(268 days)
No
The document describes a mechanical therapeutic device with different modes of operation (Aerosol, CHFO, CPEP) and does not mention any AI or ML components or capabilities. The performance studies focus on bench testing and usability, not AI/ML model performance.
Yes
The device description explicitly states, "The MetaNeb® 4 System is a therapeutic device."
No
The device is described as a "therapeutic device" used for mobilization of secretions, lung expansion therapy, and treatment/prevention of pulmonary atelectasis, which are all therapeutic functions, not diagnostic ones.
No
The device description explicitly states it has three major hardware components: Circuit, Controller, and Stand.
Based on the provided information, the MetaNeb® 4 System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- The MetaNeb® 4 System is a therapeutic device. Its intended use is to directly treat patients by mobilizing secretions, expanding lungs, and preventing/treating atelectasis. It does not analyze biological samples.
The description clearly outlines its function as a system that delivers therapy through different modes (Aerosol, CHFO, CPEP) to the patient's respiratory system. This is a direct therapeutic intervention, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The MetaNeb® 4 System is indicated for mobilization of secretions, lung expansion therapy, the treatment and prevention of pulmonary atelectasis, and also has the ability to provide supplemental oxygen when used with compressed oxygen.
Product codes
NHJ
Device Description
The MetaNeb® 4 System is a therapeutic device that uses a systematic approach to enhance normal mucus clearance and resolve or prevent patchy atelectasis.
The system has three modes:
- Aerosol for the delivery of aerosol only. In this mode CHFO and CPEP are not available. .
- . CHFO (Continuous High Frequency Oscillation) - a pneumatic form of chest physiotherapy that delivers medicated aerosol while oscillating the airways with continuous pulses of positive pressure.
- . CPEP (Continuous Positive Expiratory Pressure) - supplies medicated aerosol combined with continuous positive pressure to help hold open and expand the airways.
There are three major components to The MetaNeb® 4 System:
- Circuit includes a mouthpiece, handset, nebulizer, tubing, and filter/tri-connector. It is a single patient use, assembly that is intended for multiple treatment sessions.
- . Controller - contains the controls to select the three different modes. It also has a manometer to monitor pressure. Power is supplied by a hose connected to a 50 psi air or oxygen source, e.g., wall source, cylinder or portable medical air compressor.
- . Stand - to move the MetaNeb® 4 System from room to room.
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
5 years old and above whom can follow verbal instructions.
Intended User / Care Setting
Hospitals, sub-acute and nursing facilities, physician offices, clinics, and home settings
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 tests to demonstrate that the modified MetaNeb® 4 System is equivalent to the predicates. These tests included:
- Compatibility testing of portable air compressors to performance specifications
- Performance comparison of air source, portable compressor vs. wall source
- Biocompatibility Controller
- Material Certification
- PM2.5 testing for the controller reconfirmation only
- . Usability - home environment
The comparative testing demonstrates that the proposed modifications are substantially equivalent to the predicate devices.
Usability - We performed a usability study with 2 user groups: caregivers and lay users. The study evaluated the ability of each group to perform critical tasks related to setting the MetaNeb® 4 System up and performing simulated treatments, 100% of the participants completed all the tasks successfully without use errors that could have lead to unacceptable risk of harm.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K124032 – Hill-Rom - MetaNeb®, K051964 - CoMedica - PowerNeb®, K895485 - Percussionaire Corp (Bird) - IPV
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of three human profiles facing to the right, arranged in a way that they appear to be interconnected. The profiles are black and are set against a white background. Encircling the profiles is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 17, 2016
Hill-Rom Services Pte Ltd c/o Paul Dryden Consultant for Hill-Rom 1 Yishun Ave 7 Singapore 768923
K151689 Trade/Device Name: MetaNeb® 4 System Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: Class II Product Code: NHJ Dated: February 12, 2016 Received: February 16, 2016
Dear Mr. Dryden,
Re:
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. 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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital. Respiratory. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Expiration Date: January 31, 2017
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K151689
Device Name
MetaNeb® 4 System
Indications for Use (Describe)
The MetaNeb® 4 System is indicated for mobilization of secretions, lung expansion therapy, the treatment and prevention of pulmonary atelectasis, and also has the ability to provide supplemental oxygen when used with compressed oxygen.
Patient Population - 5 years old and above whom can follow verbal instructions.
Environment of Use - Hospitals, sub-acute and nursing facilities, physician offices, clinics, and home settings
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
510(k) Summary Page 1 of 9
| Date Prepared | 15-Mar-16 |
|---|---|
| Hill-Rom Services Pte Ltd | |
| 1 Yishun Ave 7 | |
| Singapore, 768923, Singapore | |
| Tel - 011 - 65 65945215 | |
| Fax - 011 - 65 65945201 | |
| Official Contact: | Huifang Zhu - RA / QA Specialist |
| Proprietary or Trade Name: | MetaNeb® 4 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® |
| K051964 - CoMedica - PowerNeb® | |
| K895485 - Percussionaire Corp (Bird) - IPV |
Device Description:
The MetaNeb® 4 System is a therapeutic device that uses a systematic approach to enhance normal mucus clearance and resolve or prevent patchy atelectasis.
The system has three modes:
- Aerosol for the delivery of aerosol only. In this mode CHFO and CPEP are not available. .
- . CHFO (Continuous High Frequency Oscillation) - a pneumatic form of chest physiotherapy that delivers medicated aerosol while oscillating the airways with continuous pulses of positive pressure.
- . CPEP (Continuous Positive Expiratory Pressure) - supplies medicated aerosol combined with continuous positive pressure to help hold open and expand the airways.
There are three major components to The MetaNeb® 4 System:
- Circuit includes a mouthpiece, handset, nebulizer, tubing, and filter/tri-connector. It is a ● single patient use, assembly that is intended for multiple treatment sessions.
- . Controller - contains the controls to select the three different modes. It also has a manometer to monitor pressure. Power is supplied by a hose connected to a 50 psi air or oxygen source, e.g., wall source, cylinder or portable medical air compressor.
- . Stand - to move the MetaNeb® 4 System from room to room.
The MetaNeb® 4 System incorporates 2 changes vs. the predicate MetaNeb®, K124032. The changes are listed in Table 1.
4
510(k) Summary Page 2 of 9 15-Mar-16
| | Predicate
MetaNeb® - K124031 | Difference / Modification for
Proposed Device |
|-----------------------|----------------------------------------------------------------------|------------------------------------------------------------------------|
| Environment
of use | Hospitals
sub-acute facilities
physician offices
clinics | Expanding to include
nursing facility and home setting |
| Power
sources | Air source from
facility supply, e.g., cylinder
or wall source | Adding portable medical air compressor as an
additional air source. |
Table 1 - Differences / Modifications between proposed MetaNeb® 4 System and Predicate MetaNeb® (K124032)
Indications for Use:
The MetaNeb® 4 System is indicated for mobilization of secretions, lung expansion therapy, the treatment and prevention of pulmonary atelectasis, and also has the ability to provide supplemental oxygen when used with compressed oxygen.
Patient Population - 5 years old and above whom can follow verbal instructions
Environment of Use - Hospitals, sub-acute and nursing facilities, physician offices, clinics, and home settings
Predicate Device Comparison:
The MetaNeb® 4 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 prevention of pulmonary atelectasis, and also 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 predicate Hill-Rom MetaNeb® system (K124032).
Patient Population -
The patient population is similar to the predicate MetaNeb®, K124032 but the lower age has changed to 5 years and above who can follow verbal instructions.
Discussion: The difference in patient population relates to the ability to use a mouthpiece in a home setting.
Environment of Use -
The addition of the environments of use to include nursing care facilities and home care settings is identical to the predicate Bird IPV (K895485).
5
510(k) Summary Page 3 of 9 15-Mar-16
Discussion: The expansion in the intended environments of use is substantially equivalent to the predicate Bird IPV (K895485). We have evaluated the risks associated with home use and performed a usability study that supports that the device may be used within this environment.
Technology -
The design of the MetaNeb® 4 System as a pneumatically operated system with different modes of operation: CPEP, CHFO, and aerosol only are identical to the predicate in design and basic function and performance.
Discussion: The design of MetaNeb® is identical to the predicate MetaNeb® (K124032).
Performance -
The basic performance features and parameters are identical to the predicate MetaNeb® (K124032). Discussion: The proposed changes do not alter the performance specifications of the proposed MetaNeb® 4 System and the predicate MetaNeb® (K124032).
Non-clinical Comparative Performance
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 are unchanged and identical to the predicate submission MetaNeb®, K124032. Discussion: All associated materials in the gas or fluid pathway are identical to the predicate Hill-Rom MetaNeb® (K124032). We did perform additional PM23 testing even though the controller is identical to the predicate MetaNeb® (K124032).
Bench Testing -
We performed a series of non-clinical bench tests to demonstrate that the modified MetaNeb® 4 System is equivalent to the predicates. These tests included:
- Compatibility testing of portable air compressors to performance specifications
- Performance comparison of air source, portable compressor vs. wall source ●
- Biocompatibility Controller ●
- o Material Certification
- 0 PM2.5 testing for the controller reconfirmation only
- . Usability - home environment
The comparative testing demonstrates that the proposed modifications are substantially equivalent to the predicate devices.
6
510(k) Summary
15-Mar-16
Table 2 – Substantial Equivalence Comparative Table
| | Proposed
MetaNeb® 4 System | MetaNeb®
Hill-Rom - K124032 | PowerNeb
Comedica - K051964 | IPV
Bird - K895485 |
|----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | 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 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 the
mobilization and raising of
endobronchial secretions,
bronchodilation, reducing
mucosal edema, resolution
of diffuse patchy atelectasis
in all patient
populations |
| Indications for Use | The MetaNeb® 4 System is
indicated for mobilization of
secretions, lung expansion
therapy, the treatment and
prevention of pulmonary
atelectasis, and also has the
ability to provide
supplemental oxygen when
used with compressed
oxygen. | The MetaNeb® System is
indicated for mobilization of
secretions, lung expansion
therapy, the treatment and
prevention of pulmonary
atelectasis, and also has the
ability to provide
supplemental oxygen when
used with compressed
oxygen. | PowerNeb® is indicated for
mobilization of secretions,
lung expansion therapy, the
treatment and prevention of
pulmonary atelectasis, and
also has the ability to
provide supplemental
oxygen when used with
compressed oxygen | Use of Percussaire® IPV®
is indicated for the
mobilization and raising of
endobronchial secretions,
bronchodilation, reducing
mucosal edema, and the
resolution of diffuse patchy
atelectasis in all patient
populations. |
| | | 510(k) Summary | | |
| | | Page 5 of 9 | | |
| | | 15-Mar-16 | | |
| | Proposed | MetaNeb® | PowerNeb | IPV |
| | MetaNeb® 4 System | Hill-Rom - K124032 | Comedica - K051964 | Bird - K895485 |
| Environments of Use | Hospital, sub-acute facilities | Hospital, sub-acute facilities | Hospital, sub-acute facilities | Hospital, sub-acute facilities |
| | Nursing care, Homecare | | | Homecare |
| Patient Population | | | All patients that require | |
| | 5 years old and above whom | Adult | therapy mobilization of | All patient populations |
| | can follow verbal instructions | Children > 2 years old | secretions, lung expansion | |
| | | | therapy, the treatment and | |
| | | | prevention of pulmonary | |
| | | | atelectasis. | |
| Contraindications | -Untreated tension | -Untreated tension | -Untreated tension | -Untreated tension |
| | pneumothorax | pneumothorax | pneumothorax | pneumothorax |
| | -Untrained or unskilled | -Untrained or unskilled | -Untrained or unskilled | -Lack of adequate, skilled |
| | operator | operator | operator | supervision |
| | -History of pneumothorax | -History of pneumothorax | -History of pneumothorax | |
| | -Pulmonary air leak | -Pulmonary air leak | -Pulmonary air leak | |
| | -Recent pneumonectomy | -Recent pneumonectomy | -Recent pneumonectomy | |
| | -Pulmonary hemorrhage | -Pulmonary hemorrhage | -Pulmonary hemorrhage | |
| | -Myocardial infarction
-Vomiting | -Myocardial infarction
-Vomiting | -Myocardial infarction
-Vomiting | |
| Mode of Operation | Pneumatic system using a | Pneumatic system using a | Pneumatic system using a | Pneumatic system using a |
| | fixed venturi patient circuit | fixed venturi patient circuit | fixed venturi patient circuit | variable (sliding) venturi |
| | combined with medicated | combined with medicated | combined with medicated | patient circuit combined with |
| | aerosol to deliver continuous | aerosol to deliver continuous | aerosol to deliver | medicated aerosol to deliver |
| | high frequency oscillation | high frequency oscillation | continuous high frequency | continuous high frequency |
| | therapy at 2 pre-set
frequencies and amplitude. | therapy at 2 pre-set
frequencies and amplitude. | oscillation therapy at 1 pre-
set frequency and amplitude | oscillation therapy at multiple
user settable frequencies and
amplitudes. |
| | Can deliver continuous
expiratory pressure (CPEP)
combined with medicated
aerosol. | Can deliver continuous
expiratory pressure (CPEP)
combined with medicated
aerosol. | Can deliver continuous
expiratory pressure (CPEP)
combined with medicated
aerosol | Equivalent CPEP function not
available. |
| Page 6 of 9
15-Mar-16 | | | | |
| | Proposed
MetaNeb® 4 System | MetaNeb®
Hill-Rom - K124032 | PowerNeb
Comedica - K051964 | IPV
Bird - K895485 |
| Modes | CPEP
CHFO
Aerosol Only | CPEP
CHFO
Aerosol Only | CPEP
CHFO | CHFO |
| CPEP
Continuous Positive
Expiratory Pressure | Controlled static flow with
positive pressures
$\leq$ 30 cm H2O | Controlled static flow with
positive pressures
$\leq$ 30 cm H2O | Controlled static flow with
positive pressures
$\leq$ 20 cm H2O | No static flow mode1,2 |
| CHFO
Continuous High
Frequency Oscillations | Controlled continuous flow
with frequencies up to 300
beats per minute and peak
positive pressures
$\leq$ 30 cmH2O | Controlled continuous flow
with frequencies up to 300
beats per minute and peak
positive pressures
$\leq$ 30 cmH2O | Controlled continuous flow
with frequencies up to 300
beats per minute and peak
positive pressures
$\leq$ 30 cmH2O | Controlled Intrapulmonary
Percussive Ventilation (IPV)
frequencies up to 300 beats per
minute and peak positive
pressures $\leq$ 80 cmH2O |
| Aerosol Only | Controlled continuous
constant flow to in-line
nebulizer delivering
medicated aerosol only. | Controlled continuous
constant flow to in-line
nebulizer delivering
medicated aerosol only. | Equivalent Aerosol Only
function by setting CPEP to
minimum flow with in-line
nebulizer | Can use in-line nebulizer |
| Patient Circuit | Disposable circuit referred to
as "handset" includes
connection for in-line
nebulizer | Disposable circuit referred
to as "hand-set" includes
connection for in-line
nebulizer | Disposable circuit referred
to as "hand-set" includes
connection for in-line
nebulizer | Reusable circuit includes
connection for in-line nebulizer |
| | Draw in room air mix with
medicated aerosol and gas
from controller | Draw in room air mix with
medicated aerosol and gas
from controller | Draw in room air mix with
medicated aerosol and gas
from controller | Draw in room air mix with
medicated aerosol and gas from
controller |
| | No in-line filter (Home)
In-line filter (Acute care) | In-line filter (Acute care) | | |
| Patient Circuit settings | Expiratory resistance
adjustment $\lt$ 30 cm H2O | Expiratory resistance
adjustment $\lt$ 30 cm H2O | Expiratory resistance
adjustment $\lt$ 30 cm H2O | Not applicable but the IPV can
provide pressures $\lt$ 80 cmH2O |
7
8
510(k) Summary
9
| 510(k) Summary | |||||||
|---|---|---|---|---|---|---|---|
| Page 7 of 9 | |||||||
| 15-Mar-16 | |||||||
| Proposed | MetaNeb® | PowerNeb | IPV | ||||
| MetaNeb® 4 System | Hill-Rom - K124032 | Comedica - K051964 | Bird - K895485 | ||||
| Patient Interface | Mouthpiece | Mouthpiece | Mouthpiece | Mouthpiece | |||
| Face mask | Face mask | ||||||
| Insert into ventilator circuit | Insert into ventilator circuit | Insert into ventilator circuit | |||||
| Controller | Pneumatic and air or oxygen | Pneumatic and air or oxygen | Pneumatic and air or oxygen | Pneumatic and air or oxygen | |||
| Controller settings | On/off | On/off | On/off | On/off | |||
| Mode selection | Mode selection | Mode selection | |||||
| Frequency selection for | Frequency selection for CHFO | Pressure and frequency | |||||
| CHFO mode | mode | adjustment for CHFO mode | |||||
| Pressure adjustment for | Pressure adjustment for CPEP | Pressure adjustment for | |||||
| CPEP mode | mode | CPEP mode | |||||
| Pressure manometer | Pressure manometer | Pressure manometer | |||||
| Connection for patient circuit | Connection for patient circuit | Connection for patient circuit | Connection for patient circuit | ||||
| Ventilator connection | Placed in-line in the | Placed in-line in the | Not available | Placed in-line in the | |||
| inspiratory limb of the | inspiratory limb of the | ventilator circuit with a IPV | |||||
| ventilator circuit with a | ventilator circuit with a | cone adapter | |||||
| standard "T" adapter. | standard "T" adapter. | ||||||
| Only for acute care | Only for acute care | ||||||
| environment | environment |
10
510(k) Summary Page 8 of 9 15-Mar-16
Table 3 compares the performance specifications of the proposed MetaNeb® 4 System to the predicates for Peak Pressure under various therapy mode conditions. We should note that the test set-up parameters are identical to those used when comparing the MetaNeb® in submission K124032.
The results demonstrate substantial equivalence of the maximum peak pressure of the MetaNeb® 4 System as compared to the identified predicates.
| Therapy Mode | Proposed
MetaNeb® 4
System with
Standard Patient
Circuit | MetaNeb®
Hill-Rom –
K124032
With original
Patient Circuit | PowerNeb
Comedica -
K051964 | IPV
Bird - K8954851,2 |
|--------------------------------------------------------|----------------------------------------------------------------------|-----------------------------------------------------------------------|-----------------------------------|--------------------------------------|
| CPEP Mode @
High Flow
Peak Pressure
(cmH2O) | 10.7 to 29.9 | 10.7 to 29.9 | 18.9 to 35.4 | This mode is not
available on IPV |
| CPEP Mode @
Medium Flow
Peak Pressure
(cmH2O) | 7.7 to 14.6 | 7.7 to 14.6 | 9.4 to 18.3 | |
| CPEP Mode @
Low Flow
Peak Pressure
(cmH2O) | 0.2 to 2.0 | 0.2 to 2.0 | 0.2 to 1.2 | |
| CHFO Mode @
High Flow
Peak Pressure
(cmH2O) | 11.2 to 25.4 | 11.2 to 25.4 | | 10.1 to 26.7 |
| CHFO Mode @
Low Flow
Peak Pressure
(cmH2O) | 8.7 to 20.3
From K124032
data | 8.7 to 20.3
From K124032
data | | 11 to 23 |
Table 3 - Substantial Equivalence Comparative Performance - Expiratory Pressures
1 Note: When IPV is tested at comparable setting the differences in peak pressure is