(146 days)
No
The description focuses on automatic pressure regulation using sensors and a pump, with no mention of AI, ML, or related concepts.
No
The device is described as a monitor and regulator for cuff pressure, which is a supportive function rather than directly treating a disease or condition. While it aids in patient care, its primary role is pressure management, not therapeutic intervention in itself.
No
Explanation: The device is described as a monitor that regulates and maintains pressure within an endotracheal or tracheostomy tube cuff. While it measures and monitors pressure, its primary function is active pressure management and maintenance, not the diagnosis of a condition or disease.
No
The device description explicitly states it consists of a "control unit" with "electronic automatic pressure controller with a pressure sensors and a pump," indicating significant hardware components beyond just software.
Based on the provided information, the Venner™ Tracheal Seal Monitor (TSM) is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Venner™ TSM Function: The Venner™ TSM is a device that directly interacts with a patient's airway (trachea) to monitor and regulate the pressure of an endotracheal or tracheostomy tube cuff. It does not analyze biological specimens.
- Intended Use: The intended use clearly states it's for monitoring, maintaining, and regulating pressure within a cuff in adult patients. This is a physiological monitoring and control function, not an in vitro diagnostic test.
- Device Description: The description details a pressure controller, sensors, and a pump, all components related to mechanical pressure management within the airway, not laboratory analysis of specimens.
Therefore, the Venner™ Tracheal Seal Monitor is a medical device used for patient monitoring and support, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
"The Venner™ Tracheal Seal Monitor (TSM) is indicated for use to monitor, maintain and regulate the pressure within the PneuX P.Y.TM Endotracheal or Tracheostomy Tube Cuff in adult patients who have been confined to hospital ICU units where intubation is expected to be more than 24 hours, but less than or equal to 30 days."
Product codes
BSK
Device Description
The Venner™ Tracheal Seal Monitor consists of an automatic inflation cuff controller (control unit) that connects to the Venner™ PneuX P.Y.TM Endotracheal or Tracheostomy Tube using a single patient use, sterile extension tube. The Venner™ Tracheal Seal Monitor regulates and maintains cuff pressure in endotracheal and tracheostomy tubes in adult patients in the intensive care unit (ICU) setting. The device is intended to measure, monitor and maintain a stable cuff pressure in endotracheal and tracheostomy tubes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Trachea
Indicated Patient Age Range
Adult patients
Intended User / Care Setting
Intended Users: Prescription device - healthcare professionals
Care Setting: hospital ICU units
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
Performance testing was performed to demonstrate that the Venner™ Tracheal Seal Monitor met its specifications, and is suitable and ready for commercial distribution. These tests evaluated the ability of the Venner™ Tracheal Seal Monitor to maintain and regulate cuff pressure in a variety of settings. Studies established the accuracy of the Venner™ Tracheal Seal Monitor to maintain the selected pressure; the device met its specified accuracy of +/- 5%. Other studies evaluated the ability of the Venner™ Tracheal Seal Monitor to regulate and maintain cuff pressure in a variety of physical settings, and the reaction time of the device to change the pressure in the cuff. In each study, the Venner™ Tracheal Seal Monitor was able to maintain and regulate the pressure of a cuff of an airway tube, and to quickly adapt to changes in the environment or changes programmed by the user. These studies also evaluated the performance of the safety over-pressure valve to demonstrate that the valve automatically opened with an audible "click" when the calculated cuff-tracheal seal wall pressure exceeded 57 mm Hg, and subsequently closed (or reset) when the calculated cuff-tracheal seal wall pressure returned to 27 mm Hg for safe operation. The safety valve performed within specifications and met the acceptance criteria.
The Venner™ Tracheal Seal Monitor underwent system level software verification and validation testing to demonstrate the device performs as intended, and meets its requirements. The device passed all testing and met its specifications.
The Venner™ Tracheal Seal Monitor met international safety standards, including electrical and electromagnetic safety testing (EN 60601-1, 60601-2 and 60601-4).
The sponsor also performed a series of tests to demonstrate that its device can withstand exposure to environmental stresses (i.e., random vibration, sinusoidal vibration and bump) and continue to perform as intended. In these studies, the Venner Tracheal Seal Monitor was tested according to the following standards: IEC 60068-2-64: Random Vibration, IEC 60068-2-6: Sinusoidal Vibration; IEC 60068-2-64: Random Vibration; and IEC 60068-2-27: Bump. The device successfully completed the testing.
Key Metrics
Pressure Accuracy: +/- 5% of set value
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
1 Information obtained from the purged 510(k) application K885216.
2 Information obtained from the 510(k) Summary for K092733 dated February 26, 2010.
4
5
TECHNOLOGICAL CHARACTERISTICS COMPARED TO THE PREDICATE 6 DEVICES
The Venner™ Tracheal Seal Monitor and the predicate devices share many of the same technological characteristics as summarized in the previous table. All of the devices share the same primary function: that is, to obtain a cuff-to-tracheal seal pressure of approximately 25-30 cm H2O to ensure that the cuff provides a proper seal between the tube and the patient's trachea to prevent the leakage of liquids and risk of aspiration, and to minimize the risk of over-pressure and damage to the trachea.
Two of the devices (the Venner™ Tracheal Seal Monitor and the PYTON Cuff Pressure Regulator) accomplish this goal by using a software-based, electro-mechanical control unit with similar accuracies in their measurements and other features, including alarms, indicators and safety features. Please refer to the table for additional details.
7 PERFORMANCE TESTING
The 510(k) submission provided performance data to establish the substantial equivalence of the Venner™ Tracheal Seal Monitor to the predicate devices. Performance testing was performed to demonstrate that the Venner™ Tracheal Seal Monitor met its specifications, and is suitable and ready for commercial distribution.
These tests evaluated the ability of the Venner™ Tracheal Seal Monitor to maintain and regulate cuff pressure in a variety of settings, and often compared its performance to other devices. These studies established the accuracy the Venner™ Tracheal Seal Monitor to maintain the selected pressure; the device met its specified accuracy of ± 5%. Other studies evaluated the ability of the Venner™ Tracheal Seal Monitor to regulate and maintain cuff pressure in a variety of physical settings, and the reaction time of the device to change the pressure in the cuff. In each study, the Venner™ Tracheal Seal Monitor was able to maintain and regulate the pressure of a cuff of an airway tube, and to quickly adapt to changes in the environment or changes programmed by the user. These studies also evaluated the performance of the safety over-pressure valve to demonstrate that the valve automatically opened with an audible "click" when the calculated cuff-tracheal seal wall pressure exceeded 57 mm Hg, and subsequently closed (or reset) when the calculated cuff-tracheal seal wall pressure returned to 27 mm Hg for safe operation. The safety valve performed within specifications and met the acceptance criteria.
The Venner™ Tracheal Seal Monitor underwent system level software verification and validation testing to demonstrate the device performs as intended, and meets its requirements. The device passed all testing and met its specifications.
The Venner™ Tracheal Seal Monitor met international safety standards, including electrical and electromagnetic safety testing (EN 60601-1, 60601-2 and 60601-4).
The sponsor also performed a series of tests to demonstrate that its device can withstand exposure to environmental stresses (i.e., random vibration, sinusoidal vibration and bump) and continue to perform as intended. In these studies, the Venner Tracheal Seal Monitor was
6
tested according to the following standards: IEC 60068-2-64: Random Vibration, IEC 60068-2-6: Sinusoidal Vibration; IEC 60068-2-64: Random Vibration; and IEC 60068-2-27: Bump. The device successfully completed the testing.
CONCLUSIONS 8
This 510(k) submission demonstrates that the Venner™ Tracheal Seal Monitor is substantially equivalent to the predicate devices.
7
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Venner Medical (Singapore) PTE Limited C/O Christine Brauer, Ph.D. Regulatory Affairs Consultant Brauer Device Consultants 7 Trail House Court Rockville, Maryland 20850
JUL 28 2011
Re: K110631
Trade/Device Name: Venner™ Tracheal Seal Monitor Regulation Number: 21 CFR 868.5750 Regulation Name: Inflatable Tracheal Tube Cuff Regulatory Class: II Product Code: BSK Dated: June 22, 2011 Received: June 24, 2011
Dear Dr. Brauer:
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.
8
Page 2 - Dr. Brauer
Please be advised that FDA's issuance of a substantial equivalence determination docs 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/CDR /CDRHOffices/ucm1 5809.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,
Anthony D. Ams
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
9
510(k) Number (if known):
Venner™ Tracheal Seal Monitor Device Name:
Indications for Use:
The Venner™ Tracheal Seal Monitor (TSM) is indicated for use to monitor, maintain and requlate the pressure within the Pneux P. Y. ™ Endotracheal or Tracheostomy Tube Cuff in adult patients who have been confined to hospital ICU units where intubation is expected to be more than 24 hours, but less than or equal to 30 days.
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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
L Schutthelm
(Division Sign-Ott) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K110631
Page 1 of 1