(121 days)
Pre-amendment Device
Not Found
No
The device description and performance studies focus on the mechanical and acoustic properties of the device for sputum induction, with no mention of AI or ML.
No
The intended use is for sputum sample collection, not for treating a condition, even though its mechanism of action affects secretions.
No
The device is indicated for the collection of sputum samples, which are then used for laboratory analysis and pathologic examination. It is a tool for sample collection, not for diagnosing conditions itself.
No
The device description clearly outlines a physical device with a mouthpiece, plastic tube, and Mylar reed, indicating it is a hardware-based medical device.
Based on the provided information, the LUNG FLUTE™ is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the collection of sputum samples for laboratory analysis. It is a tool to facilitate the collection process, not a device that performs the diagnostic test itself.
- Device Description: The description focuses on the mechanical action of the device to help clear mucus and produce sputum. It does not describe any components or processes that analyze biological samples in vitro.
- Performance Studies: The performance study compares the quality of the collected sputum samples (based on biomarker concentrations) using the LUNG FLUTE™ versus another collection method (nebulized hypertonic saline). It does not evaluate the performance of a diagnostic test performed by the device.
- Predicate Device: The predicate device is "Sputum induction by nebulized hypertonic saline," which is another method for sample collection, not a diagnostic device.
An IVD device is typically a reagent, instrument, or system intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. The LUNG FLUTE™'s role is to obtain the sample that will then be used in an IVD test performed elsewhere (in a laboratory).
N/A
Intended Use / Indications for Use
The LUNG FLUTE™ is indicated for the collection of sputum samples for laboratory analysis and pathologic examination.
Product codes
BYI
Device Description
The LUNG FLUTE™ 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™ 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, lung, lower respiratory tract, upper respiratory tract
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
A cohort of chronic bronchitis patients underwent sputum induction using the LUNG FLUTE™ and nebulized hypertonic saline. Sputum samples were analyzed for biomarkers indicative of lower respiratory tract samples. Salivary samples were analyzed representing upper respiratory tract samples. The biomarker analyzed were: Neurophil, Macrophages, Squamous Cells, Interleukin-8, Fibrinogen and Elastase. Wilcoxon signed rank test, using a p
§ 868.5665 Powered percussor.
(a)
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.(b)
Classification. Class II (performance standards).
0
K06 0439
Image /page/0/Picture/1 description: The image shows the text "JUN 2 2 2006" at the top. Below that, the words "MEDICAL ACOUSTICS" are printed in a larger font. Underneath the words, there is a graphic that includes a medical symbol.
510(k) SUMMARY 5.0
1
| 510(k) Summary | This summary of 510(k) safety and effectiveness information is being
submitted in accordance with the requirements of 21 C.F.R. § 807.92(c). |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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) 931-2311or (716) 635-3100
Fax: (716) 853-6693
E-mail: nsmit@medicalacoustics.com |
| Date Prepared | February 10, 2006 |
| Name | LUNG FLUTE™ |
| Classification Names | Powered Percussor |
| Device Classification | Classification: Class II
Classification Panels: Anesthesiology
Regulation Number: 868.5665 |
| Predicate Device(s) | Sputum induction by nebulized hypertonic saline. Pre-amendment
Device |
Annual program and the program and the comments of
1
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™ 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™ 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™ is indicated for the collection of sputum samples for
laboratory analysis and pathologic examination. |
| Technological
Characteristics | The LUNG FLUTE™ is a hand-held, self-powered device which facilitates
mucus clearing by vibrating the airways. The LUNG FLUTE™ uses sound
to vibrate the airways and lungs at a specific frequency. |
| Clinical
Performance | A cohort of chronic bronchitis patients underwent sputum induction using
the LUNG FLUTE™ and nebulized hypertonic saline. Sputum samples
were analyzed for biomarkers indicative of lower respiratory tract samples.
Salivary samples were analyzed representing upper respiratory tract
samples. The biomarker analyzed were: Neurophil, Macrophages,
Squamous Cells, Interleukin-8, Fibrinogen and Elastase. Wilcoxon signed
rank test, using a p