The Endologix AFX Introducer Systems are 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 Systems consist of an Introducer Sheath (45 cm working length) and either one or two Dilators. Model S17-45DD contains dual dilators: a dual-lumen dilator for introduction and management of two guidewires; and, a single-lumen dilator. Model S17-45 contains only the single-lumen dilator.

Each AFX Introducer System is enclosed in a sterile package. Each system 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, PTFE lined, 55D Pebax introducer sheath, acrylobutylstyrene (ABS) hemostasis valve housing with butyl rubber valve, and silicone 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 Vectrands for increased longitudinal strength. The distal tip of the introducer sheath includes an embedded radiopaque marker composed of 90% Platinum/10% Iridium. There are no changes to the Introducer Sheath from that cleared under K110090.
Dilators: The dilators for these systems are used to provide support and stability to the Introducer Sheath during deployment into the vasculature. The dilators are designed specifically for the Endologix AFX Introducer Systems and can accommodate a 0.035" guidewire through the central lumen. One dilator is a single lumen device and the other dilator is a dual lumen device. Both dilators are composed of 63D Pebax with 30% Barium Sulfate (BaSO4) for radiopacity and include a hydrophilic coating on the outer surface. These dilators are designed in diameter and length to be placed within the AFX Introducer Sheath component. The dilators have a tapered, atraumatic distal tip. The proximal end of the dilators includes a luer port. The dilators provide 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 Dilators from that cleared under K110090. Model S17-45 contains only the single lumen dilator; Model S17-45DD contains both dilators with the AFX Introducer System within the package.

AI/ML Overview

The provided text describes a 510(k) submission for the Endologix AFX Introducer System, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a clinical study proving device performance against specific acceptance criteria.

Therefore, many of the requested categories for a study report on acceptance criteria cannot be directly addressed from the provided document. The document lists performance tests conducted to establish equivalence, not to meet specific clinical performance acceptance criteria in the manner of a standalone study for a new device's efficacy or safety.

Here's an attempt to extract relevant information and explain where the document does not provide the requested details:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense for clinical performance. Instead, it lists tests performed to establish equivalence to a predicate device. The "reported device performance" in this context refers to the successful completion of these tests in accordance with the listed standards, thus demonstrating equivalence and safety/functionality.

Test Description	Applicable Test Standard(s)	Reported Device Performance (Implied Acceptance)
Functional/Mechanical Qualification	ISO 10555-1:1995	The device successfully met the functional and mechanical requirements outlined in ISO 10555-1:1995, supporting its intended use for introducing guidewires, catheters, and other medical devices into the vasculature.
EtO Gas Sterilization Validation	ANSI/AAMI/ISO 11135-1:2007, AAMI TIR 28: 2009	The device successfully underwent Ethylene Oxide (EtO) gas sterilization validation according to the specified standards, ensuring its sterility for clinical use.
3-year Shelf-Life Packaging Qualification	ISO 11607-1:2006	The device's packaging successfully met the qualification requirements for a 3-year shelf-life as per ISO 11607-1:2006, ensuring product integrity and sterility over time.
Biocompatibility Testing	ISO 10993-1:2009	The device demonstrated biocompatibility in accordance with ISO 10993-1:2009, indicating it is safe for contact with human tissue.

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

Sample Size for Test Set: Not specified. The document refers to "functional qualification" and other testing but does not provide details on the number of devices or components sampled for these tests.
Data Provenance: The tests were conducted to support a 510(k) submission to the FDA for a device manufactured by Endologix, Inc. in Irvine, CA, USA. The data would be considered internal company testing. The document does not specify if the tests were prospective or retrospective in the clinical study sense; rather, they are part of the device development and validation process.

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

Not applicable. This information is typically relevant for clinical studies involving expert interpretation (e.g., image analysis, diagnoses). The tests described (functional, sterilization, packaging, biocompatibility) are laboratory-based and do not involve human expert "ground truth" establishment in this manner. Evaluation is against defined technical standards and specifications.

4. Adjudication Method for the Test Set

Not applicable. As above, adjudication methods are typically used in clinical studies for resolving discrepancies in expert interpretations. The device tests described are objective, pass/fail evaluations against technical standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. The document describes a 510(k) submission focused on demonstrating substantial equivalence through technical and functional testing, not a clinical study comparing human reader performance with and without AI.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. The Endologix AFX Introducer System is a physical medical device (introducer sheath and dilators) and does not involve an algorithm or AI. Therefore, a standalone algorithm performance study is not relevant.

7. Type of Ground Truth Used

Technical standards and specifications. For the tests listed, the "ground truth" is defined by the requirements outlined in the applicable ISO and AAMI standards (e.g., ISO 10555-1 for functional aspects, ISO 10993-1 for biocompatibility). Successful completion of these tests means the device met the objective criteria set by these standards.

8. Sample Size for the Training Set

Not applicable. As this is a physical medical device and not an AI/algorithm, there is no "training set."

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

Not applicable. (See point 8).

In summary, the provided text is a 510(k) summary for a medical device that demonstrates substantial equivalence to a predicate device through engineering and laboratory testing. It is not a report on a clinical trial with acceptance criteria for clinical efficacy or diagnostic performance, which would typically involve details about human experts, ground truth, and study designs like MRMC or standalone performance.

Summary

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K11+
12

June 2011 Product Code: DYB

510(K) SUMMARY OR 510(K) STATEMENT 6.

Endologix AFX Introducer System 510(k) Summary - K TBD June 20, 2011

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
3.	Classification Name:	Catheter, Introducer (21 CFR 870.1340)
4.	Product Code:	DYB

Product Description: 5.

Each AFX Introducer System is enclosed in a sterile package. Each system 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, PTFE lined, 55D Pebax introducer sheath, acrylobutylstyrene (ABS) hemostasis valve housing with butyl rubber valve, and silicone 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 Vectrands for increased longitudinal strength. The distal tip of the introducer sheath includes an embedded radiopaque marker composed of 90% Platinum/10% Iridium. There are no changes to the Introducer Sheath from that cleared under K110090.
The dilators for these systems are used to provide support and stability to the · Dilators: Introducer Sheath during deployment into the vasculature. The dilators are designed specifically for the Endologix AFX Introducer Systems and can accommodate a 0.035" guidewire through the central lumen. One dilator is a single lumen device and the other dilator

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is a dual lumen device. Both dilators are composed of 63D Pebax with 30% Barium Sulfate (BaSO4) for radiopacity and include a hydrophilic coating on the outer surface. These dilators are designed in diameter and length to be placed within the AFX Introducer Sheath component. The dilators have a tapered, atraumatic distal tip. The proximal end of the dilators includes a luer port. The dilators provide 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 Dilators from that cleared under K110090. Model S17-45 contains only the single lumen dilator; Model S17-45DD contains both dilators with the AFX Introducer System within the package.

Q. Indications

The Endologix AFX Introducer Systems are 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 Endologix AFX Introducer Systems (Model S17-45DD containing dual dilators; Model S17-45 containing only the single-lumen dilator) are substantially equivalent to the predicate Endologix AFX Introducer System (containing the introducer sheath and dual dilators [single-lumen and dual-lumen dilators]) cleared under K110090. The descriptive characteristics of the proposed devices are sufficient to ensure equivalence to the predicate device.

Data contained within the original 510(k) that support the S17-45DD and S17-45 models include functional qualification, ethylene oxide (EtO) gas sterilization validation, 3-year shelf-life packaging qualification, and biocompatibility testing for the intended use as listed below:

Test Description	Applicable test standard (s)
Functional/Mechanical Qualification	ISO 10555-1:1995
EtO Gas Sterilization Validation	ANSI/AAMI/ISO 11135-1:2007
	AAMI TIR 28: 2009
3-year Shelf-Life Packaging Qualification	ISO 11607-1:2006
Biocompatibility Testing	ISO 10993-1:2009

List of Tests Performed to Establish Equivalence to Predicate Device Table 7-1:

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three wing-like strokes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

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

JUL 1 2 2011

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

Re: K111747

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: June 21, 2011 Received: June 22, 2011

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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Page 2 - Ms. Janet M. Fauls

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,

$\mu$

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:

Device Name: Endologix AFX Introducer System

Indications for Use: The Endologix AFX Introducer Systems are 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)

Division Sign-Off)

Page 1 of 1

جيڪي

Division of Cardiovascular Devices

510(k) Number K111741

Confidential - This document and the information contained herein may not be reproduced, used or disclosed without written permission from Endologix Incorporated

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).