THE INCOURAGE SYSTEM

K051383 · Respiratory Technologies, Incorporated · BYI · Jun 17, 2005 · Anesthesiology

Device Facts

• Record ID: K051383
• Device Name: THE INCOURAGE SYSTEM
• Applicant: Respiratory Technologies, Incorporated
• Product Code: BYI · Anesthesiology
• Decision Date: Jun 17, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5665
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Indications for Use

The inCourage™ System is indicated when external manipulation of the chest is the physician's treatment of choice to increase the clearance of mucus. It is intended for use in the treatment of a variety of Chronic Obstructive Pulmonary Diseases (COPD'S). The system promotes airway clearance and improves bronchial drainage utilizing High Frequency Chest Wall Oscillation (HFCWO).

Device Story

The inCourage™ System provides high-frequency chest wall oscillation (HFCWO) to assist in loosening and eliminating lung mucus. System components include a blower, motor-driven valve, power supply, and control board connected to an inflatable jacket via hoses. The blower-valve assembly generates oscillating air pulses, causing rhythmic inflation/deflation of the jacket against the patient's chest. Used in clinical or home settings, the device is operated by patients or caregivers under physician direction. The electronic user interface allows therapy administration. By mobilizing bronchial secretions, the device facilitates airway clearance, potentially benefiting patients with COPD or other pulmonary conditions. Performance is comparable to existing HFCWO systems.

Clinical Evidence

Bench testing only. Functional and performance comparisons were conducted between the subject device and the predicate, specifically evaluating triangular waveform characteristics, pressure, rate, and volume of airflow to demonstrate substantial equivalence.

Technological Characteristics

Powered electric percussor; utilizes blower and motor-driven valve for HFCWO. Features electronic user interface, interconnecting hoses, and inflatable jackets of varying sizes. Operates via ambient air regeneration. Software-controlled pulse delivery.

Indications for Use

Indicated for patients with pulmonary disorders, including COPD, requiring external chest manipulation to increase mucus clearance and improve bronchial drainage via HFCWO.

Regulatory Classification

Identification

A powered percussor is a device that is intended to transmit vibration through a patient's chest wall to aid in freeing mucus deposits in the lung in order to improve bronchial drainage and that may be powered by electricity or compressed gas.

Predicate Devices

• The Vest™ Airway Clearance System Model 104 (K024309)

Submission Summary (Full Text)

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# JUN 17 2005

Tech®

Advancements in Respiratory Health.

## 510(k) SUMMARY -- SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of safety and effectiveness is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR Part 807.92.

| Date of Submission: | April 19, 2005 | 17 MAY 2005 |
|--------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|-------------|
| Submitter:<br>Address: | Respiratory Technologies Inc., D.B.A. RespirTech<br>8095 215th Street West<br>Lakeville, MN 55044 | |
| Establishment Registration #: | 3004961434 | |
| Owner/Operator Number: | 9068715 | |
| Contact: | Mario Nozzarella, CEO | |
| Phone: | [phone] | |
| Fax: | [phone] | |
| Common Name of Device:<br>Proprietary Device Name:<br>Classification Name:<br>Device Class:<br>Product Code: | POWERED PERCUSSOR<br>The inCourage™ System<br>PERCUSSOR, POWERED-ELECTRIC<br>2<br>BYI | |
| Predicate Device: | The Vest™ Airway Clearance System<br>Model 104<br>510(k) Number: K24309<br>Product Code: BYI | |

## Description of Device:

The inCourage™ System is designed to assist in the loosening & eliminating of mucus from the lungs, utilizing high-frequency chest wall oscillation (HFCWO), when external manipulation of the chest is the physician's treatment of choice to increase the clearance of mucus. The primary components of The inCourage™ System include a blower, a motordriven valve, a power supply, and a control board that are connected to an inflatable iacket through interconnecting hoses. The blower-valve combination creates oscillating air that is delivered to the jacket via the interconnecting hoses. The result is a mythmic inflation and deflation of the jacket against the user's chest creating high-frequency chest wall oscillation, mobilization, and clearance of bronchial secretions.

## Intended Use:

The inCourage™ System is indicated when external manipulation of the chest is the physician's treatment of choice to increase the clearance of mucus. It is intended for use in the treatment of a variety of Chronic Obstructive Pulmonary Diseases (COPD'S). The system promotes airway clearance and improves bronchial drainage utilizing High Frequency Chest Wall Oscillation (HFCWO).

8095 215th Street West · Lakeville, MN 55044 Phone [phone] • Fax [phone] www.respirtech.com

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## Comparison of Technological Characteristics:

The inCourage™ System is equivalent to The Vest™ Airway Clearance System, Model 104 (K024309) in that it has the same indications for use, the same target population, the jacket and vest materials are both made of similar materials and are worn by the patient in similar fasion. The inCourage™ System utilizes ambient air regeneration, while the predicate uses reciprocating bellows. Both systems transport air pulses to the patient through interconnecting hoses. The pulses are delivered at similar rates and similar pressures. Both systems have the following features:

- 1. Main Unit creates pulses of air
- 2. Interconnecting Hoses delivers the air pulses from the Main Unit to the Jacket
- 3. Jacket transfers the pulses of air as a percussive therapy to the patients chest area
- 4. Electronic User Interface used to set and administer the therapy
- 5. Varying Jacket Sizes to fit a variety of patients

The administration of therapy is essentially the same between the The inCourage™ System and the predicate device.

## Performance Testing:

Functional and performance comparisons of the inCourage™ System's triangular waveform were made to the predicate device. Comparisons of the pressure, rate and volume of airflow were completed. It was concluded that the subject of this 510/k) is substantially equivalent to the predicate device.

## Conclusion/Substantial Equivalence:

Respiratory Technologies Inc., D.B.A. RespirTech believes that The inCourage™ System is substantially equivalent to The Vest™ Airway Clearance System - Model 104 (K024309) with regard to form, fit, function and intended use.

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized emblem featuring three abstract shapes resembling birds in flight, arranged in a layered formation.

Public Health Service

JUN 17 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Respiratory Technologies, Incorporated C/O Mr. Robert Mosenkis Responsible Third Party Official CITECH 5200 Butler Pike Plymouth Meeting, Pennsylvania 19462-1298

Re: K051383

Trade/Device Name: The InCourage™ System Regulation Number: 868.5665 Regulation Name: Powered Percussor Regulatory Class: BYI Product Code: II Dated: June 10, 2005 Received: June 13, 2005

Dear Mr. Mosenkis

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.

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 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.

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Page 2 - Mr. Mosenkis

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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), please contact the Office of Compliance at [phone]. 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 Division of Small Manufacturers, International 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.

Sincerely yours,

Jenette f. Michaud m.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

Enclosure

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# Indications for Use

510(k) Number (if known):

O\u02c62/383

Device Name:

The inCourage™ System

Indications For Use:

The inCourage™ System is indicated when external manipulation of the chest is the physician's treatment of choice for increasing the clearance of mucus in patients with pulmonary disorders. The system promotes airway clearance and improves bronchial drainage utilizing High Frequency Chest Wall Oscillation (HFCWO).

Mahal Mahal

Division of Anesthesiology, General Hospital, Infection Control, Dental De

510(k) Number: K051383

Prescription Use _ X_ AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use _ (21 CFR 801 Subpart C)

(Please Do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)