(337 days)
No
The description focuses on mechanical components and control electronics, with no mention of AI/ML terms or functionalities. The submission is for a contraindication expansion on an existing device, not a new technology.
Yes
The device is intended to provide "Airway Clearance Therapy and promote bronchial drainage" and is indicated for patients "having difficulty with secretion clearance, or the presence of atelectasis caused by mucus plugging," which clearly describes a medical therapeutic purpose.
No
The device is an Airway Clearance System designed for therapeutic purposes, specifically to provide Airway Clearance Therapy and promote bronchial drainage. It does not perform any diagnostic functions like detecting, identifying, or characterizing a disease or condition.
No
The device description explicitly details hardware components such as a garment with actuators, a Main Control Box, a pendant controller, a battery, and an external charger. It is not solely software.
Based on the provided information, the Monarch™ product is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Monarch™ Function: The Monarch™ product is a device that provides Airway Clearance Therapy through external manipulation of the thorax. It is a physical therapy device, not a diagnostic test performed on biological samples.
- Intended Use: The intended use clearly states it's for "Airway Clearance Therapy and promote bronchial drainage," which is a therapeutic function, not a diagnostic one.
- Device Description: The description details a garment with actuators, a control box, and a pendant controller, all designed for physical manipulation of the chest. There is no mention of analyzing biological samples.
Therefore, the Monarch™ product falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
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
BYI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thorax
Indicated Patient Age Range
15 years and older
Intended User / Care Setting
Home Care environment by patients, 15 years and older.
Description of the training set, sample size, data source, and annotation protocol
Hill-Rom has a comprehensive program for patient in-service and training that is provided by qualified trainers. The patient specific training includes:
- Pre-qualified prior to training. They must meet the criteria specific to the contraindications ●
- . Training includes the fitting and use of the device
- Reviewing specific instructions and guidelines related to product safety with the patient or ● caregiver
- . Includes review of the Warnings and Contraindications regarding active implantable devices with the patient or caregiver, referring to the Monarch Airway Clearance System User Manual.
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
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
§ 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).
0
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services seal on the left and the FDA acronym and name on the right. The FDA acronym and name are in blue, with the acronym in a square and the name in a sans-serif font. The logo is simple and professional, and it is easily recognizable.
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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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FORM FDA 3881 (7/17)
Page 1 of 1
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| Date Prepared: | 23-Oct-18 |
|---|---|
| Hill-Rom Holdings, Inc. | |
| 1 Yishun Ave 7 | |
| Singapore, 768923, Singapore | |
| Official Contact: | Joseph Braido |
| Vice President Global Regulatory Affairs and Global | |
| Compliance | |
| 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 |
| 21 CFR 868.5665 | |
| Class II | |
| Predicate Device: | K163378 – Hill-Rom Monarch® Airway Clearance System |
| 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.
4
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 | |
| Airway Clearance Therapy and promote | ||
| bronchial drainage where external manipulation | ||
| of the thorax is the physician's choice of | ||
| treatment. It is indicated for patients having | ||
| difficulty with secretion clearance, or the | ||
| presence of atelectasis caused by mucus | ||
| plugging. |
The Monarch® Airway Clearance System is
intended to be used in the Home Care
environment by patients, 15 years and older. | The Monarch® 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. |
| Patient population | 15 Years and older | 15 Years and older |
| Expanded
contraindication | • Recent placement of transvenous or
subcutaneous pacemaker | The Monarch® device uses Pulmonary Oscillating
Discs (PODs) that create a magnetic field which is
present whether the device is turned on or off. Due
to the presence of the magnetic field, people who
have an active implantable medical device, such as
any of the following, are contraindicated (if they
cannot keep the susceptible component at least 6
inches away from the Monarch® device):
• Pacemakers
• Neurostimulators
• Infusion Pumps including insulin pumps
• Implantable Cardioverter Defibrillators (ICDs)
• Circulatory Support Devices |
| Contraindications | • Head and/or neck injury that has not yet been
stabilized
• Active hemorrhage with hemodynamic
instability
• According to the American Association for
Respiratory Care (AARC) Guidelines for
Postural Drainage Therapy, the decision to
use the unit for Airway Clearance Therapy
requires careful consideration and
assessment of the individual patient's case
if the following conditions exist:
• Intracranial pressure (ICP) greater than 20 | • Head and/or neck injury that has not yet been
stabilized
• Active hemorrhage with hemodynamic instability
• According to the American Association for
Respiratory Care (AARC) Guidelines for
Postural Drainage Therapy, the decision to use
the unit for Airway Clearance Therapy requires
careful consideration and assessment of the
individual patient's case if the following
conditions exist:
• Intracranial pressure (ICP) greater than 20 |
| Table 1 - Substantial Equivalence Comparison to the Predicate and Reference Devices | |||||||
|---|---|---|---|---|---|---|---|
| -- | -- | -- | -- | -- | -- | ------------------------------------------------------------------------------------- | -- |
5
| | • Recent spinal surgery or acute spinal
injury • Bronchopleural fistula
• Pulmonary edema associated with
congestive heart failure
• Large pleural effusions or empyema
• Pulmonary embolism
• Rib fractures, with or without flail chest
• Surgical wound or healing tissue or recent
skin grafts or flaps on the thorax
• Uncontrolled hypertension
• Distended abdomen
• Recent esophageal surgery
• Active or recent gross hemoptysis
• Uncontrolled airway at risk for aspiration
such as tube feeding or a recent meal
• Subcutaneous emphysema
• Recent epidural spinal infusion or spinal
anesthesia
• Burns, open wounds, and skin infections
on the thorax
• Suspected pulmonary tuberculosis
• Lung contusion
• Bronchospasm
• Osteoporosis or osteomyelitis of the ribs
• Coagulopathy
• Complaint of chest wall pain | mm Hg
• Recent spinal surgery or acute spinal injury • Bronchopleural fistula
• Pulmonary edema associated with congestive
heart failure
• Large pleural effusions or empyema
• Pulmonary embolism
• Rib fractures, with or without flail chest
• Surgical wound or healing tissue or recent
skin grafts or flaps on the thorax
• Uncontrolled hypertension
• Distended abdomen
• Recent esophageal surgery
• Active or recent gross hemoptysis
• Uncontrolled airway at risk for aspiration
such as tube feeding or a recent meal
• Subcutaneous emphysema
• Recent epidural spinal infusion or spinal
anesthesia
• Burns, open wounds, and skin infections on
the thorax
• Suspected pulmonary tuberculosis
• Lung contusion
• Bronchospasm
• Osteoporosis or osteomyelitis of the ribs
• Coagulopathy
• Complaint of chest wall pain |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Environment of Use | Home and ambulatory | Home and ambulatory |
| External manipulation
of the chest | Yes | Yes |
| Vest with zones to
direct oscillations | 8 zones | 8 zones |
| Principle of Operation
/ Technology | Vest with installed oscillating
electromechanical actuators organized into
eight zones which include permanent magnets
as part of the actuators.
Zipper, hook and loops on the front and
shoulders for snug and evenly-distributed fit.
Battery and AC/DC powered
Remote wired into the Garment to adjust the
intensity of the oscillation | Vest with installed oscillating electromechanical
actuators organized into eight zones which include
permanent magnets as part of the actuators.
Zipper, hook and loops on the front and shoulders
for snug and evenly-distributed fit.
Battery and AC/DC powered
Remote wired into the Garment to adjust the
intensity of the oscillation |
| Technology of
oscillations | Bluetooth with App for optional control via
Smartphone Wi-Fi for device usage data
transmission
Electromechanical actuators which have a
static magnetic field of