Glidesheath Slender Tibial Pedal Kit

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December 3, 2019 Terumo Medical Corporation Liang Lu Senior Regulatory Affairs Specialist 950 Elkton Blvd. Elkton, Maryland 21921 Re: K193160 Trade/Device Name: Glidesheath Slender Tibial Pedal Kit Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: November 14, 2019 Received: November 15, 2019 Dear Liang Lu: 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 mediation-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, For Misti Malone Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) #### K193160 Device Name Glidesheath Slender Tibial Pedal Kit Indications for Use (Describe) The Glidesheath Slender Tibial Pedal Kit is indicated to facilitate placing a catheter through the skin into the lower extremity peripheral vasculature below the knee. Type of Use (Select one or both, as applicable) | <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | |--------------------------------------------------------------------------------------| | ☐ 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. SUBMITTER INFORMATION (807.92(a)(1)) #### Prepared bv: Liang Lu Senior Regulatory Affairs Specialist Terumo Medical Corporation Tel. (410) 392-7321 Fax (410) 398-6079 Prepared for: Owner/Operator Terumo Medical Corporation 265 Davidson Avenue, Suite 320 Somerset, NJ 08873, USA Registration Number: 2243441 #### Manufacturer (510(k) Applicant) Terumo Medical Corporation 950 Elkton Boulevard, Elkton, MD 21921 Registration Number: 1118880 #### Sterilization Facility Steris Isomedix Services Inc. 3459 South Clinton Ave South Plainfield, NJ 07080 Registration Number: 2246552 Contact Person: Liang Lu Senior Regulatory Affairs Specialist Terumo Medical Corporation 950 Elkton Boulevard, Elkton, MD 21921 Tel. (410) 392-7321 Fax (410) 398-6079 E-mail: liang.lu@terumomedical.com Date prepared: December 3, 2019 {4}------------------------------------------------ ### B. DEVICE NAME (807.92(a)(2)) Glidesheath Slender Tibial Pedal Kit Proprietary Name: Common Name: Introducer Sheath Classification Name: Catheter Introducer Classification Panel: Cardiovascular Regulation: 21 CFR 870.1340 Product Code: DYB Classification: Class II ### C. PREDICATE DEVICE (807.92(a)(3)) The legally marketed device(s) to which substantial equivalence is claimed is: - . Predicate Device: K181237 - Glidesheath Slender Tibial Pedal Kit, manufactured by Terumo Medical Corporation ### D. REASON FOR 510(k) SUBMISSION This premarket notification (Special 510(k)) is being submitted to extend the current Glidesheath Slender Tibial Pedal Kit (7cm entry needle) product line to include a 4cm entry needle. ### E. DEVICE DESCRIPTION (807.92(a)(4)) Both the predicate Glidesheath Slender Tibial Pedal Kit (7cm needle) and the modified Glidesheath Slender Tibial Pedal Kit (4cm needle) are used to facilitate placing a catheter through the skin into the lower extremity peripheral vasculature below the knee. It consists of an introducer (sheath and dilator), which are packaged together with a mini guide wire, an entry needle and a guide inserter. During a diagnostic or interventional procedure in a cath lab, the stainless steel entry needle (cannula) is used to gain access to the vein or artery for placement of the mini guide wire. The nitinol mini guide wire is inserted through the cannula into the patient's blood vessel. The wire is used for placement of the sheath and dilator into the vein or artery. The Guide Inserter which is attached to the Mini Guide Wire holder is used to assist the placement of the wire into the needle. Following guide wire insertion, the cannula is removed and the sheath and dilator are then inserted over the mini guide wire and into the blood vessel. The mini guide wire is then withdrawn from the vessel. The dilator maintains the integrity of the sheath and dilates the blood vessel during insertion. Once the sheath is situated in the vessel, the dilator is removed and an appropriate catheter can then be inserted through the sheath. The sheath incorporates a 1-way valve and a 3-way stopcock connected by a side tube. The sheath is coated with hydrophilic coating to minimize frictional resistance when inserting or removing the sheath from the patient's blood vessel. In addition, the sheath and dilator contain bismuth, making these devices visible under fluoroscopy. The sheath, dilator, entry needle, mini guide wire and guide inserter are provided in a single package and sterilized together. The Glidesheath Slender Tibial Pedal Kit is a disposable, ethylene oxide gas sterilized device intended for single use only. {5}------------------------------------------------ ### F. INDICATIONS FOR USE (807.92(a)(5)) The Glidesheath Slender Tibial Pedal Kit is indicated to facilitate placing a catheter through the skin into the lower extremity peripheral vasculature below the knee. Note: The indications for use are identical to the predicate device, Glidesheath Slender Tibial Pedal Kit (K181237). ### G. SUBSTANTIAL EQUIVALENCE COMPARISON (807.92(a)(6)) The Glidesheath Slender Tibial Pedal Kit, subject of this 510(k), is substantially equivalent in its intended use/indications for use, technology/principal of operation, materials, and performance to the predicate device, manufactured by Terumo Medical Corporation. A comparison of the technological characteristics is summarized in the table below. {6}------------------------------------------------ K193160 Page 4 of 7 | Device<br>Characteristic | Predicate Device: | Modified Device: | |------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------| | Manufacturer | Glidesheath Slender Tibial Pedal Kit (K181237) | Glidesheath Slender Tibial Pedal Kit | | Intended Use /<br>Indications for<br>Use | The Glidesheath Slender Tibial Pedal Kit is indicated to facilitate<br>placing a catheter through the skin into the lower extremity<br>peripheral vasculature below the knee. | Same | | Operation<br>Principle | Operated manually or by a manual process | Same | | Design /<br>Construction | Sheath, Dilator,<br>Guide Wire, Guide Inserter, Entry Needle | Same | | Materials | Sheath assembly<br>Tube:<br>Ethylene-Tetrafluoroethylene (ETFE) copolymer,<br>Bismuth trioxide, Colorant, Silicone oil | Sheath Assembly<br>Tube: Same | | | Hydrophilic Coating: Dimethyl acrylamide-glycidyl methacrylate<br>copolymer | Hydrophilic Coating: Same | | | Housing: Polypropylene | Housing: Same | | | Cap: Polypropylene | Cap: Same | | | Valve: Silicone Rubber | Valve: Same | | | Caulking Pin: Stainless Steel | Caulking Pin: Same | | | Sheath support:<br>Styrene-ethylene-butylene-styrene block copolymer, Colorant | Sheath support: Same | | | Side tube: Polybutadiene | Side tube: Same | | | Three-way stopcock:<br>Holder: Polycarbonate;<br>Cock: Polyethylene;<br>Fastener pin: Polyethylene | Three-way stopcock:<br>Holder: Same<br>Cock: Same<br>Fastener pin: Same | | | Dilator assembly | Dilator Assembly | | | Tube: Polypropylene, Bismuth subcarbonate, Colorant, Silicone oil | Tube: Same | | | Hub: Polypropylene, Colorant | Hub: Same | | | Caulking Pin: Stainless steel | Caulking Pin: Same | | | Mini guide wire | Mini Guide Wire | | | Core: Nitinol (Nickel Titanium Alloy) | Core: Same | | | Coil: Palladium | Coil: Same | | | Adhesive: Epoxy Adhesive | Adhesive: Same | | | Guide inserter | Guide inserter | | | High-density polyethylene (HDPE), Colorant | Same | | | Stainless steel entry needle | Stainless steel entry needle | | | Cannula: Stainless Steel, Silicone oil | Cannula: Same | | | Hub: Styrene-Butadiene copolymer | Hub: Same | | | Protective Sleeve: Polypropylene | Protective Sleeve: Same | | Package | Unit Pouch | Unit Pouch: Same | | | Shelf Box | Shelf Box: Same | | | Shipping Carton | Shipping Carton: Same | | Specifications | Sheath Size: 5 Fr. | Sheath Size: Same | | | Sheath Length: 10 cm | Sheath Length: Same | | | Hydrophilic Coating: full effective length (10 cm) | Hydrophilic Coating: Same | | | Dilator applicable to Guide Wire OD: 0.021" | Dilator applicable to Guide Wire OD: Same | | | Dilator Length: 15.7 cm | Dilator Length: Same | | | Guide Wire OD: 0.021" | Guide Wire OD: Same | | | Guide Wire Length: 43 cm | Guide Wire Length: Same | | | Entry Needle Type: 21/19 (G) | Entry Needle Type: Same | | | Entry Needle Length: 70 mm | Entry Needle Length: 70 mm, 40 mm | | Sterilization | Ethylene Oxide (validated in accordance with ANSI / AAMI / ISO<br>11135-1 to achieve SAL 10-6) | Same | | Shelf life | 30 months | Same | | Disposable Single | Yes | Same | | Use | | | {7}------------------------------------------------ {8}------------------------------------------------ #### H. NON-CLINICAL TESTS (807.92(b)(1)) Performance The design verification was performed via a Verification by Analysis. The Verification by Analysis demonstrates that the new 4cm needle in the Glidesheath Slender Tibial Pedal Kit meets the predetermined criteria (Product Specifications). The differences between the predicate and proposed devices do not raise any new issues regarding safety and effectiveness. Therefore, no additional physical testing is required to ensure the safety and effectiveness of the proposed Glidesheath Slender Tibial Pedal kit throughout the shelf life. Standards referenced in this Submission are provided in the Table below: | Standard<br>Designation | Standard Name | FDA<br>Recognition<br># (if<br>applicable) | |----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------| | ISO 10993-1: 2009<br>Cor. 1:2010 | Biological Evaluation of Medical Devices - Part 1:<br>Evaluation and Testing Within a Risk Management<br>Process | 2-220 | | ISO 10993-1: 2018 | Biological evaluation of medical devices - Part 1:<br>Evaluation and testing within a risk management<br>process | 2-258 | | ISO 10993-7: 2008<br>Cor.1:2009 | Biological Evaluation of Medical Devices – Part 7:<br>Ethylene Oxide Sterilization Residuals | 14-408 | | USP 38 <85> | Bacterial Endotoxins Test (Sterility) | NA | | ISO 11135: 2014 | Sterilization of Health-Care Products - Ethylene Oxide<br>- Requirements For The Development, Validation And<br>Routine Control Of A Sterilization Process For Medical<br>Devices (Sterility) | 14-452 | Standards Referenced in this Submission ### Biocompatibility There are no changes to materials or components for the Glidesheath Slender Tibial Pedal Kit, other than the transitory/transient patient contacting shorter needle length. Therefore, no additional biocompatibility testing was completed for the modified Glidesheath Slender Tibial Pedal Kit (4cm needle). ## Sterilization No changes have been made to the sterilization processes, packaging or shelf-life of the device relative to predicate. Sterilization information was leveraged from the predicate device. ## Risk Analysis A Product Risk Analysis was conducted in accordance with ISO 14971: 2012, taking into account the modifications to the previous device, and it was determined that there were no new or increased risks associated with the change. {9}------------------------------------------------ # K193160 Page 7 of 7 ## I. CONCLUSION (807.92(b)(3)) In summary, the Glidesheath Slender Tibial Pedal kit, subject of this 510(k), is substantially equivalent in its intended use, technology/principal of operation, materials, and performance to the predicate device: - Predicate Device: K181237 Glidesheath Slender Tibial Pedal Kit, . manufactured by Terumo Medical Corporation