(185 days)
No
The description focuses on electromechanical and software control of pressure and flow, with no mention of AI/ML terms or capabilities.
Yes
The device is intended for use on patients with various conditions who are unable to cough or clear secretions effectively, aiming to stimulate an effective patient cough and assist in loosening and removing secretions. This directly addresses health issues and improves physiological function.
No
The device description and intended use indicate it is an assistive therapy device for cough assistance and secretion clearance, not for diagnosing conditions.
No
The device description explicitly states it is an "electromechanical software controlled device housed in a metal and polymer case" and includes components like a blower and a butterfly valve, indicating it is a hardware device with software control, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device that assists patients with coughing and clearing secretions by applying positive and negative pressure to the lungs. This is a therapeutic or supportive function, not a diagnostic one.
- Device Description: The description details an electromechanical device that manipulates air pressure to aid in respiration and secretion clearance. It does not describe any components or processes related to analyzing biological samples (like blood, urine, tissue, etc.) to diagnose a condition.
- Lack of IVD Characteristics: The information does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting or measuring substances in biological samples.
- Providing information for the diagnosis, monitoring, or screening of diseases or conditions.
In summary, the Vital Cough is a respiratory assist device designed to help patients clear their airways, which falls under the category of medical devices used for treatment or support, not in vitro diagnosis.
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
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. A flutter feature developed by an oscillator butterfly valve may be activated during exhalation to assist in loosening and removing secretions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
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. Characterization by pressure and flow of the Acapella predicate and the Vital Cough with flutter feature is included in this submission.
Substantial Equivalence: The Vital Cough with flutter feature is substantially equivalent to the Vital Cough without a flutter feature (K120277) and the Acapella flutter device (K002768) based on comparative testing, compared specifications, waveform characterization and analysis, and indications for use.
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.
Key Metrics
Maximum Pressures: +/- 50 cm H2O (Vital Cough with Flutter, Vital Cough K120277), Human effort 19 cm H2O (Acapella K002768)
Maximum Exhalation Peak Flow: 269 LPM (Vital Cough with Flutter), 420 LPM (Vital Cough K120277), 71 LPM (Acapella K002768)
Flutter Frequency: 0-20 Hz (Vital Cough with Flutter), No flutter (Vital Cough K120277), 0-19 Hz (Acapella K002768)
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
.
יי
510(k) Summary, Section 807.92(a)(2)
:
| K132988 | |
|---|---|
| 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 | March 26, 2014 |
| Product Name | Trade Name: Vital Cough |
| Common Name: Cough Assist Device | |
| Classification | Noncontinuous Ventilator |
| 868.5905, Product Code NHJ | |
| Class II, Anesthesiology Panel | |
| 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. A flutter feature developed by an | |
| oscillator butterfly valve may be activated during exhalation | |
| to assist in loosening and removing secretions. | |
| 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. Characterization by pressure and | |
| flow of the Acapella predicate and the Vital Cough with | |
| flutter feature is included in this submission. |
... .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1
| Substantial Equivalence | The Vital Cough with flutter feature is substantially
equivalent to the Vital Cough without a flutter feature
(K120277) and the Acapella flutter device (K002768) based
on comparative testing, compared specifications, waveform
characterization and analysis, and indications for use. |
| ------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
| Feature | Vital Cough with
Flutter | Vital Cough
K120277
(predicate device) | Acapella
K002768
(predicate device) |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Maximum Pressures | +/- 50 cm H2O | +/- 50 cm H2O | Human effort
19 cm H2O |
| Maximum Exhalation
Peak Flow | 269 LPM | 420 LPM | 71 LPM |
| Flutter Frequency | 0-20 Hz | No flutter | 0-19 Hz |
| Flutter Waveform
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
.
2
| Mode of Operation | - Automatic and
manual modes
- Microprocessor
controlled - Limited to 6 cycles | - Automatic and
manual modes - Microprocessor
controlled - Limited to 6 cycles | - Manual mode
- Recommends
several cycles |
|-----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Inhalation,
Exhalation, and
Pause Times | 0 to 5 seconds, 0.2
second increments | 0 to 5 seconds, 0.2
second increments | Human effort |
| Line
Voltage
Frequency | 120-240V universal
50/60 Hz | 120-240V universal
50/60 Hz | Non-powered |
| Indications | For use on any patient
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 or
mouthpiece, or with an
adapter to a patient's
endotracheal or
tracheostomy tube | For use on any patient
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 or
mouthpiece, or with an
adapter to a patient's
endotracheal or
tracheostomy tube | Intended for use as a
positive expiratory
pressure (PEP)
device.
Indication for use:
For use as a single
patient use, hand-
held secretion
clearance and lung
expansion device that
creates vibratory
positive expiratory
pressure when a
patient exhales
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.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
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.
4
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.
5
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 | |
| 2014.03.28 | |
| 12:53:41 -04'00' |
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