(190 days)
No
The summary describes a combination device providing established therapies (MIE and OLE) and does not mention any AI/ML components or capabilities.
Yes
The device is intended for therapeutic purposes such as mobilizing secretions, lung expansion therapy, and treating/preventing pulmonary atelectasis, as stated in the "Intended Use / Indications for Use" section.
No
The device is described as providing therapies for conditions such as inability to cough or clear secretions, mobilization of secretions, lung expansion, and prevention of atelectasis. There is no mention of it being used for diagnosis, but rather for treatment and therapy.
No
The device description explicitly states it is a "2 in 1 device" and mentions "Main Unit and Patient Circuit Components," indicating hardware components beyond just software. The performance studies also include bench testing related to hardware aspects like "Simulated Life Cycle testing including Cleaning," "Biocompatibility," and "Electrical safety, EMC."
Based on the provided text, the Maximus™ System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly describes the device as being used on patients for therapeutic purposes (cough assistance, secretion mobilization, lung expansion, etc.). IVD devices are used to examine specimens from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description focuses on the therapies delivered to the patient (MIE and OLE).
- No mention of analyzing biological samples: There is no indication that the device interacts with or analyzes any biological specimens.
- Performance Studies: The performance studies described are bench tests comparing the device's performance in delivering therapies to the patient, not studies related to the accuracy of analyzing biological samples.
Therefore, the Maximus™ System is a therapeutic medical device, not an IVD.
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 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) ●
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
Volara™ mode:
Adult, Child > 2 years old (acute)
5 year (home care)
Synclara™ mode:
Adult and pediatric
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)
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.
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.
K124032 – Hill-Rom MetaNeb®, K151689 – Hill-Rom MetaNeb®, K132988 - Vital Cough
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.
K121955 - Philips Respironics Cough Assist T70, K895485 – Bird IPV
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
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
1
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
2
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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3
| Date Prepared | 14-Feb-20 |
|---|---|
| Submission Sponsor: | |
| Hill-Rom Services Pte Ltd | |
| 1 Yishun Ave 7 | |
| Singapore, 768923, Singapore | Tel - 011 - 65 6499 7391 |
| 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) |
| 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.
4
| | Proposed
Maximus™ | Predicate
MetaNeb® | Predicate
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,
intermittent (IPPB) | Device, positive pressure breathing,
intermittent (IPPB) | Device, positive pressure breathing,
intermittent (IPPB) |
| Intended Use | Indicated to help with clearing
secretions
Indicated for mobilization of
secretions
lung expansion therapy
treatment and prevention of
pulmonary atelectasis
ability to provide supplemental
oxygen when used with compressed
oxygen. | Indicated for mobilization of
secretions
lung expansion therapy
treatment and prevention of
pulmonary atelectasis,
ability to provide supplemental
oxygen when used with compressed
oxygen. | Indicated to help with clearing secretions |
| Indications for Use | 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, Model
POPT1, when used as a Volara™
System is intended for the | The MetaNeb® System is indicated
for mobilization of secretions, lung | The Vital Cough is intended for use on
patients unable to cough or clear
secretions effectively due to reduced
peak cough expiratory flaw resulting
from high spinal cord injuries,
neuromuscular deficits or severe fatigue
associated with intrinsic lung disease. It
may be used either with a facemask.
mouthpiece, or an adapter to a patient's
endotracheal tube or tracheostomy tube.
For use in a hospital, institutional
setting, or home use given adequate |
| | | | |
| | expansion therapy, the treatment and
prevention of pulmonary atelectasis,
and has the ability to provide
supplemental oxygen when used with
oxygen supply. | expansion therapy, the treatment and
prevention of pulmonary atelectasis,
and can provide supplemental
oxygen when used with compressed
oxygen. | training. For use on adult or pediatric
patients. |
| Environments of Use | Hospital
sub-acute facilities
Nursing care
Homecare | Hospital
sub-acute facilities
Nursing care
Homecare (K151689) | 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 | Adult, Child > 2 years old (acute)
5 years old (home care) | Adult and pediatric
(Age not designated) |
| Therapy Modes | Volara™ therapy modes:
CPEP, CHFO, Aerosol
Synclara™ therapy modes:
Inhale, Exhale, PAP | CPEP, CHFO, Aerosol | Inhale, Exhale, PAP |
| 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. | Not offered | Not offered |
| Volara™ features | | | |
| Continuous Positive
Expiratory Pressure
(CPEP) | Controlled static flow with
positive pressures
2 years old
Home care
5 years old and above whom
can follow verbal instructions | Acute care
Adult
Child > 2 years old | Home care
5 years old and above whom
can follow verbal instructions |
| Modes | CPEP, CHFO, Aerosol | CPEP, CHFO, Aerosol | CPEP, CHFO, Aerosol |
| Continuous Positive
Expiratory Pressure
(CPEP) | Controlled static flow with
positive pressures
$