The Maximus™ System, when used as a Synclara™ Cough System is intended for use on patients who are unable to cough or clear secretions effectively due to reduced peak cough expiratory flow or respiratory muscle weakness.

The Maximus™ System, when used as a Volara™ System is intended for the mobilization of secretions, lung expansion therapy, the treatment and prevention of pulmonary atelectasis, and has the ability to provide supplemental oxygen when used with oxygen supply.

Device Description

The Maximus™ System is a 2 in 1 device which combines 2 main types of therapies referred to as:

MIE (Mechanical Insufflation-Exsufflation) Synclara®
OLE (Oscillation and Lung Expansion) - Volara™

The modification is to add the ability to provide aerosol from the nebulizer via the Ventilator Tee adaptor during Continuous High Frequency Oscillations (CHFO) mode when connected to a ventilator. All components were cleared under K192143.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Maximus™ System, a noncontinuous ventilator. The submission is for a modification to an already cleared device (K192143) to add the ability to provide aerosol from the nebulizer via a Ventilator Tee adapter during Continuous High Frequency Oscillations (CHFO) mode when connected to a ventilator.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the comparative testing conducted, aiming to demonstrate equivalence to the predicate device. The performance metrics reported are related to aerosol delivery, specifically Mass Median Aerodynamic Diameter (MMAD), Total Respirable Dose, and Fine Particle. The acceptance criteria for these metrics were that they should be "equivalent" across different patient interfaces.

Acceptance Criteria (Implied)	Reported Device Performance
Aerosol delivery parameters (MMAD, Total Respirable Dose, Fine Particle) for the new Ventilator Tee Adaptor should be equivalent to those of already cleared patient interfaces (Mouthpiece, Face Mask).	"Testing parameters included the key particle parameters, Mass Median Aerodynamic Diameter (MMAD), Total Respirable Dose and Fine Particle, are equivalent. The comparative testing supports that the different patient interfaces are not significantly different in their delivery of aerosol."
No new or different questions of safety or effectiveness are raised by the modification.	"The differences presented above have not raised new or different questions of safety or effectiveness from the predicate."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated as a number of devices or clinical cases. The testing was described as "comparative particle characterization testing comparing the following patient interfaces: Mouthpiece, Face Mask (already cleared under K192143) and delivery through the already cleared Ventilator Tee Adaptor." It was performed at "Adult flow rates (28 Lpm) and Pediatric flow rates (12 Lpm) with 1 drug at the lowest and highest set pressures (5 and 70 cmH2O)." This indicates bench testing rather than patient data.
Data Provenance: The data is from bench testing performed by the manufacturer, Hill-Rom Services Pte Ltd. There is no mention of country of origin for the data or if it was retrospective or prospective, as it is not human subject data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not applicable. The ground truth for this submission is based on objective measurements from bench testing of aerosol delivery parameters, not expert human assessment.

4. Adjudication Method for the Test Set

Not applicable, as the evaluation is based on objective measurements from bench testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This submission describes a modification to a medical device (ventilator) and involves bench testing of its physical performance (aerosol delivery), not a diagnostic algorithm or human interpretation task. Therefore, an MRMC study is not relevant.

6. Standalone (Algorithm Only) Performance Study

No. This is a physical device, and the testing focuses on its mechanical and delivery performance. There is no AI or algorithm involved in the direct clinical function being evaluated.

7. Type of Ground Truth Used

The ground truth is established through objective physical measurements of aerosol particle characteristics (MMAD, Total Respirable Dose, Fine Particle) using standardized test methods.

8. Sample Size for the Training Set

Not applicable. This device does not involve a machine learning algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set for a machine learning algorithm, there is no ground truth to establish for it.

Summary

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May 26, 2020

Hill-Rom Services Pte Ltd Paul Dryden Consultant 1 Yishun Ave 7 Singapore 768923 Singapore

Re: K200988

Trade/Device Name: Maximus System Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: Class II Product Code: NHJ Dated: May 1, 2020 Received: May 4, 2020

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

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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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Michael Ryan Division Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K200988

Device Name

Maximus™ System

Indications for Use (Describe)

The Maximus™ System provides features of both the Synclara™ System and the Volara™ System.

Patient Population

The Maximus™ System, when used as a Synclara™ Cough System, is intended to deliver therapy to the population of pediatric to adult patients in both acute and home care settings.

The Maximus™ System, when used as a Volara™ System, is intended to deliver therapy to adults and children over the age of 2 in the acute care setting.

The Maximus™ System, when used as a Volara™ System, is intended to deliver therapy to adults and children over the age of 5 in the home care setting.

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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Date Prepared	26-May-20
Submission Sponsor:	Hill-Rom Services Pte Ltd1 Yishun Ave 7Singapore, 768923, Singapore	Tel - 011 - 65 6499 7391Fax - 011 - 65 65945201
Sponsor Contact:	Alvin Tan - R&D Executive Director
Submission Contact:	Paul Dryden – ProMedic LLC
Proprietary or Trade Name:	Maximus™ System
Common/Usual Name:	Noncontinuous ventilator (IPPB)
Classification Code/Name:	NHJ - non-continuous ventilator (IPPB)21 CFR 868.5905, Class II
Predicate Devices:	K192143 – Hill-Rom Maximus™ System

Device Description and Modification:

The Maximus™ System is a 2 in 1 device which combines 2 main types of therapies referred to as:

MIE (Mechanical Insufflation-Exsufflation) Synclara® ●
OLE (Oscillation and Lung Expansion) - Volara™

The modified Maximus™ system and the predicate are presented in Table 1.

Indications for Use:

The Maximus™ System provides features of both the Synclara™ System and the Volara™ System.

Patient Population

The Maximus™ System, when used as a Synclara™ Cough System, is intended to deliver therapy to the population of pediatric to adult patients in both acute and home care settings. The Maximus™ System, when used as a Volara™ System, is intended to deliver therapy to adults and children over the age of 2 years in the acute care setting.

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The Maximus™ System, when used as a Volara™ System, is intended to deliver therapy to adults and children over the age of 5 in the home care setting.

	Maximus™ System	PredicateMaximus™ System
510(k)		K192143
CFR	868.5905	868.5905
Classification	NHJ	NHJ
Classification name	Device, positive pressure breathing,intermittent (IPPB)	Device, positive pressure breathing,intermittent (IPPB)
Indications for Use	The Maximus™ System, Model POPT1provides features of both the Synclara™System and the Volara™ System.	The Maximus™ System, Model POPT1provides features of both the Synclara™System and the Volara™ System.
	The Maximus™ System, when used as aSynclara™ Cough System is intended for useon patients who are unable to cough or clearsecretions effectively due to reduced peakcough expiratory flow or respiratory muscleweakness.	The Maximus™ System, when used as aSynclara™ Cough System is intended for useon patients who are unable to cough or clearsecretions effectively due to reduced peakcough expiratory flow or respiratory muscleweakness.
	The Maximus™ System, Model POPT1, whenused as a Volara™ System is intended for themobilization of secretions, lung expansiontherapy, the treatment and prevention ofpulmonary atelectasis, and has the ability toprovide supplemental oxygen when used withoxygen supply.	The Maximus™ System, Model POPT1,when used as a Volara™ System is intendedfor the mobilization of secretions, lungexpansion therapy, the treatment andprevention of pulmonary atelectasis, and hasthe ability to provide supplemental oxygenwhen used with oxygen supply.
Environments of Use	Hospitalsub-acute facilitiesNursing careHomecare	Hospitalsub-acute facilitiesNursing careHomecare
Patient Population	Volara™ mode:Adult, Child > 2 years old (acute)>5 year (home care)Synclara™ mode:Adult and pediatric	Volara™ mode:Adult, Child > 2 years old (acute)>5 year (home care)Synclara™ mode:Adult and pediatric
Therapy Modes	Volara™ therapy modes:CPEP, CHFO, AerosolSynclara™ therapy modes:Inhale, Exhale, PAP	Volara™ therapy modes:CPEP, CHFO, AerosolSynclara™ therapy modes:Inhale, Exhale, PAP
Available nebulizer	Philips SideStream (K991725)	Philips SideStream (K991725)
Aerosol delivery	MouthpieceFace MaskVentilator Tee Adaptor	MouthpieceFace Mask
Pulse Oximeter Option	Can connect via Bluetooth to Beijing ChoiceElectronic Technology Co., Ltd. FingertipPulse Oximeter, K142888. Only displays theheart rate and SpO2 data.	Can connect via Bluetooth to Beijing ChoiceElectronic Technology Co., Ltd. FingertipPulse Oximeter, K142888. Only displays theheart rate and SpO2 data.
	ModifiedMaximus™	PredicateMaximus™
Continuous PositiveExpiratory Pressure(CPEP)	Controlled static flow withpositive pressures< 30 cmH2O	Controlled static flow withpositive pressures< 30 cmH2O
Continuous HighFrequency Oscillations(CHFO)	Controlled continuous flowwith frequencies up to 300beats per minute and peakpositive pressures, ≤ 70 cmH2O	Controlled continuous flowwith frequencies up to 300beats per minute and peakpositive pressures, ≤ 70 cmH2O
Aerosol	Controlled continuous constant pressure to in-line nebulizer delivering medicated aerosolonly.	Controlled continuous constant pressure to in-line nebulizer delivering medicated aerosolonly.
Maximum PositivePressure	70 cmH2O	70 cmH2O
Maximum NegativePressure	-70 cmH2O	-70 cmH2O
Inhalation, Exhalationand PAP duration	0 to 5 seconds	0 to 5 seconds
Flutter frequency	1 – 20 Hz	1 – 20 Hz
Patient Circuitconfigurations	Volara™ Patient Circuit:Disposable circuit referred to as "handset"includes connection for in-line nebulizer.Draw in room air mix withmedicated aerosol and gasfrom controller.Synclara™ Patient Circuit:Disposable single patient use circuit consistingof Bacterial/Viral filter, hose, mouthpiece andfacemask adapter.	Volara™ Patient Circuit:Disposable circuit referred to as "handset"includes connection for in-line nebulizer.Draw in room air mix withmedicated aerosol and gasfrom controller.Synclara™ Patient Circuit:Disposable single patient use circuitconsisting of Bacterial/Viral filter, hose,mouthpiece and facemask adapter.
Patient circuit settings	No resistance adjustment feature on patientcircuit.Therapy settings are all done at the controlunit.	No resistance adjustment feature on patientcircuit.Therapy settings are all done at the controlunit.
Patient Interface	Acute care:MouthpieceFace maskInsert into ventilatorAdapter to a patient's endotracheal tube ortracheostomy tube.Home care:MouthpieceFace maskInsert into ventilatorAdapter to a patient's endotracheal tube ortracheostomy tube.	Acute care:MouthpieceFace maskInsert into ventilatorAdapter to a patient's endotracheal tube ortracheostomy tube.Home care:MouthpieceFace maskInsert into ventilatorAdapter to a patient's endotracheal tube ortracheostomy tube.
	ModifiedMaximus™	PredicateMaximus™
Controller	Electro-Mechanical device	Electro-Mechanical device
Principle of operation	Air or oxygen	Air or oxygen
Setting Options	On/OffFrequency selectionfor CHFO mode (Touch Screen Control)Pressure adjustmentfor CHFO mode (Touch Screen Control)Pressure adjustmentfor CPEP mode (Touch Screen Control)Pressure manometerPressure adjustmentfor Inhale, Exhale, PAP mode (Touch ScreenControl)Flow adjustment for Inhale mode. (TouchScreen Control)Frequency adjustment for Flutter feature.(Touch Screen Control)Pressure adjustment for flutter feature.(Touch Screen Control)	On/OffFrequency selectionfor CHFO mode (Touch Screen Control)Pressure adjustmentfor CHFO mode (Touch Screen Control)Pressure adjustmentfor CPEP mode (Touch Screen Control)Pressure manometerPressure adjustmentfor Inhale, Exhale, PAP mode (Touch ScreenControl)Flow adjustment for Inhale mode. (TouchScreen Control)Frequency adjustment for Flutter feature.(Touch Screen Control)Pressure adjustment for flutter feature. (TouchScreen Control)

Table 1 – Maximus™ Substantial Equivalence Table

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Performance of Aerosol Delivery in CHFO mode

We performed comparative particle characterization testing comparing the following patient interfaces: Mouthpiece, Face Mask (already cleared under K192143) and delivery through the already cleared Ventilator Tee Adaptor.

Testing was performed at Adult flow rates (28 Lpm) and Pediatric flow rates (12 Lpm) with 1 drug at the lowest and highest set pressures (5 and 70 cmH2O). Testing parameters included the key particle parameters, Mass Median Aerodynamic Diameter (MMAD), Total Respirable Dose and Fine Particle, are equivalent. The comparative testing supports that the different patient interfaces are not significantly different in their delivery of aerosol.

Substantial Equivalence Discussion

The modified Maximus™ system is viewed as substantially equivalent to the predicate device because:

Indications - The proposed indications for use for mobilization of secretions, lung expansion therapy, the treatment and prevention of pulmonary atelectasis, and can provide supplemental oxygen when used with compressed oxygen are identical to the predicates.

Discussion: The indications for use are identical to the predicate.

Patient Population - The patient populations are identical to the predicate. Discussion: We have not changed the patient populations vs. the predicate.

Environment of Use - The environments of use identical to the predicate. Discussion: We have not changed the use environments.

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Technology - The proposed modification is only related to the ability to deliver aerosol via the Ventilator Tee Adaptor when connected to a ventilator. The device itself is identical in hardware and software. Discussion: The design of modified Maximus™ is identical to the predicate. The only performance testing was to demonstrate that the aerosol performance via the Ventilator Tee Adaptor was equivalent to the performance via a mouthpiece.

Discussion of Differences

The differences presented above have not raised new or different questions of safety or effectiveness from the predicate.

Non-clinical Performance

Biocompatibility of Patient Contacting Materials -

The materials in the gas and fluid pathway are identical to the predicate K192143. No further testing was required.

Bench Testing - We performed comparative nebulizer performance to demonstrate that the modified Maximus™ system is equivalent to the predicate. This test included:

. Comparative Nebulizer Performance across all therapy modes for adult and pediatric flow rates
The comparative testing demonstrates that the modified device is substantially equivalent to the predicate device.

Substantial Equivalence Conclusion

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

Regulation Number and Section

§ 868.5905 Noncontinuous ventilator (IPPB).

(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).