(157 days)
Not Found
No
The description focuses on mechanical operation (inflatable vest, air compressor, pre-defined cycle) and a mobile application for operation and instructions. There is no mention of adaptive algorithms, learning from patient data, or any other characteristics typically associated with AI/ML.
Yes
The device is intended to provide "airway clearance therapy and promote bronchial drainage" for patients having "difficulty with secretion clearance, or the presence of atelectasis caused by mucus plugging," which identifies it as a treatment for a medical condition.
No
The device is an airway clearance system intended for therapy and bronchial drainage, not for diagnosis. Its purpose is to assist in loosening and eliminating mucus from the lungs, which is a therapeutic function.
No
The device description explicitly states that the system consists of a vest with inflatable chambers, a control unit with an air compressor, a hose bundle, and a mobile application. While a mobile application is included, it is only one component of a larger system that includes significant hardware elements.
Based on the provided information, the LibAirty Airway Clearance System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- LibAirty Function: The LibAirty system is a therapeutic device that physically assists in clearing mucus from the lungs through external manipulation of the thorax. It does not analyze any biological specimens.
- Intended Use: The intended use is to provide airway clearance therapy and promote bronchial drainage, not to diagnose or monitor a condition through laboratory analysis.
- Device Description: The description details a mechanical system (vest, control unit, hose) that applies pressure, not a system for analyzing biological samples.
Therefore, the LibAirty Airway Clearance System falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The LibAirty Ainway Clearance System is intended to provide airway clearance therapy and promote bronchial drainage when external manipulation of the thorax is the physician's choice of treatment. It is indicated for patients having difficulty with secretion clearance, or the presence of atelectasis caused by mucus plugging.
The LibAirty Airway Clearance System is intended for hospital, home, and clinic use.
Product codes
SDS
Device Description
The LibAirty Airway Clearance System is designed to assist in the loosening and elimination of mucus from the lungs. It consists of a vest with inflatable chambers, connected to a control unit (equipped with an air compressor) that inflates and deflates the vest in a pre-defined cycle, and a mobile application.
The LibAirty Airway Clearance System was designed to provide airway clearance therapy when external manipulation of the thorax is the physician's choice or treatment, while using an inflatable vest connected to an air supply unit.
The LibAirty Airway Clearance System is designed to promote breathing at different volumes, as the inflatable vest applies oscillating pressure on the chest and back, to augment peripheral and tracheal mucus movement towards the airway opening. The system's mode of operation is inspired by the principles of the Autogenic Drainage (AD) airway clearance technique, in which adjusting the depth and location of lung volumes during respiration generates shearing forces induced by airflow which loosen, mobilize, and move secretions (i.e., mucus) from the peripheral towards the central airways. Once the mucus reaches the larger airways, it can be expelled through coughing.
The LibAirty™ Airway Clearance System is a mobile, non-sterile, single patient use device, operated by mains power supply only.
The LibAirty™ Airway Clearance System consists of:
- . A control unit equipped with an air compressor that delivers air at regulated pressures to the vest and includes a display screen and operation buttons allowing the user to adjust therapy settings and manage device operation.
- . An inflatable vest (available in different sizes) that is fastened around the chest and consists of several air chambers.
- . A hose bundle that transfers the air from the control unit to the vest's chambers.
- . A Mobile Application (App) that is used to operate the system and provide instructions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
chest and back (thorax)
Indicated Patient Age Range
Adult patients
Intended User / Care Setting
hospital, home, and clinic use.
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)
Clinical Performance Data: a comparative clinical study in subjects with bronchiectasis focusing on sputum weight post-treatment.
Study type: randomized controlled two-sequence crossover study.
Sample size: 28 subjects who completed the entire study.
Data source: Medical University of South Carolina, Charleston, South Carolina.
Key results: A significant difference was found between the weight of sputum expectorated with LibAirty system and the weight of sputum expectorated with The Vest, where treatment with the LibAirty system produced a greater sputum weight. The mean difference in sputum weights (LibAirty – The Vest) is 3.312 with a 95% Cl of (2.002, 4.621) and a p-value
§ 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
December 19, 2024
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Synchrony Medical Ltd. Anat Shani CEO 8 Ariel Sharon Or Yehuda, IL 6037607 Israel
Re: K242063
Trade/Device Name: LibAirty Airway Clearance System Regulation Number: 21 CFR 868.5665 Regulation Name: Powered Percussor Regulatory Class: Class II Product Code: SDS Dated: December 17, 2024 Received: December 17, 2024
Dear Anat Shani:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
2
Sincerely,
Ethan L. Nyberg -S
Ethan Nyberg, Ph.D. Assistant Director DHT1C: Division of Anesthesia, Respiratory, and Sleep Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
LibAirty Airway Clearance System
Indications for Use (Describe)
The LibAirty Ainway Clearance System is intended to provide airway clearance therapy and promote bronchial drainage when external manipulation of the thorax is the physician's choice of treatment. It is indicated for patients having difficulty with secretion clearance, or the presence of atelectasis caused by mucus plugging.
The LibAirty Airway Clearance System is intended for hospital, home, and clinic use.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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4
Image /page/4/Picture/0 description: The image contains the logo for Synchrony Medical. The logo consists of a stylized image of lungs surrounded by three curved lines on the left. To the right of the image are the words "SYNCHRONY" and "MEDICAL" stacked on top of each other. The text and the image are blue.
510(K) Summary
Synchrony Medical LibAirty Airway Clearance System
Submitter
Synchrony Medical Ltd. 8 Ariel Sharon Or Yehuda, 6037607 lsrael Phone: +972-74-739-0681
Contact Person:
Anat Shani, CEO anat.s@synchrony-medical.com Phone: +972 545221922
Date Prepared: July 09, 2024
Name of Device: LibAirty™ Airway Clearance System
Common or Usual Name: Airway clearing device
Classification Name: Powered percussor
Regulation: 21 CFR $868.5665
Regulatory Class: Class II
Predicate Device
The Vest Airway Clearance System by Hill-Rom Services Private Limited, cleared under K142482.
Device Description
The LibAirty Airway Clearance System is designed to assist in the loosening and elimination of mucus from the lungs. It consists of a vest with inflatable chambers, connected to a control unit (equipped with an air compressor) that inflates and deflates the vest in a pre-defined cycle, and a mobile application.
5
The LibAirty Airway Clearance System was designed to provide airway clearance therapy when external manipulation of the thorax is the physician's choice or treatment, while using an inflatable vest connected to an air supply unit.
The LibAirty Airway Clearance System is designed to promote breathing at different volumes, as the inflatable vest applies oscillating pressure on the chest and back, to augment peripheral and tracheal mucus movement towards the airway opening. The system's mode of operation is inspired by the principles of the Autogenic Drainage (AD) airway clearance technique, in which adjusting the depth and location of lung volumes during respiration generates shearing forces induced by airflow which loosen, mobilize, and move secretions (i.e., mucus) from the peripheral towards the central airways. Once the mucus reaches the larger airways, it can be expelled through coughing.
The LibAirty™ Airway Clearance System is a mobile, non-sterile, single patient use device, operated by mains power supply only.
The LibAirty™ Airway Clearance System consists of:
- . A control unit equipped with an air compressor that delivers air at regulated pressures to the vest and includes a display screen and operation buttons allowing the user to adjust therapy settings and manage device operation.
- . An inflatable vest (available in different sizes) that is fastened around the chest and consists of several air chambers.
- . A hose bundle that transfers the air from the control unit to the vest's chambers.
- . A Mobile Application (App) that is used to operate the system and provide instructions.
Intended Use / Indications for Use
The LibAirty™ Airway Clearance System is intended to provide airway clearance therapy and promote bronchial drainage when external manipulation of the physician's choice of treatment. It is indicated for patients having difficulty with secretion clearance, or the presence of atelectasis caused by mucus plugging.
The LibAirty™ Airway Clearance System is intended for hospital, home, and clinic use.
6
Image /page/6/Picture/0 description: The image shows the logo for Synchrony Medical. The logo consists of a blue lung icon surrounded by three blue arcs on the left, and the words "SYNCHRONY MEDICAL" in blue on the right. The word "SYNCHRONY" is above the word "MEDICAL".
Summary of Technological Characteristics
The LibAirty Airway Clearance System consists of an inflatable vest, a control unit, and a mobile application. The vest is comprised of several air chambers that apply oscillating pressure on the chest and back and is connected via a hose bundle to the control unit (equipped with an air compressor) that inflates and deflates the vest in a pre-defined cycle.
The LibAirty Mobile App is connected to the LibAirty Control Unit via Bluetooth communication and is used to operate the treatment and provide instructions.
Predicate Device Comparison
The LibAirty™ Airway Clearance System is substantially equivalent to the predicate device, The Vest® Airway Clearance System (K142482).
The LibAirty Airway Clearance System and The Vest Airway Clearance System were designed to provide airway clearance therapy when external manipulation of the physician's choice of treatment, while using an inflatable vest connected to an air supply unit, based on different airway clearance techniques. As a result of this difference, the physical characteristics of both devices are not identical, such as differences in the dimensions and weight, different vest design, etc. However, the differences do not raise new questions of safety or effectiveness.
A table comparing the key features of the subject and predicate device is provided below.
| Feature | LibAirty Airway
Clearance System
(subject device) | The Vest Airway
Clearance System
(predicate device,
K142482) | Comments |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | Powered-electric Percussor
868.5665 | | Identical. |
| Intended Use/
Indications for
Use | The LibAirty Airway Clearance
System is intended to provide
airway clearance therapy and
promote bronchial drainage
when external manipulation of
the thorax is the physician's
choice of treatment. It is
indicated for patients having
difficulty with secretion | The Vest Airway Clearance
System is intended to provide
airway clearance
therapy when external
manipulation of the thorax is the
physician's choice or
treatment. Indications for this
form of therapy are described
by the American Association of | Similar.
The minor differences are wording
adjustments which do not impact
the intended purpose or the clinical
use of LibAirty Airway Clearance
System in comparison to its
predicate device. |
| Feature | LibAirty Airway
Clearance System
(subject device) | The Vest Airway
Clearance System
(predicate device,
K142482) | Comments |
| | clearance, or the presence of
atelectasis caused by mucus
plugging. | Respiratory Care (AARC) in the
Clinical Practices Guidelines for
Postural Drainage Therapy.
According to AARC guidelines,
specific indications for external
manipulation of the thorax
include evidence or a
suggestion of retained
secretions, evidence that the
patient is having difficulty with
the secretion clearance,
or presence of atelectasis
caused by mucus plugging. In
addition, the Vest Airway
Clearance System is also
indicated for external
manipulation of the thorax to
promote airway clearance or
improve bronchial drainage for
the purposes of collecting
mucus for diagnostic
evaluation. | |
| User Population | Adult patients | Pediatric to Geriatrics patients | Similar.
There are no new concerns of
safety or effectiveness for the
subject device's user population in
comparison to the predicate device,
which has broader patient range. |
| Environment of
Use | The LibAirty Airway Clearance
System is intended for
hospital, home, and clinic use. | Critical care, in-patient acute
care, extended care and skilled
nursing facility care, home care,
outpatient / ambulatory care
and pulmonary diagnostic
(bronchoscopy) laboratory | Similar.
The environment of use of the
subject device is similar to the
predicate device, which has a
broader range of environments. |
| Technological
Characteristics | Vest with air chambers that
are filled by an air compressor,
connected by hoses.
An inflatable vest comprised of
six air chambers that apply
oscillating pressure on the
chest and back. Available in
various sizes and includes
adjustment straps for a snug
fit.
AC/DC powered
Mobile App connected via
Bluetooth to control the
treatment flow and provide
instructions. | Vest with air chambers that are
filled by an air generator,
connected by hoses.
An inflatable vest surrounding
the patient's torso, available in
various styles and sizes for
snug and evenly-distributed fit.
AC/DC powered
Bluetooth for data transmission
only | Similar
Both the subject device and the
predicate device were designed to
provide airway clearance
therapy when external manipulation
of the thorax is the physician's
choice of treatment, while using an
inflatable vest connected to an air
supply unit. There are no new
concerns of safety or effectiveness
for the subject device due to the
differences in the technological
characteristics. |
| External
manipulation of
the chest | Yes | Yes | Identical |
| Feature | LibAirty Airway
Clearance System | The Vest Airway
Clearance System | Comments |
| | (subject device) | (predicate device,
K142482) | |
| Principle
of
Operation
/
Technology | An inflatable vest comprised of
several air chambers that
apply oscillating pressure on
the chest and back to promote
breathing at different lung
volumes. Adjusting the depth
and location of lung volumes
during respiration generates
shearing forces induced by
airflow which loosen, mobilize,
and move secretions (i.e.,
mucus) from the peripheral
towards the central airways.
Once the mucus reaches the
larger airways, it can be
expelled through coughing. | The Vest Airway Clearance
System consists of an inflatable
vest attached to an air
generator that rapidly inflates
and deflates the vest (High
frequency chest wall
oscillation). This causes the
chest wall to be gently
compressed and released,
which creates airflow within the
lungs. This process moves the
mucus toward the large airways
where it can be cleared by
coughing or suctioning. | Identical results using different
principles.
The LibAirty Airway Clearance
System is designed to promote
breathing at different volumes
based on the principles of the
Autogenic Drainage (AD) airway
clearance technique.
The Vest Airway Clearance System
uses high frequency chest wall
oscillations.
There are no new concerns of
safety or effectiveness for the
subject device due to the
differences in the technology/
principle of operation. |
| Treatment
Modes | 7 pre-sets pressure levels
Adjustable treatment
parameters (time and
pressure level)
Mobile App (connected via
Bluetooth to control the
treatment flow and provide
instructions) | Manual
Adjustable treatment
parameters (frequency,
pressure and time)
Cough Pause (Reminds
patients to cough) | Similar.
The subject device principle of
operation is based on Autogenic
Drainage (AD) airway clearance
technique while the predicate
device uses high frequency chest
wall oscillations Both device's
software enables patients to adjust
the treatment parameters.
Comparative clinical study did not
raise any new concerns of safety or
effectiveness for the subject device
due to the minor differences
reflected in the treatment modes. |
| Acoustic
energy | Up to 65 dBA @ 1 m | 82.8 dBA @ 1 m | Similar.
The acoustic energy limit of the
subject device is lower than the
predicate device. Thus, no new
concerns of safety or effectiveness
for the subject device were raised. |
| Major
Components | Control Unit (equipped with Air
Compressor)
Inflatable Vest
Hose Bundle
Mobile Application | Air Pulse Generator
Inflatable garments of various
styles and sizes
Connecting hose | Similar
Both the subject device and the
predicate device were designed to
provide airway clearance therapy
while using an inflatable vest
connected to an air supply unit.
There were no new concerns of
safety or effectiveness for the
subject device due to the minor
differences. |
| Dimensions
(H
x W x D) | 198 x 340 x 240 mm | 241 x 330 x 241 mm | Similar.
The differences between the
subject device and the predicate
device are minor and do not raise
any new concerns of safety or
effectiveness. |
| Weight | Control Unit - 4.5 kg
Vest - Less than 1.2 Kg
(depends on the vest size) | Air Pulse Generator - 8 kg
Vest - 1.0 Kg | Similar.
The predicate device's air supply
unit is heavier than the subject
device. There are no new concerns |
| Feature | LibAirty Airway
Clearance System
(subject device) | The Vest Airway
Clearance System
(predicate device,
K142482) | Comments |
| Electrical
Specifications | 100 – 240 VAC, 50/60 Hz 1.5A
7A @ 12VDC / 90W | 100 – 230 VAC, 50 / 60 Hz
3.4 A @ 100 VAC / 2.0 A @ 230 VAC | Similar.
The differences between the
subject device and the predicate
device are minor. Thus, there are
no new concerns of safety or
effectiveness for the subject device. |
| Biocompatibility | No direct patient contact.
Patient wears an
undergarment | No direct patient contact.
Patient wears an undergarment | Identical |
| Operating
conditions | Temp – 50 to 86° F (10 to
30°C)
Relative Humidity – 30%-85%,
non-condensing
Atmospheric pressure – 70 to
106 kPa | Temp – 41 to 95° F (5 to 35°C)
Relative Humidity – 15 to 95%,
non-condensing
Atmospheric pressure – 70 to
106 kPa | Similar.
The differences between the
subject device and the predicate
device are minor and do not raise
any new concerns of safety or
effectiveness for the subject device. |
| Electrical safety | IEC 60601-1
IEC 60601-1-11 | UL/EN/IEC 60601-1 and
CAN/CSA CAN/CSA C22.2 No.
60601-1 | Similar
Both subject device and predicate
device are in compliance with FDA
recognized consensus electrical
safety standards. As both devices
are intended to be used in home
environment (among others), the
subject device was tested
according to IEC 60601-1-11 (Req.
for ME equipment and medical
electrical systems used in the home
healthcare environment) as well.
Thus, there are no new concerns of
safety or effectiveness for the
subject device. |
| Environmental
conditions | Temperature -4°F to 158°F (-
20°C to 70°C)
Relative humidity of 10% to
93% non-condensing
Atmospheric pressure of 19 to
106 kPa | Temp – 4 to 140°F (-20°C to
60°C)
Relative Humidity – 15 to 90%
non-condensing
Atmospheric pressure – 50 to
106 kPa | Similar.
The differences between the
subject device and the predicate
device are minor and do not raise
any new concerns of safety or
effectiveness for the subject device. |
Substantial Equivalence Comparison Table
7
Image /page/7/Picture/0 description: The image contains the logo for Synchro Medical. The logo consists of a stylized image of lungs surrounded by three curved lines, all in a light blue color. To the right of the lung image, the words "SYNCHRO" and "MEDICAL" are stacked on top of each other, also in a blue color.
LibAirty Airway Clearance System – 510k Submission
8
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LibAirty Airway Clearance System – 510k Submission
9
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LibAirty Airway Clearance System – 510k Submission
Document Title: 510k Summary
Page 6 of 12
Non-Clinical Performance Data
The LibAirty Airway Clearance System went through a series of verification and validation testing to demonstrate that it meets the overall predefined design input requirements and specifications.
This testing evaluated the ability of the LibAirty System to meet the system's specifications in accordance with its proposed intended use, as well as general dimensional, mechanical, electrical, functional, and labeling requirements of the system.
10
The nonclinical testing of the LibAirty Airway Clearance System included the following
- . Design Verification testing, such as: Treatment Flow - system level verification, System Pneumatics Verification, Maximal Forces Applied by LibAirty Airway Clearance System verification, etc.
- Labeling Verification ●
- . LibAirty system Lifetime and durability Verification
- Software/ Firmware validation, including Cybersecurity (IEC 62304) .
- . Electrical Safety (IEC 60601-1 and (IEC 60601-1-11)
- Electromagnetic Compatibility (IEC 60601-1-2) ●
- Electromagnetic Immunity (IEC TS 60601-4-2)
- Wireless Coexistence (IEEE ANSI C63.27) ●
- Human Factors Validation Usability study, in accordance with FDA Guidance -. Applying Human Factors and Usability Engineering to Medical Devices (February 3, 2016)
Note:
Biocompatibility - There are no patient contacting materials.
The LibAirty Airway Clearance System's vest is intended to be worn by the user over light clothing, similarly to the predicate device. Hence, there is no direct or indirect contact between the garment materials and the patient's skin.
In all instances, the LibAirty Airway Clearance System functioned as intended and the results were as expected and met the acceptance criteria.
Clinical Performance Data
In order to support the claim that the LibAirty Airway Clearance System is substantially equivalent to The Vest Airway Clearance System, Synchrony Medical performed a comparative clinical study in subjects with bronchiectasis to demonstrate that the LibAirty Airway Clearance System is non-inferior to high frequency chest wall oscillation (HFCWO) therapy applied by The Vest, the predicate device.
The primary effectiveness endpoint of the study compared the sputum weight as measured post LibAirty treatment with the sputum weight as measured post The Vest treatment.
11
The study was a randomized controlled two-sequence crossover study, and performed at the Medical University of South Carolina, Charleston, South Carolina.
Subjects older than 21 years of age, with bronchiectasis who met the inclusion criteria were enrolled and randomly allocated to one of the two treatment sequences: LibAirty (Visit 1) followed by the Vest (Visit 2) or The Vest (Visit 1) followed by the LibAirty (Visit 2) in a 1:1 ratio. A third study visit (Visit 3) was performed using the LibAirty Airway Clearance System in conjunction with a nebulizer, as defined as part of the study's secondary endpoints.
There were 28 subjects who completed the entire study, including Visit 3.
A significant difference was found between the weight of sputum expectorated with LibAirty system and the weight of sputum expectorated with The Vest, where treatment with the LibAirty system produced a greater sputum weight. The mean difference in sputum weights (LibAirty – The Vest) is 3.312 with a 95% Cl of (2.002, 4.621) and a p-value