Who is the manufacturer of AFX INTRODUCER SYSTEM?

Endologix, Inc. filed the 510(k) submission for AFX INTRODUCER SYSTEM (K110090).

What is the FDA product code for AFX INTRODUCER SYSTEM?

DYB. It is classified under 21 CFR 870.1340 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for AFX INTRODUCER SYSTEM?

510(k) clearance (submission type: Traditional).

What are the predicate devices for AFX INTRODUCER SYSTEM?

Gore Introducer Sheath with Silicone Pinch Valve (K082356 and K032073); Cook Medical Extra Large Check-Flo Introducers (K902469); Endologix IntuiTrak Introducer Sheath (P040002/S021).

Who can help prepare an FDA 510(k) submission like AFX INTRODUCER SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

AFX INTRODUCER SYSTEM

K110090 · Endologix, Inc. · DYB · May 26, 2011 · Cardiovascular

Device Facts

Record ID	K110090
Device Name	AFX INTRODUCER SYSTEM
Applicant	Endologix, Inc.
Product Code	DYB · Cardiovascular
Decision Date	May 26, 2011
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1340
Device Class	Class 2

Intended Use

The AFX Introducer System facilitates the introduction of guidewires, and other medical devices into the vasculature and minimizes blood loss associated with such introduction.

Device Story

Endologix AFX Introducer System is a vascular access device consisting of a 45 cm hydrophilically-coated Pebax introducer sheath and two dilators (one single lumen, one dual lumen). The sheath features a PTFE liner, stainless steel braid, Vectran strands for strength, and a Platinum/Iridium radiopaque marker. The system includes an ABS hemostasis valve housing with a butyl rubber valve and silicone gasket to minimize blood loss. Used by clinicians in clinical settings to provide a conduit for interventional devices; the dilators provide stability and support during insertion over a 0.035" guidewire. The dual lumen dilator supports two-guidewire procedures. The device is provided sterile for single use. By facilitating safe vascular access and reducing hemorrhage, the system enables successful delivery of endovascular therapies.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included sterilization validation (ISO 11135-1), shelf-life packaging validation (ASTM F2096-04, F1929-98, F88M-09), biocompatibility (ISO 10993 series), and performance testing per ISO 10555-1 and ISO 25539-1. Performance metrics included successful guidewire passage, crossing profile verification, leak testing at 3.0 PSI, and kink resistance during 90-degree bends.

Technological Characteristics

Materials: 72D/55D/63D Pebax, PTFE liner, ABS handle, butyl rubber valve, silicone gasket, DEHP-free PVC tubing, 90% Pt/10% Ir marker, 20% BaSO4. Energy: None (mechanical). Connectivity: None. Sterilization: Ethylene oxide (SAL 10^-6). Form factor: 45 cm sheath, 17 Fr dilator, 19 Fr sheath diameter. Features: Hydrophilic coating, stainless steel braid, Vectran reinforcement.

Indications for Use

Indicated for use in patients requiring vascular access to facilitate the introduction of guidewires, catheters, and other interventional medical devices into the vasculature while minimizing blood loss. The dual lumen dilator configuration is indicated for use in two-guidewire procedures.

Regulatory Classification

Identification

A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

Predicate Devices

Gore Introducer Sheath with Silicone Pinch Valve (K082356 and K032073)
Cook Medical Extra Large Check-Flo Introducers (K902469)
Endologix IntuiTrak Introducer Sheath (P040002/S021)

Reference Devices

Endologix Dual Lumen Catheter (K991601)
IntuiTrak Single Lumen Dilator (P040002/S021)

Related Devices

K111747 — ENDOLOGIX AFX INTRODUCER SYSTEM · Endologix, Inc. · Jul 12, 2011
K120212 — AFX INTRODUCER SYSTEM · Endologix, Inc. · Feb 9, 2012
K171866 — Sentrant Introducer Sheath with Hydrophilic Coating · Medtronic Vascular, Inc. · Dec 20, 2017
K211405 — Prelude Guide Sheath · Merit Medical Systems, Inc. · Oct 4, 2021
K203179 — Fortress Introducer Sheath System · Contract Medical International, GmbH · Nov 20, 2020

Submission Summary (Full Text)

{0}------------------------------------------------ ### MAY 2 6 2011 # APPENDIX 1 ### 510(K) SUMMARY OR 510(K) STATEMENT ### Endologix AFX Introducer System 510(k) Summary - K110090 May 6, 2011 | 1. Company: | Endologix Incorporated 11 Studebaker Irvine, CA 92618 | |----------------------------|-------------------------------------------------------------------------------------------------------------------------------------| | Contact: | Janet M. Fauls Vice President, 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. The Endologix AFX Introducer System consists of an Introducer Sheath (45 cm working length) and two Dilators. The system is enclosed in a sterile package. During clinical use, the system will allow introduction of a standard 0.035" guidewire within its inner lumen. - · 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 Vectran® strands for increased longitudinal strength. The distal tip of the introducer sheath includes an embedded radiopaque marker composed of 90% Platinum/10% Iridium. - · Dilators: The dilators for the system 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 System and can accommodate a 0.035" guidewire through the central lumen. Two dilators are included with the AFX Introducer System. Both dilators are included within the package. One dilator is a single lumen device and one dilator is a dual lumen device. Both dilators are composed of 63D Pebax with 20% Barium Sulfate (BaSO4) for radiopacity and include a {1}------------------------------------------------ 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 a standard vascular access. ### 6. Indications: The AFX Introducer System facilitates the introduction of guidewires, and other medical devices into the vasculature and minimizes blood loss associated with such introduction. ### 7. Substantial Equivalence: Documentation provided includes mechanical test results and detailed comparison to the predicate devices demonstrate that the Endologix AFX Introducer System is substantially equivalent to the Gore Introducer Sheath with Silicone Pinch Valve (K082356 and K032073), the Cook Medical Extra Large Check-Flo Introducers (K902469), and the Endologix IntuiTrak Introducer Sheath (P040002/S021). Reference is also made to the following Endologix products to support the clearance of the Endologix Dual Lumen Dilator: Dual Lumen Catheter (K991601) and IntuiTrak Single Lumen Dilator (P040002/S021) Testing includes sterilization, shelf-life packaging validation, biocompatibility testing, and performance testing to ISO 10555-1 for intravascular catheters. A summary of this testing is provided in the following tables. | Test | Test Description | Result (Pass/Fail) | |-----------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------| | Sterility | Validation of the ethylene oxide sterilization cycle in accordance with ISO 11135-1 to verify that the ethylene oxide sterilization process provides a SAL of 10-6 | Pass | Table 7-1: Steriliztation Validation | | Table 7-2: Shelf-Life Packaging Validation | | | |--|--------------------------------------------|--|--| |--|--------------------------------------------|--|--| | Test* | Test Description | Result (Pass/Fail) | |-------------------|---------------------------------------------------------------------------------------------------------------------------------------|-----------------------| | Visual Inspection | Visual inspection of the packaging (inner and outer pouch) to identify any anomalies that could impact integrity of the package | Pass | | Bubble Emission | ASTM F2096-04 Standard Test Method for Detecting Gross Leaks in Medical Packaging by Internal Pressurization | Pass | | Dye Penetration | ASTM F1929-98 (2004) Standard Test Method for Detecting Seal Leaks in Porous medical Packaging by Dye Penetration | Pass | | Peel Test | ASTM F88M-09 Standard test method for seal strength of flexible barrier materials | Pass | * Testing per ISO 11607-1: Packaging for Terminally Sterilized Medical Devices {2}------------------------------------------------ ### Table 7-3: Biocompatibility . | Test | Test Description | Result (Pass/Fail) | |-------------------------------------------|----------------------------------------------------------------------------------------------------------|------------------------------| | Cytotoxicity ISO 10993-5 | MEM Elution Using L0929 Mouse Fibroblast Cells | Pass | | Sensitization ISO 10993-10 | Murine Local Lymph Node Assay | Pass | | Intracutaneous Reactivity ISO 10993-10 | Intracutaneous Irritation Test | Pass | | Acute Systemic Toxicity ISO 10993-11 | Acute Systemic Injection Test | Pass | | Hemocompatibility ISO 10993-4 | Complement Activation Hemolysis Assay Partial Thromboplastin Time Platelet and Leukocyte Counts | Pass Pass Pass Pass | | Pyrogenicity USP < 151> | Rabbit Pyrogen Test | Pass | ### Table 7-4: Performance Testing | Test* | Test Description | Result (Pass/Fail) | |------------------------------------------------|-----------------------------------------------------------------------------------------------------|-----------------------| | Leak Testing | Connection fittings and valve seal do not leak liquid when tested at 3.0 PSI | Pass | | Bond and Component Tensile Strength | Break force of each bond meets or exceeds requirements | Pass | | Particle Size: 10-25μm <6,000 >25μm <600 | USP <788> requirements for particulate matter in injection solutions of 100 mL or less in volume | Pass Pass | * Testing per ISO 10555-1 for intravascular catheters | | Table 7-5: Compatibility with Other Devices | |--|---------------------------------------------| |--|---------------------------------------------| | Test* | Test Description | Result (Pass/Fail) | |---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|-----------------------| | Guidewire Passage | Verify the delivery system accepts 0.035" guidewire | Pass | | Crossing Profile | Verify the catheter dimensions comply with product specifications | Pass | | Open Lumen Testing | Ensure that the guidewire passes through the system while in a bent position | Pass | | Kink Test | Ensure that the delivery system will not kink when inserted through and retracted from the introducer sheath at a 90° angle | Pass | | Introducer Sheath Transfer Force Testing | Verify transfer force is in compliance with product specifications | Pass | * Testing per ISO 25539-1: Cardiovascular Implacts – Endovascular Devices {3}------------------------------------------------ | Feature | Gore Introducer Sheath with Silicone Pinch Valve (K082356 and K032073) | Cook Medical Extra Large Check-Flo Introducers (K902469) | Endologix Dual Lumen Catheter (K991601) | Endologix IntuiTrak Delivery System - Introducer Sheath - Single Lumen Dilator - (P040002 / S021) | Endologix AFX Introducer System (K110090) | |-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Code | DYB | DYB | DQY | --- | DYB | | Intended Use/ Indications for Use | Intended for use to facilitate the introduction of guidewires, catheters and other interventional medical devices into the vascular system, and to minimize blood loss associated with such introduction | Intended for use to facilitate the introduction of guidewires, catheters and other interventional medical devices into the vascular system, and to minimize blood loss associated with such introduction | For use in a two guidewire procedure | Integrated into the IntuiTrak Delivery System; intended for use to facilitate the introduction of guidewires, catheters and other interventional medical devices into the vascular system, and to minimize blood loss associated with such introduction | Introducer Sheath with Single Lumen Dilator Intended for use to facilitate the introduction of catheters and other medical devices into the vasculature and to minimize blood loss associated with such introduction Introducer Sheath with Dual Lumen Dilator Intended for use in a two guidewire procedure to facilitate the introduction of catheters and other medical devices into the vasculature and to minimize blood loss associated with such introduction | # Table 7-6: Endologix AFX Introducer System Predicates Comparison Table {4}------------------------------------------------ | Feature | Gore Introducer Sheath with Silicone Pinch Valve (K082356 and K032073) | Cook Medical Extra Large Check-Flo Introducers (K902469) | Endologix Dual Lumen Catheter (K991601) | Endologix IntuiTrak Delivery System - Introducer Sheath - Single Lumen Dilator - (P040002 / S021) | Endologix AFX Introducer System (K110090) | |-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Material | Materials biocompatible for use in the vasculature | Materials biocompatible for use in the vasculature | Materials biocompatible for use in the vasculature including: • Pebax (7233) components • Polycarbonate luer • PTFE Braided lumen | Materials biocompatible for use in the vasculature including: • Pebax for the sheath (72D) and dilator (63D) components • PTFE liner on the inner diameter of the sheath • Hydrophilic coating on the Introducer sheath and dilator • ABS handle • Silicone gasket • Butyl Rubber Trocar Valve [K945719] • DEHP free PVC Side port tubing • Polycarbonate/silicone stopcock | Materials biocompatible for use in the vasculature including: • Pebax for the sheath (72D) and dilator (63D) components • PTFE liner on the inner diameter of the sheath • Hydrophilic coating on the Introducer sheath and dilator • ABS handle • Silicone gasket • Butyl Rubber Trocar Valve [K945719] • DEHP free PVC Side port tubing • Polycarbonate and polyether stopcock | | Radiopaque Marker | Radiopaque dilator for fluoroscopic visibility | unknown | Gold | • 90% Platinum/10% Iridium marker band embedded on the distal tip of the Introducer Sheath • Dilators are loaded with 30% BaSO4 | • 90% Platinum/10% Iridium marker band embedded on the distal tip of the Introducer Sheath • Dilators are loaded with 20% BaSO4 | | Dimensions | Four configurations provided: • 18 Fr - 22Fr • 70 cm usable dilator length • 30 cm sheath length • Central dilator lumen compatible with 0.035" guidewire | Five configurations provided: • 20 Fr - 24 Fr • 56-81 cm usable dilator length • 25-65 cm outer sheath length • Central lumen compatible with 0.035" guidewire | A single catheter configuration provided: 9 Fr Catheter • 90 cm usable length • Central dilator lumen compatible with 0.035" guidewire | A single dilator configuration provided: 19 Fr Dilator • 80.6 cm usable dilator length • Central dilator lumen | A single dilatory configuration is provided: 17 Fr Dilator • 69 cm usable dilator length • 3.1 cm tapered dilator tip • 17 Fr dilator outer diameter • 6.4 mm (19 Fr) outer sheath diameter • 45 cm sheath length • 2 dilators included (single and dual lumen) • Central guidewire lumen (dilators) | | Feature | Gore Introducer Sheath with Silicone Pinch Valve (K082356 and K032073) | Cook Medical Extra Large Check-Flo Introducers (K902469) | Endologix Dual Lumen Catheter (K991601) | Endologix IntuiTrak Delivery System - Introducer Sheath - Single Lumen Dilator - (P040002 / S021) | Endologix AFX Introducer System (K110090) | | Biocompatibility | Materials biocompatible for use in the vasculature | Materials biocompatible for use in the vasculature | Materials biocompatible for use in the vasculature | Materials biocompatible for use in the vasculature | Materials biocompatible for use in the vasculature | | Sterilization | Provided sterilized to a sterility assurance level (SAL) of 10-6 by ethylene oxide sterilization process | Provided sterilized to a sterility assurance level (SAL) of 10-6 by ethylene oxide sterilization process | Provided sterilized to a sterility assurance level (SAL) of 10-6 by ethylene oxide sterilization process | Provided sterilized to a sterility assurance level (SAL) of 10-6 by ethylene oxide sterilization process | Provided sterilized to a sterility assurance level (SAL) of 10-6 by ethylene oxide sterilization process | | Introducer Sheath Simulated Use Testing | Compliant with ISO 10555-1 | Compliant with ISO 10555-1 | Compliant with ISO 10555-1 | All samples passed two 90° bends without kinking All samples passed leak testing (up to 8 psi) Crossing profile was measured and was less than 6.47 mm | All samples passed two 90° bends without kinking All samples passed leak testing (up to 8 psi) Crossing profile was measured and was less than 6.47 mm | | Tensile Testing | Compliant with ISO 10555-1 | Compliant with ISO 10555-1 | Compliant with ISO 10555-1 | Compliant with ISO 10555-1 | Compliant with ISO 10555-1 | | Shelf Life | Labeled with a 3-year shelf life. | Unknown | The Endologix Dual Lumen Catheter is labeled with a 3-year shelf life. The device functional, package functional, and packaging sterility has been qualified for this shelf life. | The Endologix IntuiTrak Delivery System is labeled with a 3-year shelf life. The device functional, package functional, and packaging sterility has been qualified for this shelf life. | The Endologix AFX Introducer System is labeled with a 3-year shelf life. The device functional, package functional, and packaging sterility has been qualified for this shelf life. | . {5}------------------------------------------------ # Endologix, Inc. K110090 510(k) Summary May 2011 {6}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/6/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of an eagle with its wings spread. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 MAY 2 6 2011 Janet M. Fauls VP, Regulatory and Clinical Affairs Endologix, Inc. 11 Studebaker Irvine, CA 92618 Re: K110090 AFX Introducer System Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter. Introducer Regulatory Class: Class II Product Code: DYB Dated: May 23, 2011 Received: May 25, 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. {7}------------------------------------------------ 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, Sincerely yours, Bram Zuckerman, MD Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health {8}------------------------------------------------ ## APPENDIX 2 ### Indications for Use 510(k) Number: K110090 Device Name: Endologix AFX Introducer System Indications for Use: The AFX Introducer System facilitates the introduction of guidewires, and other medical devices into the vasculature and minimizes 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) Division of Cardiovascular Devices 510(k) Number K110090 Page 1 of 1

AFX INTRODUCER SYSTEM

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

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AFX INTRODUCER SYSTEM

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

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