Who is the manufacturer of LibAirty Airway Clearance System?

Synchrony Medical , Ltd. filed the 510(k) submission for LibAirty Airway Clearance System (K242063).

What is the FDA product code for LibAirty Airway Clearance System?

BYI. It is classified under 21 CFR 868.5665 as a Class 2 device in the Anesthesiology panel.

What is the regulatory pathway for LibAirty Airway Clearance System?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like LibAirty Airway Clearance System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

LibAirty Airway Clearance System

Q: What are the predicate devices for LibAirty Airway Clearance System?

The Vest Airway Clearance System (K142482).

K242063 · Synchrony Medical , Ltd. · BYI · Dec 19, 2024 · Anesthesiology

Device Facts

Record ID	K242063
Device Name	LibAirty Airway Clearance System
Applicant	Synchrony Medical , Ltd.
Product Code	BYI · Anesthesiology
Decision Date	Dec 19, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.5665
Device Class	Class 2
Attributes	Therapeutic

Intended 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 clearance, or the presence of atelectasis caused by mucus plugging. The LibAirty Airway Clearance System is intended for hospital, home, and clinic use.

Device Story

Device assists in loosening/eliminating lung mucus; consists of inflatable vest with air chambers, control unit with air compressor, hose bundle, and mobile application. Operates by applying oscillating pressure to chest/back to promote breathing at different volumes; principle inspired by Autogenic Drainage (AD) technique; generates shearing forces via airflow to mobilize secretions from peripheral to central airways for expulsion via cough. Used in hospital, home, and clinic settings; operated by patient. Control unit delivers regulated air pressure; mobile app connects via Bluetooth to manage therapy settings and provide instructions. Output is mechanical oscillation; assists in bronchial drainage; benefits patient by reducing mucus plugging and atelectasis.

Clinical Evidence

Randomized controlled two-sequence crossover study (n=28) in adults with bronchiectasis. Compared LibAirty to The Vest (predicate). Primary endpoint: sputum weight post-treatment. Results: LibAirty produced greater sputum weight (mean difference 3.312, 95% CI 2.002-4.621, p < 0.0001), demonstrating superiority. No SAEs or UADEs reported. Participants reported higher satisfaction with LibAirty.

Technological Characteristics

System includes inflatable vest (multiple air chambers), control unit (air compressor), hose bundle, and mobile app. AC/DC powered. Bluetooth connectivity for app-to-control unit communication. Standards: IEC 60601-1, IEC 60601-1-11, IEC 60601-1-2, IEC TS 60601-4-2, IEEE ANSI C63.27. No patient-contacting materials (worn over clothing).

Indications for Use

Indicated for adult patients having difficulty with secretion clearance or presence of atelectasis caused by mucus plugging, where external manipulation of the thorax is the physician's choice of treatment.

Regulatory Classification

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.

Predicate Devices

The Vest Airway Clearance System (K142482)

Related Devices

K012928 — ABI VEST AIRWAY CLEARANCE SYSTEM · Advanced Respiratory · Oct 9, 2001
K053248 — SMARTVEST AIRWAY CLEARANCE SYSTEM, MODEL TL · Electromed, Inc. · Dec 1, 2005
K982889 — MEDPULSE RESPIRATORY VEST SYSTEM, MODEL 1000 · Electromed, Inc. · Jun 1, 1999
K222496 — Electromed SmartVest Airway Clearance System · Electromed, Inc. · Nov 18, 2022
K233441 — The Vest APX System (PVAPX1) · Baxter Healthcare Corportation · Mar 22, 2024

Submission Summary (Full Text)

{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) K242063 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW * The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {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}------------------------------------------------ Image /page/8/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 that form a circle. To the right of the image is the text "SYNCHRO MEDICAL" in a sans-serif font. The text and the image are both in a blue color. # LibAirty Airway Clearance System – 510k Submission {9}------------------------------------------------ Image /page/9/Picture/0 description: The image contains the logo for Synchr Medical. The logo consists of a blue lung icon surrounded by three curved lines that form a circle. To the right of the icon, the words "SYNCHR" and "MEDICAL" are stacked on top of each other in blue, sans-serif font. 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 < 0.0001. These results mean that not only non-inferiority (NI) was established but superiority was also attained. These findings were not affected by treatment arm, sequence or period. Additionally, participants completed a system evaluation questionnaire, where the reported level of satisfaction with LibAirty was higher compared to The Vest. No Serious Adverse Event (SAE) or Unanticipated Adverse Device Effect (UADE) occurred throughout the study. This study showed a superior performance of the LibAirty system when compared to The Vest. Altogether, these findings suggest that the LibAirty Airway Clearance System is an effective, safe, and easy to use airway clearance device and support the claim that the LibAirty Airway Clearance System is substantially equivalent to its predicate device, The Vest Airway Clearance System. # Conclusions The LibAirty™ Airway Clearance System is substantially equivalent The Vest Airway Clearance System. The LibAirty™ Airway Clearance System and its predicate device have the same indication for use and are both designed for the same intended use and target population. The minor technological differences between the LibAirty™ Airway Clearance System and its predicate device do not raise any new issue of safety or effectiveness. Performance data demonstrate that the LibAirty™ Airway Clearance System {12}------------------------------------------------ Image /page/12/Picture/0 description: The image contains the logo for Synchrony Medical. The logo consists of a stylized image of lungs inside of three concentric circles on the left, and the words "SYNCHRONY" and "MEDICAL" stacked on top of each other on the right. The logo is blue and white. is substantially equivalent as The Vest Airway Clearance System. Thus, the LibAirty™ Airway Clearance System is substantially equivalent to The Vest Airway Clearance System. {13}------------------------------------------------ Image /page/13/Picture/0 description: The image contains the logo for Synchrony Medical. The logo features a stylized image of lungs surrounded by three curved lines. To the right of the lung image, the words "SYNCHRONY" and "MEDICAL" are stacked on top of each other in a sans-serif font. LibAirty Airway Clearance System – 510k Submission Document Title: 510k Summary Page 10 of 12 # Substantial Equivalence Comparison Table | 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 clearance, or the presence of atelectasis caused by mucus plugging. | 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 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. | 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. | | 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 | 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. | 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. | | | LibAirty Airway Clearance System (subject device) | The Vest Airway Clearance System (predicate device, K142482) | | | Feature | | | Comments | | | adjustment straps for a snug fit. AC/DC powered Mobile App connected via Bluetooth to control the treatment flow and provide instructions.…

LibAirty Airway Clearance System

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Related Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

LibAirty Airway Clearance System

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Related Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

Create Alert

Search Filters

Agent Token

Welcome

Check your email

Welcome!