Super Sheath Introducer Sheath S-3N5/1005 S-3N7/1006 S-3W5/1007 S-3W7/1008

{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. September 17, 2024 Togo Medikit Co., Ltd. Fumiaki Kanai President MIC International Corp. 4-32-16 Ryogoku Sumida-ku Tokyo, 130-0026 Japan Re: K241230 Trade/Device Name: Super Sheath Introducer Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB, DRE Dated: May 1, 2024 Received: May 2, 2024 Dear Fumiaki Kanai: 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. 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" {1}------------------------------------------------ (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 System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 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-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 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 Rue"). 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-advicecomprehensive-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-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). {2}------------------------------------------------ Sincerely, # Sincerely, Sevan R. Sevan R. _____________________________________________________________________________________________________________________________________________________________________ For Misti Malone, PhD 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 {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K241230 Device Name Super Sheath Introducer Sheath Indications for Use (Describe) The Super Sheath Introducer Sheath is indicated for use in the introduction of diagnostic and interventional devices inserted into the human vasculature of adult and pediatric patients of all ages. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| X 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." {4}------------------------------------------------ ## 510(k) Summary #### a. Owner/Company name, address Togo Medikit Co., Ltd. 17148-6 Aza Kamekawa, Oaza Hichiya Hyuga City, Miyazaki Prefecture, 883-0062, Japan Daisuke Nagamizu, Manager, Regulatory Affairs Section, Quality Assurance Department Phone: 011-81-982-53-8000 Email: qc@togomedikit.co.jp #### b. Official Correspondent Fumiaki Kanai, President MIC International 4-32-16 Ryogoku, Sumida-ku Tokyo, 130-0026, Japan Phone: 011-81-3-6659-5482 Email: kanaif@mici.co.jp c. Date prepared September 10, 2024 #### d. Name of device Trade Name: Super Sheath Introducer Sheath Common Name: Introducer, Catheter Classification Name: Catheter Introducer Classification Regulation: 21 CFR 870.1340 Product Code: DYB Classification Panel: Cardiovascular #### e. Predicate device 510(k): K121504 Trade name: Super Sheath Introducer Sheaths and Super Sheath Introducer Sheath Set Regulation Number: 21 CFR 870.1310 Product code: DYB {5}------------------------------------------------ ## f. Description of the device The Super Sheath Introducer Sheath (hereinafter referred to as the "Subject Device") is used to introduce diagnostic or interventional devices into a blood vessel. The Subject Device is available in two products: one consisting of a Sheath and Dilator (Super Sheath Introducer Sheath without Guidewire), and the other consisting of a Sheath, Dilator, and Guidewire (Super Sheath Introducer Sheath with Guidewire), similar to the Predicate Device K121504. These devices are provided sterile and intended for single use, and the shelf-life is three years. The main component of the Sheath consists of a Sheath hub, a Sheath shaft connected to the Sheath hub, and a three-way stopcock valve connected to the hub with a side port tube. The Sheath shaft is 3.3 French size and available in 5cm and 7cm lengths. The Sheath hub contains a hemostatic valve and has a suture wing. The shape and dimensions of the three-way stopcock luer connector are modified to comply with the new applicable standard ISO 80369-7:2021. The Dilator has an open, tapered plastic tube for Guidewire insertion. The Dilator tube is press-fit into the inner hub with a bushing. The length of the Dilator tube corresponds to the length of the Sheath shaft, which is longer and available in 10.5 cm and 12.5 cm. The 0.018" Guidewire is the smallest size Guidewire and a 40 cm long, thin, flexible wire with a inserter attached to the tip. This Guidewire is a legally marketed product which is cleared by the Food and Drug Administration (K021990). The upper cap and suture wing of the Sheath hub, and the Dilator hub are colored purple. The Dilator tube and the inserter are colored blue. And the unvented cap of the three-way stopcock is pink. #### g. Indications for Use The Super Sheath Introducer Sheath is indicated for use in the introduction of diagnostic and interventional devices inserted into the human vasculature of adult and pediatric patients of all ages. #### h. Technological Characteristics The following table compares the Super Sheath Introducer Sheath to the predicate device with respect to intended use and technological characteristics, providing more detailed information regarding the basis for the determination of substantial equivalence. | Feature | Subject Device -Super<br>Sheath Introducer<br>Sheath - K241230 | Predicate Device - Super<br>Sheath Introducer<br>Sheaths and Super<br>Sheath Introducer<br>Sheath Sets - K121504 | Comparison | |--------------------------------------------|---------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------| | French Sizes<br>(available) | 3.3F | 3.3 F | Same | | Indications for Use | Super Sheath Introducer<br>Sheath is indicated for use<br>in the introduction of<br>diagnostic and | The Super Sheath<br>Introducer Sheaths and<br>Super Sheath Introducer | Same | | | | | | | | interventional devices<br>inserted into the human<br>vasculature of adult and<br>pediatric patients of all<br>ages. | Sheath Sets are indicated<br>for<br>use in the introduction of<br>diagnostic and<br>interventional devices<br>inserted into the human<br>vasculature of adult and<br>pediatric patients of all<br>ages. | | | Regulation Number | 870.1340 | 870.1340 | Same | | FDA Product Code | DYB | DYB | Same | | Prescription/<br>OTC Use | Prescription | Prescription | Same | | Components | Sheath, Dilator and<br>Guidewire | Sheath, Dilator and<br>Guidewire | Same | | Single-Use/<br>Reusable | Single-Use | Single-Use | Same | | Dimensional Comparison | | | | | Effective Length | $50 mm - 70 mm$ | $50 mm – 70 mm$ | Same | | Sheath Shaft Inner<br>Diameter (ID) | 3.3Fr | 3.3Fr | Same | | Three-way stopcock:<br>luer lock connecter | Meets ISO 80369-7-21 | Meets ISO 80369-7-21.<br>This change has already<br>been implemented and<br>documented in the LTF. | Same | | Dilator Tube Effective<br>Length | $105 mm + 5/-5 mm$<br>$125 mm + 5/-5 mm$ | $105 mm + 5/-5 mm$<br>$125 mm + 5/-5 mm$ | Same | | Dilator Distal Tip | 0.018"<br>(Only 0.018" size is<br>available) | 0.018"<br>0.021"<br>0.025" | Different<br>Removal of the 0.021"<br>and 0.025" sizes | | Guidewire | | | | | Tip Shape | Straight type | Straight type | Same | | Outer Diameter | Max OD 0.018" | Max OD 0.018" | Same | | Length - Nominal | $400 mm \pm 5 mm$ | $400 mm \pm 5 mm$ | Same | | Sterilization and Shelf Life | | | | | Sterilization Method | Ethylene Oxide | Ethylene Oxide | Same | | Sterile Package | Pouch | Pouch | Same | | Shelf-Life (Use By<br>Date) | Three (3) years | Three (3) years | Same | {6}------------------------------------------------ # i. Substantial Equivalence Many of the materials of the Predicate Device are identical to that of the subject device excepting minor material changes for the Dilator tube, inserter and case tube components. In addition, there are changes in solvents in the manufacturing process. The changes were validated via performance {7}------------------------------------------------ testing, sterilization validation, shelf-life testing, and biocompatibility testing including a biocompatibility risk assessment. The results of the validation testing and the risk assessment conducted demonstrated substantial equivalence when compared to the Predicate Device (K121504). ## j. Bench Testing The following bench tests were performed to demonstrate substantial equivalence to the Predicate Device (K121504) and verify conformity to the international standards and in-house requirements. - 1. Sheath Shaft Tensile Test - 2. Sheath Shaft Kink Test - Sheath Hub to Sheath Shaft Connection Strength Test 3. - 4. Sheath Hub to Side Tube Connection Strength Test - న. Three-Way Stop Cock to Side Tube Connection Strength Test - 6. Sheath Hemostatic Valve Pressure Test - 7. Sheath Pressure Test - Sheath Lubricity Test 8. - 9. Dilator Corrosion Resistance Test - 10. Dilator Tube Tensile Test - 11. Dilator Tube to Hub Connection Strength Test - 12. Sheath Radiopacity Test - Guidewire Radiopacity Test 13. #### k.Biocompatibility Testing We performed the following biocompatibility tests after risk assessment of biocompatibility. - 1. Cytotoxicity - 2. Intracutaneous reactivity - 3. Sensitization - 4. Acute Systemic Toxicity - 5. Hemocompatibility - 6. Pyrogen test - 7. LAL test #### l. Conclusion Based on the above discussion and the enclosed sections regarding substantial equivalence to the predicate device, Togo Medikit Co., Ltd. concludes that the Subject Device is substantially equivalent to the Predicate Device (K121504), and the Subject Device does not raise any new questions regarding safety or effectiveness.