VibraPEP

K153441 · Medica Holdings, LLC · BWF · Mar 25, 2016 · Anesthesiology

Device Facts

• Record ID: K153441
• Device Name: VibraPEP
• Applicant: Medica Holdings, LLC
• Product Code: BWF · Anesthesiology
• Decision Date: Mar 25, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5690
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

VibraPEP is a mechanical Positive Expiratory Pressure (PEP) device used in hospitals, clinics, and home settings. It consists of a curved tube, mouthpiece with therapy selector, valve tube, and cap. During exhalation, the patient blows through the device; internal hose pressure increases until it buckles, causing the hose end to open and release pressure against the tube wall. This cycle repeats, creating oscillations in the air column to promote secretion clearance. The therapy selector allows adjustment of pressure and frequency. The device is operated by the patient. It provides a non-pharmacological method to assist in airway clearance, potentially benefiting patients with respiratory conditions requiring secretion management.

Clinical Evidence

Bench testing only. Comparative performance testing evaluated average pressure, pressure amplitude, frequency, and average flow rate at 10, 20, and 40 lpm. Additional testing included cleaning validation, age testing, and mechanical drop testing. Results demonstrate equivalence to the predicate device.

Technological Characteristics

Mechanical PEP device; curved tube design with internal valve tube. Materials identical to predicate (ISO 10993 compliant for permanent mucosal contact). Operates via passive fluid dynamics (hose buckling/oscillation). No energy source required. Manual adjustment via therapy selector. Non-electronic, non-software.

Indications for Use

Indicated for patients prescribed PEP therapy to exercise lungs and improve secretion clearance. Contraindications include hemodynamic instability, intracranial pressure > 20 mm Hg, acute sinusitis, recent facial/oral/skull surgery or trauma, epistaxis, esophageal surgery, active hemoptysis, untreated pneumothorax, nausea, and known/suspected tympanic membrane rupture or middle ear pathology.

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 – RC-Cornet (K983308)

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

March 25, 2016

Medica Holdings, LLC c/o Paul Dryden Regulatory Consultant for Medica Holdings, LLC 5200 Meadows Road. Suite 150 Lake Oswego, Oregon 97035

Re: K153441

Trade/Device Name: VibraPEPTM Regulation Number: 21 CFR 868.5690 Regulation Name: Incentive Spirometer Regulatory Class: Class II Product Code: BWF Dated: February 22, 2016 Received: February 23, 2016

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.

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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Erin I. Keith -S

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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# Indications for Use

#### 510(k) Number (if known)

#### K153441

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.

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<br>March 15, 2016<br>Page 1 of 5 |
|----------------------------|----------------------------------------------------------------------------------------------------------------------|
| Date Prepared | March 15, 2016 |
| Official Contact: | George Reed<br>Medica Holdings, LLC<br>5200 Meadows Road, Suite 150<br>Lake Oswego, OR 97035<br>Tel – 503-227-1900 |
| Proprietary or Trade Name: | VibraPEP™ |
| Common/Usual Name: | Spirometer, Therapeutic (Incentive) |
| Classification Name: | BWF - 21CFR868.5690, Class II |
| Predicate Device: | Pari – RC-Cornet – K983308 |

## Device Description:

The VibraPEP™ is a Positive End Expiratory (PEP) device in which the user exhales through the device and the device generates expiratory pressure (resistance) and the Tube Valve oscillates creates a range of frequencies within the air column to the patient which help to promote secretion clearance. The VibraPEP™ has been designed to be very similar to the predicate RC-Cornet device (K983308). The basic design, form, function and performance have been compared to the predicate and have been demonstrated to be functionally equivalent and with the same intended use as the predicate.

The device is comprised of several components:

- Curved tube
- Cap for end of Tube ●
- Mouthpiece with selector ●
- Valve tube
- Drying tool ●

## 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.

## 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.

Patient - Patients who have been prescribed PEP therapy

Environment - Hospital, clinics, physician offices, home setting

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# 510(k) Summary

March 15, 2016 Page 2 of 5

## 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 .
- . Hemodynamic instability
- Intracranial pressure (IPC) > 20 mm Hg ●
- Acute sinusitis
- Recent facial, oral or skull surgery or trauma
- Epistaxis
- Esophageal surgery
- Active hemoptysis
- . Untreated pneumothorax
- Nausea ●
- Known or suspected tympanic membrane rupture or other middle ear pathology .

## Substantial Equivalence

| Features | Predicate - RC-Cornet<br>K983308 | Proposed<br>VibraPEP™ |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | The PARI RC Cornet Mucus Clearing Device<br>is a Positive Expiratory Pressure PEP Device<br>and it was designed to exercise patient's lungs<br>and to improve secretion clearance. The device<br>was designed to work with PARI LC<br>Nebulizers. | The VibraPEP™ 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. |
| Environment of Use | Hospital, clinics, physician offices, home<br>setting | Hospital, clinics, physician offices, home<br>setting |
| Patient Population | General population | Patients who have been prescribed PEP<br>therapy |
| Contraindications | • Hemodynamic instability<br>• Intracranial pressure (IPC) > 20 mm Hg<br>• Acute sinusitis<br>• Recent facial, oral or skull surgery or<br>trauma<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 | • Hemodynamic instability<br>• Intracranial pressure (IPC) > 20 mm Hg<br>• Acute sinusitis<br>• Recent facial, oral or skull surgery or<br>trauma<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 |
| Principle of Operation | 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 |

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## 510(k) Summary

March 15, 2016

| Page 3 of 5 | | | | | | |
|---------------------------------------------------------|-------------------------------------------------------------------------------------------------------|---------|---------|-----------------------------------------------------------------------------------------------------------------|---------|---------|
| Features | Predicate - RC-Cornet<br>K983308 | | | Proposed<br>VibraPEP™ | | |
| Use with a nebulizer | Pari LC nebulizer | | | No recommendation | | |
| Single patient,<br>multi-use | Yes | | | Yes | | |
| Cleaning method | Soap / water and Boiling water | | | Soap / water and Boiling water | | |
| Components that may<br>be used | Not specified<br>Tee adapter to be inserted between<br>nebulizer and mouthpiece<br>Pari LC nebulizers | | | No user supplied components | | |
| Components | 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 | | |
| Performance – Non-clinical | | | | | | |
| Materials<br>per ISO 10993 | Surface Contact<br>Mucosal membrane<br>Duration of Use – permanent (> 30 days) | | | Surface Contact<br>Mucosal membrane<br>Duration of Use – permanent (> 30 days)<br>Identical materials - K983308 | | |
| | Flow rate | | | Flow rate | | |
| | 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 |
| Ave. Pressure<br>Amplitude (cmH2O)<br>across full range | 6 – 19 | 21 – 27 | 46 – 80 | 7 – 17 | 22 – 28 | 51 – 76 |
| Ave. Flow Rate (lpm)<br>across full range | 6 – 16 | 12 – 18 | 15 – 21 | 8 – 16 | 12 – 17 | 19 – 22 |

Note: The pressure, frequency and flow testing was performed on the bench at a constant flow rate for comparative purposes.

## 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. Discussion - The indications for use are similar for the proposed device and the predicate - K983308 - RC-Cornet. The use with a nebulizer is not included.

## Patient Population -

The patient population has been clarified to be for patients who have been prescribed PEP therapy.

Discussion - The patient population is intended to be identical to the predicate device, however the predicate did not specify a patient population other than to imply general patient population. The proposed language is viewed as substantially equivalent with added clarification vs. the predicate - K983308 - RC-Cornet.

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## Environment of Use -

The proposed environments of use are Hospital, clinics, physician offices, home setting. Discussion - The environment of use is identical for the proposed device and the predicate -K983308 - RC-Cornet.

## Technology -

The design as a curved tube with mouthpiece/selector, tube valve and cap is the identical principle of operation.

Discussion - The technology for generating oscillation and expiratory pressure is identical to the predicate - K983308 - RC-Cornet.

## Non-clinical Testing

## Materials -

The materials in patient contact and the gas pathway are identical to the predicate - RC-Cornet, K983308. We have evaluated the materials and their type of relations to the patient and determined that they are characterized as:

- Surface Contact .
- . Mucosal membrane
- Duration of Use permanent (> 30 days) .

Discussion - We have been supplied identification of the materials used by the predicate. We have selected the identical materials and certify that the manufacturing processes are identical for the proposed device and the predicate K983308 - RC-Cornet. We provided Material Certifications with the predicate which has the identical indications for use, patient population, environment of use, type of patient contact.

## Comparative Bench Testing

We performed a number of performance tests which included:

- . Comparative Performance at 10, 20, and 40 lpm
- o Average Pressure
- Average Pressure Amplitude o
- Frequency O
- Average Flow Rate o
- . Cleaning validation
- . Age testing
- Mechanical / Drop test ●

The comparative bench testing demonstrated that the VibraPEP™ is equivalent to the predicate K983308 - RC-Cornet. See Table 1 above.

The comparative testing demonstrates that the proposed device is substantially equivalent to the predicate device.

## 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 have been demonstrated to be substantially equivalent to the predicate.

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# 510(k) Summary

March 15, 2016

## Page 5 of 5

There are no differences between the proposed VibraPEP™ and the predicate – K983308 – RC-Cornet and based upon the comparative performance testing we can conclude that there are no new safety or effectiveness concerns and thus can determine then to be substantially equivalent.