(606 days)
The Shinmed Ultrasonic Nebulizer is intended to spray liquid medications in aerosol form into gases that are directly delivered to the patient.
The Shinmed Ultrasonic Nebulizer is a standard direct current - ultrasonic nebulizer system designed to atomize medications into gases for patient direct breathing. The device consists of a tabletop high-frequency main unit which provides an occillation frequency of 1.63 MHz. The 30 cc disposable medicine cup in the main unit. A mask or mouthpiece is attached to the main unit with a flexible hose. The patient breaths the medicine through the mask or mouthpiece.
The provided document is a 510(k) summary for the Shinmed SW-966 Ultrasonic Nebulizer, focusing on its substantial equivalence to a predicate device. It contains very limited details regarding formal acceptance criteria or a dedicated study with statistical endpoints to "prove" the device meets acceptance criteria in the way a clinical trial for a new drug or algorithm would.
Instead, the document emphasizes equivalence in performance characteristics to a legally marketed predicate device. The "study" mentioned is a nebulizer characterization study, which compares the Shinmed device to the predicate device.
Here's an attempt to extract and present the requested information based on the provided text, with many fields being 'Not Applicable' or 'Not Specified' due to the nature of this type of regulatory submission (which focuses on equivalence rather than de novo performance proof).
Acceptance Criteria and Device Performance for Shinmed SW-966 Ultrasonic Nebulizer
The provided 510(k) summary for the Shinmed SW-966 Ultrasonic Nebulizer primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, the MicroSonic nebulizer (marketed as Lumiscope, K924081). The "acceptance criteria" can be inferred from the comparative performance data presented, which aims to show that the Shinmed device performs similarly to the predicate.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Equivalence) | Reported Device Performance (Shinmed SW-966) |
|---|---|
| Maximum Particle Size (MPS) distribution data below 10 microns (FDA suggested) | Produced MPS distribution data below 10 microns. |
| Amount of drug delivered similar to predicate device | Amount of drug delivered was similar to the predicate device. |
| Intended Use: Spray liquid medications in aerosol form into gases for direct patient delivery | Intended Use (stated): "The Shinmed Ultrasonic Nebulizer is intended to spray liquid medications in aerosol form into gases that are directly delivered to the patient." (Matches predicate's intended use) |
| Principal of Operation: Ultrasonic nebulization | Principal of Operation (stated): "standard direct current - ultrasonic nebulizer system designed to atomize medications into gases for patient direct breathing." (Matches predicate's principal of operation) |
| Technological Characteristics: No significant differences from predicate | "There are no significant differences in the characteristics of the subject devices and the predicates." |
| Oscillation frequency: 1.63 MHz (matching predicate) | Provides an oscillation frequency of 1.63 MHz. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document refers to "Nebulizer Characterization Studies" but does not detail the number of devices or measurement replicates used.
- Data Provenance: The device is manufactured by Shining World Healthcare Co., Ltd. in Taiwan. The characterization studies were presumably conducted by or for the manufacturer. No country of origin for the specific data collection is stated, nor is it explicitly labeled as retrospective or prospective. Given it's a pre-market submission, it would be prospective for the purpose of the submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Not Applicable. This type of device (ultrasonic nebulizer) primarily relies on objective physical measurements (e.g., particle size, drug output) rather than expert interpretation or ground truth derived from expert consensus. The "ground truth" here is the physical performance measurement itself.
4. Adjudication Method for the Test Set
- Not Applicable. As there are no expert interpretations involved in determining the core performance metrics, no adjudication method is necessary.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. An MRMC study is not relevant for this type of device. There are no human readers or interpretations of output typically associated with ultrasonic nebulizers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not Applicable. This is a physical medical device, not a software algorithm. Its "standalone performance" is implicitly what the nebulizer characterization studies evaluated.
7. The Type of Ground Truth Used
- Objective Physical Measurements: The ground truth for performance relied on direct physical measurements of the nebulizer's output, specifically:
- Median Particle Size (MPS) distribution (measured in microns).
- Amount of drug delivered.
8. The Sample Size for the Training Set
- Not Applicable. There is no "training set" in the context of this physical device. The device's design and manufacturing processes are established, and its performance is verified through functional testing.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set, this question is not relevant.
§ 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).