(297 days)
The Ultrasonic Nebulizer is intended to transform liquid medications into aerosol form for patient inhalation. The device can be used by adult or pediatric patients for respiratory treatment in the home, hospital or healthcare environment.
The Ultrasonic Nebulizer is a small, compact, and battery powered potable nebulizer which transforms liquid medicines into aerosol form and delivers directly to patient for inhalation. It makes patient's respiratory treatment easier and more convenient.
Here's an analysis of the K-jump® Ultrasonic Nebulizer based on the provided text, focusing on acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not contain a specific table of "acceptance criteria" for performance that would typically be found in a detailed validation study. Instead, the document focuses on demonstrating substantial equivalence to a predicate device by comparing technological characteristics and compliance with general safety and performance standards.
However, we can infer some performance characteristics and compliance requirements:
| Characteristic/Acceptance Criteria (Implied) | Reported Device Performance (K-jump Ultrasonic Nebulizer) | Predicate Device Performance (Omron Micro Air) |
|---|---|---|
| Safety and Essential Performance | Complies with ANSI/AAMI ES60601-1:2005 | Implied compliance with equivalent standards |
| Electromagnetic Compatibility (EMC) | Complies with ANSI/AAMI/IEC 60601-1-2:2007 | Implied compliance with equivalent standards |
| Nebulization Rate | 0.3 ml/min (Typical) | 0.25-0.9 ml/min |
| Vibrating Frequency | 190 kHz | 180 kHz |
| Ampoule Capacity | 7.0 ml | 7.0 ml |
| Operation Temperature | 5°C ~40°C | 0°C~45°C |
| Operation RH | 15%-93% RH (non-condensing) | 30%-85% RH |
| Storage Temperature | -25°C~70°C | -25°C~70°C |
| Storage RH | Up to 93% RH (non-condensing) | 10%-90% RH |
| Overall Intended Use | Similar to predicate | Similar |
| Overall Technology | Similar to predicate (Mesh Type) | Similar (Vibrating Mesh) |
Important Note: The document emphasizes "similar performance" and "compliance with equivalent safety standards" rather than showing specific quantitative performance targets met by the K-jump device and then presenting raw data to prove those targets were met. This is typical for a 510(k) submission where substantial equivalence to a legally marketed predicate device is being demonstrated.
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify a sample size for a "test set" in the context of clinical or performance data for this device. The submission relies on demonstrating compliance with recognized standards and similarity in technological characteristics to a predicate device.
- Sample size for test set: Not specified/applicable in this document's context.
- Data Provenance: The document does not describe patient or clinical data that would have a provenance (e.g., country of origin, retrospective/prospective). The data presented for the K-jump device are engineering specifications and compliance declarations.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The document does not describe a study involving expert-established ground truth for a test set. This type of submission focuses on engineering specifications and regulatory compliance, not typically on diagnostic accuracy or interpretation by human experts.
4. Adjudication Method for the Test Set
Not applicable. There is no mention of a test set requiring adjudication in this document.
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 device is an ultrasonic nebulizer, not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is outside the scope of this submission.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a medical apparatus, not an algorithm, so "standalone" algorithm performance is not relevant.
7. The Type of Ground Truth Used
Not applicable. The "ground truth" concept (e.g., pathology, outcomes data) is not relevant for this type of device submission, which focuses on device functionality, safety, and equivalence to a predicate. The "truth" here is established through engineering testing and compliance with recognized standards.
8. The Sample Size for the Training Set
Not applicable. The K-jump Ultrasonic Nebulizer is a physical medical device, not an AI or machine learning algorithm. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
§ 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).