(104 days)
The SmartVest® Airway Clearance System, Model SQL is designed to deliver high frequency chest wall oscillation to promote airway clearance and improve bronchial drainage. The SmartVest System is indicated when external chest manipulation is the physician's treatment of choice to enhance mucus transport.
The modified Electromed SmartVest® Airway Clearance System, Model SQL is an electrically powered percussor device designed to deliver high frequency chest wall oscillation (HFCWO) to aid in freeing mucus deposits in the lungs in order to improve bronchial drainage under the order of a physician's prescription. The primary components of both the proposed modified and predicate HFCWO Airway Clearance Systems consist of an Air Pulse Generator, an Inflatable Vest, and an Air Hose that connects the Generator to the Inflatable Vest. The Air Pulse Generator produces small volumes of pressurized air pulses that are rapidly delivered to the Inflatable Vest via the Air Hose at a selected oscillatory frequency between 5-20 times per minute (Hz). The Inflatable Vest imparts the oscillatory air pulses as pressure forces to the patient's external chest wall. These pressurized air pulses promote transient increases in airflow within the lungs that loosens mucus sufficiently to facilitate expulsion by the patient when normal respiratory function is not capable.
The Electromed SmartVest® Airway Clearance System, Model SQL, is an electrically powered percussor device designed to deliver high-frequency chest wall oscillation (HFCWO) to aid in freeing mucus deposits in the lungs. The primary components are an Air Pulse Generator, an Inflatable Vest, and an Air Hose. The Air Pulse Generator produces pressurized air pulses (5-20 Hz) delivered to the Inflatable Vest via the Air Hose, which then applies these oscillatory pulses to the patient's chest wall. This action promotes transient increases in airflow to loosen mucus, facilitating expulsion.
The provided documentation describes the acceptance criteria and the study that proves the device meets the acceptance criteria as follows:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Device Performance (Modified SmartVest® Airway Clearance System, Model SQL) |
|---|---|
| Output Performance Equivalence to Predicate Device (SmartVest® Airway Clearance System, Model TL: K053248) for: |
- Air Pulse Pressure
- Air Pulse Frequency
- Treatment Time | Demonstrated equivalence between the modified and predicate devices for air pulse pressure, air pulse frequency, and treatment time through comparison performance testing. |
| Safety and Effectiveness (no new risks compared to predicate) | Formal risk analysis revealed no new risks.
The modified device has identical indications for use, the same patient population, and the same fundamental scientific technology, not raising additional questions of safety or effectiveness. |
| Design Control Compliance (21 CFR 820) | All modification and design activities were conducted in conformance to 21 CFR 820.30 Design Control. |
| Design Verification (meeting design input requirements) | Design verification testing, including software, demonstrated that design output specifications met design input requirements. |
| Usability/Human Factors (enhanced user operation, less potential for errors) | Usability/human factors testing demonstrated enhanced user operation with less potential for errors compared to the predicate. |
| Electromagnetic Compatibility (EMC) | The modified design passed electromagnetic compatibility testing. |
| Electrical Safety | The modified design passed electrical safety testing and UL testing. |
| Compliance with Recognized Standards: - IEC 60601-1 3rd edition
- IEC 60601-1-2 3rd edition
- IEC 60601-1-6 3rd edition
- IEC 60601-1-11 3rd edition
- UL testing
- ASTM D4169-09 DC13 (Performance Testing of Shipping Containers and Systems) | The device underwent and presumably passed testing in accordance with these standards. (The document states "Testing included" these and "The modified design passed... electrical safety testing and UL testing" and "Design verification testing... demonstrated that the design output specifications met the design input requirements" which implies passing criteria for these standards were met.) |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state a specific "test set" sample size or data provenance in terms of country of origin or whether data was retrospective or prospective for the performance and safety testing. The studies mentioned are primarily engineering and usability tests comparing the modified device to its predicate.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. This device modification primarily involved engineering and usability changes to an existing, cleared device. The "ground truth" was established through comparison testing against the predicate device's established performance, compliance with regulatory standards, and internal design controls, rather than through expert-adjudicated clinical data of patient outcomes.
4. Adjudication Method for the Test Set:
Not applicable. No clinical adjudication of results is mentioned, as the studies are focused on product performance, safety, and equivalence to a predicate.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. The documentation focuses on engineering, performance and safety testing of the device itself and its equivalence to a predicate, not on the comparative effectiveness of human readers with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This device is a medical apparatus (a percussor) and not an algorithm or AI system.
7. The Type of Ground Truth Used:
The "ground truth" for the device's performance relies on several factors:
- Predicate Device Performance: The primary ground truth for output performance (air pulse pressure, frequency, treatment time) was the performance of the legally marketed predicate device (SmartVest® Airway Clearance System, Model TL: K053248).
- Regulatory Standards: Compliance with established electrical safety and medical device standards (e.g., IEC 60601 series, UL, ASTM) served as a ground truth for safety and general performance.
- Design Input Requirements: The pre-defined design input requirements served as the ground truth for design verification.
- Usability Principles: Principles of usability and human factors served as the ground truth for usability testing.
8. The Sample Size for the Training Set:
Not applicable. This device is a physical medical device, not an AI or machine learning algorithm requiring a "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no "training set" for this physical device.
§ 868.5665 Powered percussor.
(a)
Identification. A powered percussor is a device that is intended to transmit vibration through a patient's chest wall to aid in freeing mucus deposits in the lung in order to improve bronchial drainage and that may be powered by electricity or compressed gas.(b)
Classification. Class II (performance standards).