(157 days)
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.
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.
Synchronization Medical's LibAirty Airway Clearance System is an airway clearing device designed to promote bronchial drainage and aid in secretion clearance. The device consists of a vest with inflatable chambers, a control unit with an air compressor, and a mobile application. It operates by applying oscillating pressure to the chest and back, promoting movement of mucus from peripheral to central airways, where it can be expelled by coughing. The core principle of operation is based on Autogenic Drainage (AD) airway clearance technique.
The device was compared to the predicate device, The Vest Airway Clearance System, cleared under K142482.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly list "acceptance criteria" in a quantitative manner for specific performance metrics from a clinical study for the purpose of regulatory clearance. Instead, it demonstrates substantial equivalence to a predicate device through a comparative clinical study. The primary effectiveness endpoint was the sputum weight expectorated. Non-clinical performance data included various verification and validation tests, but their specific acceptance criteria values (e.g., specific thresholds for pressure, noise, etc.) are not detailed in this summary.
Given the available information, the table below reflects the primary clinical performance finding and the general conclusion regarding acceptance:
| Acceptance Criterion (Inferred from Study Goal) | Reported Device Performance (Clinical Study) |
|---|---|
| Non-inferiority in sputum weight collected compared to predicate device | LibAirty system produced greater sputum weight than The Vest (predicate device). Mean difference: 3.312 (95% CI: 2.002, 4.621), p-value < 0.0001. This demonstrates superiority, thus meeting and exceeding non-inferiority. |
| User satisfaction | Reported level of satisfaction with LibAirty was higher compared to The Vest. |
| Safety Profile | No Serious Adverse Event (SAE) or Unanticipated Adverse Device Effect (UADE) occurred throughout the study. |
| Non-clinical performance (Design Verification, System Pneumatics, Lifetime, Software, Electrical Safety, EMC, Wireless Coexistence, Human Factors) | "In all instances, the LibAirty Airway Clearance System functioned as intended and the results were as expected and met the acceptance criteria." (Specific numerical criteria not provided in this summary) |
2. Sample Size and Data Provenance
- Test Set Sample Size: 28 subjects completed the entire study.
- Data Provenance: The study was a randomized controlled two-sequence crossover study performed at the Medical University of South Carolina, Charleston, South Carolina, USA. It was a prospective clinical study designed for regulatory submission.
3. Number of Experts and Qualifications for Ground Truth
The provided document does not specify the number of experts used to establish ground truth or their qualifications. The primary effectiveness endpoint was objectively measured sputum weight, which does not inherently require expert consensus for its establishment as ground truth in the same way an image interpretation study might.
4. Adjudication Method for the Test Set
The document does not mention any adjudication method for the test set. Since the primary endpoint was the objective measurement of sputum weight, it's unlikely that an adjudication process (common in subjective assessments or image interpretation) would be necessary for this primary outcome.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or conducted as described for AI-assisted image interpretation. This study compared two devices (LibAirty and The Vest) in a crossover design based on objective sputum weight.
- Therefore, an effect size of how much human readers improve with AI vs. without AI assistance is not applicable here, as this is a medical device performance study, not an AI diagnostic aid study.
6. Standalone (Algorithm-Only) Performance
- This concept is not applicable to the LibAirty Airway Clearance System. The LibAirty system is a physical medical device (vest, compressor, mobile app) that directly provides therapy, not a diagnostic algorithm. Its performance is intrinsically linked to its physical application by a human user (the patient).
7. Type of Ground Truth Used
- The primary ground truth used for the clinical effectiveness comparison was objective outcomes data: the weight of sputum expectorated. This is a direct physiological measure of the device's effectiveness in aiding secretion clearance.
8. Sample Size for the Training Set
- The concept of a "training set" is not applicable to this medical device, as it is not an AI/machine learning model that learns from a dataset. The LibAirty system is a physical device.
9. How the Ground Truth for the Training Set was Established
- This question is not applicable as there is no "training set" for this physical medical device.
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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"
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(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).
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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
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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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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.
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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.
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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 AirwayClearance System(subject device) | The Vest AirwayClearance System(predicate device,K142482) | Comments |
|---|---|---|---|
| Classification | Powered-electric Percussor868.5665 | Identical. | |
| Intended Use/Indications forUse | The LibAirty Airway ClearanceSystem is intended to provideairway clearance therapy andpromote bronchial drainagewhen external manipulation ofthe thorax is the physician'schoice of treatment. It isindicated for patients havingdifficulty with secretion | The Vest Airway ClearanceSystem is intended to provideairway clearancetherapy when externalmanipulation of the thorax is thephysician's choice ortreatment. Indications for thisform of therapy are describedby the American Association of | Similar.The minor differences are wordingadjustments which do not impactthe intended purpose or the clinicaluse of LibAirty Airway ClearanceSystem in comparison to itspredicate device. |
| Feature | LibAirty AirwayClearance System(subject device) | The Vest AirwayClearance System(predicate device,K142482) | Comments |
| clearance, or the presence ofatelectasis caused by mucusplugging. | Respiratory Care (AARC) in theClinical Practices Guidelines forPostural Drainage Therapy.According to AARC guidelines,specific indications for externalmanipulation of the thoraxinclude evidence or asuggestion of retainedsecretions, evidence that thepatient is having difficulty withthe secretion clearance,or presence of atelectasiscaused by mucus plugging. Inaddition, the Vest AirwayClearance System is alsoindicated for externalmanipulation of the thorax topromote airway clearance orimprove bronchial drainage forthe purposes of collectingmucus for diagnosticevaluation. | ||
| User Population | Adult patients | Pediatric to Geriatrics patients | Similar.There are no new concerns ofsafety or effectiveness for thesubject device's user population incomparison to the predicate device,which has broader patient range. |
| Environment ofUse | The LibAirty Airway ClearanceSystem is intended forhospital, home, and clinic use. | Critical care, in-patient acutecare, extended care and skillednursing facility care, home care,outpatient / ambulatory careand pulmonary diagnostic(bronchoscopy) laboratory | Similar.The environment of use of thesubject device is similar to thepredicate device, which has abroader range of environments. |
| TechnologicalCharacteristics | Vest with air chambers thatare filled by an air compressor,connected by hoses.An inflatable vest comprised ofsix air chambers that applyoscillating pressure on thechest and back. Available invarious sizes and includesadjustment straps for a snugfit.AC/DC poweredMobile App connected viaBluetooth to control thetreatment flow and provideinstructions. | Vest with air chambers that arefilled by an air generator,connected by hoses.An inflatable vest surroundingthe patient's torso, available invarious styles and sizes forsnug and evenly-distributed fit.AC/DC poweredBluetooth for data transmissiononly | SimilarBoth the subject device and thepredicate device were designed toprovide airway clearancetherapy when external manipulationof the thorax is the physician'schoice of treatment, while using aninflatable vest connected to an airsupply unit. There are no newconcerns of safety or effectivenessfor the subject device due to thedifferences in the technologicalcharacteristics. |
| Externalmanipulation ofthe chest | Yes | Yes | Identical |
| Feature | LibAirty AirwayClearance System | The Vest AirwayClearance System | Comments |
| (subject device) | (predicate device,K142482) | ||
| PrincipleofOperation/Technology | An inflatable vest comprised ofseveral air chambers thatapply oscillating pressure onthe chest and back to promotebreathing at different lungvolumes. Adjusting the depthand location of lung volumesduring respiration generatesshearing forces induced byairflow which loosen, mobilize,and move secretions (i.e.,mucus) from the peripheraltowards the central airways.Once the mucus reaches thelarger airways, it can beexpelled through coughing. | The Vest Airway ClearanceSystem consists of an inflatablevest attached to an airgenerator that rapidly inflatesand deflates the vest (Highfrequency chest walloscillation). This causes thechest wall to be gentlycompressed and released,which creates airflow within thelungs. This process moves themucus toward the large airwayswhere it can be cleared bycoughing or suctioning. | Identical results using differentprinciples.The LibAirty Airway ClearanceSystem is designed to promotebreathing at different volumesbased on the principles of theAutogenic Drainage (AD) airwayclearance technique.The Vest Airway Clearance Systemuses high frequency chest walloscillations.There are no new concerns ofsafety or effectiveness for thesubject device due to thedifferences in the technology/principle of operation. |
| TreatmentModes | 7 pre-sets pressure levelsAdjustable treatmentparameters (time andpressure level)Mobile App (connected viaBluetooth to control thetreatment flow and provideinstructions) | ManualAdjustable treatmentparameters (frequency,pressure and time)Cough Pause (Remindspatients to cough) | Similar.The subject device principle ofoperation is based on AutogenicDrainage (AD) airway clearancetechnique while the predicatedevice uses high frequency chestwall oscillations Both device'ssoftware enables patients to adjustthe treatment parameters.Comparative clinical study did notraise any new concerns of safety oreffectiveness for the subject devicedue to the minor differencesreflected in the treatment modes. |
| Acousticenergy | Up to 65 dBA @ 1 m | 82.8 dBA @ 1 m | Similar.The acoustic energy limit of thesubject device is lower than thepredicate device. Thus, no newconcerns of safety or effectivenessfor the subject device were raised. |
| MajorComponents | Control Unit (equipped with AirCompressor)Inflatable VestHose BundleMobile Application | Air Pulse GeneratorInflatable garments of variousstyles and sizesConnecting hose | SimilarBoth the subject device and thepredicate device were designed toprovide airway clearance therapywhile using an inflatable vestconnected to an air supply unit.There were no new concerns ofsafety or effectiveness for thesubject device due to the minordifferences. |
| Dimensions(Hx W x D) | 198 x 340 x 240 mm | 241 x 330 x 241 mm | Similar.The differences between thesubject device and the predicatedevice are minor and do not raiseany new concerns of safety oreffectiveness. |
| Weight | Control Unit - 4.5 kgVest - Less than 1.2 Kg(depends on the vest size) | Air Pulse Generator - 8 kgVest - 1.0 Kg | Similar.The predicate device's air supplyunit is heavier than the subjectdevice. There are no new concerns |
| Feature | LibAirty AirwayClearance System(subject device) | The Vest AirwayClearance System(predicate device,K142482) | Comments |
| ElectricalSpecifications | 100 – 240 VAC, 50/60 Hz 1.5A7A @ 12VDC / 90W | 100 – 230 VAC, 50 / 60 Hz3.4 A @ 100 VAC / 2.0 A @ 230 VAC | Similar.The differences between thesubject device and the predicatedevice are minor. Thus, there areno new concerns of safety oreffectiveness for the subject device. |
| Biocompatibility | No direct patient contact.Patient wears anundergarment | No direct patient contact.Patient wears an undergarment | Identical |
| Operatingconditions | Temp – 50 to 86° F (10 to30°C)Relative Humidity – 30%-85%,non-condensingAtmospheric pressure – 70 to106 kPa | Temp – 41 to 95° F (5 to 35°C)Relative Humidity – 15 to 95%,non-condensingAtmospheric pressure – 70 to106 kPa | Similar.The differences between thesubject device and the predicatedevice are minor and do not raiseany new concerns of safety oreffectiveness for the subject device. |
| Electrical safety | IEC 60601-1IEC 60601-1-11 | UL/EN/IEC 60601-1 andCAN/CSA CAN/CSA C22.2 No.60601-1 | SimilarBoth subject device and predicatedevice are in compliance with FDArecognized consensus electricalsafety standards. As both devicesare intended to be used in homeenvironment (among others), thesubject device was testedaccording to IEC 60601-1-11 (Req.for ME equipment and medicalelectrical systems used in the homehealthcare environment) as well.Thus, there are no new concerns ofsafety or effectiveness for thesubject device. |
| Environmentalconditions | Temperature -4°F to 158°F (-20°C to 70°C)Relative humidity of 10% to93% non-condensingAtmospheric pressure of 19 to106 kPa | Temp – 4 to 140°F (-20°C to60°C)Relative Humidity – 15 to 90%non-condensingAtmospheric pressure – 50 to106 kPa | Similar.The differences between thesubject device and the predicatedevice are minor and do not raiseany new concerns of safety oreffectiveness for the subject device. |
Substantial Equivalence Comparison Table
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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
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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
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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.
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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.
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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
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is substantially equivalent as The Vest Airway Clearance System. Thus, the LibAirty™ Airway Clearance System is substantially equivalent to The Vest Airway Clearance System.
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LibAirty Airway Clearance System – 510k Submission
Document Title: 510k Summary
Page 10 of 12
Substantial Equivalence Comparison Table
| Feature | LibAirty AirwayClearance System(subject device) | The Vest AirwayClearance System(predicate device,K142482) | Comments |
|---|---|---|---|
| Classification | Powered-electric Percussor868.5665 | Identical. | |
| Intended Use/Indications forUse | The LibAirty Airway ClearanceSystem is intended to provideairway clearance therapy andpromote bronchial drainagewhen external manipulation ofthe thorax is the physician'schoice of treatment. It isindicated for patients havingdifficulty with secretionclearance, or the presence ofatelectasis caused by mucusplugging. | The Vest Airway ClearanceSystem is intended to provideairway clearancetherapy when externalmanipulation of the thorax is thephysician's choice ortreatment. Indications for thisform of therapy are describedby the American Association ofRespiratory Care (AARC) in theClinical Practices Guidelines forPostural Drainage Therapy.According to AARC guidelines,specific indications for externalmanipulation of the thoraxinclude evidence or asuggestion of retainedsecretions, evidence that thepatient is having difficulty withthe secretion clearance,or presence of atelectasiscaused by mucus plugging. Inaddition, the Vest AirwayClearance System is alsoindicated for externalmanipulation of the thorax topromote airway clearance orimprove bronchial drainage forthe purposes of collectingmucus for diagnosticevaluation. | Similar.The minor differences are wordingadjustments which do not impactthe intended purpose or the clinicaluse of LibAirty Airway ClearanceSystem in comparison to itspredicate device. |
| User Population | Adult patients | Pediatric to Geriatrics patients | Similar.There are no new concerns ofsafety or effectiveness for thesubject device's user population incomparison to the predicate device,which has broader patient range. |
| Environment ofUse | The LibAirty Airway ClearanceSystem is intended forhospital, home, and clinic use. | Critical care, in-patient acutecare, extended care and skillednursing facility care, home care,outpatient / ambulatory careand pulmonary diagnostic(bronchoscopy) laboratory | Similar.The environment of use of thesubject device is similar to thepredicate device, which has abroader range of environments. |
| TechnologicalCharacteristics | Vest with air chambers thatare filled by an air compressor,connected by hoses.An inflatable vest comprised ofsix air chambers that applyoscillating pressure on thechest and back. Available invarious sizes and includes | Vest with air chambers that arefilled by an air generator,connected by hoses.An inflatable vest surroundingthe patient's torso, available invarious styles and sizes forsnug and evenly-distributed fit. | SimilarBoth the subject device and thepredicate device were designed toprovide airway clearancetherapy when external manipulationof the thorax is the physician'schoice of treatment, while using aninflatable vest connected to an air. |
| LibAirty AirwayClearance System(subject device) | The Vest AirwayClearance System(predicate device,K142482) | ||
| Feature | Comments | ||
| adjustment straps for a snugfit.AC/DC poweredMobile App connected viaBluetooth to control thetreatment flow and provideinstructions. | AC/DC poweredBluetooth for data transmissiononly | supply unit. There are no newconcerns of safety or effectivenessfor the subject device due to thedifferences in the technologicalcharacteristics. | |
| Externalmanipulation ofthe chest | Yes | Yes | Identical |
| PrincipleofOperation/Technology | An inflatable vest comprised ofseveral air chambers thatapply oscillating pressure onthe chest and back to promotebreathing at different lungvolumes. Adjusting the depthand location of lung volumesduring respiration generatesshearing forces induced byairflow which loosen, mobilize,and move secretions (i.e.,mucus) from the peripheraltowards the central airways.Once the mucus reaches thelarger airways, it can beexpelled through coughing. | The Vest Airway ClearanceSystem consists of an inflatablevest attached to an airgenerator that rapidly inflatesand deflates the vest (Highfrequency chest walloscillation). This causes thechest wall to be gentlycompressed and released,which creates airflow within thelungs. This process moves themucus toward the large airwayswhere it can be cleared bycoughing or suctioning. | Identical results using differentprinciples.The LibAirty Airway ClearanceSystem is designed to promotebreathing at different volumes,based on the principles of theAutogenic Drainage (AD) airwayclearance technique.The Vest Airway Clearance Systemuses high frequency chest walloscillations.There are no new concerns ofsafety or effectiveness for thesubject device due to thedifferences in the technology/principle of operation. |
| TreatmentModes | 7 pre-sets pressure levelsAdjustable treatmentparameters (time andpressure level)Mobile App (connected viaBluetooth to control thetreatment flow and provideinstructions) | ManualAdjustable treatmentparameters (frequency,pressure and time)Cough Pause (Remindspatients to cough) | Similar.The subject device principle ofoperation is based on AutogenicDrainage (AD) airway clearancetechnique while the predicatedevice uses high frequency chestwall oscillations Both device'ssoftware enables patients to adjustthe treatment parameters.Comparative clinical study did notraise any new concerns of safety oreffectiveness for the subject devicedue to the minor differencesreflected in the treatment modes. |
| Acousticenergy | Up to 65 dBA @ 1 m | 82.8 dBA @ 1 m | Similar.The acoustic energy limit of thesubject device is lower than thepredicate device. Thus, no newconcerns of safety or effectivenessfor the subject device were raised. |
| MajorComponents | Control Unit (equipped with AirCompressor)Inflatable VestHose BundleMobile Application | Air Pulse GeneratorInflatable garments of variousstyles and sizesConnecting hose | SimilarBoth the subject device and thepredicate device were designed toprovide airway clearance therapywhile using an inflatable vestconnected to an air supply unit.There were no new concerns ofsafety or effectiveness for thesubject device. |
| Feature | LibAirty AirwayClearance System(subject device) | The Vest AirwayClearance System(predicate device,K142482) | Comments |
| subject device due to the minor differences. | |||
| Dimensions(Hx 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 kgVest - Less than 1.2 Kg(depends on the vest size) | Air Pulse Generator - 8 kgVest - 1.0 Kg | Similar.The predicate device's air supply unit is heavier than the subject device. There were no new concerns of safety or effectiveness raised due to the differences in devices' weight. |
| ElectricalSpecifications | 100 - 240 VAC, 50/60 Hz 1.5A7A @ 12VDC / 90W | 100 - 230 VAC, 50 / 60 Hz3.4 A @ 100 VAC / 2.0 A @ 230 VAC | Similar.The differences between the subject device and the predicate device are minor. Thus, no new concerns of safety or effectiveness for the subject device were raised. |
| Biocompatibility | No direct patient contact.Patient wears anundergarment | No direct patient contact.Patient wears an undergarment | Identical |
| Operatingconditions | Temp - 50 to 86° F (10 to30°C)Relative Humidity - 30%-85%,non-condensingAtmospheric pressure - 70 to106 kPa | Temp - 41 to 95° F (5 to 35°C)Relative Humidity - 15 to 95%,non-condensingAtmospheric pressure - 70 to106 kPa | Similar.The differences between the subject device and the predicate device are minor. Thus, no new concerns of safety or effectiveness for the subject device were raised. |
| Electrical safety | IEC 60601-1IEC 60601-1-11 | UL/EN/IEC 60601-1 andCAN/CSA CAN/CSA C22.2 No.60601-1 | SimilarBoth 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, no new concerns of safety or effectiveness for the subject device were raised. |
| Environmentalconditions | Temperature -4°F to 158°F (-20°C to 70°C)Relative humidity of 10% to 93% non-condensingAtmospheric pressure of 19 to 106 kPa | Temp -4 to 140°F (-20°C to 60°C)Relative Humidity - 15 to 90% non-condensingAtmospheric pressure - 50 to 106 kPa | Similar.The differences between the subject device and the predicate device are minor. Thus, no new concerns of safety or effectiveness for the subject device were raised. |
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LibAirty Airway Clearance System – 510k Submission
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LibAirty Airway Clearance System – 510k Submission
§ 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).