The Lung Flute® Therapeutic is shaped like a pipe or flute with a plastic mouthpiece at one end. A Mylar reed is attached inside a square hardened plastic tube that flairs on the end to increase the internal air mass, which provides acoustical impedance. When the patient exhales through the "flute-like" device, the reed inside the tube oscillates and acts in tandem with the rest of the device and the lung cavity itself to produce a sound frequency that approximates the resonance frequency of pulmonary secretions. The Lung Flute® Therapeutic facilitates mucus clearing by generating and delivering a specific low frequency sound that vibrates the airways and lung secretions, causing lung secretions to thin and become expelled.

AI/ML Overview

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Similar sputum amounts compared to predicate	Lung Flute® Therapeutic produced similar amounts of sputum compared to Acapella.
Similar spirometry performance compared to predicate	Lung Flute® Therapeutic performed similarly on spirometry compared to Acapella.
Similar questionnaire results (CCQ and SGRQ) compared to predicate	Lung Flute® Therapeutic performed similarly on Chronic COPD Questionnaire (CCQ) and St. Georges Respiratory Questionnaire (SGRQ) compared to Acapella.
Similar daily diary recordings (breathlessness, cough, sputum scale) compared to predicate	Similar daily diary recordings of breathlessness, cough, and sputum scale (BCSS) were maintained.
Similar daily emergency inhaler use compared to predicate	Similar daily use of emergency inhaler was recorded.

Note: The document explicitly states "Performance standards have not been established by the FDA under section 514 of the Federal, Food, Drug and Cosmetic Act." Therefore, the acceptance criteria are implicitly derived from demonstrating substantial equivalence to the predicate device, Acapella.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the exact sample size for the clinical study (test set). It mentions "A cohort of chronic bronchitic patients". The provenance of the data (country of origin, retrospective or prospective) is also not specified.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This information is not applicable. The device is a therapeutic device for mucus clearing, not a diagnostic device requiring expert interpretation for ground truth establishment. The performance was assessed through objective and patient-reported measures, not expert annotation.

4. Adjudication Method for the Test Set

This information is not applicable as the study did not involve expert adjudication of results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. The device is a therapeutic device, not an AI-assisted diagnostic tool for human readers.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

This information is not applicable. The device is a physical therapeutic device used by a patient, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" or primary measures of effectiveness were:

Sputum samples weighed: Objective physiological measurement.
Spirometry performance: Objective physiological measurement.
Chronic COPD Questionnaire (CCQ) and St. Georges Respiratory Questionnaire (SGRQ): Patient-reported outcomes.
Daily diary recordings of breathlessness, cough, and sputum scale (BCSS): Patient-reported outcomes.
Daily use of emergency inhaler: Patient-reported outcome/behavioral measure.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical therapeutic device, not an AI model that requires a training set.

9. How the Ground Truth for the Training Set was Established

This information is not applicable, as there is no training set for this type of device.

Summary

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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: (905) 346-1876 Fax: (716) 853-6693 E-mail: nsmit@medicalacoustics.com

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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PerformanceStandards	Performance standards have not been established by the FDA undersection 514 of the Federal, Food, Drug and Cosmetic Act.
DeviceDescription	The Lung Flute® Therapeutic is shaped like a pipe or flute with a plasticmouthpiece at one end. A Mylar reed is attached inside a square hardenedplastic tube that flairs on the end to increase the internal air mass, whichprovides acoustical impedance. When the patient exhales through the "flute-like" device, the reed inside the tube oscillates and acts in tandem with therest of the device and the lung cavity itself to produce a sound frequencythat approximates the resonance frequency of pulmonary secretions. TheLung Flute® Therapeutic facilitates mucus clearing by generating anddelivering a specific low frequency sound that vibrates the airways and lungsecretions, causing lung secretions to thin and become expelled.
Indications forUse	The Lung Flute® Therapeutic is indicated for Positive Expiratory Pressure(PEP) therapy.
TechnologicalCharacteristics	The Lung Flute® Therapeutic is a hand-held, self-powered device whichfacilitates mucus clearing by vibrating the airways. The Lung Flute®Therapeutic uses sound to vibrate the airways and lungs at a specificfrequency.
ClinicalPerformance	A cohort of chronic bronchitic patients underwent Positive ExpiratoryPressure Therapy with the Lung Flute® Therapeutic and Acapella for eightweeks. Sputum samples were weighed, spirometry was performed andChronic COPD questionnaire (CCQ) and St. Georges respiratoryquestionnaire (SGRQ) was used. A daily diary was also maintainedrecording breathlessness, cough and sputum scale (BCSS). Daily use ofemergency inhaler was also recorded. A mixed model analysis was used todetermine significance.
	The Lung Flute® Therapeutic and Acapella produced similar amounts ofsputum, performed similarly on spirometry and questionnaires
	Conclusion: Positive Expiratory Pressure therapy produced similar resultsfor both products.
SubstantialEquivalence	Based on the clinical performance, the Lung Flute® Therapeutic issubstantial 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 (800) 638-2041 or (301) 796-7100 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(Part 21 CFR 801 Subpart D)	X
	AND/OR
Over-The-Counter Use(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
Page	of

Regulation Number and Section

§ 868.5690 Incentive spirometer.

(a)
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.(b)
Classification. Class II (performance standards).