(245 days)
The SIMEOX 200 airway clearance device is intended to promote airway clearance and to improve bronchial drainage by enhancing mobilization of bronchial secretions via high frequency oscillatory vibrations and intermittent negative pressure to the airway during exhalation. The device is intended to be prescribed for use in patients capable of independently generating cough.
SIMEOX 200 is intended for use in the home, hospital, and other healthcare institutions by individuals weighing at least 23 Kg.
The SIMEOX 200 Airway Clearance Device consists of a portable generator and a single patient use expiratory kit. The patient inhales from the ambient environment, naturally and independent of the device, and then exhales into the device mouthpiece. During the patient's exhalation, the SIMEOX 200 generates a pneumatic vibration throughout the airway. This vibration, applied at 6 Hz or 12 Hz via negative pressure pulses, disseminates throughout the bronchial tree in order to decrease mucus viscosity and increase secretion mobility. During or after therapy, the patient can clear the secretions by coughing independently.
This document describes the FDA's 510(k) clearance for the SIMEOX 200 Airway Clearance Device. It primarily focuses on demonstrating substantial equivalence to predicate devices through technical specifications and non-clinical performance testing.
The provided text does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of human-in-the-loop performance, AI assistance, or expert-based ground truth establishment for diagnostic purposes.
The document states:
- "Performance verification testing was conducted on the bench with the SIMEOX 200 Airway Clearance Device to demonstrate the subject device performs to its pre-specified requirement specifications, which align with those of the predicate devices."
- "The SIMEOX 200 device also went through comprehensive software verification and validation testing to confirm the device operates within specification."
- "Testing demonstrated the SIMEOX 200 performed as intended and was safe and effective."
- "A human factors validation study was conducted with simulated first-time use of the product in adult users and dyads of children with caregivers. The study concluded that the device is safe for its intended users."
This indicates that the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to engineering and safety performance specifications, rather than clinical performance metrics typically associated with AI/diagnostic devices (like sensitivity, specificity, or reader improvement).
Therefore, I cannot populate the requested table and study details as they are not present in the provided text. The document describes a medical device (Airway Clearance Device), not an AI or diagnostic device that would typically involve the type of acceptance criteria and studies you've outlined.
The acceptance criteria implied are the device's ability to meet its pre-specified parameters (e.g., pressure range, oscillation frequencies) and demonstration of safety and effectiveness through bench testing, software validation, and human factors validation.
Here's a summary of the information that is available, reframing it in the context of device performance rather than AI/diagnostic performance:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied from document) | Reported Device Performance (from document) |
|---|---|
| Technical Specifications: | |
| Exhalation Pressure (Negative) | 0 to -60 cm H2O. Stated as "nearly identical to that of SimplyClear and falls within a subset of the SimplyClear available negative pressure range." |
| Inhalation Pressure (Positive) | Atmospheric (0 cm H2O). Bench verification testing confirms operation within prespecified operating specifications for negative pressure delivery, consistent with predicate devices in exsufflation-only mode. |
| Oscillation Frequencies | Fixed Frequencies: 12 Hz (first 8 phases), 6 Hz (final 2 phases). Stated as "within the available frequencies during SimplyClear treatment." |
| Power Modes | Standard Mode (25%, 50%, 75%, 100% power) and ADAPT Mode (automatically regulated). Stated as "operating conditions are within the range available for the SimplyClear." |
| Trigger Settings | Manual Trigger or DETECT Trigger. |
| Cycle Duration | 10 breaths (exhalations). |
| Duration of Treatment | Max 10 cycles (100 exhalations) or 60 minutes, whichever occurs first. |
| Safety and Effectiveness: | |
| Biocompatibility | Expiratory kit accessories not considered cytotoxic, sensitizing, or irritating; demonstrated biocompatible. |
| Human Factors | Device safe for intended users (adults, children with caregivers) in simulated first-time use. |
| Software Verification & Validation | Confirmed device operates within specification. |
| Cybersecurity, Wireless, EMC, Electrical, | Comprehensive testing conducted. |
| Mechanical, Thermal Safety | |
| Overall Performance | Bench testing confirms device complies with specifications, operates equivalently to predicates, is as safe, as effective, and performs as well as legally marketed predicate devices. "Performed as intended and was safe and effective." |
Regarding the other requested information, it is largely not applicable or not provided for this type of device and submission:
2. Sample size used for the test set and the data provenance:
* Test Set: Not explicitly stated in terms of a "test set" for performance metrics like sensitivity/specificity. Performance testing was "on the bench" and included software V&V and human factors simulation.
* Data Provenance: Not applicable for this type of technical/safety validation. The human factors study involved "simulated first-time use," but details about participant numbers or demographic provenance are not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* This is not relevant for this device's 510(k) submission, as it's not a diagnostic device requiring expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
* Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
* Not applicable, as this is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* Not applicable, as this is not an AI/algorithm-driven device in the sense of image analysis or diagnostic prediction. Its "performance" is based on its physical and software operation parameters.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
* "Ground truth" in this context refers to the pre-defined engineering specifications and safety standards (e.g., pressure measurements, frequency measurements against a calibrated standard, successful execution of software functions, successful completion of simulated tasks in human factors). It's not a clinical or diagnostic ground truth.
8. The sample size for the training set:
* Not applicable. This device does not use machine learning that requires a "training set."
9. How the ground truth for the training set was established:
* Not applicable.
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December 23, 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 & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in smaller blue letters below that.
Inogen, Inc. % Michael Nilo President and Principal Consultant Nilo Medical Consulting Group 3706 Butler Street #313 Pittsburgh, Pennsylvania 15201
Re: K241091
Trade/Device Name: SIMEOX 200 Airway Clearance Device Regulation Number: 21 CFR 868.5665 Regulation Name: Powered Percussor Regulatory Class: Class II Product Code: SDT Dated: November 27, 2024 Received: November 27, 2024
Dear Michael Nilo:
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.
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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" (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 QS 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 Rule"). 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-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 medical devices and radiation-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-regulatory
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assistance/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).
Sincerely,
Ethan L. Nyberg -S
Ethan Nyberg, Ph.D. Assistant Director, Respiratory Devices Team DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia 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
510(k) Number (if known) K241091
Device Name SIMEOX 200 Airway Clearance Device
Indications for Use (Describe)
The SIMEOX 200 airway clearance device is intended to promote airway clearance and to improve bronchial drainage by enhancing mobilization of bronchial secretions via high frequency oscillatory vibrations and intermittent negative pressure to the airway during exhalation. The device is intended to be prescribed for use in patients capable of independently generating cough.
SIMEOX 200 is intended for use in the home, hospital, and other healthcare institutions by individuals weighing at least 23 Kg.
| 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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510(K) SUMMARY
| DATE OF PREPARATION | December 20, 2024 |
|---|---|
| APPLICANT | Inogen, Inc.859 Ward DriveSuite 200Goleta, California 93111 |
| OFFICIAL CORRESPONDENT | Michael Nilo, MS BME, PresidentNilo Medical Consulting Group3706 Butler Street, #313Pittsburgh, PA 15201Phone: (717) 421-4396E-mail: michael.nilo@nilomed.com |
| DEVICE NAME | SIMEOX 200 Airway Clearance Device |
| DEVICE CLASSIFICATION | Common Name: Powered percussorRegulation: 21 CFR 868.5665Class II |
| PRIMARY PREDICATE DEVICE | AirPhysio Positive Expiratory Pressure (PEP) Device(K203209) |
| SECONDARY PREDICATEDEVICE | Philips Respironics SimplyClear Device (K122111) |
DEVICE DESCRIPTION
The SIMEOX 200 Airway Clearance Device consists of a portable generator and a single patient use expiratory kit. The patient inhales from the ambient environment, naturally and independent of the device, and then exhales into the device mouthpiece. During the patient's exhalation, the SIMEOX 200 generates a pneumatic vibration throughout the airway. This vibration, applied at 6 Hz or 12 Hz via negative pressure pulses, disseminates throughout the bronchial tree in order to decrease mucus viscosity and increase secretion mobility. During or after therapy, the patient can clear the secretions by coughing independently.
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The SIMEOX 200 device is housed within an acrylonitrile butadiene styrene polycarbonate (ABS/PC) unit, with control buttons located on the front and top panels. The "Go" button, which is located on the front panel of the device, is used to start the pneumatic vibration signal of SIMEOX 200. Beneath the "Go" button is a connection inlet for the expiratory kit and mouthpiece. This inlet is equipped with a stainless-steel grid to prevent large particles from penetrating inside the air circuit. The remote controller has a redundant "Go" button for ease of use. The device also has an external power supply with an AC cord, and an optional Lithium-Ion battery.
Expiratory kits, which consist of the mouthpiece and respiratory tubing, are available in two different versions and are supplied separately from the SIMEOX 200 device. TUB10 expiratory kits come with one polyvinyl chloride (PVC) respiratory tube, one styrene-butadiene copolymer (SBC) filter with a polypropylene membrane, and 10 single-use polypropylene mouthpieces, each intended to be disposed of after each use. Similarly, TUB25 expiratory kits come with one PVC respiratory tube, one SBC filter with a polypropylene membrane, and 3 reusable polypropylene mouthpieces, each intended to be used up to ten times. The filters supplied in both kits each come with an RFID tag, which tracks the number of uses of the filter and tube. The RFID tag ensures that the device will not operate upon connection to an expiratory kit that has expended its maximal number of uses (10 maximal uses for TUB10, and 25 maximal uses for TUB25).
INDICATIONS FOR USE
The SIMEOX 200 airway clearance device is intended to promote airway clearance and to improve bronchial drainage by enhancing mobilization of bronchial secretions via high frequency oscillatory vibrations and intermittent negative pressure to the airway during exhalation. The device is intended to be prescribed for use in patients capable of independently generating cough.
SIMEOX 200 is intended for use in the home, hospital, and other healthcare institutions by individuals weighing at least 23 Kg.
PRINCIPLES OF OPERATION / MECHANISM OF ACTION
The SIMEOX 200 Airway Clearance Device promotes airway clearance by loosening and mobilizing secretions. Therapy is delivered via exhalation into the device plastic mouthpiece. During exhalation, a high frequency negative pressure oscillation (pneumatic vibration) is applied to the airways which loosens mucus from the bronchial walls, increasing its mobilization.
Airway oscillation (vibration) during exhalation is an established mechanism of action used to loosen mucus and mobilize secretions from the airways for expectoration.
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KEY TECHNICAL SPECIFICATIONS
The SIMEOX 200 has two different Therapy settings. The first is Standard Mode, which can be set to 25%. 50%. 75%, or 100% power. Standard Mode gives the same amount of air flow while you breathe out into the device for your entire exhalation. The other type of Therapy mode is ADAPT Mode. With ADAPT Mode, the device will decrease the amount of airflow during your exhalation, which may make breathing into the device more comfortable.
The SIMEOX 200 has two different Trigger settings, also. The first is a Manual Trigger, which means the device will not start the airflow unless you press the GO button, either the button on the device on the one on the remote control. The other Trigger is the DETECT Trigger. When the DETECT Trigger is chosen, the GO button must be pressed, but the device will not start air flow therapy until you begin breathing out into the mouthpiece. This may help you if it is difficult to coordinate the GO button with your exhalations.
Both Therapy Modes can be used with both Trigger Modes, so any combination of Therapy and Trigger may be chosen.
A summary of key specifications for device operation are as follows:
- Power Modes: Standard Mode (adjustable at 25%, 50%, 75%, or 100% total power)* and . Adapt Mode (power is automatically regulated by the device, consisting of decreased power over the course of each exhalation).
- Cycle Duration: 10 breaths (exhalations). The device generates vibration during exhalation . into the device mouthpiece.
- . Oscillation Frequency: 12 Hz for the first eight (8) exhalations of each 10-breath cycle and 6 Hz for the last two (2) exhalations of each 10-breath cycle, to enable secretion transport.
- Duration of treatment: The device will perform a maximum of 10 cycles (i.e., 100 exhalations) ● or 60 minutes of therapy, whichever occurs first, prior to shutting down, for each mode of operation.
- Activation of Therapy (Detect and Manual Trigger): In Detect Trigger, after the patient . presses the 'Go' button, the device does not deliver a signal until it detects patient exhalation has begun. With the device set to Manual Trigger, therapy is initiated as soon as the 'Go' button is activated.
SUBSTANTIAL EQUIVALENCE
The SIMEOX 200 Airway Clearance Device is substantially equivalent in intended use and technological characteristics to two predicate devices. The primary predicate device for the SIMEOX 200 is the AirPhysio device (K203209). The secondary predicate is the SimplyClear device (K122111). All three devices, the subject device and the two predicates, are intended to improve the clearance of mucosal secretions from the airways by vibrating the airway walls to assist in loosening mucus. All three devices apply this vibration during exhalation into the device via a patient mouthpiece. All three devices may be used with therapy being delivered during
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exhalation-only, with inhalation occurring at an ambient/atmospheric pressure: this is inherent to the SIMEOX 200 and AirPhysio devices, and this is one available operating mode for the SimplyClear Device, namely, exsufflation-only mode.
The following table summarizes the key technical characteristics between the SIMEOX 200 Airway Clearance Device, the SimplyClear Device, and the AirPhysio Device.
| SUBJECT DEVICE(SIMEOX-200) | PRIMARYPREDICATE(AIRPHYSIO) | SECONDARYPREDICATE(SIMPLYCLEAR) | SUMMARY/DISCUSSION | |
|---|---|---|---|---|
| ProductName | SIMEOX-200Airway ClearanceDevice | AirPhysio PositiveExpiratoryPressure (PEP)Device | SimplyClearDevice | N/A |
| Manufacturer | Inogen, Inc. | AirPhysio Pty Ltd | Philips RespironicsInc., USA | N/A |
| 510(k)number | K241091 | K203209 | K122111 | N/A |
| RegulatoryClassification | 21 CFR 868.5665 | 21 CFR 868.5665 | 21 CFR 868.5665 | Identical |
| RegulatoryIdentification | A poweredpercussor is adevice that isintended to transmitvibration through apatient's chest wallto aid in freeingmucus deposits inthe lung in order toimprove bronchialdrainage and thatmay be powered byelectricity orcompressed gas. | A poweredpercussor is a devicethat is intended totransmit vibrationthrough a patient'schest wall to aid infreeing mucusdeposits in the lungin order to improvebronchial drainageand that may bepowered byelectricity orcompressed gas. | A poweredpercussor is adevice that isintended totransmit vibrationthrough a patient'schest wall to aidin freeing mucusdeposits in thelung in order toimprove bronchialdrainage and thatmay be poweredby electricity orcompressed gas. | Identical |
| Classification | Class II | Class II | Class II | Identical |
| Indicationsfor Use | The SIMEOX 200airway clearancedevice is intended to | AirPhysio isindicated for use as a | Intended Use: ThePhilips RespironicsSimplyClear device | Identical: All 3devices are |
| promote airway | Pressure (PEP)Device for | assists patients inloosening,mobilizing andclearing secretionsby providing highfrequencyoscillatoryvibrations whilegradually applying apositive pressure tothe airway, thenrapidly shifting to anegative pressure.The oscillatoryvibrations assist inloosening andmobilizing thesecretions while therapid shift inpressure produces ahigh expiratoryflow rate from thelungs, whichpromotes theclearance ofsecretions. | patients inloosening,mobilizing andclearingsecretions byproviding highfrequencyoscillatoryvibrations to theairways.Different: OnlySimplyClear isintended forpatients with"inability tocough", thereforeSIMEOX-200treats a subset ofSimplyClearintended use.OnlySimplyClear isintended forpatients withendotracheal ortracheostomytube, thereforeSIMEOX 200treats a subset ofthe SimplyClearintended use.SIMEOX 200and theSimplyClear inexsufflation-onlymode delivervibrationnegative pressureduringexhalation.AirPhysiodelivers vibration | |
| clearance and to | improving the | |||
| improve bronchial | clearance of mucus | |||
| drainage by | secretions from the | |||
| enhancing | airways. | |||
| mobilization of | ||||
| bronchial secretions | AirPhysio vibrates | |||
| via high frequency | the airway walls to | |||
| oscillatory | assist in loosening | |||
| vibrations and | mucus and | |||
| intermittent negative | intermittently | |||
| pressure to the | increases | |||
| airway during | endobronchial | |||
| exhalation. The | pressure so that the | |||
| device is intended to | airway patency can | |||
| be prescribed for use | be maintained during | |||
| in patients capable | exhalation, reducing | |||
| of independently | the potential of | |||
| generating cough. | mucus becoming | |||
| trapped as it moves | ||||
| SIMEOX 200 is | up the airways. | |||
| intended for use in | ||||
| the home, hospital, | The device may also | |||
| and other healthcare | be useful in the | |||
| institutions by | removal of mucus | |||
| individuals weighing | from patients who | |||
| at least 23 Kg. | have chronic | |||
| bronchitis or | Indications for Use:The SimplyCleardevice may be usedeither with afacemask ormouthpiece, or withan adapter to apatient'sendotracheal ortracheostomy tube.It is for use on adultor pediatric patientshaving difficultywith secretionclearance and/orinability to cough. | |||
| bronchiectasis and inconjunction with amedical need forpositive expiratorypressure (PEP)therapy. | ||||
| The SimplyCleardevice is for use in ahospital,institutionalenvironment or inthe home. | via positivepressure duringexhalation. | |||
| DeviceDescription | The SIMEOX 200Airway ClearanceDevice consists of aportable generatorand single patientuse expiratory kit.The devicepromotes airwayclearance byloosening andmobilizingsecretions. Therapyis delivered viaexhalation into thedevice plasticmouthpiece. Duringexhalation, a highfrequency negativepressure oscillatoryvibration is appliedto the chest wall viathe airways andloosens mucus fromthe bronchial walls,increasingmobilization. | AirPhysio is a small,handheld expirationresistance device,consisting of ahardened plasticmouthpiece at oneend, a plastic coverwith an opening atthe other end, and avalve on the insidecreated by a high-density stainless-steel ball resting in aplastic conical cone.Exhalation throughthe device causesvibrations, assistingto loosen mucusfrom the airways.The resistance isincreased by tiltingthe device. | The PhilipsRespironicsSimplyClear devicepromotes airwayclearance byloosening,mobilizing andclearing secretions.The loosening andmobilization occurby graduallyapplying air pulsegenerated highfrequencyoscillatoryvibrations on thepositive andnegative pressuresapplied to the chestwall via the airways.The high frequencyoscillatoryvibrations releasemucus from thebronchial walls,increasingmobilization. Thepositive to negativeshift in pressureproduces a highexpiratory flowfrom the lungs,promoting theclearance of themobilized secretionsvia coughing. | Identical: Alldevices deliverthe mechanismof action ofloosening mucusin the airwaysvia application ofvibration to theairways duringexhalation.The SimplyClearmay be operatedin anexsufflation-onlymode, in whichno positivepressure isadministeredduringinhalation.The SIMEOX200 does notinclude theSimplyClearfeature of rapidpressure changesto generatecough, andtherefore, theSIMEOX 200 isintended for asubset of theSimply Clearindications:namely, theloosening of |
| mucus, but notthe generation ofcough. SIMEOX-200 is intendedfor patients whocan generate acoughindependently. | ||||
| Principles ofOperation /Mechanismof Action | Airway Oscillation(vibration) duringexhalation to loosenmucus and mobilizesecretions from theairways forexpectoration(pneumaticoscillation) | Airway Oscillation(vibration) duringexhalation to loosenmucus and mobilizesecretions from theairways forexpectorationcombined withPositive ExpiratoryPressure (PEP) | Airway Oscillation(vibration) duringexhalation-onlyand/or duringinhalation andexhalation to loosenmucus and mobilizesecretions from theairways forexpectoration.Insufflation-exsufflation modeavailable to assistpatients withinability to cough. | All devicesoperate on themechanism ofhigh frequencyoscillatoryvibration appliedwithin theairways in orderto loosen andmobilize mucus,enabling removalviaexpectoration. |
| PatientPopulation | Patients havingdifficulty withsecretion clearance.Patients weighing >23 Kg | Patients who havechronic bronchitis orbronchiectasis | Adult or pediatricpatients havingdifficulty withsecretion clearanceand/or inability tocough | Identical: Alldevices areintended to treatpatients havingdifficultyclearingsecretions.SimplyClear islabeled for bothadult andpediatric patientswhereasSIMEOX-200 islabeled forpatientsweighing >23Kg.Different: OnlySimplyClear is |
| Environments of Use | Home / Healthcarefacility | Home / Healthcarefacility | Home / Healthcarefacility | intended forpatients with "inability tocough", thereforeSIMEOX-200treats a subset ofthose who canuse SimplyClear |
| Prescription /OTC | Prescription | Prescription | Prescription | Identical |
| PatientInterface | Mouthpiece | Mouthpiece | MouthpieceFacemask,tracheostomy orendotrachealtube. | Identical:MouthpieceDifferent:Facemask,tracheostomy orendotrachealtubes are onlyinterface optionsfor theSimplyCleardevice; thereforeSIMEOX-200treats a subset ofthose who canuse SimplyClear |
| Phases ofTherapy | Exsufflation Only | Exsufflation Only | Exsufflation-OnlyMode Available;Insufflation/Exsufflation (I-E) ModeAvailable | Identical: Alldevices operatein exsufflation-only modeDiscussion: TheI-E modeavailable on theSimplyCleardevice is out ofscope forpredicatecomparison inthe context of theSIMEOX-200,which offers a |
| Power Source | Battery or MainsPower | None; ManualExhalation-PoweredDevice | Battery or MainsPower | subset of theSimplyClearcapabilities.Identical:SIMEOX-200and SimplyClearare both poweredby battery ormains powerDiscussion:AirPhysio is amechanicallypowered deviceand therefore theSimplyClear isthe technologicalreference for thischaracteristic. |
| Modes ofOperation | Manual or Auto | Manual | Manual or Auto | Identical:SIMEOX-200and SimplyClearare both operatedwith eitherManual or AutoModeDiscussion:AirPhysio is amechanicallypowered deviceand therefore theSimplyClear isthe technologicalreference for thischaracteristic. |
| Power/ FlowSettings | Manual Mode :Available PowerSettings (25%;50%; 75% or 100%)Auto Mode :Power Setting isservo-controlled | Manual | Low, Medium, High | Identical:SIMEOX-200and SimplyClearare both able tobe operated indifferent powermodes.SIMEOX-200operating |
| conditions arewithin the rangeavailable for theSimplyClear | ||||
| High-frequencyoscillations | Yes(during exhalationonly) | Yes(during exhalationonly) | Yes(available duringexhalation only;and/or availableduringinhalation/exhalation) | Identical |
| ExhalationPressure(Negative) | 0 to -60 cm H2O | N/A | 0 to -70 cm H2O | Identical:SIMEOX-200pressure range isnearly identicalto that ofSimplyClear andfalls within asubset of theSimplyClearavailablenegative pressurerange.Discussion:AirPhysio is amechanicallypowered deviceand therefore theSimplyClear isthe technologicalreference for thischaracteristic. |
| InhalationPressure(Positive) | Atmospheric (0 cmH2O) | Atmospheric (0 cmH2O) | 0 to 70 cm H2O | Identical: Alldevices operatein exsufflation-only mode.Discussion:Benchverificationtesting of theSIMEOX 200confirms thedevice operates |
| within itsprespecifiedoperatingspecifications fornegative pressuredelivery, whichare in keepingwith those of thepredicate devicesset toexsufflation-only(Positivepressure settingof 0 cm H2O).Thisdemonstrates thatthe SIMEOX200 performs tothe same criticalinput and outputspecifications asthe predicatedevices. | ||||
| Identical:Frequenciesavailable withSIMEOX 200therapy arewithin theavailablefrequenciesduringSimplyCleartreatment.Discussion:AirPhysio is amechanicallypowered deviceand therefore theSimplyClear isthe technologicalreference for this | ||||
| OscillationFrequencies | Fixed Frequencies12 Hz (first 8phases of treatmentcycle)6 Hz (final twophases of treatmentcycle) | VariableFrequencies(Determined by usertilting the device) | VariableFrequencies (Userselected)Range: 0 to 20 Hz | |
| characteristic.¥ | ||||
| User Interface | Activation buttons,Hierarchal menusystem,Visual feedback ondevice respiratoryoutputs | None | - Activation buttons- Hierarchal menusystem- Visual feedback ondevice respiratoryoutputs | Identical:SIMEOX 200and SimplyClearallow for thecontrol oftherapy andvisual feedbackvia a userinterface.Discussion:AirPhysio is amechanicallypowered deviceand therefore theSimplyClear isthe technologicalreference for thischaracteristic. |
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PERFORMANCE DATA PRESENTED IN THIS 510(K)
Performance verification testing was conducted on the bench with the SIMEOX 200 Airwav Clearance Device to demonstrate the subject device performs to its pre-specified requirement specifications, which align with those of the predicate devices. . The SIMEOX 200 device also went through comprehensive software verification and validation testing to confirm the device operates within specification. Testing demonstrated the SIMEOX 200 performed as intended and was safe and effective.
Biocompatibility testing was conducted in accordance with ISO 10993-1, and these studies concluded the SIMEOX 200 expiratory kit accessories were not considered cytotoxic, sensitizing or irritating and were demonstrated and biocompatible for their intended use.
A human factors validation study was conducted with simulated first-time use of the product in adult users and dyads of children with caregivers. The study concluded that the device is safe for its intended users.
Comprehensive cybersecurity, wireless, electromagnetic compatibility, and electrical, mechanical and thermal safety testing have been conducted.
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CONCLUSIONS
The SIMEOX 200 Airway Clearance Device is substantially equivalent to the predicate devices. The SIMEOX 200 Airway Clearance Device that is the subject of this 510(k) has been validated in nonclinical testing which confirms the device complies with its specifications and operates equivalently to the cited predicates. The indications for use, technological characteristics, and principles of operation are similar to the predicate devices.
The conclusions drawn from the nonclinical testing in this submission demonstrate that the SIMOEX 200 is as safe, as effective, and performs as well as the legally marketed device predicates and therefore, that the SIMEOX 200 Airway Clearance Device is substantially equivalent to the predicate devices across its intended range of performance measures.
§ 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).