ELECTRO FLO PERCUSSOR, MODEL 5000

K031876 · Med Systems · BYI · Nov 21, 2003 · Anesthesiology

Device Facts

• Record ID: K031876
• Device Name: ELECTRO FLO PERCUSSOR, MODEL 5000
• Applicant: Med Systems
• Product Code: BYI · Anesthesiology
• Decision Date: Nov 21, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5665
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of the Med Systems Electro Flo Percussor Model 5000 is 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 Med Systems Electro Flo Percussor Model 5000is also indicated for external manipulation of the thorax to promote airway clearance or improve bronchial drainage for purposes of collecting mucus for diagnostic evaluation.

Device Story

Electrically cycled hammer device for airway clearance therapy; provides external manipulation of thorax. Operates via electronic solenoid to deliver percussive force to chest wall; promotes bronchial drainage and mucus clearance. Used in clinical settings; operated by healthcare professionals. Output is mechanical percussion; assists in clearing retained secretions or collecting mucus for diagnostic evaluation. Benefits patient by improving airway patency and reducing mucus plugging.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing and electrical safety testing.

Technological Characteristics

Powered chest percussor; electronic solenoid actuation; 120V 60Hz AC power source; 1.5 lb weight; 5-25 Hz operating speed. Standalone device.

Indications for Use

Indicated for patients requiring airway clearance therapy due to retained secretions, difficulty with secretion clearance, or atelectasis caused by mucus plugging; applicable to conditions such as COPD, cystic fibrosis, emphysema, and other obstructive lung conditions.

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

• Med Systems 2500 Fluid Flo (K802399)
• PURITAN BENNETT McSHIRLEY (K801982)
• SOUTHWEST MEDICAL MFG. INC (STROM) (K821265, K821570, K813438)

Submission Summary (Full Text)

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NOV 2 1 2003

K031876

# EXHIBIT 2 510(k) Summary of Safety and Effectiveness

MED SYSTEMS 2631 Ariane Drive San Diego, CA 92117 Phone [phone] Fax [phone] medsystems.com

# June 9, 2003 Contact: Jim Davis, President

- 1. Identification of the Device: Proprietary-Trade Name: Med Systems Electro Flo Percussor Model 5000 Classification Name: Powered Chest Percussor Product Code BYI Common/Usual Name: Powered Chest Percussor
- 2. Equivalent legally marketed devices: This product is similar in function to the Model 2500 "Fluid Flo" percussor that our company has manufactured for hospitals since 10-23-82 under 510(k) number K802399. (Company formerly known as Medical Equipment Development Co., Inc.) as well as PURITAN BENNETT McSHIRLEY | K801982 and SOUTHWEST MEDICAL MFG. INC (STROM) K821265, K821570 K813438
- 3. Indications for Use (intended use) : The intended use of the Med Systems Electro Flo Percussor Model 5000 is 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 Med Systems Electro Flo Percussor Model 5000is 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

- 4. Description of the Device:. The Model 5000 "Electro Flo" Percussor is just an electrically cycled hammer. It has the exact same function and operation as the Model 2500 "Fluid Flo" percussor that our company has manufactured for hospitals since 10-23-82 under 510(k) number K802399. The "Fluid Flo" percussor is cycled by an oscillating pneumatic valve whereas the "Electro Flo" percussor is cycled electronically.

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| Feature | Med Systems<br>2500 Fluid Flo<br>K802399 | PURITAN<br>BENNETT<br>McSHIRLEY<br>K801982 | SOUTHWEST<br>MEDICAL<br>MFG. INC<br>STROM<br>K821265,<br>K821570<br>K813438 | Med Systems<br>5000 Electro Flo<br>(This<br>submission) |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|-----------------------------------------------------------------------------|---------------------------------------------------------|
| INDICATION<br>For USE | For respiratory<br>secretion<br>clearance for<br>COPD, cystic<br>fibrosis,<br>emphysema,<br>atelectasis and<br>other obstructive<br>lung conditions | SAME | SAME | SAME |
| Power and<br>Control | Pneumatic<br>Solenoid | Electric Solenoid | Electric Motor | Electronic<br>Solenoid |
| Speed | 5 to 15 Hz | 6 to 60 Hz | 5 to 60 Hz | 5 to 25 Hz |
| Weight | 1.5 pounds | 3 pounds | 5 pounds | 1.5 pounds |
| Energy source | Pneumatic | 120 v 60 Hz AC | 120 v 60 Hz AC | 120 v 60 Hz AC |

#### 5. Substantial Equivalence Chart

- 6. Conclusion
After analyzing bench and electrical safety testing data, it is the conclusion of MED Systems that the Med Systems Electro Flo Percussor Model 5000 is as safe and effective as the predicate device, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device.

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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 lines representing its body and head. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 1 2003

MED Systems C/O Mr. Daniel Kamm, P.E. Kamm & Associates P.O. Box 7007 Deerfield, Illinois 60015

Re: K031876

Trade/Device Name: Electro Flo Percussor, Model 5000 Regulation Number: 21 CFR 868.5665 Regulation Name: Percussor, Powered-Electric Regulation Class: II Product Code: BYI Dated: August 20, 2003 Received: August 25, 2003

### Dear Mr. Kamm:

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. Daniel Kamm, P.E.

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 (OS) 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 vours.

Chiu Lin, 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

Enclosure

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### j) Indications for Use

510(k) Number_ ماركا (13) 510

Device Name: Med Systems Electro Flo Percussor Model 5000

Indications for Use:

The intended use of the Med Systems Electro Flo Percussor Model 5000 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 (1) (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 Med Systems Electro Flo Percussor Model 5000 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.

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---------------------------------------------------------------------------------|-----------------------------|
| Prescription Use | <b>X</b> |
| OR | Over the Counter Use ______ |
| (Per 21 CFR 801.109) | |
| (Division Sign-Off) | |
| Division of Anesthesiology, General Hospital, Infection Control, Dental Devices | |
| 510(k) Number: | K031876 |

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