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

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 ●

AI/ML Overview

The provided text describes the 510(k) summary for the VibraPEP™ device, which is an incentive spirometer. This document focuses on demonstrating substantial equivalence to a predicate device (Pari – RC-Cornet – K983308) rather than presenting a standalone study with defined acceptance criteria for a novel AI/device performance.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable in this context, as this is a traditional medical device submission based on substantial equivalence to an existing device, not an AI or imaging device requiring extensive performance studies against clinical ground truth.

However, based on the provided text, I can infer the acceptance criteria by comparing the proposed device's performance to the predicate device, as this is the basis for demonstrating substantial equivalence. The "study" proving acceptance is the "Comparative Bench Testing".

Here's the information extracted and inferred from the document:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria (Predicate Device K983308 Performance Range)	Reported Device Performance (VibraPEP™ Range)
At 10 lpm Flow Rate:
Average Pressure (cmH2O)	11 – 14	10 – 13
Average Pressure Amplitude (cmH2O)	6 – 19	7 – 17
Average Flow Rate (lpm)	6 – 16	8 – 16
At 20 lpm Flow Rate:
Average Pressure (cmH2O)	17 – 21	18 – 21
Average Pressure Amplitude (cmH2O)	21 – 27	22 – 28
Average Flow Rate (lpm)	12 – 18	12 – 17
At 40 lpm Flow Rate:
Average Pressure (cmH2O)	23 – 44	27 – 41
Average Pressure Amplitude (cmH2O)	46 – 80	51 – 76
Average Flow Rate (lpm)	15 – 21	19 – 22
Cleaning Method	Soap / water and Boiling water (same as predicate)	Soap / water and Boiling water
Material Biocompatibility (ISO 10993)	Identical to predicate (Surface Contact, Mucosal membrane, Permanent > 30 days)	Identical materials - K983308 (Same characterization)

Note on Acceptance Criteria: The acceptance criteria are implicitly met if the proposed device's performance falls within or is sufficiently similar to the predicate device's performance ranges, demonstrating "functional equivalence." The document states: "The comparative bench testing demonstrated that the VibraPEP™ is equivalent to the predicate K983308 - RC-Cornet."

2. Sample Size for the Test Set and Data Provenance

Sample Size: Not explicitly stated as a "sample size" in the context of patients or discrete cases. The testing was comparative bench testing, implying a certain number of devices were tested and measurements taken over various flow rates. The text notes "a number of performance tests" were done.
Data Provenance: Not applicable in the traditional sense of human data. This was bench testing performed by the manufacturer, Medica Holdings, LLC.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Not applicable. This was bench testing of a physical device's mechanical performance (pressure, flow rate, amplitude). There was no "ground truth" established by human experts in the way it would be for an AI diagnostic algorithm. The "ground truth" would be the measured physical properties of the predicate device under controlled conditions.

4. Adjudication Method for the Test Set

Not applicable. This was bench testing against a predicate device's measured performance. There was no human expert adjudication of results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This is a physical medical device (incentive spirometer), not an AI diagnostic tool involving human readers.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

No. This is a physical medical device. There is no "algorithm" in the context of AI independent of human use here. The performance described is the standalone performance of the physical device itself.

7. The Type of Ground Truth Used

The "ground truth" for comparison was the measured performance data (average pressure, average pressure amplitude, average flow rate, material composition, cleaning validation, age testing, mechanical/drop test results) of the predicate device (Pari – RC-Cornet – K983308) under controlled bench test conditions.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI or machine learning model that requires a "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable. As above, no training set was used.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of three stylized human profiles facing to the right, with flowing lines beneath them.

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 (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,

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) SummaryMarch 15, 2016Page 1 of 5
Date Prepared	March 15, 2016
Official Contact:	George ReedMedica Holdings, LLC5200 Meadows Road, Suite 150Lake Oswego, OR 97035Tel – 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 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-CornetK983308	ProposedVibraPEP™
Indications for use	The PARI RC Cornet Mucus Clearing Deviceis a Positive Expiratory Pressure PEP Deviceand it was designed to exercise patient's lungsand to improve secretion clearance. The devicewas designed to work with PARI LCNebulizers.	The VibraPEP™ Mucus Clearing Deviceis a Positive Expiratory Pressure, PEPDevice. It was designed to exercisepatient's lungs and to improve secretionclearance.
Environment of Use	Hospital, clinics, physician offices, homesetting	Hospital, clinics, physician offices, homesetting
Patient Population	General population	Patients who have been prescribed PEPtherapy
Contraindications	• Hemodynamic instability• Intracranial pressure (IPC) > 20 mm Hg• Acute sinusitis• Recent facial, oral or skull surgery ortrauma• Epistaxis• Esophageal surgery• Active hemoptysis• Untreated pneumothorax• Nausea• Known or suspected tympanic membranerupture or other middle ear pathology	• Hemodynamic instability• Intracranial pressure (IPC) > 20 mm Hg• Acute sinusitis• Recent facial, oral or skull surgery ortrauma• Epistaxis• Esophageal surgery• Active hemoptysis• Untreated pneumothorax• Nausea• Known or suspected tympanic membranerupture or other middle ear pathology
Principle of Operation	Tube valve that upon patient exhalation willcreate PEP and oscillationAdjustable to create different frequencies	Tube valve that upon patient exhalationwill create PEP and oscillationAdjustable to create different frequencies

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510(k) Summary

March 15, 2016

Page 3 of 5
Features	Predicate - RC-CornetK983308			ProposedVibraPEP™
Use with a nebulizer	Pari LC nebulizer			No recommendation
Single patient,multi-use	Yes			Yes
Cleaning method	Soap / water and Boiling water			Soap / water and Boiling water
Components that maybe used	Not specifiedTee adapter to be inserted betweennebulizer and mouthpiecePari LC nebulizers			No user supplied components
Components	Curved tubeMouthpiece / selectorTube ValveCapDrying device			Curved tubeMouthpiece / selectorTube ValveCapDrying device
Performance – Non-clinical
Materialsper ISO 10993	Surface ContactMucosal membraneDuration of Use – permanent (> 30 days)			Surface ContactMucosal membraneDuration of Use – permanent (> 30 days)Identical materials - K983308
	Flow rate			Flow rate
	10 lpm	20 lpm	40 lpm	10 lpm	20 lpm	40 lpm
Ave. Pressure(cmH2O)across full range	11 – 14	17 – 21	23 – 44	10 – 13	18 – 21	27 – 41
Ave. PressureAmplitude (cmH2O)across full range	6 – 19	21 – 27	46 – 80	7 – 17	22 – 28	51 – 76
Ave. Flow Rate (lpm)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.

Regulation Number and Section

§ 868.5690 Incentive spirometer.

(a)
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.(b)
Classification. Class II (performance standards).