Monarch Airway Clearance System

K163378 · Hill-Rom Services Pte, Ltd. · BYI · Mar 17, 2017 · Anesthesiology

Device Facts

• Record ID: K163378
• Device Name: Monarch Airway Clearance System
• Applicant: Hill-Rom Services Pte, Ltd.
• Product Code: BYI · Anesthesiology
• Decision Date: Mar 17, 2017
• 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 provides airway clearance therapy via high-frequency chest wall oscillation; intended for home use by patients 15+ years. Device consists of garment with 8 zones of electromechanical actuators, main control box, and tethered pendant controller. User wears undergarment; device fits via zipper and hook-and-loop adjustments. Pendant provides visual feedback and therapy setting adjustments. System operates on battery or AC/DC power. Actuators generate oscillations to mobilize bronchial secretions; performance parameters (force/frequency) designed to be comparable to predicate/reference devices. Healthcare providers prescribe therapy; patients operate device independently in home environment. Bluetooth/App connectivity supports optional control and usage data transmission.

Clinical Evidence

Bench testing only. Comparative performance testing against predicate (K142482) and reference (K122480) devices evaluated peak force on a mannequin across various chest locations, frequencies, and intensity levels. Additional testing included garment durability, simulated life cycle, and human factors/usability validation in the home environment. Results confirmed performance specifications met and equivalence to predicate/reference devices.

Technological Characteristics

Garment with 8 zones of electromechanical actuators; pendant controller with LCD; battery (24V) or AC/DC powered. 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. No direct patient contact (undergarment required).

Indications for Use

Indicated for patients 15 years and older with difficulty clearing secretions or atelectasis due to mucus plugging, where external thoracic manipulation is prescribed.

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

• Hill-Rom - Vest® Model 105 (K142482)

Reference Devices

• IBC – AffloVest (K122480)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 17, 2017

Hill-rom Services Pte Ltd c/o Paul Dryden Consultant for Hill-rom 1 Yishun Ave 7 Singapore North East 768923 SINGAPORE

Re: K163378

Trade/Device Name: Monarch™ Airway Clearance System Regulation Number: 21 CFR 868.5665 Regulation Name: Powered Percussor Regulatory Class: Class II Product Code: BYI Dated: February 14, 2017 Received: February 15, 2017

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. 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.

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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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

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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)

K163378

Device Name

# Monarch™M Airway Clearance System

#### 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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## 510(k) Summary Page 1 of 5 14-Mar-17

| Date Prepared | 14-Mar-17 |
|---------------------------------------------------------------------------------------|-------------------------------------------------------------------|
| Hill-Rom Services Pte Ltd<br>1 Yishun Ave 7<br>Singapore North East, SINGAPORE 768923 | Tel - 011 - 65 6594521<br>Fax - 011 - 65 6594520 |
| Official Contact: | Huifang Zhu - RA / QA Specialist |
| Proprietary or Trade Name: | Monarch™ Airway Clearance system |
| Common/Usual Name: | Electric-powered, percussor |
| Classification Code/Name: | BYI - electric-powered, percussor<br>21 CFR 868.5665<br>Class II |
| Predicate Device:<br>Reference Device: | K142482 – Hill-Rom - Vest® Model 105<br>K122480 – IBC – AffloVest |

## Device Description:

The Monarch™ Airway Clearance System 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 a 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 chest 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

## 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.

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| Feature | Primary Predicate | Reference | Subject Device |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Hill-Rom Vest Model 105 | IBC AffloVest | Monarch™ Airway<br>Clearance System |
| | K142482 | K122480 | |
| Classification | | BYI - Powered-electric Percussor<br>868.5665 | |
| Indications for Use | The Vest® Airway Clearance<br>Systems is intended to<br>provide airway clearance<br>therapy when external<br>manipulation of the thorax is<br>the physician's choice or<br>treatment. Indications for this<br>form of therapy are described<br>by the American Association<br>of Respiratory Care (AARC)<br>in the Clinical Practices<br>Guidelines for Postural<br>Drainage Therapy.<br><br>According to AARC<br>guidelines, specific<br>indications for external<br>manipulation of the thorax<br>include evidence or a<br>suggestion of retained<br>secretions, evidence that the<br>patient is having difficulty<br>with the secretion clearance,<br>or presence of atelectasis<br>caused by mucus plugging. In<br>addition, the Vest® Airway<br>Clearance System is also<br>indicated for external<br>manipulation of the thorax to<br>promote airway clearance or<br>improve bronchial drainage<br>for the purposes of collecting<br>mucus for diagnostic<br>evaluation. | The International Biophysics<br>Corporation AffloVest is<br>intended for promoting<br>airway clearance and<br>improvement of bronchial<br>drainage by enhancing<br>mobilization of bronchial<br>secretions where external<br>manipulation of the thorax is<br>the physician's choice of<br>treatment | The Monarch™ product is<br>intended to provide Airway<br>Clearance Therapy and<br>promote bronchial drainage<br>where external manipulation<br>of the thorax is the<br>physician's choice of<br>treatment. It is indicated for<br>patients having difficulty with<br>secretion clearance, or the<br>presence of atelectasis caused<br>by mucus plugging.<br><br>The Monarch™ Airway<br>Clearance System is intended<br>to be used in the Home Care<br>environment by patients, 15<br>years and older. |
| Patient population | Pediatric to Geriatrics | Not specified | 15 Years and older |
| Feature | Primary Predicate | Reference | Subject Device |
| | Hill-Rom Vest Model 105<br>K142482 | IBC AffloVest<br>K122480 | Monarch™ Airway Clearance System |
| Environment of Use | Yes | Yes | Yes |
| Homecare | Others as well | | |
| External manipulation<br>of the chest | Yes | Yes | Yes |
| Vest with zones to<br>direct oscillations | No zones | 6 zones | 8 zones |
| Principle of Operation<br>/ Technology | Vest with air pockets that are<br>filled by a remote air generators | Vest with installed oscillating<br>vibratory motors organized<br>into six zones. | Vest with installed oscillating<br>electromechanical actuators organized<br>into eight zones. |
| | Buckles and straps on the front<br>and shoulders for snug and<br>evenly-distributed fit. | Buckles and straps on the<br>front and shoulders for snug<br>and evenly-distributed fit. | Zipper, hook and loops on the front<br>and shoulders for snug and evenly-<br>distributed fit. |
| | AC/DC powered | | Battery and AC/DC powered |
| | | Battery and AC/DC powered | |
| | Remote wired into the vest for<br>start, stop, pause | Remote wired into the vest to<br>adjust the intensity of the<br>oscillation | Remote wired into the Garment to<br>adjust the intensity of the oscillation |
| | Bluetooth for data transmission<br>only | | Bluetooth with App for optional<br>control via Smartphone Wi-Fi for<br>device usage data transmission |
| Technology of<br>oscillations | Controller which generates air<br>pockets | Electric motors | Electromechanical actuators |
| Power sources | 110 VAC | 110 VAC<br>22.2 V Battery | 110 VAC<br>24 V Battery |
| Modes | Manual<br>Programmable<br>Cough Pause | 9 pre-set programs | Manual<br>Programmable<br>Cough Pause |
| Therapy Peak Force<br>across all settings | Peak Force (N)<br>3.1 to 31.7 | Peak Force (N)<br>4.9 to 9.5 | Peak Force (N)<br>2.2 to 25.9 |
| Acoustic energy | 82.8 dBA @ 1 m | 48 dBA @1 m | 43.6 dBA @ 0.3 m per IEC 60601-1<br>clause 9.6.2 |
| Weight of worn<br>components | 1.0 kg | 5.4 kg | 6.0 kg |
| Useful life of External<br>Shell | 5 years / 60 cleaning cycles | - - | 5 years / 60 cleaning cycles |
| Components /<br>Accessories | Garment cover<br>Supply hose<br>Air generator controller | Garment cover<br>Battery<br>AC/DC adapter | Garment cover<br>Battery<br>AC/DC adapter |
| Biocompatibility | No direct patient contact<br>Patient wears an undergarment | No direct patient contact<br>Patient wears an<br>undergarment | No direct patient contact<br>Patient wears an undergarment |
| Electrical safety | ES 60601-1<br>CAN/CSA C22.2 No. 60601-1 | Not specified | ES 60601-1<br>CAN/CSA C22.2 No. 60601-1IEC<br>60601-1-2<br>IEC 60601-1-11 |
| Operating conditions | Temp - 41 to 95°F<br>Humidity - 15 to 95%<br>Atmospheric pressure - 70 to<br>106 kPa | Temp - 41 to 95°F<br>Humidity - 15 - 93%<br>Atmospheric pressure - 70 -<br>106 kPa | Temp - 41 to 95°F<br>Humidity - 15 to 90%<br>Atmospheric pressure - 70 to 106 kPa |
| Environmental<br>conditions | Temp - - 4 to 140°F<br>Humidity - 15 to 90%<br>Atmospheric pressure - 50 to<br>106 kPa | Temp - 68 to 122°F<br>Humidity - 0 to 93% | Temp - - 4 to 140°F<br>Humidity - 15 to 90%<br>Atmospheric pressure - 50 to 106 kPa |
| Feature | Primary Predicate<br>Hill-Rom Vest Model 105 | Reference<br>IBC AffloVest | Subject Device<br>Monarch™ Airway Clearance<br>System |
| | K142482 | K122480 | -- |
| Operating conditions | Temp - 41 to 95°F<br>Humidity - 15 to 95%<br>Atmospheric pressure – 70 to 106 kPa | Temp - 41 to 95°F<br>Humidity - 15 - 93%<br>Atmospheric pressure - 70 - 106 kPa | Temp - 41 to 95°F<br>Humidity - 15 to 90%<br>Atmospheric pressure – 70 to 106 kPa |
| Environmental conditions | Temp – -4 to 140°F<br>Humidity - 15 to 90%<br>Atmospheric pressure - 50 to 106 kPa | Temp – 68 to 122°F<br>Humidity - 0 to 93% | Temp – -4 to 140°F<br>Humidity - 15 to 90%<br>Atmospheric pressure - 50 to 106 kPa |

# Table 1 – Substantial Equivalence Comparison to the Predicate and Reference Devices

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# 510(k) Summary

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# 510(k) Summary Page 4 of 5 14-Mar-17

## Discussion of Substantial Equivalence

The Monarch™ Airway Clearance System is viewed as substantially equivalent to the predicate and reference devices because:

Indications - The Monarch™ Airway Clearance System has similar indications for use related to airway clearance via chest wall oscillation.

Discussion: The subject device is indications for use there are no new concerns of safety or effectiveness for the proposed indication.

Patient Population - The Monarch™ Airway Clearance System has a patient population of 15 years and older which is within the age range of the predicate and reference. Discussion: The subject device has a narrower patient range than the predicate and reference devices, but this does not raise any new concerns of safety or effectiveness.

Environment of Use - The environment of use for home care settings is similar to the predicate Hill-Rom Vest Model 105, K142482, which has a broad range of environments. Discussion: The subject device has a narrower environment of use as this is the target market. This difference does not raise any new concerns of safety or effectiveness.

Technology - The technology of high frequency chest wall oscillation is similar to the predicate and reference devices.

Discussion: The design and technology of the subject device is similar to the reference device. In that the characteristics of the use of an electrical actuator / motor operated in zones in a vest. Whereas the predicate uses air pockets with no specific zones to generate oscillation throughout the whole chest area vs. specific areas (zones) of the chest. We performed comparative testing demonstrating the difference of how the oscillations are generated is equivalent in the generation of force and frequency to the predicate and the reference devices.

Performance - The performance features and parameters were compared to the predicate and reference devices and the subject device as intended performs in-between the 2 devices. Discussion: We performed comparative testing across all modes and the performance results were substantially equivalent.

## Non-clinical Comparative Performance

Biocompatibility - There are no materials in direct contact with the patient.

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Discussion: The user wears an undergarment which keeps any materials from direct contact. This is similar to the predicate and reference devices.

# Bench Testing -

We performed a series of non-clinical bench testing to demonstrate equivalence to the predicate and reference devices. These tests included:

- Peak Force of the vest against the chest of a mannequin comparison .
- Measured at different chest locations o
- Frequencies low, middle and high range of the device о
- o Intensity levels - low, middle, high range
- O Objective was that the Monarch performance would be higher than AffloVest (K122480) but below the predicate Vest Model 105 (K142482)
- . Durability of Garment Cover to cleaning
- Simulated Life Cycle testing ●
- . Usability – home environment

All the testing demonstrates that the Monarch™ Airway Clearance System met its performance specifications and / or is substantially equivalent to the identified predicate or reference devices.

## Human Factors / Usability Testing -

Hill-Rom conducted a human factors (HF) validation usability test of Hill-Rom's Monarch Airway Clearance System. The test's goal was to evaluate the extent to which representative users can interact with the device.

The human factors validation test included individuals representing two distinct user groups.

## Substantial Equivalence Conclusion

Based upon the risk analysis, comparative performance testing and the usability testing we have demonstrated through that the proposed device and predicates can be found to be substantially equivalent.