(238 days)
No
The description focuses on the mechanical and acoustic principles of the device (vibrating a column of gas, electro-acoustical transducer, frequency generator) and does not mention any AI or ML components for data analysis, pattern recognition, or adaptive therapy.
Yes
The device is indicated as an airway secretion clearance device, a lung expansion device, and for promoting bronchial drainage, airway clearance, and expectoration, all of which are therapeutic indications.
No
The device is described as an airway secretion clearance device and a lung expansion device, creating vibrations and applying positive expiratory pressure to promote bronchial drainage, airway clearance, and expectoration. Its intended use is therapeutic, not diagnostic.
No
The device description clearly outlines hardware components including an electro-acoustical transducer (audio speaker), a Hand-held Transducer (HHT), a Treatment Control Unit (TCU), a waveguide, and a mouthpiece. This indicates it is a physical device with software control, not a software-only medical device.
Based on the provided information, the Vibralung Acoustical Percussor is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Vibralung Function: The Vibralung Acoustical Percussor is a therapeutic device. Its intended use is to physically assist in clearing airway secretions and expanding the lungs by applying vibrations and positive expiratory pressure. It interacts directly with the patient's respiratory system, not with specimens taken from the body.
- Lack of Specimen Analysis: The description and performance studies focus on the device's effect on the patient's airways and sputum production, not on analyzing biological samples.
Therefore, the Vibralung Acoustical Percussor falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
BYI
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
airways, lung
Indicated Patient Age Range
Not Found. "Anyone who is able to read and / or follow verbal instructions"
Intended User / Care Setting
Hospital and Home
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Two (2) studies were performed with the Vibralung Acoustical Percussor.
Study 1: 10 subjects with mild to moderate cystic fibrosis (CF). Study type: Non-randomized, within-subject comparison of treatment with sound vs. without sound. Objective: Determine if Vibralung can be a positive treatment option to improve mucous discharge in subjects with cystic fibrosis (CF) and assess safety. Key results: 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: 11 subjects. Study type: Comparison against Vest predicate. Objective: Assess the effects of the Vibralung on sputum clearance when compared to the Vest predicate for five days. Key results: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K063645, K103176, K991561, K002768, K091557
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
| Page 1 of 12 | ||||
|---|---|---|---|---|
| MAY 23 2014 | ||||
| Date Prepared | 23-May-14 | |||
| Company | Westmed, Inc. | |||
| 5580 South Nogales Highway | ||||
| Tucson, AZ 85706 | ||||
| Tel - 520-294-7987 | ||||
| Fax - 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 K002768 | ||||
| Medical 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.
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.
1
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:
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.
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:
2
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 | Airway
Clearance | PEP | Aerosol
delivery | Contact
with airway | Applied
During | Technology |
|---------------------------------------------|---------------------|-----|---------------------|------------------------|----------------------------|------------------------------------------------------|
| Frequencer
K063645
K100749
K103176 | X | - | - | External
Chest wall | Inhalation /
exhalation | Acoustical
power head
applied to
chest wall |
| Acapella
K991561
K002768 | X | X | X | Direct
Mouthpiece | Exhalation | Interrupted
airflow at a
frequency |
| Lung Flute
K091557 | X | X | - | Direct
Mouthpiece | Exhalation | Interrupted
airflow with
reed for
frequency |
3
510(k) Summary
Table 2 - Substantial Equivalence Table - Frequencer
| Criteria | Vibralung | Dymedso Frequencer
K063645, K100749,
K103176 |
|---------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| FDA Classification | BYI - Percussor, power-electric
868.5665 | BYI - Percussor, power-electric
868.5665 |
| Indications for Use | 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 acrosol drug
delivery. | The Frequencer provides airway
clearance therapy and promotes
bronchial drainage by inducing vibration
in the chest walls. This device is
intended to be a component of postural
drainage therapy by providing a
convenient method of external thorax
manipulation. |
| 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 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. | Patients having respiratory ailments
which involves defective mucociliary
clearance, as is typical in patients
suffering from Cystic Fibrosis, chronic
bronchitis, bronchiectasis, ciliary
dyskinesia syndrome, asthma, muscular
dystrophy, neuromuscular degenerative
disorders, post-operative atelectasis and
thoracic wall defects. |
| Prescription/OTC | Prescription use | Prescription use |
| Principle of Operation | Acoustical generator uses sound waves to
vibrate the gas column in the airway at
various frequencies | Acoustical generator applied externally
to the chest that transmits sound through
the chest wall, vibrating the airways. |
| Technology employed | Loudspeaker controlled to apply a range
of frequencies | Loudspeaker controlled to apply a range
of frequencies |
| How it interfaces with
the patient | The patient uses a mouthpiece and the
acoustical sound is directed to the airway | In contact with the chest wall, but the
vibrations of the loudspeaker create a
vibration and frequency through the
chest wall to the airways |
| Patient Effort | Effort independent | Effort independent |
| Patient Breathing
Maneuver | Normal inspiratory & expiatory pattern | Normal inspiratory & expiatory pattern |
| Chest wall Frequency | N/A | 20 - 100 Hz |
| Airway Acoustical
Frequency | 5 - 1,200 Hz generated; up to 7,000 Hz
actual resulting from harmonics and
resonance | 20 - 65 Hz generated and applied to
external chest wall; up to 9,000 Hz
actual resulting from harmonics and
resonance |
| Criteria | Vibralung | DHD - Acapella
K991561
K002768 |
| FDA Classification | BYI - Percussor, power-electric
868.5665 | BWF - Incentive Spirometer
868.5690 |
| Indications for Use . | 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. | Indicated for use as a PEP device.
Improves clearance of secretions, reduce
the need of postural drainage, facilitates
opening of airways, prevents or reverses
atelectasis.
It may be used simultaneously with
nebulized aerosol drug delivery. |
| Criteria | Vibralung | DHD - Acapella
K991561
K002768 |
| Environments of use | Hospital and home settings | Hospital and home settings |
| 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. | Cystic Fibrosis, COPD, asthma and lung
diseases with secretory problems
Patients with atelectasis. |
| Prescription/OTC | Prescription use | Prescription use |
| Principle of Operation
Secretion Clearance | Acoustical generator uses sound waves to
vibrate the "column" of gas in the
airways at various frequencies | Creates airflow interruption during
exhalation which vibrates the "column"
of gas in the airways at various
frequencies |
| Technology employed
for
Secretion Clearance | Loudspeaker controlled to apply a range
of frequencies | Unstable counterweighted lever and
magnet mechanism action during
exhalation, to interrupt the exhaled
airflow as it is directed through the
device. This deliberately unstable
mechanism repeatedly interrupts
airflow, affecting both frequency and
amplitude. Backpressure (PEP) is
simultaneously created by directing
airflow through an adjustable small
diameter restriction. |
| Technology employed
for Positive
Expiratory Pressure
(PEP) | Variable resistor valve is placed in the
expiratory part of the wye; generates PEP
up to 4 cmH2O during resting breathing
or 10 – 20 cmH2O during PEP maneuver. | Airflow is diverted through a restriction
in the device creating a backpressure
which is PEP up to 60 cmH2O at 30
L/min |
| Principle of Operation
PEP | Creating resistance to exhalation creates
backpressure known as PEP which opens
the airways | Creating resistance to exhalation creates
backpressure known as PEP which
opens the airways |
| Technology employed
for in-line nebulizer | Y-adapter that allows for a nebulizer to
be placed in-line | Connector that allows for a nebulizer to
be placed in-line |
| Principle of Operation
Nebulizer | Standard off-the-shelf nebulizer that is
fitted in-line and has a reservoir, spacer
like device. Circulaire II (K955047 /
K926055) | Standard off-the-shelf nebulizer that is
fitted in-line |
| How it interfaces with
the patient? | The patient uses a mouthpiece | The patient uses a mouthpiece |
| Patient Effort | Effort independent | Effort dependent |
| Patient Breathing
Maneuver | Normal inspiratory & expiratory pattern | Deliberate exhalation maneuver |
| Airway Acoustical
Frequency | 5 – 1,200 Hz generated; up to 7,000 Hz
actual resulting from harmonics and
resonance | ~11 Hz up to >10,000 Hz actual
resulting from harmonics and resonance |
4
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
5
510(k) Summary
、
6
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.
7
Page 8 of 12
23-May-14
Table 4 - Substantial Equivalence Table - Lung Flute
| Criteria | Vibralung | Medical Acoustics
Lung Flute
K091557 |
|---------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| FDA Classification | BYI - Percussor, powered-electric
868.5665 | BWF - Incentive Spirometer
868.5690 |
| Indications for Use | 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. | Mentioned in 510(k) summary –
facilitates mucus clearing by vibrating
the airway.
The Lung Flute is indicated for PEP
therapy. |
| Environments of use | Hospital and home settings | Hospital and home settings |
| 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. | Not specific but mentions COPD
patients |
| Prescription/OTC | Prescription use | Prescription use |
| Principle of Operation
Secretion Clearance | Acoustical generator uses sound waves to
vibrate the "column" of gas in the
airways at various frequencies | Uses acoustical impedance to produce
sound waves that vibrate the "column"
of gas in the airways at various
frequencies |
| Technology employed
for
Secretion Clearance | Loudspeaker controlled to apply a range
of frequencies | Reed which vibrates during exhalation
to produce sound frequencies |
| Technology employed
for Positive
Expiratory Pressure
(PEP) | Variable resistor valve is placed in the
expiratory part of the wye; generates PEP
up to $4 cmH_2O$ during resting breathing
or 10 – 20 $cmH_2O$ during PEP maneuver. | Airflow encounters restriction through
the device creating a back pressure
which is PEP 2.5 $cm H_2O$ . |
| Principle of Operation
PEP | Creating resistance to exhalation creates
backpressure known as PEP which opens
the airways | Creating resistance to exhalation
creates backpressure known as PEP
which opens the airways |
| How it interfaces with
the patient? | The patient uses a mouthpiece | The patient uses a mouthpiece |
| Patient Effort | Effort independent | Effort dependent |
| Patient Breathing
Maneuver | Normal inspiratory & expiratory
breathing pattern | Deliberate exhalation maneuver |
| Airway Acoustical
Frequency | 5 – 1,200 Hz generated; up to 7,000 Hz
actual resulting from harmonics and | ~11 Hz up to >10,000 Hz actual
resulting from harmonics and
resonance |
8
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.
9
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 |
10
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 | 10,000 Hz |
|---|---|
| Green Acapella | 10,000 Hz |
| Lung Flute | 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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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)
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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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