SIMEOX 200 Airway Clearance Device

K241091 · Inogen, Inc. · SDT · Dec 23, 2024 · Anesthesiology

Device Facts

• Record ID: K241091
• Device Name: SIMEOX 200 Airway Clearance Device
• Applicant: Inogen, Inc.
• Product Code: SDT · Anesthesiology
• Decision Date: Dec 23, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5665
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended 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.

Device Story

Portable airway clearance device; consists of generator unit and single-patient-use expiratory kit (mouthpiece, tubing, filter). Patient inhales ambient air; exhales into mouthpiece. Device applies high-frequency negative pressure oscillations (6 Hz or 12 Hz) during exhalation to loosen mucus and increase secretion mobility. Used in home or clinical settings by patients weighing ≥23 kg. Features manual or 'DETECT' trigger (starts upon sensing exhalation). Includes RFID-based usage tracking for expiratory kits. Output is pneumatic vibration; assists patient in clearing secretions via independent cough. Benefits include improved bronchial drainage and reduced mucus viscosity.

Clinical Evidence

Bench testing only. Includes performance verification, software verification/validation, biocompatibility (ISO 10993-1), human factors validation study (simulated use in adults and child/caregiver dyads), and cybersecurity/EMC/electrical/mechanical safety testing.

Technological Characteristics

ABS/PC housing; stainless-steel grid inlet. Powered by AC or Li-ion battery. Expiratory kits use PVC tubing, SBC filters, polypropylene mouthpieces. RFID-based usage lockout. Oscillation via pneumatic negative pressure pulses (0 to -60 cm H2O). Fixed frequencies (12 Hz/6 Hz).

Indications for Use

Indicated for patients weighing at least 23 kg with difficulty clearing bronchial secretions who are capable of independently generating a cough.

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

• AirPhysio Positive Expiratory Pressure (PEP) Device (K203209)
• Philips Respironics SimplyClear Device (K122111)

Submission Summary (Full Text)

{0}------------------------------------------------

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.

{1}------------------------------------------------

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

{2}------------------------------------------------

assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] 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

{3}------------------------------------------------

# 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) | |
|------------------------------------------------------------------------------------------|--|
| <span style="font-size: 10pt;"> Prescription Use (Part 21 CFR 801 Subpart D) </span> | |
| <span style="font-size: 10pt;">Over-The-Counter Use (21 CFR 801 Subpart C)</span> | |

#### 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}------------------------------------------------

#### 510(K) SUMMARY

| DATE OF PREPARATION | December 20, 2024 |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| APPLICANT | Inogen, Inc.<br>859 Ward Drive<br>Suite 200<br>Goleta, California 93111 |
| OFFICIAL CORRESPONDENT | Michael Nilo, MS BME, President<br>Nilo Medical Consulting Group<br>3706 Butler Street, #313<br>Pittsburgh, PA 15201<br>Phone: [phone]<br>E-mail: [e-mail] |
| DEVICE NAME | SIMEOX 200 Airway Clearance Device |
| DEVICE CLASSIFICATION | Common Name: Powered percussor<br>Regulation: 21 CFR 868.5665<br>Class II |
| PRIMARY PREDICATE DEVICE | AirPhysio Positive Expiratory Pressure (PEP) Device<br>(K203209) |
| SECONDARY PREDICATE<br>DEVICE | 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.

{5}------------------------------------------------

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.

{6}------------------------------------------------

## 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

{7}------------------------------------------------

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<br>(SIMEOX-200) | PRIMARY<br>PREDICATE<br>(AIRPHYSIO) | SECONDARY<br>PREDICATE<br>(SIMPLYCLEAR) | SUMMARY/<br>DISCUSSION |
|--------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product<br>Name | SIMEOX-200<br>Airway Clearance<br>Device | AirPhysio Positive<br>Expiratory<br>Pressure (PEP)<br>Device | SimplyClear<br>Device | N/A |
| Manufacturer | Inogen, Inc. | AirPhysio Pty Ltd | Philips Respironics<br>Inc., USA | N/A |
| 510(k)<br>number | K241091 | K203209 | K122111 | N/A |
| Regulatory<br>Classification | 21 CFR 868.5665 | 21 CFR 868.5665 | 21 CFR 868.5665 | Identical |
| Regulatory<br>Identification | A powered<br>percussor is a<br>device that is<br>intended to transmit<br>vibration through a<br>patient's chest wall<br>to aid in freeing<br>mucus deposits in<br>the lung in order to<br>improve bronchial<br>drainage and that<br>may be powered by<br>electricity or<br>compressed gas. | A powered<br>percussor is a device<br>that is intended to<br>transmit vibration<br>through a patient's<br>chest wall to aid in<br>freeing mucus<br>deposits in the lung<br>in order to improve<br>bronchial drainage<br>and that may be<br>powered by<br>electricity or<br>compressed gas. | A powered<br>percussor is a<br>device that is<br>intended to<br>transmit vibration<br>through a patient's<br>chest wall to aid<br>in freeing mucus<br>deposits in the<br>lung in order to<br>improve bronchial<br>drainage and that<br>may be powered<br>by electricity or<br>compressed gas. | Identical |
| Classification | Class II | Class II | Class II | Identical |
| Indications<br>for Use | The SIMEOX 200<br>airway clearance<br>device is intended to | AirPhysio is<br>indicated for use as a | Intended Use: The<br>Philips Respironics<br>SimplyClear device | Identical: All 3<br>devices are |
| | | | | |
| promote airway | Pressure (PEP)<br>Device for | assists patients in<br>loosening,<br>mobilizing and<br>clearing secretions<br>by providing high<br>frequency<br>oscillatory<br>vibrations while<br>gradually applying a<br>positive pressure to<br>the airway, then<br>rapidly shifting to a<br>negative pressure.<br>The oscillatory<br>vibrations assist in<br>loosening and<br>mobilizing the<br>secretions while the<br>rapid shift in<br>pressure produces a<br>high expiratory<br>flow rate from the<br>lungs, which<br>promotes the<br>clearance of<br>secretions. | patients in<br>loosening,<br>mobilizing and<br>clearing<br>secretions by<br>providing high<br>frequency<br>oscillatory<br>vibrations to the<br>airways.<br>Different: Only<br>SimplyClear is<br>intended for<br>patients with<br>"inability to<br>cough", therefore<br>SIMEOX-200<br>treats a subset of<br>SimplyClear<br>intended use.<br>Only<br>SimplyClear is<br>intended for<br>patients with<br>endotracheal or<br>tracheostomy<br>tube, therefore<br>SIMEOX 200<br>treats a subset of<br>the SimplyClear<br>intended use.<br>SIMEOX 200<br>and the<br>SimplyClear in<br>exsufflation-only<br>mode deliver<br>vibration<br>negative pressure<br>during<br>exhalation.<br>AirPhysio<br>delivers 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…