← Product Code [BTO](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTO) · K100950 # VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE (K100950) _Venner Medical (Singapore) Pte, Ltd. · BTO · Jul 13, 2010 · Anesthesiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTO/K100950 ## Device Facts - **Applicant:** Venner Medical (Singapore) Pte, Ltd. - **Product Code:** [BTO](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTO.md) - **Decision Date:** Jul 13, 2010 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 868.5800 - **Device Class:** Class 2 - **Review Panel:** Anesthesiology - **Attributes:** Therapeutic ## Intended Use The Venner Pneux P.Y.TM Tracheostomy Tube (TT) is a tracheostomy tube intended to be inserted into the patient's trachea via a tracheostomy stoma during extended periods (not more than 30 days) of intensive or critical care to facilitate ventiliation and for evacuation or drainage of secretion from the subglottice space. ## Device Story Venner Pneux P.Y. Tracheostomy Tube; inserted into patient trachea via stoma; used in intensive/critical care settings for up to 30 days; facilitates mechanical ventilation; provides subglottic space drainage/secretion evacuation; operated by clinicians; benefits patient by maintaining airway patency and reducing risk of ventilator-associated complications through secretion management. ## Clinical Evidence Bench testing only. ## Technological Characteristics Tracheostomy tube; includes cuff for tracheal seal; designed for subglottic suctioning; intended for short-term use (up to 30 days). ## Regulatory Identification A tracheostomy tube and tube cuff is a device intended to be placed into a surgical opening of the trachea to facilitate ventilation to the lungs. The cuff may be a separate or integral part of the tracheostomy tube and is, when inflated, intended to establish a seal between the tracheal wall and the tracheostomy tube. The cuff is used to prevent the patient's aspiration of substances, such as blood or vomit, or to provide a means for positive-pressure ventilation of the patient. This device is made of either stainless steel or plastic. ## Related Devices - [K093135](/device/K093135.md) — VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE AND ENDO TRACHEAL TUBE · Venner Medical (Singapore) Pte, Ltd. · Apr 2, 2010 - [K122531](/device/K122531.md) — SHILEY NEONATAL TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY T · Covidien · Oct 9, 2012 - [K193077](/device/K193077.md) — Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff · Covidien · Jun 1, 2020 - [K242921](/device/K242921.md) — 5300600-5301000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, sizes 6.0-10.0mm; 5310600-5311000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, Fenestrated, sizes 6.0-10.0mm; 5400600-5401000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, sizes 6.0-10.0mm; 5410500-5411000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, Fenestrated, sizes 6.0-10.0mm · Vitaltec Corporation · Jun 10, 2025 - [K192511](/device/K192511.md) — Venner PneuX™ TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 8.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 9.0 mm · Venner Medical (Singapore) Pte, Ltd. · Jul 22, 2020 ## Submission Summary (Full Text) {0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three curved shapes that resemble a stylized human form or a caduceus, a symbol often associated with medicine and healthcare. The logo is black and white. ### DEPARTMENT OF HEALTH & HUMAN SERVICES 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 Advena Limited 2626 Valley View Lane, Suite 4 Dallas, Texas 75234 JUL 1 8 2010 Re: K100950 Trade/Device Name: Venner Pneux P.Y. "Tracheostomy Tube Regulation Number: 21 CFR 868.5800 Regulation Name: Tracheostomy Tube and Tube Cuff Regulatory Class: II Product Code: BTO Dated: July 2, 2010 Received: July 9, 2010 Dear Ms. Burton: 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. {1}------------------------------------------------ ## Page 2- Ms. 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely vours. for Watson, B.S., M.S., M.B.A. At thony I Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health ## Enclosure {2}------------------------------------------------ # SECTION 4 - Indications for Use Statement #### Indications for Use 510(k) Number (if known): Device Name: Venner Pneux P.Y.TM TracheostomyTube The Venner PneuxP. Y.TM Tracheostomy Tube (TT) is a tracheostomy tube intended to be inserted into the patient's trachea via a tracheostomy stoma during extended periods (not more than 30 days) of intensive or critical care to facilitate ventiliation and for evacuation or drainage of secretion from the subglottice space. Prescription Use _X AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) # (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IFNEEDED) :. Concurrence of CDRH, Office of Device Evaluation (ODE) L. Schutter 510(k) Number: Page 1 of 1 (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices 100950 4-1 --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTO/K100950](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTO/K100950) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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