I-NEB INSIGHT AAD SYSTEM

K052941 · Profile Therapeutics Plc · CAF · Dec 9, 2005 · Anesthesiology

Device Facts

• Record ID: K052941
• Device Name: I-NEB INSIGHT AAD SYSTEM
• Applicant: Profile Therapeutics Plc
• Product Code: CAF · Anesthesiology
• Decision Date: Dec 9, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 (Vibrating Thesm) Mebathe I-neb AAD System for inhalation by the patient in the approved for use with the sub-acute institution, or hospital environment.

Device Story

I-neb Insight AAD System is a portable, reusable, ultrasonic (vibrating mesh) nebulizer; aerosolizes liquid medication for patient inhalation. Used in hospitals, sub-acute institutions, and nursing homes. Operated by clinicians to deliver therapy and teach optimized breathing techniques. Device includes a monitoring function and Patient Logging System (PLS) to track therapy aspects; provides feedback to both patient and clinician. Clinicians use output to monitor patient adherence and optimize inhalation therapy.

Clinical Evidence

Bench testing only. Design verification tests were performed to confirm compliance with product requirements and risk analysis.

Technological Characteristics

Ultrasonic (vibrating mesh) nebulizer system. Portable, reusable, single-patient use. Includes monitoring and data logging (PLS) capabilities. Complies with FDA guidance for software contained in medical devices (May 1998).

Indications for Use

Indicated for patients requiring aerosolized liquid medication inhalation in hospital, sub-acute, or nursing home environments. Prescription use only.

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.

Submission Summary (Full Text)

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I-neb Insight AAD Sy Special 510(k) Premarket Notification Tab 3

Image /page/0/Picture/2 description: The image shows the logo for Respironics. The logo features a stylized human figure inside a triangle, above the word "RESPIRONICS" in a sans-serif font. Below the company name is the website address, "www.respironics.com".

DEC 9 2005

#### Non-Confidential Summary of Safety and Effectiveness Tab 3

## Substantial Equivalence

The modified device has the following similarities to the previously cleared predicate devices:

- Same intended use. .
- Same operating principle. .
- Same technology. .
- Same manufacturing process. .

Design verification tests were performed on the I-neb Insight AAD System as a Design vehicution costs vario portuct requirements. All tests were verified to meet result of the risk andrysis and procession of therapeutics plc has determined that the the required accepturies enterial the safety and effectiveness of the device. In mouncedions nave no impact in this submission is substantially equivalent to the predicate devices.

The modified device complies with the applicable standards referenced in the The Modifica device complex muri dustry "Guidance for the Content of Pre-market Submissions for Software Contained in Medical Devices," May 1998.

## Intended 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 (Vibrating Thesm) Mebathe I-neb AAD System for inhalation by the patient in the approved for use with the sub-acute institution, or hospital environment.

## Device Description

The I-neb Insight AAD System is a portable, single patient use, reusable, ultrasonic (vibrating mesh) nebulizer system designed to aerosolize liquid medication (Vibrating Thesh) nebuilder System for inhalation by the patient in the approved for ass mursing home, sub-acute institution, or hospital environment.

I-neb insight has a monitoring function and it provides feedback to both patient and clinician regarding different aspects of inhaled aerosol therapy. The I-neb insight is designed to be used by the clinician to display a patients THE I Theo InSight is adaly. And it can be used to aid the teaching of optimized

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## I-neb Insight AAD System Special 510(k) Premarket Notification Tab 3

Image /page/1/Picture/1 description: The image shows the logo for Respironics. The logo features a stylized human figure inside of a triangle. Below the figure is the text "RESPIRONICS" and the website "www.respiranics.com".

breathing. It may also be used by the clinician to interrogate the I-Neb AAD
AND AND AND AND Andress (RLC) which can provide the clinician with de breathing. It Thay also be used by the clinician provide the clinician with device System Patient Logging System (1 ES) Which can provide we was and the make information that they need to

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The eagle is positioned to the right of a circular seal that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter.

Public Health Service

2005 DEC 9

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Profile Therapeutics PLC C/O Ms. Barbara Campbell Respironics, Incorporated 1010 Murry Ridge Lane Murrysville, Pennsylvania 15668-8525

Re: K052941

Trade/Device Name: I-neb Insight AAD System Regulation Number: 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: November 15, 2005 Received: November 18, 2005

Dear Ms. Campbell:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becalen 9 week the device is substantially equivalent (for the referenced above and have determined and as neally marketed predicate devices marketed in indications for use stated in the environment date of the Medical Device interstate comments, or to devices that have been reclassified in accordance with the provisions of Amendments, of to devices mat nave oben formers of the shall of a premarket the rederal Pood, Drug, and Ocometic , to certify, market the device, subject to the general approval application (1117). 1 The general controls provisions of the Act include confors provisions of the Fiel. The Jisting of devices, good manufacturing practice, requirements for aibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III If your device is classified (300 lbs 100 roll of the started on the May 100 may be subjecting (PMA), it may be subject to such additions, Title 21, Parts 800 to 898. In the Cloud your device can be found in the South I veces of I veces 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 mean that FDA has made a determination that your device complies with other requirements Incall that I DA mas made a decembers and regulations administered by other Federal agencies. of the Act of any I ederal statutes and regisements, including, but not limited to: registration Touring (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice alla listing (21 CFR Pat 807), abolity systems (QS) regulation (21 CFR Part 820); and if
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 640); a requirents as set form in the quality bystems (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 will anow you to begal finding of substantial equivalence of your device to a premarket notification. THE PDF Managers of 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 advice for Jour de at [phone]. Also, please note the regulation picase contact the Other or Somphilies of Somewarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may other general mirelination in the mational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincercly yours,

Chris Liu, Ph.D.

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

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I-neb Insight AAD System 510(k) Premarket Notification Tab 1

Image /page/4/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 sans-serif font. Below the company name is the website address, "www.respironics.com".

#### Indications for use Tab 1

# Indications for Use

- K (To be assigned) 510(k) Number:
I-neb Insight AAD System Device Name:

The intended purpose of the I-neb Insight AAD System is Intended Use: The intended purpose of thorating mesh) nebulizer that is it is an ultrasonic (vibrating inmedication approved
system designed to aerosolize liquid medicalation by the system designed to acrosolize liquid manhalation by the for use with the for use with acuto for use with the I new care, nursing home, sub-acute patient in the mospital environment.

Prescription Use 区

or

Over-the-counter use

(Per CFR 801.109)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ann Sullivan

K052941