FlowGuide (FG60F); GuidionShort (GS60F)

{0} FDA U.S. FOOD & DRUG ADMINISTRATION April 17, 2025 IMDS Operations B.V. Edwin Schulting CEO Ceintuurbaan Noord 150 Roden, NL9301NZ Netherlands Re: K242337 Trade/Device Name: FlowGuide (FG60F); GuidionShort (GS60F) Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: March 17, 2025 Received: March 17, 2025 Dear Edwin Schulting: 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" (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). U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K242337 - Edwin Schulting Page 2 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 QS 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 (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 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 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. 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). {2} K242337 - Edwin Schulting Page 3 Sincerely, Brian D. Pullin -S for Lydia Glaw 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} FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF | DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. | | --- | --- | | 510(k) Number (if known) K242337 | | | Device Name FlowGuide (FG60F), GuidionShort (GS60F) | | | Indications for Use (Describe) The Guide extension family catheters are intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement and exchange of guide wires and other interventional devices. The Guide extension family catheters are contraindicated in vessels less than 2.5mm in diameter, vessels in the neurovasculature, and the venous system. | | | Type of Use (Select one or both, as applicable) ☑ 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} 005 510(k) Summary Guidion 510(k) Submission IMDS # 510(k) Summary [As required by 21 CFR 807.92] Date Prepared: August 5th, 2024 ## Submitter's Name / Contact Person **Manufacturer** IMDS Operations BV Ceintuurbaan Noord 150 9301 NZ Roden, The Netherlands Establishment Registration #3007740583 **Contact Person** Aljosja Kot Director of Quality and Regulatory Tel: 0031651453880 Fax: 0031508200231 ## General Information **Trade Name** FlowGuide and GuidionShort **Common/Usual Name** Rapid Exchange Guide Extension Catheter **Classification Name** Catheter, percutaneous **Product Code** DQY **Predicate Device** K210110, Guidion Rapid Exchange Guide Extension Catheter, IMDS Operations B.V. **Reference Device** K212211, TrapLiner, Vascular Solutions, LLC ## Device Description The FlowGuide and GuidionShort are single lumen rapid exchange catheters being compatible with 6F and larger guide catheters and may be placed over either an exchange length or 180cm guide wire. The 150cm long device has a stainless-steel shaft section. The stainless-steel shaft is followed distally by a 15 cm lumen section. The catheters have a radiopaque distal end which enables visibility while using standard fluoroscopic methods. The device has two positioning marks located at 95cm and 105cm from the distal tip, respectively. The catheters are delivered through a guiding catheter resulting in an inner diameter that is approximately 1 French smaller than the guide catheter. The catheters have a proximal hub which indicates guide catheter compatibility. The FlowGuide has 9 perfusion holes in the distal shaft intended to reduce pressure dampening. ## Intended Use FlowGuide and GuidionShort catheters are intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement and exchange of guide wires and other interventional devices. The Guide extension family catheters are contraindicated in vessels less than 2.5mm in diameter, vessels in the neurovasculature, and the venous system. Page 1 of 3 {5} 005 510(k) Summary Guidion 510(k) Submission IMDS # Technological Characteristics Comparison The FlowGuide and GuidionShort are similar in design to the predicate device and both are Rapid Exchange Guide Extension Catheters intended to be used to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement and exchange of guide wires and other interventional devices. | # | Item | FlowGuide and GuidionShort catheter | Guidion Catheter | | --- | --- | --- | --- | | | Model number (s) | FG60F, GS60F | G60F25150 | | 1 | Type clinically based | Guide Extension catheter | Guide Extension catheter | | 2 | Design construction | Rx, single lumen | Rx, single lumen | | 3 | Distal shaft material | Stainless steel coiling embedded in a polymer shaft | Stainless steel coiling embedded in a polymer shaft | | 4 | Proximal shaft | Stainless steel | Stainless steel | | 5 | Distal radiopaque markers | 1 | 1 | | 6 | Proximal radiopaque marker distal shaft | 1 | 0 | | 7 | Radiopaque marker material | TPE/ Tungsten | TPE/ Tungsten | | 8 | Effective length | 150 (cm) | 150 (cm) | | 9 | Length distal shaft | 15 (cm) | 25 (cm) | | 10 | Required guide catheter ID | 6F 1.78 (mm) | 6F 1.78 (mm) | | 11 | Tip design shape | Straight | Straight | | 12 | Inner diameter distal shaft | 6F 1.42 (mm) | 6F 1.42 (mm) | | 13 | Distal shaft perfusion holes | Yes, FG60F only | No | | 14 | Product coating | Hydrophilic | Hydrophilic | With the exception of a shorter distal shaft length and perfusion holes for the FlowGuide the products are similar in design and technological characteristics to the predicate device. The shorter distal shaft length and perfusion holes are known features as evaluated from the reference device and were successfully evaluated in performance tests. Page 2 of 3 {6} 005 510(k) Summary Guidion 510(k) Submission IMDS # Substantial Equivalence and Summary of Studies The technological differences between the subject and predicate devices have been evaluated through performance and biocompatibility tests and results did not raise new questions of safety or effectiveness. The FlowGuide and GuidionShort Guide Extension catheters are substantially equivalent to the specified predicate device based on comparisons of the device functionality, technological characteristics, and indications for use. The device design has been verified through the following tests: 1) Visual inspection 2) Kink resistance/ flexibility 3) Radiopacity 4) Catheter bond strength 5) Crossing profile 6) Catheter preparation, deployment & retraction 7) End stop strength 8) Tip length 9) Coating lubricity 10) Perfusion flow 11) Corrosion resistance 12) Torque strength 13) Effective length 14) Length distal shaft 15) Inner diameter 16) Coating Particulate Evaluation 17) Coating integrity 18) Packaging integrity FlowGuide and GuidionShort are meeting the requirements for biocompatibility in accordance with ISO 10993-1: - Cytotoxicity - Sensitization - Irritation - Systemic toxicity - Pyrogenicity - Hemocompatibility The results of the verification tests met the specified acceptance criteria and did not raise new safety or performance issues. Therefore, the FlowGuide and GuidionShort Rapid Exchange Guide Extension catheters are substantially equivalent to the predicate device. Page 3 of 3