(31 days)
The Agilis NxT Steerable Introducer Dual-Reach is indicated for the introduction of various cardiovascular catheters into the heart, including the left side of the heart, during the treatment of cardiac arrhythmias.
The Agilis™ NxT Steerable Introducer Dual-Reach™™ is a sterile, single-use device that consists of a dilator and steerable introducer, which is designed to provide flexible catheter positioning in the cardiac anatomy. The inner diameter of the steerable introducer is 13F. The steerable introducer includes a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. It has a sideport with a three-way stopcock for air or blood aspiration, fluid infusion, blood sampling, and pressure monitoring. The handle is equipped with a rotating collar to deflect the tip clockwise ≥180° and counterclockwise ≥90°. The steerable introducer features distal vent holes to facilitate aspiration and minimize cavitation and a radiopaque tip marker to improve fluoroscopic visualization.
This document is a 510(k) premarket notification for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study proving the device meets specific acceptance criteria in the way a clinical trial would for an AI/algorithm-based product.
The information provided describes design verification activities for a hardware medical device (steerable introducer), not an AI algorithm. Therefore, many of the requested categories (e.g., sample size for test/training set, ground truth experts, MRMC studies, standalone algorithm performance) are not applicable.
Here's an analysis based on the provided text, addressing the relevant points:
1. Table of Acceptance Criteria and Reported Device Performance
The submission states: "Design verification activities were performed and met the respective acceptance criteria to ensure that the devices in scope of this submission are safe and effective." However, specific numerical acceptance criteria and their corresponding reported device performance values are not detailed in this summary. The document lists the types of testing performed and the standards met.
| Acceptance Criterion (Type of Test) | Reported Device Performance (Implied) |
|---|---|
| Performance testing of modified design | Met acceptance criteria (no specific numerical values provided) |
| Biocompatibility testing | Met acceptance criteria (no specific numerical values provided) |
| Sterility testing | Met acceptance criteria (no specific numerical values provided) |
| Shelf-life testing | Met acceptance criteria (no specific numerical values provided) |
| Adherence to ISO 80369-7 (Small-bore connectors) | Compliance confirmed |
| Adherence to ANSI AAMI ISO 10993-1 (Biological evaluation) | Compliance confirmed |
| Adherence to ANSI AAMI ISO 11135 (Sterilization) | Compliance confirmed |
| Adherence to ANSI AAMI ST72 (Bacterial endotoxins) | Compliance confirmed |
| Adherence to ISO 11607-1 & -2 (Packaging) | Compliance confirmed |
| Adherence to ISO 15223-1 & ISO 20417 (Symbols & Information to be supplied) | Compliance confirmed |
2. Sample Size Used for the Test Set and Data Provenance
This is not applicable as the document describes physical device testing, not an AI/algorithm-based test set with data provenance. "Test set" here refers to the physical devices subjected to various engineering and biological tests. The sample sizes for each specific test (e.g., number of devices for durability, sterility, or biocompatibility) are not provided in this summary, but would be part of the full design verification report.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. "Ground truth" in the context of expert consensus is relevant for AI algorithms interpreting medical images or data. For a physical medical device like an introducer, "ground truth" is typically established by engineering specifications, validated test methods, and biological safety standards. Experts involved would be engineers, microbiologists, and other technical specialists relevant to the specific tests performed (e.g., biocompatibility specialist, sterilization expert).
4. Adjudication Method for the Test Set
Not applicable. This refers to methods for reconciling differing expert opinions on ground truth for AI algorithms. For device performance testing, adjudication involves comparing test results against predefined acceptance criteria from engineering specifications and regulatory standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. without AI Assistance
Not applicable. This is a hardware device (catheter introducer), not an AI system that assists human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a hardware device, not a standalone algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is based on established engineering specifications, international and national standards (e.g., ISO, ANSI AAMI listed), and regulatory requirements for mechanical performance, material compatibility, biocompatibility, and sterility. For example, for biocompatibility, the ground truth is that the materials do not elicit an adverse biological response as defined by ISO 10993-1.
8. The Sample Size for the Training Set
Not applicable. This refers to AI/machine learning models.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This refers to AI/machine learning models.
Summary of Study Type:
The study referenced is a series of non-clinical design verification activities and laboratory tests. These tests were conducted to demonstrate that the modifications made to the Agilis NxT Steerable Introducer Dual-Reach™ (the subject device) did not adversely affect its safety and effectiveness and that it continues to meet established performance, biological safety, and sterility standards, making it substantially equivalent to its predicate device. This is typical for a 510(k) submission for a modified hardware device.
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December 13, 2024
Abbott Medical Juan Ordonez Sr. Regulatory Affairs Specialist 14901 DeVeau Place Minnetonka, Minnesota 55345
Re: K243493
Trade/Device Name: Agilis NxT Steerable Introducer Dual-Reach Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: November 8, 2024 Received: November 12, 2024
Dear Juan Ordonez:
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" (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).
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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 QS 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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 medical devices and radiation-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).
Sincerelv.
Digitally signed by Finn E. Finn E. Donaldson -Donaldson - s Date: 2024.12.13 S 14:22:20 -05'00'
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Finn Donaldson Acting Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K243493
Device Name Agilis NxT Steerable Introducer Dual-Reach
Indications for Use (Describe)
The Agilis NxT Steerable Introducer Dual-Reach is indicated for the introduction of various cardiovascular catheters into the heart, including the left side of the heart, during the treatment of cardiac arrhythmias.
Type of Use (Select one or both, as applicable)
| ☑ Description Use (Part 21 CFR 801 Subpart D) |
|---|
| □ Over-The-Counter Use (21 CFR 801 Subpart C) |
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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| 510(k) Information | |
|---|---|
| 510(k) Number | K243493 |
| 510(k) Type | Special 510(k) |
| Date Prepared | 12-Dec-2024 |
| Submitter Information | |
| Manufacturer Name &Address | Abbott Medical14901 DeVeau PlaceMinnetonka, MN 55345 USA |
| Contact Person | Juan OrdonezSr. Regulatory Affairs Specialist612-619-8354juan.ordonez3@abbott.com |
| Device Information | |
| Trade Name | Agilis™ NxT Steerable Introducer Dual-Reach™™ |
| Common Name | Introducer, Catheter |
| Class | II |
| Classification Name | 21 CFR 870.1340 Catheter Introducer |
| Product Code | DYB - Introducer, catheter |
| Predicate Device | Agilis™ NxT Steerable Introducer Dual-Reach (K241370 - Cleared on 13thJune-2024) |
| Device Description | The Agilis™ NxT Steerable Introducer Dual-Reach™™ is a sterile, single-use device that consists of adilator and steerable introducer, which is designed to provide flexible catheter positioning in thecardiac anatomy. The inner diameter of the steerable introducer is 13F. The steerable introducerincludes a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. Ithas a sideport with a three-way stopcock for air or blood aspiration, fluid infusion, blood sampling,and pressure monitoring. The handle is equipped with a rotating collar to deflect the tip clockwise≥180° and counterclockwise ≥90°. The steerable introducer features distal vent holes to facilitateaspiration and minimize cavitation and a radiopaque tip marker to improve fluoroscopic visualization. |
| Indications for Use | The Agilis™ NxT Steerable Introducer Dual-Reach™™ is indicated for the introduction of variouscardiovascular catheters into the heart, including the left side of the heart, during the treatment ofcardiac arrhythmias. |
| Predicate Comparison | |
| Comparison oftechnologicalCharacteristics | The subject device, Agilis™ NxT Steerable Introducer Dual-Reach™™, and the predicate device,Agilis™ NxT Steerable Introducer Dual-Reach (K241370) have the same intended use andindications for use. They use the same fundamental scientific technology to facilitate catheterintroduction into the heart. The subject device was modified to include:Additional curl (medium and large) deflectable configurations A distal tip wall thickness reduction An increase in pull ring, pull wires and braid wire size An improved pull wire lock mechanism A minor modification to the side port location of the hemostasis hub A packaging tray adoption from 8.5F Agilis models A minor modification to the deflection angleAll risks associated with these modifications were mitigated to acceptable levels. No new questionsof safety or effectiveness were raised. |
| Predicate Comparison Continued | |
| Non-Clinical TestingSummary | Design verification activities were performed and met the respective acceptance criteria to ensure thatthe devices in scope of this submission are safe and effective.TestingThe Agilist™ NXT Steerable Introducer Dual-Reach™ was developed and tested in accordance withthe following industry guidance documents and standards:Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings - LabelingConsiderations, issued October 10, 2019 ISO 80369-7 Section Edition 2021-05, Small-bore connectors for liquids and gases inhealthcare 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 - Ethyleneoxide - Requirements for the development, validation and routine control of a sterilizationprocess for medical devices - Amendment 1: Revision of Annex E, Single batch release ANSI AAMI ST72:2019, Bacterial endotoxins - Test methods, routine monitoring, andalternatives to batch testing ISO 11607-1 Second edition 2019-02 [Including AMD1:2023], Packaging for terminallysterilized medical devices - Part 1: Requirements for materials, sterile barrier systems andpackaging 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 informationto be supplied by the manufacturer - Part 1: General requirements ISO 20417 First edition 2021-04 Corrected version 2021-12, Medical devices - Informationto be supplied by the manufacturer Types of Testing Performed Performance testing of modified design Biocompatibility testing Sterility testing Shelf-life |
| Statement of Equivalence | The subject and predicate devices have the same intended use, and the same indications for use. Thedevices operate using the same fundamental scientific technology to facilitate catheter introductioninto the heart. The testing completed and summarized in this Special 510(k) provides objectiveevidence that the subject device is substantially equivalent to the predicate device. |
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§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).