(134 days)
K991601, P040002/S021
No
The device description and performance testing focus on the physical components and mechanical properties of a standard introducer system, with no mention of AI or ML capabilities.
No
This device, an introducer system, facilitates the introduction of other medical devices into the vasculature; it does not directly treat a condition or restore a function.
No
The device is an introducer system used to facilitate the insertion of other medical devices into the vasculature, which is an interventional function, not a diagnostic one.
No
The device description clearly outlines physical components such as an Introducer Sheath, Dilators, and various materials (PTFE, Pebax, ABS, rubber, silicone, PVC, stainless steel, Vectran, Platinum/Iridium, Barium Sulfate). The performance testing also focuses on physical characteristics and material compatibility. There is no mention of software as a component or function of the device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "facilitate the introduction of guidewires, and other medical devices into the vasculature and minimizes blood loss associated with such introduction." This describes a device used in vivo (within the body) for procedural access, not for testing samples in vitro (outside the body).
- Device Description: The description details components designed for insertion into the vasculature (sheath, dilators, hemostasis valve, etc.). These are all consistent with a device used for vascular access during medical procedures.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnostic, monitoring, or compatibility purposes.
Therefore, the Endologix AFX Introducer System is a medical device used for vascular access, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DYB
Device Description
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 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.
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)
Testing includes sterilization, shelf-life packaging validation, biocompatibility testing, and performance testing to ISO 10555-1 for intravascular catheters.
Sterilization: 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. Result: Pass.
Shelf-Life Packaging Validation:
Visual Inspection: Visual inspection of the packaging (inner and outer pouch) to identify any anomalies that could impact integrity of the package. Result: Pass.
Bubble Emission: ASTM F2096-04 Standard Test Method for Detecting Gross Leaks in Medical Packaging by Internal Pressurization. Result: Pass.
Dye Penetration: ASTM F1929-98 (2004) Standard Test Method for Detecting Seal Leaks in Porous medical Packaging by Dye Penetration. Result: Pass.
Peel Test: ASTM F88M-09 Standard test method for seal strength of flexible barrier materials. Result: Pass.
*Testing per ISO 11607-1: Packaging for Terminally Sterilized Medical Devices.
Biocompatibility:
Cytotoxicity ISO 10993-5: MEM Elution Using L0929 Mouse Fibroblast Cells. Result: Pass.
Sensitization ISO 10993-10: Murine Local Lymph Node Assay. Result: Pass.
Intracutaneous Reactivity ISO 10993-10: Intracutaneous Irritation Test. Result: Pass.
Acute Systemic Toxicity ISO 10993-11: Acute Systemic Injection Test. Result: Pass.
Hemocompatibility ISO 10993-4: Complement Activation, Hemolysis Assay, Partial Thromboplastin Time, Platelet and Leukocyte Counts. Result: Pass (for all).
Pyrogenicity USP : Rabbit Pyrogen Test. Result: Pass.
Performance Testing:
Leak Testing: Connection fittings and valve seal do not leak liquid when tested at 3.0 PSI. Result: Pass.
Bond and Component Tensile Strength: Break force of each bond meets or exceeds requirements. Result: Pass.
Particle Size: 10-25μm 25μm requirements for particulate matter in injection solutions of 100 mL or less in volume. Result: Pass (both).
*Testing per ISO 10555-1 for intravascular catheters.
Compatibility with Other Devices:
Guidewire Passage: Verify the delivery system accepts 0.035" guidewire. Result: Pass.
Crossing Profile: Verify the catheter dimensions comply with product specifications. Result: Pass.
Open Lumen Testing: Ensure that the guidewire passes through the system while in a bent position. Result: Pass.
Kink Test: Ensure that the delivery system will not kink when inserted through and retracted from the introducer sheath at a 90° angle. Result: Pass.
Introducer Sheath Transfer Force Testing: Verify transfer force is in compliance with product specifications. Result: Pass.
*Testing per ISO 25539-1: Cardiovascular Implants – Endovascular Devices.
Introducer Sheath Simulated Use Testing: 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.
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.
K082356, K032073, K902469, P040002/S021
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.
K991601, P040002/S021
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
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
| 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 25μm 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