(16 days)
P040002/5031
No
The summary describes a mechanical introducer system and does not mention any software, algorithms, or AI/ML related terms.
No
Explanation: This device is intended to facilitate the introduction of other medical devices into the vasculature, not to treat a condition or disease itself. It is an accessory device rather than a therapeutic one.
No
The device is described as an "Introducer System" to facilitate the introduction of other medical devices into the vasculature, not to diagnose a condition. Its intended use is procedural (to aid in other medical interventions), not diagnostic.
No
The device description explicitly states it consists of physical components: an Introducer Sheath, Dilator, and a peel-away wire straightener. It also mentions functional/mechanical qualification testing, indicating hardware is involved.
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 during a medical procedure to access the body's internal structures (vasculature).
- Device Description: The description details a physical system (sheath, dilator, wire straightener) used for insertion into the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information about a person's health. There is no mention of analyzing specimens or providing diagnostic information in the provided text.
Therefore, the Endologix AFX Introducer System is a medical device used for procedural access, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DYB
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.
- 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 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).
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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 |
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.
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.
P040002/5031
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
KI₂O₂/₂ page 1 of 2
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 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, 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
1
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 |
2
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.
3
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
4
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
Page 1 of 1
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K120212