(226 days)
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.
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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Vital Cough device:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a numerical or pass/fail format relative to a specific study outcome for the Vital Cough device. Instead, it employs a substantial equivalence approach by comparing the Vital Cough's features and performance parameters to a legally marketed predicate device, the Emerson Cough Assist (K002598).
The comparison table serves as the de facto "acceptance criteria" in this context, demonstrating that the Vital Cough performs at a comparable or improved level for key functions.
| Feature | Acceptance Criteria (Predicate Device Performance - Emerson Cough Assist) | Reported Device Performance (Vital Cough) | Met Acceptance Criteria? |
|---|---|---|---|
| Positive Pressure | +60 cm H2O | +50 cm H2O | Comparable |
| Negative Pressure | -60 cm H2O | -50 cm H2O | Comparable |
| Maximum Inhalation Flow | 3.3 liters/sec (published), 5.5 liters/sec (measured) | 7.3 liters/sec | Improved |
| Maximum Exhalation Flow | 10 liters/sec (published), 6.4 liters/sec (measured) | 7.7 liters/sec | Improved |
| Mode of Operation | Mechanical switch control | Software controlled | Different (Upgrade) |
| Patient Use | Adult and pediatric, hospital or institution environment or in the home | Adult and pediatric, hospital or institution environment or in the home | Equivalent |
Note: The FDA's 510(k) clearance process fundamentally relies on demonstrating substantial equivalence to a predicate device, rather than strict, predefined numerical acceptance criteria against a clinical outcome. The "Met Acceptance Criteria?" column reflects whether the Vital Cough meets or exceeds the predicate's performance in the relevant parameter.
Study Proving Acceptance Criteria:
The document describes non-clinical testing to demonstrate compliance and performance:
- IEC 60601-1 general requirements for electrical safety
- IEC 60601-1-2 electromagnetic compatibility standards
- No toxic substances found in the output air of the device
- Conformity to ISO 9703 anesthesia and respiratory care alarm signals (auditory and visual)
Beyond these safety and performance standards, the primary "study" proving the device meets the acceptance criteria (i.e., is substantially equivalent) is the key feature comparison table itself, which presents direct measurements and design aspects of the Vital Cough against the predicate. This comparison would have involved internal engineering testing and measurements to generate the reported flow and pressure values.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in the traditional sense of a clinical trial or image dataset. The "test set" here refers to the device itself and its measured performance. There's no mention of a human or patient test set for evaluating the device's immediate efficacy or diagnostic accuracy. The values (+50 cm H2O, 7.3 liters/sec, etc.) are likely derived from laboratory measurements of a small number of manufactured units or prototypes.
- Data Provenance: The data (flow rates, pressures) are technical measurements from the device itself, presumably generated through internal testing by Lung Assist, Inc. The country of origin for this data would be the USA (Boulder, CO) where Lung Assist, Inc. is located. It is
retrospective in nature, as these measurements would have been completed prior to submission. - Retrospective or Prospective: Retrospective, as these are measurements taken from the device prior to submission for clearance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable to this type of device and submission. "Ground truth" in the context of device performance usually refers to clinical outcomes or expert labels. For a mechanical device like Vital Cough, the "ground truth" for its operational parameters (pressure, flow) is established by direct physical measurement using calibrated equipment, not by expert consensus or clinical assessment.
4. Adjudication Method for the Test Set
Not applicable. There's no multi-reader or observational data requiring adjudication in this technical comparison.
5. 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. The Vital Cough is a mechanical medical device, not an AI-powered diagnostic or assistive tool for human readers. There are no "human readers" or "AI assistance" involved in its direct function.
6. If a Standalone (i.e., algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm or AI device. Its performance is inherent in its mechanical and software design.
7. The Type of Ground Truth Used
The "ground truth" for the performance claims (e.g., maximum inhalation flow of 7.3 liters/sec, positive pressure of +50 cm H2O) is based on direct engineering measurements and physical testing of the Vital Cough device using calibrated instrumentation.
8. The Sample Size for the Training Set
Not applicable. This device does not employ machine learning or AI that would require a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set is used.
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K120277 510(k) Summary, Section 807.92(a)(2)
| 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 | August 15, 2012 |
| Product Name | Trade Name: Vital CoughCommon Name: Cough Assist Device |
| Classification | Noncontinuous Ventilator868.5905, Product Code NHJClass II |
| 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. |
| 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. |
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| Substantial Equivalence | The Vital Cough is substantially equivalent to the EmersonCough Assist device (K002598). The modes, frequency,output, and indications for use are equivalent. Differences aresafety 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 published5.5 liters/sec measured | 7.3 liters/sec |
| Maximum Exhalation Flow | 10 liters/sec published6.4 liters/sec measured | 7.7 liters/sec |
| Mode of Operation | Mechanical switch control | Software controlled |
| Patient Use | Adult and pediatric, hospitalor institution environment orin the home given adequatetraining a physicians'prescription | Adult and pediatric, hospitalor institution environment orin the home given adequatetraining a physicians'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 (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
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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
§ 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).