Monarch Airway Clearance System

K173603 · Hill-Rom Holdings, Inc. · BYI · Oct 24, 2018 · Anesthesiology

Device Facts

• Record ID: K173603
• Device Name: Monarch Airway Clearance System
• Applicant: Hill-Rom Holdings, Inc.
• Product Code: BYI · Anesthesiology
• Decision Date: Oct 24, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5665
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

Monarch Airway Clearance System Model 1000 provides high-frequency chest wall oscillation (HFCWO) for airway clearance; promotes bronchial drainage. Device consists of garment with 8 zones of electromechanical actuators (containing permanent magnets), main control box, and tethered pendant controller. Used in home/ambulatory settings by patients 15+ years. User adjusts therapy intensity via pendant; system provides visual feedback. Device operates on battery or AC/DC power. Actuators create magnetic field; contraindication added for active implantable medical devices (e.g., pacemakers, ICDs) due to potential interference. Healthcare providers prescribe therapy; patients self-administer. Benefits include improved secretion clearance and reduced mucus plugging. Device includes Bluetooth/Wi-Fi for app-based control and usage data transmission.

Clinical Evidence

Bench testing only. No clinical data. Electromagnetic compatibility testing performed per ISO 14117:2012 to evaluate static flux density relative to active implants. Human factors/usability knowledge assessment study conducted to verify patient understanding of magnetic interference warnings; 100% pass rate achieved.

Technological Characteristics

Garment-based HFCWO system with 8 zones of electromechanical actuators containing permanent magnets. Static magnetic field <1 mT at 1 inch (2.5 cm). Power: 100-240 VAC or 24V battery. Connectivity: Bluetooth (app control) and Wi-Fi (data transmission). Electrical safety: ES 60601-1, CAN/CSA C22.2 No. 60601-1, IEC 60601-1-2, IEC 60601-1-11. Biocompatibility: No direct patient contact (undergarment required).

Indications for Use

Indicated for patients 15 years and older with difficulty clearing secretions or atelectasis caused by mucus plugging. Contraindicated for patients with active implants (pacemakers, neurostimulators, insulin pumps, ICDs, circulatory support devices) unless a 6-inch distance is maintained, and various clinical conditions including unstable head/neck injury, active hemorrhage, ICP > 20 mmHg, recent spinal surgery/injury, bronchopleural fistula, pulmonary edema, large pleural effusions, pulmonary embolism, rib fractures, surgical wounds/grafts on thorax, uncontrolled hypertension, distended abdomen, recent esophageal surgery, active hemoptysis, uncontrolled airway, subcutaneous emphysema, recent spinal anesthesia, thoracic burns/infections, suspected TB, lung contusion, bronchospasm, rib osteoporosis/osteomyelitis, coagulopathy, or chest wall pain.

Regulatory Classification

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.

Predicate Devices

• Monarch® Airway Clearance System Model 1000 (K163378)

Submission Summary (Full Text)

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October 24, 2018

Hill-Rom Holdings, Inc. c/o Paul Dryden Consultant for Hill-Rom 1 Yishun Ave 7 Singapore, 768923, Singapore

Re: K173603

Trade/Device Name: Monarch Airway Clearance System Model 1000 Regulation Number: 21 CFR 868.5665 Regulation Name: Powered Percussor Regulatory Class: Class II Product Code: BYI Dated: September 21, 2018 Received: September 24, 2018

Dear Paul Dryden:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products, and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# James J. Lee -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital. Respiratory. Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

### K173603

Device Name

## Monarch™ Airway Clearance System Model 1000

### Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)

XX Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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| Date Prepared: | 23-Oct-18 |
|---------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| Hill-Rom Holdings, Inc.<br>1 Yishun Ave 7<br>Singapore, 768923, Singapore | |
| Official Contact: | Joseph Braido<br>Vice President Global Regulatory Affairs and Global<br>Compliance<br>Tel - 312-819-9324 |
| Proprietary or Trade Name: | Monarch®Airway Clearance system Model 1000 |
| Common/Usual Name: | Electric-powered, percussor |
| Classification Code/Name: | BYI – electric-powered, percussor<br>21 CFR 868.5665<br>Class II |
| Predicate Device: | K163378 – Hill-Rom Monarch® Airway Clearance System<br>Model 1000 |

### Device Description:

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.

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# Indications for Use:

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.

| Feature | Predicate | Subject Device |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Monarch® Airway Clearance System | Monarch® Airway Clearance System |
| | K163378 | - - |
| Classification | BYI – Powered-electric Percussor | 868.5665 |
| Indications for Use | The Monarch® product is intended to provide<br>Airway Clearance Therapy and promote<br>bronchial drainage where external manipulation<br>of the thorax is the physician's choice of<br>treatment. It is indicated for patients having<br>difficulty with secretion clearance, or the<br>presence of atelectasis caused by mucus<br>plugging.<br><br>The Monarch® Airway Clearance System is<br>intended to be used in the Home Care<br>environment by patients, 15 years and older. | The Monarch® product is intended to provide<br>Airway Clearance Therapy and promote bronchial<br>drainage where external manipulation of the thorax<br>is the physician's choice of treatment. It is indicated<br>for patients having difficulty with secretion<br>clearance, or the presence of atelectasis caused by<br>mucus plugging.<br><br>The Monarch® Airway Clearance System is<br>intended to be used in the Home Care environment<br>by patients, 15 years and older. |
| Patient population | 15 Years and older | 15 Years and older |
| Expanded<br>contraindication | • Recent placement of transvenous or<br>subcutaneous pacemaker | The Monarch® device uses Pulmonary Oscillating<br>Discs (PODs) that create a magnetic field which is<br>present whether the device is turned on or off. Due<br>to the presence of the magnetic field, people who<br>have an active implantable medical device, such as<br>any of the following, are contraindicated (if they<br>cannot keep the susceptible component at least 6<br>inches away from the Monarch® device):<br>• Pacemakers<br>• Neurostimulators<br>• Infusion Pumps including insulin pumps<br>• Implantable Cardioverter Defibrillators (ICDs)<br>• Circulatory Support Devices |
| Contraindications | • Head and/or neck injury that has not yet been<br>stabilized<br>• Active hemorrhage with hemodynamic<br>instability<br>• According to the American Association for<br>Respiratory Care (AARC) Guidelines for<br>Postural Drainage Therapy, the decision to<br>use the unit for Airway Clearance Therapy<br>requires careful consideration and<br>assessment of the individual patient's case<br>if the following conditions exist:<br>• Intracranial pressure (ICP) greater than 20 | • Head and/or neck injury that has not yet been<br>stabilized<br>• Active hemorrhage with hemodynamic instability<br>• According to the American Association for<br>Respiratory Care (AARC) Guidelines for<br>Postural Drainage Therapy, the decision to use<br>the unit for Airway Clearance Therapy requires<br>careful consideration and assessment of the<br>individual patient's case if the following<br>conditions exist:<br>• Intracranial pressure (ICP) greater than 20 |

| | | | | | | Table 1 - Substantial Equivalence Comparison to the Predicate and Reference Devices | |
|--|--|--|--|--|--|-------------------------------------------------------------------------------------|--|
|--|--|--|--|--|--|-------------------------------------------------------------------------------------|--|

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| | • Recent spinal surgery or acute spinal<br>injury • Bronchopleural fistula<br>• Pulmonary edema associated with<br>congestive heart failure<br>• Large pleural effusions or empyema<br>• Pulmonary embolism<br>• Rib fractures, with or without flail chest<br>• Surgical wound or healing tissue or recent<br>skin grafts or flaps on the thorax<br>• Uncontrolled hypertension<br>• Distended abdomen<br>• Recent esophageal surgery<br>• Active or recent gross hemoptysis<br>• Uncontrolled airway at risk for aspiration<br>such as tube feeding or a recent meal<br>• Subcutaneous emphysema<br>• Recent epidural spinal infusion or spinal<br>anesthesia<br>• Burns, open wounds, and skin infections<br>on the thorax<br>• Suspected pulmonary tuberculosis<br>• Lung contusion<br>• Bronchospasm<br>• Osteoporosis or osteomyelitis of the ribs<br>• Coagulopathy<br>• Complaint of chest wall pain | mm Hg<br>• Recent spinal surgery or acute spinal injury • Bronchopleural fistula<br>• Pulmonary edema associated with congestive<br>heart failure<br>• Large pleural effusions or empyema<br>• Pulmonary embolism<br>• Rib fractures, with or without flail chest<br>• Surgical wound or healing tissue or recent<br>skin grafts or flaps on the thorax<br>• Uncontrolled hypertension<br>• Distended abdomen<br>• Recent esophageal surgery<br>• Active or recent gross hemoptysis<br>• Uncontrolled airway at risk for aspiration<br>such as tube feeding or a recent meal<br>• Subcutaneous emphysema<br>• Recent epidural spinal infusion or spinal<br>anesthesia<br>• Burns, open wounds, and skin infections on<br>the thorax<br>• Suspected pulmonary tuberculosis<br>• Lung contusion<br>• Bronchospasm<br>• Osteoporosis or osteomyelitis of the ribs<br>• Coagulopathy<br>• Complaint of chest wall pain |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Environment of Use | Home and ambulatory | Home and ambulatory |
| External manipulation<br>of the chest | Yes | Yes |
| Vest with zones to<br>direct oscillations | 8 zones | 8 zones |
| Principle of Operation<br>/ Technology | Vest with installed oscillating<br>electromechanical actuators organized into<br>eight zones which include permanent magnets<br>as part of the actuators.<br>Zipper, hook and loops on the front and<br>shoulders for snug and evenly-distributed fit.<br>Battery and AC/DC powered<br>Remote wired into the Garment to adjust the<br>intensity of the oscillation | Vest with installed oscillating electromechanical<br>actuators organized into eight zones which include<br>permanent magnets as part of the actuators.<br>Zipper, hook and loops on the front and shoulders<br>for snug and evenly-distributed fit.<br>Battery and AC/DC powered<br>Remote wired into the Garment to adjust the<br>intensity of the oscillation |
| Technology of<br>oscillations | Bluetooth with App for optional control via<br>Smartphone Wi-Fi for device usage data<br>transmission<br>Electromechanical actuators which have a<br>static magnetic field of <1mT at ~ 1 inch | Bluetooth with App for optional control via<br>Smartphone Wi-Fi for device usage data<br>transmission<br>Electromechanical actuators which have a static<br>magnetic field of <1mT at ~ 1 inch (2.5cm) |
| Power sources | 100 -240 VAC | 100 -240 VAC |
| | 24 V Battery | 24 V Battery |
| Modes | Manual | Manual |
| | Programmable | Programmable |
| | Cough Pause | Cough Pause |
| Therapy Peak Force | Peak Force (N) | Peak Force (N) |
| across all settings | 2.2 to 25.9 | 2.2 to 25.9 |
| Components / | Garment cover | Garment cover |
| Accessories | Battery | Battery |
| | AC/DC adapter | AC/DC adapter |
| Biocompatibility | No direct patient contact | No direct patient contact |
| | Patient wears an undergarment | Patient wears an undergarment |
| Electrical safety | ES 60601-1 | ES 60601-1 |
| | CAN/CSA C22.2 No. 60601-1IEC 60601-1-2 | CAN/CSA C22.2 No. 60601-1IEC 60601-1-2 |
| | IEC 60601-1-11 | IEC 60601-1-11 |
| Magnetic Interference | Not tested | ISO14708 |
| Evaluation with Active | | Clause 27.6 and 27.7 |
| Implants | | ISO 14117:2012 |
| | | Clause 4.6 and 4.7 |
| Operating conditions | Temp - 41 to 95ºF | Temp - 41 to 95ºF |
| | Humidity - 15 to 90% | Humidity - 15 to 90% |
| | Atmospheric pressure - 70 to 106 kPa | Atmospheric pressure - 70 to 106 kPa |
| Environmental | Temp -4 to 140°F | Temp -4 to 140°F |
| conditions | Humidity - 15 to 90% | Humidity - 15 to 90% |
| | Atmospheric pressure - 50 to 106 kPa | Atmospheric pressure - 50 to 106 kPa |

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### Discussion of Substantial Equivalence

The Monarch® Airway Clearance System is substantially equivalent to the predicate because:

Indications - The Monarch® Airway Clearance System has the identical indications for use. Discussion: The subject device indications, for use, therefore, do not raise different concerns of safety or effectiveness compared to the predicate. This includes the use of permanent magnets and their magnetic field and active implants.

Patient population – The Monarch® Airway Clearance System has the identical patient population of 15 years and older, as the predicate.

Environment of Use - The environment of use of a home care settings is identical to the predicate.

Technology - The technology of high frequency chest wall oscillation is identical to the predicate. Discussion: The design and technology of the subject device is similar to the predicate which does not raise concerns of safety or effectiveness.

### Non-clinical Comparative Performance

Electromagnetic Compatibility: We performed electromagnetic compatibility based upon ISO 14117:2012 for protection against static flux density of 1 mT and up to 50 mT. Discussion: This confirmed that the static flux density is < 1 mT at 1 inch (2.5 cm) from the PODs. The contraindication for the Bystander states to remain at least 6 inches (15 cm) away. The results support the contraindication for the Bystander and are in alignment with the design and performance requirements of active implants.

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### Bench Testing -

The predicate for this 510(k) is the Monarch® Model 1000 (K163378)…