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The BreatheBand® device is intended to deliver high-frequency chest wall oscillation (HFCWO) therapy to promote airway clearance and aid in general bronchial drainage when external chest manipulation or manipulation of the thorax is the physician's treatment of choice to enhance mucus transport.

It is indicated for adult patients (22 years of age and older) experiencing difficulty with secretion clearance.

The BreatheBand® device is intended for use in the home-care environment.

The BreatheBand® device is non-invasive, reusable, and intended for single-patient use.

The BreatheBand® Model 1000 (BreatheBand®) consists of the following major components:

• 2 Bands, each Band has 4 actuator 'Pods,' a control box, and fasteners.
• 1 Remote, which is a touchscreen device for controlling the Bands.
• 3 Charging Power Supplies for charging both Bands and the Remote simultaneously.
• 1 Carrying Case, which can house and protect the system when not in use.
• 1 Instructions For Use (IFU) document.

The Bands are worn across the thorax in an "X" configuration as demonstrated in the IFU. The Remote communicates with the Bands to control the actuators' settings, such as frequency, intensity, and duration of treatment, to implement the prescribed treatment as specified by a physician. In addition, error messages are displayed on the Remote screen when indicated. The treatment status, such as settings and length of the treatment remaining, as well as the system status (battery levels), are displayed on the Remote screen.

The Bands are adjustable in terms of overall length (to fit larger or smaller torso sizes). Once adjustments are made to the fit, the user can remove and replace the Bands without re-adjusting.

Charging the Bands and Remote batteries is accomplished between therapy sessions, and the system will not provide therapy while connected to a charger. The battery capacity is sufficient for three typical therapy sessions on one full battery charge.

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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.

2. Sample Size Used for the Test Set and Data Provenance

• Magnetic Interference Test: Not explicitly stated how many devices were tested, but it's referred to as "We performed electromagnetic compatibility". This is typically bench testing on a representative sample of devices.
  • Data Provenance: Bench test data. Country of origin not specified, but likely where the manufacturer's R&D or testing facilities are located. Retrospective in the sense that it's an evaluation of an existing device.
• Human Factors / Usability Testing: "All participants" passed, but the specific number of participants is not provided.
  • Data Provenance: Prospective human factors study. Country of origin not specified.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

There's no mention of experts establishing a ground truth in the traditional sense for these tests.

• For the magnetic interference test, the "ground truth" is established by the accepted standard ISO 14117:2012 for static flux density limits and the defined distance for safe operation of active implants.
• For the human factors/usability test, the "ground truth" is a pre-defined correct understanding of the magnetic interference warnings, assessed via a knowledge assessment. The developers or human factor specialists design these assessments.

4. Adjudication Method for the Test Set

Not applicable in the context of these tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. This type of study (MRMC) is typically used for diagnostic imaging devices to compare human interpretation with and without AI assistance. The Monarch Airway Clearance System is a therapeutic device, and this specific submission focuses on safety regarding magnetic interference.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

No, this question is not applicable. The Monarch system is a physical device, not an algorithm. The magnetic interference testing is a standalone evaluation of the device's physical properties.

7. The Type of Ground Truth Used

• Magnetic Interference: The ground truth is based on established engineering standards (ISO 14117:2012) and scientific understanding of safe magnetic field exposure limits for active implants.
• Human Factors/Usability: The ground truth for the knowledge assessment is the correct understanding of the device's warnings and contraindications as specified in its user manual and labeling.

8. The Sample Size for the Training Set

Not applicable. This device does not use machine learning or AI that would require a "training set" in the conventional sense.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for an AI/ML algorithm.

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