Maximus System

K200988 · Hill-Rom Services Pte, Ltd. · NHJ · May 26, 2020 · Anesthesiology

Device Facts

• Record ID: K200988
• Device Name: Maximus System
• Applicant: Hill-Rom Services Pte, Ltd.
• Product Code: NHJ · Anesthesiology
• Decision Date: May 26, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

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

Maximus System is a 2-in-1 electro-mechanical device combining Mechanical Insufflation-Exsufflation (MIE) and Oscillation and Lung Expansion (OLE) therapies. Inputs include air or oxygen; device transforms these into controlled pressure/flow outputs for secretion clearance and lung expansion. Used in acute and home care settings by clinicians or patients. Features include Synclara (Inhale, Exhale, PAP) and Volara (CPEP, CHFO, Aerosol) modes. Modification adds aerosol delivery via Ventilator Tee adaptor during CHFO mode. Output is delivered via mouthpiece, face mask, or ventilator circuit. Healthcare providers use touch screen controls to adjust frequency, pressure, and flow. Device benefits patients by assisting airway clearance and lung expansion; supplemental oxygen can be provided. Bluetooth connectivity allows display of heart rate and SpO2 from external pulse oximeter.

Clinical Evidence

Bench testing only. Comparative nebulizer performance testing conducted at adult (28 Lpm) and pediatric (12 Lpm) flow rates across pressure ranges (5-70 cmH2O). Metrics included Mass Median Aerodynamic Diameter (MMAD), Total Respirable Dose, and Fine Particle fraction. Results demonstrated equivalence between the new Ventilator Tee Adaptor and previously cleared interfaces.

Technological Characteristics

Electro-mechanical controller; air/oxygen source. Therapy modes: MIE (Inhale, Exhale, PAP) and OLE (CPEP, CHFO, Aerosol). CHFO: up to 300 bpm, ≤70 cmH2O. CPEP: <30 cmH2O. Flutter: 1-20 Hz. Touch screen interface. Connectivity: Bluetooth for external pulse oximeter. Patient circuits: disposable single-patient use. Aerosol delivery via Philips SideStream nebulizer. Materials identical to predicate K192143.

Indications for Use

Indicated for pediatric to adult patients unable to cough/clear secretions effectively due to reduced peak cough expiratory flow or respiratory muscle weakness (Synclara mode). Indicated for adults and children >2 years (acute care) or >5 years (home care) for secretion mobilization, lung expansion, and treatment/prevention of pulmonary atelectasis (Volara mode).

Regulatory Classification

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.

Predicate Devices

• Maximus™ System (K192143)

Reference Devices

• Philips SideStream (K991725)
• Beijing Choice Electronic Technology Co., Ltd. Fingertip Pulse Oximeter (K142888)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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 ([e-mail]) or phone [phone] 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.

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 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.

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 Ltd<br>1 Yishun Ave 7<br>Singapore, 768923, Singapore | Tel - 011 - 65 6499 7391<br>Fax - 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)<br>21 CFR 868.5905, Class II | |
| Predicate Devices: | K192143 – Hill-Rom Maximus™ System | |

### Device Description and Modification:

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.

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.

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.

### 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 | Predicate<br>Maximus™ System |
|------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | | K192143 |
| CFR | 868.5905 | 868.5905 |
| Classification | NHJ | NHJ |
| Classification name | Device, positive pressure breathing,<br>intermittent (IPPB) | Device, positive pressure breathing,<br>intermittent (IPPB) |
| Indications for Use | The Maximus™ System, Model POPT1<br>provides features of both the Synclara™<br>System and the Volara™ System. | The Maximus™ System, Model POPT1<br>provides features of both the Synclara™<br>System and the Volara™ System. |
| | The Maximus™ System, when used as a<br>Synclara™ Cough System is intended for use<br>on patients who are unable to cough or clear<br>secretions effectively due to reduced peak<br>cough expiratory flow or respiratory muscle<br>weakness. | The Maximus™ System, when used as a<br>Synclara™ Cough System is intended for use<br>on patients who are unable to cough or clear<br>secretions effectively due to reduced peak<br>cough expiratory flow or respiratory muscle<br>weakness. |
| | The Maximus™ System, Model POPT1, when<br>used as a Volara™ System is intended for the<br>mobilization of secretions, lung expansion<br>therapy, the treatment and prevention of<br>pulmonary atelectasis, and has the ability to<br>provide supplemental oxygen when used with<br>oxygen supply. | The Maximus™ System, Model POPT1,<br>when used as a Volara™ System is intended<br>for the mobilization of secretions, lung<br>expansion therapy, the treatment and<br>prevention of pulmonary atelectasis, and has<br>the ability to provide supplemental oxygen<br>when used with oxygen supply. |
| Environments of Use | Hospital<br>sub-acute facilities<br>Nursing care<br>Homecare | Hospital<br>sub-acute facilities<br>Nursing care<br>Homecare |
| Patient Population | Volara™ mode:<br>Adult, Child > 2 years old (acute)<br>>5 year (home care)<br>Synclara™ mode:<br>Adult and pediatric | Volara™ mode:<br>Adult, Child > 2 years old (acute)<br>>5 year (home care)<br>Synclara™ mode:<br>Adult and pediatric |
| Therapy Modes | Volara™ therapy modes:<br>CPEP, CHFO, Aerosol<br>Synclara™ therapy modes:<br>Inhale, Exhale, PAP | Volara™ therapy modes:<br>CPEP, CHFO, Aerosol<br>Synclara™ therapy modes:<br>Inhale, Exhale, PAP |
| Available nebulizer | Philips SideStream (K991725) | Philips SideStream (K991725) |
| Aerosol delivery | Mouthpiece<br>Face Mask<br>Ventilator Tee Adaptor | Mouthpiece<br>Face Mask |
| Pulse Oximeter Option | Can connect via Bluetooth to Beijing Choice<br>Electronic Technology Co., Ltd. Fingertip<br>Pulse Oximeter, K142888. Only displays the<br>heart rate and SpO2 data. | Can connect via Bluetooth to Beijing Choice<br>Electronic Technology Co., Ltd. Fingertip<br>Pulse Oximeter, K142888. Only displays the<br>heart rate and SpO2 data. |
| | Modified<br>Maximus™ | Predicate<br>Maximus™ |
| Continuous Positive<br>Expiratory Pressure<br>(CPEP) | Controlled static flow with<br>positive pressures<br>< 30 cmH2O | Controlled static flow with<br>positive pressures<br>< 30 cmH2O |
| Continuous High<br>Frequency Oscillations<br>(CHFO) | Controlled continuous flow<br>with frequencies up to 300<br>beats per minute and peak<br>positive pressures, ≤ 70 cmH2O | Controlled continuous flow<br>with frequencies up to 300<br>beats per minute and peak<br>positive pressures, ≤ 70 cmH2O |
| Aerosol | Controlled continuous constant pressure to in-<br>line nebulizer delivering medicated aerosol<br>only. | Controlled continuous constant pressure to in-<br>line nebulizer delivering medicated aerosol<br>only. |
| Maximum Positive<br>Pressure | 70 cmH2O | 70 cmH2O |
| Maximum Negative<br>Pressure | -70 cmH2O | -70 cmH2O |
| Inhalation, Exhalation<br>and PAP duration | 0 to 5 seconds | 0 to 5 seconds |
| Flutter frequency | 1 – 20 Hz | 1 – 20 Hz |
| Patient Circuit<br>configurations | Volara™ Patient Circuit:<br>Disposable circuit referred to as "handset"<br>includes connection for in-line nebulizer.<br>Draw in room air mix with<br>medicated aerosol and gas<br>from controller.<br>Synclara™ Patient Circuit:<br>Disposable single patient use circuit consisting<br>of Bacterial/Viral filter, hose, mouthpiece and<br>facemask adapter. | Volara™ Patient Circuit:<br>Disposable circuit referred to as "handset"<br>includes connection for in-line nebulizer.<br>Draw in room air mix with<br>medicated aerosol and gas<br>from controller.<br>Synclara™ Patient Circuit:<br>Disposable single patient use circuit<br>consisting of Bacterial/Viral filter, hose,<br>mouthpiece and facemask adapter. |
| Patient circuit settings | No resistance adjustment feature on patient<br>circuit.<br>Therapy settings are all done at the control<br>unit. | No resistance adjustment feature on patient<br>circuit.<br>Therapy settings are all done at the control<br>unit. |
| Patient Interface | Acute care:<br>Mouthpiece<br>Face mask<br>Insert into ventilator<br>Adapter to a patient's endotracheal tube or<br>tracheostomy tube.<br>Home care:<br>Mouthpiece<br>Face mask<br>Insert into ventilator<br>Adapter to a patient's endotracheal tube or<br>tracheostomy tube. | Acute care:<br>Mouthpiece<br>Face mask<br>Insert into ventilator<br>Adapter to a patient's endotracheal tube or<br>tracheostomy tube.<br>Home care:<br>Mouthpiece<br>Face mask<br>Insert into ventilator<br>Adapter to a patient's endotracheal tube or<br>tracheostomy tube. |
| | Modified<br>Maximus™ | Predicate<br>Maximus™ |
| Controller | Electro-Mechanical device | Electro-Mechanical device |
| Principle of operation | Air or oxygen | Air or oxygen |
| Setting Options | On/Off<br>Frequency selection<br>for CHFO mode (Touch Screen Control)<br>Pressure adjustment<br>for CHFO mode (Touch Screen Control)<br>Pressure adjustment<br>for CPEP mode (Touch Screen Control)<br>Pressure manometer<br>Pressure adjustment<br>for Inhale, Exhale, PAP mode (Touch Screen<br>Control)<br>Flow adjustment for Inhale mode. (Touch<br>Screen Control)<br>Frequency adjustment for Flutter feature.<br>(Touch Screen Control)<br>Pressure adjustment for flutter feature.<br>(Touch Screen Control) | On/Off<br>Frequency selection<br>for CHFO mode (Touch Screen Control)<br>Pressure adjustment<br>for CHFO mode (Touch Screen Control)<br>Pressure adjustment<br>for CPEP mode (Touch Screen Control)<br>Pressure manometer<br>Pressure adjustment<br>for Inhale, Exhale, PAP mode (Touch Screen<br>Control)<br>Flow adjustment for Inhale mode. (Touch<br>Screen Control)<br>Frequency adjustment for Flutter feature.<br>(Touch Screen Control)<br>Pressure adjustment for flutter feature. (Touch<br>Screen 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.