MEDPULSE RESPIRATORY VEST SYSTEM, MODEL 1000

K982889 · Electromed, Inc. · BYI · Jun 1, 1999 · Anesthesiology

Device Facts

• Record ID: K982889
• Device Name: MEDPULSE RESPIRATORY VEST SYSTEM, MODEL 1000
• Applicant: Electromed, Inc.
• Product Code: BYI · Anesthesiology
• Decision Date: Jun 1, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5665
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Intended Use of the Medpulse™ Respiratory Vest System is to provide high frequency chest wall oscillation to promote respiratory mucus clearance where external manipulations of the chest is the physician's treatment of choice.

Device Story

Medpulse™ Respiratory Vest System is a powered percussor for bronchial mucus clearance. System components: air-pulse generator, inflatable vest, air connection tubing. Operation: generator delivers alternating positive pressure air pulses to vest; rapid inflation/deflation cycles create high frequency chest wall oscillation. Operator controls: frequency, time settings, pressure amplitude per physician prescription. Used in clinical or home settings to assist patients with airway clearance. Output: mechanical oscillation of chest wall to mobilize mucus. Benefits: enhanced bronchial drainage and mucus transport.

Clinical Evidence

Bench testing only. Performance testing compared the Medpulse™ System to the predicate ThAIRapy® System, demonstrating substantial equivalence in pressure amplitude, pulse frequency, and pressure waveform shape.

Technological Characteristics

Powered percussor (21 CFR 868.5665). System consists of an air-pulse generator, inflatable vest, and air connection tubing. Operates via pneumatic delivery of alternating positive pressure air pulses. Frequency, time, and pressure are operator-controlled. No software or electronic algorithm details provided.

Indications for Use

Indicated for patients requiring high frequency chest wall oscillation to promote airway clearance and improve bronchial drainage when external chest manipulation is the physician's treatment of choice to enhance mucus transport.

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

• ThAIRapyR Vest System (K884098)

Submission Summary (Full Text)

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# 1977 510(k) Submission ELECTROMED, INC. Medpulse™ Respiratory Vest System

K982889
August 6, 1998

## SUMMARY OF SAFETY AND EFFECTIVENESS

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

Submitter: Electromed, Inc. 14920 Minnetonka Ind. Rd. Minnetonka, MN 55345 Phone# [phone] Contact: Chet Sievert, Jr., Regulatory Consultant

Device Name: Proprietary Name: MedpulseTM Respiratory Vest System Common Name: Powered Percussor Classification: Powered Percussor-Electric (21 CFR 868.5665) Class II

Predicate Device: ThAIRapyR Vest System, #K884098

#### Description of Device:

The Medpulse™ Respiratory Vest System is a high frequency chest wall oscillation device designed to aid in bronchial mucus clearance. The system consists of an air-pulse generator, an inflatable vest and air connection tubing. Alternating positive pressure air pulses are delivered to the inflatable vest via the air-pulse generator. Rapidly alternating positive pressure air pulses result in the inflation and deflation of the vest which frequency chest wall oscillation to the patient and thus enhances clearance of mucus from the lungs. The frequency of the air-pulses, time settings and amount of pressure are operator controlled according to physician's prescription.

### Intended Use:

The Intended Use of the Medpulse™ Respiratory Vest System is to provide high frequency chest wall oscillation to promote respiratory mucus clearance where external manipulations of the chest is the physician's treatment of choice.

### Commarisons of Technological Characteristics:

The Medpulse™ System and the ThAIRapy® System were comparitavely tested and found to be substantially equivalent with regard to form, fit and function. Both systems utilize similar technologies which deliver pulsed compressed air to the vest at similiar frequencies and pressures.

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## Performance Testing:

The Electromed Medpulse™ System was functionally compared and performance tested against the predicate ThAIRapy® System which resulted in a demonstration of substantial equivalence regarding pressure amplitude, pulse frequency, pressure waveform shape, and thus performance.

### Conclusion:

Electromed, Inc. believes that their Medpulse™ Respiratory Vest System is substantially equivalent to the Predicate system with regard to form, fit, function and intended use.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 1999

Mr. Chet Sievert, Jr. Electromed, Inc. 14920 Minnetonko Industrial Road Minnetonka, MN 55345

Re: K982889 Medpulse™ Respiratory Vest System Requlatory Class: II (two) Product Code: 73 BYI Dated: April 29, 1999 Received: April 30, 1999

Dear Mr. Sievert:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Chet Sievert, Jr.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594–4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Device Name: Medpulse™ Respiratory Vest System

## Indications for Use

The Electromed Medpulse™ RespiratoryVest System is designed specifically to deliver I its Lievency chest wall oscillation to promote airway clearance and improve bronchial drainage. The Medpulse™ Respiratory Vest System is indicated when external chest manipulation is the physician's treatment of choice to enhance mucus transport.

Arh. A. Ciarlousli.

(Division Sign-Off) Division of Cardiovascular and Neurological Device 510(k) Number .

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Prescriptions use

801.109

OTC