(128 days)
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Not Found
No
The 510(k) summary describes a simple mechanical manometer for measuring airway pressure and contains no mention of AI, ML, or related concepts.
No
The device provides visual indication of airway pressure; it does not directly treat or alleviate a medical condition.
Yes
The device provides "visual indication of a patient's airway pressure," which is a measurement used to aid in diagnosis or monitoring a patient's condition.
No
The device description explicitly states it is a "Disposable Column Manometer," which is a physical hardware device used to measure pressure. It is not described as software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide visual indication of a patient's airway pressure during ventilation. This is a measurement of a physiological parameter (pressure) within the body, not an analysis of a sample taken from the body (like blood, urine, tissue, etc.).
- Device Description: The description is of a "Disposable Column Manometer," which is a device for measuring pressure.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances, or providing diagnostic information based on laboratory tests.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device measures a physical parameter directly related to the patient's respiratory system.
N/A
Intended Use / Indications for Use
The Ventlab Pressure-Chek Disposable Column Manometer provides visual indication of a patient's airway pressure during ventilation. It may be connected to the manometer or proximal ports on ventilator devices such as resuscitation bags, hyperinflation systems, CPAP masks and CPAP circuits. This device is a single patient use, non-sterile device that is indicated in both hospital and homecare applications.
Product codes
CAP
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
airway
Indicated Patient Age Range
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Intended User / Care Setting
hospital and homecare applications.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 868.2600 Airway pressure monitor.
(a)
Identification. An airway pressure monitor is a device used to measure the pressure in a patient's upper airway. The device may include a pressure gauge and an alarm.(b)
Classification. Class II (performance standards).
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image is a seal for the U.S. Department of Health & Human Services. The seal is circular and contains an abstract image of a bird-like figure with three tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top of the circle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. James A. Cochie Vice-President, Regulatory Affairs/ Quality Assuarance Ventlab Corporation 155 Boyce Drive Mocksville, North Carolina 27028
2 4 2012 MAY
Re: K120118
Trade/Device Name: Ventlab Pressure-Check Disposable Column Manometer Regulation Number: 21 CFR 868.2600 Regulation Name: Airway Pressure Monitor Regulatory Class: II Product Code: CAP Dated: April 24, 2012 Received: April 25, 2012
Dear Mr. Cochie:
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 Eederal Register.
1
Page 2 -- Mr. Cochie
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 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
2
Indications for Use
510(k) Number (if known): K120 (18
Device Name: _ Ventlab Pressure-Chek Disposable Column Manometer
Indications for Use:
The Ventlab Pressure-Chek Disposable Column Manometer provides visual indication of a patient's airway pressure during ventilation. It may be connected to the manometer or proximal ports on ventilator devices such as resuscitation bags, hyperinflation systems, CPAP masks and CPAP circuits. This device is a single patient use, non-sterile device that is indicated in both hospital and homecare applications.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
K. hulla
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K120118
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