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510(k) Data Aggregation
(382 days)
Ultrasonic Mesh Nebulizer
The Ultrasonic Mesh Nebulizer designed to aerosolized liquid medications for inhalation by patient, the device may be used with pediatic (>4 years of age), defined by the prescribed medication, and adult patients in the home, hospital and sub-acute care settings.
It is not intended for use with Pentamidine.
The proposed devices are vibrating mesh nebulizers that use low frequency vibration to create aerosol and deliver aerosolized medication to the lower respiratory tract by using a vibrating mesh to create aerosol and provide fine particles to the patient's lungs. The mesh plate has holes to create low velocity aerosol.
The proposed devices are portable size, curvaceous body design that is convenient to hold, Which are battery powered, 3.7V d.c. internally lithium battery. The medication container capacity is 8ml maximum.
For devices, they are pushed by certain circuit frequency vibration to make piezoelectric ceramic vibrate harmony that caused high speed vibration of metal mesh. And the medicine liguid will be quickly popped through micro mesh hole of metal mesh plate to be countless micro atomizing particles. This will be further transferred by inhalation treatment using masks or mouthpieces to patients' respiratory system.
There are 3 models included, MY-123/MY-125/ the three models have same intended use, mechanism of action, principle and specification. The difference between three models is appearance.
The provided text describes a 510(k) premarket notification for an Ultrasonic Mesh Nebulizer (K201397). This submission focuses on demonstrating substantial equivalence to a predicate device (Intelligent Mesh Nebulizer, K171549) rather than proving the device meets acceptance criteria through a traditional clinical study with defined performance metrics for an AI/CAD/imaging device.
Therefore, the requested information regarding acceptance criteria, study design for proving device performance, sample sizes, expert involvement for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable in the context of this 510(k) submission.
The document primarily provides a comparison of the proposed device's characteristics and performance to a predicate device to demonstrate substantial equivalence. The "acceptance criteria" here are implicitly that the new device performs "as well as" the predicate device in terms of aerosol delivery characteristics and various safety tests.
Here's how the provided information aligns with your request, highlighting the differences:
1. Table of Acceptance Criteria and Reported Device Performance
Instead of clearly defined acceptance criteria with pass/fail thresholds for clinical performance (as would be typical for an AI/CAD device), the document presents a comparative table showing the performance characteristics of the Subject Device (Ultrasonic Mesh Nebulizer) against the Predicate Device (Intelligent Mesh Nebulizer).
The "acceptance" in this context is based on the new device being sufficiently similar to and performing comparably to the legally marketed predicate device across various parameters.
| Item | Predicate Device (Intelligent Mesh Nebulizer - K171549) | Subject Device (Ultrasonic Mesh Nebulizer) | Remark (Comparison for Substantial Equivalence) |
|---|---|---|---|
| General Comparison | |||
| K Number | K171549 | / | / |
| Sponsor | Qingdao Future Medical Technology Co., Ltd | Shenzhen Ivankaca Technology Co., Ltd | / |
| Trade/Device Name | Intelligent Mesh Nebulizer | Ultrasonic Mesh Nebulizer | / |
| Model(s) | NEB002 | MY-123, MY-125, MY-126 | / |
| Regulation Number | 21 CFR 868.5630 | 21 CFR 868.5630 | same |
| Regulation Name | Nebulizer | Nebulizer | same |
| Classification Name | Nebulizer (Direct Patient Interface) | Nebulizer (Direct Patient Interface) | same |
| Regulatory Class | Class II | Class II | same |
| Product Code | CAF | CAF | same |
| Review Panel | Anesthesiology | Anesthesiology | same |
| Intended Use/Indications for Use | Designed to aerosolized liquid medications for inhalation by patient, used with pediatric (>4 years) and adult patients in home, hospital, sub-acute care settings. Not for Pentamidine. | Designed to aerosolized liquid medications for inhalation by patient, used with pediatric (>4 years) and adult patients in home, hospital, sub-acute care settings. Not for Pentamidine. | same |
| Prescription/OTC | Prescription | Prescription | same |
| Performance Comparison | |||
| Lithium battery | 3.7Vd.c. | 3.7Vd.c. | Same |
| Nebulizing Method | Vibrating Mesh | Vibrating Mesh | same |
| Vibration Frequency | Approx. 110KHz | Approx. 110KHz | same |
| Nebulization Rate/Aerosol Flow rate | 0.2ml/min minimum | 0.2ml/min minimum | same |
| Medicine Capacity | 8ml maximum, 0.5ml minimum | 8ml maximum, 0.5ml minimum | same |
| Nebulizer Components Cleanable | Yes | Yes | same |
| Use | Single Patient | Single Patient | same |
| Patient Connector | Mouthpiece or mask | Mouthpiece or mask | same |
| Dimensions (mm) | 50mm(L)×74mm(W)×111mm(H) | Approx. 42(L)x55(W)x109(H)mm (MY-123); 49(L)x56(W)x120(H)mm (MY-125); 45(L)x47(W)x120(H)mm (MY-126) | different |
| Weight (kg) | Approx. 106g | MY-123: 113±5g; MY-125: 116±5g; MY-126: 110±5g | different |
| Operating Conditions | 5°C to 40°C, 15% to 90% RH | 5°C to 40°C, 15% to 90% RH | same |
| Storage Conditions | -25°C to 70°C, ≤90% RH | -25°C to 70°C, ≤90% RH | same |
| Safety Comparison | |||
| Patient Contact Materials | PVC | PVC | same |
| Biocompatibility | Comply with 10993-1 | Comply with 10993-1 (various tests listed: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Ames Test, Chromosomal Aberration, Micronucleus Test, Subcutaneous Implantation Test, and ISO 18562 suite for respiratory gas pathways) | same (compliance) |
| Electrical safety | Comply with 60601-1 | Comply with AAMI/ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) | same (compliance) |
| EMC | Comply with 60601-1-2 | Comply with IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests | same (compliance) |
| Comparative Particle Test | (Values for Salbutamol, Budesonide, Ipratropium bromide with Big mask) | (Values for Salbutamol, Budesonide, Ipratropium bromide with Mouthpiece, Small mask, Big mask) | Comparable ranges |
| MMAD(µm) | 3.70±0.66 (Salb.); 3.29±0.12 (Budes.); 3.87±0.72 (Ipra.) | Mouthpiece: 3.68±0.68, 3.28±0.08, 3.84 ± 0.66; Small mask: 3.75±0.63, 3.25±0.11, 3.85 ± 0.66; Big mask: 3.72±0.65, 3.31±0.10, 3.88 ± 0.68 | Considered comparable |
| GSD | 1.85±0.04 (Salb.); 2.50±0.033 (Budes.); 1.81±0.03 (Ipra.) | Mouthpiece: 1.84±0.03, 2.44±0.02, 1.83 ± 0.035; Small mask: 1.86±0.05, 2.46 ± 0.025, 1.84 ± 0.035; Big mask: 1.82 ± 0.035, 2.48 ± 0.031, 1.84 ± 0.032 | Considered comparable |
| Respirable fraction (1-5 µm) | 62.8% ± 11.3 (Salb.); 57.6% ± 9.8 (Budes.); 63.8% ± 11.6 (Ipra.) | Mouthpiece: 63.5% ± 10.5, 61.7% ± 10.5, 62.4% ± 10.6; Small mask: 63.8% ± 11.8, 60.8 % ± 11.6, 63.4% ± 11.3; Big mask: 64.5% ± 10.2, 58.8% ± 10.2, 64.5% ± 11.9 | Considered comparable |
| Fine particle fraction (FPF |
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(122 days)
ULTRASONIC MESH NEBULIZER
The ultrasonic mesh nebulizer model NM211A is an ultrasonic (vibrating mesh) nebulizer system designed to aerosolize medications for inhalation by the patient. The device may be used by adult and pediatric patients at the discretion of their physician at home, hospital & sub-acute care setting.
The ultrasonic mesh nebulizer model NM211A is an ultrasonic (vibrating mesh) nebulizer system designed to aerosolize medications for inhalation by the patient.
The provided text is a 510(k) summary for a medical device (Ultrasonic Mesh Nebulizer Model NM211A), which primarily focuses on regulatory clearance based on substantial equivalence to a predicate device. It states the indications for use but does not contain information about specific acceptance criteria or a study proving the device meets those criteria, especially in the context of AI/ML performance.
Therefore, I cannot provide the requested information from the given document. The document describes a traditional device clearance, not one for an AI/ML-driven medical product that would typically involve acceptance criteria related to algorithm performance, training/test sets, ground truth establishment, or clinical effectiveness studies as described in your prompt.
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(173 days)
ULTRASONIC MESH NEBULIZER
The ultrasonic mesh nebulizer model NE105 is an ultrasonic (vibrating mesh) nebulizer system designed to aerosolize medications for inhalation by the patient. The device may be used by adult and pediatric patients at the discretion of their physician at home, hospital &sub-acute care setting.
The Ultrasonic Mebulizer NE105 is similar to the predicate device, the FDA-cleared Model NE-U22 Micro Air Vibrating Mesh Nebulizer, cleared under 510(k) K062263. Similarities are that both, the NE105 and the predicate NE-U22, are identical in purpose, function, core technology and method of operation. They are single-patient use, reusable electronic nebulizers, using micro-perforated vibrating mesh technology to aerosolize liquid medications. They have the same 'Indication for Use' stating that they are for inhalation therapy by adults and pediatric patients in a home, hospital & sub-acute care setting. Both devices are hand-held and portable. Power input for both devices is provided by either AA batteries or an AC/DC adapter. The model NE105 incorporates several design differences in comparison with the predicate NE-U22, mainly body shape, dimension/weight, a larger capacity reservoir, power source and software controlled electronics.
The provided 510(k) summary for the Ultrasonic Mesh Nebulizer NE105 focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with acceptance criteria and performance data in a typical clinical trial format.
Here's a breakdown of the requested information based on the document:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence submission for a nebulizer, the "acceptance criteria" are primarily based on demonstrating performance similar to the predicate device and compliance with relevant safety and performance standards. There isn't a direct table of clinical performance metrics like sensitivity/specificity. Instead, the performance is assessed through non-clinical tests.
| Acceptance Criteria (Demonstrated Equivalence/Compliance) | Reported Device Performance |
|---|---|
| EMC and Electrical Safety (Compliance with IEC 60601-1, IEC 60601-1-2) | Verification by testing laboratories; certified with Declaration of Conformity. Device conforms to all applicable requirements in its intended operational environment. |
| Biocompatibility (Compliance with ISO 10993-1 for body-contacting components) | Testing (Cytotoxicity, Sensitization, Subchronic Toxicity, Genotoxicity, Implantation) confirmed biocompatibility of materials. |
| Software Performance (Performs within specifications, safe for intended use) | Test results concluded software performs within specifications and is safe. Permanent hazard analysis implemented in development process; clear software architecture; test protocol sufficiently verifies main functional operation. |
| Cleaning Effectiveness (Sufficiency of cleaning instructions) | Validation of manual cleaning method confirmed nebulizer can be cleaned as per instructions. |
| Simulated Lifetime Performance (No change in performance, effectiveness, safety after simulated lifetime) | "Simulated Lifetime Study" by renowned laboratory and in-house 1000-cycle life test concluded no change in performance, effectiveness, and safety when cleaned as per instructions. |
| Aerosol Characterization (Particle Size Distribution) (Results in line with predicate device) | Performed by Piper Medical Lab. All tests confirmed results were in line with the predicate device. |
| Aerosol Characterization (Total Medication Dose Delivered) (Results in line with predicate device) | Performed by Piper Medical Lab. All tests confirmed results were in line with the predicate device. |
| Inter-Sample and Intra-Sample Variability (No measurable inter-sample variance) | Tests showed no indication of any measurable inter-sample variance. |
| Overall Performance Equivalence to Predicate | Model NE105 performed equally well compared with the predicate device across all aerosol characterization tests. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify a "sample size" in the context of human subjects or clinical data, as it explicitly states, "The NE105 did not conduct, nor rely upon, clinical tests to determine substantial equivalence." The testing described is primarily laboratory-based and engineering/design validation. For simulated lifetime testing, "an in-house 1000-cycle life test was performed," which could be considered a sample size for that specific test.
- Data Provenance: Not applicable as clinical data was not used for this submission. The tests were performed by various "testing laboratories" and "Piper Medical Lab," implying engineering/testing facilities. The submitter is from China.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This submission relies on objective engineering and laboratory test results against established standards and comparison to a predicate device, not subjective expert assessment of clinical data to establish a "ground truth."
4. Adjudication Method for the Test Set
Not applicable. There's no clinical test set requiring adjudication in this submission.
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. This is a medical device for drug delivery (nebulizer), not an AI-powered diagnostic or interpretive device. Therefore, no MRMC or AI-assisted studies were performed or are relevant.
6. If a Standalone (i.e. algorithm only, without human-in-the-loop performance) was done
Not applicable. This device does not involve an algorithm for interpretation or diagnosis; it is a physical device for drug delivery.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established through:
- Compliance with recognized standards: IEC 60601-1, IEC 60601-1-2, ISO 10993-1.
- Benchmarking against a predicate device: Specifically for aerosol characterization (particle size distribution and total medication dose delivered).
- Design validation tests: Ensuring the device meets its own specified design requirements (e.g., software functionality, cleaning effectiveness, simulated lifetime).
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device that requires a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable, as no training set was used.
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