(128 days)
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.
Ventlab Pressure-Chek Disposable Column Manometer
Analysis of Ventlab Pressure-Check Disposable Column Manometer (K120118)
This document is a 510(k) clearance letter from the FDA. It declares the Ventlab Pressure-Check Disposable Column Manometer substantially equivalent to a predicate device. However, it does not contain details about the specific acceptance criteria or a study proving the device meets those criteria.
FDA 510(k) clearance is primarily based on demonstrating substantial equivalence to a legally marketed predicate device. This typically involves showing that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness. The detailed study data outlining performance metrics against specific acceptance criteria is usually submitted by the manufacturer as part of their 510(k) submission, but this information is not typically included in the public-facing clearance letter.
Therefore, based solely on the provided text, I cannot answer most of your questions as the requested information is not present. The document focuses on the regulatory clearance process rather than specific performance study details.
Here's what I can extract from the provided text and what I cannot:
1. A table of acceptance criteria and the reported device performance:
- Cannot provide. The document does not specify acceptance criteria or report specific device performance metrics from a study.
2. Sample size used for the test set and the data provenance:
- Cannot provide. The document does not mention any specific test set sample size or data provenance (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Cannot provide. The document does not describe any expert ground truth establishment process or qualifications.
4. Adjudication method for the test set:
- Cannot provide. The document does not describe any adjudication method.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Cannot provide. This device is a manometer (a physical device for measuring pressure), not an AI algorithm. Therefore, an MRMC study related to AI assistance would not be applicable or expected for this type of product.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
- Cannot provide. As noted above, this is a physical manometer, not an algorithm.
7. The type of ground truth used:
- Cannot provide. The document does not describe the specific ground truth used for any testing. For a manometer, ground truth would typically involve reference pressure measurements from calibrated equipment.
8. The sample size for the training set:
- Not applicable. This is a hardware device, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established:
- Not applicable. As above, there is no training set for this type of device.
In summary, the provided FDA clearance letter confirms the regulatory status of the Ventlab Pressure-Check Disposable Column Manometer but does not contain the detailed technical study information you are requesting. That information would typically be found in the manufacturer's 510(k) submission, which is not publicly available in its entirety.
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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.
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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
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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
4-1
§ 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).