Predicate Devices

Acapella

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on mechanical vibration and sound frequency for mucus clearing, with no mention of AI or ML algorithms for analysis, diagnosis, or treatment.

Therapeutic

Yes
The device is specifically indicated for Positive Expiratory Pressure (PEP) Therapy, which is a therapeutic intervention for respiratory conditions. It is designed to facilitate mucus clearing and thin lung secretions, directly addressing a health issue.

Diagnostic

No

The Lung Flute® Therapeutic is described as a device for Positive Expiratory Pressure (PEP) Therapy, which facilitates mucus clearing by vibrating airways and lung secretions. There is no mention of it being used to detect, diagnose, or monitor a medical condition.

SaMD (Software as a Medical Device)

No

The device description clearly details a physical device with a mouthpiece, plastic tube, and Mylar reed, indicating it is a hardware-based medical device.

IVD (In Vitro Diagnostic)

Based on the provided information, the Lung Flute® Therapeutic is not an IVD (In Vitro Diagnostic) device.

Here's why:

Intended Use: The intended use is for Positive Expiratory Pressure (PEP) Therapy, which is a therapeutic intervention to help clear mucus from the airways. This is a treatment, not a diagnostic test performed on samples taken from the body.
Device Description: The description details a physical device that the patient exhales through to generate vibrations within the airways. It does not involve analyzing biological samples (like blood, urine, or tissue) to diagnose a condition or provide information about a patient's health status.
Lack of IVD Characteristics: The description does not mention any components or processes typically associated with IVD devices, such as reagents, assays, sample collection, or analysis of biological markers.

In summary, the Lung Flute® Therapeutic is a therapeutic device used for airway clearance, not a diagnostic device used to test samples.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes (comma separated list FDA assigned to the subject device)

BWF

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

airways and lung secretions

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

A cohort of chronic bronchitic patients underwent Positive Expiratory Pressure Therapy with the Lung Flute® Therapeutic and Acapella for eight weeks. Sputum samples were weighed, spirometry was performed and Chronic COPD questionnaire (CCQ) and St. Georges respiratory questionnaire (SGRQ) was used. A daily diary was also maintained recording breathlessness, cough and sputum scale (BCSS). Daily use of emergency inhaler was also recorded. A mixed model analysis was used to determine significance.

The Lung Flute® Therapeutic and Acapella produced similar amounts of sputum, performed similarly on spirometry and questionnaires Conclusion: Positive Expiratory Pressure therapy produced similar results for both products.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Acapella

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

Summary

0

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

б

1

| Performance
Standards | Performance standards have not been established by the FDA under
section 514 of the Federal, Food, Drug and Cosmetic Act. |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
Description | 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. |
| Indications for
Use | The Lung Flute® Therapeutic is indicated for Positive Expiratory Pressure
(PEP) therapy. |
| Technological
Characteristics | The Lung Flute® Therapeutic is a hand-held, self-powered device which
facilitates mucus clearing by vibrating the airways. The Lung Flute®
Therapeutic uses sound to vibrate the airways and lungs at a specific
frequency. |
| Clinical
Performance | A cohort of chronic bronchitic patients underwent Positive Expiratory
Pressure Therapy with the Lung Flute® Therapeutic and Acapella for eight
weeks. Sputum samples were weighed, spirometry was performed and
Chronic COPD questionnaire (CCQ) and St. Georges respiratory
questionnaire (SGRQ) was used. A daily diary was also maintained
recording breathlessness, cough and sputum scale (BCSS). Daily use of
emergency inhaler was also recorded. A mixed model analysis was used to
determine significance. |
| | The Lung Flute® Therapeutic and Acapella produced similar amounts of
sputum, performed similarly on spirometry and questionnaires |
| | Conclusion: Positive Expiratory Pressure therapy produced similar results
for both products. |
| Substantial
Equivalence | Based on the clinical performance, the Lung Flute® Therapeutic is
substantial equivalent to the Acapella; a FDA 510(k) cleared device. |

2

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.

3

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

4

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