eRapid Nebulizer System

K223840 · Pari Respiratory Equipment, Inc. · CAF · Aug 11, 2023 · Anesthesiology

Device Facts

• Record ID: K223840
• Device Name: eRapid Nebulizer System
• Applicant: Pari Respiratory Equipment, Inc.
• Product Code: CAF · Anesthesiology
• Decision Date: Aug 11, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The eRapid NCP 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

The eRapid NCP Nebulizer System is a portable, handheld electronic nebulizer for aerosolizing liquid medications. It consists of a controller and a nebulizer handset connected by a cord. The device uses micro-perforated vibrating membrane technology: a piezoelectric actuator, driven by an electronic circuit in the controller, vibrates a stainless steel membrane with laser-drilled holes against a fluid reservoir. This vibration creates liquid jets that disperse into a stream of droplets. The device is intended for use in hospitals, nursing homes, and home environments by patients or caregivers. The user initiates treatment via an On/Off button; the device operates continuously until the reservoir is empty, an error is detected, or a maximum time limit is reached. The controller provides audio-visual feedback regarding status and failures. By delivering medication as an aerosol, the device enables inhalation therapy for respiratory diseases, benefiting patients by facilitating targeted drug delivery to the lungs.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing, including aerosol performance (Total Output Rate, Mass Median Diameter, Fine Particle Fraction), biocompatibility, EMC/electrical safety (ANSI/AAMI ES60601-1, IEC 60601-1-2), software verification/validation, simulated use testing, and validation of cleaning/disinfection methods.

Technological Characteristics

Materials: Polypropylene, silicone rubber, stainless steel, ceramics, ABS, PC, TPE. Principle: Piezo-driven micro-perforated vibrating membrane (117 kHz). Power: 5V DC (rechargeable NiMH battery pack or AC adapter). Form factor: Handheld controller with tethered handset. Connectivity: Standalone. Software: Moderate level of concern, Class B per IEC 62304. Sterilization: Manual cleaning/disinfection (chemical or thermal).

Indications for Use

Indicated for adult and pediatric patients age 4 and older who can coordinate breathing through a mouthpiece and have been prescribed medication for nebulization. No specific contraindications listed.

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 Nebulizer System (K112859)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.

August 11, 2023

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

Re: K223840

Trade/Device Name: eRapid Nebulizer System Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: Class II Product Code: CAF Dated: July 5, 2023 Received: July 10, 2023

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 (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 located 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.

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

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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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-regulatoryassistance/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 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) K223840

Device Name eRapid NCP Nebulizer System

### Indications for Use (Describe)

The eRapid NCP 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) | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| <div> <span> <svg fill="none" height="16" viewbox="0 0 16 16" width="16" xmlns="http://www.w3.org/2000/svg"> <path d="M13.25 4.75L6.75 11.25L2.75 7.25" stroke="#000" stroke-linecap="round" stroke-linejoin="round" stroke-width="1.5"></path> </svg> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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# 1. Submitter Information

| Name: | PARI Respiratory Equipment, Inc. |
|----------------------|---------------------------------------|
| Address: | 2412 Pari Way<br>Midlothian, VA 23112 |
| Phone: | [phone], ext. 269 |
| Fax: | [phone] |
| Contact Name: | Michael Judge |
| Email: | [e-mail] |
| Device Name | |
| Name of Device: | eRapid NCP Nebulizer System |
| Common Name: | Nebulizer |
| Classification Name: | Nebulizer (21 CFR 868.5630) |
| Regulatory Class: | II |
| Product Code: | CAF |

# 3. Legally Marketed Predicate Device

eRapid Nebulizer System, K112859

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

# 4. Device Description

2.

Both the eRapid NCP and the predicate eRapid device are identical in purpose, function, core technology and method of operation. They are single-patient use, reusable electronic nebulizers, using micro-perforated vibrating membrane technology to aerosolize liquid medications. They are for adult and pediatric inhalation therapy in a home care, nursing home, sub-acute institution, 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 for both devices is provided by either AA batteries, or a DC or AC adapter. Alternate power cords, plugs and adapters allow their use in any country.

# 5. 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 only the On/Off 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 3). 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

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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.

Image /page/4/Figure/1 description: This image shows a diagram of a drug delivery system. The system consists of a reservoir containing the drug, electronics, a membrane with laser-drilled holes, a piezo actuator, and batteries. The drug is released as an aerosol through the laser-drilled holes.

# Figure 3: Principle of function of the vibrating membrane technology for aerosol generation

# 6. Indication for Use

The eRapid NCP 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.

| PRODUCT | FDA-Cleared eRapid<br>Nebulizer System | eRapid NCP Nebulizer System |
|---------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Classification | Nebulizer 21 CFR 868.5630 | Nebulizer 21 CFR 868.5630 |
| 510k No. | K112859 | K223840 |
| Manufacturer (Reg.<br>No.) | PARI Respiratory Equipment, Inc.<br>(2954963) | PARI Respiratory Equipment, Inc.<br>(2954963) |
| Regulatory Class | II | II |
| Product Code | CAF | CAF |
| Intended Use / | The eRapid Nebulizer is a handheld | The eRapid NCP Nebulizer System |
| Indications for Use | nebulizer designed to aerosolize any<br>medications prescribed by a physi-<br>cian. The eRapid Nebulizer System<br>is intended for adult and pediatric<br>patients, and may be used in hospi-<br>tals, hospital-type facilities, nursing<br>homes, sub-acute institutions, and<br>home environments. | is to be used with patients for whom<br>doctors have prescribed medicine<br>for nebulization. It is intended for<br>adult and pediatric patients age 4<br>and older who can coordinate<br>breathing through a mouthpiece,<br>and may be used in hospitals, hospi-<br>tal-type facilities, nursing homes,<br>sub-acute institutions and home en-<br>vironments. |
| Prescription Use | Rx Only | Rx Only |
| | | |
| METHOD OF OPERATION | | |
| Technology Used | Micro-perforated vibrating mem-<br>brane technology to aerosolize liq-<br>uid medications | Micro-perforated vibrating mem-<br>brane technology to aerosolize liq-<br>uid medications |
| Aerosol Direction/<br>Output | Sprayed into aerosol chamber,<br>cleared by inspiratory flow | Sprayed into aerosol chamber,<br>cleared by inspiratory flow |
| Breath Enhanced/<br>Controlled/ Triggered | Breath enhanced two-way valve<br>system. | Breath enhanced two-way valve<br>system. |
| Fluid Delivery –<br>Generator | Direct contact between aerosol head<br>and fluid in sealed chamber (medi-<br>cation reservoir). | Direct contact between aerosol head<br>and fluid in sealed chamber (medi-<br>cation reservoir). |
| Configuration | Remote (tethered) only. | Remote (tethered) only. |
| Automatic Shut-off | Yes. Automatic shut-off when:<br>(1) medication reservoir is empty;<br>(2) out-of-range parameters are de-<br>tected; or (3) programmed maxi-<br>mum operating time) is reached. | Yes. Automatic shut-off when:<br>(1) medication reservoir is empty;<br>(2) out-of-range parameters are de-<br>tected; or (3) programmed maxi-<br>mum operating time) is reached. |
| DESIGN CAPACITIES | | |
| Medication Reservoir | | |
| Min. Fill | 2.0 mL | 2.0 mL |
| Max. Fill | 6.0 mL | 6.0 mL |
| Residue | Approx. 1.0 ml residue (depending<br>on filled volume) | Approx. 1.0 ml residue (depending<br>on filled volume) |
| AEROSOL PERFORMANCE | | |
| Total Output Rate<br>(mg/min) | 619 (AVG) SD=72 | 663 (AVG) SD=60 |
| Mass Median Diameter<br>( $\mu$ m) | 4.35 (AVG) SD=0.09 | 4.37 (AVG SD=0.10 |
| Geometrical<br>Standard Deviation | 1.53 | 1.53 |
| Fine Particle Fraction<br><5 (%) | 63.56 | 63.15 |
| ELECTRICAL COMPARISON (eBase Controller) | | |
| | eBase (Round) 1st Generation | eBase (NCP) 2nd Generation |
| Mean Frequency (Hz) | 117040 | 117650 |
| Mean Power (Watts) | 1.255 | 1.253 |
| | | |
| SOFTWARE | | |
| Level of Concern | Moderate | Moderate |
| Device-Specific | Yes | Yes |
| Dependent on External<br>Devices | No | No |
| Function | By continuous loop: (1) conducts<br>power pre-processing; (2) supervis-<br>es the nebulizer's aerosol genera-<br>tion; and (3) communicates to the<br>user on the operational status of the<br>device and out-of-range parameters.<br>These functions are performed con-<br>tinuously until the medication res-<br>ervoir is empty, out-of-range pa-<br>rameters are detected, or pro-<br>grammed maximum operating time<br>(Tmax) is reached. | By continuous loop: (1) conducts<br>power pre-processing; (2) supervis-<br>es the nebulizer's aerosol genera-<br>tion; and (3) communicates to the<br>user on the operational status of the<br>device and out-of-range parameters.<br>These functions are performed con-<br>tinuously until the medication res-<br>ervoir is empty, out-of-range pa-<br>rameters are detected, or pro-<br>grammed maximum operating time<br>(Tmax) is reached. |
| Audio-Visual Signals | LED, tone sounds, and illuminated<br>display showing graphical symbols<br>concerning battery level, operation- | Tone sounds, and illuminated dis-<br>play showing graphical symbols<br>concerning battery level, operation- |
| | al status and failure mode. | al status and failure mode. |
| ELECTRICAL CONECTION | | |
| CISPR 11 Group | II | II |
| CISPR 11 Class | B | B |
| Protection Class | B-with power supply. Internally<br>powered - with batteries | B-with power supply. Internally<br>powered - with batteries |
| Liquid Protection Rating<br>(controller) | IPX0 (No Protection) | IP22 |
| Rated Supply Voltage<br>(controller) | 12V | 5V |
| Rated Input Current<br>(controller) | 300 mA | 750 mA |
| Rated Input Power<br>(Controller) | 3.6 W | 3.75 W |
| Electrical Requirement<br>(power supply) | 100V - 240V, 50 Hz/60 Hz | 100V - 240V, 50 Hz/60 Hz |
| Battery Operation | Four AA disposable or rechargeable<br>batteries | Three NiMH AA rechargeable bat-<br>tery pack |
| Frequency power for<br>vibrating mesh mem-<br>brane | 1.8w, 117 kHz | 1.8w, 117 kHz |
| NEBULIZER MATERIALS | | |
| Mouthpiece | Polypropylene | Polypropylene |
| Valve(s) | Silicone rubber | Silicone rubber |
| Aerosol chamber | Polypropylene | Polypropylene |
| Fluid feed | Polypropylene, Thermoplastic elas-<br>tomer | Polypropylene, Thermoplastic elas-<br>tomer |
| Aerosol Head | Stainless steel, ceramics, adhesive | Stainless steel, ceramics, adhesive |
| Medication Reservoir | Polypropylene, Thermoplastic elastomer | Polypropylene, Thermoplastic elastomer |
| Medication Cover | Polypropylene, POM, Thermo-plastic elastomer | Polypropylene, POM, Thermo-plastic elastomer |
| <b>MECHANICAL</b> | | |
| Weight<br>Controller, Nebulizer<br>Handset, w/Batteries | Approx. 9.5 oz. (269g) | Approx. 9.3 oz. (264g) |
| Dimensions<br>Controller | H 43.5 mm Ø 117 mm | L 157mm x W 66mm x H 22mm |
| Handset | L 145 x W 50 x H 63 mm | L 145 x W 50 x H 63 mm |
| Temperature Range | 59° to 95°F (15° – 35°C) | 59° to 95°F (15° – 35°C) |
| Humidity | 30% to 95% | 30% to 95% |
| Ambient Temperature | - 4° to 140°F (-25° – 70°C) | - 4° to 140°F (-25° – 70°C) |
| Ambient Humidity | 10% to 95% | 10% to 95% |
| <b>CLEANING / DISINFECTION</b> | | |
| Cleaning | Cleaning with detergent and water. | Cleaning with detergent and water. |
| Disinfection | Disinfection with chemical (Control III) or thermal means (boiling) | Disinfection with chemical (Control III) or thermal means (boiling) |
| Cleaning Aid | PP/TPE accessory to mechanically<br>rinse the aerosol head membrane<br>pores by means of backwashing<br>(back flushing). | PP/TPE accessory to mechanically<br>rinse the aerosol head membrane<br>pores by means of backwashing<br>(back flushing). |

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

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### eRapid NCP Nebulizer System and Predicate eRapid Nebulizer system a.

Similarities are that both the eRapid NCP and the predicate eRapid 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, microperforated 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 NCP and the predicate eRapid 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 two devices are a 2nd generation eBase controller. The redesigned eBase Controller features: (1) Different housing design with a more modern user interface, (2) Integrated rechargeable battery pack, (3) Higher resolution LCD display, (4)

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Adjustable settings for audio and visual features. In addition, The eBase NCP Controller will require a new Connection Cord and Power Supply.

Only the part of the Connection Cord that plugs into the eBase NCP Controller was modified. The other end of the Connection Cord, which is already part of the FDA-cleared device, has not been changed.

Differences from FDA-cleared device are thus confined to the new control unit, connection cord, and power supply.

# 8. Performance Data

The following performance data were provided in support of a substantial equivalence determination.

### Biocompatibility and Airpath Testing a.

The eRapid NCP Nebulizer System u…