The Vibralung Acoustical Percussor is indicated as an airway secretion clearance device that creates vibrations in the airways and as a lung expansion device that applies Positive Expiratory Pressure (PEP) as a patient breathes through the device. It may be used to promote bronchial drainage, airway clearance and expectoration. The Vibralung may be used simultaneously with aerosol drug delivery.

Device Description

The proposed Vibralung Acoustical Percussor provides airway clearance therapy (ACT) and promotes mucokinesis by inducing vibration in airways by vibrating the column of gas in the airways at a variety of different frequencies. It is an acoustic device that induces oscillatory sound waves by means of an electro-acoustical transducer (audio speaker), referred to as the "Hand-held Transducer" or HHT, which is interfaced to the patient's airway through a mouthpiece. The transducer unit is connected to a frequency generator, referred to as the "Treatment Control Unit" or TCU, which is set to produce frequencies between 5 and 1,200 Hz in different ranges that are user-selectable.

The HHT directs sound waves into the patient's airways through a waveguide and a mouthpiece.

In addition, the Vibralung can provide Positive Expiratory Pressure (PEP) and may simultaneously provide nebulized aerosol drug delivery.

There are two different Y-adapters available that act as "waveguides" to direct sound waves from the audio speaker in the HHT to the mouthpiece that is held in the patient's mouth in the same manner as with other breathing treatment mouthpieces.

The purpose of the Y-adapters is two-fold:

· To direct the sound waves into the airway opening, and
· To provide separate pathways for inhalation and exhalation gas flow with minimal mixing and rebreathing of exhaled gas.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Vibralung Acoustical Percussor, based on the provided document:

Acceptance Criteria and Device Performance

The document describes a substantial equivalence comparison rather than explicitly stating numerical acceptance criteria for device performance against predefined thresholds. Instead, the device's performance is deemed "substantially equivalent" to predicate devices, implying that its performance is comparable and acceptable. The core "performance" criteria are based on its ability to generate acoustic frequencies and provide Positive Expiratory Pressure (PEP) within ranges consistent with the physiological effects of the predicate devices.

Table of Acceptance Criteria (Implied by Substantial Equivalence) and Reported Device Performance:

Criterion Category	Specific Criterion (Implied)	Vibralung Acoustical Percussor Performance	Equivalence/Performance Statement
Airway Vibration	Generation of acoustic frequencies for airway clearance.	Generates sound frequencies in the range of 5 to 1,200 Hz. Actual resulting frequencies (due to harmonics and resonance) range from 5 Hz to ~1,700 Hz (Low Mode), 5 Hz to 3,000 Hz (Medium Mode), 5 Hz to 3,000 Hz (High Mode), and 5 Hz to >7,000 Hz (Random Noise Mode).	"Substantially equivalent" in terms of acoustic frequencies and amplitudes to predicate devices, which also demonstrate acoustic frequencies inclusive of and higher than the Vibralung.
Positive Expiratory Pressure (PEP)	Ability to create expiratory resistance to open airways.	Generates PEP up to 4 cmH2O during resting breathing or 10-20 cmH2O during a PEP maneuver (using a variable resistor valve).	"Both devices created PEP during exhalation. Both devices produce about a substantially equivalent level of expiratory resistance (PEP), 4 cm H2O for Vibralung and 2.5 cm H2O for the Lung Flute." (Compared to Lung Flute predicate)
Mucous Clearance	Capability to improve mucous discharge.	In Study 1, showed a "greater improvement to LCI with the device use with sound than without sound." In Study 2, showed "similar results in sputum wet weight, pellet weight, or dry weight, when comparing the 2 devices" (to the Vest predicate).	Demonstrated improvement in lung clearance index (LCI) with sound, and equivalent sputum clearance to a predicate device.
Safety	Absence of new safety concerns and safe for patient use.	In Study 1, "The results demonstrated that the Vibralung device is safe for patient use."	"does not raise any new safety concerns"
Concomitant Aerosol Drug Delivery	Accommodation of in-line nebulizer.	Allows for a nebulizer to be placed in-line via a Y-adapter.	"substantially equivalent - both devices allow for an in-line nebulizer to be attached." (Compared to DHD Acapella predicate)

Study Information

2. Sample Sizes Used for the Test Set and Data Provenance:

Study 1: 10 subjects (mild to moderate Cystic Fibrosis). Retrospective/Prospective information is not explicitly stated, but the description "were subjected to two treatments... on two different days" suggests a prospective, interventional design. The country of origin is not specified.
Study 2: 11 subjects. Retrospective/Prospective information is not explicitly stated, but the description "designed to assess the effects... for five days" suggests a prospective, interventional design. The country of origin is not specified.
Non-clinical Testing: Details on sample size for components/materials are not provided, only the types of tests performed.

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

The document does not mention the use of experts to establish a "ground truth" for the test set in the sense of independent review or adjudication of study outcomes. The studies focused on objective physiological measurements (LCI, sputum production, pulmonary function) and safety assessments.

4. Adjudication Method for the Test Set:

Not applicable. The studies did not involve subjective assessments requiring adjudication by multiple experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI vs. Without AI Assistance:

Not applicable. This device is not an AI-powered diagnostic or interpretive tool that would involve human readers or MRMC studies.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This is a medical device for airway clearance, not an algorithm. The "standalone" performance would be its inherent physical and physiological effects, which are what the non-clinical and clinical studies assess.

7. The Type of Ground Truth Used:

Clinical Studies (Study 1 & 2): Physiological measurements and clinical outcomes, such as:
- Lung Clearance Index (LCI)
- Pulmonary function (FVC, FEV1)
- Peripheral oxygen saturation (SaO2)
- Total sputum production (wet weight, pellet weight, dry weight)
- Patient symptoms and safety assessments.
Non-Clinical Testing: Engineering and performance specifications, such as inspiratory resistance, airway pressure, sound pressure level, mechanical dead space, particle characterization (for aerosol performance), acoustical testing (frequency ranges), electrical safety (IEC standards), accelerated aging, and cleaning validation.

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI or machine learning system that requires a "training set."

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set mentioned for this type of device.

Summary

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Page 1 of 12
	MAY 23 2014
Date Prepared	23-May-14
Company	Westmed, Inc.5580 South Nogales Highway
	Tucson, AZ 85706
	Tel - 520-294-7987Fax - 520-294-2780
Official Contact:	John McKinnon - CEO
Proprietary or Trade Name:	Vibralung Acoustical Percussor
Common/Usual Name:	Electric powered percussor
Classification / CFR:	BYI / CFR 868.5665 / Class 2
Device:	Vibralung Acoustical Percussor
Predicate Devices:	Dymedso - Frequencer - K063645 and K103176 (Primary)DHD Healthcare (Smiths) - Acapella - K991561 and K002768Medical Acoustics - Lung Flute - K091557

Device Description: The proposed Vibralung Acoustical Percussor provides airway clearance therapy (ACT) and promotes mucokinesis by inducing vibration in airways by vibrating the column of gas in the airways at a variety of different frequencies. It is an acoustic device that induces oscillatory sound waves by means of an electro-acoustical transducer (audio speaker), referred to as the "Hand-held Transducer" or HHT, which is interfaced to the patient's airway through a mouthpiece. The transducer unit is connected to a frequency generator, referred to as the "Treatment Control Unit" or TCU, which is set to produce frequencies between 5 and 1,200 Hz in different ranges that are user-selectable.

The HHT directs sound waves into the patient's airways through a waveguide and a mouthpiece.

In addition, the Vibralung can provide Positive Expiratory Pressure (PEP) and may simultaneously provide nebulized aerosol drug delivery.

The purpose of the Y-adapters is two-fold:

· To direct the sound waves into the airway opening, and
· To provide separate pathways for inhalation and exhalation gas flow with minimal mixing and rebreathing of exhaled gas.

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510(k) Summary Page 2 of 12 23-May-14

The Standard Y-adapter allows ambient breathing without aerosol therapy. It contains an ambient air intake port with a valve for one-way inspiratory flow while preventing exhalation through the port. The exhalation is directed through one branch of the Y-adapter and out to the room through a variable expiratory resistor that also provides Positive Expiratory Pressure (PEP).

The other Y-adapter (Aerosol Y-adapter) allows the device to be coupled to the airway opening (mouth) while interfaced with Westmed's Circulaire aerosol drug delivery system to enable aerosolized medication to be delivered concomitantly with ACT. In this configuration, inhalation and exhalation pathways plus PEP are incorporated into the Circulaire device.

Indications for Use:

Patient Population - Cystic Fibrosis, COPD, asthma and lung diseases with secretory problems, patients with neuromuscular disease affecting the ability to effectively cough. Anyone who is able to read and / or follow verbal instructions

Environment of Use - Hospital and Home

Contraindications: ACT or use of the Vibralung Acoustical Percussor, especially with Positive Expiratory Pressure, may be contraindicated in patients who have untreated air leaks, tension pneumothorax, bronchopleural fistula, recent hemoptysis, or pulmonary hemorrhage because it may exacerbate those conditions. Prescribers should weigh benefits against risks in patients with these conditions.

Adverse Reactions: If the patient complains of dry or sore throat or mouth brought about by treatment with the Vibralung, consider adding nebulization with normal saline if it is not already being done. If the patient complains of sore mouth, jaw or teeth brought about by using the Vibralung device, the healthcare practitioners should assess the patient complains of dizziness or light-headedness, assess the patient for possible hyperventilation while using the device. If the patient appears to be hyperventilating, pause the treatment and coach the patient to alter their breathing pattern appropriately. Any other adverse reactions should be fully assessed before continuing therapy with the Vibralung Acoustical Percussor.

Level of Patient Contact and Duration:

In accordance with G95-1 and ISO 10993-1 the Vibralung components are primarily considered as:

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510(k) Summary Page 3 of 12 23-May-14

Components in the nebulized aerosol gas pathway

External Communicating (indirect contact but in the gas pathway) .
Tissue Contacting .
. Permanent Duration of Use for those components in the nebulizer aeroso! path

Components in the gas pathway but NOT in the nebulized aerosol gas pathway

External Communicating (indirect contact but in the gas pathway) ●
Tissue Contacting .
Limited Duration of Use (less than 24 hr of accumulated exposure) .

Components in Direct Contact patient contact

Surface Contacting ●
. Mucosal membrane
. Limited duration of use (less than 24h)

All the materials in the Vibralung have been utilized in Westmed devices which have substantially equivalent levels of patient contact and duration of use.

Predicate Device Comparison:

Table 1: Predicates by Indications for Use and Airway Clearance technology

Predicate	AirwayClearance	PEP	Aerosoldelivery	Contactwith airway	AppliedDuring	Technology
FrequencerK063645 K100749 K103176	X	-	-	ExternalChest wall	Inhalation /exhalation	Acousticalpower headapplied tochest wall
AcapellaK991561 K002768	X	X	X	DirectMouthpiece	Exhalation	Interruptedairflow at afrequency
Lung FluteK091557	X	X	-	DirectMouthpiece	Exhalation	Interruptedairflow withreed forfrequency

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510(k) Summary

Table 2 - Substantial Equivalence Table - Frequencer

Criteria	Vibralung	Dymedso FrequencerK063645, K100749,K103176
FDA Classification	BYI - Percussor, power-electric868.5665	BYI - Percussor, power-electric868.5665
Indications for Use	The Vibralung Acoustical Percussor isindicated as an airway secretion clearancedevice that creates vibrations in theairways and as a lung expansion devicethat applies Positive Expiratory Pressure(PEP) as a patient breathes through thedevice. It may be used to promotebronchial drainage, airway clearance andexpectoration. The Vibralung may beused simultaneously with acrosol drugdelivery.	The Frequencer provides airwayclearance therapy and promotesbronchial drainage by inducing vibrationin the chest walls. This device isintended to be a component of posturaldrainage therapy by providing aconvenient method of external thoraxmanipulation.
Other indications	Applies Positive Expiratory Pressure(PEP)Simultaneously used with nebulizer	No
Environments of use	Hospital and home settings	Hospital and home settings
Patient Population	Cystic Fibrosis, COPD, asthma and lungdiseases with secretory problems, patientswith neuromuscular disease affecting theability to effectively cough. Anyone whois able to read and / or follow verbalinstructions.	Patients having respiratory ailmentswhich involves defective mucociliaryclearance, as is typical in patientssuffering from Cystic Fibrosis, chronicbronchitis, bronchiectasis, ciliarydyskinesia syndrome, asthma, musculardystrophy, neuromuscular degenerativedisorders, post-operative atelectasis andthoracic wall defects.
Prescription/OTC	Prescription use	Prescription use
Principle of Operation	Acoustical generator uses sound waves tovibrate the gas column in the airway atvarious frequencies	Acoustical generator applied externallyto the chest that transmits sound throughthe chest wall, vibrating the airways.
Technology employed	Loudspeaker controlled to apply a rangeof frequencies	Loudspeaker controlled to apply a rangeof frequencies
How it interfaces withthe patient	The patient uses a mouthpiece and theacoustical sound is directed to the airway	In contact with the chest wall, but thevibrations of the loudspeaker create avibration and frequency through thechest wall to the airways
Patient Effort	Effort independent	Effort independent
Patient BreathingManeuver	Normal inspiratory & expiatory pattern	Normal inspiratory & expiatory pattern
Chest wall Frequency	N/A	20 - 100 Hz
Airway AcousticalFrequency	5 - 1,200 Hz generated; up to 7,000 Hzactual resulting from harmonics andresonance	20 - 65 Hz generated and applied toexternal chest wall; up to 9,000 Hzactual resulting from harmonics andresonance
Criteria	Vibralung	DHD - AcapellaK991561 K002768
FDA Classification	BYI - Percussor, power-electric868.5665	BWF - Incentive Spirometer868.5690
Indications for Use .	The Vibralung Acoustical Percussor isindicated as an airway secretion clearancedevice that creates vibrations in theairways and as a lung expansion devicethat applies Positive Expiratory Pressure(PEP) as a patient breathes through thedevice. It may be used to promotebronchial drainage, airway clearance andexpectoration. The Vibralung may beused simultaneously with aerosol drugdelivery.	Indicated for use as a PEP device.Improves clearance of secretions, reducethe need of postural drainage, facilitatesopening of airways, prevents or reversesatelectasis.It may be used simultaneously withnebulized aerosol drug delivery.
Criteria	Vibralung	DHD - AcapellaK991561 K002768
Environments of use	Hospital and home settings	Hospital and home settings
Patient Population	Cystic Fibrosis, COPD, asthma and lungdiseases with secretory problems, patientswith neuromuscular disease affecting theability to effectively cough. Anyone whois able to read and / or follow verbalinstructions.	Cystic Fibrosis, COPD, asthma and lungdiseases with secretory problemsPatients with atelectasis.
Prescription/OTC	Prescription use	Prescription use
Principle of OperationSecretion Clearance	Acoustical generator uses sound waves tovibrate the "column" of gas in theairways at various frequencies	Creates airflow interruption duringexhalation which vibrates the "column"of gas in the airways at variousfrequencies
Technology employedforSecretion Clearance	Loudspeaker controlled to apply a rangeof frequencies	Unstable counterweighted lever andmagnet mechanism action duringexhalation, to interrupt the exhaledairflow as it is directed through thedevice. This deliberately unstablemechanism repeatedly interruptsairflow, affecting both frequency andamplitude. Backpressure (PEP) issimultaneously created by directingairflow through an adjustable smalldiameter restriction.
Technology employedfor PositiveExpiratory Pressure(PEP)	Variable resistor valve is placed in theexpiratory part of the wye; generates PEPup to 4 cmH2O during resting breathingor 10 – 20 cmH2O during PEP maneuver.	Airflow is diverted through a restrictionin the device creating a backpressurewhich is PEP up to 60 cmH2O at 30L/min
Principle of OperationPEP	Creating resistance to exhalation createsbackpressure known as PEP which opensthe airways	Creating resistance to exhalation createsbackpressure known as PEP whichopens the airways
Technology employedfor in-line nebulizer	Y-adapter that allows for a nebulizer tobe placed in-line	Connector that allows for a nebulizer tobe placed in-line
Principle of OperationNebulizer	Standard off-the-shelf nebulizer that isfitted in-line and has a reservoir, spacerlike device. Circulaire II (K955047 /K926055)	Standard off-the-shelf nebulizer that isfitted in-line
How it interfaces withthe patient?	The patient uses a mouthpiece	The patient uses a mouthpiece
Patient Effort	Effort independent	Effort dependent
Patient BreathingManeuver	Normal inspiratory & expiratory pattern	Deliberate exhalation maneuver
Airway AcousticalFrequency	5 – 1,200 Hz generated; up to 7,000 Hzactual resulting from harmonics andresonance	~11 Hz up to >10,000 Hz actualresulting from harmonics and resonance

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510(k) Summary Page 5 of 12 23-May-14

The Vibralung is viewed as substantially equivalent to the predicate, Dymedso The Frequencer, K063645, K100749, and K103176, because:

Indications

The airway clearance and bronchial drainage indications for use are substantially equivalent. Discussion - The indications for use are substantially equivalent for the proposed device and the predicate, Dymedso Frequencer, K063645, K100749, and K103176.

Technology

The Vibralung technology of creating a frequency for vibrating the airways is substantially equivalent to the predicate Dymedso Frequencer, K063645, K100749, and K103176. They both use a loudspeaker that can generate acoustical sound at various frequencies that vibrate the gas in the airways.

Discussion - The technology is substantially equivalent for the proposed device and the predicate, Dymedso Frequencer, K063645, K100749, and K103176.

Environment of Use

The environments of use, hospital and home are substantially equivalent to the predicate. Discussion - The environments of use are substantially equivalent to the predicate, Dymedso The Frequencer, K063645, K100749, and K103176.

Patient Population

The patient population of those with Cystic Fibrosis, COPD, asthma and lung diseases with secretory problems is substantially equivalent to the predicate.

Discussion - The patient population for which airway clearance is indicated, is substantially equivalent to the predicate.

Table 3 - Substantial Equivalence Table - Acapella

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510(k) Summary

、

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The Vibralung is viewed as substantially equivalent to the predicate DHD- Acapella - K991561 and K002768 because:

Indications: There are 3 indications for use for comparing the Vibralung to the DHD - Acapella.

. The airway clearance and bronchial drainage indications for use are substantially equivalent.
Indicated for use as a PEP device which facilitates opening of airways is substantially . equivalent.
. It may be used simultaneously with aerosol drug delivery.

Discussion - The indications for use are substantially equivalent for the proposed device and the predicate, Dymedso Frequencer, K063645, K100749, and K103176.

Technology

Secretion Clearance: The Vibralung technology of creating a frequency for vibrating the airways is different than the predicate DHD - Acapella, K991561 and K002768. Vibralung uses a loudspeaker to generate sound waves that create acoustical vibrations in the airways. The predicate, DHD-Acapella, uses an unstable counterweighted balance mechanism that varies the frequency and amplitude of a pressure wave and creates vibration in the airway during exhalation. Nevertheless, the physiological effects are the same regardless of the mechanism that produces the vibrations. Discussion - The technology for creating the vibrations in the airway is done differently but the results are the same. The physiological results are substantially equivalent to the predicate DHD -Acapella - K991561 and K002768.

Positive Expiratory Pressure (PEP): Both the Vibralung and predicate. DHD Acapella, K991561 and K002768, create expiratory resistance / pressure during exhalation. The Vibralung does it with an adjustable resistor valve in the exhalation side of the Y-adapter and the predicate has a diverting air flow path that creates backpressure (resistance) during exhalation, Discussion - Both devices create PEP during exhalation.

Simultaneous nebulized aerosol drug delivery: Both the Vibralung and predicate DHD -

Acapella, K991561 and K002768 can accommodate an in-line nebulizer should the clinician wish to provide aerosol treatment while a patient is using the devices.

Discussion - The use of an in-line nebulizer is substantially equivalent - both devices allow for an in-line nebulizer to be attached.

Environment of Use: The environments of use, hospital and home, are substantially equivalent to the predicate.

Discussion - The environments of use are substantially equivalent to the predicate DHD - Acapella. K991561 and K002768.

Patient Population: The patient population of those with Cystic Fibrosis. COPD, asthma and lung diseases with secretory problems is substantially equivalent to the predicate.

Discussion - The patient population is substantially equivalent to the predicate DHD - Acapella, K991561 and K002768.

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Page 8 of 12

23-May-14

Table 4 - Substantial Equivalence Table - Lung Flute

Criteria	Vibralung	Medical AcousticsLung FluteK091557
FDA Classification	BYI - Percussor, powered-electric868.5665	BWF - Incentive Spirometer868.5690
Indications for Use	The Vibralung Acoustical Percussor isindicated as an airway secretion clearancedevice that creates vibrations in theairways and as a lung expansion devicethat applies Positive Expiratory Pressure(PEP) as a patient breathes through thedevice. It may be used to promotebronchial drainage, airway clearance andexpectoration. The Vibralung may beused simultaneously with aerosol drugdelivery.	Mentioned in 510(k) summary –facilitates mucus clearing by vibratingthe airway.The Lung Flute is indicated for PEPtherapy.
Environments of use	Hospital and home settings	Hospital and home settings
Patient Population	Cystic Fibrosis, COPD, asthma and lungdiseases with secretory problems,patients with neuromuscular diseaseaffecting the ability to effectively cough.Anyone who is able to read and / orfollow verbal instructions.	Not specific but mentions COPDpatients
Prescription/OTC	Prescription use	Prescription use
Principle of OperationSecretion Clearance	Acoustical generator uses sound waves tovibrate the "column" of gas in theairways at various frequencies	Uses acoustical impedance to producesound waves that vibrate the "column"of gas in the airways at variousfrequencies
Technology employedforSecretion Clearance	Loudspeaker controlled to apply a rangeof frequencies	Reed which vibrates during exhalationto produce sound frequencies
Technology employedfor PositiveExpiratory Pressure(PEP)	Variable resistor valve is placed in theexpiratory part of the wye; generates PEPup to $4 cmH_2O$ during resting breathingor 10 – 20 $cmH_2O$ during PEP maneuver.	Airflow encounters restriction throughthe device creating a back pressurewhich is PEP 2.5 $cm H_2O$ .
Principle of OperationPEP	Creating resistance to exhalation createsbackpressure known as PEP which opensthe airways	Creating resistance to exhalationcreates backpressure known as PEPwhich opens the airways
How it interfaces withthe patient?	The patient uses a mouthpiece	The patient uses a mouthpiece
Patient Effort	Effort independent	Effort dependent
Patient BreathingManeuver	Normal inspiratory & expiratorybreathing pattern	Deliberate exhalation maneuver
Airway AcousticalFrequency	5 – 1,200 Hz generated; up to 7,000 Hzactual resulting from harmonics and	~11 Hz up to >10,000 Hz actualresulting from harmonics andresonance

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Page 9 of 12 23-May-14

The Vibralung is viewed as substantially equivalent to the predicate Medical Acoustics ~ Lung Flute - K091557 because:

Indications: There are 2 indications for use for comparing the Vibralung to the Medical Acoustics -Lung Flute.

The airway clearance and bronchial drainage indications for use are substantially equivalent. .
. Indicated for use as a PEP device that facilitates opening of airways is substantially equivalent.

Discussion - The indications for use are substantially equivalent the proposed Vibralung and to the predicate Medical Acoustics - Lung Flute - K091557.

Technology

Secretion Clearance: The Vibralung technology for creating a frequency for vibrating the airways is different than the predicate Medical Acoustics - Lung Flute - K091557. Vibralung uses a loudspeaker to generate sound waves that create acoustical vibrations in the airways, while the predicate. Medical Acoustics - Lung Flute uses a vibrating reed that provides a sound frequency that creates vibration in the airway during exhalation.

Discussion - The technology for creating the vibrations in the airway is done differently but the results are the same. The physiological results are substantially equivalent to the predicate Medical Acoustics - Lung Flute - K091557.

Positive Expiratory Pressure (PEP): Both the Vibralung and predicate Medical Acoustics - Lung Flute - K091557 create expiratory resistance / pressure during exhalation. The Vibralung does it with an adjustable resistor valve in the exhalation side of the Y-adapter and the predicate has a diverting air flow path that creates some backpressure (resistance) during exhalation. Discussion - Both devices created PEP during exhalation. Both devices produce about a substantially equivalent level of expiratory resistance (PEP), 4 cm H2O for Vibralung and 2.5 cm H2O for the Lung Flute.

Environment of Use: The environments of use - hospital and home are substantially equivalent to the predicate.

Discussion - The environments of use are substantially equivalent to the predicate Medical Acoustics - Lung Flute - K091557.

Patient Population: The patient population is not specifically listed in the predicates for Use or 510(k) Summary. However, there are references to patients who require secretion clearance as well as PEP treatment, thus the patients would, by implication, include those with Cystic Fibrosis, COPD, asthma and lung diseases with secretory problems as substantially equivalent to the predicate.

Discussion - The patient population is substantially equivalent to the predicate Medical Acoustics -Lung Flute - K091557.

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Page 10 of 12 23-May-14

Non-clinical Testing Summary -

We performed a number of non-clinical tests to demonstrate that the Vibralung Acoustical Percussor to be substantially equivalent and will perform within specification.

. Verification and Validation Testing
Inspiratory Resistance .
- o Inspiratory Resistance
- o Airway Pressure and Sound Pressure Level
. Mechanical Dead Space
Aerosol Performance During Treatment ●
- Particle Characterization with and without aerosolization o
- Particle Characterization of the Acapella Predicate with and without aerosolization o
- Acoustic Aerosol Performance o
. Comparative Acoustical Testing vs. Predicates
. Treatment Control Unit
. Human Factors Study
. Accelerated Aging
. Cleaning
Electrical Safety, EMC, EMI .
- O IEC 60601
- . O EN 5501
  - lEC 60601-1 236815
  - o IEC 60601-1-11 236815-1
  - o IEC 62133

Comparison of Predicate Devices:

We have performed comparative testing for the Vibralung and the Predicates. The spectral analysis patterns for the Vibralung are different than the predicate devices for a number of reasons, but they also contain the same frequencies.

The Vibralung lung device generates sound frequencies in the range of 5 to 1,200 Hz. ● However, when these frequencies are reproduced by the loudspeaker, mounted in the HHT and conducted to the patient through a waveguide Y-adapter, the sound experiences the normal phenomena of harmonics and resonance with the following ranges:

Low Mode	5 Hz to ~1,700 Hz
Medium Mode	5 Hz to 3,000 Hz
High Mode	5 Hz to 3,000 Hz
Random Noise Mode	5 Hz to >7,000 Hz

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Page 11 of 12 23-May-14

Likewise, the predicate devices generate sound frequencies as a consequence of their . operation. These frequencies likewise experience harmonics and resonance that yields resulting frequencies closely substantially equivalent to the Vibralung:

Blue Acapella	<11 Hz to >10,000 Hz
Green Acapella	<11 Hz to >10,000 Hz
Lung Flute	<11 Hz to >10,000 Hz
The Frequencer	30 Hz to ~9,000 Hz (@ 65 Hz setting)

Like the predicate devices, the Vibralung has a number of frequency components. But . unlike the predicates, many of these are deliberately created.
. Like the predicate devices, the Vibralung is also subject to resonance whereby additional frequencies are created due to internal resonance and harmonics.
. Like the predicate devices, the Vibralung demonstrates low frequency components. Unlike the predicate devices, they are not as defined and pronounced.

Summary: These studies demonstrate that all the predicate devices demonstrate acoustic frequencies that are inclusive of, and even higher than, those frequencies generated by the Vibralung Acoustical Percussor.

Both the predicate devices and the Vibralung generate resonance and harmonic frequencies. This is a normally occurring phenomenon any time sound is directed through tubes.

The Vibralung and the predicate devices are substantially equivalent in terms of the acoustic frequencies and amplitudes they employ for airway clearance therapy.

Clinical Testing:

Two (2) studies were performed with the Vibralung Acoustical Percussor.

Study 1 included 10 subjects to determine if Vibralung can be a positive treatment option to improve mucous discharge in subjects with cystic fibrosis (CF); and to assess if the treatment was safe for the patient. The subjects with mild to moderate CF were subjected to two treatments: (1) with sound, and (2) without sound, each for a period of 20 minutes on two different days. On each visit we measured pulmonary function, lung clearance index (LCI), symptoms and peripheral oxygen saturation (SaO2) at baseline and 1 and 4 hours post-treatment, and total sputum production was collected over 4 hours. Although the results indicated no change from baseline to 4 hours post treatment in FVC, FEV1, and SaO2, there was a greater improvement to LCI with the device use with sound than without sound. The results demonstrated that the Vibralung device is safe for patient use.

Study 2 was designed to assess the effects of the Vibralung on sputum clearance when compared to the Vest predicate for five days. There were 11 subjects. Similar results in sputum wet weight, pellet weight, or dry weight, when comparing the 2 devices. The results demonstrated that the Vibralung is equivalent in performance for sputum clearance.

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Page 12 of 12 23-May-14

Substantial Equivalence Conclusion:

The sponsor has demonstrated through performance testing, design and features, non-clinical, and clinical testing that the proposed Vibralung Acoustic Percussor device does not raise any new safety concerns and is substantially equivalent to the identified predicates.

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Image /page/12/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 27, 2014

Westmed, Inc. C/O Mr. Paul Dryden President. Promedic, Inc. 5580 S. Nogales Hwy. Tucson, AZ 85706 USA

Re: K133057

Trade/Device Name: Vibralung Acoustic Processor Regulation Number: 21 CFR 868.5665 Regulation Name: Electric powered percussor Regulatory Class: Class II Product Code: BYI Dated: April 24th, 2014 Received: April 25th, 2014

Dear Mr. Dryden,

This letter corrects our substantially equivalent letter of May 23, 2014.

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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Page 2 - Mr. Dryden

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 Purobit-Sheth, M.D. Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith. M.S. 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known) K133057

Device Name Vibralung Acoustical Percussor

Indications for Use (Describe)

The Vibralung Acoustical Percussor is indicated as an airway secretion clearance device that creates vibrations in the airways and as a lung expansion device that applies Positive Expiratory Pressure (PEP) as a patient breather through the device. It may be used to promote bronchial drainage, airway clearance and expectoration. The Vibralung may be used simultaneously with aerosol drug delivery.

Patient Population - Cystic Fibrosis, COPD, asthma and lung diseases with secretory problems, with neuromuscular disease affecting the ability to effectively cough. Anyone who is able to read and / or follow verbal instructions

Environment of Use - Hospital and Home

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

[ ] Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

A CONSULTION CONTROLLER FOR EDALUSE ONLY CONTROLLER CONTROLLER CONTRACTOR CONSULTION CONTRACTOR CONTRACTOR CONTRACTOR CONTRACTOR CONTRACTOR CONTRACTOR CONTRACTOR CONTRACTOR C Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Image /page/14/Picture/14 description: The image shows the logo for the Food and Drug Administration (FDA). The logo is in black and white and features the letters "FDA" in a stylized font. The letters are bold and have a slightly rounded appearance. The logo is simple and recognizable, and it is often used on products that have been approved by the FDA.

Anya C. Harry -S 2014.05.23 03:23:19 -04'00'

FORM FDA 3881 (9/13)

PSC Publishing Services (301) 443-4760 EP

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Regulation Number and Section

§ 868.5665 Powered percussor.

(a)
Identification. A powered percussor is a device that is intended to transmit vibration through a patient's chest wall to aid in freeing mucus deposits in the lung in order to improve bronchial drainage and that may be powered by electricity or compressed gas.(b)
Classification. Class II (performance standards).