TRUSELECT Microcatheter

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION". July 28, 2020 Boston Scientific Corporation Ms. Aoife Tobin Senior Regulatory Affairs Specialist 3 Scimed Place Maple Grove, Minnesota 55311 Re: K201792 Trade/Device Name: TRUSELECT™ Microcatheter Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II Product Code: KRA Dated: June 29, 2020 Received: June 30, 2020 Dear Ms. Tobin: 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, Gregory O'Connell 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) K201792 Device Name TRUSELECT™ Microcatheter Indications for Use (Describe) The TRUSELECTM Microcatheters are intended for peripheral vascular use. The microcatheter can be used for selective infusion of diagnostic, embolic, or therapeutic materials into the vessel. | Type of Use ( <i>Select one or both, as applicable</i> ) | |----------------------------------------------------------| |----------------------------------------------------------| | <div> <span> <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | |--------------------------------------------------------------------------------------------------------------------------------| | <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Sub </span> </div> | |_ | 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 510(k) Summary Complying with 21 CFR 807.92 #### l. SUBMITTER INFORMATION Submitter name: Boston Scientific Corporation Submitter address: Three Scimed Place Maple Grove, MN 55311-1566 USA Telephone: 011-353-21-4531341/011-353-86-1009795 Fax: 011-353-21-4343354 e-mail: Aoife.Tobin@bsci.com Contact person name: Aoife Tobin Date Prepared: July 27, 2020 #### II. DEVICE INFORMATION Trade Name: TRUSELECT™ Microcatheter Table 1 and 2 as follows summarizes the relevant device information for the subject devices. | Table 1. TRUSELECT™ Microcatheter Name of Devices | |---------------------------------------------------| | | | UPN | GTIN | Product Description | |---------------|----------------|-------------------------------| | M001394101050 | 08714729976608 | TRUSELECT™ 105cm Straight Tip | | M001394101300 | 08714729976615 | TRUSELECT™ 130cm Straight Tip | | M001394101550 | 08714729976622 | TRUSELECT™ 155cm Straight Tip | | M001394101750 | 08714729976639 | TRUSELECT™ 175cm Straight Tip | | M001394111050 | 08714729976646 | TRUSELECT™ 105cm Bern Tip | | M001394111300 | 08714729976653 | TRUSELECT™ 130cm Bern Tip | | M001394111550 | 08714729976660 | TRUSELECT™ 155cm Bern Tip | | M001394111750 | 08714729976677 | TRUSELECT™ 175cm Bern Tip | {4}------------------------------------------------ | Common or<br>Usual Name | Classification<br>Number | Classification<br>Name | Product<br>Code | Product<br>Code Name | Regulatory<br>Class | |-------------------------|--------------------------|---------------------------------|-----------------|---------------------------------|---------------------| | Microcatheter | 21 CFR Part<br>870.1210 | Continuous<br>Flush<br>Catheter | KRA | Continuous<br>Flush<br>Catheter | II | ## Table 2 Additional Device Information #### lll. PREDICATE DEVICE IDENTIFICATION ## Name of Predicate Device Direxion™ Microcatheter, K163701 Predicate devices referenced above have not been subject to a design-related recall. #### IV. DEVICE DESCRIPTION The TRUSELECT™ Microcatheter is a low profile 2.0F microcatheter intended for use in the peripheral vasculature. The microcatheter can be coaxially tracked over a steerable guidewire in order to access distal, tortuous vasculature. Once the sub-selective region has been accessed, the microcatheter can be used for the controlled and selective infusion of diagnostic, embolic, or therapeutic materials into vessels. Diagnostic, therapeutic and embolic agents such as heparinized saline, contrast media, chemotherapy agents such as doxorubicin and irinotecan, polyvinyl alcohol (PVA) flakes and polymer and hydrogel spherical embolics (microspheres) can be delivered to targeted vessels. The microcatheter maintains chemotherapy chemical compatibility. It has a straight internal diameter design (021" ID, (0.53 mm)) with a 2.0F OD tapered tip. The microcatheter includes eight UPNs, covering a range of lengths (105, 130, 155 and 175cm) and tip shapes (straight or bern), and is compatible with 0.040" ID guide catheters and 0.014" & 0.016" quidewires. It is compatible with embolic particles of up to 700 microns and 0.018" (0.46 mm) embolic coils. The TRUSELECT™ Microcatheters are provided sterile, using 100% ethylene oxide (EO) gas sterilization, and are intended for hospital and single use only. These devices utilize HydroPass Hydrophillic Coating for the reduction of surface friction during placement. #### V. INDICATIONS FOR USE The TRUSELECT™ Microcatheters are intended for peripheral vascular use. The microcatheter can be used for selective infusion of diagnostic, embolic, or therapeutic materials into the vessel Predicate and subject device Intended use and Indications for Use are the same. {5}------------------------------------------------ #### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS There are differences in the technological characteristics between the predicate and subject devices. However, the differences in materials, dimensions and packaging, as documented in the following table, do not raise new questions of safety and effectiveness in comparison to the predicate device (K163701). | Materials | Catheter shaft materials and coating differ from the predicate. | |------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Dimensions | The catheter is available in an additional length, 175cm, compared to the predicate. The outer diameter of the subject device distal tip is 2.0 Fr compared to the predicate outer tip diameter of 2.4 Fr. | | Packaging | The predicate device also uses a mounting card in addition to the carrier tube assembly to contain the microcatheter in the pouch. | The purpose of this 510(k) submission is to receive clearance for the different technological differences between the subject and predicate devices. #### SUMMARY OF NON-CLINICAL PERFORMANCE TESTING VII. Bench testing and biocompatibility testing were performed to support a determination of substantial equivalence. The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the testing. The following biocompatibility tests were completed on the TRUSELECT™ Microcatheter: | Cytotoxicity ISO 10993-5 | |---------------------------------------------| | Sensitization ISO 10993-10 | | Irritation ISO 10993-10 | | Material Mediated Pyrogenicity ISO 10993-11 | | Acute Systemic Toxicity ISO 10993-11 | | Hemocompatibility ISO 10993-4 | | Genotoxicity ISO 10993-3 | The following in-vitro performance tests were completed for the TRUSELECT™ Microcatheter: | Catheter Design / Material<br>Changes | Manifold Connection | |---------------------------------------|----------------------------------------------| | | Guidewire Compatibility | | | Guide Catheter Compatibility | | | Proximal OD/ Outside Diameter | | | Catheter ID | | | Microcatheter Coating Lubricity & Durability | | | Microcatheter Coating Length | | | Distal End Flexibility (Distal 5cm) | | | Proximal End Stiffness | | | Proximal Shaft Kink | TRUSELECT™ Microcatheters Premarket Notification - Special 510(k) Page 3 of 4 {6}------------------------------------------------ | Distal Shaft Kink | |---------------------------------------------------| | Effective Length | | Tip OD | | Steam Shaping Mandrel Compatibility | | Shapability | | Infusion Stability | | Marker Band Location/Tip Length | | Microcatheter to Microspheres Compatibility | | Microcatheter to PVA particle Compatibility | | Microcatheter to Gelfoam Compatibility | | Microcatheter to 0.018 Embolic Coil Compatibility | | Dead Space Volume | | Max Infusion Pressure (Dynamic Burst) | | Static Burst | | Chemical Compatibility | | Flow Rate | | Marker Band Tensile | | Full Catheter Tensile | | Tip Tensile | | Tip Shape | | Particulate Matter | | Corrosion Resistance | #### CONCLUSION VIII. Based on the intended use, technological characteristics, and non-clinical performance data provided, the TRUSELECT™ Microcatheter is substantially equivalent to the predicate device K163701. The design and material changes for the subject device do not raise new questions of safety or effectiveness.