Guidion

{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 and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. March 31, 2021 IMDS Operations B.V. Edwin Schulting CEO Ceintuurbaan Noord 150 Roden, Drenthe 9301 NZ Netherlands ## Re: K210110 Trade/Device Name: Guidion Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: January 14, 2021 Received: January 19, 2021 ## 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 (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, Lydia Glaw Assistant Director DHT2C: Division of Coronary and Peripheral Interventional 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) K210110 Device Name Guidion Catheter Indications for Use (Describe) Guidion 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. Type of Use (Select one or both, as applicable) | <div style="display:inline-block;"><span style="text-decoration: overline;">☑</span> Prescription Use (Part 21 CFR 201 Subpart D)</div> | <div style="display:inline-block;">☐ Over-The-Counter Use (21 CFR 201 Subpart C)</div> | |-----------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------| |-----------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------| || | Prescription Use (Part 21 CFR 801 Subpart D) __ Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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To the right of the atom symbol is the text "IMDS", with the "I" and "DS" in dark teal and the "M" in light teal. # 510(k) Summary Date Prepared: March 22nd , 2021 Submitter's Name / Contact Person Manufacturer IMDS Operations BV Ceintuurbaan Noord 150 9301 NZ Roden . The Netherlands Establishment Registration #3007740583 Contact Person Florence Wagter Director of Quality and Regulatory Tel: 0031651453880 Fax: 0031508200231 #### General Information Trade Name Common/ Usual Name Classification Name Product Code Predicate Device Reference Device Guidion Catheter Rapid Exchange Guide Extension Catheter Catheter, percutaneous DOY K172090, Guideliner V3 Catheter, Vascular Solutions, Inc. None #### Device Description The Guidion catheter is a single lumen rapid exchange catheter offered in sizes being compatible with 5F; 6F; 7F and 8F guide catheters and may be placed over an guide wire. The 150cm long device has a stainless steel shaft section. The stainless steel shaft is followed distally by a 25cm lumen section. The Guidion catheter has 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 Guidion catheter is delivered through a guiding catheter resulting in an inner diameter that is approximately 1 French smaller than the guide catheter. The Guidion catheter has a proximal hub which indicates guide catheter compatibility. #### Intended Use Guidion 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. | K210110 | | Page 1 of 3 | |---------|--|-------------| |---------|--|-------------| {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for IMDS. The logo consists of a blue molecular structure on the left and the letters "IMDS" in black on the right. The molecular structure is made up of a black circle and several blue circles connected by lines. #### Technological Characteristics Comparison The Guidion is 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 | Guidion<br>catheter | Guideliner V3<br>Catheter | |----|---------------------------------|--------------------------------------------------------------|--------------------------------------------------------------| | | Model number (s) | G50F25150,<br>G60F25150,<br>G70F25150 &<br>G80F25150 | 5569, 5571, 5572<br>& 5573 | | 1 | Type clinically based | Guide Extension<br>catheter | Guide Extension<br>catheter | | 2 | Design construction | Rx, single lumen | Rx, single lumen | | 2 | Distal shaft material | Stainless steel coiling<br>embedded in a<br>polymer shaft | Stainless steel coiling<br>embedded in a<br>polymer shaft | | 3 | Proximal shaft | Stainless steel | Stainless steel | | 4 | Distal radiopague markers | 1 | 1 | | 5 | Radiopaque tip/ marker material | TPE/ Tungsten | Platinum/ Iridium | | 6 | Effective length | 150 (cm) | 150 (cm) | | 7 | Length distal shaft | 25 (cm) | 25 (cm) | | 8 | Required guide catheter ID | 5F 1.42 (mm)<br>6F 1.78 (mm)<br>7F 1.98 (mm)<br>8F 2.24 (mm) | 5F 1.42 (mm)<br>6F 1.78 (mm)<br>7F 1.98 (mm)<br>8F 2.24 (mm) | | 9 | Tip design shape | Straight | Straight | | 10 | Inner diameter distal shaft | 5F 1.04 (mm)<br>6F 1.42 (mm)<br>7F 1.57 (mm)<br>8F 1.80 (mm) | 5F 1.17 (mm)<br>6F 1.42 (mm)<br>7F 1.57 (mm)<br>8F 1.80 (mm) | | 11 | Product coating | Hydrophilic | Silicon | With the exception of dimensional, material and package configuration differences, the Guidion is similar in design and technological characteristics to the predicate device. The dimensional, material and package configuration differences were successfully evaluated in performance tests. | K210110 | | Page 2 of 3 | |---------|--|-------------| |---------|--|-------------| {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for IMDS. The logo consists of a blue molecular structure on the left and the text "IMDS" on the right. The "I" is dark green, while the "MDS" is blue. #### 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 Guidion Rapid Exchange Guide Extension catheter is 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) Kind resistance/ flexibility - 2) Radiopacity - 3) Catheter bond strength - 4) Crossing profile - 5) Catheter preparation, deployment & retraction - 6) Hub bond strength - 7) Proximal shaft depth marker position - 8) Torque strength - 9) Effective length - 10) Length distal shaft - 11) Inner diameter - 12) Coating Particulate Evaluation - 13) Coating integrity - 14) Packaging integrity Device samples passed the following biocompatibility tests performed 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 Guidion Rapid Exchange Guide Extension catheter is substantially equivalent to the predicate device. | K210110 | | Page 3 of 6 | |---------|--|-------------| |---------|--|-------------|