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 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

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study proving device performance for the Monarch™ Airway Clearance System:

It's important to note that the provided document is a 510(k) Summary, which aims to demonstrate substantial equivalence to a predicate device rather than providing a detailed clinical trial report or a comprehensive standalone performance study. Therefore, some information typically found in a full study report (like the exact statistical methods used for comparison or detailed effect sizes for human-in-the-loop studies) might not be present or explicitly stated.

Acceptance Criteria and Reported Device Performance

The document describes the device's performance in comparison to predicate and reference devices, rather than against specific, pre-defined quantitative acceptance criteria in a strict sense. The "acceptance criteria" appear to be based on the concept of "substantial equivalence" to the identified predicate devices, particularly regarding performance parameters.

Table of Acceptance Criteria (as inferred from the "Discussion of Substantial Equivalence" and "Bench Testing" sections):

Acceptance Criteria (Inferred from Substantial Equivalence)	Reported Device Performance (Comparative)
Indications: Similar indications for use related to airway clearance via chest wall oscillation.	The Monarch™ product provides Airway Clearance Therapy and promotes bronchial drainage where external manipulation of the thorax is the physician's choice of treatment, indicated for patients having difficulty with secretion clearance or atelectasis caused by mucus plugging. This is similar to the Vest® Airway Clearance Systems (K142482) and IBC AffloVest (K122480).
Patient Population: Within the age range of the predicate and reference devices. (Narrower range is acceptable if it doesn't raise new safety/effectiveness concerns).	Intended for patients 15 years and older. This is a narrower range than the predicate (Pediatric to Geriatrics) but within its scope, deemed not to raise new safety/effectiveness concerns.
Environment of Use: Similar to predicate (home care settings). (Narrower range is acceptable if it doesn't raise new safety/effectiveness concerns).	Intended for Home Care environment. This is a narrower environment of use compared to the predicate (which has a broad range), but deemed not to raise new safety/effectiveness concerns as it's the target market.
Technology: High frequency chest wall oscillation with similar design and technology (electrical actuator/motor in zones in a vest).	Utilizes oscillating electromechanical actuators organized into eight zones. This is similar to the reference device (IBC AffloVest with 6 zones of oscillating vibratory motors). Comparative testing was performed to demonstrate equivalence in force and frequency generation, suggesting acceptable performance compared to the predicate's air-pocket system.
Performance: Performance features and parameters comparable to predicate and reference devices. Expected to perform "in-between the 2 devices" in some aspects.	Bench testing comparison performed across modes. "Performance results were substantially equivalent." Specific objective for peak force: "Monarch performance would be higher than AffloVest (K122480) but below the predicate Vest Model 105 (K142482)."Specific parameters cited:- Peak Force (N): 2.2 to 25.9 (Monarch™) - Predicate (Vest Model 105): 3.1 to 31.7 - Reference (AffloVest): 4.9 to 9.5 (Monarch™ falls largely within or near the range of the predicate and reference, consistent with the objective.)- Acoustic energy: 43.6 dBA @ 0.3 m (Monarch™) - Predicate (Vest Model 105): 82.8 dBA @ 1 m - Reference (AffloVest): 48 dBA @ 1 m (Monarch™ appears quieter than both, which is typically a positive attribute.)- Weight of worn components: 6.0 kg (Monarch™) - Predicate (Vest Model 105): 1.0 kg - Reference (AffloVest): 5.4 kg (Monarch™ is heavier than the predicate but comparable to the reference.)- Durability: Garment cover durability to cleaning tested (5 years/60 cycles).- Simulated Life Cycle Testing: Performed.- Usability: Demonstrated for home environment.
Biocompatibility: No direct patient contact, similar to predicate/reference.	No direct patient contact; user wears an undergarment. Similar to predicate and reference devices.
Electrical Safety: Compliance with relevant standards.	Complies with ES 60601-1, CAN/CSA C22.2 No. 60601-1, IEC 60601-1-2, IEC 60601-1-11.
Operating/Environmental Conditions: Within acceptable ranges for operation and storage.	Operating: Temp 41-95°F, Humidity 15-90%, Pressure 70-106 kPa. Environmental: Temp -4-140°F, Humidity 15-90%, Pressure 50-106 kPa. These ranges are comparable to or within the ranges of the predicate and reference devices.

Study Details:

Sample sizes used for the test set and the data provenance:
- The document describes "Non-clinical Bench Testing" and "Human Factors / Usability Testing."
- Bench Testing: No specific numerical sample sizes (e.g., number of garments, number of tests run) are provided for the bench tests (Peak Force, Durability, Simulated Life Cycle). The "test set" here refers to measurements taken on the device itself under various conditions (different chest locations on a mannequin, frequencies, intensity levels).
- Human Factors / Usability Testing: The test included "individuals representing two distinct user groups." The exact number of participants is not specified.
- Data Provenance: Not explicitly stated for bench testing, but typically performed in a controlled lab environment. Human Factors testing would involve human participants (countries not specified, but the applicant company is Hill-Rom Services Pte Ltd, Singapore, with a US consultant, so testing could have occurred in Singapore or the US). The document implies these were prospective tests performed to support the 510(k) submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- For this type of device (Powered Percussor), the "ground truth" is primarily based on engineering specifications and comparative physical performance measurements rather than expert interpretation of medical images or conditions.
- For the Human Factors / Usability testing, the "ground truth" is whether users can safely and effectively interact with the device. This is established by observing representative users. The document doesn't specify the number or qualifications of experts involved in the observation or assessment of usability, but usually, human factors specialists are involved.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable in the context of physical performance testing of a device or usability testing. Adjudication methods like '2+1' (two readers agree, third is tie-breaker) are common in diagnostic imaging studies where subjective interpretation is key. Here, the "truth" is either a measured physical parameter or an observed behavior.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. This device is a therapeutic medical device (airway clearance system), not an AI-powered diagnostic imaging tool. Therefore, a study comparing human readers with and without AI assistance is not relevant to this product. The evaluation focuses on the physical performance of the device and its usability.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in spirit, standalone performance was assessed for the physical device. The "Non-clinical Comparative Performance" bench testing section describes tests of the device's physical output (Peak Force, Durability, Life Cycle) operating on its own (or with a mannequin) without continuous human-in-the-loop real-time control other than setting parameters.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the performance evaluation relied on:
  - Physical measurements/benchtop data: Quantifiable output (peak force, acoustic energy, weight) directly measured from the device.
  - Engineering specifications/standards: Compliance with electrical safety (IEC 60601-1 series).
  - Comparative data: The performance of the predicate and reference devices served as the comparative "truth" against which the new device was evaluated for substantial equivalence.
  - Observed user interaction/usability: For the human factors testing, the ability of users to successfully perform tasks with the device.
The sample size for the training set:
- Not applicable. This document describes the testing and comparison of a physical medical device, not an AI/ML algorithm that requires a "training set." The device's control system is likely based on traditional embedded software and hardware logic, not a machine learning model that learns from data.
How the ground truth for the training set was established:
- Not applicable, as there is no "training set" for this type of device.

Summary

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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™ 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 Ltd1 Yishun Ave 7Singapore North East, SINGAPORE 768923	Tel - 011 - 65 6594521Fax - 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, percussor21 CFR 868.5665Class II
Predicate Device:Reference Device:	K142482 – Hill-Rom - Vest® Model 105K122480 – IBC – AffloVest

Device Description:

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™ 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™ AirwayClearance System
	K142482	K122480
Classification		BYI - Powered-electric Percussor868.5665
Indications for Use	The Vest® Airway ClearanceSystems is intended toprovide airway clearancetherapy when externalmanipulation of the thorax isthe physician's choice ortreatment. Indications for thisform of therapy are describedby the American Associationof Respiratory Care (AARC)in the Clinical PracticesGuidelines for PosturalDrainage Therapy.According to AARCguidelines, specificindications for externalmanipulation of the thoraxinclude evidence or asuggestion of retainedsecretions, evidence that thepatient is having difficultywith the secretion clearance,or presence of atelectasiscaused by mucus plugging. Inaddition, the Vest® AirwayClearance System is alsoindicated for externalmanipulation of the thorax topromote airway clearance orimprove bronchial drainagefor the purposes of collectingmucus for diagnosticevaluation.	The International BiophysicsCorporation AffloVest isintended for promotingairway clearance andimprovement of bronchialdrainage by enhancingmobilization of bronchialsecretions where externalmanipulation of the thorax isthe physician's choice oftreatment	The Monarch™ product isintended to provide AirwayClearance Therapy andpromote bronchial drainagewhere external manipulationof the thorax is thephysician's choice oftreatment. It is indicated forpatients having difficulty withsecretion clearance, or thepresence of atelectasis causedby mucus plugging.The Monarch™ AirwayClearance System is intendedto be used in the Home Careenvironment by patients, 15years and older.
Patient population	Pediatric to Geriatrics	Not specified	15 Years and older
Feature	Primary Predicate	Reference	Subject Device
	Hill-Rom Vest Model 105K142482	IBC AffloVestK122480	Monarch™ Airway Clearance System
Environment of Use	Yes	Yes	Yes
Homecare	Others as well
External manipulationof the chest	Yes	Yes	Yes
Vest with zones todirect oscillations	No zones	6 zones	8 zones
Principle of Operation/ Technology	Vest with air pockets that arefilled by a remote air generators	Vest with installed oscillatingvibratory motors organizedinto six zones.	Vest with installed oscillatingelectromechanical actuators organizedinto eight zones.
	Buckles and straps on the frontand shoulders for snug andevenly-distributed fit.	Buckles and straps on thefront and shoulders for snugand evenly-distributed fit.	Zipper, hook and loops on the frontand shoulders for snug and evenly-distributed fit.
	AC/DC powered		Battery and AC/DC powered
		Battery and AC/DC powered
	Remote wired into the vest forstart, stop, pause	Remote wired into the vest toadjust the intensity of theoscillation	Remote wired into the Garment toadjust the intensity of the oscillation
	Bluetooth for data transmissiononly		Bluetooth with App for optionalcontrol via Smartphone Wi-Fi fordevice usage data transmission
Technology ofoscillations	Controller which generates airpockets	Electric motors	Electromechanical actuators
Power sources	110 VAC	110 VAC22.2 V Battery	110 VAC24 V Battery
Modes	ManualProgrammableCough Pause	9 pre-set programs	ManualProgrammableCough Pause
Therapy Peak Forceacross all settings	Peak Force (N)3.1 to 31.7	Peak Force (N)4.9 to 9.5	Peak Force (N)2.2 to 25.9
Acoustic energy	82.8 dBA @ 1 m	48 dBA @1 m	43.6 dBA @ 0.3 m per IEC 60601-1clause 9.6.2
Weight of worncomponents	1.0 kg	5.4 kg	6.0 kg
Useful life of ExternalShell	5 years / 60 cleaning cycles	- -	5 years / 60 cleaning cycles
Components /Accessories	Garment coverSupply hoseAir generator controller	Garment coverBatteryAC/DC adapter	Garment coverBatteryAC/DC adapter
Biocompatibility	No direct patient contactPatient wears an undergarment	No direct patient contactPatient wears anundergarment	No direct patient contactPatient wears an undergarment
Electrical safety	ES 60601-1CAN/CSA C22.2 No. 60601-1	Not specified	ES 60601-1CAN/CSA C22.2 No. 60601-1IEC60601-1-2IEC 60601-1-11
Operating conditions	Temp - 41 to 95°FHumidity - 15 to 95%Atmospheric pressure - 70 to106 kPa	Temp - 41 to 95°FHumidity - 15 - 93%Atmospheric pressure - 70 -106 kPa	Temp - 41 to 95°FHumidity - 15 to 90%Atmospheric pressure - 70 to 106 kPa
Environmentalconditions	Temp - - 4 to 140°FHumidity - 15 to 90%Atmospheric pressure - 50 to106 kPa	Temp - 68 to 122°FHumidity - 0 to 93%	Temp - - 4 to 140°FHumidity - 15 to 90%Atmospheric pressure - 50 to 106 kPa
Feature	Primary PredicateHill-Rom Vest Model 105	ReferenceIBC AffloVest	Subject DeviceMonarch™ Airway ClearanceSystem
	K142482	K122480	--
Operating conditions	Temp - 41 to 95°FHumidity - 15 to 95%Atmospheric pressure – 70 to 106 kPa	Temp - 41 to 95°FHumidity - 15 - 93%Atmospheric pressure - 70 - 106 kPa	Temp - 41 to 95°FHumidity - 15 to 90%Atmospheric pressure – 70 to 106 kPa
Environmental conditions	Temp – -4 to 140°FHumidity - 15 to 90%Atmospheric pressure - 50 to 106 kPa	Temp – 68 to 122°FHumidity - 0 to 93%	Temp – -4 to 140°FHumidity - 15 to 90%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.

Regulation Number and Section

§ 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).