TrapIt

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The Department of Health & Human Services logo features a stylized human figure, while the FDA part includes the acronym "FDA" in a blue square, followed by "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text. January 21, 2020 IMDS Operations B.V. Edwin Schulting CEO Ceintuurbaan Noord 150 9301 NZ Roden The Netherlands Re: K191229 Trade/Device Name: TrapIt Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: December 16, 2019 Received: December 18, 2019 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 {1}------------------------------------------------ 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 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 (OS) 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) K191229 Device Name TrapIt Indications for Use (Describe) The TrapIT Trapping Balloon Catheter is indicated to facilitate interventional device exchange while maintaining wire position in patients undergoing PCI procedures. TrapIT Trapping Balloon Catheter is not intended for use outside of the guide catheter. | 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." {3}------------------------------------------------ Image /page/3/Picture/2 description: The image shows the logo for IMDS. The logo consists of a dark green circle connected to three light blue circles. To the right of the circles is the text "IMDS" in a dark blue sans-serif font. # 510(k) Summary [As required by 21 CFR 807.92] Date Prepared: April 26th, 2019 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 Assurance and Regulatory Affairs Tel: 0031651453880 Fax: 0031508200231 General Information Trade Name Common/ Usual Name Classification Name Product Code Predicate Device TrapIt Trapping Balloon Catheter Catheter, percutaneous DOY K162253. Trapper Exchange Device, Creganna Medical ### Device Description The TrapIt Trapping Balloon Catheters have an integrated shaft system and a balloon near the distal tip. The shaft has a lumen which is used for inflation of the balloon with contrast medium. As aid in positioning the balloon in a guide catheter a tactile feedback stop is integrated in the shaft of the 100 cm compatible TrapIt has a shaft depth marking that aid in gauging balloon catheter position relative to the guiding catheter tip when used in 90 cm guide catheters. ### Intended Use The Traping Balloon Catheter is indicated to facilitate interventional device exchange while maintaining wire position in patients undergoing PCI procedures. TrapIt Trapping Balloon Catheter is not intended for use outside of the guide catheter. ### Technological Characteristics Comparison The TrapIt is similar in design to the predicate device and both are dedicated trapping, percutaneous balloon catheters intended to facilitate interventional device exchange in a PCI procedure. With the exception of dimensional, material and package configuration differences, the TrapIt is similar in design and technological characteristics to the predicate device. The dimensional, material and package configuration differences were successfully evaluated in performance tests. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the text "510(k) Summary TrapIt". The text is in bold font and is centered in the image. The background is white. Image /page/4/Picture/1 description: The image shows the logo for IMDS. The logo consists of a blue graphic on the left and the text "IMDS" on the right. The graphic is a blue circle with a smaller blue circle connected to it by a line. The text "IMDS" is in a bold, sans-serif font. The "I" and "M" are blue, and the "DS" are black. #### 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 TrapIt Trapping Balloon 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) Kink resistance/ flexibility - 2) Radiopacity - 3) Catheter bond strength - Tip bond strength 4) - ર) Crossing profile - Balloon preparation, deployment & retraction 6) - Balloon rated burst 7) - 8) Balloon fatigue - 9) Balloon compliance - 10) Effective length - 11) Tip length - 12) Balloon inflation time - 13) Balloon deflation time - 14) Shaft outer diameter - 15) Coating Particulate Evaluation - 16) 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 TrapIt Trapping Balloon Catheter is substantially equivalent to the predicate device.