Agilis™ NxT Steerable Introducer Dual-Reach™ (I-V2-MED)

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June 13, 2024 Abbott Medical Alyssa Timmers Principle Regulatory Affairs Specialist 14901 DeVeau Place Minnetonka, Minnesota 55345 Re: K241370 Trade/Device Name: Agilis™ NxT Steerable Introducer Dual-Reach™ (I-V2-MED) Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: May 14, 2024 Received: May 14, 2024 Dear Alyssa Timmers: 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" {1}------------------------------------------------ (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). 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 OS 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 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-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 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. 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-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. 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Katherine Trivedi Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices {2}------------------------------------------------ Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K241370 Device Name Agilis™ NxT Steerable Introducer Dual-Reach™ (I-V2-MED) Indications for Use (Describe) The Agilis NxT Steerable Introducer Dual-Reach™ is indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum. | 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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The "a" is made up of three horizontal bars connected by vertical lines, forming a square shape with an open top. | 510(k) Information | | |----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | K241370 | | 510(k) Type | Special 510(k) | | Date Prepared | 14 May 2024 | | Submitter Information | | | Manufacturer Name &<br>Address | Abbott Medical<br>14901 DeVeau Place<br>Minnetonka, MN 55345 USA | | Contact Person | Alyssa Timmers<br>Principal Regulatory Affairs Specialist<br>651-756-3706<br>alyssa.timmers@abbott.com | | EnSite™ X EP System Device Information | | | Trade Name | Agilis™ NxT Steerable Introducer Dual-Reach™ | | Common Name | Introducer, Catheter | | Class | II | | Classification Name | 870.1340 Catheter Introducer | | Product Code | DYB | | Predicate Device | Agilis™ NxT Steerable Introducer (K061363) | | Device Description | The Agilis™ NxT Steerable Introducer Dual-Reach™ set consists of a dilator and steerable<br>introducer, which is designed to provide flexible catheter positioning in the cardiac<br>anatomy. The inner diameter of the steerable introducer is 13 F. The steerable introducer<br>includes a hemostasis valve to minimize blood loss during catheter introduction and/or<br>exchange. It has a sideport with three-way stopcock for air or blood aspiration, fluid<br>infusion, blood sampling, and pressure monitoring. The handle is equipped with a rotating<br>collar to deflect the tip clockwise ≥135° and counterclockwise ≥90°. Actual curve angles<br>will vary. The steerable introducer features distal vent holes to facilitate aspiration and<br>minimize cavitation and a radiopaque tip marker to improve fluoroscopic visualization. | | Indications for Use | The Agilis NxT Steerable Introducer Dual-Reach™ is indicated for introducing various<br>cardiovascular catheters into the heart, including the left side of the heart through the<br>interatrial septum. | | Predicate Comparison | | | Comparison | The subject device, Agilis™ NxT Steerable Introducer Dual-Reach™, and the predicate<br>device, Agilis™ NxT Steerable Introducer have the same intended use and indications for<br>use. They use the same fundamental scientific technology to facilitate catheter introduction<br>into the heart. The subject device was modified to include:<br>A larger French size introducer and dilator, An increased number of vent holes, A modified hemostasis seal, An increase in braid wires and pull wires, Slight modifications to the shaft materials, and A minor modification in deflection angles. All risks associated with these modifications were mitigated to acceptable levels. No new<br>questions of safety or effectiveness were raised. | | Predicate Comparison Continued | | | Non-Clinical Testing<br>Summary | Design verification activities were performed and met the respective acceptance criteria to ensure that the devices in scope of this submission are substantially equivalent to the predicate device. | | | Testing | | | The Agilis™ NXT Steerable Introducer Dual-Reach™ was developed and tested in accordance with the following industry guidance documents and standards: Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings - Labeling Considerations ISO 80369-7 Section Edition 2021-05, Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications ANSI AAMI ISO 10993-1:2018, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process ANSI AAMI ISO 11135:2014/A1:2018, Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices - Amendment 1: Revision of Annex E, Single batch release ANSI AAMI ST72:2019, Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing ISO 11607-1 Second edition 2019-02 [Including AMD1:2023], Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems [Including Amendment 1 (2023)] ISO 11607-2 Second edition 2019-02, Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes ISO 15223-1 Fourth edition 2021-07, Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements ISO 20417 First edition 2021-04 Corrected version 2021-12, Medical devices - Information to be supplied by the manufacturer | | | Types of Testing Performed Performance testing of modified design and packaging Biocompatibility testing Sterility testing | | Statement of<br>Equivalence | The subject and predicate devices have the same intended use, and the same indications for use. The devices operate using the same fundamental scientific technology to facilitate catheter introduction into the heart. The testing completed and summarized in this Special 510(k) provides objective evidence the subject device is substantially equivalent to the predicate device | {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for Abbott, a healthcare company. The logo consists of a stylized letter "a" in blue, followed by the company name "Abbott" in black, bold font. The "a" symbol is a rounded, geometric shape, and the word "Abbott" is written in a clear, sans-serif typeface.