:
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The sample size for the training set:
- Not Applicable. This is a hardware medical device, not an AI/machine learning algorithm requiring a "training set."
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How the ground truth for the training set was established:
- Not Applicable. As there is no training set for an AI algorithm. The device's design and engineering are based on established pneumatic principles and medical needs for respiratory therapy.
§ 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).