VITAL COUGH

K120277 · Lung Assist, Inc. · NHJ · Sep 12, 2012 · Anesthesiology

Device Facts

• Record ID: K120277
• Device Name: VITAL COUGH
• Applicant: Lung Assist, Inc.
• Product Code: NHJ · Anesthesiology
• Decision Date: Sep 12, 2012
• 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 cough assist device; provides positive and negative pressure via adjustable blower to stimulate patient cough. Input: user commands via touch screen. Output: positive/negative pressure delivered through facemask, mouthpiece, or endotracheal/tracheostomy tube adapter. Used in hospital, institutional, or home settings; operated by clinicians or trained patients. Device shifts rapidly from lung inflation (positive pressure) to deflation (negative pressure) to assist secretion clearance. Benefits patients with compromised cough reflex by mechanically simulating effective cough. Software-controlled operation replaces mechanical switch control found in predicate.

Clinical Evidence

Bench testing only. Device complies with IEC 60601-1 (electrical safety) and IEC 60601-1-2 (electromagnetic compatibility). Output air tested for toxic substances (none found). Device conforms to ISO 9703 for anesthesia and respiratory care alarm signals.

Technological Characteristics

Electromechanical device in metal/polymer housing. Features touch screen interface. Uses adjustable blower for positive/negative pressure generation. Software-controlled. Complies with IEC 60601-1, IEC 60601-1-2, and ISO 9703.

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

• Emerson Cough Assist (K002598)

Submission Summary (Full Text)

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## K120277 510(k) Summary, Section 807.92(a)(2)

| 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 | August 15, 2012 |
| Product Name | Trade Name: Vital Cough<br>Common Name: Cough Assist Device |
| Classification | Noncontinuous Ventilator<br>868.5905, Product Code NHJ<br>Class II |
| 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. |
| 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. |

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SEP

1 2 2012

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| Substantial Equivalence | The Vital Cough is substantially equivalent to the Emerson<br>Cough Assist device (K002598). The modes, frequency,<br>output, and indications for use are equivalent. Differences are<br>safety related and upgrades to current technologies. |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
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## Key Feature Comparison, MI-E Device

| Feature | Emerson Cough Assist | Vital Cough |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Positive Pressure | +60 cm H2O | +50 cm H2O |
| Negative Pressure | -60 cm H2O | -50 cm H2O |
| Maximum Inhalation Flow | 3.3 liters/sec published<br>5.5 liters/sec measured | 7.3 liters/sec |
| Maximum Exhalation Flow | 10 liters/sec published<br>6.4 liters/sec measured | 7.7 liters/sec |
| Mode of Operation | Mechanical switch control | Software controlled |
| Patient Use | Adult and pediatric, hospital<br>or institution environment or<br>in the home given adequate<br>training a physicians'<br>prescription | Adult and pediatric, hospital<br>or institution environment or<br>in the home given adequate<br>training a physicians'<br>prescription |

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the circumference. Inside the circle is a stylized image of an eagle.

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

Lung Assist, Incorporated
Mr. Lewis Ward
Vice President Operations
4655 Kirkwood Court
Boulder, Colorado 80301

SEP 12 2012

Re: K120277

Trade/Device Name: Vital Cough Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: NHJ Dated: August 17, 2012 Received: August 31, 2012

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, listing 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 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.

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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 (OS) 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/Safety/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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Nh for

Anthony D. Watson, B.S., M.S., M.B.A. 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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## INDICATIONS FOR USE

K|20277 510(k) Number (if known):

Device Name: Vital Cough

Indications for 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.

Prescription Use _ AND/OR X (Part 21 CFR 801 Subpart D)

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

L. Shielts

(Division Sign-Off (Division of Anesthesiology, General Hospital Infection Control, Dental Devices

**510(k) Number:** K-120