The Endologix AFX Introducer System is intended for use to facilitate the introduction of guidewires, catheters, and other medical devices into the vasculature and minimize blood loss associated with such introduction.

Device Description

The Endologix AFX Introducer System, Model S17-45 consists of an Introducer Sheath (45cm working length), Dilator, and a peel-away wire straightener. The AFX Introducer System is a single-use sterile device that is compatible with a standard 0.035" guidewire.

AI/ML Overview

This document describes a Special 510(k) submission for the Endologix AFX Introducer System, Model S17-45, which involves a minor modification to an already cleared device. Therefore, the information provided focuses on demonstrating substantial equivalence to the predicate device rather than presenting a de novo clinical study with extensive acceptance criteria and performance metrics typically associated with novel devices or significant device changes.

1. Table of Acceptance Criteria and Reported Device Performance

Evaluation	Applicable Test Standard(s)	Acceptance Criteria (Implied)	Reported Device Performance
Functional/Mechanical Qualification	BS EN ISO 10555-1:2009	Device meets performance requirements for introducer catheters as per standard.	Demonstrated substantial equivalence to predicate device through successful completion of tests outlined in the standard.
EO Gas Sterilization Validation	ANSI/AAMI/ISO 11135-1: 2007	Device is sterile after processing as per standard.	Sterilization process was validated and found compliant with the standard.
EO Gas Sterilization Validation	AAMI TIR 28: 2009	Ensures proper ethylene oxide sterilization practices for healthcare products.	Sterilization process was validated and found compliant with the standard.
Biocompatibility Testing	ISO 10993-1: 2009	Device materials are biocompatible and do not pose unacceptable biological risks.	Biocompatibility was demonstrated in accordance with the standard.
Overall Substantial Equivalence	N/A	Modified device performs as safely and effectively as the predicate device (K111747) for its intended use.	"The descriptive characteristics of the proposed device are sufficient to ensure equivalence to the predicate device... the evaluations listed... have been performed on the modified AFX Introducer System to support the determination of substantially equivalence." (FDA cleared the device, indicating this criterion was met).

Explanation of Implied Acceptance Criteria: For a Special 510(k) submission involving a minor modification to an already cleared device, the "acceptance criteria" are primarily based on demonstrating that the modification does not negatively impact the safety and effectiveness of the device compared to the predicate. This is typically achieved by performing specific tests against recognized standards and ensuring the modified device continues to meet the performance characteristics established for the predicate. Specific numerical performance metrics are usually not presented as "acceptance criteria" in this context unless the modification specifically impacts a measurable performance claim.

Study Type: This is not a clinical study on patient outcomes or a comparative effectiveness study in the traditional sense. It's a bench testing and validation study designed to demonstrate that the changes (replacement of a butyl rubber valve with a silicone valve, modification of hemostasis valve housing, and addition of a peel-away wire straightener) to the AFX Introducer System maintain the device's substantial equivalence to its predicate device (K111747).

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: The document does not specify the exact sample sizes used for each individual test (e.g., number of devices tested for functional or mechanical qualification). This is typical for such submissions as the focus is on confirming adherence to established standards rather than statistical clinical significance.
Data Provenance: The data provenance is from bench testing conducted by Endologix, Inc. to assess various aspects of the modified device against recognized industry standards. The country of origin of the data is Endologix, Inc. (Irvine, CA, USA). The data is prospective in the sense that the tests were specifically performed after the device modification to validate its performance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Number of Experts: Not applicable in the context of this submission. "Ground truth" for bench testing is established by the specifications of the device and the requirements of the applicable test standards. The tests are designed to objectively measure specific characteristics.
Qualifications of Experts: The testing would have been conducted by trained engineers and technicians at Endologix, Inc., with expertise in medical device testing and quality assurance, and familiarity with the relevant ISO and AAMI standards.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies where expert consensus is needed to establish a "true" diagnosis or outcome for a patient. In bench testing, the results are objectively measured against pre-defined criteria from the standards. Any discrepancies would be handled through a formal investigation process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study assesses how human readers (e.g., radiologists) perform with and without an AI assistant across multiple cases. The submission is for a physical medical device (introducer system) and does not involve AI or human interpretation of outputs that would warrant an MRMC study.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone (algorithm only) performance study was not done. This concept applies to AI/ML software devices. The Endologix AFX Introducer System is a physical medical device and does not inherently have an "algorithm-only" or "human-in-the-loop" component in this context.

7. The Type of Ground Truth Used

Ground truth for bench testing: The "ground truth" for the tests performed (Functional/Mechanical Qualification, Sterilization Validation, Biocompatibility) is defined by the requirements and specifications within the referenced international consensus standards (BS EN ISO 10555-1:2009, ANSI/AAMI/ISO 11135-1: 2007, AAMI TIR 28: 2009, ISO 10993-1: 2009) and the design specifications of the Endologix AFX Introducer System. The tests were performed to demonstrate compliance with these objective standards.

8. The Sample Size for the Training Set

Not applicable. This submission is for a physical medical device. The concept of a "training set" is relevant for AI/ML models.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As stated above, there is no training set for this device.

Summary

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Endologix, Inc. Special 510(k) Modified AFX Introducer System, Model S17-45 FEB - 9 2012

January 2012 Product Code: DYB

5. 510(K) SUMMARY

Endologix AFX Introducer System 510(k) Summary - K TBD January 23, 2012

1.	Company:	Endologix, Inc.11 StudebakerIrvine, CA 92618
	Contact:	Janet M. FaulsVP, Regulatory and Clinical Affairs(949) 595-7203(949) 595-7313 (fax)jfauls@endologix.com
2.	Proprietary Trade Name:	Endologix AFX Introducer System, Model S17-45
3.	Classification Name:	Catheter, Introducer (21 CFR 870.1340)
4.	Product Code:	DYB

ട്. Product Description:

The Endologix AFX Introducer System, Model S17-45 consists of an Introducer Sheath (45cm working length), Dilator, and a peel-away wire straightener.

The AFX Introducer System is a single-use sterile device that is compatible with a standard 0.035" guidewire.

· Introducer Sheath: The Introducer Sheath provides a conduit for introducing other interventional devices, including guidewires and interventional catheters, into the vasculature. The main components of this assembly are a hydrophilically-coated polytetrafluoroethylene (PTFE) lined 55D Pebax introducer sheath, acrylobutylstyrene (ABS) hemostasis valve housing with silicone valve and gasket assembly, 3-way stopcock/valve, and sideport diethylhexyl phthalate (DEHP)-free polyvinylchloride (PVC) tubing. The Pebax introducer sheath also includes an embedded stainless steel braid for increased strength and kink resistance, and embedded Vectran® strands for increased longitudinal strength. The distal tip of the introducer sheath includes an embedded radiopaque marker composed of 90% Platinum/10% Iridium. The only change to the Introducer Sheath from that cleared under K111747 is replacement of the butyl rubber valve with a silicone valve and modification of the hemostasis valve housing to accommodate the silicone valve.
· Dilator: The dilator for this system is used to provide support and stability to the Introducer Sheath during deployment into the vasculature. The dilator is designed specifically for the Endologix AFX Introducer System and can accommodate a 0.035" guidewire through the

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K120212 Page 2 of 2

January 2012 Product Code: DYB

central lumen. The dilator is composed of 63D Pebax with 30% Barium Sulfate (BaSO2) for radiopacity and a hydrophilic coating on the outer surface. The dilator is designed in diameter and length to be placed within the AFX Introducer Sheath component. The dilator has a tapered, atraumatic distal tip. The proximal end of the dilator includes a luer port. The dilator provides stiffness to the assembly so that the introducer sheath can be placed within the vasculature during standard vascular access. There are no changes to the dilator from that cleared under K111747.

· Peel-away Wire Straightener: A newly added peel-away wire straightener has been added to the AFX Introducer System as a convenience option for our customers. The peel-away wire straightener is useful in straightening guidewires prior to feeding into the introducer sheath. This 8 cm length wire straightener is identical in materials (55D Pebax), lumen and outer diameter, construction, and processing as the wire straightener currently packaged with the AFX Endovascular AAA bifurcated delivery system (approved under P040002/5031).

6. Indications

The Endologix AFX Introducer System, Model S17-45 is intended for use to facilitate the introduction of guidewires, catheters and other medical devices into the vasculature and minimize blood loss associated with such introduction.

7. Substantial Equivalence

Documentation provided includes a detailed comparison which demonstrates that the proposed AFX Introducer System, Model S17-45 is substantially equivalent to the current Endologix AFX Introducer System, Model S17-45 cleared under K111747. The descriptive characteristics of the proposed device are sufficient to ensure equivalence to the predicate device: In addition, the evaluations listed in Table 5-1 have been performed on the modified AFX Introducer System to support the determination of substantially equivalence to the 510(k) cleared AFX Introducer System:

Evaluation	Applicable test standard(s)
Functional/Mechanical Qualification	BS EN ISO 10555-1:2009
EO Gas Sterilization Validation	ANSI/AAMI/ISO 11135-1: 2007
EO Gas Sterilization Validation	AAMI TIR 28: 2009
Biocompatibility Testing	ISO 10993-1: 2009

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird figure.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

FEB - 9 2012

Endologix, Inc. c/o Janet M. Fauls VP, Regulatory and Clinical Affairs 11 Studebaker Irvine, CA 92618

Re: K120212

Trade/Device Name: AFX Introducer System Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II (two) Product Code: DYB Dated: January 23, 2012 Received: January 24, 2012

Dear Ms. Fauls:

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.

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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 device-related 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

W. A. Allehenne

/ Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number: TBD K120212

Device Name: Endologix AFX Introducer System

Device Model: Model S17-45

Indications for Use: The Endologix AFX Introducer System is intended for use to facilitate the introduction of guidewires, catheters, and other medical devices into the vasculature and minimize blood loss associated with such introduction.

Prescription Use ______x (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

M.A. Hillelence

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(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number K120212

Regulation Number and Section

§ 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).