(486 days)
The Smiths Medical acapella® Choice Blue Vibratory PEP Device is intended for use as a Positive Expiratory Pressure (PEP) device for adults and children (5 years and up). It may also be used simultaneously with nebulized aerosol drug delivery.
The subject and predicate acapella® devices are within Smiths Medical's product family for a therapeutic spirometer hand-held vibratory positive expiratory pressure (PEP) device provided to the end-user as a non-sterile, single patient use. The subject device helps aid in the mobilization and expectoration of secretions that accumulate in the lungs of adult and pediatric users who may have Cystic Fibrosis, COPD, asthma, including lung diseases with secretory problems, and patients with atelectasis.
The subject device provides PEP therapy to a patient by producing airflow vibrations that can be delivered in any position to effectively mobilize secretions, open airways and deliver medication (nebulization). These devices have been found to give independence to patients with chronic respiratory diseases, as the therapy can be done at the patient's convenience without the need for clinical assistance.
This document, a 510(k) Premarket Notification from Smiths Medical for the acapella® Choice Blue Vibratory PEP Device, focuses on demonstrating substantial equivalence to a predicate device (acapella® DH) rather than proving the device meets new acceptance criteria through a comprehensive clinical study as one might expect for a novel AI/imaging device. Therefore, much of the requested information regarding AI model performance (e.g., sample size for training/test sets, expert adjudication, MRMC studies, standalone performance) is not applicable or present in this document, as the device is a mechanical medical device, not an AI or imaging system.
The "acceptance criteria" discussed here primarily revolve around demonstrating that the new device's performance is comparable to or better than the predicate device across various non-clinical engineering and functional characteristics.
Here's the information extracted and interpreted based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't provide a single, consolidated table of clearly defined "acceptance criteria" with quantitative "reported device performance" for each. Instead, it describes general non-clinical tests and states that they "passed and were verified against their requirements and acceptance criteria." The comparison is primarily against the predicate device.
Key Performance / Equivalence Assessments:
| Feature/Test | Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|---|
| Device Performance (Bench Testing) | Must maintain fundamental scientific technology (positive expiratory pressure therapy, oscillatory frequency, etc.). Minimum expiratory flow required of 15 L/M must be met. Functional performance (drop, online therapeutic output, orientation, breakaway pressure, inhalation mode resistance, stutter tests) must meet specifications. | "The technology for delivery PEP therapy is unchanged between the subject and the predicate devices." "The subject device shares the same technological characteristics as the 510(k) cleared for the predicate device, acapella® DH (K002768)." "Minimum expiratory flow required: 15 L/M" "Performance testing (bench) - drop, online therapeutic output, orientation, breakaway pressure, inhalation mode resistance and stutter tests. (...) passed and were verified against their requirements and acceptance criteria." "The principal of operation is identical to the predicate." |
| Nebulizer Compatibility & Drug Delivery | Aerosol performance of any medication, nebulizer, and flow rate should not be statistically different (at 95% confidence) between the acapella® Choice Blue and acapella® DH when compared to the nebulizer by itself. Drug delivery performance with the new device + nebulizer should be clinically comparable to the nebulizer alone. | "Specifications were established via a performance test using an eight-stage cascade impactor..." "The acceptance criteria of the test were that the aerosol performance of any medication, nebulizer, and flow rate would not be statistically different at a confidence level of 95% between the acapella® Choice Blue Vibratory PEP Device and acapella® DH as compared to the nebulizer by itself." "The delivery of aerosolized drugs with acapella® Choice Blue Vibratory PEP Device when connected to a small volume nebulizer was found to be clinically comparable to the performance of the nebulizer alone." |
| Reprocessing (Cleaning & Disinfection) | New cleaning method (soap/water & boiling water) must be validated. | "Reprocessing (cleaning and disinfection) verification (...) passed and were verified against their requirements and acceptance criteria." "Cleaning and disinfection methods are different, and the differences validated." |
| Biocompatibility | Must be biocompatible per ISO 10993-1 for external communicating (indirect gas pathway) and mucosal membrane contact, with prolonged duration of use. Must be biocompatible per ISO 18562 for gas pathway safety. | "Biocompatibility per ISO 10993-1 (...) passed and were verified against their requirements and acceptance criteria." "Biocompatibility per ISO 18562 for gas pathway safety (...) passed and were verified against their requirements and acceptance criteria." |
| Other Non-Clinical Tests (E.g., Packaging, Shelf-Life, Temp Exposure) | Must meet established standards (e.g., ASTM D4169 for packaging). Device must maintain performance over its stated shelf-life (2 years) and under anticipated environmental conditions. | "Temperature exposure and accelerated aging (...) passed and were verified against their requirements and acceptance criteria." "Packaging (transport and distribution) per ASTM D4169 (...) passed and were verified against their requirements and acceptance criteria." "Shelf-life: 2 years." |
| Overall Substantial Equivalence | Differences from the predicate device (materials, openable body for cleaning) must not affect intended use or indication for use, alter fundamental scientific technology, raise new questions of safety/risks, or impact effectiveness compared to the predicate. | "Smiths Medical has determined these two (2) modifications do not affect the device's intended use, indication for use or alter the device's fundamental scientific technology of Positive Expiratory Pressure therapy." "The differences between the subject and predicate device do not impact the indications for use, intended use, mechanical and/or fundamental scientific technology of the device, do not raise new or different questions of safety risks imposed on the patient or device use and that the subject device is as safe and effective as the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set:
- For Nebulizer compatibility/drug delivery verification: "Three (3) device samples were tested per each drug." (Drugs mentioned: albuterol sulfate, cromolyn sodium, ipratropium bromide). This indicates a sample size of 3 devices per drug for this specific test.
- For other non-clinical bench tests (e.g., performance, reprocessing, packaging, biocompatibility, temperature exposure/accelerated aging), specific sample sizes are not provided in this summary, but it's stated that "components comprising each configuration... were assessed and tested appropriately to design controls."
- Data Provenance: Not explicitly stated, but given it's a 510(k) submission for a physical medical device, the data provenance would be from internal laboratory bench testing and verification studies conducted by the manufacturer, Smiths Medical, or their designated testing facilities. It is inherently "prospective" in the sense that the new device was built and then tested to demonstrate performance. Origin (country) is not specified but Smiths Medical is listed with a Minneapolis, MN address.
3. Number of Experts Used to Establish Ground Truth for Test Set and Qualifications
This information is not applicable and not provided in this document. This is a submission for a mechanical medical device, not an AI/imaging device requiring expert interpretation of diagnostic output to establish ground truth. The "ground truth" for this device's performance is based on physical measurements and adherence to engineering specifications and comparison to the predicate device.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. Adjudication methods (e.g., 2+1, 3+1) are relevant for clinical studies involving human interpretation (e.g., radiology reads) where discrepancies need to be resolved. This document describes non-clinical engineering and functional testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC study was not done. This type of study is relevant for AI systems or diagnostic tools where human readers are interpreting images or data, and the effect of AI assistance on human performance is being evaluated. This document is for a mechanical therapeutic device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This concept is not applicable to this device. A "standalone" performance study refers to an AI algorithm's diagnostic accuracy without human involvement. This device is a physical therapeutic device, not an algorithm. Bench tests were performed on the device to assess its mechanical and physical performance.
7. The Type of Ground Truth Used
The "ground truth" for this review is primarily based on:
- Engineering Specifications and Bench Test Results: Adherence to defined physical parameters, flow rates, pressure generation, durability, and material properties.
- Comparison to Predicate Device: The performance and characteristics of the new device are directly compared to the legally marketed predicate device (acapella® DH) to demonstrate substantial equivalence.
- Established Standards: Compliance with relevant ISO standards (e.g., ISO 10993-1 for biocompatibility, ISO 18562 for gas pathway safety) and ASTM standards (e.g., ASTM D4169 for packaging).
8. The Sample Size for the Training Set
This information is not applicable and not provided. This device is not an AI/machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
This information is not applicable and not provided, as there is no training set for a mechanical medical device.
§ 868.5690 Incentive spirometer.
(a)
Identification. An incentive spirometer is a device that indicates a patient's breathing volume or flow and that provides an incentive to the patient to improve his or her ventilation.(b)
Classification. Class II (performance standards).