Maximus System
Device Facts
| Record ID | K192143 |
|---|---|
| Device Name | Maximus System |
| Applicant | Hill-Rom Services Pte, Ltd. |
| Product Code | NHJ · Anesthesiology |
| Decision Date | Feb 14, 2020 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5905 |
| Device Class | Class 2 |
| Attributes | Therapeutic, Pediatric |
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.
Device Story
Maximus™ System is a 2-in-1 electro-mechanical device combining Synclara™ (MIE) and Volara™ (OLE) therapy systems. Inputs include air or oxygen; device transforms these via software-controlled pressure/flow settings to provide MIE, CPEP, CHFO, and aerosol therapy. Output is delivered to patients via mouthpiece, face mask, or ventilator circuit adapter. Used in hospital, sub-acute, nursing, and home settings by clinicians or trained home users. Features a GUI touch screen for therapy control and pressure/flow adjustments. Can connect via Bluetooth to a pulse oximeter (K142888) to display SpO2 and heart rate. Benefits include secretion clearance, lung expansion, and atelectasis prevention. Software replaces manual controls of predicate devices, allowing precise parameter management.
Clinical Evidence
Bench testing only. Testing included simulated life cycle, cleaning, biocompatibility (ISO 10993, ISO 18562), electrical safety, EMC, and comparative performance across CHFO, CPEP, aerosol, and MIE modes. Nebulizer performance was compared across therapy modes and flow rates. Usability testing was conducted for different user types. Results demonstrated substantial equivalence to predicate devices.
Technological Characteristics
Electro-mechanical device; air/oxygen source. Materials tested per ISO 10993-1 and ISO 18562. Connectivity: Bluetooth (BLE) for pulse oximeter. User interface: GUI touch screen. Therapy modes: MIE, CPEP, CHFO, Aerosol. Pressure range: up to 70 cmH2O. Software-controlled settings. Disposable patient circuits (handsets/filters).
Indications for Use
Indicated for patients unable to cough/clear secretions effectively due to reduced peak cough expiratory flow or respiratory muscle weakness (Synclara mode); mobilization of secretions, lung expansion therapy, treatment/prevention of pulmonary atelectasis, and supplemental oxygen delivery (Volara mode). Synclara mode: pediatric to adult, acute/home care. Volara mode: adults/children >2 years (acute care), >5 years (home care).
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
Reference Devices
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
February 14, 2020
Hill-Rom Services Pte Ltd Paul Dryden Consultant for Hill-Rom 1 Yishun Ave 7 Singapore, Sg 768923
Re: K192143
Trade/Device Name: Maximus™ System Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: Class II Product Code: NHJ Dated: January 20, 2020 Received: January 21, 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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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 (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 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)
# K192143
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 | 14-Feb-20 |
|----------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| Submission Sponsor:<br>Hill-Rom Services Pte Ltd<br>1 Yishun Ave 7<br>Singapore, 768923, Singapore | Tel - 011 - 65 6499 7391<br>Fax - 011 - 65 65945201 |
| Official Contact: | Alvin Tan – R&D Executive Director |
| 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: | K124032 – Hill-Rom MetaNeb®<br>K151689 – Hill-Rom MetaNeb®<br>K132988 - Vital Cough |
| Reference Devices: | K121955 - Philips Respironics Cough Assist T70 |
### Device Description:
The Maximus™ System is a 2 in 1 device which is a combination of two (2) already cleared devices. The Maximus™ System provides the individual therapies of the predicates: Vital Cough and MetaNeb®. The Maximus™ can be programmed to allow the user to provide both therapies or one only. The 2 main types of therapies are referred to as:
- . MIE (Mechanical Insufflation-Exsufflation)
- OLE (Oscillation and Lung Expansion) ●
The Maximus™ system and the relevant predicates are presented in Tables 1 to 3.
K895485 – Bird IPV
#### 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 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.
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| | Proposed<br>Maximus™ | Predicate<br>MetaNeb® | Predicate<br>Vital Cough with Flutter |
|------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | TBD | K124032 and K151689 | K132958 |
| CFR | 868.5905 | 868.5905 | 868.5905 |
| Classification | NHJ | NHJ | NHJ |
| Classification name | Device, positive pressure breathing,<br>intermittent (IPPB) | Device, positive pressure breathing,<br>intermittent (IPPB) | Device, positive pressure breathing,<br>intermittent (IPPB) |
| Intended Use | Indicated to help with clearing<br>secretions<br>Indicated for mobilization of<br>secretions<br>lung expansion therapy<br>treatment and prevention of<br>pulmonary atelectasis<br>ability to provide supplemental<br>oxygen when used with compressed<br>oxygen. | Indicated for mobilization of<br>secretions<br>lung expansion therapy<br>treatment and prevention of<br>pulmonary atelectasis,<br>ability to provide supplemental<br>oxygen when used with compressed<br>oxygen. | Indicated to help with clearing secretions |
| Indications for Use | The Maximus™ System, Model<br>POPT1 provides features of both the<br>Synclara™ System and the Volara™<br>System.<br>The Maximus™ System, when used<br>as a Synclara™ Cough System is<br>intended for use on patients who are<br>unable to cough or clear secretions<br>effectively due to reduced peak cough<br>expiratory flow or respiratory muscle<br>weakness.<br>The Maximus™ System, Model<br>POPT1, when used as a Volara™<br>System is intended for the | The MetaNeb® System is indicated<br>for mobilization of secretions, lung | The Vital Cough is intended for use on<br>patients unable to cough or clear<br>secretions effectively due to reduced<br>peak cough expiratory flaw resulting<br>from high spinal cord injuries,<br>neuromuscular deficits or severe fatigue<br>associated with intrinsic lung disease. It<br>may be used either with a facemask.<br>mouthpiece, or an adapter to a patient's<br>endotracheal tube or tracheostomy tube.<br>For use in a hospital, institutional<br>setting, or home use given adequate |
| | | | |
| | expansion therapy, the treatment and<br>prevention of pulmonary atelectasis,<br>and has the ability to provide<br>supplemental oxygen when used with<br>oxygen supply. | expansion therapy, the treatment and<br>prevention of pulmonary atelectasis,<br>and can provide supplemental<br>oxygen when used with compressed<br>oxygen. | training. For use on adult or pediatric<br>patients. |
| Environments of Use | Hospital<br>sub-acute facilities<br>Nursing care<br>Homecare | Hospital<br>sub-acute facilities<br>Nursing care<br>Homecare (K151689) | 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 | Adult, Child > 2 years old (acute)<br>>5 years old (home care) | Adult and pediatric<br>(Age not designated) |
| Therapy Modes | Volara™ therapy modes:<br>CPEP, CHFO, Aerosol<br>Synclara™ therapy modes:<br>Inhale, Exhale, PAP | CPEP, CHFO, Aerosol | Inhale, Exhale, PAP |
| Pulse Oximeter Option | Can connect via Bluetooth to Beijing<br>Choice Electronic Technology Co.,<br>Ltd. Fingertip Pulse Oximeter,<br>K142888. Only displays the heart rate<br>and SpO2 data. | Not offered | Not offered |
| Volara™ features | | | |
| 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 | Device does not offer this feature. |
| 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, ≤ 30 cmH2O | Device does not offer this feature. |
| Aerosol | Controlled continuous constant<br>pressure to in-line nebulizer<br>delivering medicated aerosol only via<br>mouthpiece and face mask.<br>Aerosol may not be delivered when<br>the in-line ventilator adapter is used | Controlled continuous constant<br>pressure to in-line nebulizer<br>delivering medicated aerosol only via<br>mouthpiece, face mask or in-line<br>ventilator adapter. | Device does not offer this feature. |
| | Proposed<br>Maximus™ | Predicate<br>MetaNeb® | Predicate<br>Vital Cough with Flutter |
| Synclara™ features | | | |
| Maximum Positive<br>Pressure | 70 cmH2O* | Device does not offer this feature. | 50 cmH2O |
| Maximum Negative<br>Pressure | -70 cmH2O* | Device does not offer this feature. | -50 cmH2O |
| Inhalation, Exhalation<br>and PAP duration | 0 to 5 seconds | Device does not offer this feature. | 0 to 5 seconds |
| Flutter frequency | 1 – 20 Hz | Device does not offer this feature. | 0 – 20 Hz |
| Accessories | | | |
| Patient Circuit<br>configurations | Volara™ Patient Circuit:<br>Disposable circuit referred to as<br>"handset" includes connection for in-<br>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,<br>hose, mouthpiece and facemask<br>adapter. | Disposable circuit referred to as<br>"handset" includes<br>connection for in-line<br>nebulizer.<br>Draw in room air mix with<br>medicated aerosol and gas<br>from controller. | Disposable single patient use circuit<br>consisting of Bacterial/Viral filter,<br>hose, mouthpiece and facemask adapter. |
| Patient circuit settings | No resistance adjustment feature on<br>patient circuit.<br>Therapy settings are all done at the<br>control unit. | Expiratory resistance<br>Adjustment | No resistance adjustment feature on<br>patient circuit.<br>Therapy settings are all done at the<br>control unit. |
| | * Use of Reference Philips Respironics Cough Assist T70 (K121955)<br>+ Use of Reference Bird IPV (K895485) for this pressure | | |
| | Proposed<br>Maximus™ | Predicate<br>MetaNeb® | Predicate<br>Vital Cough with Flutter |
| Patient Interface | Acute care:<br>Mouthpiece<br>Face mask<br>Insert into ventilator<br>Adapter to a patient's endotracheal<br>tube or tracheostomy tube.<br>Home care:<br>Mouthpiece<br>Face mask<br>Insert into ventilator<br>Adapter to a patient's endotracheal<br>tube or tracheostomy tube. | Acute care:<br>Mouthpiece<br>Face mask<br>Insert into ventilator<br>Adapter to a patient's endotracheal<br>tube or tracheostomy tube.<br>Home care:<br>Mouthpiece<br>Face mask<br>Insert into ventilator<br>Adapter to a patient's endotracheal<br>tube or tracheostomy tube. | Mouthpiece<br>Face mask<br>Adapter to a patient's endotracheal tube<br>or tracheostomy tube. |
| Controller | | | |
| Principle of operation | Electro-Mechanical device<br>Air or oxygen | Pneumatic<br>Air or oxygen | Pneumatic<br>Air or oxygen |
| Setting Options | On/Off<br>Frequency selection<br>for CHFO mode (Touch Screen<br>Control)<br>Pressure adjustment<br>for CHFO mode (Touch Screen<br>Control)<br>Pressure adjustment<br>for CPEP mode (Touch Screen<br>Control)<br>Pressure manometer<br>Pressure adjustment<br>for Inhale, Exhale, PAP mode (Touch<br>Screen Control)<br>Flow adjustment for Inhale mode.<br>(Touch Screen Control)<br>Frequency adjustment for Flutter<br>feature. (Touch Screen Control)<br>Pressure adjustment for flutter<br>feature (Touch Screen Control) | On/off<br>Frequency selection<br>for CHFO mode (control knob)<br>-<br>Pressure adjustment<br>for CPEP mode (control knob)<br>Pressure manometer<br>-<br>-<br>- | On/Off<br>-<br>-<br>Pressure manometer<br>Pressure adjustment<br>for Inhale, Exhale, PAP mode (Touch<br>Screen Control)<br>Flow adjustment for Inhale mode.<br>(Touch Screen Control)<br>Frequency adjustment for Flutter feature.<br>(Touch Screen Control) |
# Table 1 – Maximus™ Substantial Equivalence Table
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| Table 2 - Substantial Equivalence of Volara™ Oscillation and Lung Expansion Therapy |
|-------------------------------------------------------------------------------------|
|-------------------------------------------------------------------------------------|
| | Proposed<br>Volara™ | Primary Predicate<br>MetaNeb® | Secondary Predicate<br>MetaNeb® 4 System |
|-------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | | K124032 | K151689 |
| CFR classification | | Regulation Number: 868.5905<br>Product code: NHJ | |
| Indications for Use<br>(Brief) | Indicated for mobilization of secretions,<br>lung expansion therapy, treatment and<br>prevention of pulmonary atelectasis, ability<br>to provide supplemental oxygen when used<br>with oxygen. | Indicated for mobilization of secretions,<br>lung expansion therapy, treatment and<br>prevention of pulmonary atelectasis, ability<br>to provide supplemental oxygen when used<br>with compressed oxygen. | Indicated for mobilization of secretions,<br>lung expansion therapy, treatment and<br>prevention of pulmonary atelectasis, ability<br>to provide supplemental oxygen when used<br>with compressed oxygen. |
| Environment of Use | Hospital<br>Sub-acute facilities<br>Nursing care<br>Homecare | Hospital<br>Sub-acute facilities | Hospital<br>Sub-acute facilities<br>Nursing care<br>Homecare |
| Patient Population | Acute care<br>Adult<br>Child > 2 years old<br>Home care<br>5 years old and above whom<br>can follow verbal instructions | Acute care<br>Adult<br>Child > 2 years old | Home care<br>5 years old and above whom<br>can follow verbal instructions |
| Modes | CPEP, CHFO, Aerosol | CPEP, CHFO, Aerosol | CPEP, CHFO, Aerosol |
| Continuous Positive<br>Expiratory Pressure<br>(CPEP) | Controlled static flow with<br>positive pressures<br>$< 30 cmH_2O$ | Controlled static flow with<br>positive pressures<br>$< 30 cmH_2O$ | Controlled static flow with<br>positive pressures<br>$< 30 cmH_2O$ |
| Continuous High<br>Frequency Oscillations<br>(CHFO) | Controlled continuous flow with<br>frequencies up to 300 beats per minute and<br>peak positive pressures $\le 70 cmH_2O$ * | Controlled continuous flow with<br>frequencies up to 300 beats per minute and<br>peak<br>positive pressures $\le 30 cmH_2O$ | Controlled continuous flow with<br>frequencies up to 300 beats per minute and<br>peak<br>positive pressures $\le 30 cmH_2O$ |
| Aerosol Only | Controlled continuous constant pressure to<br>in-line nebulizer delivering medicated<br>aerosol only via mouthpiece and face mask.<br>Aerosol may not be delivered when the in-<br>line ventilator adapter is used. | Controlled continuous constant pressure to<br>in-line nebulizer delivering medicated<br>aerosol only via mouthpiece, face mask or<br>in-line ventilator adapter. | Controlled continuous constant pressure to<br>in-line nebulizer delivering medicated<br>aerosol only. |
| | Proposed<br>Volara™ | Primary Predicate<br>MetaNeb® | Secondary Predicate<br>MetaNeb® 4 System |
| * Use of Reference Bird IPV (K895485) for this pressure | | | |
| Patient Circuit | Disposable circuit referred to as “handset”<br>includes connection for in-line nebulizer.<br>Draw in room air mix with medicated<br>aerosol and gas from controller. | Disposable circuit referred to as "handset"<br>includes connection for in-line nebulizer.<br>Draw in room air mix with medicated<br>aerosol and gas from controller. | Disposable circuit referred to as "handset"<br>includes connection for in-line nebulizer.<br>Draw in room air mix with medicated<br>aerosol and gas from controller.<br>No in-line filter (Home)<br>In-line filter (Acute care) |
| Patient Circuit Settings | No resistance adjustment feature on patient<br>circuit.<br>Adjustments all done at the control unit. | Expiratory resistance adjustment | Expiratory resistance adjustment |
| Patient Interface | Acute care<br>Mouthpiece<br>Face mask<br>Insert into ventilator circuit<br>Home care<br>Mouthpiece<br>Face mask | Acute<br>Mouthpiece<br>Face mask<br>Insert into ventilator circuit | Home<br>Mouthpiece<br>Face mask |
| Controller | Electro-Mechanical device and air | Pneumatic and air or oxygen | Pneumatic and air or oxygen |
| Controller settings | 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 | On/off<br>Frequency selection<br>for CHFO mode (control knob)<br>–<br>Pressure adjustment<br>for CPEP mode (control knob)<br>Pressure manometer | On/off<br>Frequency selection<br>for CHFO mode (control knob)<br>–<br>Pressure adjustment<br>for CPEP mode (control knob)<br>Pressure manometer |
| Ventilator connection | Placed in-line in the inspiratory limb of the<br>ventilator circuit with a standard "T"<br>adapter.<br>Only for acute care environment | Placed in-line in the inspiratory limb of the<br>ventilator circuit with a standard "T"<br>adapter.<br>Only for acute care environment | Placed in-line in the inspiratory limb of the<br>ventilator circuit with a standard "T"<br>adapter.<br>Only for acute care environment |
| | Proposed<br>Synclara™ | Primary Predicate device<br>Vital Cough with Flutter | Secondary Predicate device<br>Vital Cough |
| 510(k) Number | | K132988 | K120277 |
| CFR classification | Regulation Number: 868.5905<br>Product code: NHJ | | |
| Indications for Use | For use on patients who are unable to<br>cough or clear secretions effectively due to<br>reduced peak cough expiratory flow or<br>respiratory muscle weakness. | For use on any patient unable to cough or<br>clear secretions effectively due to reduced<br>peak cough resulting from high. spinal cord<br>injuries, neuromuscular deficits clearance<br>and lung or severe fatigue or severe fatigue<br>associated with intrinsic lung disease. | For use on any patient unable to cough or<br>clear secretions effectively due to reduced<br>peak cough resulting from high. spinal cord<br>injuries, neuromuscular deficits clearance<br>and lung or severe fatigue or severe fatigue<br>associated with intrinsic lung disease. |
| Environment of Use | Home, hospital/Institution | Home, hospital/Institution | Home, hospital/Institution |
| Patient Population | Adult and pediatric | Adult and pediatric | Adult and pediatric |
| Modes | Inhale, Exhale, PAP | Inhale, Exhale, PAP | Inhale, Exhale, PAP |
| Maximum Positive<br>Pressure | 70 cmH2O*<br>Maximum pre-set is 50 cmH2O in home<br>setting | 50 cmH2O | 50 cmH2O |
| Maximum Negative<br>Pressure | -70 cmH2O* | -50 cmH2O | -50 cmH2O |
| Inhalation, Exhalation<br>and PAP duration | 0 to 5 seconds | 0 to 5 seconds | 0 to 5 seconds |
| Flutter Frequency | 1 – 20 Hz | 0 - 20 Hz…
