(382 days)
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 |
§ 868.5630 Nebulizer.
(a)
Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.(b)
Classification. Class II (performance standards).