(134 days)
The AFX Introducer System facilitates the introduction of guidewires, and other medical devices into the vasculature and minimizes blood loss associated with such introduction.
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.
The provided document describes the Endologix AFX Introducer System, an introducer sheath and dilator system. The information outlines various tests conducted to demonstrate the device's substantial equivalence to predicate devices, focusing on regulatory and performance aspects.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document presents several tables detailing various tests performed on the Endologix AFX Introducer System. The "Result (Pass/Fail)" column serves as the reported device performance against the implied acceptance criteria for each test.
| Test Category | Specific Test / Acceptance Criteria Description | Reported Device Performance (Result) |
|---|---|---|
| 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 | Pass |
| Shelf-Life Packaging Validation | Visual inspection of the packaging to identify any anomalies that could impact integrity | Pass |
| Bubble Emission (ASTM F2096-04) for detecting gross leaks | Pass | |
| Dye Penetration (ASTM F1929-98 (2004)) for detecting seal leaks | Pass | |
| Peel Test (ASTM F88M-09) for seal strength of flexible barrier materials | Pass | |
| Biocompatibility | Cytotoxicity (ISO 10993-5) using MEM Elution | 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 (for each sub-test) | |
| Pyrogenicity (USP <151>) - Rabbit Pyrogen Test | Pass | |
| Performance Testing (ISO 10555-1) | 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 meets or exceeds requirements) | Pass | |
| Particle Size (USP <788> requirements: 10-25μm <6,000, >25μm <600) | Pass (for each size range) | |
| Compatibility with Other Devices (ISO 25539-1) | Guidewire Passage (verify system accepts 0.035" guidewire) | Pass |
| Crossing Profile (verify catheter dimensions comply with product specifications) | Pass | |
| Open Lumen Testing (ensure guidewire passes while in a bent position) | Pass | |
| Kink Test (ensure delivery system will not kink when inserted through and retracted from introducer sheath at a 90° angle) | Pass | |
| Introducer Sheath Transfer Force Testing (verify transfer force complies with product specifications) | Pass | |
| Simulated Use Testing (Introducer Sheath) | All samples passed two 90° bends without kinking | Passed |
| All samples passed leak testing (up to 8 psi) | Passed | |
| Crossing profile was measured and was less than 6.47 mm | Passed | |
| Tensile Testing | Compliant with ISO 10555-1 | Compliant |
| Shelf Life | Device functional, package functional, and packaging sterility qualified for a 3-year shelf life | Qualified |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific numerical sample sizes (e.g., how many devices were tested for leak testing or biocompatibility). Instead, it uses phrases like "All samples passed" for some performance tests, implying that an appropriate number of units were tested.
The data provenance is not specified in terms of country of origin or whether it was retrospective or prospective. These are standard laboratory and engineering tests, typically conducted by the manufacturer as part of the device development and regulatory submission process.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This section is not applicable to the provided document. The tests performed are purely engineering, materials science, and biological safety evaluations for a medical device. They do not involve interpretation of medical images or data by human experts for ground truth establishment. Therefore, there are no "experts" in the context of clinical interpretation, nor is there "ground truth" to be established by them in this type of submission.
4. Adjudication Method for the Test Set
This section is not applicable. The tests involve objective measurements (e.g., passed/failed, numerical results for strength/leakage, etc.), not subjective assessments requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This section is not applicable. The document describes a physical medical device (introducer system), not an AI-powered diagnostic or interpretive tool. Therefore, no MRMC study or AI assistance evaluation was performed or is relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This section is not applicable. The device is a physical medical instrument, not an algorithm.
7. The Type of Ground Truth Used
For the engineering and biocompatibility tests, the "ground truth" is defined by established industry standards, regulatory guidelines (e.g., ISO, ASTM, USP), and internal product specifications. For instance:
- Sterility: SAL of 10^-6 as per ISO 11135-1.
- Packaging: Integrity and strength as per ISO 11607-1, ASTM F2096-04, ASTM F1929-98, ASTM F88M-09.
- Biocompatibility: Established biological responses and lack of toxicity as per ISO 10993 series.
- Performance: Physical and mechanical properties meeting requirements of ISO 10555-1 and ISO 25539-1 (e.g., no leaks at 3.0 PSI, sufficient bond strength, specific particle size limits, acceptance of 0.035" guidewire, no kinking at 90°).
These standards and specifications serve as the "ground truth" or acceptance criteria against which the device's performance is measured.
8. The Sample Size for the Training Set
This section is not applicable. The submission pertains to a physical medical device, not a machine learning model, so there is no concept of a "training set."
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the same reasons as above.
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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 Incorporated11 StudebakerIrvine, CA 92618 |
|---|---|
| Contact: | Janet M. FaulsVice 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
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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 inaccordance with ISO 11135-1 to verify that the ethylene oxidesterilization 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) toidentify any anomalies that could impact integrity of thepackage | Pass |
| Bubble Emission | ASTM F2096-04 Standard Test Method for Detecting GrossLeaks in Medical Packaging by Internal Pressurization | Pass |
| Dye Penetration | ASTM F1929-98 (2004) Standard Test Method for DetectingSeal Leaks in Porous medical Packaging by Dye Penetration | Pass |
| Peel Test | ASTM F88M-09 Standard test method for seal strength offlexible barrier materials | Pass |
- Testing per ISO 11607-1: Packaging for Terminally Sterilized Medical Devices
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Table 7-3: Biocompatibility
.
| Test | Test Description | Result(Pass/Fail) |
|---|---|---|
| CytotoxicityISO 10993-5 | MEM Elution Using L0929 Mouse Fibroblast Cells | Pass |
| SensitizationISO 10993-10 | Murine Local Lymph Node Assay | Pass |
| Intracutaneous ReactivityISO 10993-10 | Intracutaneous Irritation Test | Pass |
| Acute Systemic ToxicityISO 10993-11 | Acute Systemic Injection Test | Pass |
| HemocompatibilityISO 10993-4 | Complement ActivationHemolysis AssayPartial Thromboplastin TimePlatelet and Leukocyte Counts | PassPassPassPass |
| 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 whentested at 3.0 PSI | Pass |
| Bond and ComponentTensile 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 injectionsolutions of 100 mL or less in volume | PassPass |
- 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 productspecifications | Pass |
| Open Lumen Testing | Ensure that the guidewire passes through the system while ina bent position | Pass |
| Kink Test | Ensure that the delivery system will not kink when insertedthrough and retracted from the introducer sheath at a 90° angle | Pass |
| Introducer Sheath TransferForce Testing | Verify transfer force is in compliance with productspecifications | Pass |
- Testing per ISO 25539-1: Cardiovascular Implacts – Endovascular Devices
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| Feature | Gore Introducer Sheath withSilicone Pinch Valve(K082356 and K032073) | Cook Medical Extra LargeCheck-Flo Introducers(K902469) | EndologixDual Lumen Catheter(K991601) | Endologix IntuiTrakDelivery System- Introducer Sheath -Single Lumen Dilator -(P040002 / S021) | EndologixAFX Introducer System(K110090) |
|---|---|---|---|---|---|
| Product Code | DYB | DYB | DQY | --- | DYB |
| Intended Use/Indications forUse | Intended for use to facilitate theintroduction of guidewires,catheters and other interventionalmedical devices into the vascularsystem, and to minimize blood lossassociated with such introduction | Intended for use to facilitate theintroduction of guidewires,catheters and other interventionalmedical devices into the vascularsystem, and to minimize bloodloss associated with suchintroduction | For use in a two guidewireprocedure | Integrated into the IntuiTrak DeliverySystem; intended for use to facilitate theintroduction of guidewires, catheters andother interventional medical devices intothe vascular system, and to minimizeblood loss associated with suchintroduction | Introducer Sheath with Single LumenDilatorIntended for use to facilitate theintroduction of catheters and othermedical devices into the vasculatureand to minimize blood loss associatedwith such introductionIntroducer Sheath with Dual LumenDilatorIntended for use in a two guidewireprocedure to facilitate the introductionof catheters and other medical devicesinto the vasculature and to minimizeblood loss associated with suchintroduction |
Table 7-6: Endologix AFX Introducer System Predicates Comparison Table
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| Feature | Gore Introducer Sheath withSilicone Pinch Valve(K082356 and K032073) | Cook Medical Extra LargeCheck-Flo Introducers(K902469) | EndologixDual Lumen Catheter(K991601) | Endologix IntuiTrakDelivery System- Introducer Sheath -Single Lumen Dilator -(P040002 / S021) | EndologixAFX Introducer System(K110090) |
|---|---|---|---|---|---|
| Material | Materials biocompatible for use inthe vasculature | Materials biocompatible for usein the vasculature | Materials biocompatible foruse in the vasculatureincluding:• Pebax (7233) components• Polycarbonate luer• PTFE Braided lumen | Materials biocompatible for use in thevasculature including:• Pebax for the sheath (72D) anddilator (63D) components• PTFE liner on the inner diameter ofthe sheath• Hydrophilic coating on theIntroducer 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 thevasculature including:• Pebax for the sheath (72D) anddilator (63D) components• PTFE liner on the inner diameterof the sheath• Hydrophilic coating on theIntroducer sheath and dilator• ABS handle• Silicone gasket• Butyl Rubber Trocar Valve[K945719]• DEHP free PVC Side port tubing• Polycarbonate and polyetherstopcock |
| RadiopaqueMarker | Radiopaque dilator forfluoroscopic visibility | unknown | Gold | • 90% Platinum/10% Iridium markerband embedded on the distal tip ofthe Introducer Sheath• Dilators are loaded with 30% BaSO4 | • 90% Platinum/10% Iridium markerband embedded on the distal tip ofthe 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 lumencompatible with 0.035"guidewire | Five configurations provided:• 20 Fr - 24 Fr• 56-81 cm usable dilatorlength• 25-65 cm outer sheathlength• Central lumen compatiblewith 0.035" guidewire | A single catheterconfiguration provided:9 Fr Catheter• 90 cm usable length• Central dilator lumencompatible 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 isprovided: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 sheathdiameter• 45 cm sheath length• 2 dilators included (single anddual lumen)• Central guidewire lumen(dilators) |
| Feature | Gore Introducer Sheath withSilicone Pinch Valve(K082356 and K032073) | Cook Medical Extra LargeCheck-Flo Introducers(K902469) | EndologixDual Lumen Catheter(K991601) | Endologix IntuiTrakDelivery System- Introducer Sheath -Single Lumen Dilator -(P040002 / S021) | EndologixAFX Introducer System(K110090) |
| Biocompatibility | Materials biocompatible for use inthe vasculature | Materials biocompatible for usein the vasculature | Materials biocompatible foruse in the vasculature | Materials biocompatible for use in thevasculature | Materials biocompatible for use in thevasculature |
| Sterilization | Provided sterilized to a sterilityassurance level (SAL) of 10-6 byethylene oxide sterilization process | Provided sterilized to a sterilityassurance level (SAL) of 10-6 byethylene oxide sterilizationprocess | Provided sterilized to asterility assurance level (SAL)of 10-6 by ethylene oxidesterilization process | Provided sterilized to a sterilityassurance level (SAL) of 10-6 byethylene oxide sterilization process | Provided sterilized to a sterilityassurance level (SAL) of 10-6 byethylene oxide sterilization process |
| Introducer SheathSimulated UseTesting | Compliant with ISO 10555-1 | Compliant with ISO 10555-1 | Compliant with ISO 10555-1 | All samples passed two 90° bendswithout kinking All samples passed leak testing (upto 8 psi) Crossing profile was measured andwas less than 6.47 mm | All samples passed two 90° bendswithout kinking All samples passed leak testing(up to 8 psi) Crossing profile was measured andwas 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 LumenCatheter is labeled with a3-year shelf life. The devicefunctional, packagefunctional, and packagingsterility has been qualified forthis shelf life. | The Endologix IntuiTrak DeliverySystem is labeled with a 3-year shelf life.The device functional, packagefunctional, and packaging sterility hasbeen qualified for this shelf life. | The Endologix AFX IntroducerSystem is labeled with a 3-year shelflife. The device functional, packagefunctional, and packaging sterility hasbeen qualified for this shelf life. |
.
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Endologix, Inc.
K110090 510(k) Summary
May 2011
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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.
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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,
Sincerely yours,
Bram Zuckerman, MD Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
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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
§ 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).