(268 days)
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® 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, CHFO (Continuous High Frequency Oscillation), and CPEP (Continuous Positive Expiratory Pressure). There are three major components: Circuit, Controller, and Stand.
Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets those criteria, structured according to your request:
Device Name: MetaNeb® 4 System
1. Table of Acceptance Criteria and Reported Device Performance
The submission primarily focuses on demonstrating substantial equivalence to predicate devices, particularly the MetaNeb® (K124032), rather than establishing new, specific performance acceptance criteria for the MetaNeb® 4 System itself. The acceptance criteria are implicitly met by showing the MetaNeb® 4 System performs equivalently or better than the identified predicates in key performance parameters.
The key performance comparisons are related to peak pressure in different therapy modes.
| Acceptance Criteria (Implicitly, equivalence to predicate performance) | Reported Device Performance (MetaNeb® 4 System) | Predicate Performance (MetaNeb® K124032) |
|---|---|---|
| CPEP Mode @ High Flow Peak Pressure (cmH2O): Equivalent to predicate. | 10.7 to 29.9 | 10.7 to 29.9 |
| CPEP Mode @ Medium Flow Peak Pressure (cmH2O): Equivalent to predicate. | 7.7 to 14.6 | 7.7 to 14.6 |
| CPEP Mode @ Low Flow Peak Pressure (cmH2O): Equivalent to predicate. | 0.2 to 2.0 | 0.2 to 2.0 |
| CHFO Mode @ High Flow Peak Pressure (cmH2O): Equivalent to predicate. | 11.2 to 25.4 | 11.2 to 25.4 |
| CHFO Mode @ Low Flow Peak Pressure (cmH2O): Equivalent to predicate, specifically referencing K124032 data. | 8.7 to 20.3 | 8.7 to 20.3 |
| Usability (Home Environment): All critical tasks completed successfully without use errors leading to unacceptable harm. | 100% of participants (caregivers and lay users) completed all tasks successfully without use errors that could lead to unacceptable risk of harm. | Not directly comparable, as the predicate did not include home use. |
2. Sample Size Used for the Test Set and Data Provenance
- Performance Comparison (Peak Pressure): The sample size for the bench tests is not explicitly stated as a numerical value (i.e., 'n'). The testing involved comparing the MetaNeb® 4 System to the MetaNeb® (K124032), PowerNeb (K051964), and IPV (K895485). The data provenance is generally "bench testing" performed by the manufacturer (Hill-Rom Services Pte Ltd). It's a prospective study of the device's physical performance characteristics.
- Usability Study: The sample size is referred to as "2 user groups: caregivers and lay users." The specific number of participants within each group is not provided in this summary. The data provenance is a usability study conducted to evaluate the device's use in the home environment, likely a prospective study. The country of origin of the data is not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this submission. The "ground truth" for the performance tests (peak pressure) is the physical measurement of the device's output, compared against its own specifications and the previously cleared predicate devices' performance. For the usability study, the "ground truth" is the observation of user performance, not expert consensus on medical images or diagnoses.
4. Adjudication Method for the Test Set
This information is not applicable as it typically refers to methods for resolving discrepancies in expert interpretations (e.g., in medical image analysis). For bench testing, direct measurement and data collection are used. For the usability study, observations of user performance were recorded, often with predefined criteria for success/failure, but an adjudication method for conflicting expert opinions is not mentioned because experts (in the sense of adjudicators) are not setting the "ground truth."
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This information is not applicable. The MetaNeb® 4 System is a therapeutic medical device (non-continuous ventilator), not an AI/CAD (Computer-Aided Detection/Diagnosis) system. Therefore, MRMC studies and AI-assisted improvements for human readers are not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. The MetaNeb® 4 System is a physical device, not an algorithm.
7. The Type of Ground Truth Used
- Performance Comparison (Peak Pressure): The ground truth is established through physical measurements and engineering specifications of the device's output in various modes, compared to the previously established performance of predicate devices. This falls under bench testing data.
- Usability Study: The ground truth is established through direct observation of user performance in conducting critical tasks with the device in a simulated environment. This is a form of empirical user performance data.
8. The Sample Size for the Training Set
This information is not applicable. Since this is a physical medical device (MetaNeb® 4 System) and its development involved engineering design and validation against performance specifications and predicate devices, there isn't a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated above (not an AI/ML device). Engineering validation and design controls are used during device development, which are different from establishing ground truth for a "training set" in AI.
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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
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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
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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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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 868.5905Class 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.
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510(k) Summary Page 2 of 9 15-Mar-16
| PredicateMetaNeb® - K124031 | Difference / Modification forProposed Device | |
|---|---|---|
| Environmentof use | Hospitalssub-acute facilitiesphysician officesclinics | Expanding to includenursing facility and home setting |
| Powersources | Air source fromfacility supply, e.g., cylinderor wall source | Adding portable medical air compressor as anadditional 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).
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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.
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510(k) Summary
15-Mar-16
Table 2 – Substantial Equivalence Comparative Table
| ProposedMetaNeb® 4 System | MetaNeb®Hill-Rom - K124032 | PowerNebComedica - K051964 | IPVBird - K895485 | |
|---|---|---|---|---|
| Intended Use | Indicated for mobilization ofsecretionslung expansion therapytreatment and prevention ofpulmonary atelectasisability to providesupplemental oxygen whenused with compressedoxygen. | Indicated for mobilizationof secretionslung expansion therapytreatment and prevention ofpulmonary atelectasisability to providesupplemental oxygen whenused with compressedoxygen. | Indicated for mobilizationof secretionslung expansion therapytreatment and prevention ofpulmonary atelectasisability to providesupplemental oxygen whenused with compressedoxygen. | Indicated for themobilization and raising ofendobronchial secretions,bronchodilation, reducingmucosal edema, resolutionof diffuse patchy atelectasisin all patientpopulations |
| Indications for Use | The MetaNeb® 4 System isindicated for mobilization ofsecretions, lung expansiontherapy, the treatment andprevention of pulmonaryatelectasis, and also has theability to providesupplemental oxygen whenused with compressedoxygen. | The MetaNeb® System isindicated for mobilization ofsecretions, lung expansiontherapy, the treatment andprevention of pulmonaryatelectasis, and also has theability to providesupplemental oxygen whenused with compressedoxygen. | PowerNeb® is indicated formobilization of secretions,lung expansion therapy, thetreatment and prevention ofpulmonary atelectasis, andalso has the ability toprovide supplementaloxygen when used withcompressed oxygen | Use of Percussaire® IPV®is indicated for themobilization and raising ofendobronchial secretions,bronchodilation, reducingmucosal edema, and theresolution of diffuse patchyatelectasis in all patientpopulations. |
| 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-setfrequencies and amplitude. | therapy at 2 pre-setfrequencies and amplitude. | oscillation therapy at 1 pre-set frequency and amplitude | oscillation therapy at multipleuser settable frequencies andamplitudes. | |
| Can deliver continuousexpiratory pressure (CPEP)combined with medicatedaerosol. | Can deliver continuousexpiratory pressure (CPEP)combined with medicatedaerosol. | Can deliver continuousexpiratory pressure (CPEP)combined with medicatedaerosol | Equivalent CPEP function notavailable. | |
| Page 6 of 915-Mar-16 | ||||
| ProposedMetaNeb® 4 System | MetaNeb®Hill-Rom - K124032 | PowerNebComedica - K051964 | IPVBird - K895485 | |
| Modes | CPEPCHFOAerosol Only | CPEPCHFOAerosol Only | CPEPCHFO | CHFO |
| CPEPContinuous PositiveExpiratory Pressure | Controlled static flow withpositive pressures$\leq$ 30 cm H2O | Controlled static flow withpositive pressures$\leq$ 30 cm H2O | Controlled static flow withpositive pressures$\leq$ 20 cm H2O | No static flow mode1,2 |
| CHFOContinuous HighFrequency Oscillations | Controlled continuous flowwith frequencies up to 300beats per minute and peakpositive pressures$\leq$ 30 cmH2O | Controlled continuous flowwith frequencies up to 300beats per minute and peakpositive pressures$\leq$ 30 cmH2O | Controlled continuous flowwith frequencies up to 300beats per minute and peakpositive pressures$\leq$ 30 cmH2O | Controlled IntrapulmonaryPercussive Ventilation (IPV)frequencies up to 300 beats perminute and peak positivepressures $\leq$ 80 cmH2O |
| Aerosol Only | Controlled continuousconstant flow to in-linenebulizer deliveringmedicated aerosol only. | Controlled continuousconstant flow to in-linenebulizer deliveringmedicated aerosol only. | Equivalent Aerosol Onlyfunction by setting CPEP tominimum flow with in-linenebulizer | Can use in-line nebulizer |
| Patient Circuit | Disposable circuit referred toas "handset" includesconnection for in-linenebulizer | Disposable circuit referredto as "hand-set" includesconnection for in-linenebulizer | Disposable circuit referredto as "hand-set" includesconnection for in-linenebulizer | Reusable circuit includesconnection for in-line nebulizer |
| Draw in room air mix withmedicated aerosol and gasfrom controller | Draw in room air mix withmedicated aerosol and gasfrom controller | Draw in room air mix withmedicated aerosol and gasfrom controller | Draw in room air mix withmedicated aerosol and gas fromcontroller | |
| No in-line filter (Home)In-line filter (Acute care) | In-line filter (Acute care) | |||
| Patient Circuit settings | Expiratory resistanceadjustment $\lt$ 30 cm H2O | Expiratory resistanceadjustment $\lt$ 30 cm H2O | Expiratory resistanceadjustment $\lt$ 30 cm H2O | Not applicable but the IPV canprovide pressures $\lt$ 80 cmH2O |
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510(k) Summary
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| 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 |
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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 | ProposedMetaNeb® 4System withStandard PatientCircuit | MetaNeb®Hill-Rom –K124032With originalPatient Circuit | PowerNebComedica -K051964 | IPVBird - K8954851,2 |
|---|---|---|---|---|
| CPEP Mode @High FlowPeak Pressure(cmH2O) | 10.7 to 29.9 | 10.7 to 29.9 | 18.9 to 35.4 | This mode is notavailable on IPV |
| CPEP Mode @Medium FlowPeak Pressure(cmH2O) | 7.7 to 14.6 | 7.7 to 14.6 | 9.4 to 18.3 | |
| CPEP Mode @Low FlowPeak Pressure(cmH2O) | 0.2 to 2.0 | 0.2 to 2.0 | 0.2 to 1.2 | |
| CHFO Mode @High FlowPeak Pressure(cmH2O) | 11.2 to 25.4 | 11.2 to 25.4 | 10.1 to 26.7 | |
| CHFO Mode @Low FlowPeak Pressure(cmH2O) | 8.7 to 20.3From K124032data | 8.7 to 20.3From K124032data | 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 < 5 cmH2O.
2 Note: IPV is capable of a maximum peak pressure of 80 cmHzO
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510(k) Summary Page 9 of 9 15-Mar-16
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.
Substantial Equivalence Conclusion -
The sponsor has demonstrated through performance testing, design and features, and non-clinical testing that the proposed device and predicate have been found to 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).