(337 days)
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® 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.
The provided text describes a 510(k) premarket notification for the Monarch Airway Clearance System Model 1000. This submission specifically addresses an expansion of the contraindication related to active implants, rather than an entirely new device or performance claim where a traditional acceptance criteria study would be performed. The device itself is stated to be identical to that cleared under K163378.
Therefore, the information presented focuses on demonstrating substantial equivalence to a predicate device, particularly regarding the magnetic interference for active implants, rather than proving the device meets new performance criteria.
Here's an analysis of the provided information, framed to address your questions as much as possible given the context:
1. Table of Acceptance Criteria and Reported Device Performance
Because this submission is an amendment to an existing clearance, focusing on a contraindication, the "acceptance criteria" here relate to demonstrating safety regarding magnetic interference with active implants. There aren't traditional performance metrics like sensitivity or specificity for a diagnostic device.
| Acceptance Criterion (for this 510(k) amendment) | Reported Device Performance |
|---|---|
| Magnetic Interference with Active Implants (Static Flux Density) | < 1 mT at 1 inch (2.5 cm) from the Pulmonary Oscillating Discs (PODs) |
| Contraindication Effectiveness | Device requires a 6-inch (15 cm) separation from active implants. Results support this contraindication and alignment with design/performance requirements of active implants. |
| User Understanding of Magnetic Interference Warnings (Human Factors/Usability) | 100% of participants passed knowledge assessment tasks related to magnetic interference warnings. |
2. Sample Size Used for the Test Set and Data Provenance
- Magnetic Interference Test: Not explicitly stated how many devices were tested, but it's referred to as "We performed electromagnetic compatibility". This is typically bench testing on a representative sample of devices.
- Data Provenance: Bench test data. Country of origin not specified, but likely where the manufacturer's R&D or testing facilities are located. Retrospective in the sense that it's an evaluation of an existing device.
- Human Factors / Usability Testing: "All participants" passed, but the specific number of participants is not provided.
- Data Provenance: Prospective human factors study. Country of origin not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
There's no mention of experts establishing a ground truth in the traditional sense for these tests.
- For the magnetic interference test, the "ground truth" is established by the accepted standard ISO 14117:2012 for static flux density limits and the defined distance for safe operation of active implants.
- For the human factors/usability test, the "ground truth" is a pre-defined correct understanding of the magnetic interference warnings, assessed via a knowledge assessment. The developers or human factor specialists design these assessments.
4. Adjudication Method for the Test Set
Not applicable in the context of these tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. This type of study (MRMC) is typically used for diagnostic imaging devices to compare human interpretation with and without AI assistance. The Monarch Airway Clearance System is a therapeutic device, and this specific submission focuses on safety regarding magnetic interference.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
No, this question is not applicable. The Monarch system is a physical device, not an algorithm. The magnetic interference testing is a standalone evaluation of the device's physical properties.
7. The Type of Ground Truth Used
- Magnetic Interference: The ground truth is based on established engineering standards (ISO 14117:2012) and scientific understanding of safe magnetic field exposure limits for active implants.
- Human Factors/Usability: The ground truth for the knowledge assessment is the correct understanding of the device's warnings and contraindications as specified in its user manual and labeling.
8. The Sample Size for the Training Set
Not applicable. This device does not use machine learning or AI that would require a "training set" in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI/ML algorithm.
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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 (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
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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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FORM FDA 3881 (7/17)
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| Date Prepared: | 23-Oct-18 |
|---|---|
| Hill-Rom Holdings, Inc.1 Yishun Ave 7Singapore, 768923, Singapore | |
| Official Contact: | Joseph BraidoVice President Global Regulatory Affairs and GlobalComplianceTel - 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, percussor21 CFR 868.5665Class II |
| Predicate Device: | K163378 – Hill-Rom Monarch® Airway Clearance SystemModel 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 provideAirway Clearance Therapy and promotebronchial drainage where external manipulationof the thorax is the physician's choice oftreatment. It is indicated for patients havingdifficulty with secretion clearance, or thepresence of atelectasis caused by mucusplugging.The Monarch® Airway Clearance System isintended to be used in the Home Careenvironment by patients, 15 years and older. | The Monarch® product is intended to provideAirway Clearance Therapy and promote bronchialdrainage where external manipulation of the thoraxis the physician's choice of treatment. It is indicatedfor patients having difficulty with secretionclearance, or the presence of atelectasis caused bymucus plugging.The Monarch® Airway Clearance System isintended to be used in the Home Care environmentby patients, 15 years and older. |
| Patient population | 15 Years and older | 15 Years and older |
| Expandedcontraindication | • Recent placement of transvenous orsubcutaneous pacemaker | The Monarch® device uses Pulmonary OscillatingDiscs (PODs) that create a magnetic field which ispresent whether the device is turned on or off. Dueto the presence of the magnetic field, people whohave an active implantable medical device, such asany of the following, are contraindicated (if theycannot keep the susceptible component at least 6inches 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 beenstabilized• Active hemorrhage with hemodynamicinstability• According to the American Association forRespiratory Care (AARC) Guidelines forPostural Drainage Therapy, the decision touse the unit for Airway Clearance Therapyrequires careful consideration andassessment of the individual patient's caseif the following conditions exist:• Intracranial pressure (ICP) greater than 20 | • Head and/or neck injury that has not yet beenstabilized• Active hemorrhage with hemodynamic instability• According to the American Association forRespiratory Care (AARC) Guidelines forPostural Drainage Therapy, the decision to usethe unit for Airway Clearance Therapy requirescareful consideration and assessment of theindividual patient's case if the followingconditions exist:• 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 spinalinjury • Bronchopleural fistula• Pulmonary edema associated withcongestive heart failure• Large pleural effusions or empyema• Pulmonary embolism• Rib fractures, with or without flail chest• Surgical wound or healing tissue or recentskin grafts or flaps on the thorax• Uncontrolled hypertension• Distended abdomen• Recent esophageal surgery• Active or recent gross hemoptysis• Uncontrolled airway at risk for aspirationsuch as tube feeding or a recent meal• Subcutaneous emphysema• Recent epidural spinal infusion or spinalanesthesia• Burns, open wounds, and skin infectionson 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 congestiveheart failure• Large pleural effusions or empyema• Pulmonary embolism• Rib fractures, with or without flail chest• Surgical wound or healing tissue or recentskin grafts or flaps on the thorax• Uncontrolled hypertension• Distended abdomen• Recent esophageal surgery• Active or recent gross hemoptysis• Uncontrolled airway at risk for aspirationsuch as tube feeding or a recent meal• Subcutaneous emphysema• Recent epidural spinal infusion or spinalanesthesia• Burns, open wounds, and skin infections onthe 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 manipulationof the chest | Yes | Yes |
| Vest with zones todirect oscillations | 8 zones | 8 zones |
| Principle of Operation/ Technology | Vest with installed oscillatingelectromechanical actuators organized intoeight zones which include permanent magnetsas part of the actuators.Zipper, hook and loops on the front andshoulders for snug and evenly-distributed fit.Battery and AC/DC poweredRemote wired into the Garment to adjust theintensity of the oscillation | Vest with installed oscillating electromechanicalactuators organized into eight zones which includepermanent magnets as part of the actuators.Zipper, hook and loops on the front and shouldersfor snug and evenly-distributed fit.Battery and AC/DC poweredRemote wired into the Garment to adjust theintensity of the oscillation |
| Technology ofoscillations | Bluetooth with App for optional control viaSmartphone Wi-Fi for device usage datatransmissionElectromechanical actuators which have astatic magnetic field of <1mT at ~ 1 inch | Bluetooth with App for optional control viaSmartphone Wi-Fi for device usage datatransmissionElectromechanical actuators which have a staticmagnetic 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) determined to be substantially equivalent itself, with no changes in the design or 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.
Training -
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.
Human Factors / Usability Testing -
A knowledge assessment study was performed to test the participant's understanding of two knowledge tasks related to magnetic interference warnings. All participants passed.
Substantial Equivalence Conclusion
Based upon the risk analysis, performance testing and the usability testing we have demonstrated substantial equivalence.
§ 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).