(20 days)
Not Found
No
The device description and performance studies focus on the physical components and mechanical properties of an introducer system, with no mention of AI or ML.
No
The device is an introducer system designed to facilitate the introduction of other medical devices into the vasculature; it does not directly treat a condition.
No
This device is intended for facilitating the introduction of other medical devices into the vasculature, not for diagnosing medical conditions.
No
The device description clearly outlines physical components made of materials like Pebax, PTFE, ABS, butyl rubber, silicone, PVC, stainless steel, and Platinum/Iridium. It also details physical tests like functional/mechanical qualification, sterilization validation, shelf-life packaging qualification, and biocompatibility testing, all of which are associated with hardware devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "facilitate the introduction of guidewires, catheters, and other medical devices into the vasculature and minimize blood loss associated with such introduction." This describes a device used in vivo (within the body) for procedural access, not a device used in vitro (outside the body) to examine specimens from the body.
- Device Description: The description details components like sheaths, dilators, valves, and tubing designed for insertion into the vasculature. These are typical components of devices used for vascular access and intervention.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, tissue, etc.) or to provide diagnostic information based on such analysis.
Therefore, the Endologix AFX Introducer Systems are medical devices used for vascular access and are not classified as In Vitro Diagnostics.
N/A
Intended Use / 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.
Product codes
DYB
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vasculature
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
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 |
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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 Studebaker
Irvine, CA 92618 |
|----|-------------------------|-------------------------------------------------------------------------------------------------------------------------|
| | Contact: | Janet M. Fauls
VP, 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 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.
- 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
1
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:
2
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.
3
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
4
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