Velox Nebulizer System

K162785 · Pari Respiratory Equipment, Inc. · CAF · Apr 14, 2017 · Anesthesiology

Device Facts

• Record ID: K162785
• Device Name: Velox Nebulizer System
• Applicant: Pari Respiratory Equipment, Inc.
• Product Code: CAF · Anesthesiology
• Decision Date: Apr 14, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

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

Device Story

Handheld, portable, reusable, single-patient electronic nebulizer; uses piezo-driven, micro-perforated vibrating membrane to aerosolize liquid medication. Input: liquid medication in reservoir. Operation: user presses on/off switch; controller sends electrical charge to aerosol head; piezo-actuator vibrates; fluid ejected through membrane as droplets; aerosol deposited into chamber. Breath-enhanced two-way valve system allows inhalation of aerosolized medication. Used in hospitals, nursing homes, sub-acute institutions, and homes. Operated by patients or caregivers. Output: aerosolized medication for inhalation. Provides optical/acoustical feedback on status and errors. Benefits: efficient delivery of prescribed respiratory medication. No pause function, breath trigger, or interrupter; continuous nebulization until reservoir empty or Tmax reached.

Clinical Evidence

Bench testing only. Aerosol characterization (next generation impaction) showed MMAD, GSD, RF, and RD comparable to predicate. Biocompatibility (ISO 10993-1), gas path analysis, electrical safety (IEC 60601-1 series), EMC (IEC 60601-1-2), and simulated use (365 nebulizations/52 disinfection cycles) confirmed device performance and safety over one-year lifetime.

Technological Characteristics

Materials: polypropylene, thermoplastic elastomer, stainless steel, piezo-ceramic, polyamide film, medical adhesives. Principle: piezo-driven micro-perforated vibrating membrane. Energy: AC power or 3x AA batteries. Form factor: handheld, integrated controller/nebulizer. Connectivity: standalone. Sterilization: non-sterile. Software: moderate level of concern, embedded control logic.

Indications for Use

Indicated for adult and pediatric patients 4 years and older who can coordinate breathing through a mouthpiece, for whom doctors have prescribed medication for nebulization.

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)

Reference Devices

• Philips Respironics I-Neb AAD System (K042991)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 14, 2017

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

Re: K162785

Trade/Device Name: Velox Nebulizer System Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: Class II Product Code: CAF Dated: March 8, 2017 Received: March 8, 2017

Dear Mr. 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. 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 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

# Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Indications for Use

510(k) Number (if known) K162785

Device Name Velox Nebulizer System

#### Indications for Use (Describe)

The Velox Nebulizer System is a handheld nebulizer that is to be used with patients for whom doctors have prescribed medication for nebulization. It is intended for adult and pediatric patients 4 years and older who can coordinate breathing through a mouthpiece, and may be used in 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)

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# SECTION 6: 510(K) SUMMARY

#### 1. Submitter

PARI Respiratory Equipment, Inc. 2412 PARI Way Midlothian, Virginia 23112

Phone: [phone] Fax:

Contact Person: Mike Judge x 269 Date Prepared: September 15, 2016

#### 2. Device Name

| Name of Device: | Velox™ Nebulizer System |
|-----------------------|-------------------------------------------------------|
| Common or Usual Name: | Nebulizer |
| Classification Name: | Nebulizer, Direct Patient Interface (21 CFR 868.5630) |
| Regulatory Class: | II |
| Product Code: | CAF |

There are no other variants or model numbers of this device.

#### 3. Legally Marketed Predicate Device

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

### a. Primary Predicate Device

eRapid® Nebulizer System, K112859

Additionally, the Philips Respironics I-Neb AAD System, cleared under K042991, is used in this 510(k) submission as a reference device.

#### Device Description 4.

The Velox Nebulizer System is a portable, reusable, single-patient use, handheld electronic nebulizer that uses a piezo-driven, micro-perforated vibrating membrane technology to aerosolize liquid medications for the treatment or prophylaxis of respiratory diseases. It is to be used with adult and pediatric patients for whom doctors have prescribed medication, i.e. it is for prescription use only. It may be used in hospital-type facilities, nursing homes, sub-acute institutions and home environments. It is provided non-sterile.

The device consists of two major components. One of these components is the nebulizer itself, which has the following materials in its construction: (1) polypropylene: (2); thermoplastic elastomer; (3) stainless steel; (4) piezo-ceramic; (5) capton; and, (6) medical grade adhesives. It contains, as subcomponents, the following: (1) a medication cap, (2) a medication reservoir, (3) an aerosol head, (4) an aerosol chamber; and, (5) a mouthpiece.

The second major component is a Controller that is attached to the Nebulizer for its operation. This component, the body of which is constructed of acrylonitrile butadiene styrene and thermoplastic elastomer, has the following principal internal subcomponents: (1)

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a circuit board: (2) a USB connector: (3) a patient interface (on/off switch); and (4) AA battery housing.

The controller's functions are to; (1) conduct power pre-processing; (2) supervise, through incorporated software, the nebulizer's aerosol generation; and, (3) generate optical and acoustical feedback to the user on nebulization status and out-of-range parameters.

The incorporated software is device-specific and: (1) controls the power to the aerosol head, i.e., either to have the aerosol head active and generate aerosol, or shut-off; (2) controls optical and acoustical feedback to the user; and; (3) is not dependent for its operation on any external devices, such as a monitor, printer, keyboard or mouse.

Energy sources for the device are provided by: (1) connection to a mains power source, via an AC Power Supply; or. (2) disposable/rechargeable AA batteries.

The device has two associated accessories: (1) a cleaning aid, branded VELOXcare, that assists in debris removal from the membrane prior to cleaning; and, as heretofore noted. (2) an AC Power Supply to provide mains power to the device when desired or required.

#### Mechanism of Action 5.

The Velox Nebulizer System's mode of action is permanent, i.e., once the on/off switch is on the controller pressed, permanent nebulization occurs until the medication is nebulized. There is no pause function. Further, there is no breath trigger or interrupter.

Nebulization is accomplished as follows. When the on/off button is pressed the controller sends an electrical charge to the aerosol head in the nebulizer. The charge alternation causes the piezo-actuator to vibrate. Vibration motion then builds up a positive pressure in the boundary layer of the liquid column, ejecting the fluid through the holes as droplets and creating the aerosol on the front side of the membrane. This aerosol is deposited vertically into the aerosol chamber. Once in the chamber it is available for inhalation by the patient.

The inhalation is via a breath-enhanced two-way valve system. During inhalation the inhalation valves open to allow fresh air to enter the aerosol chamber. This inhaled fresh air stream, takes the aerosolized medication, with minimum depositional loss, through the mouthpiece into the patient's respiratory tract. Note that, during inhalation, the exhalation valve on the mouthpiece is closed, preventing any aerosol dilution on its way to the patient. During exhalation, the inhalation valves close and the exhalation valve opens, driving the expired air out of the mouthpiece.

#### 6. Indications for Use

The Velox Nebulizer System is a handheld nebulizer that is to be used with patients for whom doctors have prescribed medication for nebulization. It is intended for adult and pediatric patients 4 years 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.

The foregoing statement for the subject device is identical to that of the predicate eRapid® device (with the exception of the "4 years and older who can coordinate breathing through a mouthpiece" restriction. The indications are substantially equivalent; the subject device indication statement simply provides a quantification of patient age, and clarification of the patient's breathing

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coordination ability at that age). Further, both the subject and predicate device have the same intended use.

#### Comparison of Technological Characteristics with the Predicate Device 7.

# Table 1. Substantial Equivalence Comparison

| PRODUCT | VELOX NEBULIZER<br>SYSTEM | ERAPID NEBULIZER<br>SYSTEM |
|----------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DEVICE | CAF, Nebulizer (direct patient interface), | CAF, Nebulizer (direct patient interface), |
| CLASSIFICATION | 21 CFR 868.5630 | 21 CFR 868.5630 |
| 510K NO. | n/a | K112859 |
| MANUFACTURER<br>(REG. NO.) | PARI Respiratory Equipment, Inc. (2954963) | PARI Respiratory Equipment, Inc. (2954963) |
| INTENDED USE | The Velox is a handheld nebulizer that will be<br>used with patients for whom doctors have<br>prescribed medication for nebulization. | The eRapid is a handheld nebulizer that will be used<br>with patients for whom doctors have prescribed<br>medication for nebulization. |
| Environment of use | Home care, nursing home, sub-acute institution, or<br>hospital | Home care, nursing home, sub-acute institution, or<br>hospital |
| Target Population | Adult and pediatric patients 4 years and older who<br>can coordinate breathing through a mouthpiece | Adult and pediatric |
| Prescription Use | Rx Only | Rx Only |
| METHOD OF OPERATION | | |
| Technology Used | Micro-perforated vibrating membrane technology:<br>active, vibrating membrane | Micro-perforated vibrating membrane technology:<br>active, vibrating membrane |
| Aerosol<br>Direction/Output | Vertically sprayed into aerosol chamber, cleared<br>by inspiratory flow | Horizontally sprayed into aerosol chamber, cleared<br>by inspiratory flow |
| Breath Enhanced/<br>Controlled/<br>Triggered | Breath enhanced two-way valve system.<br>Permanent nebulization - no breath trigger or<br>control. | Breath enhanced two-way valve system. Permanent<br>nebulization - no breath trigger or control. |
| Fluid Delivery -<br>Generator | Direct contact between aerosol head and fluid in<br>sealed chamber (medication reservoir). | Direct contact between aerosol head and fluid in<br>sealed chamber (medication reservoir). |
| Configuration | Controller component is connected directly to the<br>nebulizer component. No connection cord for<br>operation. | Nebulizer and controller are separate components,<br>joined by a connection cord for operation. |
| Automatic Shut-off | Yes. Automatic shut-off when: (1) medication<br>reservoir is empty; (2) out-of-range parameters<br>are detected; or (3) programmed maximum<br>operating time) is reached. | Yes. Automatic shut-off when: (1) medication<br>reservoir is empty: (2) out-of-range parameters are<br>detected; or (3) programmed maximum operating<br>time) is reached. |
| PRODUCT | VELOX NEBULIZER<br>SYSTEM | ERAPID NEBULIZER<br>SYSTEM |
| DESIGN CAPACITIES | | |
| Medication Reservoir | 2.0 mL | 2.0 mL |
| Min. Fill | 6.0 mL | 6.0 mL |
| Max. Fill | Approx. 1.0 ml residue (depending on filled | Approx. 1.0 ml residue (depending on filled volume) |
| Residue | volume) | |
| PERFORMANCE | | |
| MMAD | Mass Median Aerodynamic Diameter of subject device is slightly lower than that of eRapid. | |
| GSD | Geometric Standard Deviation of subject device is substantially equivalent to that of eRapid | |
| RF | Respirable Fraction of subject device is slightly higher than that of eRapid | |
| RD | Respirable Dose of subject device is substantially equivalent to that of eRapid | |
| SOFTWARE | | |
| Level of Concern | Moderate | Moderate |
| Device-Specific | Yes | Yes |
| Dependent on<br>External Devices | No | No |
| Function | By continuous loop: (1) conducts power pre-<br>processing; (2) supervises the nebulizer's aerosol<br>generation; and (3) communicates to the user on<br>the operational status of the device and out-of-<br>range parameters. These functions are performed<br>continuously until the medication reservoir is<br>empty, out-of-range parameters are detected, or<br>programmed maximum operating time (Tmax) is<br>reached. | By continuous loop: (1) conducts power pre-<br>processing; (2) supervises the nebulizer's aerosol<br>generation; and (3) communicates to the user on the<br>operational status of the device and out-of-range<br>parameters. These functions are performed<br>continuously until the medication reservoir is empty,<br>out-of-range parameters are detected, or<br>programmed maximum operating time (Tmax) is<br>reached. |
| | It should be noted however, that, unlike the<br>predicate device's software, the subject device's<br>software has: (1) no integral pause function that<br>enables treatment interruption for user<br>convenience; and, (2) no separate cleaning aid<br>mode that allows the user to operate a cleaning<br>aid. | It should be noted however, that the predicate<br>device's software has: (1) an integral pause function<br>that enables treatment interruption for user<br>convenience; and, (2) a separate cleaning aid mode<br>that allows the user to operate a cleaning aid. |
| Audiovisual Signals | LED and tone sounds concerning battery level,<br>operational status and failure mode. | LED, tone sounds and illuminated display showing<br>graphical symbols concerning battery level,<br>operational status and failure mode. |
| ELECTRICAL CONNECTION | | |
| PRODUCT | VELOX NEBULIZER<br>SYSTEM | ERAPID NEBULIZER<br>SYSTEM |
| Power Wattage | < 2.0 W under normal load | < 2.0 W under normal load |
| AC Power Supply | | |
| Input | 100-240 VAC / 50-60 Hz | 100-240 VAC / 50-60 Hz |
| Output | 5 V | 12 V |
| Battery Operation | | |
| AA Disposable | 3 x 1.5 V | 4 x 1.5 V |
| AA Rechargeable | 3 x 1.2 V | 4 x 1.2 V |
| Classification<br>According To IEC<br>60601 - 1 | | |
| Type of electric shock<br>protection (AC Power<br>Supply) | Protection Class II | Protection Class II |
| Degree of protection<br>from electric shock of<br>the part used<br>(nebulizer) | Type BF | Type BF |
| Degree of protection<br>against water ingress<br>in accordance with EN<br>60529 (IP rating) | IP-22 | No protection |
| Degree of protection<br>when used in the<br>presence of flammable<br>mixtures of<br>anesthetics with air,<br>with oxygen, or with<br>nitrous oxide | No protection | No protection |
| Operating Mode | Continuous operation | Continuous operation |
| NEBULIZER MATERIALS | | |
| Medication Cap | PP, TPE | PP, POM, TPE |
| Medication Reservoir | PP, TPE | – |
| Fluid Feed | N/A | PP, TPE |
| Headmount | N/A | PP, stainless steel |
| Housing | PP, TPE | N/A |
| Aerosol Head | Stainless steel, piezoceramic,<br>polyamide film, adhesive | Stainless steel, piezoceramic, polyamide film,<br>adhesive |
| PRODUCT | VELOX NEBULIZER<br>SYSTEM | ERAPID NEBULIZER<br>SYSTEM |
| Inhalation Valve | TPE | Silicone |
| Aerosol chamber | PP | PP |
| Mouthpiece | PP | PP |
| Exhalation Valve | TPE | Silicone |
| MECHANICAL | | |
| Dimensions | | |
| Nebulizer (L /W /H) | 145 x 61 x 65 mm | 145 x 50 x 63 mm |
| Controller (H /Ø) | 70 x 61 x 92 mm | 40 mm x Ø 116 mm |
| Weight (approx.) | | |
| Handset w/o med. | 45g | 55g |
| System w/batt. | 285g | 300g |
| CLEANING / DISINFECTION |…