VITAL COUGH by LUNG ASSIST, INC.

The Vital Cough is intended for use on patients unable to cough or clear secretions effectively due to reduced peak cough expiratory flow resulting from high spinal cord injuries, neuromuscular deficits or severe fatigue associated with intrinsic lung disease. It may be used either with a facemask, mouthpiece, or an adapter to a patient's endotracheal tube or tracheostomy tube. For use in a hospital, institutional setting, or home use given adequate training. For use on adult or pediatric patients.

Device Description

The device is an electromechanical software controlled device housed in a metal and polymer case. A touch screen displays outputs and receives commands from the user. The device develops positive and negative pressure through an adjustable blower. In inhale mode the lungs are inflated. The device rapidly shifts to providing negative pressure with the intended goal of rapidly deflating the lungs to stimulate an effective patient cough. A flutter feature developed by an oscillator butterfly valve may be activated during exhalation to assist in loosening and removing secretions.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the Vital Cough device, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

The acceptance criteria for the Vital Cough with flutter feature are implicitly established through substantial equivalence claims to two predicate devices: the Vital Cough without a flutter feature (K120277) and the Acapella flutter device (K002768). The study aims to demonstrate that the new device's performance, particularly with the added flutter feature, is comparable and safe for its intended use.

Explicit Performance Characteristics and Comparison:

Feature	Acceptance Criteria (Predicate - Vital Cough K120277)	Acceptance Criteria (Predicate - Acapella K002768)	Reported Device Performance (Vital Cough with Flutter)
Maximum Pressures	+/- 50 cm H2O	Human effort (19 cm H2O)	+/- 50 cm H2O
Maximum Exhalation Peak Flow	420 LPM	71 LPM	269 LPM
Flutter Frequency	No flutter	0-19 Hz	0-20 Hz
Flutter Waveform Technology	No flutter	Square waveform	Square waveform
Mode of Operation	Automatic & manual modes, Microprocessor controlled, Limited to 6 cycles	Manual mode, Recommends several cycles	Automatic & manual modes, Microprocessor controlled, Limited to 6 cycles
Inhalation, Exhalation, and Pause Times	0 to 5 seconds, 0.2 second increments	Human effort	0 to 5 seconds, 0.2 second increments
Line Voltage Frequency	120-240V universal 50/60 Hz	Non-powered	120-240V universal 50/60 Hz
Benefits	Creates negative expiratory and positive inspiratory pressure, improves secretion clearance, adjustable pressure, accommodates low flow rates.	Creates positive expiratory pressure (PEP) and vibration, improves secretion clearance, allows patient to adjust frequency/pressure, accommodates low flow rates.	Creates negative expiratory and positive inspiratory pressure, and vibrations, improves secretion clearance, adjustable frequency and pressure, accommodates low flow rates.
Indications for Use	For use on patients unable to cough or clear secretions effectively due to specific conditions (spinal cord injuries, neuromuscular deficits, severe fatigue from intrinsic lung disease), for use with facemask/mouthpiece/adapter to endotracheal/tracheostomy tube, in hospital/institutional/home settings, for adult/pediatric patients.	For use as a PEP device for secretion clearance and lung expansion, creating vibratory positive expiratory pressure.	For use on patients unable to cough or clear secretions effectively due to specific conditions (spinal cord injuries, neuromuscular deficits, severe fatigue from intrinsic lung disease), for use with facemask/mouthpiece/adapter to endotracheal/tracheostomy tube, in hospital/institutional/home settings, for adult/pediatric patients.

Summary of Device Meeting Acceptance Criteria:

The Vital Cough with flutter demonstrates substantial equivalence primarily by matching or exceeding the performance characteristics of its predicate devices where applicable.

Pressure and Flutter Characteristics: It achieves the same maximum positive/negative pressures as the original Vital Cough (K120277) and offers a comparable flutter frequency range and waveform technology to the Acapella (K002768).
Fundamental Functionality: The core MI/E (Mechanical Insufflation-Exsufflation) design is present in both the new device and the predicate Vital Cough. The added flutter feature is directly compared to the Acapella.
Indications for Use: The new device maintains the same broad indications for use as the original Vital Cough, which covers a wider patient population and method of use than the Acapella.
Operating Modes and Settings: It shares the same microprocessor-controlled automatic and manual modes, and adjustable time intervals as the original Vital Cough.

The submission specifically highlights that "The Vital Cough with flutter is substantially equivalent to the Vital Cough cleared device cleared under K120277 based on intended use, comparative testing, frequency and waveform. The MIE design is in both devices. The added flutter feature has the same indication for use to clear secretions as the original Vital Cough and the Acapella. The pressure and flow differences are due to the Vital Cough MI/E activity. The flutter activity is substantially equivalent. The Vital Cough with flutter is a mechanical device driven by a fan. The Acapella is driven by himan effort. The Vital Cough device does the work for the patient."

Study Information

The 510(k) summary provided does not describe a clinical study involving human subjects or a large-scale data analysis (like an AI study). Instead, it relies on non-clinical testing to demonstrate substantial equivalence.

Sample size used for the test set and the data provenance: Not applicable. The documentation refers to "comparative testing" and "waveform characterization and analysis" between the new device and the predicate devices, implying bench testing and engineering comparisons rather than a human-subject test set.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the context of diagnostic AI or clinical studies, is not established here. The comparison is against established technical specifications and performance characteristics of predicate devices.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This is not an AI-assisted diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is an electromechanical device, not a standalone algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for comparison is the published technical specifications, performance data, and established intended uses of the predicate devices (Vital Cough K120277 and Acapella K002768). For non-clinical testing, this would involve laboratory measurements against those specifications.
The sample size for the training set: Not applicable. This device does not use machine learning or AI algorithms requiring a training set.
How the ground truth for the training set was established: Not applicable.

Non-Clinical Testing Details Provided:

The summary states the following non-clinical testing was conducted:

Compliance with IEC 60601-1 (general requirements for electrical safety).
Compliance with IEC 60601-1-2 (electromagnetic compatibility standards).
Verification that no toxic substances were found in the output air.
Conformity to ISO 9703 (anesthesia and respiratory care alarm signals, auditory and visual).
Characterization by pressure and flow of the Acapella predicate and the Vital Cough with flutter feature. This is the core of the performance comparison for substantial equivalence.

In essence, the study focuses on engineering and safety testing to demonstrate that the new device, with its added flutter feature, is functionally equivalent and safe compared to already legally marketed devices, primarily the original Vital Cough and the Acapella.

Summary

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510(k) Summary, Section 807.92(a)(2)

	K132988
Submitted by	Lung Assist, Inc.4655 Kirkwood CourtBoulder, CO 80301
Contact Person	Lewis WardVice President Operations4655 Kirkwood CourtBoulder, CO 80301303-516-1024303-530-4774 Faxlwward@qwest.net
Date Prepared	March 26, 2014
Product Name	Trade Name: Vital CoughCommon Name: Cough Assist Device
Classification	Noncontinuous Ventilator868.5905, Product Code NHJClass II, Anesthesiology Panel
Intended Use	The Vital Cough is intended for use on patients unable tocough or clear secretions effectively due to reduced peakcough expiratory flow resulting from high spinal cordinjuries, neuromuscular deficits or severe fatigue associatedwith intrinsic lung disease. It may be used either with afacemask, mouthpiece, or an adapter to a patient'sendotracheal tube or tracheostomy tube. For use in ahospital, institutional setting, or home use given adequatetraining. For use on adult or pediatric patients.
Technological Characteristics	The device is an electromechanical software controlleddevice housed in a metal and polymer case. A touch screendisplays outputs and receives commands from the user. Thedevice develops positive and negative pressure through anadjustable blower. In inhale mode the lungs are inflated.The device rapidly shifts to providing negative pressure withthe intended goal of rapidly deflating the lungs to stimulatean effective patient cough. A flutter feature developed by anoscillator butterfly valve may be activated during exhalationto assist in loosening and removing secretions.
Non-clinical Testing	The Vital Cough complies with the IEC 60601-1 generalrequirements for electrical safety and IEC 60601-1-2electromagnetic compatibility standards. No toxic substanceshave been found in the output air of the device. The deviceconforms to ISO 9703 anesthesia and respiratory care alarmsignals, auditory and visual. Characterization by pressure andflow of the Acapella predicate and the Vital Cough withflutter feature is included in this submission.

... .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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Substantial Equivalence	The Vital Cough with flutter feature is substantiallyequivalent to the Vital Cough without a flutter feature(K120277) and the Acapella flutter device (K002768) basedon comparative testing, compared specifications, waveformcharacterization and analysis, and indications for use.
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Feature	Vital Cough withFlutter	Vital CoughK120277(predicate device)	AcapellaK002768(predicate device)
Maximum Pressures	+/- 50 cm H2O	+/- 50 cm H2O	Human effort19 cm H2O
Maximum ExhalationPeak Flow	269 LPM	420 LPM	71 LPM
Flutter Frequency	0-20 Hz	No flutter	0-19 Hz
Flutter WaveformTechnology	Square waveform	No flutter	Square waveform
Benefits	Creates a negative expiratory pressure, a positive inspiratory pressure, and vibrations. Improves secretion clearance. Adjustable frequency and pressure. Accommodates patients with very low flow rates. Creates a positive inspiratory pressure	Creates a negative expiratory pressure and a positive inspiratory pressure. Improves secretion clearance. Adjustable pressure. Accommodates patients with very low flow rates. Creates a positive inspiratory pressure	Creates a positive expiratory pressure (PEP) and vibration therapy. Improves secretion clearance. Inhalation without removing device from the patient's mouth. The device performs in any spatial orientation. Allows patients to adjust frequency and pressure. Accommodates patients with very low flow rates. No effect on inspiration

Key Feature Comparison, MI/E Device

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Mode of Operation	- Automatic andmanual modes- Microprocessorcontrolled- Limited to 6 cycles	- Automatic andmanual modes- Microprocessorcontrolled- Limited to 6 cycles	- Manual mode- Recommendsseveral cycles
Inhalation,Exhalation, andPause Times	0 to 5 seconds, 0.2second increments	0 to 5 seconds, 0.2second increments	Human effort
LineVoltageFrequency	120-240V universal50/60 Hz	120-240V universal50/60 Hz	Non-powered
Indications	For use on any patientunable to cough orclear secretionseffectively due toreduced peak coughexpiratory flow,resulting from highspinal cord injuries,neuromuscular deficitsor severe fatigueassociated withintrinsic lung disease.It may be used eitherwith a facemask ormouthpiece, or with anadapter to a patient'sendotracheal ortracheostomy tube	For use on any patientunable to cough orclear secretionseffectively due toreduced peak coughexpiratory flow,resulting from highspinal cord injuries,neuromuscular deficitsor severe fatigueassociated withintrinsic lung disease.It may be used eitherwith a facemask ormouthpiece, or with anadapter to a patient'sendotracheal ortracheostomy tube	Intended for use as apositive expiratorypressure (PEP)device.Indication for use:For use as a singlepatient use, hand-held secretionclearance and lungexpansion device thatcreates vibratorypositive expiratorypressure when apatient exhalesthrough the device.

Summary:

The Vital Cough with flutter is substantially equivalent to the Vital Cough cleared device cleared under K120277 based on intended use, comparative testing, frequency and waveform. The MIE design is in both devices. The added flutter feature has the same indication for use to clear secretions as the original Vital Cough and the Acapella. The pressure and flow differences are due to the Vital Cough MI/E activity. The flutter activity is substantially equivalent. The Vital Cough with flutter is a mechanical device driven by a fan. The Acapella is driven by himan effort. The Vital Cough device does the work for the patient.

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center -- WO66-G609 Silver Spring, MD 20993-0002

March 28, 2014

Lung Assist. Incorporation Mr. Lewis Ward Vice President Operations 4655 Kirkwood Court Boulder, CO 80301

Re: K132988

Trade/Device Name: Vital Cough Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Codc: NHJ Dated: February 11, 2014 Received: February 25, 2014

Dear Mr. Ward:

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. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into cither 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 - Mr. Ward

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/Safetw/ReportalProblem/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.

FOR

Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Sincercly yours.

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K132988

Device Name Vital Cough

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
	Anya C. Harry -S2014.03.2812:53:41 -04'00'

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FORM FDA 3881 (1/14)

Regulation Number and Section

§ 868.5905 Noncontinuous ventilator (IPPB).

(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).