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 Description

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: the nebulizer and a Controller. The nebulizer contains a medication cap, medication reservoir, aerosol head, aerosol chamber, and mouthpiece. The Controller contains a circuit board, USB connector, patient interface (on/off switch), and AA battery housing. The controller's functions are to conduct power pre-processing, supervise aerosol generation through incorporated software, and generate optical and acoustical feedback to the user. The device is powered by connection to a mains power source via an AC Power Supply or disposable/rechargeable AA batteries. Associated accessories include a cleaning aid and an AC Power Supply.

AI/ML Overview

The provided text describes the regulatory clearance of a medical device (Velox Nebulizer System) and does not contain information about an AI/ML powered device. Therefore, it is impossible to extract the requested information regarding acceptance criteria and study details for an AI/ML powered device.

The document is a 510(k) premarket notification for a nebulizer, a physical medical device. The "Software Verification and Validation Testing" section mentions that the software for this device is of a "moderate" level of concern and controls basic functions of the nebulizer (power, aerosol generation, user feedback) but there is no indication that it uses AI or machine learning algorithms for its operation or for diagnostic purposes.

Therefore, I cannot provide the detailed information requested for an AI/ML powered device, such as effect size of human readers improving with AI, standalone performance, or details about ground truth establishment for AI/ML models.

Summary

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three figures in profile facing right.

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.

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

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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

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

Indications for Use

510(k) Number (if known) K162785

Device Name Velox Nebulizer System

Indications for Use (Describe)

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 PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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

SECTION 6: 510(K) SUMMARY

1. Submitter

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

Phone: 804-253-7274 804-253-0260 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 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)

{4}------------------------------------------------

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

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

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 NEBULIZERSYSTEM	ERAPID NEBULIZERSYSTEM
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(REG. NO.)	PARI Respiratory Equipment, Inc. (2954963)	PARI Respiratory Equipment, Inc. (2954963)
INTENDED USE	The Velox is a handheld nebulizer that will beused with patients for whom doctors haveprescribed medication for nebulization.	The eRapid is a handheld nebulizer that will be usedwith patients for whom doctors have prescribedmedication for nebulization.
Environment of use	Home care, nursing home, sub-acute institution, orhospital	Home care, nursing home, sub-acute institution, orhospital
Target Population	Adult and pediatric patients 4 years and older whocan coordinate breathing through a mouthpiece	Adult and pediatric
Prescription Use	Rx Only	Rx Only
METHOD OF OPERATION
Technology Used	Micro-perforated vibrating membrane technology:active, vibrating membrane	Micro-perforated vibrating membrane technology:active, vibrating membrane
AerosolDirection/Output	Vertically sprayed into aerosol chamber, clearedby inspiratory flow	Horizontally sprayed into aerosol chamber, clearedby inspiratory flow
Breath Enhanced/Controlled/Triggered	Breath enhanced two-way valve system.Permanent nebulization - no breath trigger orcontrol.	Breath enhanced two-way valve system. Permanentnebulization - no breath trigger or control.
Fluid Delivery -Generator	Direct contact between aerosol head and fluid insealed chamber (medication reservoir).	Direct contact between aerosol head and fluid insealed chamber (medication reservoir).
Configuration	Controller component is connected directly to thenebulizer component. No connection cord foroperation.	Nebulizer and controller are separate components,joined by a connection cord for operation.
Automatic Shut-off	Yes. Automatic shut-off when: (1) medicationreservoir is empty; (2) out-of-range parametersare detected; or (3) programmed maximumoperating time) is reached.	Yes. Automatic shut-off when: (1) medicationreservoir is empty: (2) out-of-range parameters aredetected; or (3) programmed maximum operatingtime) is reached.
PRODUCT	VELOX NEBULIZERSYSTEM	ERAPID NEBULIZERSYSTEM
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 onExternal Devices	No	No
Function	By continuous loop: (1) conducts power pre-processing; (2) supervises the nebulizer's aerosolgeneration; and (3) communicates to the user onthe operational status of the device and out-of-range parameters. These functions are performedcontinuously until the medication reservoir isempty, out-of-range parameters are detected, orprogrammed maximum operating time (Tmax) isreached.	By continuous loop: (1) conducts power pre-processing; (2) supervises the nebulizer's aerosolgeneration; and (3) communicates to the user on theoperational status of the device and out-of-rangeparameters. These functions are performedcontinuously until the medication reservoir is empty,out-of-range parameters are detected, orprogrammed maximum operating time (Tmax) isreached.
	It should be noted however, that, unlike thepredicate device's software, the subject device'ssoftware has: (1) no integral pause function thatenables treatment interruption for userconvenience; and, (2) no separate cleaning aidmode that allows the user to operate a cleaningaid.	It should be noted however, that the predicatedevice's software has: (1) an integral pause functionthat enables treatment interruption for userconvenience; and, (2) a separate cleaning aid modethat allows the user to operate a cleaning aid.
Audiovisual Signals	LED and tone sounds concerning battery level,operational status and failure mode.	LED, tone sounds and illuminated display showinggraphical symbols concerning battery level,operational status and failure mode.
ELECTRICAL CONNECTION
PRODUCT	VELOX NEBULIZERSYSTEM	ERAPID NEBULIZERSYSTEM
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
ClassificationAccording To IEC60601 - 1
Type of electric shockprotection (AC PowerSupply)	Protection Class II	Protection Class II
Degree of protectionfrom electric shock ofthe part used(nebulizer)	Type BF	Type BF
Degree of protectionagainst water ingressin accordance with EN60529 (IP rating)	IP-22	No protection
Degree of protectionwhen used in thepresence of flammablemixtures ofanesthetics with air,with oxygen, or withnitrous 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,polyamide film, adhesive	Stainless steel, piezoceramic, polyamide film,adhesive
PRODUCT	VELOX NEBULIZERSYSTEM	ERAPID NEBULIZERSYSTEM
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
Cleaning	Cleaning with detergent and water.	Cleaning with detergent and water.
Disinfection	Disinfection with chemical (Control III) or thermalmeans (boiling).	Disinfection with chemical (Control III) or thermalmeans (boiling or autoclaving).
Cleaning Aid	PP/TPE accessory to mechanically rinse theaerosol head membrane pores by means ofbackwashing (back flushing). Device unique - notinterchangeable with other PRE vibrationaltechnology devices.	PP/TPE accessory to mechanically rinse the aerosolhead membrane pores by means of backwashing(back flushing). Interchangeable with other PREvibrational technology devices.

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

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

{8}------------------------------------------------

a. Velox and Primary Predicate eRapid

Similarities are that both the Velox 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, 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 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, (2) disposable/rechargeable AA batteries.

{9}------------------------------------------------

Both the Velox 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, permanent 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.

System design and mode of action differ. Relative to design the Velox: (1) has fewer separate Nebulizer operating parts than those of the predicate eRapid; (2) has no connection cord linking its controller and nebulizer, as is the case with the predicate eRapid; (3) the direction of generated spray from the aerosol head to the aerosol chamber is vertical in the Velox, as opposed to horizontal in the predicate eRapid; and, (4) because the Velox's nebulization is fairly rapid, it has no pause function like that in the eRapid.

8. Performance Data

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

a. Biocompatibility Testing

The nebulizer's medication reservoir, aerosol head and tubing from the cup to the mouthpiece (aerosol chamber and inside of the mouthpiece) are permanent exposure, external-communicating devices (tissues, bone, dentin). The outside of the mouthpiece is a permanent exposure, surface-mucosal membrane contact component.

A biocompatibility evaluation for the Velox device was conducted in accordance with FDA's 2016 Guidance entitled, "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The evaluation included the following tests: (1) In-Vitro Cytotoxicity, (2) Genotoxicity; (3) Implantation; (4) Irritation/Intracutaneous Reactivity; and, (5) Skin Sensitization/Delayed Type Hypersensitivity.

Under the parameters of the tests it is concluded that they are biocompatible, and that there are no new issues of safety regarding their use as intended.

Gas Path Testing

The emitted air quality of the PARI Velox device was evaluated to determine whether it may produce potentially harmful gases, VOCs, or particulates, as follows:

1. Ozone Gas Analysis
1. Carbon Monoxide and Carbon Dioxide Gas Analysis
1. Volatile Organic Compounds Analysis
1. Particular Matter Analysis (EPA PM2.5)

All air quality tests concluded that the subject device meets applicable standards and does not introduce new issues of safety pertaining to emitted air.

b. Electrical Safety and Electromagnetic Compatibility (EMC)

Electrical safety and EMC testing were conducted on the device's controller and AC power supply. Testing establishes that, with respect to electrical safety, the Velox meets

{10}------------------------------------------------

the applicable requirements of: (1) IEC 60601-1; (2) IEC 60601-1-6; (3) IEC 60601-1-11; and (4) IEC 62366. Further, EMC testing establishes that the Velox Nebulizer System and AC Power Supply meet the applicable requirements of IEC 60601-1-2:2007.

c. Software Verification and Validation Testing

Verification and validation testing was conducted in accordance with, and documentation was provided as recommended by FDA's Guidance 337, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". The software for this device is of a "moderate" level of concern, since a failure or latent flaw in the software could lead to a delay in delivery of appropriate medical care.

d. Aerosol Characterization

An aerosol characterization (particle size distribution) by next generation impaction was made with the Velox and the eRapid predicate. With respect to aerosol performance the Velox's: (1) MMAD was slightly lower than that of the predicate eRapid; (2) GSD was very similar to that of the predicate eRapid; (3) RF (Respirable Fraction) was slightly higher than that of the predicate eRapid; and, (4) RD (Respirable Dose) was very similar compared to that of the predicate eRapid.

e. Simulated Use Test

Testing was made to determine if the Velox remained within specification over its envisioned lifetime usage of one year, using 365 nebulizations and 52 weekly disinfection cvcles. The testing concluded that the device remained within those specifications and the nebulizer could be cleaned and disinfected effectively by use of the methods stated in the IFU.

f. Mechanical Testing

1) Packaging Drop Test

A drop test was performed, based on EN/ISO 2248:1985, Complete, filled transport packages— Vertical impact test by dropping, to determine that the design and strength of the Velox Nebulizer System sales/transport packaging is sufficient for transport, storage and sales. The testing concluded that the packaging is satisfactory for the envisioned uses.

2) Environmental Conditions Test

An environmental conditions test was conducted in order to define the device's optimal operating conditions of temperature and relative humidity for incorporation into the IFU. The testing established these environmental conditions.

g. Cleaning and Disinfection Validation

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.

{11}------------------------------------------------

9. Conclusion

Based upon the foregoing the Velox™ Nebulizer System is substantially equivalent to the eRapid Nebulizer System, which is a legally marketed predicate device. As heretofore noted the Velox's indications for use and intended use are substantially equivalent to the predicate device. Further, the performance testing and comparison show that this device is as safe and as effective as the predicate device.

Regulation Number and Section

§ 868.5630 Nebulizer.

(a)
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.(b)
Classification. Class II (performance standards).