Predicate Devices

K142482 – Hill-Rom - Vest® Model 105

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on mechanical components and user-controlled settings, with no mention of AI or ML technologies.

Therapeutic

Yes
The device is intended to provide "Airway Clearance Therapy and promote bronchial drainage" for patients with "difficulty with secretion clearance, or the presence of atelectasis caused by mucus plugging," which are therapeutic purposes.

Diagnostic

No

The device is an airway clearance system used to provide therapy and promote bronchial drainage, not to diagnose a condition.

SaMD (Software as a Medical Device)

No

The device description clearly outlines multiple hardware components including a garment with actuators, a main control box, a pendant controller, a battery, and an external charger. This is not a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided information, the Monarch™ product is not an IVD (In Vitro Diagnostic) device.

Here's why:

Intended Use: The intended use is to provide Airway Clearance Therapy and promote bronchial drainage through external manipulation of the thorax. This is a physical therapy, not a diagnostic test performed on biological samples.
Device Description: The device consists of a garment with actuators, a control box, and a pendant. These components are designed to apply physical force to the chest, not to analyze biological samples.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.

Therefore, the Monarch™ Airway Clearance System falls under the category of a therapeutic device, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

BYI

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

thorax / chest

Indicated Patient Age Range

15 years and older

Intended User / Care Setting

Home Care environment by patients

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical Comparative Performance
Biocompatibility - There are no materials in direct contact with the patient.
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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Peak Force (N): 2.2 to 25.9
Acoustic energy: 43.6 dBA @ 0.3 m per IEC 60601-1 clause 9.6.2
Weight of worn components: 6.0 kg

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K142482 – Hill-Rom - Vest® Model 105

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K122480 – IBC – AffloVest

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

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.

1

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™ 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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FORM FDA 3881 (8/14)

Page 1 of 1

PSC Publishing Services (301) 443-6740 ве

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

Date Prepared	14-Mar-17
Hill-Rom Services Pte Ltd
1 Yishun Ave 7
Singapore North East, SINGAPORE 768923	Tel - 011 - 65 6594521
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
21 CFR 868.5665
Class II
Predicate Device:
Reference Device:	K142482 – Hill-Rom - Vest® Model 105
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.

4

Feature	Primary Predicate	Reference	Subject Device
	Hill-Rom Vest Model 105	IBC AffloVest	Monarch™ Airway
Clearance System
	K142482	K122480
Classification		BYI - Powered-electric Percussor
868.5665
Indications for Use	The Vest® Airway Clearance
Systems is intended to
provide airway clearance
therapy when external
manipulation of the thorax is
the physician's choice or
treatment. Indications for this
form of therapy are described
by the American Association
of Respiratory Care (AARC)
in the Clinical Practices
Guidelines for Postural
Drainage Therapy.

According to AARC
guidelines, specific
indications for external
manipulation of the thorax
include evidence or a
suggestion of retained
secretions, evidence that the
patient is having difficulty
with the secretion clearance,
or presence of atelectasis
caused by mucus plugging. In
addition, the Vest® Airway
Clearance System is also
indicated for external
manipulation of the thorax to
promote airway clearance or
improve bronchial drainage
for the purposes of collecting
mucus for diagnostic
evaluation. | The International Biophysics
Corporation AffloVest is
intended for promoting
airway clearance and
improvement of bronchial
drainage by enhancing
mobilization of bronchial
secretions where external
manipulation of the thorax is
the physician's choice of
treatment | 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.

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

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510(k) Summary

6

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.

7

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.