Amplatzer Trevisio Intravascular Delivery System

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains 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 features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text. October 16, 2019 Abbott Medical Gabrielle Zaeska Regulatory Affairs Manager 5050 Nathan Lane Plymouth, Minnesota 55442 Re: K190581 Trade/Device Name: Amplatzer™ Trevisio™ Intravascular Delivery System Regulation Number: 21 CFR 870.125021 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: DOY Dated: March 5, 2019 Received: March 6, 2019 Dear Gabrielle Zaeska: This letter corrects our substantially equivalent letter of April 5, 2019. 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. {1}------------------------------------------------ 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 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. # Rachel E. Neubrander -S Rachel Neubrander Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular 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) K190581 #### Device Name Amplatzer™ Trevisio™ Intravascular Delivery System Indications for Use (Describe) The Amplatzer™ Trevisio™ Intravascular Delivery System is intended to pathway through which devices are introduced within the chambers and coronary vasculature of the heart or in the peripheral vasculature. Type of Use (Select one or both, as applicable) X 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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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 | Submitter: | Abbott Medical<br>5050 Nathan Lane<br>Plymouth, MN 55442 | |-------------------------|------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Gabrielle Zaeska<br>Manager, Regulatory Affairs<br>Phone: 651-756-5691<br>Fax: 651-756-5744<br>E-mail: Gabrielle.Zaeska@abbott.com | | Date Prepared: | March 1, 2019 | | Trade Name: | AmplatzerTM TrevisioTM Intravascular Delivery System | | Common Name: | Catheter Delivery System | | Classification: | Class II, 21 CFR 870.1250<br>Catheter, Percutaneous | | Product Code: | DQY | | Predicate<br>Device(s): | AMPLATZER TorqVue Delivery System (K072313, cleared 02<br>November 2007) | {4}------------------------------------------------ The Amplatzer™ Trevisio™ Intravascular Delivery System (ATV) is an Device Description: extension of the Amplatzer TorqVue Delivery System (ITV) product line. This device is also referred to as "Flex Cable" on internal Abbott Medical documentation. The Trevisio Delivery System components are identical to the cleared ITV device which include a delivery system sheath, dilator, loader, hemostasis valve with extension tube and stopcock, delivery cable and plastic vise. In comparison to ITV, the cable component of the Trevisio Delivery System has been designed with a flexible distal tip to reduce bias when delivering an implant device; allowing physicians to more accurately assess placement prior to device release. Like ITV, the distal end of the sheath is offered in a 45° curve and is radiopaque for visibility under fluoroscopy. Figure 1 illustrates the delivery system and identifies the following essential components ● Loader (A) -introduces an Amplatzer device into the sheath ● Hemostasis valve (B)with extension tube and stopcock-allows flushing of the delivery system and controls blood backflow ● Delivery System Sheath (C) -provides a pathway through which an Amplatzer device is delivered Dilator (D) -eases penetration of tissue and minimizes vessel O trauma Delivery Cable (E) -attaches to the device to control its 0 movement through the sheath Plastic Vise (F) -attaches to the delivery cable and serves as a 0 handle for disconnecting (unscrewing) the delivery cable from the device. Figure 1. Amplatzer™ Trevisio™ Delivery System Components C {5}------------------------------------------------ | Intended Use: | The Amplatzer™ Trevisio™ Intravascular Delivery System is intended to provide a pathway through which devices are introduced within the chambers and coronary vasculature of the heart or in the peripheral vasculature. | |---------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |---------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| The Amplatzer Trevisio Intravascular Delivery System is an extension of Comparison to predicate: the Amplatzer TorqVue Delivery System (K072313) product line. The current TorqVue Delivery System includes a delivery system sheath, dilator, loader, hemostasis valve, delivery cable, and plastic vise for the delivery of Amplatzer occlusion devices. The Trevisio Delivery System components are identical to the TorqVue Delivery System with the exception of a more flexible delivery cable with device positioning mark. The differences between the subject Trevisio device (ATV) and predicate TorqVue Delivery System (ITV) are: - The ATV device is only offered in 45° sheath curve ● - The ATV delivery cable includes more flexible distal tip - The ATV delivery cable includes a proximal mark to provide physician with an indication of when the device is nearing the tip of the delivery sheath, reducing the need for fluoroscopy. - The ATV packaging will incorporate a protective tube and ● modified backing card tabs to support the cable. The intended use of the Amplatzer Trevisio Delivery System is identical to that of the Amplatzer TorqVue Delivery System; there has been no change as a result of the proposed modifications. {6}------------------------------------------------ | Functional and | The new cable design and system were tested to ensure the device | |-----------------|-----------------------------------------------------------------------| | Safety Testing: | performs as intended. Because there are no changes to the ITV | | | components besides the enhanced delivery cable, bench and laboratory | | | testing was not performed on those individual components which remain | | | unchanged. The following testing of the new cable and system level | | | testing was performed: | - Delivery Cable Distal Flexibility - Delivery Cable Outer Diameter - Delivery Cable Length ● - Delivery Cable Leak ● - Sheath Material Separation - Torque Strength - Tensile Strength - Delivery Cable Advancement force - Marker Visibility - Deploy and Recapture - Device Release - Shelf Life - Biocompatibility ● - Corrosion #### Abbott Medical considers the Amplatzer Trevisio Intravascular Delivery Conclusion: System to be substantially equivalent to the TorqVue Delivery System. This conclusion is based upon the devices' similarities in principles of operation, technology, materials and indications for use.