(31 days)
Not Found
No
The device description focuses on mechanical and physical features, and there is no mention of AI, ML, or related concepts in the provided text.
No
The device is an introducer for catheters, designed to facilitate the delivery of other instruments (catheters) for treatment. It does not provide the treatment itself.
No
The device is an introducer, designed to facilitate the insertion of other catheters for treatment, and its function is not to diagnose conditions.
No
The device description clearly outlines a physical, sterile, single-use device consisting of a dilator and steerable introducer with various hardware components like a hemostasis valve, sideport, handle, vent holes, and a radiopaque tip marker. The performance studies also focus on testing of the physical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "introduction of various cardiovascular catheters into the heart... during the treatment of cardiac arrhythmias." This describes a device used in vivo (within the body) for a procedural purpose (introducing catheters).
- Device Description: The description details a physical device designed to be inserted into the body to facilitate catheter placement. It mentions features like a hemostasis valve, sideport for fluid/blood management, and a steerable tip for positioning within the cardiac anatomy. These are characteristics of an invasive medical device used for a procedure, not a device used to test samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) to provide diagnostic information. The device's function is purely mechanical and procedural.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
DYB
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
heart, left side of the heart
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Testing
The Agilist™ 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, issued October 10, 2019
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
Biocompatibility testing
Sterility testing
Shelf-life
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Agilis™ NxT Steerable Introducer Dual-Reach (K241370 - Cleared on 13thJune-2024)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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).
1
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'
2
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
3
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 Medical |
| 14901 DeVeau Place | |
| Minnetonka, MN 55345 USA | |
| Contact Person | Juan Ordonez |
| Sr. Regulatory Affairs Specialist | |
| 612-619-8354 | |
| juan.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 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. | |
| Indications for Use | 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. | |
| Predicate Comparison | |
| Comparison of | |
| technological | |
| Characteristics | 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 and | |
| indications for use. They use the same fundamental scientific technology to facilitate catheter | |
| introduction 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 questions | |
| of safety or effectiveness were raised. | |
| Predicate Comparison Continued | |
| Non-Clinical Testing | |
| Summary | 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. |
Testing
The Agilist™ 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, issued October 10, 2019 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 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. 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 that the subject device is substantially equivalent to the predicate device. |
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