(309 days)
The Ventlab Cuff Sentry Cuff Inflation Device is designed to measure and regulate intracuff pressures of endotracheal and tracheostomy tubes. This device is a single patient use, non-sterile prescription device that is indicated for patients in all age groups who are managed with inflatable air-filled cuffs. It is intended for use in hospitals, pre-hospitals (EMS), extended care facilities and outpatient clinics.
Ventlab Cuff Sentry Cuff Inflation Device
The provided document is a 510(k) premarket notification letter from the FDA regarding the Ventlab Cuff Sentry Cuff Inflation Device. It confirms that the device is substantially equivalent to legally marketed predicate devices.
However, this document does not contain any information about acceptance criteria, detailed study designs, sample sizes, expert qualifications, adjudication methods, or specific performance metrics of the device. It is a regulatory approval letter, not a technical report or study summary.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based solely on the provided text.
To answer your questions, I would need access to the actual 510(k) submission (e.g., summary of safety and effectiveness, or the full submission) which would detail the performance data and the methods used to demonstrate substantial equivalence.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. James Cochie Vice President, Regulatory Affairs Ventlab Corporation 155 Boyce Drive Mocksville, North Carolina 27028
JUL 2 2 2011
Re: K102674
Trade/Device Name: Ventlab Cuff Sentry Cuff Inflation Device Regulation Number: 21 CFR 868.5750 Regulation Name: Inflatable Tracheal Tube Cuff Regulatory Class: II Product Code: BSK Dated: July 15, 2011 Received: July 19, 2011
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 Federal 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.
Richard C. Chapman 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): K102674
Device Name: Ventlab Cuff Sentry Cuff Inflation Device
Indications for Use:
The Ventlab Cuff Sentry Cuff Inflation Device is designed to measure and regulate intracuff pressures of endotracheal and tracheostomy tubes. This device is a single patient use, non-sterile prescription device that is indicated for patients in all age groups who are managed with inflatable air-filled cuffs. It is intended for use in hospitals, pre-hospitals (EMS), extended care facilities and outpatient clinics.
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)
signature
Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K10
4-1
§ 868.5750 Inflatable tracheal tube cuff.
(a)
Identification. An inflatable tracheal tube cuff is a device used to provide an airtight seal between a tracheal tube and a patient's trachea.(b)
Classification. Class II (performance standards).