(121 days)
The LUNG FLUTE™ is indicated for the collection of sputum samples for laboratory analysis and pathologic examination.
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.
The provided text describes the LUNG FLUTE™ device and its clinical performance study. Here's an analysis of the requested information based on the given text:
Acceptance Criteria and Study Details for LUNG FLUTE™ (K060439)
The LUNG FLUTE™ is a device designed to facilitate mucus clearing by generating a specific low-frequency sound, primarily indicated for the collection of sputum samples for laboratory analysis and pathologic examination.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Sputum samples collected by the LUNG FLUTE™ should contain biomarkers indicative of lower respiratory tract samples. | A cohort of chronic bronchitis patients underwent sputum induction using the LUNG FLUTE™. Sputum samples were analyzed for biomarkers (Neutrophil, Macrophages, Squamous Cells, Interleukin-8, Fibrinogen, and Elastase). Salivary samples (representing upper respiratory tract) were also analyzed. |
| Biomarker concentrations in LUNG FLUTE™ induced sputum samples should be similar to those obtained via nebulized hypertonic saline (predicate device). | The LUNG FLUTE™ and nebulized hypertonic saline produced similar concentrations for Neutrophils, Macrophages, Squamous Cells, and Interleukin-8. |
| Biomarker concentrations in LUNG FLUTE™ induced sputum samples should be significantly different from salivary samples (to distinguish lower vs. upper respiratory tract). | Concentrations of Neutrophils, Macrophages, Squamous Cells, and Interleukin-8 in LUNG FLUTE™ induced sputum were significantly different from saliva. |
| The device should be substantially equivalent to the predicate device (sputum induction by nebulized hypertonic saline) based on clinical performance. | Conclusion: Biomarkers found in sputum from samples obtained by nebulized hypertonic saline were similar to those found in sputum samples obtained using the LUNG FLUTE™. Based on this clinical performance, the LUNG FLUTE™ is considered substantially equivalent to sputum induction by nebulized hypertonic saline. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: "A cohort of chronic bronchitis patients" was used. The exact number of patients is not specified in the provided text.
- Data Provenance: The text does not explicitly state the country of origin. It describes a clinical study being submitted for FDA approval in the US. The study appears to be prospective as it involved patients undergoing sputum induction for comparison.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
There is no mention of experts used to establish ground truth in the traditional sense, as this study focuses on objective biomarker analysis. Laboratory analysis was performed on the collected sputum and salivary samples. The qualifications of the individuals who performed the laboratory analysis are not specified.
4. Adjudication Method for the Test Set
There is no mention of an adjudication method in the provided text. The evaluation relied on quantitative biomarker analysis and statistical comparison.
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
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted as the LUNG FLUTE™ is a device for sputum collection, not an AI or imaging diagnostic tool that would involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable as the LUNG FLUTE™ is a physical medical device, not an algorithm or AI system. Its performance is evaluated by the characteristics of the sputum it helps collect.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth used was biomarker analysis of sputum and salivary samples. This is a form of objective laboratory data, not expert consensus or pathology on its own (though pathology would be performed on the collected sputum after collection). The comparison was made against a well-established method (nebulized hypertonic saline) and control samples (saliva).
8. The Sample Size for the Training Set
There is no mention of a training set. This study describes a clinical trial evaluating the performance of a medical device, not the development or training of an algorithm.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as there was no mention of a training set for an algorithm.
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K06 0439
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510(k) SUMMARY 5.0
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| 510(k) Summary | This summary of 510(k) safety and effectiveness information is beingsubmitted 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 TechnologyAddress: 255 Great Arrow Ave., Suite 23, Buffalo, NY 14207Phone: (905) 931-2311or (716) 635-3100Fax: (716) 853-6693E-mail: nsmit@medicalacoustics.com |
| Date Prepared | February 10, 2006 |
| Name | LUNG FLUTE™ |
| Classification Names | Powered Percussor |
| Device Classification | Classification: Class IIClassification Panels: AnesthesiologyRegulation Number: 868.5665 |
| Predicate Device(s) | Sputum induction by nebulized hypertonic saline. Pre-amendmentDevice |
Annual program and the program and the comments of
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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™ 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™ facilitates mucus clearing by generating and delivering aspecific low frequency sound that vibrates the airways and lung secretions,causing lung secretions to thin and become expelled. |
| Indications forUse | The LUNG FLUTE™ is indicated for the collection of sputum samples forlaboratory analysis and pathologic examination. |
| TechnologicalCharacteristics | The LUNG FLUTE™ is a hand-held, self-powered device which facilitatesmucus clearing by vibrating the airways. The LUNG FLUTE™ uses soundto vibrate the airways and lungs at a specific frequency. |
| ClinicalPerformance | A cohort of chronic bronchitis patients underwent sputum induction usingthe LUNG FLUTE™ and nebulized hypertonic saline. Sputum sampleswere analyzed for biomarkers indicative of lower respiratory tract samples.Salivary samples were analyzed representing upper respiratory tractsamples. The biomarker analyzed were: Neurophil, Macrophages,Squamous Cells, Interleukin-8, Fibrinogen and Elastase. Wilcoxon signedrank test, using a p<0.05, was used to compare concentrations and establishsignificance.The LUNG FLUTE™ and nebulized hypertonic saline produced similarconcentrations for Neurophils, Macrophages, Squamous Cells, Interleukin-8and were significantly different from saliva.Conclusion: biomarkers found in sputum from samples obtained bynebulized hypertonic saline were similar to those found in sputum samplesobtained using the LUNG FLUTE™ |
| SubstantialEquivalence | Based on the clinical performance, the LUNG FLUTE™ is substantialequivalent to sputum induction by nebulized hypertonic saline. A pre-amendment device. |
:
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the emblem.
JUN 2 2 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Nicolaas J. Smit, PhD VP, Science and Technology Medical Acoustics, LLC 255 Great Arrow Avenue, Suite 23 Buffalo, New York 14207
Re: K060439
Trade/Device Name: Lung Flute® Regulation Number: 21 CFR 868.5665 Regulation Name: Powered Percussor Regulatory Class: II Product Code: BYI Dated: June 6, 2006 Received: June 8, 2006
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 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 - 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); 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.
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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
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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Appendix 1
Indications for Use
510(k) Number (if known): K060439
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
The Lung Flute® is indicated for the collection of sputum samples for laboratory analysis and pathologic examination.
| Prescription Use | X |
|---|---|
| (Part 21 CFR 801 Subpart D) |
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)
W. Mah for AAb
(Sign-Off)
mn of Anesthesiology, General Hospital,
con Control, Dental Devices
Number: K 060439
Page __ of ___________________________________________________________________________________________________________________________________________________________________
§ 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).