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 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.

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.

AI/ML Overview

The provided document does not contain information about specific acceptance criteria, a study proving the device meets these criteria, or any of the detailed aspects like sample sizes, expert qualifications, or MRMC studies that would be expected for such a description.

The document is a 510(k) Premarket Notification for the I-neb AAD System, primarily focusing on establishing substantial equivalence to predicate devices. It describes the device, its intended use, and compares its attributes and differences with existing legally marketed nebulizers (Prodose AAD System, Halolite AAD System, and NeU04).

Therefore, I cannot provide the requested table and study details as they are not present in the provided text.

The document confirms that:

Device Name: I-neb AAD System
Intended Use: 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.
Regulatory Status: The FDA reviewed the 510(k) and determined the device is substantially equivalent to legally marketed predicate devices. This allows the device to be marketed.

However, specific performance acceptance criteria (e.g., aerosol particle size distribution, drug delivery efficiency, dosage accuracy) and details of a study demonstrating compliance with such criteria are not included in this summary of safety and effectiveness or the accompanying FDA approval letter. These details would typically be found in test reports, which are not part of this submission summary.

Summary

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SEP 2 3 2005

I-neb AAD System 510(k) Premarket Notification Section 3

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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 CampbellVice President, Corporate QA/RARespironics Inc, Corporate Services1010 Murry Ridge LaneMurrysville, PA 15668-8525
Predicate Devices:	Prodose AAD System, K030747Halolite AAD System K991685NeU04 K923024

Device Description

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).

und damesed by I 1011-07-11 been developed by Profile in collaboration with Omron Healthcare (Japan).

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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."

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.

AttributeUse	ProdoseK030747	HaloliteK991685	NeU04K923024	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 ofNebulized drug	Yes	Yes	No	Yes
Drug Delivery on demand	Yes	Yes	No	Yes
Used in hospitals, homecare, nursing home, sub-acute institutions	Yes	Yes	Yes	Yes

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I-neb AAD System 510(k) Premarket Notification
Section 3

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Yes

Single Patient reusable

Yes

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1-neb AAD System

510(k) Premarket Notification
Section 3 Section 3

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AttributeDesign	ProdoseK030747	HaloliteK991685	NeU04K923024	I-neb
LCD Display	Yes	Yes	No	Yes
Software Driven	Yes	Yes	Yes	Yes
Mode of Operation	BreathActivated	BreathActivated	ConstantOutput	BreathActivated
Drug delivery triggered by	PatientInhalation	PatientInhalation	ConstantOutput	PatientInhalation
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 &Mains	Battery &/orMains	Battery &/orMains
RF Disc	Yes	No	No	Yes
Materials
Materials in Contact withPatient	Polycarbonate	Polycarbonate	Rabalon	Polycarbonate
Packaging
Provided clean, non-sterile	Yes	Yes	Yes	Yes
Performance Standards /Specifications Applicableunder Section 514	No	No	No	No

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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.
1. 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

1. 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.
1. 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.

1. 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.
1. 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.
1. 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

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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.

1. 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.
1. 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.
1. 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.
1. The I-neb AAD system ultrasonic horn operates at 180 kHz whereas the Ne04 operates at 65 kHz.
1. 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.
1. 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.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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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.

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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

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I-neb AAD System 510(k) Premarket Notification Section 2

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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)

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

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).