Venti-Trach Tracheostomy Tube (570 Series); Venti-Trach Tracheostomy Tube (571 Series); Venti-Trach Tracheostomy Tube (580 Series); Venti-Trach Tracheostomy Tube (581 Series)

{0} FDA U.S. FOOD & DRUG ADMINISTRATION September 11, 2026 Vitaltec Corporation % Ming-Yie Jan Principal Consultant RUSCERT Technology Co., LTD. 8F., No. 187, Lequn 2nd Rd., Zhongshan Dist. Taipei City, 10462 Taiwan Re: K253063 Trade/Device Name: Venti-Trach Tracheostomy Tube (570 Series); Venti-Trach Tracheostomy Tube (571 Series); Venti-Trach Tracheostomy Tube (580 Series); Venti-Trach Tracheostomy Tube (581 Series) Regulation Number: 21 CFR 868.5800 Regulation Name: Tracheostomy Tube And Tube Cuff Regulatory Class: Class II Product Code: BTO Dated: August 14, 2026 Received: August 14, 2026 Dear Ming-Yie Jan: 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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K253063 - Ming-Yie Jan Page 2 Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. {2} K253063 - Ming-Yie Jan Page 3 See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # Bradley Q. Quinn -S Bradley Quinn Assistant Director DHT1C: Division of Anesthesia, Respiratory, and Sleep Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} | Indications for Use | | | | --- | --- | --- | | Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K253063 | ? | | Please provide the device trade name(s). | | ? | | Venti-Trach Tracheostomy Tube (570 series); Venti-Trach Tracheostomy Tube (571 series); Venti-Trach Tracheostomy Tube (580 series); Venti-Trach Tracheostomy Tube (581 series) | | | | Please provide your Indications for Use below. | | ? | | Venti-Trach tracheostomy tube is indicated for airway maintenance of tracheostomized patients. The device is operated by health professionals in medical institutions for single patient use. It may be continuous use by replacement and each one should be used within 29 days. | | | | Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? | {4} # 510(k) Summary ## Venti-Trach Tracheostomy Tube ### 1. General Information | 510(k) Owner | Vitaltec Corporation | | --- | --- | | Address | No. 12, Lane 4-30, Chyuan-Zhou Rd., Hou-Li Dist. | | Applicant | Joseph Chang / Managing Director | | Contact Information | Phone: 886-4-2558 0886 Email: sales@vitaltec.com.tw | | Date prepared | September 17, 2025 | ### 2. Subject Device Description | Proprietary Name | Venti-Trach Tracheostomy Tube | | --- | --- | | Regulation Number | 21 CFR 868.5800 | | Regulation Name | Tracheostomy tube and tube cuff | | Regulatory Class | Class II | | Product Code | BTO | | Common Name | Tracheostomy Tube | ### 3. Predicate Device | Proprietary Name | Rota-Trach Disposable Standard Tracheostomy Tube | | --- | --- | | Premarket Notification | K242921 | | Regulation Number | 21 CFR 868.5800 | | Regulation Name | Tracheostomy tube and tube cuff | | Regulatory Class | Class II | | Product Code | BTO | | Common Name | Tracheostomy Tube | ### 4. Device Description Venti-Trach Tracheostomy Tube is a respiratory device inserted into the patient's trachea through a stoma, making direct contact with the tracheal mucosal membrane 5-1 {5} tissue. It may be with or without a cuff attaching around the tube of the device. The design of the cuff could seal the space between the tube and the patient's trachea from inhaling undesired or foreign matters and for assistance of positive pressure ventilation. # 5. Indications for Use: Venti-Trach tracheostomy tube is indicated for airway maintenance of tracheostomized patients. The device is operated by health professionals in medical institutions for single patient use. It may be continuous use by replacement and each one should be used within 29 days. # 6. Substantial Equivalence Table below provides a comparison of the indications for use and key technological characteristics of Venti-Trach Tracheostomy Tube with that of the Predicate, Rota-Trach Disposable Standard Tracheostomy Tube (K242921). | Model Particular | Subject Device Venti-Trach Tracheostomy Tube | Predicate Device Rota-Trach Disposable Standard Tracheostomy Tube | Comparison (Same/ Similar/ Different) | | --- | --- | --- | --- | | Intended use defined under 21 CFR 872.4200 | Venti-Trach Tracheostomy Tube is intended for the airway management of tracheostomized adult patients. The device is operated by health professionals in medical institutions for single patient use. It may be continuous use by replacement and each one should be used within 29 days. | Rota-Trach Disposable Standard Tracheostomy Tube is intended for the airway management of tracheostomized adult patients. The device is operated by health professionals in medical institutions for single patient use. It may be continuous use by replacement and each one should be used within 29 days. | Same | | Indications for use | Venti-Trach Disposable Standard Tracheostomy Tube is indicated for airway maintenance of tracheostomized patients. | Rota-Trach Disposable Standard Tracheostomy Tube is indicated for airway maintenance of tracheostomized patients. | Same | 5-2 {6} | **Patient Population** | Adults with average height, weight, and anthropometrics | Adults with average height, weight, and anthropometrics | Same | | --- | --- | --- | --- | | **Principle of operation** | The tracheostomy tube functions as an artificial airway by being inserted into the trachea through a tracheostomy stoma. It serves as a conduit for ventilation and oxygenation while allowing connection to respiratory care devices. The tube is secured in place using integrated locking mechanisms and a neck strap. If present, a fenestration permits partial airflow through the vocal cords to facilitate speech. An introducer is used to assist with insertion and is removed afterward. | The tracheostomy tube functions as an artificial airway by being inserted into the trachea through a tracheostomy stoma. It serves as a conduit for ventilation and oxygenation while allowing connection to respiratory care devices. The tube is secured in place using integrated locking mechanisms and a neck strap. If present, a fenestration permits partial airflow through the vocal cords to facilitate speech. An introducer is used to assist with insertion and is removed afterward. | Same | | **Invasive or Noninvasive** | Surgically Invasive | Surgically Invasive | Same | | **Maximum Use** | Recommended 29 Days | Recommended 29 Days | Same | | **Functionality** | Venti-Trach Tracheostomy Tube provides an alternate pathway for breathing when the natural airway is blocked or injured. It creates direct route to the trachea, bypassing upper airway obstructions. It can be connected to respiratory equipment, like ventilators, to assist with breathing and provide mechanical ventilation. | Rota-Trach Tracheostomy Tube provides an alternate pathway for breathing when the natural airway is blocked or injured. It creates direct route to the trachea, bypassing upper airway obstructions. It can be connected to respiratory equipment, like ventilators, to assist with breathing and provide mechanical ventilation. | Same | 5-3 {7} | Dimension | The tube has a fixed curvature of 105°. Dimensions for each size are specified as follows: ID (Inside Diameter): Cannula internal diameter, also expressed as the tube size. OD (Outside Diameter): Cannula external diameter. TL (Tube Length): Overall length of the tube. CRD (Cuff Resting Diameter, Ø mm): For cuffed models only. | The tube has a fixed curvature of 100°. Dimensions for each size are specified as follows: ID (Inside Diameter): Cannula internal diameter, also expressed as the tube size. OD (Outside Diameter): Cannula external diameter. TL (Tube Length): Overall length of the tube. CRD (Cuff Resting Diameter, Ø mm): For cuffed models only. | Similar (Analysis 1) | | --- | --- | --- | --- | | Size/ID (mm) | OD (mm) | TL (mm) | CRD (mm) | Size/ID (mm) | OD (mm) | TL (mm) | CRD (mm) | | 6.0 | 9.0 | 64 | 21 | 6.0 | 8.3 | 55 | 21 | | 6.5 | 9.5 | 67 | 22 | 6.5 | 9.0 | 60 | 22 | | 7.0 | 10.0 | 70 | 24 | 7.0 | 9.6 | 65 | 23 | | 7.5 | 10.5 | 74 | 26 | 7.5 | 10.3 | 70 | 24 | | 8.0 | 11.0 | 77 | 28 | 8.0 | 11.0 | 76 | 26 | | 8.5 | 11.5 | 78 | 30 | 8.5 | 11.6 | 82 | 28 | | 9.0 | 12.0 | 81 | 30 | 9.0 | 12.3 | 89 | 30 | | 10.0 | 13.0 | 87 | 33 | 10.0 | 13.3 | 97 | 33 | | Material Composition | Cannula | PVC | Cannula | PVC | Similar (Analysis 2) | | 15mm connector | PP | 15mm connector | PP | | Cuff | PVC | Cuff | PVC | | Neck plate | PVC | Neck plate | TPR | | Pilot ballon w/t inflating tube | PVC | Pilot ballon w/t inflating tube | PVC | | Introducer | HDPE | Introducer | HDPE | | Neck strap | 100% Cotton | Neck strap | 100% Cotton | | | | Component | Cannula; 15mm connector; cuff; neck plate; | Cannula; 15mm connector; cuff; neck plate; | Similar (Analysis 3) | 5-4 {8} | | pilot ballon w/t inflating tube; introducer; neck strap. | pilot ballon w/t inflating tube; introducer; neck strap; disconnect wedge | | | --- | --- | --- | --- | | **Sterilization** | Ethylene Oxide (EO) Sterile SAL 10^{-6} to End User | Ethylene Oxide (EO) Sterile SAL 10^{-6} to End User | Same | | **Shelf Life** | 3-year shelf life intended | 3-year shelf life intended | Same | | **Single Use Single Patient Use** | Yes | Yes | Same | | **Environment of Use** | Critical care settings, Acute care settings, Long term care facilities | Critical care settings, Acute care settings, Long term care facilities | Same | | **Biocompatibility** | Compatibility materials ISO 10993-1: 2018 | Compatibility materials ISO 10993-1: 2009 | Similar Subject device conforms to ISO 10993-1:2018 (latest version, superseding ISO 10993-1:2009 used for predicate). No new biocompatibility risk is introduced. | | **Biocompatibility evaluation endpoints** | Cytotoxicity, sensitization, irritation, acute systemic toxicity, pyrogenicity, subchronic toxicity, genotoxicity, implantation and chemical characterization. | Cytotoxicity, sensitization, irritation, acute systemic toxicity, pyrogenicity, subchronic toxicity, genotoxicity, implantation and chemical characterization. | Same | | **Device standard** | ISO 5366:2016 ISO 18190:2016 ISO 5356-1:2015 | ISO 5366:2016 ISO 18190:2016 ISO 5356-1:2015 | Same | ### Substantial Equivalence Discussion #### Analysis 1: The subject device incorporates a 105° tube curvature, compared with the 100° curvature of the predicate device, leading to minor variations in tube length, outer 5-5 {9} diameter and cuff diameter. For devices of the same size specification, the total tube length differs by less than 10 mm, the outer diameter by less than 0.7 mm, and the cuff diameter by less than 2 mm. These geometric differences have been verified through applicable tests in accordance with ISO 5366:2016 (see Design Control Activities Summary), and are disclosed in the Instructions for Use (IFU) and product labeling. # **Analysis 2:** The subject device differs from the predicate device by a material change in the neck plate, from TPR to PVC. No new biocompatibility testing is needed because the same PVC material is already used in the predicate device's tube, which has direct airway contact. Since the subject device's neck plate only touches intact skin, the risk of a new biological response is considered lower than what has already been proven safe, thus justifying the change without additional testing. Please refer to Biocompatibility Evaluation (RDE-23090001) for the detail justification of the biological risk. # **Analysis 3:** The subject device does not include a disconnect wedge. According to the following, the absence of a wedge does not impact device safety or performance. (1) The neck plate material was changed from TPR to PVC, providing higher rigidity and stability so that removal does not require auxiliary tools. (2) The 15 mm connector conforms with ISO 5366 and ISO 5356-1, allowing safe removal by standard handling. (3) The wedge is not a standard requirement. Some marketed models, such as the marketed device K173384 (IFU #10001029-004), do not include this accessory. # **Conclusion** According to the discussion above, the indications for use of subject device, Venti-Trach Tracheostomy Tube is same as predicate device, Rota-Trach Disposable Standard Tracheostomy Tube, and the other differences in non-significant characteristics are clarified, the substantial equivalent is claimed. Since the differences of the devices do not raise different questions of safety and effectiveness, Venti-Trach Tracheostomy Tube is as safe and effective as legally marketed Rota-Trach Disposable Standard Tracheostomy Tube. # **7. Design Control Activities** The risks arisen from the design modifications activities have been identified and evaluated are controlled through a failure modes and effects analysis (FMEA) that described in FDA-recognized standard, ISO 14971:2019. The safety and effectiveness of Venti-Trach Tracheostomy Tube are also verified and validated according to device-specific, FDA-recognized standard, ISO 5366:2016, ISO 5356-1:2015, ISO 10993-1:2018 and ASTM F1980. 5-6 {10} ## **8. Conclusion** Based on the information provided in this premarket notification, the same indications for use with small modifications, Venti-Trach Tracheostomy Tube raises no new questions of safety and effectiveness and subject device is substantially equivalent to predicate device in terms of safety, effectiveness, and performance. 5-7