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.

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. The Venner™ Tracheal Seal Monitor consists of an electronic automatic pressure controller with a pressure sensors and a pump, and provides a user interface with adjustable settings, indicators and alarms.

AI/ML Overview

The Venner™ Tracheal Seal Monitor is indicated for use to monitor, maintain, and regulate the pressure within the PneuX P.Y.™ Endotracheal or Tracheostomy Tube Cuff in adult patients in ICU units where intubation is expected to be more than 24 hours but less than or equal to 30 days.

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Pressure Accuracy: ± 5% of set value	Met: The device met its specified accuracy of ± 5%.
Safety Valve Operation: Automatically open when calculated cuff-tracheal seal wall pressure exceeds 57 mmHg and close/reset when it returns to 27 mmHg	Met: The safety valve performed within specifications.

Study Details

Sample Size and Data Provenance:
The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). While "a variety of settings" and "other devices" are mentioned as comparators, specific details are lacking.

Number of Experts and Qualifications:
Not specified. The document does not indicate the number of experts used to establish ground truth or their qualifications.

Adjudication Method:
Not specified. The document does not describe any adjudication method for establishing ground truth.

Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. The performance testing focused on the device's technical specifications and engineering performance rather than its impact on human reader performance.

Standalone Performance (Algorithm Only):
Yes, a standalone performance study was done. The performance testing evaluated the device's ability to maintain and regulate cuff pressure, its reaction time to change pressure, and the performance of its safety over-pressure valve. This involved testing the device against its specifications in various physical settings and environmental stresses. The device also underwent system-level software verification and validation testing to ensure it performed as intended and met its requirements.

Type of Ground Truth:
The ground truth used for performance testing appears to be based on engineering specifications and predefined thresholds. For example, the pressure accuracy was compared against a ± 5% tolerance, and the safety valve operation was evaluated against specific pressure thresholds (57 mmHg for opening, 27 mmHg for closing/resetting).

Sample Size for Training Set:
Not applicable. The described testing is not typical for an AI/ML algorithm that would require a "training set." The device is an electro-mechanical control unit with software, and its validation focused on meeting pre-defined engineering and safety standards.

How Ground Truth for Training Set Was Established:
Not applicable, as there was no explicit "training set" in the context of an AI/ML algorithm. The ground truth for the device's performance was established through its design specifications and industry safety standards to demonstrate functional accuracy and safety.

Summary

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< 11063 / JUL 28 2011

SUMMARY OF SAFETY AND EFFECTIVENESS

l GENERAL INFORMATION

1.1 Submitter and Owner of the 510(k)

Venner. Medical (Singapore) Pte Ltd 35 Joo Koon Circle Singapore 629110

1.2 Official Correspondent

Christine L. Brauer, PhD Regulatory Affairs Consultant 7 Trail House Court Rockville, MD 20850

Telephone: (301) 545-1990 Fax: (301) 545-1992 E-mail: chrisbrauer@earthlink.net

1.3 Date of Preparation

February 25, 2011

NAME OF THE DEVICE 2

2.1 Trade/Proprietary Name

Venner™ Tracheal Seal Monitor

Common/Usual Name 2.2

Cuff pressure regulator and monitor

2.3 Classification Information

Classification Name: Inflatable Tracheal Tube Cuff

Classification Regulation: 21 CFR § 868.5750

Class: ||

Product Code: BSK

Anesthesiology Panel:

000010

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3 PREDICATE DEVICES

The predicate devices are as follows:

1. the Lanz Pressure Valve cleared under premarket notification K885216; and,
1. the PYTON Cuff Pressure Regulator cleared under premarket notification K092733.

The predicate devices are cuff pressure regulators, have been cleared by FDA and classified under 21 CFR § 868.5750, as Class II medical devices.

DESCRIPTION OF THE DEVICE 4

During intubation, variations in cuff pressure may occur for multiple reasons, including the transfusion of gases through the cuff, changes in tracheal compliance, modifications in the location of the cuff within the airway, and other reasons. Maintaining a consistent and stable cuff pressure is intended to help minimize complications. such as excessive tracheal wall pressure that may lead to necrosis, and problems associated with inadequate tracheal wall pressure, such as aspiration pneumonia.

The Venner™ Tracheal Seal Monitor consists of an electronic automatic pressure controller with a pressure sensors and a pump, and provides a user interface with adjustable settings, indicators and alarms. The Venner Tracheal Seal Monitor is intended to be used with the following commercially available devices:

1. The Venner™ Pneux P.Y.™ Endotracheal Tube: This endotracheal tube was cleared by FDA under premarket notification K093135. It is a straight, cuffed, wire reinforced tracheal tube. It is packaged separately and provided as a sterile, single use device.
1. The Venner™ PneuX P.Y.TM Tracheostomy Tube: The tracheostomy tube was cleared by FDA under premarket notification K100950. It is a straight, flexible, cuffed tracheostomy tube with an adjustable neck plate. It is packaged separately and provided as a sterile, single use device.
1. Extension Tube: The extension tube is a class I. medical device exempt from premarket notification under 21 CFR § 868.5860. The extension tube connects the Venner Tracheal Seal Monitor to the cuff of an endotracheal or tracheostomy tube. It uses a non-luer connector at the proximal end to connect to the control unit and a patented luer slip connector at the distal end with a unique design feature to prevent

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accidental misconnection of the air line to a standard luer lock connector (i.e., standard infusion sets and catheters with female lugged luer lock connectors). It is packaged separately and provided as a sterile, single patient use device.

5 INDICATIONS FOR USE AND INTENDED USE

The Venner™ Tracheal Seal Monitor has the following 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."

This is the same intended use as the predicate devices.

The Venner™ Tracheal Seal Monitor and the predicate devices share the same intended use namely, to maintain and regulate pressure in the cuffs of endotracheal and tracheostomy tubes in patients who require intubation. Two of the devices (the Venner™ Tracheal Seal Monitor and the PYTON Cuff Pressure Regulator) also measure and monitor cuff pressure.

Each device is intended to ensure proper inflation of the cuff to provide a seal between the airway tube and the patient's trachea by maintaining and regulating cuff pressure. The Venner™ Tracheal Seal Monitor and the predicate devices all 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 overpressure and damage to the trachea. The devices are intended for use for the same patient population: patients who require intubation. The table on the following page establishes the Venner™ Tracheal Seal Monitor and the predicate devices have the same intended use.

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Device Characteristic	A Comparison of the Venner™ Tracheal Seal Monitor to the Predicate Devices
	Venner™ Tracheal Seal Monitor andExtension Tube	Lanz Pressure ValveMallinckrodt, Inc.K8852161	PYTON Cuff Pressure RegulatorARM Medical Devices, Inc.K0927332
Indications for Use	... is indicated for use to monitor, maintainand regulate the pressure within the PneuXP.Y.T™ Endotracheal or Tracheostomy TubeCuff in adult patients who have beenconfined to hospital ICU units whereintubation is expected to be more than 24hours, but less than or equal to 30 days	... is indicated for use with cuffedtracheal and tracheostomy tubes whenintracuff pressures of approximately 30cm H₂O are judged by the clinician to beappropriate	... to measure and regulate intra-cuffpressures of endotracheal supraglotticairways or tracheostomy tubes...forpatients who are intubated... in hospitals,pre-hospital (EMS), extended carefacilities and outpatient clinics...
Intended Use	To regulate and maintain cuff pressureTo measure and monitor cuff pressure	To regulate and maintain cuff pressure	To regulate and maintain cuff pressureTo measure and monitor cuff pressure
Intended Patient Population	Adult patients requiring intubation	Patients requiring intubation	Patients requiring intubation
Intended Users	Prescription device - healthcareprofessionals	Prescription device - healthcareprofessionals	Prescription device - healthcareprofessionals
Operational Environment	Intensive care units (ICU)	Unspecified	Multiple settings where a patient may beintubated, including the ICU
Primary Device Functions	To continuously measure cuff pressureTo regulate and maintain cuff pressure	To regulate and maintain cuff pressure	To continuously measure cuff pressureTo regulate and maintain cuff pressure
Cuff-Tracheal Seal PressureRange	Default: 30 cm H₂O (22 mmHg)Range: 10 - 50 mmHg in 10 mmHgintervals	Recommended setting: 30 cm H₂O	Default: 25 cm H₂ORange: 0 - 85 cm H₂O
Pressure Monitor and ControlMechanisms	Control unit consists of an electronic,software-driven device with pressuresensors and stepping motor to adjustpressure	Elastic balloon aids in regulating pressureby expanding and contracting	Control unit consists of an electronic,software-driven device with pressuresensors and pump to adjust pressure
Pressure Accuracy	$\pm$ 5% of set value	Not available	$\pm$ 2.0 cm H₂O
System Components	Control unit (capital equipment)Extension tube (single patient use) toconnect control unit to endotracheal ortracheostomy tube	Single patient use device attached to theendotracheal or tracheostomy tube	Control unit (capital equipment)Plastic tubing set (single patient use) toconnect control unit to endotracheal ortracheostomy tube
User Interface	Digital display with cuff pressure andpushbuttons	Visual inspection of balloon	LED back-lit LCD digital display with cuffpressure and pushbuttons
Device Characteristic	Venner™ Tracheal Seal Monitor and Extension Tube	Lanz Pressure ValveMallinckrodt, Inc.K885216¹	PYTON Cuff Pressure RegulatorARM Medical Devices, Inc.K092733²
Alarms	Multiple alarms, including alarms for pressure, air leak, malposition, blockage	One alarm when pressure exceeds 25 cm H₂O	Yes although details not provided
Safety Valve	Incorporates a pressure relief valve if cuff-tracheal seal pressure were to exceed 57 mmHg	No	Incorporates a pressure relief valve if cuff-tracheal seal pressure were to exceed 100 cm H₂O
Power source	Electrical	Manual	Electrical with battery backup

1 Information obtained from the purged 510(k) application K885216.
2 Information obtained from the 510(k) Summary for K092733 dated February 26, 2010.

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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

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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.

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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.

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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

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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

Regulation Number and Section

§ 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).