(337 days)
The Monarch™ product is intended to provide Airway Clearance Therapy and promote bronchial drainage where external manipulation of the thorax is the physician's choice of treatment. It is indicated for patients having difficulty with secretion clearance, or the presence of atelectasis caused by mucus plugging. The Monarch™ Airway Clearance System is intended to be used in the Home Care environment by patients, 15 years and older.
The Monarch® Airway Clearance System Model 1000 (hereinafter referred to as Monarch®) consists of a garment which contains actuators together with the Main Control Box and pendant controller. The Main control box contains the electronics used to control the actuators which are organized into 8 discrete zones. The pendant controller is tethered to the garment and consists of an LCD display and selection controls to facilitate visual feedback of the therapy and system information while allowing the user to adjust the therapy settings to adhere to the prescribed therapy ordered by the physician. It has adjustment mechanisms over each shoulder and on each side of the mid torso area to provide the wearer with a personal and evenly distributed snug fit. The buckles on each side of the device together with the front zipper help provide a repeatable fitting by allowing the wearer to wear and remove the garment without making changes to the adjustment mechanisms. The product also includes an external charger for the battery and can run on either power source as per desired by the user. The major components to the Monarch® Airway Clearance System are: . Garment - which contains the "pods" Garment shell covers the underlying the garment ● Pendant controls the device function ● Battery installed in the backpack cover ● Garment adjustment mechanisms means to secure and adjust the fit of the Garment to the user . This submission is specific to an expansion of the contraindication related to active implants. The device is identical to that cleared under K163378.
The provided text describes a 510(k) premarket notification for the Monarch Airway Clearance System Model 1000. This submission specifically addresses an expansion of the contraindication related to active implants, rather than an entirely new device or performance claim where a traditional acceptance criteria study would be performed. The device itself is stated to be identical to that cleared under K163378.
Therefore, the information presented focuses on demonstrating substantial equivalence to a predicate device, particularly regarding the magnetic interference for active implants, rather than proving the device meets new performance criteria.
Here's an analysis of the provided information, framed to address your questions as much as possible given the context:
1. Table of Acceptance Criteria and Reported Device Performance
Because this submission is an amendment to an existing clearance, focusing on a contraindication, the "acceptance criteria" here relate to demonstrating safety regarding magnetic interference with active implants. There aren't traditional performance metrics like sensitivity or specificity for a diagnostic device.
| Acceptance Criterion (for this 510(k) amendment) | Reported Device Performance |
|---|---|
| Magnetic Interference with Active Implants (Static Flux Density) |
§ 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).