VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE AND ENDO TRACHEAL TUBE

K093135 · Venner Medical (Singapore) Pte, Ltd. · BTR · Apr 2, 2010 · Anesthesiology

Device Facts

• Record ID: K093135
• Device Name: VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE AND ENDO TRACHEAL TUBE
• Applicant: Venner Medical (Singapore) Pte, Ltd.
• Product Code: BTR · Anesthesiology
• Decision Date: Apr 2, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5730
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Venner PneuxP.Y.TM EndoTracheal Tube (ETT) is an endotracheal tube intended to be used for patients undergoing tracheal tube intubation during extended periods (not more than 30 deays) and for evacuation or drainage of secretion from the subglottice space. It is also compatible with tracheal intubation during routine anesthesia.

Device Story

Venner Pneux P.Y. EndoTracheal Tube (ETT) facilitates airway management; provides conduit for ventilation; features integrated lumen for subglottic secretion drainage. Used in clinical settings (OR, ICU) by physicians/anesthesiologists. Device inserted into trachea; cuff inflated to seal airway; suction applied to drainage port to remove secretions from subglottic space. Reduces risk of ventilator-associated pneumonia by preventing secretion aspiration. Mechanical device; no electronic components or software.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Endotracheal tube with integrated subglottic suction lumen. Materials: Medical grade plastics/polymers. Energy source: None (mechanical). Connectivity: None. Sterilization: Ethylene oxide (implied standard for tracheal tubes).

Indications for Use

Indicated for patients requiring tracheal intubation for extended periods (up to 30 days) and for subglottic secretion drainage. Compatible with routine anesthesia.

Regulatory Classification

Identification

A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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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 Ms. Judy Burton Director of US Operations Advena Limited 2626 Valley View Lane, Suite 4 Dallas, Texas 75234

MAY 2 4 2010

Re: K093135

Trade/Device Name: Venner Pneux P. Y. EndoTracheal Tube Regulation Number: 21 CFR 868.5730 Regulation Name: Tracheal Tube Regulatory Class: II Product Code: BTR Dated: March 25, 2010 Received: March 30, 2010

Dear Ms. Burton:

This letter corrects our substantially equivalent letter of April 2, 2010.

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- Ms. Judy Burton

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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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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# SECTION 4 - Indications for Use Statement

Indications for Use

510(k) Number (if known): K093135

Device Name: Venner Pneux P.Y.TM EndoTracheal Tube

The Venner PneuxP.Y.TM EndoTracheal Tube (ETT) is an endotracheal tube intended to be used for patients undergoing tracheal tube intubation during extended periods (not more than 30 deays) and for evacuation or drainage of secretion from the subglottice space. It is also compatible with tracheal intubation during routine anesthesia.

Prescription Use

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Concurrence of CDRH,

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(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

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510(k) Number: k093135