Boosting Catheter

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three human profiles facing to the right. The profiles are stacked on top of each other and are connected by a series of lines. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 November 2, 2016 QXMédical, LLC Fernando Di Caprio Chief Technology Officer 2820 Patton Road Roseville, Minnesota 55113 Re: K160561 Trade/Device Name: Boosting Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: September 30, 2016 Received: October 3, 2016 Dear Fernando Di Caprio: 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. 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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {1}------------------------------------------------ If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, # Brian D. Pullin -S for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K160561 Device Name Boosting Catheter Indications for Use (Describe) The Boosting Catheter is intended for use in conjunction with guiding catheters or sheaths during coronary and peripheral interventional procedures to guide and support interventional devices, traverse discrete portions of the vasculature, allow for interventional device exchanges and provide a conduit for infusion of saline solution, diagnostic contrast agents and therapeutic agents. Type of Use (Select one or both, as applicable): | <label><input checked="checked" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | |--------------------------------------------------------------------------------------------------------| | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> | #### 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 - K160561 #### Date Prepared: October 27, 2016 #### Submitter Information: | Submitter's Name/Address | Contact Person | |--------------------------|----------------------------------------| | QXMédical, LLC | Fernando Di Caprio, | | 2820 Patton Road | Chief Technical Officer | | Roseville, MN 55113 | Phone: (651) 842-2053 | | | Email: fernando.dicaprio@qxmedical.com | #### Device Information: | Device Trade Name | Boosting Catheter™ | |-----------------------------|----------------------------------------------| | Device Common Name | Guiding Catheter | | Device Classification Name | Catheter, Percutaneous (per 21 CFR 870.1250) | | Classification Product Code | DQY | | Regulatory Classification | Class II (per 21 CFR 870.1250) | | Review Panel | Cardiovascular | ## Performance Standards: No performance standards applicable to this product have been developed under Section 514 of the Act. ### Predicate Devices: | Predicate Device | 510(k) Status | |-----------------------------|---------------| | Access and Support Catheter | K123311 | | Concierge Guiding Catheter | K132409 | #### Reference Devices: | Reference Device | 510(k) Status | |---------------------|---------------| | Guidezilla Catheter | K123765 | | CrossBoss Catheter | K091841 | {4}------------------------------------------------ #### Device Description: The Boosting Catheter is an over-the-wire percutaneous catheter with an atraumatic tip. The catheter has an effective length of 150cm and available in four (4) diameter models; each compatible with various guiding catheters or sheaths as shown in the following table: | Catalog<br>Number | Model<br>Number | Catheter<br>I.D. | Catheter<br>O.D. | Compatible<br>Guiding Catheter | Compatible<br>Sheath | |-------------------|-----------------|------------------|------------------|--------------------------------|------------------------| | BC52-150 | 9005-001 | 0.052" | 0.064" | 6 Fr (0.066" MIN ID) | 5 Fr (0.066" MIN ID) | | BC57-150 | 9005-002 | 0.057" | 0.068" | 6 Fr (0.070" MIN ID) | 5.5 Fr (0.072" MIN ID) | | BC63-150 | 9005-003 | 0.063" | 0.076" | 7 Fr (0.078" MIN ID) | 6 Fr (0.079" MIN ID) | | BC72-150 | 9005-004 | 0.072" | 0.086" | 8 Fr (0.088" MIN ID) | 7 Fr (0.092" MIN ID) | The Boosting Catheter is constructed with a proximal manipulation shaft connected to a distal tube or guiding catheter segment. The manipulation shaft is used to advance the distal tube segment over a guidewire and through a guiding catheter (or sheath) to a desired location in the coronary or peripheral vasculature. Once positioned, diagnostic or interventional devices (including guidewires) may be delivered or exchanged though the guiding catheter and the Boosting Catheter distal tube segment. Further, procedural fluids (such as saline, contrast agents or therapeutic agents) can be delivered through the guiding catheter and the distal tube segment to a desired location in the coronary or peripheral vasculature. The distal tube segment has two (2) radiopaque markers to facilitate fluoroscopic guidance and a lubricious outer coating to assist with catheter advancement. The manipulation shaft has a molded handle and strain relief to assist with handling. The strain relief is printed with the catheter dimensional information. The device is supplied sterile and intended for single use only. #### Intended Use/Indications for Use: The Boosting Catheter is intended for use in conjunction with guiding catheters or sheaths during coronary and peripheral interventional procedures to guide and support interventional devices, including guidewires, traverse discrete portions of the vasculature, allow for interventional device exchanges and provide a conduit for infusion of saline solution, diagnostic contrast agents and therapeutic agents. {5}------------------------------------------------ ### Comparison of Technological Characteristics with the Predicate Devices: The Boosting Catheter has similar intended use as the predicate devices along with similar principle of use, body contact duration (< 24 h) and intended anatomical location (coronary and peripheral vasculature). Additionally, the Boosting Catheter and the predicate devices are technologically similar with regards to the following characteristics: - Construction, including over-the-wire configuration ● - Materials - Design and manufacturing techniques - Hydrophilic coating - Radiopaque tip - Dimensions (ID, OD, overall length) - Guidewire, sheath and guiding catheter compatibility - Packaging - Sterilization The differences between the Boosting Catheter and the predicate devices are: - Guidewire lumen configuration and length ● - Addition of some materials common to other cardiovascular catheters . The test data presented in this submission demonstrate substantial equivalence of the Boosting Catheter. #### Summary of Non-Clinical Testing: The Boosting Catheter underwent mechanical, performance, and biocompatibility assessments to support a determination of substantial equivalence. These tests provide reasonable assurance that the device meets the established performance criteria and will perform as intended. The mechanical and performance tests performed on the Boosting Catheter included: | Mechanical and Performance Test Summary | | |-----------------------------------------|----------------------------| | Visual inspections | Torque strength | | Dimensional evaluations | Tensile strength | | Device compatibility | Simulated use | | Guiding catheter/sheath compatibility | Coating adherence | | Device support | Particulate evaluation | | Catheter stiffness & flexibility | Fluoroscopic visualization | {6}------------------------------------------------ | Mechanical and Performance Test Summary | | |-----------------------------------------|-------------------------------| | Device retraction & insertion | Fluid delivery | | Catheter fatigue | Shelf life testing | | Catheter kink resistance | Package integrity | | Corrosion resistance | Shipping/distribution testing | | | Environmental conditioning | The biocompatibility tests performed on the Boosting Catheter included: | Biocompatibility Test Summary | | |----------------------------------------|------------------------------------| | Cytotoxicity | Hemolysis | | Sensitization | Immunology (complement activation) | | Irritation / Intracutaneous reactivity | In Vivo Thromboresistance | | Systemic toxicity (acute) | Pyrogenicity (material mediated) | | Genotoxicity | Physicochemical tests | ## Clinical Testing Clinical evaluation was not required for this device. # Substantial Equivalence Comparison Summary Based on a comparison of the intended use/indications for use, principle of use, intended anatomical location, and technological characteristics, along with the results from a series of non-clinical tests, the Boosting Catheter has been shown to be substantially equivalent to the predicate devices.