(190 days)
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.
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 provided text is a 510(k) premarket notification for the Maximus™ System, a medical device for respiratory therapy. It outlines the device's indications for use and compares it to predicate devices to establish substantial equivalence with respect to safety and effectiveness.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly present a formal "acceptance criteria" table with numerical targets, as is common for diagnostic accuracy studies. Instead, it argues for substantial equivalence to predicate devices. This means the primary acceptance criterion is that the Maximus™ System performs functionally and safely similar to its predicates (MetaNeb® and Vital Cough) and does not raise new or different questions of safety or effectiveness.
The comparison tables (Table 1, Table 2, Table 3 – although some are presented partially) serve as the 'reported device performance' against the implicit acceptance criterion of equivalence to the predicates.
| Feature / Performance Metric | Acceptance Criteria (Implicit - Equivalence to Predicates) | Reported Maximus™ System Performance |
|---|---|---|
| Indications for Use | Identical to predicates (MetaNeb® K124032, K151689; Vital Cough K132988) | Identical for mobilization of secretions, lung expansion therapy, treatment and prevention of pulmonary atelectasis, ability to provide supplemental oxygen. The Maximus™ System combines features of Synclara™ (MIE) and Volara™ (OLE). |
| Patient Population | Identical to predicates | Volara™ mode: Adult, Child > 2 years old (acute); >5 years old (home care). Synclara™ mode: Adult and pediatric. (Identical to respective predicates). |
| Environment of Use | Identical to predicates | Hospital, sub-acute facilities, nursing care, homecare. (Identical to respective predicates). |
| OLE: Peak Positive Pressures | ≤ 30 cmH2O (Predicate MetaNeb®) | Up to 70 cmH2O (Supported by reference device Bird IPV K895425 with 80 cmH2O) |
| OLE: Patient Circuit - Adjustable Resistance | Present (Predicate MetaNeb®) | No resistance adjustment feature; therapy settings done at control unit. |
| MIE: Max Positive and Negative Pressures | +50 cmH2O / -50 cmH2O (Predicate Vital Cough) | +70 cmH2O / -70 cmH2O (Supported by reference device Philips Respironics Cough Assist T70 K121955 with same pressures). Max pre-set of +50 cmH2O in home setting. |
| Nebulizer Performance | Substantially equivalent to predicate | Comparative nebulizer performance across all therapy modes and pressure ranges demonstrated substantial equivalence with the Philips SideStream nebulizer. Mouthpiece vs. face mask performance also equivalent. |
| Software Control / User Interface | Manual (Predicates) | Software-controlled, GUI screen. Performance and usability evaluated. |
| Pulse Oximeter Connection | Not offered (Predicates) | Can connect via Bluetooth to cleared Beijing Choice Electronic Technology Co., Ltd. Fingertip Pulse Oximeter (K142888). Displays heart rate and SpO2. (This is an added feature, not a comparative one, but is deemed not to raise new safety/effectiveness questions). |
| Biocompatibility | Meet applicable requirements (ISO 10993, ISO 18562) | Materials in gas and fluid pathway tested per ISO 10993-1 and ISO 18562 and found to meet applicable requirements. |
| Bench Testing Performance | Substantially equivalent to predicates | Demonstrated equivalence through: Simulated Life Cycle, Biocompatibility, Software V&V, Electrical safety/EMC, Comparative Performance in CHFO, CPEP, Aerosol and MIE modes, Comparative Nebulizer Performance, Inter-/Intra-sample variability, pre-/post-cleaning nebulizer performance, Usability. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily describes bench testing and comparative performance testing against predicate devices and reference devices. It does not refer to clinical studies with patient test sets in the context of diagnostic accuracy. Therefore, details regarding "sample size for the test set" or "data provenance (country of origin, retrospective/prospective)" for patient data are not applicable to this 510(k) submission, which focuses on substantial equivalence based on performance and safety characteristics compared to existing devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided. As this is a medical device submitting for substantial equivalence based on engineering and performance criteria rather than diagnostic accuracy with a ground truth established by experts, this type of detail is not expected or relevant in this context. The "ground truth" here is the established safe and effective operation of the predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no human adjudication of a "test set" in the context of diagnostic performance as described in the document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The Maximus™ System is a therapeutic device (noncontinuous ventilator), not a diagnostic AI system that "assists human readers." Therefore, an MRMC comparative effectiveness study is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. The Maximus™ System is a physical electro-mechanical device that delivers therapy, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this 510(k) submission for substantial equivalence is the established safe and effective performance of the predicate devices (Hill-Rom MetaNeb® and Vital Cough), as well as reference devices (Bird IPV and Philips Respironics Cough Assist T70) for specific performance parameters. The device's performance is compared against these established benchmarks through various bench tests.
8. The sample size for the training set
Not applicable. The document describes a physical medical device, not a machine learning model that requires a "training set."
9. How the ground truth for the training set was established
Not applicable. As there is no machine learning model or "training set," this question is not relevant.
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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:Hill-Rom Services Pte Ltd1 Yishun Ave 7Singapore, 768923, Singapore | Tel - 011 - 65 6499 7391Fax - 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)21 CFR 868.5905, Class II |
| Predicate Devices: | K124032 – Hill-Rom MetaNeb®K151689 – Hill-Rom MetaNeb®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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| ProposedMaximus™ | PredicateMetaNeb® | PredicateVital 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,intermittent (IPPB) | Device, positive pressure breathing,intermittent (IPPB) | Device, positive pressure breathing,intermittent (IPPB) |
| Intended Use | Indicated to help with clearingsecretionsIndicated for mobilization ofsecretionslung expansion therapytreatment and prevention ofpulmonary atelectasisability to provide supplementaloxygen when used with compressedoxygen. | Indicated for mobilization ofsecretionslung expansion therapytreatment and prevention ofpulmonary atelectasis,ability to provide supplementaloxygen when used with compressedoxygen. | Indicated to help with clearing secretions |
| Indications for Use | The Maximus™ System, ModelPOPT1 provides features of both theSynclara™ System and the Volara™System.The Maximus™ System, when usedas a Synclara™ Cough System isintended for use on patients who areunable to cough or clear secretionseffectively due to reduced peak coughexpiratory flow or respiratory muscleweakness.The Maximus™ System, ModelPOPT1, when used as a Volara™System is intended for the | The MetaNeb® System is indicatedfor mobilization of secretions, lung | The Vital Cough is intended for use onpatients unable to cough or clearsecretions effectively due to reducedpeak cough expiratory flaw resultingfrom high spinal cord injuries,neuromuscular deficits or severe fatigueassociated with intrinsic lung disease. Itmay be used either with a facemask.mouthpiece, or an adapter to a patient'sendotracheal tube or tracheostomy tube.For use in a hospital, institutionalsetting, or home use given adequate |
| expansion therapy, the treatment andprevention of pulmonary atelectasis,and has the ability to providesupplemental oxygen when used withoxygen supply. | expansion therapy, the treatment andprevention of pulmonary atelectasis,and can provide supplementaloxygen when used with compressedoxygen. | training. For use on adult or pediatricpatients. | |
| Environments of Use | Hospitalsub-acute facilitiesNursing careHomecare | Hospitalsub-acute facilitiesNursing careHomecare (K151689) | Hospitalsub-acute facilitiesNursing careHomecare |
| Patient Population | Volara™ mode:Adult, Child > 2 years old (acute)>5 year (home care)Synclara™ mode:Adult and pediatric | Adult, Child > 2 years old (acute)>5 years old (home care) | Adult and pediatric(Age not designated) |
| Therapy Modes | Volara™ therapy modes:CPEP, CHFO, AerosolSynclara™ therapy modes:Inhale, Exhale, PAP | CPEP, CHFO, Aerosol | Inhale, Exhale, PAP |
| Pulse Oximeter Option | Can connect via Bluetooth to BeijingChoice Electronic Technology Co.,Ltd. Fingertip Pulse Oximeter,K142888. Only displays the heart rateand SpO2 data. | Not offered | Not offered |
| Volara™ features | |||
| Continuous PositiveExpiratory Pressure(CPEP) | Controlled static flow withpositive pressures< 30 cmH2O | Controlled static flow withpositive pressures< 30 cmH2O | Device does not offer this feature. |
| 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, ≤ 30 cmH2O | Device does not offer this feature. |
| Aerosol | Controlled continuous constantpressure to in-line nebulizerdelivering medicated aerosol only viamouthpiece and face mask.Aerosol may not be delivered whenthe in-line ventilator adapter is used | Controlled continuous constantpressure to in-line nebulizerdelivering medicated aerosol only viamouthpiece, face mask or in-lineventilator adapter. | Device does not offer this feature. |
| ProposedMaximus™ | PredicateMetaNeb® | PredicateVital Cough with Flutter | |
| Synclara™ features | |||
| Maximum PositivePressure | 70 cmH2O* | Device does not offer this feature. | 50 cmH2O |
| Maximum NegativePressure | -70 cmH2O* | Device does not offer this feature. | -50 cmH2O |
| Inhalation, Exhalationand 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 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 circuitconsisting of Bacterial/Viral filter,hose, mouthpiece and facemaskadapter. | Disposable circuit referred to as"handset" includesconnection for in-linenebulizer.Draw in room air mix withmedicated aerosol and gasfrom controller. | Disposable single patient use circuitconsisting of Bacterial/Viral filter,hose, mouthpiece and facemask adapter. |
| Patient circuit settings | No resistance adjustment feature onpatient circuit.Therapy settings are all done at thecontrol unit. | Expiratory resistanceAdjustment | No resistance adjustment feature onpatient circuit.Therapy settings are all done at thecontrol unit. |
| * Use of Reference Philips Respironics Cough Assist T70 (K121955)+ Use of Reference Bird IPV (K895485) for this pressure | |||
| ProposedMaximus™ | PredicateMetaNeb® | PredicateVital Cough with Flutter | |
| Patient Interface | Acute care:MouthpieceFace maskInsert into ventilatorAdapter to a patient's endotrachealtube or tracheostomy tube.Home care:MouthpieceFace maskInsert into ventilatorAdapter to a patient's endotrachealtube or tracheostomy tube. | Acute care:MouthpieceFace maskInsert into ventilatorAdapter to a patient's endotrachealtube or tracheostomy tube.Home care:MouthpieceFace maskInsert into ventilatorAdapter to a patient's endotrachealtube or tracheostomy tube. | MouthpieceFace maskAdapter to a patient's endotracheal tubeor tracheostomy tube. |
| Controller | |||
| Principle of operation | Electro-Mechanical deviceAir or oxygen | PneumaticAir or oxygen | PneumaticAir or oxygen |
| Setting Options | On/OffFrequency selectionfor CHFO mode (Touch ScreenControl)Pressure adjustmentfor CHFO mode (Touch ScreenControl)Pressure adjustmentfor CPEP mode (Touch ScreenControl)Pressure manometerPressure adjustmentfor Inhale, Exhale, PAP mode (TouchScreen Control)Flow adjustment for Inhale mode.(Touch Screen Control)Frequency adjustment for Flutterfeature. (Touch Screen Control)Pressure adjustment for flutterfeature (Touch Screen Control) | On/offFrequency selectionfor CHFO mode (control knob)-Pressure adjustmentfor CPEP mode (control knob)Pressure manometer--- | On/Off--Pressure manometerPressure adjustmentfor Inhale, Exhale, PAP mode (TouchScreen Control)Flow adjustment for Inhale mode.(Touch Screen Control)Frequency adjustment for Flutter feature.(Touch Screen Control) |
Table 1 – Maximus™ Substantial Equivalence Table
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| Table 2 - Substantial Equivalence of Volara™ Oscillation and Lung Expansion Therapy |
|---|
| ------------------------------------------------------------------------------------- |
| ProposedVolara™ | Primary PredicateMetaNeb® | Secondary PredicateMetaNeb® 4 System | |
|---|---|---|---|
| 510(k) Number | K124032 | K151689 | |
| CFR classification | Regulation Number: 868.5905Product code: NHJ | ||
| Indications for Use(Brief) | Indicated for mobilization of secretions,lung expansion therapy, treatment andprevention of pulmonary atelectasis, abilityto provide supplemental oxygen when usedwith oxygen. | Indicated for mobilization of secretions,lung expansion therapy, treatment andprevention of pulmonary atelectasis, abilityto provide supplemental oxygen when usedwith compressed oxygen. | Indicated for mobilization of secretions,lung expansion therapy, treatment andprevention of pulmonary atelectasis, abilityto provide supplemental oxygen when usedwith compressed oxygen. |
| Environment of Use | HospitalSub-acute facilitiesNursing careHomecare | HospitalSub-acute facilities | HospitalSub-acute facilitiesNursing careHomecare |
| Patient Population | Acute careAdultChild > 2 years oldHome care5 years old and above whomcan follow verbal instructions | Acute careAdultChild > 2 years old | Home care5 years old and above whomcan follow verbal instructions |
| Modes | CPEP, CHFO, Aerosol | CPEP, CHFO, Aerosol | CPEP, CHFO, Aerosol |
| Continuous PositiveExpiratory Pressure(CPEP) | Controlled static flow withpositive pressures$< 30 cmH_2O$ | Controlled static flow withpositive pressures$< 30 cmH_2O$ | Controlled static flow withpositive pressures$< 30 cmH_2O$ |
| Continuous HighFrequency Oscillations(CHFO) | Controlled continuous flow withfrequencies up to 300 beats per minute andpeak positive pressures $\le 70 cmH_2O$ * | Controlled continuous flow withfrequencies up to 300 beats per minute andpeakpositive pressures $\le 30 cmH_2O$ | Controlled continuous flow withfrequencies up to 300 beats per minute andpeakpositive pressures $\le 30 cmH_2O$ |
| Aerosol Only | Controlled continuous constant pressure toin-line nebulizer delivering medicatedaerosol only via mouthpiece and face mask.Aerosol may not be delivered when the in-line ventilator adapter is used. | Controlled continuous constant pressure toin-line nebulizer delivering medicatedaerosol only via mouthpiece, face mask orin-line ventilator adapter. | Controlled continuous constant pressure toin-line nebulizer delivering medicatedaerosol only. |
| ProposedVolara™ | Primary PredicateMetaNeb® | Secondary PredicateMetaNeb® 4 System | |
| * Use of Reference Bird IPV (K895485) for this pressure | |||
| Patient Circuit | Disposable circuit referred to as “handset”includes connection for in-line nebulizer.Draw in room air mix with medicatedaerosol and gas from controller. | Disposable circuit referred to as "handset"includes connection for in-line nebulizer.Draw in room air mix with medicatedaerosol and gas from controller. | Disposable circuit referred to as "handset"includes connection for in-line nebulizer.Draw in room air mix with medicatedaerosol and gas from controller.No in-line filter (Home)In-line filter (Acute care) |
| Patient Circuit Settings | No resistance adjustment feature on patientcircuit.Adjustments all done at the control unit. | Expiratory resistance adjustment | Expiratory resistance adjustment |
| Patient Interface | Acute careMouthpieceFace maskInsert into ventilator circuitHome careMouthpieceFace mask | AcuteMouthpieceFace maskInsert into ventilator circuit | HomeMouthpieceFace mask |
| Controller | Electro-Mechanical device and air | Pneumatic and air or oxygen | Pneumatic and air or oxygen |
| Controller settings | On/OffFrequency selectionfor CHFO mode (Touch Screen Control)Pressure adjustmentfor CHFO mode (Touch Screen Control)Pressure adjustmentfor CPEP mode (Touch Screen Control)Pressure manometer | On/offFrequency selectionfor CHFO mode (control knob)–Pressure adjustmentfor CPEP mode (control knob)Pressure manometer | On/offFrequency selectionfor CHFO mode (control knob)–Pressure adjustmentfor CPEP mode (control knob)Pressure manometer |
| Ventilator connection | Placed in-line in the inspiratory limb of theventilator circuit with a standard "T"adapter.Only for acute care environment | Placed in-line in the inspiratory limb of theventilator circuit with a standard "T"adapter.Only for acute care environment | Placed in-line in the inspiratory limb of theventilator circuit with a standard "T"adapter.Only for acute care environment |
| ProposedSynclara™ | Primary Predicate deviceVital Cough with Flutter | Secondary Predicate deviceVital Cough | |
| 510(k) Number | K132988 | K120277 | |
| CFR classification | Regulation Number: 868.5905Product code: NHJ | ||
| Indications for Use | For use on patients who are unable tocough or clear secretions effectively due toreduced peak cough expiratory flow orrespiratory muscle weakness. | For use on any patient unable to cough orclear secretions effectively due to reducedpeak cough resulting from high. spinal cordinjuries, neuromuscular deficits clearanceand lung or severe fatigue or severe fatigueassociated with intrinsic lung disease. | For use on any patient unable to cough orclear secretions effectively due to reducedpeak cough resulting from high. spinal cordinjuries, neuromuscular deficits clearanceand lung or severe fatigue or severe fatigueassociated 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 PositivePressure | 70 cmH2O*Maximum pre-set is 50 cmH2O in homesetting | 50 cmH2O | 50 cmH2O |
| Maximum NegativePressure | -70 cmH2O* | -50 cmH2O | -50 cmH2O |
| Inhalation, Exhalationand PAP duration | 0 to 5 seconds | 0 to 5 seconds | 0 to 5 seconds |
| Flutter Frequency | 1 – 20 Hz | 0 - 20 Hz | No Flutter |
| Patient Circuit | Disposable single patient use circuitconsisting of Bacterial/Viral filter, hose,mouthpiece and facemask adapter. | Disposable single patient use circuitconsisting of Bacterial/Viral filter, hose,mouthpiece and facemask adapter. | Disposable single patient use circuitconsisting of Bacterial/Viral filter, hose,mouthpiece and facemask adapter. |
| Patient Interface | facemask, mouthpiece, or an adapter to apatient's endotracheal tube or tracheostomytube. | facemask, mouthpiece, or an adapter to apatient's endotracheal tube or tracheostomytube. | facemask, mouthpiece, or an adapter to apatient's endotracheal tube or tracheostomytube. |
| * Use of Reference Philips Respironics Cough Assist T70 (K121955) |
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Table 3 – Substantial Equivalence Comparison – Synclara™ - MIE Therapy
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| ProposedSynclara™ | Primary Predicate deviceVital Cough with Flutter | Secondary Predicate deviceVital Cough | |
|---|---|---|---|
| Controller settings | On/Off | On/Off | On/Off |
| Pressure adjustmentfor Inhale, Exhale, PAP mode (TouchScreen Control) | Pressure adjustmentfor Inhale, Exhale, PAP mode (TouchScreen Control) | Pressure adjustmentfor Inhale, Exhale, PAP mode (Touch ScreenControl) | |
| Flow adjustment for Inhale mode. (TouchScreen Control) | Flow adjustment for Inhale mode. (TouchScreen Control) | Flow adjustment for Inhale mode. (TouchScreen Control) | |
| Frequency adjustment for Flutter feature.(Touch Screen Control) | Frequency adjustment for Flutter feature.(Touch Screen Control) | - | |
| Pressure adjustment for flutter feature.(Touch Screen Control) | - | - | |
| Pressure manometer | Pressure manometer | Pressure manometer |
Substantial Equivalence Discussion
The Maximus™ system is viewed as substantially equivalent to the predicate devices because:
Indications - The proposed indications for use for mobilization of secretions, lung expansion therapy, the treatment and pulmonary atelectasis, and has the ability to provide supplemental oxygen when used with compressed oxygen are identical to the predicates. Discussion: The indications for use are identical to the predicates Hill-Rom MetaNeb® system (K124032) and Vital Cough (K132988). The subject device is a new design of these technologies. We have of the patient interface to include a face mask in the home setting.
Patient Population – The patient populations are identical to the predicates. Discussion: We have not changed the patient populations vs. the predicates.
Environment of Use – The environments of use identical to the predicates. Discussion: We have not changed the use environments.
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Technology - The Maximus™ is a redesign of the combination of the MetaNeb® system and the Vital Cough system into a single unit. The software-controlled Maximus™ replaces the manual control systems. Functionally the performance and therapy mode functions and performance are identical to the respective predicates.
We have added changes to some of the pressure limits based upon reference devices with similar indications for use and clinician input.
The Maximus™ can connect to a cleared pulse oximeter via BLE and can display only the heart rate and SpO2 for the convenience of the user. Connects to K142888. The predicates do not have the feature.
Discussion: The design of Maximus™ is different from the predicates in that it allows for software control of settings and the user interface is a GUI screen. We have evaluated the performance and usability with different user types.
Performance – The basic performance features and parameters are identical to the predicates. We have proposed some changes listed below with their respective rationale.
Rationale and Support of Product Differences / Modifications
OLE
Higher Peak Positive Pressures
We have found that clinicians want to provide a higher Positive Peak Pressure up to 70 cm H2O vs. the original 30 cmH2O. The reference device Bird IPV (K895485) has similar indications for use and patient population and provides peak expiratory pressures up to 80 cm H2O.
Patient Circuit - Adjustable Resistance
The predicate patient circuit has a selector ring which could be adjusted manually. The proposed change in Maximus™ with the touch screen is that controls would be performed on-screen.
MIE
Higher Maximum Positive and Negative Pressures
We have found that clinicians want to be able to provide a wider range of Maximum Positive and Negative pressures during couch assist. We are proposing to increase the range from +50 cm H2O to +70 cm H2O. The reference Philips Respironics Cough Assist T70 (K121955) has the same indications for use and population that provides pressures of +70 cm H2O.
Nebulizer Performance
The comparative nebulizer performance across all therapy modes and range of pressures demonstrated that the Maximus performance with the Philips SideStream nebulizer was substantially equivalent to the predicate. In addition, testing demonstrated that the performance with a mouthpiece vs. a face mask were equivalent. Aerosol may not be delivered when the in-line ventilator adapter is used.
Manual Mode
The Manual Mode is restricted to highly trained home users via "pass key".
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Discussion of Differences
The differences presented above have not raised new or different questions of safety or effectiveness from the predicates or the reference devices cited.
Non-clinical Comparative Performance
Biocompatibility of Patient Contacting Materials - The materials in the gas and fluid pathway are considered as having 2 types of patient contact:
- External communicating, tissue contacting, permanent duration and
- . Surface contact, mucosal contact, permanent duration for the mouthpiece
- The materials have been tested per ISO 10993-1 and ISO 18562.
Discussion: All associated materials in the gas or fluid pathway have been tested per ISO 10993-1 and ISO 18562 and found to meet the applicable requirements.
Bench Testing - We performed a series of non-clinical bench testing to demonstrate that the Maximus™ system is equivalent to the predicates. These tests included:
- Simulated Life Cycle testing including Cleaning ●
- Biocompatibility Main Unit and Patient Circuit Components .
- o ISO 10993
- o ISO 18562
- Software verification and validation ●
- Electrical safety, EMC ●
- Comparative Performance in CHFO, CPEP, Aerosol and MIE modes
- Comparative Nebulizer Performance across all therapy modes for adult and pediatric flow ● rates
- . Inter- and Intra-sample variability and pre- and post-cleaning nebulizer performance
- . Usability
The comparative testing demonstrates that the proposed device is substantially equivalent to the predicate devices.
Comparative Performance
We compared the proposed Maximus across all therapy modes vs. the applicable predicate and reference devices.
These tests included:
- Continuous High Frequency Oscillation (CHFO) ●
- Continuous Positive Expiratory Pressure (CPEP) ●
- Aerosol ●
- . Comparative Bench Testing of MIE (Mechanical Insufflation-Exsufflation)
- Comparative Nebulizer Performance across all therapy modes for adult and pediatric flow . rates
Discussion: The differences in some of the pressure limits is supported by the cleared reference devcies which have the same indications for use, patient population and environments of use. Any difference in performance or pressure limits do not raise new risk concerns and thus the Maximus™ system can be found to be substantially equivalent to the predicates.
Substantial Equivalence Conclusion
Based upon the risk analysis, comparative performance testing and the usability testing we have demonstrated that the proposed device and predicates can be found to be substantially equivalent.
§ 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).