Who is the manufacturer of MODIFIED HD GUIDE CATHETER?

Concentric Medical, Inc. filed the 510(k) submission for MODIFIED HD GUIDE CATHETER (K133177).

What is the FDA product code for MODIFIED HD GUIDE CATHETER?

DQY. It is classified under 21 CFR 870.1250 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for MODIFIED HD GUIDE CATHETER?

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

What are the predicate devices for MODIFIED HD GUIDE CATHETER?

Concentric HD Guide Catheter (K090335); Modified HD Guide Catheter (K110483).

Who can help prepare an FDA 510(k) submission like MODIFIED HD GUIDE CATHETER?

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.

MODIFIED HD GUIDE CATHETER

K133177 · Concentric Medical, Inc. · DQY · Feb 25, 2014 · Cardiovascular

Device Facts

Record ID	K133177
Device Name	MODIFIED HD GUIDE CATHETER
Applicant	Concentric Medical, Inc.
Product Code	DQY · Cardiovascular
Decision Date	Feb 25, 2014
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1250
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Modified HD Guide Catheter is indicated for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary and neuro vascular systems. It may also be used as a diagnostic angiographic catheter and as a conduit for retrieval devices.

Device Story

Modified HD Guide Catheter is a single-lumen, braid-reinforced, variable-stiffness catheter with a hydrophilic coating, radiopaque distal marker, and proximal luer hub. Used in peripheral, coronary, and neurovascular systems to facilitate insertion/guidance of microcatheters, perform diagnostic angiography, and serve as a conduit for retrieval devices during thrombectomy. Operated by physicians in clinical settings. Device provides support in distal anatomy and allows adjunctive aspiration during retriever withdrawal. Output is visual angiographic guidance and mechanical support for interventional tools. Benefits include improved access to distal anatomy and successful clot retrieval in acute ischemic stroke patients.

Clinical Evidence

Clinical evidence includes retrospective review of TREVO 2 (n=99) and TREVO (n=34) studies. Results showed revascularization rates of 84.8% and 96.7% respectively, with no device-related adverse events. Literature review of 15 articles confirmed safety and efficacy in acute ischemic stroke thrombectomy. Post-market surveillance (MDRs) from 2008-2013 showed low complaint rates (0.21%) with no new risks identified.

Technological Characteristics

Single-lumen, braid-reinforced (stainless steel) catheter; Pebax outer jacket; polyolefin strain relief; PTFE braid securement; polyurethane hub; platinum/iridium marker band; acrylic adhesive; hydrophilic coating. Dimensions: 3.9F-6.3F. Sterilization: EO. Standalone device.

Indications for Use

Indicated for use in facilitating insertion/guidance of occlusion, infusion, or microcatheters into peripheral, coronary, and neurovascular vessels; diagnostic angiography; and as a conduit for retrieval devices in patients undergoing thrombectomy procedures.

Regulatory Classification

Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Predicate Devices

Concentric HD Guide Catheter (K090335)
Modified HD Guide Catheter (K110483)

Reference Devices

Concentric Balloon Guide Catheter (K112404)

Related Devices

K092298 — MODIFICATION TO MODIFIED HD GUIDE CATHETER · Concentric Medical, Inc. · Nov 5, 2009
K080583 — MODIFIED HD GUIDE CATHETER · Concentric Medical, Inc. · Jul 18, 2008
K090335 — HD GUIDE CATHETER · Concentric Medical, Inc. · May 6, 2009
K110483 — MODIFIED HD GUIDE CATHETER · Concentric Medical, Inc. · Apr 4, 2011
K091703 — HD GUIDE CATHETER, MODEL 90019, 90022, 90023, 90120, 90121, 90130, 90131 · Concentric Medical, Inc. · Oct 14, 2009

Submission Summary (Full Text)

{0}------------------------------------------------ K133177 FEB 2 5 2014 ## 510(k) Summary | Summary Date: | January 30, 2014 | | |----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------| | Submitter Name and Address: | Concentric Medical, Inc. 301 E. Evelyn Avenue Mountain View, CA 94041 Tel 650-938-2100 Fax 650-237-5230 Facility Registration #2954917 | | | Contact: | Rhoda Santos Principal Regulatory Affairs Specialist Phone: 510 413-2269 Fax: 510 413-2558 Email: rhoda.santos@stryker.com | | | Trade Name: | Modified HD Guide Catheter | | | Common Name: | Percutaneous Catheter | | | Classification Name: | Percutaneous Catheter, 21CFR 870.1250 – Class II | | | Product Code: | DQY and DQO | | | Legally Marketed Predicate Devices: | Reference (Clearance Date) | Device | | | K090335 (May 6, 2009) | Concentric HD Guide Catheter | | | K110483 (April 4, 2011) | Modified HD Guide Catheter | | | K112404 (March 15, 2012) | Concentric Balloon Guide Catheter | | Device Description: | The Modified HD Guide Catheters are single lumen, braided, variable stiffness shaft catheters designed for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary or neuro vascular system. The catheters include a radiopaque marker on the distal and for angiographic visualization | | adapter is provided with each catheter. and a luer hub on the proximal end allowing attachments for flushing and aspiration. The catheter shaft has a hydrophilic coating to reduce friction during use. A rotating hemostatic valve with side-arm {1}------------------------------------------------ #### Accessories: The Modified HD Guide Catheter is packaged with a Rotating Hemostasis Valve. #### Indications for Use / Intended Use: The proposed Indications for Use are as follows: The Modified HD Guide Catheter is indicated for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary and neuro vascular systems. It may also be used as a diagnostic angiographic catheter and as a conduit for retrieval devices. #### Technological Characteristics and Product Feature Comparison: The subject device has the same technological characteristics as the predicate devices (K090335 and K110483). The device design, materials, fundamental scientific technology, materials and processes for packaging and sterilization have not been changed from the previous predicate devices (K090335 and K110483). The subject device differs from the predicate device, K112404 primarily in that it does not include a balloon at the distal tip or a second lumen. A tabular comparison of the specific technological characteristics between the predicate devices and subject device is provided below. {2}------------------------------------------------ | Product Feature Comparison of Subject Device with Predicate Devices | | | | | |---------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Feature | Predicate Device, K112404 | Predicate Device, K090335 | Predicate Device, K110483 | Subject Device | | Indications for Use | The Concentric Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The Balloon Guide Catheter is also indicated for use as a conduit for Retrieval devices | The HD Guide Catheter is indicated for the removal/aspiration of fresh, soft emboli and thrombi from vessels in the arterial system. | The Modified HD Guide Catheter is indicated for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary and neuro vascular systems. It may also be used as a diagnostic angiographic catheter. | The Modified HD Guide Catheter is indicated for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary and neuro vascular systems. It may also be used as a diagnostic angiographic catheter and as a conduit for retrieval devices. | | Feature Device Description | Predicate Device, K112404 | Predicate Device, K090335 | Predicate Device, K110483 | Subject Device | | | The Concentric Balloon Guide Catheters are coaxial-lumen, braid- reinforced, variable stiffness catheters designed for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. A radiopaque marker is included on the distal end for angiographic visualization. A compliant balloon is mounted on the distal end to provide temporary vascular occlusion during angiographic procedures. A bifurcated luer hub on the proximal end allows attachments for flushing, inflation and aspiration. Balloon Guide Catheter dimensions and maximum recommended balloon inflation volume are indicated on product label. If indicated on product label, a dilator is provided. | The HD Guide Catheter consists of a single lumen, braided, variable stiffness shaft with a radiopaque marker on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating to reduce friction during use. A rotating hemostatic valve with side-arm adapter is provided with each catheter. | Same as predicate device, K090335 | Same as predicate devices, K090335 and K110483 | | Feature | Predicate Device, K112404 | Predicate Device, K090335 | Predicate Device, K110483 | Subject Device | | Outer Jacket | Pebax® | Pebax® | Same as predicate device, K090335 | Same as predicate devices, K090335 and K114083 | | Braid | Stainless Steel | Stainless Steel | Same as predicate device, K090335 | Same as predicate devices, K090335 and K114083 | | Strain Relief | Polyolefin | Polyolefin | Same as predicate device, K090335 | Same as predicate devices, K090335 and K114083 | | Braid distal end securement | PTFE | PTFE | Same as predicate device, K090335 | Same as predicate devices, K090335 and K114083 | | Catheter Hub | Polyurethane | Pebax | Same as predicate device, K090335 | Same as predicate devices, K090335 and K114083 | | Marker Band | Platinum/Iridium | Platinum/Iridium | Same as predicate device, K090335 | Same as predicate devices, K090335 and K114083 | | Adhesive | Acrylic (Acrylated Urethane) | Acrylic (Acrylated Urethane) | Same as predicate device, K090335 | Same as predicate devices, K090335 and K114083 | | Outer jacket coating | NA | hydrophilic coating | Same as predicate device, K090335 | Same as predicate devices, K090335 and K114083 | | Labeled Shaft Outer Diameter | 7F - 9F | 3.9F - 5.2F | 6.3F | Same as predicate devices, K090335 and K114083 | | Effective Lengths | 80cm or 95cm | 115 cm – 136 cm | 105-120 cm | Same as predicate devices, K090335 and K114083 | | Accessory Devices Provided | Dilator | Rotating Hemostatic Valve | Same as predicate device, K090335 | Same as predicate devices, K090335 and K114083 | | Packaging Materials and Configuration | Polyethylene Tube and HDPE Packaging Card | Polyethylene Tube and HDPE Packaging Card | Same as predicate device, K090335 | Same as predicate devices, K090335 and K114083 | | Sterilization Method | EO Sterilization | Same | Same | Same | | How Supplied | Sterile, Single Use | Same | Same | Same | C ... De t Feature Comparison of Subject Device with Produ : {3}------------------------------------------------ # 510(k) Summary (cont {4}------------------------------------------------ # 510(k) Summary (cont {5}------------------------------------------------ #### Risk Assessment Risk assessment of the Modified HD Guide Catheter has been conducted in accordance with EN ISO 14971:2012. As a result of the risk assessment, the Instructions for Use have been revised to include recommended aspiration procedure steps for use of the Modified HD Guide Catheter with retrieval devices. #### Testing and Non-Clinical Performance Data: The results of verification and validation conducted on the Modified HD Guide Catheter demonstrate that it performs as designed, is suitable for its intended use and is substantially equivalent to the predicate devices (K090335 and K110483). The same performance standards, specifications and results as those submitted in the predicate devices (K090335 and K110483) are applicable to the subject device because the designs are identical and no changes have been made to the design, materials, processes, or packaging materials as a result of the expanded indications for use. Therefore, the following design verification tests submitted in the predicate devices (K090335 and K110483) are applicable to the subject device and its new indications for use: - . Tip Patency during Aspiration: the ability of the device tip to maintain patency during aspiration during simulated use testing was successfully evaluated. - Air Leak Resistance during Aspiration: the ability of the device to resist leakage ♥ during aspiration was successfully evaluated. - Leak Testing: the ability of the device to resist leakage was successfully evaluated. - Dimensional Testing: dimensions of the device were successfully verified. . - Tensile Testing: the tensile strength of the device was successfully evaluated. . - . Kink Resistance Testing: the ability of the device to withstand curves without kinking was successfully evaluated. - . Flexural Fatigue Testing: the flexural fatigue tolerance of the device was successfully evaluated. - Torque Testing: the ability of the device to withstand torsional forces was successfully evaluated. - Tip Flexibility Testing: the force to deflect the catheter tip was successfully . evaluated. - Coating Lubricity and Durability Testing: the durability of the hydrophilic coating . was successfully evaluated. - Flow Rate Testing: the rate of flow through the device lumen was successfully . evaluated. - . Luer Testing: luer integrity and conformance to luer standards was successfully evaluated. To support the expansion of the Indications for Use (IFU), performance testing utilized design validation / simulated use testing to confirm that the subject device and accessories meets user needs "as a conduit for retrieval devices" and continue to meet design requirements of the predicate device. Simulated use testing evaluates the device's ability to be used in a neurovascular model per procedural instructions outlined in the modified Instructions for Use. Based on the results of the risk assessment, no other testing was required to demonstrate the device meets intended uses. {6}------------------------------------------------ Design validation/simulated use testing was conducted using a neurovascular model cast from actual human neurovascular arteries. This bench testing model replicates the tortuosity, diameter and location of the arteries in the neurovasculature. The model incorporates a re-circulating water bath at 37℃ pressurized between 2 - 2.5 psi (100 -126 mm Hg) to simulate the human arterial circulation. The simulated use tests described in Table 2 were conducted in support of the expanded indications for use. Finished sterilized devices were used for the simulated use testing. All design validation testing followed the procedural instructions outlined in the Instructions for Use which was revised to include a "Recommended Aspiration Procedure" for use with retrieval devices. Based on the successful completion of the testing, the subject device and its accessories have met all of the pre-specified requirements. A summary of the design validation / simulated use testing and the results is described in Table 2 below. | Test | Test Method Summary | Results | |-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------| | Tip Patency during Aspiration | Purpose: Tip patency is evaluated in a neurovascular model to verify that the distal tip of catheter remains patent during vigorous aspiration to avoid loss of suction at the distal tip. | Pass All samples met acceptance criteria for expanded indications for use. | | | Method: A neurovascular model is placed in a re- circulating water bath at 37°C and pressurized to simulate human arterial circulation. The catheter is placed in the model to a specified location following procedural instructions outlined in the Instructions for Use. The catheter is aspirated vigorously using a 60 cc syringe and the shape of the distal tip is visually verified to determine if distal tip remains patent during aspiration. | Device continues to meet same design requirements as predicate devices (K090335 and K110483). | | Lumen Compatibility | Purpose: Lumen compatibility is evaluated in a neurovascular model to verify that guidewires and other devices shall pass through the inner shaft of the catheter with no more than moderate resistance. | Pass All samples met acceptance criteria for expanded indications for use. | | | Method: A neurovascular model is placed in a re- circulating water bath at 37°C and pressurized to simulate human arterial circulation. The catheter is placed in the model to a specified location following procedural instructions outlined in the Instructions for Use. A "compatible device" is inserted through the inner shaft of the catheter and assessed for degree of resistance through inner shaft, i.e., easy, moderate, difficult, or not possible. | Device continues to meet same design requirements as predicate devices (K090335 and K110483). | Table 2: Design Validation / Simulated Use Testing of Subject Device and Accessories {7}------------------------------------------------ # 510(k) Summary (cont.) ・ | Test | Test Method Summary | Results | |----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Lumen and Retriever Compatibility | Purpose: Lumen and Retriever compatibility is evaluated in a neurovascular model to verify that the Retriever and microcatheter (as a system) is able to be withdrawn through the catheter and completely removed from the model without device fracture. Method: A neurovascular model is placed in a re- circulating water bath at 37°C and pressurized to simulate human arterial circulation. The Retriever and microcatheter is inserted through the catheter to reach a specified target location following procedural instructions outlined in the Instructions for Use. The Retriever and microcatheter (as a system) is pulled back through the catheter and completely remove them from the model. The Retriever is visually inspected for damage. | Pass All samples met acceptance criteria for expanded indications for use. Device continues to meet same design requirements as predicate devices (K090335 and K110483). | | Infusion and Aspiration | Purpose: Infusion and aspiration of the catheter is evaluated in a neurovascular model to verify that the user is able to aspirate and inject fluid thru the Extension Tubing with 60cc syringe. Method: A neurovascular model is placed in a re- circulating water bath at 37°C and pressurized to simulate human arterial circulation. The catheter is placed in the model to a specified location following procedural instructions outlined in the Instructions for Use. The Retriever and microcatheter are advanced (as a system) through the BGC. The extension tubing is attached to the Y-arm of the rotating hemostasis valve. Fluid is infused vigorously through extension tubing with a 60cc syringe. While retracting both the Retriever and microcatheter (as a system) through the catheter to completely remove the system from the model, a 60cc syringe is used to aspirate through the extension tubing. When the Retriever is retracted into the catheter tip, the user aspirates to 60cc's vigorously as the Retriever is fully retracted in the catheter. The catheter is visually inspected for damage. | Pass All samples met acceptance criteria for expanded indications for use. Device continues to meet same design requirements as predicate devices (K090335 and K110483). | | Test | Test Method Summary | Results | | Distal tip stability | Purpose: Distal tip stability is evaluated in a neurovascular model to verify that the distal tip does not move during retraction of the Retriever and microcatheter (as a system) into the catheter. Method: A neurovascular model is placed in a re- circulating water bath at 37°C and pressurized to simulate human arterial circulation. The catheter is placed in the model to a specified location following procedural instructions outlined in the Instructions for Use. The Retriever and microcatehter are advanced (as a system) through the catheter. The extension tubing is attached to the Y-arm of the rotating hemostasis valve. Fluid is infused vigorously through extension tubing with a 60cc syringe. While retracting both the Retriever and microcatheter (as a system) through the catheter to completely remove the system from the model, a 60cc syringe is used to aspirate through the extension tubing. When the Retriever is retracted into the catheter tip, the user aspirates to 60cc's vigorously as the Retriever is fully retracted in the catheter. The catheter is visually inspected for damage. The distal tip of catheter is visually inspected to verify it does not move forward or back during retraction of the Retriever and microcatheter (as a system). | Pass All samples met acceptance criteria for expanded indications for use. Device continues to meet same design requirements as predicate devices (K090335 and K110483). | | Mechanical and Functional Integrity | Purpose: The catheter is inspected for mechanical and functional integrity following simulated use in a neurovascular model to verify that the catheter maintains mechanical integrity (e.g., visible damage, shaft kink, hub joints, shaft joints, tip separation, corrosion) and that catheter function was not impaired by the introducer sheath. Method: A neurovascular model is placed in a re- circulating water bath at 37°C and pressurized to simulate human arterial circulation. The catheter is placed in the model to a specified location following procedural instructions outlined in the Instructions for Use. The Retriever and microcatehter are advanced (as a system) through the catheter. The extension tubing is attached to the Y-arm of the rotating hemostasis valve. Fluid is infused vigorously through extension tubing with a 60cc syringe. While retracting both the Retriever and microcatheter (as a system) through the catheter to completely remove the system from the model, a 60cc syringe is used to aspirate through the extension tubing. When the Retriever is retracted into the catheter tip, the user aspirates to 60cc's vigorously as the Retriever is fully | Pass All samples met acceptance criteria for expanded indications for use. Device continues to meet same design requirements as predicate devices (K090335 and K110483). | | | retracted in the catheter. The catheter is visually | | | Test | Test Method Summary | Results | | Retriever Fracture | Purpose: Retriever fracture is evaluated in a neurovascular model to verify that the Retriever is free from fractures following simulated use testing. | Pass All samples met acceptance criteria for expanded indications for use. | | | Method: A neurovascular model is placed in a re- circulating water bath at 37°C and pressurized to simulate human arterial circulation. The catheter is placed in the model to a specified location following procedural instructions outlined in the Instructions for Use. The Retriever and microcatheter are advanced (as a system) through the catheter. The extension tubing is attached to the Y-arm of the rotating hemostasis valve. Fluid is infused vigorously through extension tubing with a 60cc syringe. While retracting both the Retriever and microcatheter (as a system) through the catheter to completely remove the system from the model, a 60cc syringe is used to aspirate through the extension tubing. When the Retriever is retracted into the catheter tip, the user aspirates to 60cc's vigorously as the Retriever is fully retracted in the catheter. The catheter is visually inspected for damage. The Retriever is removed from the microcatheter and visually inspected for fractures. | Device continues to meet same design requirements as predicate devices (K090335 and K110483). | | Liquid leak resistance | Purpose: Liquid leak resistance of the catheter is evaluated in a neurovascular model to verify that the catheter does not leak from the shaft or hub/shaft interface during use. | Pass All samples met acceptance criteria for expanded indications for use. | | | Method: A neurovascular model is placed in a re- circulating water bath at 37°C and pressurized to simulate human arterial circulation. The catheter is placed in the model to a specified location following procedural instructions outlined in the Instructions for Use. The Retriever and microcatheter are advanced (as a system) through the catheter. The extension tubing is attached to the Y-arm of the rotating hemostasis valve. Fluid is infused vigorously through extension tubing with a 60cc syringe. While retracting both the Retriever and microcatheter (as a system) through the catheter to completely remove the system from the model, a 60cc syringe is used to aspirate through the extension tubing. When the Retriever is retracted into the catheter tip, the user aspirates to 60cc's vigorously as the Retriever is fully retracted in the catheter. The catheter is visually inspected for leaks from the shaft or hub/shaft interface during use. | Device continues to meet same design requirements as predicate devices (K090335 and K110483). | · {8}------------------------------------------------ # 510(k) Summary (cont.) {9}------------------------------------------------ ### 510(k) Summary (cont.) Based on conformance with these test requirements, the Modified HD Guide Catheter is as safe, as effective, and performs as well as or better than the legally marketed predicate devices (K090335 and K110483). {10}------------------------------------------------ #### Clinical Performance Data: To demonstrate su…