I-NEB AAD SYSTEM
Device Facts
| Record ID | K042991 |
|---|---|
| Device Name | I-NEB AAD SYSTEM |
| Applicant | Profile Therapeutics Plc |
| Product Code | CAF · Anesthesiology |
| Decision Date | Sep 23, 2005 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5630 |
| Device Class | Class 2 |
| Attributes | Therapeutic, Pediatric |
Indications for Use
The intended purpose of the I-neb AAD System is that is it is an ultrasonic (vibrating mesh) nebulizer system designed to aerosolize liquid medication approved for use with the I-neb AAD System for inhalation by the patient in the home care, nursing home, sub-acute institution, or hospital environment.
Device Story
Portable, reusable, ultrasonic (vibrating mesh) nebulizer for liquid medication delivery. Input: patient breathing pattern via pressure transducer. Operation: microprocessor analyzes breathing; vibrating horn forces liquid through porous mesh to create aerosol; Adaptive Aerosol Delivery (AAD) technology pulses aerosol only during patient inspiration. Output: aerosolized medication delivered via mouthpiece. Used in home, nursing home, sub-acute, or hospital settings; operated by patient. Healthcare provider uses device to ensure targeted drug delivery; output affects clinical decision-making by optimizing medication deposition based on individual breathing patterns. Benefits: improved treatment efficiency, reduced treatment times, and visual feedback via LCD display.
Clinical Evidence
No clinical data provided. Substantial equivalence is based on bench testing and technological comparison to legally marketed predicate devices.
Technological Characteristics
Ultrasonic vibrating mesh nebulizer; 180 kHz frequency. Materials: Polycarbonate mouthpiece, Platinum porous mesh, Titanium ultrasonic horn. Power: 3.8V internal rechargeable Lithium battery or mains. Features: pressure transducer for breath-actuation, microprocessor for pulse timing, LCD graphic display, RF transponder disc for operational settings. Clean, non-sterile delivery.
Indications for Use
Indicated for patients requiring nebulized drug delivery, including adults and children age 2 years and older who can coordinate breathing into a mouthpiece.
Regulatory Classification
Identification
A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.
Predicate Devices
Submission Summary (Full Text)
{0}------------------------------------------------
SEP 2 3 2005
I-neb AAD System 510(k) Premarket Notification Section 3
Image /page/0/Picture/2 description: The image shows the Resprionics logo. The logo consists of a triangle with a stylized figure inside, followed by the word "RESPIRONICS" in a bold sans-serif font. Below the logo is the website address "www.resprionics.com".
### Non-Confidential Summary of Safety and Effectiveness Section 3
| Proprietary or Trade Name: | I-neb AAD System |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Common / Usual Name: | Ultrasonic (vibrating mesh) Nebulizer |
| Classification Name: | Nebulizer, Direct Patient Interface |
| Official Contact: | Barbara Campbell<br>Vice President, Corporate QA/RA<br>Respironics Inc, Corporate Services<br>1010 Murry Ridge Lane<br>Murrysville, PA 15668-8525 |
| Predicate Devices: | Prodose AAD System, K030747<br>Halolite AAD System K991685<br>NeU04 K923024 |
# Device Description
The I-neb AAD system is a portable, single patient use, reusable, ultrasonic (vibrating mesh) nebulizer system designed to aerosolize liquid medication approved for use with the I-neb AAD System for inhalation by the patient in the home care, nursing home, sub-acute institution, or hospital environment.
The I-neb AAD system consists of a hand-piece containing:-
- an ultrasonic horn (to vibrate the mesh) .
- a pressure transducer, (to monitor patient breathing) .
- a microprocessor (to calculate aerosol pulse time based on breathing pattern) ●
- a medication chamber (to hold the medication) .
- a porous mesh (to create aerosol and determine particle size). .
- a mouthpiece, which includes a bi-directional flap valve (to guide aerosol to the patient) .
- a disc, which has a bi-directional, inductively coupled, Rf transponder (to enable fine . tuning operational parameters to be sent to the device).
The I-neb AAD system incorporates the vibrating mesh technology developed and utilized in Omron's ultrasonic nebulizers, and the Adaptive Aerosol Delivery (AAD) technology developed and utilized by Profile's AAD system jet nebulizers.
und damesed by I 1011-07-11 been developed by Profile in collaboration with Omron Healthcare (Japan).
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image is a logo for Respironics. The logo features a triangle shape with a stylized figure inside. Below the triangle is the word "RESPIRONICS" in a sans-serif font. Underneath the company name is the website address, "www.respironics.com."
The vibrating mesh technology creates a low velocity aerosol by squeezing the liquid medication through 5-6,000 separate 3 micron holes during each vibration, creating thousands of droplets. the AAD technology is based on sensitive pressure transducers, microprocessors and firmware which together analyses a patient's breathing pattern and determines the appropriate aerosol wilse time to ensure that medication is only delivered during patient inspiration. The length of each pulse of aerosol is calculated based on the measured inspiration time of the r ne single or breaths and the I-neb continues to monitor the breathing pattern throughout provious into creatis any changes in the breathing pattern. When the appropriate dose of medication has been delivered, the system indicates that the treatment is complete.
# 1. Intended use
The intended purpose of the I-neb AAD System is that is it is an ultrasonic (vibrating mesh) The Intended parpose or an aerosolize liquid medication approved for use with the I-neb AAD System for inhalation by the patient in the home care, nursing home, sub-acute institution, or hospital environment.
# 2. Environment of Use -
Home care, nursing home, sub-acute institutions or hospital.
# 3. Patient Population -
Patients requiring nebulized drug delivery, adults and children age 2 years upwards who can coordinate breathing into a mouthpiece..
| Comparison to Other Legally Marketed Predicate Devices | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | A M S A S C S S S C S S S C S S S C S S S C S S S C S S S C S S S C F C S S S C F C S S . C . C . C . C . C |
The following comparison table details the primary attributes of the intended device and the legally marketed predicate devices. The most significant attributes have been listed.
| Attribute<br>Use | Prodose<br>K030747 | Halolite<br>K991685 | NeU04<br>K923024 | I-neb |
|---------------------------------------------------------------------------|--------------------|---------------------|------------------|-------|
| Small Volume Nebulizer | Yes | Yes | Yes | Yes |
| Intended to nebulize drugs | Yes | Yes | Yes | Yes |
| Jet Nebulizer | Yes | Yes | No | No |
| Ultrasonic Nebulizer | No | No | Yes | Yes |
| Synchronized Delivery of<br>Nebulized drug | Yes | Yes | No | Yes |
| Drug Delivery on demand | Yes | Yes | No | Yes |
| Used in hospitals, home<br>care, nursing home, sub-<br>acute institutions | Yes | Yes | Yes | Yes |
{2}------------------------------------------------
I-neb AAD System 510(k) Premarket Notification
Section 3
Image /page/2/Picture/1 description: The image is a logo for Respironics. The logo features a stylized human figure inside of a triangle. Below the figure is the word "RESPIRONICS" in a sans-serif font, and below that is the website address "www.respironics.com".
Yes
:
Single Patient reusable
:
Yes
Yes
Yes
:
{3}------------------------------------------------
# 1-neb AAD System
510(k) Premarket Notification
Section 3 Section 3
Image /page/3/Picture/1 description: The image shows the logo for Respironics. The logo features a stylized figure inside of a triangle above the word "RESPIRONICS". Below the company name is the website address, www.respironics.com.
| Attribute<br>Design | Prodose<br>K030747 | Halolite<br>K991685 | NeU04<br>K923024 | I-neb |
|---------------------------------------------------------------------------|-----------------------|-----------------------|-----------------------|-----------------------|
| LCD Display | Yes | Yes | No | Yes |
| Software Driven | Yes | Yes | Yes | Yes |
| Mode of Operation | Breath<br>Activated | Breath<br>Activated | Constant<br>Output | Breath<br>Activated |
| Drug delivery triggered by | Patient<br>Inhalation | Patient<br>Inhalation | Constant<br>Output | Patient<br>Inhalation |
| Maximum Pulse time | 5 Seconds | 0.5 Seconds | N/A | 5 Seconds |
| Used with Mouthpiece | Yes | Yes | No | Yes |
| Used with a Mask | No | No | Yes | No |
| Power Supply | Mains Only | Battery &<br>Mains | Battery &/or<br>Mains | Battery &/or<br>Mains |
| RF Disc | Yes | No | No | Yes |
| Materials | | | | |
| Materials in Contact with<br>Patient | Polycarbonate | Polycarbonate | Rabalon | Polycarbonate |
| Packaging | | | | |
| Provided clean, non-sterile | Yes | Yes | Yes | Yes |
| Performance Standards /<br>Specifications Applicable<br>under Section 514 | No | No | No | No |
{4}------------------------------------------------
Image /page/4/Picture/1 description: The image shows the logo for Respironics. The logo consists of a triangle shape with a stylized human figure inside, followed by the word "RESPIRONICS" in a bold, sans-serif font. Below the company name is the website address, "www.respironics.com".
# Differences Between Other Legally Marketed Predicate Devices
The main differences between the intended device, I-neb AAD System, and the predicate device Prodose AAD System are -
- 1. I-neb AAD system utilises a high frequency vibrating horn and porous mesh to generate 1-neo ATD System atinodose AAD System utilises a pneumatic concentric jet and baffle system to generate aerosol.
- 2. The I-neb and Prodose AAD Systems use the same user interface i.e. a disc containing a The I-new and I romono der chip. In Prodose this disc transmits a pre-set drug dose to the handset as well as other operational settings. In I-Nneb, the disc does not control the drug dose but does transmit other operational settings.
Note:- The same programmed disc can be used to operate both I-neb and Prodose
- 3. The dose of drug delivered by the I-neb AAD system is controlled by the medication chamber volume rather than a programmed value in the disc.
- 4. The I-neb AAD system is a portable, battery powered device. The Prodose AAD System is a mains powered device that should not be used outside.
Note:- The I-neb AAD system can be operated via a mains power supply as an alternative to using battery power.
- 5. The Prodose handpiece is powered by an internally created DC supply from the 115v mains power supply unit. The I-neb handpiece has an internal 3.8-volt Lithium rechargeable battery.
- 6. The firmware in the I-neb AAD system also unlimited treatments from a single disc, whereas the Prodose AAD System firmware only permitted the number of treatments programmed onto the disc (maximum 256).
There are no other differences between the I-neb device and the predicate Prodose device, which would be significant to patient safety or effectiveness.
The main differences between the new device, I-neb AAD System and the predicate device Halolite AAD System are -
- 1. The I-neb AAD System provides a user-friendly LCD graphic display to show visual information such as "treatment completed", "message codes" "battery power level" and mountation as " as "treawith the flashing LED lights used in Halolite AAD System for visual feedback.
- 2. The I-neb AAD System user interface is a micro-processor disc. This permits the I-neb device to be supplied with information stored in the disc rather than relying on users
{5}------------------------------------------------
Image /page/5/Picture/1 description: The image is a logo for Respironics. The logo features a stylized figure inside a triangle, above the word "RESPIRONICS" in a sans-serif font. Below the company name is the website address, "www.respironics.com", in a smaller font. The background is black, and the text and logo are white.
selecting the correctly colored buttons on the front of Halo/ite. The disc also prevents scieeting the corrects | obtered by inappropriate button pressing as the I-neb device needs to be restarted to deliver further doses.
- 3. The I-neb handpiece is powered by an internal rechargeable 3.8 volt Lithium battery. The Halolite handpiece has an internal single use 9 volt battery.
- 4. The I-neb AAD System is able to supply longer aerosol pulses (up to 5 seconds) into long inhalation cycles, shortening treatment times for patients with these types of breathing patterns.
There are no other differences between the I-neb device and the predicate Halolite device, which would be significant to patient safety or effectiveness.
The main differences between the intended device, I-neb AAD System, and the predicate device NeU04 are -
- 1. I-neb AAD system contains a pressure transducer, microprocessor and device firmware as the main elements of the AAD technology which the NeU04 does not.
- 2. The I-neb AAD system utilizes a Platinum porous mesh to create aerosol, whereas the NeU04 utilises a Ceramic porous mesh to create aerosol. The liquid medication passes through the Titanium ultrasonic horn / Stainless Steel pump in NeU04 but sits between the Titanium horn and mesh in the I-neb AAD system.
- 3. The I-neb AAD system ultrasonic horn operates at 180 kHz whereas the Ne04 operates at 65 kHz.
- 4. The I-neb handpiece is powered by an internal rechargeable 3.8 volt Lithium battery. The NeU04 handpiece uses 4 x 1.5v single use (AA) batteries.
- 5. The I-neb AAD system utilizes a polycarbonate mouthpiece, whereas the NeU04 utilises a Rabalon elastomer mask for patient contact.
There are no other differences between the I-neb device and the predicate NeU04 device, which would be significant to patient safety or effectiveness.
{6}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.
### Public Health Service
SEP 2 3 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Profile Therapeutics PLC C/O Ms. Barbara Campbell Respironics, Incorporated Corporate Services 1010 Murry Ridge Lane Murrysville, Pennsylvania 15668-8525
Re: K042991
Trade/Device Name: I-neb AAD System Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: August 22, 2005 Received: September 14, 2005
Dear Ms. Campbell:
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 mendments, or to devices that have been reclassified in accordance with the provisions of Amendinents, or to are and Cosmetic Act (Act) that do not require approval of a premarket the Federal I Vou may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provision annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 Wr ), it nay of be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device of the read on oncements concerning your device in the Federal Register.
{7}------------------------------------------------
Page 2 - Ms. Campbell
Please be advised that FDA's issuance of a substantial equivalence determination does not I least be act result mination that your device complies with other requirements moun that I Drima mass statutes and regulations administered by other Federal agencies. or the Flor of any I vary - out's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and fishly (21 ce read on 1) (2) regulation (QS) regulation (21 (FFR Part 820); and if requirences as bet form in oroduct radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter "Hiffication. The FDA finding of substantial equivalence of your device to a premaired predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), If you desire specific ac no Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the maj obtain of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Ours
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{8}------------------------------------------------
### I-neb AAD System 510(k) Premarket Notification Section 2
Image /page/8/Picture/1 description: The image shows the logo for Respironics. The logo consists of a triangle with a stylized human figure inside, above the word "RESPIRONICS" in a bold, sans-serif font. Below the company name is the website address "www.respironics.com".
### Indications for use Section 2
# Indications for Use
- K 042991 (Tobe assigned) 510(k) Number:
- I-neb AAD System Device Name:
- The intended purpose of the I-neb AAD System is that is it is Intended Use: The Intended purpose of esh) nebulizer system designed to an ultrasonic (vibrating moon) newsiting moon) for use with the l-neb
aerosolize liquid medication approved for use with the mose of c aerosofize liquid medioution upper and in the home care, AAD System for innulation by this partic prohospital environment.
Prescription Use 区 (Per CFR 801.109)
or
Over-the-counter use _________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Aua Sullom
(Division Sign-Off)
Division o thesiclogy. Ger Infection Control, Dental Dental D
510(k) Number: K042991
