LUNG FLUTE THERAPEUTIC

K091557 · Medical Acoustics · BWF · Jan 4, 2010 · Anesthesiology

Device Facts

• Record ID: K091557
• Device Name: LUNG FLUTE THERAPEUTIC
• Applicant: Medical Acoustics
• Product Code: BWF · Anesthesiology
• Decision Date: Jan 4, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Lung Flute® Therapeutic is indicated for Positive Expiratory Pressure (PEP) therapy.

Device Story

Lung Flute® Therapeutic is a hand-held, self-powered device for airway clearance; functions as an incentive spirometer. Device consists of a plastic mouthpiece attached to a hardened plastic tube containing a Mylar reed. Patient exhales through device; reed oscillates to generate low-frequency sound waves; sound waves vibrate airways and pulmonary secretions; secretions thin and are expelled. Used by patients with chronic bronchitis or COPD; facilitates mucus clearing. Clinical benefit demonstrated via sputum production and respiratory questionnaires. No external power or software required.

Clinical Evidence

Clinical study involved a cohort of chronic bronchitic patients comparing Lung Flute® Therapeutic to Acapella over eight weeks. Endpoints included sputum weight, spirometry, Chronic COPD questionnaire (CCQ), St. Georges respiratory questionnaire (SGRQ), and Breathlessness, Cough and Sputum Scale (BCSS). Results showed both devices produced similar amounts of sputum and performed similarly on spirometry and questionnaires. Mixed model analysis confirmed no significant difference in therapeutic outcomes.

Technological Characteristics

Hand-held, self-powered device. Materials: plastic mouthpiece, hardened plastic tube, Mylar reed. Principle: acoustical impedance via reed oscillation to generate low-frequency sound waves for airway vibration. Dimensions: flute-like form factor. No software, electronics, or external energy source.

Indications for Use

Indicated for Positive Expiratory Pressure (PEP) therapy in patients requiring airway clearance.

Regulatory Classification

Identification

An incentive spirometer is a device that indicates a patient's breathing volume or flow and that provides an incentive to the patient to improve his or her ventilation.

Predicate Devices

• Acapella

Submission Summary (Full Text)

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C091557

# 510(k) SUMMARY న్.. JAN - 4 2010 This summary of 510(k) safety and effectiveness information is being 510(k) submitted in accordance with the requirements of 21 C.F.R. § 807.92(c). Summary Submitter Medical Acoustics LLC Contact Person

Name: Nicolaas J. Smit PhD, VP Science and Technology Address: 255 Great Arrow Ave., Suite 23, Buffalo, NY 14207 Phone: [phone] Fax: [phone] E-mail: [e-mail]

| Date Prepared | May 20, 2009 |
|-----------------------|---------------------------------------|
| Name | Lung Flute ^® Therapeutic |
| Classification Names | Incentive Spirometer |
| Device Classification | Classification: Class II |
| | Classification Panels: Anesthesiology |
| | Regulation Number: 868.5690 |
| Predicate Device(s) | Acapella |

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| Performance<br>Standards | Performance standards have not been established by the FDA under<br>section 514 of the Federal, Food, Drug and Cosmetic Act. |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>Description | The Lung Flute® Therapeutic is shaped like a pipe or flute with a plastic<br>mouthpiece at one end. A Mylar reed is attached inside a square hardened<br>plastic tube that flairs on the end to increase the internal air mass, which<br>provides acoustical impedance. When the patient exhales through the "flute-<br>like" device, the reed inside the tube oscillates and acts in tandem with the<br>rest of the device and the lung cavity itself to produce a sound frequency<br>that approximates the resonance frequency of pulmonary secretions. The<br>Lung Flute® Therapeutic facilitates mucus clearing by generating and<br>delivering a specific low frequency sound that vibrates the airways and lung<br>secretions, causing lung secretions to thin and become expelled. |
| Indications for<br>Use | The Lung Flute® Therapeutic is indicated for Positive Expiratory Pressure<br>(PEP) therapy. |
| Technological<br>Characteristics | The Lung Flute® Therapeutic is a hand-held, self-powered device which<br>facilitates mucus clearing by vibrating the airways. The Lung Flute®<br>Therapeutic uses sound to vibrate the airways and lungs at a specific<br>frequency. |
| Clinical<br>Performance | A cohort of chronic bronchitic patients underwent Positive Expiratory<br>Pressure Therapy with the Lung Flute® Therapeutic and Acapella for eight<br>weeks. Sputum samples were weighed, spirometry was performed and<br>Chronic COPD questionnaire (CCQ) and St. Georges respiratory<br>questionnaire (SGRQ) was used. A daily diary was also maintained<br>recording breathlessness, cough and sputum scale (BCSS). Daily use of<br>emergency inhaler was also recorded. A mixed model analysis was used to<br>determine significance. |
| | The Lung Flute® Therapeutic and Acapella produced similar amounts of<br>sputum, performed similarly on spirometry and questionnaires |
| | Conclusion: Positive Expiratory Pressure therapy produced similar results<br>for both products. |
| Substantial<br>Equivalence | Based on the clinical performance, the Lung Flute® Therapeutic is<br>substantial equivalent to the Acapella; a FDA 510(k) cleared device. |

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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 & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right.

### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Dr. Nicolaas J. Smit Vice President Medical Acoustics 255 Great Arrow Avenue Suite 23 Buffalo, New York 14207

JAN - 4 2010

Re: K091557 Trade/Device Name: Lung Flute® Therapeutic Regulation Number: 21CFR 868.5690 Regulation Name: Incentive Spirometer Regulatory Class: II Product Code: BWF Dated: December 23, 2009 Received: December 23, 2009

Dear Dr. Smit:

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 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- Dr. Smit

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safèty/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

:h for

Anthony D. Watson, BS, MS, MBA 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 4.

Page 1 of 1

510(k) Number (if known): 16091557

Device Name: Lung Flute® Therapeutic

Indications for Use:

The Lung Flute® Therapeutic is indicated for Positive Expiratory Pressure (PEP) Therapy.

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | X |
|-------------------------------------------------|--------|
| | AND/OR |
| Over-The-Counter Use<br>(21 CFR 801 Subpart C) | |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

| 510(k) Number: | k091557 |
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