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The portable (Ultrasonic) nebulizer is an ultrasonic vibrating mesh nebulizer system designed to aerosolize liquid medications for inhalation by the patient. The device may be used with pediatric (5 years and older), defined by the prescribed medication, and adult patients in hospital/ institutional settings, home, schools, and long-term care facilities. It is not intended for use with Pentamidine.

The Portable (Ultrasonic) nebulizer NBM-1 is small, handheld, internally powered general purpose nebulizer which utilizes ultrasound vibrating mesh technology to generate aerosol. The Portable (Ultrasonic) nebulizer provides a vapor mist of medicine that has much smaller particles and can travel much deeper into the patient's lungs, resulting in much faster relief. The ultrasonic nebulizer is made up of main unit, medicine cup, adult mask, kid mask and mouth piece. The shell of nebulizer, battery cover and spray nozzle are made of ABS, the button decoration ring is silica gel, the medicine cup and button are made by PC, the mask is made of PVC, the mouth piece is made of PP and the nebulizer piece is stainless steel.

The provided FDA 510(k) summary for the "Portable (Ultrasonic) Nebulizer" (K230379) does not describe a study involving an AI/Machine Learning diagnostic device or human-in-the-loop performance. Instead, it describes a Class II medical device which is a nebulizer, and its substantial equivalence determination to a predicate device.

Therefore, the request for acceptance criteria and studies proving an AI device meets acceptance criteria (including details like expert ground truth, MRMC studies, standalone performance, training/test set sample sizes, etc.) cannot be fulfilled from the provided document. The document focuses on the physical and electrical safety, performance, and biocompatibility of a medical device, not on the performance metrics of an AI algorithm.

Here's a breakdown of what the document does provide, and why it doesn't fit the requested AI/ML framework:

• Device: Portable (Ultrasonic) Nebulizer (NBM-1) and its predicate device (Intelligent Mesh Nebulizer K171549). These are physical devices that aerosolize liquid medications.

• Acceptance Criteria/Performance (as reported for a physical device): The document reports various physical and performance characteristics, comparing them to the predicate device and relevant standards. This is done to demonstrate "substantial equivalence."

  Acceptance Criteria (from predicate/standards)	Reported Device Performance (NBM-1)
  General
  Product Code: CAF	CAF (SE)
  Regulation #: 21CFR868.5630	21CFR868.5630 (SE)
  Intended Use	Similar (Pediatric 5+ years, adult patients in hospital/institutional settings, home, schools, long-term care facilities; not for Pentamidine) (SE, Remark 1)
  Principle of operation: Vibrating mesh	Vibrating mesh (SE)
  Aerosolization: Continuous during inhalation/exhalation	Continuous during inhalation and exhalation (SE)
  Compressed gas source: None needed	None needed (SE)
  Duration of Use: Single patient, multi-use	Single patient, multi-use (SE)
  Waterproof: IP22	IP22 (SE)
  Protection against electric shock: Type BF applied part	Type BF applied part (SE)
  Type of protection against electric shock: Internally power equipment	Internally power equipment (SE)
  Model of operation: Continuous operation	Continuous operation (SE)
  Power off: ON / OFF Button	On/Off button (SE)
  Patient Connector: Mouthpiece/masks	Mouthpiece or masks (SE)
  Biocompatibility: Compliance with ISO 10993	All patient contacting materials compliant with ISO 10993 (various parts, e.g., -3, -5, -6, -10, -11, -17, -18) and ISO 18562 (various parts, e.g., -1, -2, -3). Concluded biocompatible. (SE)
  Electrical Safety: Compliance with IEC 60601-1 and IEC 60601-1-11	Compliance with AAMI/ANSI ES60601-1:2005/(R)2012, C1:2009/(R)2012 and A IEC 60601-1-11:2015. (SE)
  EMC: Compliance with IEC 60601-1-2	Compliance with IEC 60601-1-2:2014. (SE)
  Software: Compliance with FDA Guidance & IEC 62304	Software verification and validation conducted per FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 1, 2005" and IEC 62304:2015. (SE)
  Clinical Performance
  Ultrasonic Oscillation Frequency: Approx. 110KHz	110 KHz ± 10KHz (SE)
  Nebulization rate: ≥ 0.2 ml/min	>0.2mL/min. (SE)
  Medicine Capacity: 8ml max, 0.5ml min	6 ml (Similar, Remark 2: "within the predicate device"; tested for safety & performance)
  Aerosol Performance (Particle Size MMAD, GSD, Doses)	Subject (NBM-1) vs. Predicate (NEB001) for Various Drugs (Albuterol Sulfate, Ipratropium Bromide, Cromolyn Sodium) - Adult & Pediatric:

  • Particle Size (MMAD):
    NBM-1 Adult: 2.09-2.10; NEB001 Adult: 2.27-2.37
    NBM-1 Pediatric: 3.66-3.64; NEB001 Pediatric: 3.73-3.73
  • Geometric Standard Deviation:
    NBM-1 Adult: 1.94-1.78; NEB001 Adult: 1.80-1.67
    NBM-1 Pediatric: 2.01-1.97; NEB001 Pediatric: 2.10-1.90
  • Total Dose Delivered by device:
    NBM-1 Adult: 1,529-7,236; NEB001 Adult: 1,541-6,983
    NBM-1 Pediatric: 1,593-7,394; NEB001 Pediatric: 1,624-7,279
  • Total Respirable Dose (0.5-5um):
    NBM-1 Adult: 1,048-5,341; NEB001 Adult: 1,133-5,157
    NBM-1 Pediatric: 961-4,581; NEB001 Pediatric: 932-4,369
  • Coarse Particle Dose (>4.7um):
    NBM-1 Adult: 397-1,626; NEB001 Adult: 333-1,507
    NBM-1 Pediatric: 618-2,715; NEB001 Pediatric: 665-2,790
  • **Fine Particle Dose (

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This ultrasonic nebulizer is intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing for use by both the adult and pediatric populations.

The ICEL Evolusonic Portable Ultrasonic Nebulizer has been developed with the patient's necessities in mind for the delivery of spray liquids in aerosol form into gases directly to the patient for breathing, for use by the adult and pediatric populations. The device runs on standard AC power and easily upgrades to battery operation (rechargeable battery or sold separately). It can be plugged into an electrical outlet using the AC/DC converter, and it can also be plugged directly into an automobile cigarette lighter for use when traveling.

The provided text describes the submission for K983736 for the ICEL Evolusonic Portable Ultrasonic Nebulizer. The submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a separate "test set" in the context of clinical data for performance evaluation. All testing described is non-clinical. The "samples" for the non-clinical tests would have been the ICEL Evolusonic Portable Ultrasonic Nebulizer devices, and the tests were performed in a laboratory setting. There is no mention of country of origin for the data or whether it was retrospective or prospective in the clinical sense, as no clinical studies were performed.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. No ground truth in the clinical sense was established by experts for a test set, as no clinical studies were performed. The "ground truth" for the non-clinical tests was based on established engineering standards and guidelines (FDA Reviewer Guidance, IEC 601-1).

4. Adjudication Method for the Test Set

Not applicable. As no clinical studies were performed, there was no expert adjudication process for a test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "No clinical tests were performed and none are submitted with this 510(k) submission."

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical medical device (an ultrasonic nebulizer), not an algorithm or AI. Therefore, the concept of "standalone algorithm performance" is not relevant.

7. The Type of Ground Truth Used

The "ground truth" for this submission refers to compliance with safety and performance standards established by regulatory guidelines.

• Electrical and Environmental Tests: Compliance with requirements outlined in the FDA's "Reviewer Guidance for Premarket Notification Submission" (November 1993 edition).
• EMI Testing: Compliance with requirements outlined in the FDA's "Reviewer Guidance for Premarket Notification Submission" (Para. h7ia).
• Electrical Evaluation: Compliance with IEC 601-1 and the FDA's "Reviewer Guidance for Premarket Notification Submission" (Para. (h)(4) and (h)(6)).
• Nebulizer Characterization Study: Compliance with Federal Good Laboratory Practices (21 CFR Part 58 (FDA) or 40 CFR Part 160 (EPA)) and passing results according to established nebulizer characterization protocols.

8. The Sample Size for the Training Set

Not applicable. The device is a physical medical device, not an AI or algorithm that requires a "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no "training set" for this type of device.

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