(226 days)
Not Found
No
The summary describes a standard electromechanical device with software control for pressure adjustments, but there is no mention of AI or ML capabilities, image processing, or data sets for training or testing.
Yes
The device is intended to treat patients unable to cough or clear secretions effectively due to various medical conditions, aiming to stimulate an effective patient cough. This direct physiological intervention for a medical condition classifies it as a therapeutic device.
No
The device description indicates that the Vital Cough is designed to "stimulate an effective patient cough" by developing positive and negative pressure, aiding in clearing secretions. This is a therapeutic function, not a diagnostic one. While it may be used for patients with certain conditions, its purpose is to treat or manage a physical function, not to identify or monitor a disease or condition.
No
The device description explicitly states it is an "electromechanical software controlled device housed in a metal and polymer case" and develops pressure through an "adjustable blower," indicating it includes significant hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Vital Cough Function: The Vital Cough device is a mechanical device that assists patients with coughing by applying positive and negative pressure to the lungs. It directly interacts with the patient's respiratory system.
- Lack of Sample Analysis: The description does not mention the device analyzing any biological samples from the patient. Its function is purely mechanical assistance.
- Intended Use: The intended use describes assisting patients with clearing secretions due to reduced peak cough expiratory flow, which is a physical function, not a diagnostic test on a sample.
Therefore, the Vital Cough falls under the category of a medical device that provides therapeutic or supportive care, rather than an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
NHJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lungs
Indicated Patient Age Range
adult or pediatric patients
Intended User / Care Setting
hospital, institutional setting, or home use given adequate training.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The Vital Cough complies with the IEC 60601-1 general requirements for electrical safety and IEC 60601-1-2 electromagnetic compatibility standards. No toxic substances have been found in the output air of the device. The device conforms to ISO 9703 anesthesia and respiratory care alarm signals, auditory and visual.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
K120277 510(k) Summary, Section 807.92(a)(2)
| Submitted by | Lung Assist; Inc.
4655 Kirkwood Court
Boulder, CO 80301 |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Lewis Ward
Vice President Operations
4655 Kirkwood Court
Boulder, CO 80301
303-516-1024
303-530-4774 Fax
lwward@qwest.net |
| Date Prepared | August 15, 2012 |
| Product Name | Trade Name: Vital Cough
Common Name: Cough Assist Device |
| Classification | Noncontinuous Ventilator
868.5905, Product Code NHJ
Class II |
| 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. |
| Technological Characteristics | 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. |
| Non-clinical Testing | |
| | The Vital Cough complies with the IEC 60601-1 general
requirements for electrical safety and IEC 60601-1-2
electromagnetic compatibility standards. No toxic substances
have been found in the output air of the device. The device
conforms to ISO 9703 anesthesia and respiratory care alarm
signals, auditory and visual. |
: ・
Page 1 of 2
·
SEP
1 2 2012
1
| Substantial Equivalence | The Vital Cough is substantially equivalent to the Emerson
Cough Assist device (K002598). The modes, frequency,
output, and indications for use are equivalent. Differences are
safety related and upgrades to current technologies. |
| ------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
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 | |
| 5.5 liters/sec measured | 7.3 liters/sec | |
| Maximum Exhalation Flow | 10 liters/sec published | |
| 6.4 liters/sec measured | 7.7 liters/sec | |
| Mode of Operation | Mechanical switch control | Software controlled |
| Patient Use | Adult and pediatric, hospital | |
| or institution environment or | ||
| in the home given adequate | ||
| training a physicians' | ||
| prescription | Adult and pediatric, hospital | |
| or institution environment or | ||
| in the home given adequate | ||
| training a physicians' | ||
| prescription |
.
2
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.
3
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 (800) 638-2041 or (301) 796-7100 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
4
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