VibraPEP
Device Facts
| Record ID | K163091 |
|---|---|
| Device Name | VibraPEP |
| Applicant | Medica Holdings, LLC |
| Product Code | BWF · Anesthesiology |
| Decision Date | Feb 21, 2017 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5690 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The VibraPEP™ Mucus Clearing Device is a Positive Expiratory Pressure, PEP device. It was designed to exercise patient's lungs and to improve secretion clearance. The device may be connected via a Valved Tadapter for use with a jet nebulizer for aerosol drug delivery. The VibraPEP™ Mucus Clearing Device is not intended to be used while connected to a jet nebulizer which is delivering nebulized steroidal drugs or antibiotics.
Device Story
VibraPEP is an Oscillatory PEP (OPEP) device; curved pipe-like structure with internal hose. Patient exhales through device; hose pressure increases, buckles at bend, and releases against wall; creates oscillation effect to vibrate airways and thin mucus. Device includes therapy selector to adjust pressure/frequency. New version adds Valved T-adapter for connection to general-purpose jet nebulizers. Used in hospitals, clinics, physician offices, or home settings by patients. During inhalation, patient receives aerosolized medication; during exhalation, one-way valve directs flow through VibraPEP for PEP therapy. Healthcare providers use device to facilitate secretion clearance; output is mechanical oscillation. Benefits include improved airway clearance and potential for simultaneous aerosol drug delivery.
Clinical Evidence
Bench testing only. Performance testing compared subject device, reference (K153441), and predicate (K983308) across flow rates (10, 20, 40 lpm). Nebulizer performance (MMAD, GSD, total dose, respirable dose) tested with three drugs (Albuterol, Cromoly Sodium, Ipratropium Bromide) using two cleared nebulizers; no statistically significant differences found between standalone and attached configurations. Mechanical testing included aging, cleaning, and drop testing.
Technological Characteristics
OPEP device; curved tube with internal valve hose. Materials: T-adapter and mouthpiece evaluated per ISO 10993-1 (permanent contact, mucosal membrane). Energy source: patient-generated expiratory flow. Connectivity: mechanical T-adapter for nebulizer integration. Sterilization: soap/water or boiling water. No software or electronic components.
Indications for Use
Indicated for patients prescribed PEP therapy to exercise lungs and improve secretion clearance. Contraindicated for patients unable to tolerate increased work of breathing (acute asthma, COPD), intracranial pressure > 20 mm Hg, hemodynamic instability, recent facial/oral/skull surgery or trauma, acute sinusitis, epistaxis, esophageal surgery, active hemoptysis, nausea, known/suspected tympanic membrane rupture/middle ear pathology, or untreated pneumothorax.
Regulatory Classification
Identification
An incentive spirometer is a device that indicates a patient's breathing volume or flow and that provides an incentive to the patient to improve his or her ventilation.
Predicate Devices
- Pari / Medica Holdings - RC-Cornet (K983308)
Reference Devices
Submission Summary (Full Text)
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 21, 2017
Medica Holdings, LLC % Paul Dryden Consultant Promedic, LLC 24301 Woodsage Dr. Bonita Springs, Florida 34134
Re: K163091
Trade/Device Name: VibraPEPTM Regulation Number: 21 CFR 868.5690 Regulation Name: Incentive Spirometer Regulatory Class: II Product Code: BWF Dated: January 15, 2017 Received: January 17, 2017
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. 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.
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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 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,
Tina
Kiang-S
Tina Kiang, Ph.D. Acting 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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# Indications for Use
510(k) Number (if known)
### K163091
Device Name
# VibraPEP™
Indications for Use (Describe)
The VibraPEP™ Mucus Clearing Device is a Positive Expiratory Pressure, PEP device. It was designed to exercise patient's lungs and to improve secretion clearance. The device may be connected via a Valved Tadapter for use with a jet nebulizer for aerosol drug delivery. The VibraPEP™ Mucus Clearing Device is not intended to be used while connected to a jet nebulizer which is delivering nebulized steroidal drugs or antibiotics.
Patient - Patients who have been prescribed PEP Therapy
Environment - Hospital, clinics, physician offices, home 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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### 510(k) Summary February 21, 2017
Page 1 of 8
| Date Prepared | February 21, 2017 |
|----------------------------|--------------------------------------------------------------------------------------------------------------------|
| Official Contact: | George Reed<br>Medica Holdings, LLC<br>5200 Meadows Road, Suite 150<br>Lake Oswego, OR 97035<br>Tel - 503-223-5360 |
| Proprietary or Trade Name: | VibraPEP™ |
| Common/Usual Name: | Spirometer, Therapeutic (Incentive) |
| Classification Name: | BWF - 21CFR868.5690, Class II |
| Predicate Device: | Pari / Medica Holdings - RC-Cornet – K983308 |
| Reference Device: | Medica Holdings – VibraPEP™ - K153441 |
### Device Description:
The proposed device is the identical VibraPEP™ cleared under K153441 but with a Valved T-adapter and mouthpiece that allow the user to connect a general purpose jet nebulizer.
The VibraPEP™ is an Oscillatory PEP (OPEP) device that looks like a curved shaped pipe with a plastic mouthpiece at one end. A long hose is attached inside. As the patient blows through the VibraPEP™, the hose pressure increases and buckles at the bending of the tube. When the peak pressure is reached, the hose end opens and is catapulted against the wall releasing its pressure. This process is repeated, providing an oscillation effect with pressure during the exhalation phase. By rotating the therapy selector, pressure and flow can be adjusted to achieve optimal therapy for each patient. The VibraPEP™ facilitates mucus clearing by generating and delivering an oscillation effect that vibrates the airways and lung secretions, causing lung secretions to thin and become expelled.
### Device Description:
The VibraPEP™ is similar to the predicate RC-Cornet device, cleared on K983308. It has been demonstrated to be functionally equivalent and with the same intended use to the predicate.
The primary device is comprised of several components:
- Curved tube
- Cap for end of Tube ●
- Mouthpiece with selector ●
- Valve tube
- Drying tool
- . Valved T-adapter for use to connect a general purpose nebulizer
The VibraPEP can allow the patient to connect a standard jet nebulizer via a "tee" adapter and during inhalation receive an aerosol treatment, but with a one-way valve, upon exhalation the user exhales through the VibraPEP™ device to PEP therapy.
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# 510(k) Summary
February 21, 2017 Page 2 of 8
### Principle of Operation
The VibraPEP™ is a curved tube in which a long valve is inserted. As the patient blows through the VibraPEP, the hose pressure increases and buckles at the bending of the tube. When the peak pressure is reached, the hose end opens and is catapulted against the wall releasing its pressure. This process is repeated, providing an oscillation effect during the entire exhalation phase. By rotating the therapy selector, pressure and flow can be adjusted to increase or decrease the pressure and frequency of PEP therapy.
The modification in this submission is the addition of a Valved T-adapter which allows one to connect a general purpose nebulizer and the VibraPEP™ together. Due to the directional valve in the Valved Tadapter, a patient during inhalation would inhale the aerosolized medications from the nebulizer and during exhalation the valve prevent flow back to the nebulizer and the patient then exhaled through the VibraPEP™. It is the same as if the patient used the 2 devices separately.
### Compatibility with aerosolized medications:
Medications which open your airways or help to thin mucus would be good choices to use with your VibraPEPTM Oscillating PEP because they would help remove or thin the mucus in your lungs.
Medications you want to stay in your lungs, like antibiotics and steroids, should be taken after you have completed your VibraPEP™ Oscillating PEP treatment.
### Indications for Use:
The VibraPEP™ Mucus Clearing Device is a Positive Expiratory Pressure, PEP device. It was designed to exercise patient's lungs and to improve secretion clearance. The device may be connected via a Valved T-adapter for use with a jet nebulizer for aerosol drug delivery. The VibraPEPIM Mucus Clearing Device is not intended to be used while connected to a jet nebulizer which is delivering nebulized steroidal drugs or antibiotics.
Patient - Patients who have been prescribed PEP Therapy
Environment - Hospital, clinics, physician offices, home setting
### Contraindications:
Although no absolute contraindications to the use of PEP Therapy have been reported, the following should be carefully evaluated before a decision is made to initiate therapy:
- Inability to tolerate increased work of breathing ●
- Patients unable to tolerate the increased work of breathing (acute asthma. COPD) ●
- Intracranial pressure (ICP) > 20 mm Hg .
- Hemodynamic instability .
- Recent facial, oral, or skull surgery or trauma .
- Acute sinusitis
- . Epistaxis
- . Esophageal surgery
- . Active hemoptysis
- Nausea
- Known or suspected tympanic membrane rupture or other middle . ear pathology
- . Untreated pneumothorax
### Substantial Equivalence
The following tables present the comparison and then we discuss the differences.
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### 510(k) Summary February 21, 2017 Page 3 of 8
# Table 1 - Comparison Predicate and Reference to Proposed Device
| Features | Predicate<br>RC-Cornet<br>K983308 | Reference<br>VibraPEP™<br>K153441 | Proposed<br>VibraPEP™<br>with Valved T-adapter |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | The PARI RC Cornet Mucus Clearing<br>Device is a Positive Expiratory Pressure PEP<br>Device and it was designed to exercise<br>patient's lungs and to improve secretion<br>clearance.<br><br>The device was designed to work with PARI<br>LC Nebulizers. | The VibraPEPT™ Mucus Clearing Device is<br>a Positive Expiratory Pressure, PEP device.<br>It was designed to exercise patient's lungs<br>and to improve secretion clearance. | The VibraPEPTM Mucus Clearing Device<br>is a Positive Expiratory Pressure, PEP<br>device. It was designed to exercise<br>patient's lungs and to improve secretion<br>clearance. The device may be connected<br>via a Valved T-adapter for use with a jet<br>nebulizer for aerosol drug delivery. |
| Environment of Use | Hospital, clinics, physician offices, home<br>setting | Hospital, clinics, physician offices, home<br>setting | Hospital, clinics, physician offices, home<br>setting |
| Patient Population | Children 4 years and older to adults | Patients who have been prescribed PEP<br>Therapy | Patients who have been prescribed PEP<br>Therapy |
| Contraindications | - Intracranial pressure (IPC) > 20 mm Hg<br>- Hemodynamic instability<br>- Recent facial, oral or skull surgery or<br>trauma<br>- Acute sinusitis<br>- Epistaxis<br>- Esophageal surgery<br>- Active hemoptysis<br>- Untreated pneumothorax<br>- Nausea<br>- Known or suspected tympanic membrane<br>rupture or other middle ear pathology | - Intracranial pressure (IPC) > 20 mm Hg<br>- Hemodynamic instability<br>- Recent facial, oral or skull surgery or<br>trauma<br>- Acute sinusitis<br>- Epistaxis<br>- Esophageal surgery<br>- Active hemoptysis<br>- Untreated pneumothorax<br>- Nausea<br>- Known or suspected tympanic membrane<br>rupture or other middle ear pathology<br>- Patients unable to tolerate the increased<br>work of breathing (acute asthma, COPD) | - Intracranial pressure (IPC) > 20 mm Hg<br>- Hemodynamic instability<br>- Recent facial, oral or skull surgery or<br>trauma<br>- Acute sinusitis<br>- Epistaxis<br>- Esophageal surgery<br>- Active hemoptysis<br>- Untreated pneumothorax<br>- Nausea<br>- Known or suspected tympanic membrane<br>rupture or other middle ear pathology<br>- Patients unable to tolerate the increased<br>work of breathing (acute asthma, COPD) |
| Principle of<br>Operation (PEP) | Tube valve that upon patient exhalation<br>will create PEP and oscillation<br><br>Adjustable to create different frequencies | Tube valve that upon patient exhalation will<br>create PEP and oscillation<br><br>Adjustable to create different frequencies | Tube valve that upon patient exhalation<br>will create PEP and oscillation<br><br>Adjustable to create different frequencies |
| Features | Predicate<br>RC-Cornet<br>K983308 | Reference<br>VibraPEPTM<br>K153441 | Proposed<br>VibraPEPTM<br>with Valved T-adapter |
| Use with a nebulizer | Use of a Valved T-adapter to connect the<br>outlet of the nebulizer | No | Use of a Valved T-adapter to connect the<br>outlet of the nebulizer |
| Specified Nebulizer | Pari LC | None | General Purpose small volume nebulizers |
| Duration of Use | Single patient, multi-use | Single patient, multi-use | Single patient, multi-use |
| Cleaning method | Soap / water<br>Boiling water | Soap / water<br>Boiling water | Soap / water<br>Boiling water |
| Accessories | Valved – T-adapter to be inserted between<br>nebulizer and mouthpiece | None | Valved T- adapter to be inserted between<br>nebulizer and mouthpiece |
| | Pari LC nebulizers | | User supplied cleared jet nebulizer |
| Components | Curved tube<br>Mouthpiece / selector<br>Tube Valve<br>Cap<br>Drying device<br>T-adapter | Curved tube<br>Mouthpiece / selector<br>Tube Valve<br>Cap<br>Drying device | Curved tube<br>Mouthpiece / selector<br>Tube Valve<br>Cap<br>Drying device<br>Valved T-adapter |
| Biocompatibility<br>ISO 10993-1 | Surface Contact<br>Mucosal membrane<br>Externally Communicating<br>Tissue<br>Duration of Use – permanent (> 30 days) | Surface Contact<br>Mucosal membrane<br>Duration of Use – permanent (> 30 days) | Surface Contact<br>Mucosal membrane<br>Externally Communicating<br>Tissue<br>Duration of Use – permanent (> 30 days)<br>Cytotoxicity<br>Sensitization<br>Irritation<br>Leachable / Extractable 2 solvents<br>Risk Based Assessment |
| Performance Testing – Non-clinical | | | |
| Shelf-life | Not specified | 1 year | 1 year |
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# 510(k) Summary
February 21, 2017
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# 510(k) Summary
February 21, 2017 Page 5 of 8
| Features | Predicate<br>RC-Cornet<br>K983308 | Reference<br>VibraPEPTM<br>K153441 | Proposed<br>VibraPEPTM<br>with Valved T-adapter | | | | | | |
|----------------------------------------------------------------------------------------|-----------------------------------|----------------------------------------------------|-------------------------------------------------|-----------|---------|---------|----------------|----------------------------------------------------|----------------|
| Performance without the Valved T-adapter Data from K153441 Across Settings 1, 3, and 5 | | | | | | | | | |
| | Flow Rate | | | Flow Rate | | | Flow Rate | | |
| | 10 lpm | 20 lpm | 40 lpm | 10 lpm | 20 lpm | 40 lpm | 10 lpm | 20 lpm | 40 lpm |
| Ave. Pressure<br>(cmH2O)<br>across full range | 11 - 14 | 17 - 21 | 23 - 44 | 10 - 13 | 18 - 21 | 27 - 41 | 10 - 13 | 18 - 21 | 27 - 41 |
| Ave. Pressure<br>Amplitude (cmH2O)<br>across full range | 6 - 19 | 21 - 27 | 46 - 80 | 7 - 17 | 22 - 28 | 51 - 76 | 7 - 17 | 22 - 28 | 51 - 76 |
| Ave. Flow Rate<br>(lpm) across full<br>range | 6 - 16 | 12 - 18 | 15 - 21 | 8 - 16 | 12 - 17 | 19 - 22 | 8 - 16 | 12 - 17 | 19 - 22 |
| Performance with Valves T-adapter Across Settings 1, 3, and 5 | | | | | | | | | |
| Ave. Pressure<br>(cmH2O)<br>across full range | 10<br>13<br>15 | Setting 1 - 22<br>Setting 3 - 19<br>Setting 5 - 19 | 41<br>39<br>30 | N/A | N/A | N/A | 9<br>12<br>13 | Setting 1 - 21<br>Setting 3 - 18<br>Setting 5 - 18 | 40<br>38<br>29 |
| Ave. Pressure<br>Amplitude (cmH2O)<br>across full range | 5<br>6<br>18 | Setting 1 - 20<br>Setting 3 - 21<br>Setting 5 - 26 | 60<br>54<br>50 | N/A | N/A | N/A | 5<br>6<br>13 | Setting 1 - 19<br>Setting 3 - 19<br>Setting 5 - 24 | 58<br>52<br>46 |
| Frequency (Hz) | 16<br>15<br>9 | Setting 1 - 17<br>Setting 3 - 16<br>Setting 5 - 13 | 20<br>21<br>17 | | | | 15<br>15<br>8 | Setting 1 - 17<br>Setting 3 - 16<br>Setting 5 - 13 | 20<br>21<br>18 |
| Ave. Flow Rate<br>(lpm) across full<br>range | 10<br>10<br>10 | 20 | 40<br>40<br>40 | N/A | N/A | N/A | 10<br>10<br>10 | 20 | 40<br>40<br>40 |
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# 510(k) Summary
# February 21, 2017
### Page 6 of 8
### Table 2 - Comparison of General Purpose Nebulizer as Standalone vs. Attached to VibraPEP™
| Measurement<br>(Mean) | Standalone<br>configuration | With<br>VibraPEP | Standalone<br>Configuration | With<br>VibraPEP | Standalone<br>configuration | With<br>VibraPEP |
|----------------------------------------------------|-----------------------------|------------------|-----------------------------|------------------|-----------------------------|------------------|
| Westmed - VixOne (K800562) | | | | | | |
| | Albuterol | | Cromoly Sodium | | Ipratropium Bromide | |
| MMAD (um) | 1.7 | 1.37 | 1.67 | 1.43 | 1.53 | 1.37 |
| GSD | 2.24 | 2.21 | 2.04 | 1.75 | 2.11 | 2.09 |
| Total Dose (ug) | 1256 | 1050 | 6295 | 5212 | 262 | 252 |
| Total Respirable<br>Dose (0.5-5) | 896 | 790 | 4939 | 4106 | 174 | 147 |
| Coarse Particle > 4.7 | 266 | 154 | 881 | 555 | 72 | 83 |
| Fine particle (<4.7) | 990 | 896 | 5413 | 4657 | 190 | 169 |
| Ultra-Fine Particle<br>(<1.0) | 347 | 351 | 1804 | 2460 | 64 | 69 |
| Statistical analysis<br>Significant<br>differences | No | | No | | No | |
| Hudson RCI MicroMist (K930525) | | | | | | |
| | Albuterol | | Cromoly Sodium | | Ipratropium Bromide | |
| MMAD (um) | 1.77 | 1.40 | 1.60 | 1.43 | 1.53 | 1.47 |
| GSD | 2.94 | 2.28 | 2.69 | 2.75 | 2.74 | 2.83 |
| Total Dose (ug) | 863 | 779 | 2803 | 2482 | 127 | 119 |
| Total Respirable<br>Dose (0.5-5) | 497 | 493 | 1696 | 1556 | 62 | 60 |
| Coarse Particle > 4.7 | 277 | 193 | 782 | 564 | 52 | 44 |
| Fine particle (<4.7) | 586 | 586 | 2022 | 1918 | 75 | 75 |
| Ultra-Fine Particle<br>(<1.0) | 231 | 250 | 828 | 878 | 31 | 34 |
| Statistical analysis<br>Significant<br>differences | No | | No | | No | |
### Discussion of Substantial Equivalence
The VibraPEP™ oscillator PEP device is viewed as substantially equivalent to the predicate device because:
Indications for Use – The proposed indications for use are to exercise patient's lungs and to improve secretion clearance. The device may be connected via a Valved T-adapter for simultaneous use with a iet nebulizer for aerosol drug delivery.
Discussion - The indications for use as a PEP device are similar to the predicate K983308 – RC Cornett and the reference K153441 - VibraPEP. For simultaneous use with nebulized aerosol drug delivery. the proposed VibraPEP is similar to the predicate - K983308 - RC-Cornet.
Differences - The proposed VibraPEP has been evaluated using 2 cleared general purpose small volume jet nebulizers for aerosol delivery and the testing has shown that the performance of the nebulizer with or without attachment to the VibraPEP is similar. The predicate does not disclose aerosol performance.
Patient Population - The patient population of those that are prescribed PEP therapy is similar to the reference - K153441 - VibraPEP.
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## 510(k) Summary
# February 21, 2017
### Page 7 of 8
Discussion - The patient population is unchanged compared to the reference - K153441 - VibraPEP. Differences - There are no differences between the proposed VibraPEP and the reference - K153441 -VibraPEP.
Environment of Use – The proposed environments of use are Hospital, clinics, physician offices, home setting.
Discussion - The environment of use is unchanged compared to the reference - K153441 - VibraPEP. Differences - There are no differences between the proposed VibraPEP and the reference - K153441 -VibraPEP.
Technology - The technology for delivery PEP therapy is unchanged compared to the reference -K153441 - VibraPEP. The ability to connect a nebulizer in-line that allows the user to inhale the aerosolized drug and then exhale through the PEP device is similar to the predicate - K983308 - RC Cornet. Both devices use an in-line T-adapter.
Discussion - The technology for PEP and connecting the nebulizer are similar for both the predicate -K983308 - RC Cornet and reference - K153441 - VibraPEP.
Differences - There are no differences between the proposed VibraPEP and the reference - K153441 -VibraPEP and predicate - K983308 - RC Cornet which raise different questions of safety and effectiveness.
Accessories - The ability to use a Tee adapter to connect a nebulizer is the same as the predicate -K983308 - RC Cornet.
Discussion - The use of the similarly designed T-adapter and use with nebulizers has been shown to not alter the performance of the nebulizer to aerosol a delivered drug.
Differences - Testing has demonstrated that any differences between the proposed VibraPEP and the reference – K153441 – VibraPEP and predicate – K983308 – RC Cornet related to use with a nebulizer has not raise different questions of safety and effectiveness.
### Performance Testing - Non-clinical
Biocompatibility and Materials - The new materials (other components are the same as the predicate) in the gas pathway are only the T-adapter and mouthpiece which have been evaluated per ISO 10993-1. They are characterized as:
- External Communicating (Indirect gas pathway)
- Tissue / Bone / Dentin communicating .
- . Duration of Use - permanent (> 30 days)
And
- Surface Contact
- Mucosal membrane
- Duration of Use permanent (> 30 days) ●
Discussion - We tested the all components of the VibraPEP including the new components. Testing was performed with final, finished product and was found to be non-reactive. We do not supply the nebulizer, but any nebulizer used has been cleared under 510(k) and use with the VibraPEP does not change its intended use.
Differences - Testing has demonstrated that the proposed VibraPEP meets the ISO 10993 requirements and the proposed materials have not raise different questions of safety and effectiveness.
### Comparative Performance
- · A series of tests were performed comparing the predicate, reference and subject device
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### 510(k) Summary February 21, 2017 Page 8 of 8
# Across flow rates of 10, 20, and 40 lpm
- o Average Pressure
- o Average Pressure Amplitude
- Frequency o
●
- 0 Average Flow Rate
Discussion – We demonstrated that the addition of the Valved T-adapter and mouthpiece do not alter the performance of the VibraPEP™ with the Valved T-adapter as compared to the predicate – K983308 - RC Cornet.
Nebulizer performance – We tested samples of cleared small volume jet nebulizers with 3 drugs with and without connection to the VibraPEP. The results show that there were no statistically significant differences between the performances in all configurations.
Discussion - We have demonstrated that the addition of the T-adapter and mouthpiece do not alter the performance of the nebulizer and thus can be used simultaneously with the VibraPEP as indicated with the predicate - K983308 - RC Cornet, which can be used with its specified nebulizer in the same manner.
PEP performance - We tested samples of the VibraPEP™ with the T-adapter and compared performed to the VibraPEP without T-adapter as well as we compared the predicate RC Cornet and its T-adapter for PEP performance. The results show that there no differences between performance. Discussion - We have demonstrated that the addition of the T-adapter and mouthpiece do not alter the PEP performance.
Effects of Aging, Cleaning, and Drop testing - We performed testing related to aging and cleaning that included mechanical drop testing of the new components, Valved T-adapter and mouthpiece, and found that they continued to meet their performance specifications.
Differences - Testing has demonstrated when a nebulizer is connected to the proposed VibraPEP the performance of the nebulizer is not significantly changed, thus we can stated that there are no different questions of safety and effectiveness.
## Discussion of Differences and Substantial Equivalence Conclusion
As detailed above, the indications for use, patient population, environment of use, technology or principle of operation, and performance are substantially equivalent to the predicate.
There are no differences between the proposed VibraPEP™ and the predicate - K983308 - RC-Cornet and reference - K153441 - VibraPEP based upon the comparative performance testing which raise different questions of safety and effectiveness.
