Sheridan Spiral-Flex Endotracheal Tubes

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. TeleflexMedical, Inc Lori Pfohl Senior Regulatory Affairs Specialist 3015 Carrington Mill Blvd, Suite 600 North Morrisville, North Carolina 27560 Re: K192324 Trade/Device Name: Sheridan Spiral-Flex Endotracheal Tubes Regulation Number: 21 CFR 868.5730 Regulation Name: Tracheal Tube Regulatory Class: Class II Product Code: BTR Dated: August 22, 2019 Received: August 27, 2019 ## Dear Lori Pfohl: 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. 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 located 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. 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 {1}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-device-safety/medical-device-reportingmdr-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/medicaldevices/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. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/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, Todd Courtney Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) #### Device Name Sheridan Spiral-Flex Endotracheal Tubes #### Indications for Use (Describe) Sheridan cuffed, uncuffed and reinforced tracheal tubes are designed for oral or nasal intubation and are indicated for airway management. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------| | <span style="font-family: DejaVu Sans, sans-serif">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: DejaVu Sans, sans-serif">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff @fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## 510(k) Summary ## A. Name, Address, Phone and Fax Number of Applicant Teleflex Medical, Inc. 3015 Carrington Mill Blvd Morrisville, NC 27560 Phone: 919-433-4831 Fax: 919-361-3939 ## B. Contact Person Lori Pfohl Senior Regulatory Affairs Specialist ## C. Date Prepared August 23, 2019 ## D. Device Name | Trade Name: | Teleflex Sheridan Spiral-Flex Tracheal Tube | |-----------------------|---------------------------------------------| | Common Name: | Tube, Tracheal | | Product Code: | BTR | | Regulation Number: | CFR 868.5730 | | Classification Name: | Tracheal Tube | | Classification: | II | | Classification Panel: | Anesthesiology | ## E. Predicate Device This submission demonstrates substantial equivalence to the predicate device: Sheridan Reinforced Tracheal Tube K844296 and Spiral-Flex Tracheal Tube K860105 ## F. Device Description The Sheridan Spiral-Flex Endotracheal Tubes are spiral tracheal tubes that are inserted into the trachea via the mouth or the nose in order to establish a patent airway to allow ventilation. The subject device are sterile, single use devices. The tracheal tubes contain a compatible cuff, inflation line, pilot balloon and one-way valve. Each tracheal tube is supplied with an appropriately sized 15mm connector. {4}------------------------------------------------ ## G. Indications for Use Sheridan cuffed, uncuffed and reinforced tracheal tubes are designed for oral or nasal intubation and are indicated for airway management. ## H. Contraindications None ## I. Substantial Equivalence The subject device is substantially equivalent to the predicate devices with respect to intended use, technology and construction. The differences between the predicates and the subject devices are minor and any risks have been mitigated through testing. Table 07.1 summarizes the differences between the subject and predicate device. The subject devices are substantially equivalent to the predicate device: | Features | Teleflex Sheridan Spiral-Flex<br>Tracheal Tube (Subject<br>Device) | Teleflex<br>Sheridan Reinforced<br>Tracheal Tube<br>K844296 (Predicate<br>Device 1) | Teleflex Sheridan<br>Spiral-Flex Tracheal<br>Tube K860105<br>(Predicate Device-2) | |------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------| | Classification<br>Name | Tracheal Tube | Same | Same | | Regulation<br>Number | 868.5730 | Same | Same | | FDA Procode | BTR | BTR | BTR | | Class | II | Same | Same | | Indication for Use | Sheridan cuffed, uncuffed<br>and reinforced tracheal tubes<br>are designed for oral or nasal<br>intubation and are indicated<br>for airway management. | Intended for airway<br>management<br>procedures requiring<br>flexing of the neck | Airway management<br>procedures requiring<br>flexing of the neck | | Contraindications | None | None | None | | Single Use | Yes | Yes | Same | | Population | Adult and Pediatric | Adult | Adult and Pediatric | | Size Range | Cuffed oral/nasal 5.0–9.0 mm<br>Uncuffed 3.0–5.0 mm | Oral 5.0 – 10.0 mm<br>Nasal 5.0 – 9.0 mm | Uncuffed<br>Oral 2.0 – 7.0 mm<br>Nasal 2.0 – 7.0 mm | Table 07.1 - Comparison of Predicate vs. Subject Devices {5}------------------------------------------------ | Sterile | Yes | Yes | Same | |-------------------------|----------------------------------------------------------------------|----------------|----------------| | Sterilization<br>Method | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide | | Valve System | Integral pilot balloon and<br>valve | Same | Same | | Shaft Material | PVC. Spiral wire completely<br>embedded between two<br>layers of PVC | Same | Same | | Connector | Standard 15mm | Same | Same | | Cuff Design | High Volume tapered cuff | Same | Same | | Murphy Eye | Yes | Same | Same | | Bite Block | Yes | Same | Same | | Stylet | Yes | Same | Same | | Tube Tip | Beveled | Same | Same | | X-Ray Marker | At extreme end | Same | Same | ## J. Comparison to the Predicate Table 7.1 illustrates the similarities and differences between the subject and predicate devices. The basic technological and operating principles are the same for both devices. Although the wording is not identical, both the subject and predicate devices are for airway management. Both the subject and predicate devices are intended for similar patient populations adult and pediatric, male and female. Both the subject and predicate devices are disposable, sterile, single patient use devices. As evidenced by comparison Table 7.1. above, the subject device is substantially equivalent to the predicate device. There are no significant differences that would affect safety and efficacy. ## K. Performance Data The bench testing performed verifies that the performance of the subject device is substantially equivalent in terms of critical performance characteristics to the predicate device. These tests include: - Visual Inspection (No delamination on tip of reinforced tubes) ● - Cuff inflation deflation test ● - Inflation system leak test - Cuff herniation test - Pilot Cuff Pull test ● - Simulated Use Test - ISO 10993-1:2009 - Biological Evaluation of Medical Devices -- Part 1: Evaluation and testing within a risk management process The testing performed verifies that the performance of the subject device is substantially equivalent in terms of critical performance characteristics to the predicate device. The subject devices were tested to the requirements of ASTM F623. {6}------------------------------------------------ # L. Conclusion The subject device has the same intended use and technological characteristics and construction as the predicate. Test results demonstrate that the subject device meets it's intended use. It is for these reasons that the subject device can be found substantially equivalent to the predicate devices.