(41 days)
No
The summary does not mention AI, ML, or any related concepts. The device description focuses on mechanical therapies and aerosol delivery.
Yes
The device is intended for the prevention and treatment of pulmonary conditions, and to address issues like ineffective coughing and secretion clearance, which are therapeutic uses.
No
The "Intended Use / Indications for Use" and "Device Description" sections clearly state that the Maximus™ System is used for therapeutic purposes such as assisting with coughing, mobilizing secretions, lung expansion therapy, and treating/preventing pulmonary atelectasis. There is no mention of the device being used to diagnose conditions.
No
The device description clearly states it is a "2 in 1 device" combining two types of therapies (MIE and OLE) and mentions components like a nebulizer and ventilator tee adaptor, indicating it is a hardware device with software control, not a software-only device.
Based on the provided text, the Maximus™ System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use describes therapies delivered to the patient (cough assistance, secretion mobilization, lung expansion). IVD devices are used to examine specimens from the body (like blood, urine, tissue) to diagnose or monitor conditions.
- Device Description: The description focuses on mechanical therapies (MIE and OLE) and aerosol delivery. It doesn't mention any components or functions related to analyzing biological samples.
- Performance Studies: The performance studies described are related to the delivery of therapy (nebulizer performance, aerosol delivery) and not the analysis of biological samples. The metrics measured (MMAD, Total Respirable Dose, Fine Particle) are relevant to aerosol delivery, not diagnostic testing.
Therefore, the Maximus™ System is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
NHJ
Device Description
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™
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
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.
Intended User / Care Setting
Acute care setting
Home care setting
Hospital
sub-acute facilities
Nursing care
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance of Aerosol Delivery in CHFO mode: Comparative particle characterization testing was performed 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.
Bench Testing: Comparative nebulizer performance was performed 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K192143 – Hill-Rom Maximus™ System
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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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
1
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
2
Indications for Use
510(k) Number (if known)
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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FORM FDA 3881
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
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Date Prepared | 26-May-20 | |
---|---|---|
Submission Sponsor: | Hill-Rom Services Pte Ltd | |
1 Yishun Ave 7 | ||
Singapore, 768923, Singapore | Tel - 011 - 65 6499 7391 | |
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) | |
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.
4
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
Maximus™ 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 POPT1
provides features of both the Synclara™
System and the Volara™ System. | The Maximus™ System, Model POPT1
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
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, Model POPT1, 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, Model POPT1,
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. |
| Environments of Use | Hospital
sub-acute facilities
Nursing care
Homecare | Hospital
sub-acute facilities
Nursing care
Homecare |
| 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, Aerosol
Synclara™ therapy modes:
Inhale, Exhale, PAP | Volara™ therapy modes:
CPEP, CHFO, Aerosol
Synclara™ therapy modes:
Inhale, Exhale, PAP |
| Available nebulizer | Philips SideStream (K991725) | Philips SideStream (K991725) |
| Aerosol delivery | Mouthpiece
Face Mask
Ventilator Tee Adaptor | Mouthpiece
Face Mask |
| Pulse Oximeter Option | Can connect via Bluetooth to Beijing Choice
Electronic Technology Co., Ltd. Fingertip
Pulse Oximeter, K142888. Only displays the
heart rate and SpO2 data. | Can connect via Bluetooth to Beijing Choice
Electronic Technology Co., Ltd. Fingertip
Pulse Oximeter, K142888. Only displays the
heart rate and SpO2 data. |
| | Modified
Maximus™ | Predicate
Maximus™ |
| Continuous Positive
Expiratory Pressure
(CPEP) | Controlled static flow with
positive pressures