THE VEST AIRWAY CLEARANCE SYSTEM, MODEL 104

K024309 · Advanced Respiratory · BYI · Feb 21, 2003 · Anesthesiology

Device Facts

• Record ID: K024309
• Device Name: THE VEST AIRWAY CLEARANCE SYSTEM, MODEL 104
• Applicant: Advanced Respiratory
• Product Code: BYI · Anesthesiology
• Decision Date: Feb 21, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5665
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The intended use of the Advanced Respiratory Vest Airway Clearance System is to promote airway clearance or improve bronchial drainage by enhancing mobilization of bronchial secretions where external manipulation of the thorax is the physician's choice of treatment. The indications typically follow the Clinical Practice Guideline published by the American Association for Respiratory Care (AARC) 1991. In addition, the device is also indicated for the purpose of collecting mucus for diagnostic evaluation.

Device Story

High-frequency chest wall oscillator; promotes bronchial secretion mobilization. System comprises air-pulse generator and inflatable vest. Generator delivers oscillating positive pressure air pulses to vest; vest inflates/deflates against patient chest to create high-frequency oscillation. Used in various settings; operated by patient or clinician. Output is mechanical chest wall oscillation; assists in airway clearance and mucus collection for diagnostics. Replaces analog potentiometers with digital microprocessor control via momentary switches for frequency and pressure adjustment.

Clinical Evidence

Bench testing only. Functional and performance comparisons were conducted against the predicate device (K993629) to validate the transition to digital control systems.

Technological Characteristics

Powered percussor; reciprocating bellows for air pulse generation; inflatable vest. Digital control system using microprocessor and momentary switches for frequency/pressure adjustment. Class II device.

Indications for Use

Indicated for patients requiring airway clearance therapy or bronchial drainage via external thoracic manipulation. Specific indications include evidence of retained secretions, difficulty with secretion clearance, atelectasis caused by mucus plugging, or collection of mucus for diagnostic evaluation. Follows AARC 1991 Clinical Practice Guidelines.

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™ Vest System (K012928)
• The Vest™ Vest System (K993629)

Submission Summary (Full Text)

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K024309

Image /page/0/Picture/1 description: The image shows the logo for Advanced Respiratory. The logo consists of a black diamond shape with a white "O" inside of it on the left. To the right of the diamond is the text "Advanced Respiratory" in a serif font, with "Advanced" on top of "Respiratory".

651-490-1468 800-426-4224 Fax [phone]

Advanced Respiratory 1020 West County Road F St. Paul, Minnesota 55126 www.thevest.com

Formerly American Biosystems, Inc

FEB 2 1 2003

l 1 December 2002

## SUMMARY OF SAFETY AND EFFECTIVENESS

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

| Submitter: | Eric J. Larson<br>Manager of Quality Systems and Regulatory Affairs<br>Advanced Respiratory, Inc.<br>1020 W. County Road F<br>Shoreview, MN 55126<br>Phone: [phone] Fax: [phone] |
|-------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Eric J. Larson |
| Name of Device: | Modified VestTM Airway Clearance System |
| Classification: | Powered Percussor, Class II |
| Predicate Device: | The VestTM Vest System, 510(K) number: K012928, K993629 |

#### Description of Device:

The Advanced Respiratory Vest™ Airway Clearance System is a high-frequency chest wall oscillator designed to be used in a wide variety of settings for enhancing the mobilization of bronchial secretions. The primary components of The Vest™ Airway Clearance System include an air-pulse generator and an inflatable vest. Oscillating positive pressure air pulses are applied to the vest by the air-pulse generator. The resulting pressure pulses cause the vest to inflate and deflate against the chest of the user creating high-frequency chest wall oscillation and mobilization of bronchial secretions.

**Your source for**

Image /page/0/Picture/13 description: The image shows the logo for "The Vest Airway Clearance System". The words "The Vest" are in a stylized font, with "The" being smaller and above "Vest". Below this, in a smaller, simpler font, are the words "Airway Clearance System". The logo is in black and white.

So everyone can breathe a little easier

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#### SUMMARY OF SAFETY AND EFFECTIVENESS (continued)

#### Intended Use:

The intended use of the Advanced Respiratory Vest Airway Clearance System is to promote airway clearance or improve bronchial drainage by enhancing mobilization of bronchial secretions where external manipulation of the thorax is the physician's choice of treatment. The indications typically follow the Clinical Practice Guideline published by the American Association for Respiratory Care (AARC) 1991. In addition, the device is also indicated for the purpose of collecting mucus for diagnostic evaluation.

#### Comparison of Technological Characteristics:

The Modified Vest™ System is equivalent to Advanced Respiratory's previously cleared LINK Vest™ Airway Clearance System (K012928) and its Vest™ Airway Clearance System (a.k.a. ThAIRapy® Vest System) (K993629) in that the new model is intended to promote airway clearance or improve bronchial drainage by enhancing the mobilization of bronchial secretions when external manipulation of the thorax is the physician's choice of treatment. All devices have reciprocating bellows that generate the air pulses. The same vests will be used on the new device as were available for the predicate devices. Operator controls remain consistent with predicate devices. The user can adjust air pulse frequency and pressure. The reason for this submission is to due to the change from analog to digital control of device frequency and pressure. The predicate device contains analog potentiometers that were rotated to control device frequency and pressure. The new device has momentary switches that are depressed to send a digital signal for microprocessor control of frequency and pressure.

#### Performance Testing:

The Modified Advanced Respiratory Vest™ Airway Clearance System was compared to the predicate model The Vest™ ThAIRapy System (K993629). Functional and performance comparisons were made and it is concluded that the device that is the subject of this 510(k) is substantially equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle with three stripes representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### FEB 2 1 2003

Advanced Respiratory C/O Mr. Ned E. Devine Entela, Incorporated 3033 Madison Avenue, SE Grand Rapids, Michigan 49548

Re: K024309

Trade/Device Name: The Vest™ Airway Clearance System Regulation Number: 868.5665 Regulation Name: Powered Percussor Regulatory Class: II Product Code: BYI Dated: February 6, 2003 Received: February 7, 2003

Dear Mr. Devine:

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 vour 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. Devine

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/dsma/dsmamain.html

Sincerely yours,

Susan Runne:

Susan Runner, DDS, MA Interim 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 STATEMENT

ENCLOSURE F-INDICATIONS FOR USE STATEMENT-PREMARKET NOTIFICATION 510(K) ADVANCED RESPIRATORY, INC. PAGE

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510(K) Number (if known)_ _ Ko24300

Device Name: Modified Vest™ Airway Clearance System

Indications for use:

The intended use of the Modified Vest™ Airway Clearance System is the same as the predicate device, which is to provide airway clearance therapy when external manipulation of the thorax is the physician's choice of treatment. Indications for this form of therapy are described by the American Association for Respiratory Care (AARC) in the Clinical Practices Guidelines for Postural Drainage Therapy (1991). According to AARC guidelines, specific indications for external manipulation of the thorax include evidence or a suggestion of retained secretions, evidence that the patient is having difficulty with the secretion clearance, or presence of atelectasis caused by mucus plugging. In addition, the Vest™ Airway Clearance System is also indicated for external manipulation of the thorax to promote airway clearance or improve bronchial drainage for purposes of collecting mucus for diagnostic evaluation.

- 1. Bronchial Hygiene Guidelines Committee, American Association for Respiratory Care. AARC clinical practice guideline: postural drainage therapy. Respiratory Care 1991; 36: 1418 - 1426.
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Concurrence of CDRH, Office of Device Evaluation (ODE)

**Prescription Use**
(Per 21 CFR 801.109) √

Avestin

(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices

510(k) Number: K024309

OR

Over the Counter Use__________________________________________________________________________________________________________________________________________________________

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