(245 days)
No
The document describes a mechanical device that generates pneumatic vibrations. There is no mention of AI, ML, or any data-driven decision-making process within the device's operation. The performance studies focus on mechanical function, software validation, biocompatibility, human factors, and safety testing, not on the performance of an AI/ML algorithm.
Yes
The device is intended to promote airway clearance and improve bronchial drainage, which are therapeutic actions to alleviate symptoms and improve a patient's condition.
No
The device's intended use and description clearly state it is for promoting airway clearance and improving bronchial drainage by enhancing mobilization of bronchial secretions, which are therapeutic actions, not diagnostic.
No
The device description explicitly states it consists of a "portable generator and a single patient use expiratory kit," indicating physical hardware components beyond just software.
Based on the provided information, the SIMEOX 200 airway clearance device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- SIMEOX 200 Function: The SIMEOX 200 is a device that physically interacts with the patient's airway during exhalation to mobilize secretions. It does not analyze any biological samples taken from the patient.
- Intended Use: The intended use clearly states it's for "promoting airway clearance and to improve bronchial drainage by enhancing mobilization of bronchial secretions." This is a therapeutic function, not a diagnostic one.
- Device Description: The description details how the device generates pneumatic vibrations and negative pressure during exhalation, which is a mechanical action on the airway.
- Lack of IVD Indicators: There is no mention of analyzing samples, detecting biomarkers, or any other activities typically associated with IVDs.
Therefore, the SIMEOX 200 is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
SDT
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 exhalies 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
airways, bronchial tree, bronchial walls, lungs
Indicated Patient Age Range
individuals weighing at least 23 Kg (implicitly adult and older pediatric patients)
Intended User / Care Setting
Home, hospital, and other healthcare institutions
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5665 Powered percussor.
(a)
Identification. A powered percussor is a device that is intended to transmit vibration through a patient's chest wall to aid in freeing mucus deposits in the lung in order to improve bronchial drainage and that may be powered by electricity or compressed gas.(b)
Classification. Class II (performance standards).
0
December 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 (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
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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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4
510(K) SUMMARY
| DATE OF PREPARATION | December 20, 2024 |
|---|---|
| APPLICANT | Inogen, Inc. |
| 859 Ward Drive | |
| Suite 200 | |
| Goleta, California 93111 | |
| OFFICIAL CORRESPONDENT | Michael Nilo, MS BME, President |
| Nilo Medical Consulting Group | |
| 3706 Butler Street, #313 | |
| Pittsburgh, PA 15201 | |
| Phone: (717) 421-4396 | |
| E-mail: michael.nilo@nilomed.com | |
| DEVICE NAME | SIMEOX 200 Airway Clearance Device |
| DEVICE CLASSIFICATION | Common Name: Powered percussor |
| Regulation: 21 CFR 868.5665 | |
| Class II | |
| PRIMARY PREDICATE DEVICE | AirPhysio Positive Expiratory Pressure (PEP) Device |
| (K203209) | |
| SECONDARY PREDICATE | |
| 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
(SIMEOX-200) | PRIMARY
PREDICATE
(AIRPHYSIO) | SECONDARY
PREDICATE
(SIMPLYCLEAR) | SUMMARY/
DISCUSSION |
|--------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product
Name | SIMEOX-200
Airway Clearance
Device | AirPhysio Positive
Expiratory
Pressure (PEP)
Device | SimplyClear
Device | N/A |
| Manufacturer | Inogen, Inc. | AirPhysio Pty Ltd | Philips Respironics
Inc., USA | N/A |
| 510(k)
number | K241091 | K203209 | K122111 | N/A |
| Regulatory
Classification | 21 CFR 868.5665 | 21 CFR 868.5665 | 21 CFR 868.5665 | Identical |
| Regulatory
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. | 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. | 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. | Identical |
| Classification | Class II | Class II | Class II | Identical |
| Indications
for Use | The SIMEOX 200
airway clearance
device is intended to | AirPhysio is
indicated for use as a | Intended Use: The
Philips Respironics
SimplyClear device | Identical: All 3
devices are |
| | | | | |
| promote airway | Pressure (PEP)
Device for | assists patients in
loosening,
mobilizing and
clearing secretions
by providing high
frequency
oscillatory
vibrations while
gradually applying a
positive pressure to
the airway, then
rapidly shifting to a
negative pressure.
The oscillatory
vibrations assist in
loosening and
mobilizing the
secretions while the
rapid shift in
pressure produces a
high expiratory
flow rate from the
lungs, which
promotes the
clearance of
secretions. | patients in
loosening,
mobilizing and
clearing
secretions by
providing high
frequency
oscillatory
vibrations to the
airways.
Different: Only
SimplyClear is
intended for
patients with
"inability to
cough", therefore
SIMEOX-200
treats a subset of
SimplyClear
intended use.
Only
SimplyClear is
intended for
patients with
endotracheal or
tracheostomy
tube, therefore
SIMEOX 200
treats a subset of
the SimplyClear
intended use.
SIMEOX 200
and the
SimplyClear in
exsufflation-only
mode deliver
vibration
negative pressure
during
exhalation.
AirPhysio
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 | | | |
| 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 SimplyClear
device may be used
either with a
facemask or
mouthpiece, or with
an adapter to a
patient's
endotracheal or
tracheostomy tube.
It is for use on adult
or pediatric patients
having difficulty
with secretion
clearance and/or
inability to cough. | | |
| | bronchiectasis and in
conjunction with a
medical need for
positive expiratory
pressure (PEP)
therapy. | | | |
| | | | The SimplyClear
device is for use in a
hospital,
institutional
environment or in
the home. | via positive
pressure during
exhalation. |
| Device
Description | The SIMEOX 200
Airway Clearance
Device consists of a
portable generator
and single patient
use expiratory kit.
The 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 oscillatory
vibration is applied
to the chest wall via
the airways and
loosens mucus from
the bronchial walls,
increasing
mobilization. | AirPhysio is a small,
handheld expiration
resistance device,
consisting of a
hardened plastic
mouthpiece at one
end, a plastic cover
with an opening at
the other end, and a
valve on the inside
created by a high-
density stainless-
steel ball resting in a
plastic conical cone.
Exhalation through
the device causes
vibrations, assisting
to loosen mucus
from the airways.
The resistance is
increased by tilting
the device. | The Philips
Respironics
SimplyClear device
promotes airway
clearance by
loosening,
mobilizing and
clearing secretions.
The loosening and
mobilization occur
by gradually
applying air pulse
generated high
frequency
oscillatory
vibrations on the
positive and
negative pressures
applied to the chest
wall via the airways.
The high frequency
oscillatory
vibrations release
mucus from the
bronchial walls,
increasing
mobilization. The
positive to negative
shift in pressure
produces a high
expiratory flow
from the lungs,
promoting the
clearance of the
mobilized secretions
via coughing. | Identical: All
devices deliver
the mechanism
of action of
loosening mucus
in the airways
via application of
vibration to the
airways during
exhalation.
The SimplyClear
may be operated
in an
exsufflation-only
mode, in which
no positive
pressure is
administered
during
inhalation.
The SIMEOX
200 does not
include the
SimplyClear
feature of rapid
pressure changes
to generate
cough, and
therefore, the
SIMEOX 200 is
intended for a
subset of the
Simply Clear
indications:
namely, the
loosening of |
| | | | | |
| | | | | mucus, but not
the generation of
cough. SIMEOX-
200 is intended
for patients who
can generate a
cough
independently. |
| Principles of
Operation /
Mechanism
of Action | Airway Oscillation
(vibration) during
exhalation to loosen
mucus and mobilize
secretions from the
airways for
expectoration
(pneumatic
oscillation) | Airway Oscillation
(vibration) during
exhalation to loosen
mucus and mobilize
secretions from the
airways for
expectoration
combined with
Positive Expiratory
Pressure (PEP) | Airway Oscillation
(vibration) during
exhalation-only
and/or during
inhalation and
exhalation to loosen
mucus and mobilize
secretions from the
airways for
expectoration.
Insufflation-
exsufflation mode
available to assist
patients with
inability to cough. | All devices
operate on the
mechanism of
high frequency
oscillatory
vibration applied
within the
airways in order
to loosen and
mobilize mucus,
enabling removal
via
expectoration. |
| Patient
Population | Patients having
difficulty with
secretion clearance.
Patients weighing >
23 Kg | Patients who have
chronic bronchitis or
bronchiectasis | Adult or pediatric
patients having
difficulty with
secretion clearance
and/or inability to
cough | Identical: All
devices are
intended to treat
patients having
difficulty
clearing
secretions.
SimplyClear is
labeled for both
adult and
pediatric patients
whereas
SIMEOX-200 is
labeled for
patients
weighing >23
Kg.
Different: Only
SimplyClear is |
| Environment
s of Use | Home / Healthcare
facility | Home / Healthcare
facility | Home / Healthcare
facility | intended for
patients with "inability to
cough", therefore
SIMEOX-200
treats a subset of
those who can
use SimplyClear |
| Prescription /
OTC | Prescription | Prescription | Prescription | Identical |
| Patient
Interface | Mouthpiece | Mouthpiece | Mouthpiece
Facemask,
tracheostomy or
endotracheal
tube. | Identical:
Mouthpiece
Different:
Facemask,
tracheostomy or
endotracheal
tubes are only
interface options
for the
SimplyClear
device; therefore
SIMEOX-200
treats a subset of
those who can
use SimplyClear |
| Phases of
Therapy | Exsufflation Only | Exsufflation Only | Exsufflation-Only
Mode Available;
Insufflation/Exsufflation (I-E) Mode
Available | Identical: All
devices operate
in exsufflation-
only mode
Discussion: The
I-E mode
available on the
SimplyClear
device is out of
scope for
predicate
comparison in
the context of the
SIMEOX-200,
which offers a |
| | | | | |
| Power Source | Battery or Mains
Power | None; Manual
Exhalation-Powered
Device | Battery or Mains
Power | subset of the
SimplyClear
capabilities.
Identical:
SIMEOX-200
and SimplyClear
are both powered
by battery or
mains power
Discussion:
AirPhysio is a
mechanically
powered device
and therefore the
SimplyClear is
the technological
reference for this
characteristic. |
| Modes of
Operation | Manual or Auto | Manual | Manual or Auto | Identical:
SIMEOX-200
and SimplyClear
are both operated
with either
Manual or Auto
Mode
Discussion:
AirPhysio is a
mechanically
powered device
and therefore the
SimplyClear is
the technological
reference for this
characteristic. |
| Power/ Flow
Settings | Manual Mode :
Available Power
Settings (25%;
50%; 75% or 100%)
Auto Mode :
Power Setting is
servo-controlled | Manual | Low, Medium, High | Identical:
SIMEOX-200
and SimplyClear
are both able to
be operated in
different power
modes.
SIMEOX-200
operating |
| | | | | conditions are
within the range
available for the
SimplyClear |
| High-frequency
oscillations | Yes
(during exhalation
only) | Yes
(during exhalation
only) | Yes
(available during
exhalation only;
and/or available
during
inhalation/exhalatio
n) | Identical |
| Exhalation
Pressure
(Negative) | 0 to -60 cm H2O | N/A | 0 to -70 cm H2O | Identical:
SIMEOX-200
pressure range is
nearly identical
to that of
SimplyClear and
falls within a
subset of the
SimplyClear
available
negative pressure
range.
Discussion:
AirPhysio is a
mechanically
powered device
and therefore the
SimplyClear is
the technological
reference for this
characteristic. |
| Inhalation
Pressure
(Positive) | Atmospheric (0 cm
H2O) | Atmospheric (0 cm
H2O) | 0 to 70 cm H2O | Identical: All
devices operate
in exsufflation-
only mode.
Discussion:
Bench
verification
testing of the
SIMEOX 200
confirms the
device operates |
| | | | | |
| | | | | within its
prespecified
operating
specifications for
negative pressure
delivery, which
are in keeping
with those of the
predicate devices
set to
exsufflation-only
(Positive
pressure setting
of 0 cm H2O).
This
demonstrates that
the SIMEOX
200 performs to
the same critical
input and output
specifications as
the predicate
devices. |
| | | | | Identical:
Frequencies
available with
SIMEOX 200
therapy are
within the
available
frequencies
during
SimplyClear
treatment.
Discussion:
AirPhysio is a
mechanically
powered device
and therefore the
SimplyClear is
the technological
reference for this |
| Oscillation
Frequencies | Fixed Frequencies
12 Hz (first 8
phases of treatment
cycle)
6 Hz (final two
phases of treatment
cycle) | Variable
Frequencies
(Determined by user
tilting the device) | Variable
Frequencies (User
selected)
Range: 0 to 20 Hz | |
| | | | | characteristic.¥ |
| User Interface | Activation buttons,
Hierarchal menu
system,
Visual feedback on
device respiratory
outputs | None | - Activation buttons
- Hierarchal menu
system - Visual feedback on
device respiratory
outputs | Identical:
SIMEOX 200
and SimplyClear
allow for the
control of
therapy and
visual feedback
via a user
interface.
Discussion:
AirPhysio is a
mechanically
powered device
and therefore the
SimplyClear is
the technological
reference for this
characteristic. |
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9
10
11
12
13
14
15
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.
16
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.