eRapid with eTrack System

K251572 · Pari Respiratory Equipment, Inc. · CAF · Dec 19, 2025 · Anesthesiology

Device Facts

• Record ID: K251572
• Device Name: eRapid with eTrack System
• Applicant: Pari Respiratory Equipment, Inc.
• Product Code: CAF · Anesthesiology
• Decision Date: Dec 19, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The eRapid Nebulizer System is to be used with patients for whom doctors have prescribed medicine for nebulization. It is intended for adult and pediatric patients age 4 and older who can coordinate breathing through a mouthpiece, and may be used in hospitals, hospital-type facilities, nursing homes, sub-acute institutions and home environments.

Device Story

eRapid with eTrack is a portable, reusable, single-patient use electronic nebulizer. It uses micro-perforated vibrating membrane technology to aerosolize liquid medications. A piezoelectric actuator, driven by an electronic controller, vibrates a stainless steel membrane at high frequency to create liquid jets that disperse into droplets. The device is used in home, hospital, nursing home, and sub-acute settings by patients or clinicians. The controller provides power and monitors operational status, including automatic shut-off when the reservoir is empty, parameters are out-of-range, or maximum time is reached. The eTrack controller adds Wi-Fi and Bluetooth connectivity. The device is tethered; the handset connects to the controller via cord. Power is supplied by AA batteries or AC/DC adapter. The healthcare provider uses the device to deliver prescribed respiratory medication; the output is an aerosol stream for inhalation. Benefits include portable, efficient delivery of nebulized drugs.

Clinical Evidence

Bench testing only. Evidence includes aerosol performance testing (Total Output Rate, Mass Median Diameter, Fine Particle Fraction), biocompatibility evaluation, electromagnetic compatibility (EMC) and electrical safety testing per IEC 60601 series, software validation, simulated use testing, cleaning/disinfection validation, cybersecurity risk assessment, and wireless coexistence testing.

Technological Characteristics

Micro-perforated vibrating membrane technology; piezoelectric actuator. Materials: Polypropylene (Bormed), Silicone rubber, ABS, TPE, PC. Power: 3x NiMH AA batteries or AC adapter (100-240V). Connectivity: Wi-Fi and Bluetooth. IP22 rating. Applied part: Type BF. Software: Moderate level of concern, Class B per IEC 62304.

Indications for Use

Indicated for adult and pediatric patients age 4 and older requiring nebulized medication who can coordinate breathing through a mouthpiece.

Regulatory Classification

Identification

A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.

Predicate Devices

• eRapid NCP Nebulizer System (K223840)

Reference Devices

• AireHealth Nebulizer (K201167)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

December 19, 2025

PARI Respiratory Equipment Inc
Michael Judge
VP Regulatory Affairs
2412 Pari Way
Midlothian, Virginia 23112

Re: K251572
Trade/Device Name: eRapid with eTrack System
Regulation Number: 21 CFR 868.5630
Regulation Name: Nebulizer
Regulatory Class: Class II
Product Code: CAF
Dated: November 24, 2025
Received: November 24, 2025

Dear Michael Judge:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K251572 - Michael Judge
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the 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 (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-reporting-combination-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-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-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).

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K251572 - Michael Judge
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Sincerely,

Ethan L. Nyberg -S

Ethan Nyberg, Ph.D.
Assistant Director
DHT1C: Division of Anesthesia, Respiratory, and Sleep Devices
OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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FORM FDA 3881 (6/20)
Page 1 of 1
PSC Publishing Services [phone]
EF

| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K251572 | |
| Device Name eRapid with eTrack System | |
| Indications for Use (Describe) The eRapid Nebulizer System is to be used with patients for whom doctors have prescribed medicine for nebulization. It is intended for adult and pediatric patients age 4 and older who can coordinate breathing through a mouthpiece, and may be used in hospitals, hospital-type facilities, nursing homes, sub-acute institutions and home environments. | |
| Type of Use (Select one or both, as applicable) ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* | |
| The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail] | |
| "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." | |

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510(K) SUMMARY
APRIL 30, 2025

# 1. Submitter Information

Name: PARI Respiratory Equipment, Inc.
Address: 2412 Pari Way
Midlothian, VA 23112
Phone: [phone], ext. 269
Fax: [phone]
Contact Name: Michael Judge
Email: [e-mail]

# 2. Device Name

Name of Device: eRapid with eTrack Nebulizer
Common Name: Nebulizer
510(k) Number: K223840
Classification Name: Nebulizer Direct Patient Interface (21 CFR 868.5630)
Regulatory Class: II
Product Code: CAF

# 3. Legally Marketed Predicate Device

Trade/Device Name: eRapid NCP Nebulizer System
Classification Name: Nebulizer (Direct Patient Interface)
Proprietary Name: eRapid NCP Nebulizer System
510(k) Number: K223840
Regulation No.: 868.5630
Class: Class II
Panel: Anesthesiology
Product Code: CAF

The following predicate device has not been subject to a design-related recall.

# 4. Reference Device

Trade/Device Name: AireHealthTM Nebulizer
510(k) Number: K201167
Regulation Number: 21 CFR 868.5630
Regulation Name: Nebulizer
Regulatory Class: Class II
Product Code: CAF
Dated: November 2, 2020
Received: November 3, 2020

# 5. Device Description

The eRapid with eTrack controller is a single-patient use, reusable electronic nebulizers, using micro-perforated vibrating membrane technology to aerosolize liquid medications. It is for adult and pediatric inhalation therapy in a home care, nursing home, sub-acute institution,

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or hospital environment. The devices are hand-held and portable, consisting of a controller and a nebulizer handset, connected with a connection cord. Power input is provided by either AA batteries, or a DC or AC adapter. Alternate power cords, plugs and adapters allow their use in any country.

# 6. Mechanism of Action

The medication is filled into the medication reservoir of the nebulizer handset for presenting its liquid content to the vibrating membrane of the nebulizer to generate aerosol for inhalation. There is selection button on the controller to turn on the device, and start the treatment. When the treatment is done the device automatically shuts off.

This eFlow technology uses a wafer-thin plate or membrane of stainless steel, which is perforated with numerous laser-drilled holes (Figure 1). The size of the membrane holes determines the aerosol particle size. There is no other mechanism in place that changes the aerosol particle size, whether through software and/or user interface. This micro-perforated membrane vibrates at a high frequency against a body of fluid. The vibration source is the piezoelectric actuator that is activated by an electronic drive circuit of the Controller. The actuator and the perforated membrane are the main components of the aerosol head that is in contact with the liquid medication to be aerosolized. Liquid jets are created as an inertial response to the vibration of the membrane. Surface tension and hydrodynamic effects then cause these jets to disperse to produce a stream of precisely controlled droplets.

Figure 1: Principle of function of the vibrating membrane technology for aerosol generation

# 7. Indication for Use

The eRapid with eTrack Nebulizer System is to be used with patients for whom doctors have prescribed medicine for nebulization. It is intended for adult and pediatric patients age 4 and older who can coordinate breathing through a mouthpiece, and may be used in hospitals, hospital-type facilities, nursing homes, sub-acute institutions and home environments.

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8. Comparison of eRapid NCP Nebulizer system to the Predicate Device

| PRODUCT | FDA-Cleared eR-apid NCP Nebulizer System (K223840) | eRapid with eTrack Nebulizer System (K251572) | Comparison |
| --- | --- | --- | --- |
| Device Classi-fication | Nebulizer (direct patient interface) 21 CFR 868.5630 | Nebulizer (direct patient interface) 21 CFR 868.5630 | Identical |
| 510k No. | K223840 | K251572 | |
| Manufacturer (Reg. No.) | PARI Respiratory Equipment, Inc. | PARI Respiratory Equipment, Inc. | Identical |
| Product Code | CAF | CAF | Identical |
| Intended Use / Indications for Use | The eRapid Nebu- lizer System is to be used with pa- tients for whom doctors have pre- scribed medicine for nebulization. It is intended for adult and pediatric patients age 4 and older who can co- ordinate breathing through a mouth- piece, and may be used in hospitals, hospital type facili- ties, nursing homes, sub-acute institutions and home environ- ments. | The eRapid with eTrack Nebulizer System is to be used with patients for whom doctors have prescribed medicine for nebu- lization. It is in- tended for adult and pediatric patients age 4 and older who can coordinate breathing through a mouthpiece, and may be used in hospitals, hospital type facilities, nur- sing homes, sub- acute institutions and home environ- ments. | Identical |
| Prescription Use | Rx Only | Rx Only | Identical |
| METHOD OF OPERATION | | | |
| Technology Used | Micro-perforated vibrating mem- brane technology to aerosolize liquid | Micro-perforated vibrating mem- brane technology to aerosolize liquid | Identical |

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| | medications | medications | |
| --- | --- | --- | --- |
| Aerosol Direction/Output | Sprayed into aerosol chamber, cleared by inspiratory flow | Sprayed into aerosol chamber, cleared by inspiratory flow | Identical |
| Breath Enhanced/Controlled/Triggered | Breath enhanced two-way valve system. | Breath enhanced two-way valve system. | Identical |
| Fluid Delivery | Direct contact between aerosol head and fluid in sealed chamber (medication reservoir). | Direct contact between aerosol head and fluid in sealed chamber (medication reservoir). | Identical |
| Generator Configuration | Remote (tethered) only. | Remote (tethered) only. | Identical |
| Automatic Shut-off | Yes. Automatic shut-off when: (1) medication reservoir is empty; (2) out-of-range parameters are detected; or (3) programmed maximum operating time is reached. | Yes. Automatic shut-off when: (1) medication reservoir is empty; (2) out-of-range parameters are detected; or (3) programmed maximum operating time is reached. | Identical |

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| PRODUCT | FDA-Cleared eRapid NCP Nebulizer System (K223840) | eRapid with eTrack Nebulizer System | Comparison |
| --- | --- | --- | --- |
| DESIGN CAPACITIES | | | |
| Medication Reservoir
Min. Fill
Max. Fill
Residue | 2.0 mL
6.0 mL
Approx. 1.0 ml residue (depending on filled volume) | 2.0 mL
6.0 mL
Approx. 1.0 ml residue (depending on filled volume) | Identical |
| AEROSOL PERFORMANCE | | | |
| Total Output Rate (mg/min) | 663 (AVG) SD=72 | 650 (AVG) SD=57 | Similar |
| Mass Median Diameter (μm) | 4.37 (AVG) SD=0.10 | 4.36 (AVG) SD=0.08 | Similar |
| Geometrical Standard Deviation | 1.53 (AVG) SD=0.02 | 1.53 (AVG) SD=0.02 | Similar |
| Fine Particle Fraction <5 (%) | 63.15 | 63.47 | Similar |
| ELECTRICAL COMPARISON (Controller Output signal) | | | |
| Mean Frequency (Hz) | eBase (NCP) 2^{nd} Generation | eTrack 2^{nd} Generation | Identical |
| | 117650 | 117650 | |

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| Mean Power (Watts) | 1.253 | 1.253 | Identical |
| --- | --- | --- | --- |
| SOFTWARE | | | |
| Level of Concern | Moderate | Moderate | Identical |
| Device-Specific | Yes | Yes | Identical |
| Dependent on External Devices | No | No | Identical |
| Function | By continuous loop: (1) conducts power preprocessing; (2) supervises the nebulizer's aerosol generation; and (3) communicates to the user on the operational status of the device and out-of-range parameters. These functions are performed continuously until the medication reservoir is empty, out-of-range parameters are detected, or programmed maximum operating time (Tmax) is reached. | By continuous loop: (1) conducts power preprocessing; (2) supervises the nebulizer's aerosol generation; and (3) communicates to the user on the operational status of the device and out-of-range parameters. These functions are performed continuously until the medication reservoir is empty, out-of-range parameters are detected, or programmed maximum operating time (Tmax) is reached. | Identical |
| Audio-Visual Signals | Tone sounds, and illuminated display | Tone sounds, and illuminated display showing graphical | Identical |

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| Wireless Connection | showing graphical symbols concerning battery level, operational status and failure mode.
None | symbols concerning battery level, operational status and failure mode.
Wi-Fi and Bluetooth | Different Reference K201167 nebulizer with wireless connectivity |
| --- | --- | --- | --- |
| PRODUCT | Predicate
eRapid NCP Nebulizer System (K223840) | eRapid with eTrack Nebulizer System | Comparison |
| ELECTRICAL CONNECTION | | | |
| CISPR 11 Group | 1 | 1 | Identical |
| CISPR 11 Class | B | B | Identical |
| Protection Class | —□ with power supply. Internally powered – with batteries | —□ with power supply. Internally powered – with batteries | Identical |
| Applied Part Type | BF ☑ (nebuliser handset is classified as applied part) | BF ☑ (nebuliser handset is classified as applied part) | Identical |
| Liquid Protection Rating (controller) | IP22 | IP22 | Identical |
| Rated Supply Voltage (controller) | 5V | 5V | Identical |
| Rated Input Current (controller) | 750 mA | 750 mA | Identical |
| Rated Input | 3.75 W | 3.75 W | Identical |

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| Power (Controller) | | | |
| --- | --- | --- | --- |
| Electrical Re- quirement (power sup- ply) | 100V – 240V, 50 Hz/60 Hz | 100V – 240V, 50 Hz/60 Hz | Identical |
| Battery Opera- tion | Three NiMH AA rechargeable bat- tery pack | Three NiMH AA rechargeable bat- tery pack | Identical |
| NEBULIZER MATERIALS | | | |
| Mouthpiece | Polypropylene | Polypropylene (Bormed) | Identical (Different manu- facturer) |
| Valve(s) | Silicone rubber | Silicone rubber | Identical |

a. eRapid with eTrack Nebulizer System and Predicate eRapid NCP Nebulizer system

Both the eRapid with eTrack and the predicate eRapid NCP device are identical in purpose, function, core technology and energy sources. That is, they are portable, reusable, single-patient use, handheld electronic nebulizers that use a piezo-driven, micro-perforated vibrating membrane technology to aerosolize liquid medications for the treatment or prophylaxis of respiratory diseases. They are to be used with adult and pediatric patients for whom doctors have prescribed medication, i.e. they are for prescription use only. They may be used in hospitals, hospital-type facilities, nursing homes, sub-acute institutions and home environments. Energy sources for the devices are provided by: (1) connection to a mains power source, via an AC Power Supply; or, batteries.

Both the eRapid with eTrack and the predicate eRapid NCP employ breath enhanced, two-way valve systems. Further, both devices have permanent modes of action, i.e., once the on/off switch on the controller is pressed, continuous nebulization occurs until the medication is nebulized. Neither has any breath trigger or interrupter. Fluid delivery / generation for both devices is by direct contact between the aerosol head and the fluid in sealed medication reservoir.

The difference between the three devices are: 1) The eTrack controller has built in wireless and Bluetooth connectivity modules; 2) The manufacturer of handset material (Polypropylene) is different; 3) The adhesive used to bond the substrate to the piezo was changed to Delo Monopox.

Differences from FDA-cleared device are thus confined to the connectivity feature and the material of the handset.

9. Performance Data

The following performance data were provided in support of an SE determination.

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a. Biocompatibility and Airpath Testing

The eRapid with eTrack Nebulizer System uses the identical eRapid Nebulizer Handset (except for the manufacturer of material of the handset) that was previously cleared in the predicate eRapid NCP Nebulizer System. All other materials used are identical in both formulation and processing, and no other chemicals have been added (e.g., plasticizers, fillers, color additives, cleaning agents, mold release agents, etc.).

The components proposed in the eRapid with eTrack Nebulizer System, eTrack Controller (1), Connection Cord (2), AC Power Supply (3), and the Handset (4) have been evaluated for biocompatibility.

The following common materials were used. Handset: PP (Bormed HG820MO), Silicone, TPE, Controller (Housing): ABS, TPE, Connection Cord: PP, TPE, and AC Power Supply (Housing): PC. Biocompatibility and Airpath testing was performed on the handset to account for the manufacturer change.

According to the note in ISO 10993-1 chapter 5.2.2 no further biological evaluation is needed, when housings of the device that come in contact with any intact skin, are made from materials in common use.

b. Electromagnetic Compatibility (EMC) and Electrical Safety

EMC testing and Electrical Safety testing were conducted on the eTrack controller, connection cord and AC power supply. These components were evaluated according to following standards:

- ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/ (R)2012 and A2:2010/(R)2012
- IEC 60601-1-2:2014 (+AMD1:2020)
- IEC 60601-1-6:2010, AMD1:2013, AMD2:2020
- IEC 60601-1-11:2015/AMD1:2020

c. Software Verification and Validation Testing

The software for this device is of a "moderate level of concern" and validation testing was conducted in accordance with FDA's guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued May 2005" Software safety classification is Class B, according to recognized standard IEC 62304.

d. Aerosol Performance

When considering aerosol performance, the eRapid with eTrack Nebulizer is substantially equivalent to the predicate eRapid NCP Nebulizer. The handset, including the aerosol head, is solely responsible for aerosol performance and is the same handset as used in the predicate eRapid NCP Nebulizer system (except the manufacturer of the polypropylene material and the adhesive used to bond the piezo to the substrate are different).

The only variable in the eFlow technology that allows for a change to the aerosol performance is the dimension of the laser drilled holes in the vibrating mesh contained in the Aerosol Head. The hole size in the aerosol head determines the particle size of the aerosol. The aerosol particle size is not controlled or changed electronically or with software. Both the predicate and the subject

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handset used the same aerosol head, except for the adhesive used to bond the piezo to the substrate. Performance comparison tests were conducted on heads made by the current adhesive (MLT) and the needs made of new adhesive (Delo Monopox). Both the heads performed as per specification and there was no significant difference to suggest that the adhesive change had any effect.

As stated above the controller does not affect the aerosol performance and only provides a fixed power and frequency to the Nebulizer Handset. Both controllers have been electrically tested to demonstrate they produce the same frequency and power, within the accepted tolerance.

To further substantiate that the two controllers produce the same result, aerosol performance testing was done, and the results compared. The results were similar within the acceptable tolerance limits.

e. Simulated Use Testing

Testing was conducted to determine if the eRapid with eTrack Nebulizer System performed within specifications stated in the IFU, throughout its useful lifecycle. The testing concluded that the device remained within those specifications

f. Validation of Cleaning and Disinfection Methods

Microbiological efficiency control tests were conducted in order to validate the nebulizer cleaning and disinfection methods in the IFU. Testing involved validation of: (1) a manual cleaning method; (2) a chemical disinfection method; and (3) two thermal disinfection methods. All testing concluded that the nebulizer could be cleaned and disinfected effectively by use of the methods stated in the IFU.

g. Cybersecurity

A risk assessment was conducted to determine the elements related to cybersecurity and the risks were mitigated to below the level of concern.

h. Wireless Coexistence

An assessment was done to determine how the data transfer was affected in the presence of other wireless equipment.

10. Conclusion

Based on the FDA guidelines and relevant tests, we believe that the eRapid with eTrack Nebulizer System is substantially equivalent to the previously cleared predicate device.

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