VITAL COUGH

K132988 · Lung Assist, Inc. · NHJ · Mar 28, 2014 · Anesthesiology

Device Facts

• Record ID: K132988
• Device Name: VITAL COUGH
• Applicant: Lung Assist, Inc.
• Product Code: NHJ · Anesthesiology
• Decision Date: Mar 28, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

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 Story

Vital Cough is an electromechanical, microprocessor-controlled cough assist device; used in hospitals, institutions, or homes by clinicians or trained patients. Device utilizes an adjustable blower to generate positive inspiratory pressure and negative expiratory pressure to stimulate cough; includes an oscillator butterfly valve to provide flutter therapy (0-20 Hz) during exhalation to loosen secretions. User interacts via touch screen to set inhalation/exhalation times and pressures. Device output assists in secretion clearance for patients with compromised respiratory function. Benefits include improved airway clearance through mechanical pressure shifts and vibration therapy.

Clinical Evidence

Bench testing only. Compliance with IEC 60601-1 (electrical safety) and IEC 60601-1-2 (EMC). Output air tested for toxicity (none found). Performance characterization included pressure and flow waveform analysis comparing the subject device to the Acapella predicate.

Technological Characteristics

Electromechanical device; metal and polymer housing; touch screen interface. Operates via adjustable blower for positive/negative pressure generation; oscillator butterfly valve for flutter therapy. Universal power (120-240V, 50/60 Hz). Software-controlled. Complies with ISO 9703 for alarm signals.

Indications for Use

Indicated for adult and pediatric patients unable to cough or clear secretions effectively due to reduced peak cough expiratory flow caused by high spinal cord injuries, neuromuscular deficits, or severe fatigue from intrinsic lung disease.

Regulatory Classification

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.

Predicate Devices

• Vital Cough (K120277)
• Acapella (K002768)

Submission Summary (Full Text)

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

:

| | K132988 |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted by | Lung Assist, Inc.<br>4655 Kirkwood Court<br>Boulder, CO 80301 |
| Contact Person | Lewis Ward<br>Vice President Operations<br>4655 Kirkwood Court<br>Boulder, CO 80301<br>303-516-1024<br>303-530-4774 Fax<br>[e-mail] |
| Date Prepared | March 26, 2014 |
| Product Name | Trade Name: Vital Cough<br>Common Name: Cough Assist Device |
| Classification | Noncontinuous Ventilator<br>868.5905, Product Code NHJ<br>Class II, Anesthesiology Panel |
| Intended Use | The Vital Cough is intended for use on patients unable to<br>cough or clear secretions effectively due to reduced peak<br>cough expiratory flow resulting from high spinal cord<br>injuries, neuromuscular deficits or severe fatigue associated<br>with intrinsic lung disease. It may be used either with a<br>facemask, mouthpiece, or an adapter to a patient's<br>endotracheal tube or tracheostomy tube. For use in a<br>hospital, institutional setting, or home use given adequate<br>training. For use on adult or pediatric patients. |
| Technological Characteristics | The device is an electromechanical software controlled<br>device housed in a metal and polymer case. A touch screen<br>displays outputs and receives commands from the user. The<br>device develops positive and negative pressure through an<br>adjustable blower. In inhale mode the lungs are inflated.<br>The device rapidly shifts to providing negative pressure with<br>the intended goal of rapidly deflating the lungs to stimulate<br>an effective patient cough. A flutter feature developed by an<br>oscillator butterfly valve may be activated during exhalation<br>to assist in loosening and removing secretions. |
| Non-clinical Testing | The Vital Cough complies with the IEC 60601-1 general<br>requirements for electrical safety and IEC 60601-1-2<br>electromagnetic compatibility standards. No toxic substances<br>have been found in the output air of the device. The device<br>conforms to ISO 9703 anesthesia and respiratory care alarm<br>signals, auditory and visual. Characterization by pressure and<br>flow of the Acapella predicate and the Vital Cough with<br>flutter feature is included in this submission. |

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

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| Substantial Equivalence | The Vital Cough with flutter feature is substantially<br>equivalent to the Vital Cough without a flutter feature<br>(K120277) and the Acapella flutter device (K002768) based<br>on comparative testing, compared specifications, waveform<br>characterization and analysis, and indications for use. |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| Feature | Vital Cough with<br>Flutter | Vital Cough<br>K120277<br>(predicate device) | Acapella<br>K002768<br>(predicate device) |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Maximum Pressures | +/- 50 cm H2O | +/- 50 cm H2O | Human effort<br>19 cm H2O |
| Maximum Exhalation<br>Peak Flow | 269 LPM | 420 LPM | 71 LPM |
| Flutter Frequency | 0-20 Hz | No flutter | 0-19 Hz |
| Flutter Waveform<br>Technology | 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 and<br>manual modes<br>- Microprocessor<br>controlled<br>- Limited to 6 cycles | - Automatic and<br>manual modes<br>- Microprocessor<br>controlled<br>- Limited to 6 cycles | - Manual mode<br>- Recommends<br>several cycles |
|-----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Inhalation,<br>Exhalation, and<br>Pause Times | 0 to 5 seconds, 0.2<br>second increments | 0 to 5 seconds, 0.2<br>second increments | Human effort |
| Line<br>Voltage<br>Frequency | 120-240V universal<br>50/60 Hz | 120-240V universal<br>50/60 Hz | Non-powered |
| Indications | For use on any patient<br>unable to cough or<br>clear secretions<br>effectively due to<br>reduced peak cough<br>expiratory flow,<br>resulting from high<br>spinal cord injuries,<br>neuromuscular deficits<br>or severe fatigue<br>associated with<br>intrinsic lung disease.<br>It may be used either<br>with a facemask or<br>mouthpiece, or with an<br>adapter to a patient's<br>endotracheal or<br>tracheostomy tube | For use on any patient<br>unable to cough or<br>clear secretions<br>effectively due to<br>reduced peak cough<br>expiratory flow,<br>resulting from high<br>spinal cord injuries,<br>neuromuscular deficits<br>or severe fatigue<br>associated with<br>intrinsic lung disease.<br>It may be used either<br>with a facemask or<br>mouthpiece, or with an<br>adapter to a patient's<br>endotracheal or<br>tracheostomy tube | Intended for use as a<br>positive expiratory<br>pressure (PEP)<br>device.<br>Indication for use:<br>For use as a single<br>patient use, hand-<br>held secretion<br>clearance and lung<br>expansion device that<br>creates vibratory<br>positive expiratory<br>pressure when a<br>patient exhales<br>through 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 [phone] or [phone] 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 [phone] or [phone] 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)

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.

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 -S<br>2014.03.28<br>12:53:41 -04'00' |

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