(193 days)
No
The description focuses on the mechanical and electronic components of the nebulizer and controller, including a circuit board and incorporated software for supervising aerosol generation and providing feedback. There is no mention of AI, ML, or any learning or adaptive capabilities. The performance studies are standard tests for medical devices of this type (biocompatibility, electrical safety, aerosol characterization, etc.) and do not suggest the use of AI/ML.
Yes
The device is described as a nebulizer used to aerosolize liquid medications for the treatment or prophylaxis of respiratory diseases, indicating a direct therapeutic purpose.
No
Explanation: The device, the Velox Nebulizer System, is described as a treatment device that aerosolizes liquid medications for the treatment or prophylaxis of respiratory diseases. It does not perform any diagnostic function.
No
The device description clearly states it is a "handheld electronic nebulizer" and consists of two major hardware components: the nebulizer and a Controller, which contains a circuit board, USB connector, patient interface, and battery housing. Performance studies also include hardware-specific testing like electrical safety, EMC, and mechanical testing.
Based on the provided information, the Velox Nebulizer System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Definition of IVD: An IVD device is used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Velox Nebulizer System's Function: The Velox Nebulizer System is a device that aerosolizes liquid medications for inhalation. It delivers medication to the respiratory tract.
- Intended Use: The intended use clearly states it's for delivering prescribed medication to patients for respiratory diseases. It does not involve analyzing biological specimens.
The device's function is to administer treatment, not to perform diagnostic testing on biological samples.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
CAF
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. 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) 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult and pediatric patients 4 years and older
Intended User / Care Setting
used with patients for whom doctors have prescribed medication
hospital-type facilities, nursing homes, sub-acute institutions and home environments.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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:
- Ozone Gas Analysis
- Carbon Monoxide and Carbon Dioxide Gas Analysis
- Volatile Organic Compounds Analysis
- 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 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 cycles. 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:
-
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. -
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
eRapid® Nebulizer System, K112859
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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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)
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: 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 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)
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 NEBULIZER
SYSTEM | ERAPID NEBULIZER
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
(REG. NO.) | PARI Respiratory Equipment, Inc. (2954963) | PARI Respiratory Equipment, Inc. (2954963) |
| INTENDED USE | The Velox is a handheld nebulizer that will be
used with patients for whom doctors have
prescribed medication for nebulization. | The eRapid is a handheld nebulizer that will be used
with patients for whom doctors have prescribed
medication for nebulization. |
| Environment of use | Home care, nursing home, sub-acute institution, or
hospital | Home care, nursing home, sub-acute institution, or
hospital |
| Target Population | Adult and pediatric patients 4 years and older who
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:
active, vibrating membrane | Micro-perforated vibrating membrane technology:
active, vibrating membrane |
| Aerosol
Direction/Output | Vertically sprayed into aerosol chamber, cleared
by inspiratory flow | Horizontally sprayed into aerosol chamber, cleared
by inspiratory flow |
| Breath Enhanced/
Controlled/
Triggered | Breath enhanced two-way valve system.
Permanent nebulization - no breath trigger or
control. | Breath enhanced two-way valve system. Permanent
nebulization - no breath trigger or control. |
| Fluid Delivery -
Generator | Direct contact between aerosol head and fluid in
sealed chamber (medication reservoir). | Direct contact between aerosol head and fluid in
sealed chamber (medication reservoir). |
| Configuration | Controller component is connected directly to the
nebulizer component. No connection cord for
operation. | Nebulizer and controller are separate components,
joined by a connection cord for operation. |
| 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. |
| PRODUCT | VELOX NEBULIZER
SYSTEM | ERAPID NEBULIZER
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
External Devices | No | No |
| Function | By continuous loop: (1) conducts power pre-
processing; (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 pre-
processing; (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. |
| | It should be noted however, that, unlike the
predicate device's software, the subject device's
software has: (1) no integral pause function that
enables treatment interruption for user
convenience; and, (2) no separate cleaning aid
mode that allows the user to operate a cleaning
aid. | It should be noted however, that the predicate
device's software has: (1) an integral pause function
that enables treatment interruption for user
convenience; and, (2) a separate cleaning aid mode
that 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 showing
graphical symbols concerning battery level,
operational status and failure mode. |
| ELECTRICAL CONNECTION | | |
| PRODUCT | VELOX NEBULIZER
SYSTEM | ERAPID NEBULIZER
SYSTEM |
| Power Wattage |