Who is the manufacturer of Route 92 Medical Delivery Catheter?

Route 92 Medical, Inc. filed the 510(k) submission for Route 92 Medical Delivery Catheter (K190431).

What is the FDA product code for Route 92 Medical Delivery 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 Route 92 Medical Delivery Catheter?

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

Who can help prepare an FDA 510(k) submission like Route 92 Medical Delivery 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.

Route 92 Medical Delivery Catheter

K190431 · Route 92 Medical, Inc. · DQY · Mar 21, 2019 · Cardiovascular

Device Facts

Record ID	K190431
Device Name	Route 92 Medical Delivery Catheter
Applicant	Route 92 Medical, Inc.
Product Code	DQY · Cardiovascular
Decision Date	Mar 21, 2019
Decision	SESE
Submission Type	Special
Regulation	21 CFR 870.1250
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Route 92 Medical Delivery Catheter is indicated for use with compatible catheters in facilitating the insertion and guidance of catheters into a selected blood vessel in the neurovascular system.

Device Story

Single-lumen, variable stiffness, hydrophilically coated catheter with flexible, tapered tip; includes luer hub for guidewire/fluid/contrast injection. Used by physicians trained in neurovascular interventional techniques in clinical settings. Device is inserted through a compatible catheter and advanced to targeted neurovascular location under fluoroscopy using standard endovascular techniques. Steam-shapeable tip allows navigation through complex vasculature. Facilitates delivery of other catheters to target sites; aids in endovascular procedures. Benefits patient by enabling precise access to neurovascular anatomy.

Clinical Evidence

Bench testing only. No clinical data provided. Performance testing included package/label integrity (ASTM F2096, F88, D4169), mechanical properties (tensile, kink, torsion, tip flexibility), leakage (ISO 10555-1), coating integrity, particulate recovery (USP <788>), burst pressure, flow rate, and simulated use in neurovascular models.

Technological Characteristics

Single-lumen catheter; shaft: stainless steel and Pebax; luer: polycarbonate; marker bands: Tungsten/Pebax. Hydrophilic coating. Dimensions: 0.019" ID, 0.062" OD, 151 cm length. Sterilization: Ethylene Oxide. Steam-shapeable tip. No software or electronic components.

Indications for Use

Indicated for use with compatible catheters to facilitate insertion and guidance of catheters into neurovascular blood vessels. For use by physicians trained in neurovascular interventional techniques.

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

Route 92 Medical Delivery Catheter (K182512)

Related Devices

K182512 — Route 92 Medical Delivery Catheter · Route 92 Medical, Inc. · Dec 10, 2018
K242420 — pNOVUS 21 Microcatheter · Phenox, Ltd. · Nov 12, 2024
K202752 — AXS Vecta 46 Intermediate Catheter · Stryker Neurovascular · Aug 27, 2021
K190833 — AXS Vecta Aspiration Catheter · Stryker Neurovascular · Dec 15, 2019
K232542 — Wedge XL Delivery Catheter · MicroVention, Inc. · May 16, 2024

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. March 21, 2019 Route 92 Medical Inc. Kathy Tansev Senior Director of Regulatory Affairs and Quality Assurance 1700 South El Camino Real, Suite 206 San Mateo, California 94402 Re: K190431 Trade/Device Name: Route 92 Medical Delivery Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DOY Dated: February 20, 2019 Received: February 22, 2019 Dear Kathy Tansey: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. 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 {1}------------------------------------------------ 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Digitally signed by Xiaolin Zheng -S Lin Zheng Date: 2019.03.21 14:57:10-04'00' for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K190431 Device Name Route 92 Medical Delivery Catheter Indications for Use (Describe) The Route 92 Medical Delivery Catheter is indicated for use with compatible catheters in facilitating the insertion and guidance of catheters into a selected blood vessel in the neurovascular system. | Type of Use (Select one or both, as applicable) | | |------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------| | <div> ×</div> Prescription Use (Part 21 CFR 801 Subpart D) | <div></div> Over-The-Counter Use (21 CFR 801 Subpart C) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # K190431 510(k) Summary | 510(k) Summary | | |------------------------------------|--------------------------------------------------------------------------------------------------------------------------| | Sponsor: | Route 92 Medical 1700 S. El Camino Real, Suite 206 San Mateo, CA 94022 Phone: 408-391-6536 Fax: 650-343-5827 | | Contact: | Kathy Tansey | | Date Prepared: | March 18, 2019 | | Device Name: | Route 92 Medical Delivery Catheter | | Common Name: | Percutaneous Catheter | | Classification Name: | Percutaneous Catheter (Product Code DQY, 21 CFR 870.1250) | | Legally Marketed Predicate Device: | Route 92 Medical Delivery Catheter (K182512) | #### Device Description The modified Route 92 Medical Delivery Catheter is a single-lumen, variable stiffness, hydrophilically coated catheter with a flexible tapered tip. The tapered tip is delineated by two radiopaque markers. On the proximal end is a luer hub for guidewire introduction and fluid or contrast injection. The devices are provided sterile and non-pyrogenic and are intended for single use only. During use, a standard neurovascular guidewire may be inserted through the Delivery Catheter. The Delivery Catheter is inserted through a compatible catheter. The Delivery Catheter and compatible catheter are advanced to the targeted location under fluoroscopy using standard endovascular techniques. #### Indications for Use The Route 92 Medical Delivery Catheter is indicated for use with compatible catheters in facilitating the insertion and guidance of catheters into a selected blood vessel in the neurovascular system. #### Comparison to Predicate Device The method of action, design, and materials of the modified Route 92 Medical Delivery Catheter are equivalent to the cleared Route 92 Medical Delivery Catheter as shown in the following table. | Attribute | Cleared Route 92 Medical Delivery Catheter (K182512) | Modified Route 92 Medical Delivery Catheter | |---------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | The Route 92 Medical Delivery Catheter is indicated for use with compatible catheters in facilitating the insertion and | Same as cleared device | | Attribute | Cleared Route 92 Medical Delivery Catheter (K182512) | Modified Route 92 Medical Delivery Catheter | | Device Description | The Delivery Catheter is a sterile, single- use, single-lumen, hydrophilically coated, variable stiffness catheter with a flexible, tapered tip. | Same as cleared device | | User | Physicians trained in neurovascular interventional techniques | Same as cleared device | | Anatomical Sites | Neurovasculature only | Same as cleared device | | Materials | Biocompatible polymers and metals commonly used in the manufacture of medical devices Catheter Shaft: stainless steel and varying durometers of Pebax Luer: polycarbonate Marker bands: Tungsten/Pebax | Same as cleared device | | Coating | Hydrophilic coating | Same as cleared device | | Inner Diameter | 0.019" | Same as cleared device | | Outer Diameter | 0.062" | Same as cleared device | | Working Length | 143 cm | 151 cm | | Length of Polymer Section (non- hypotube section) | 38 cm | 71 cm | | Hydrophilic Coating Length | 48.5 cm | 90 cm | | Steam Shapeable Tip | Not discussed in labeling | Steam shaping added to labeling | | Packaging | The shelf carton contains two (2) sterile pouches, each containing a Delivery Catheter and one (1) Directions for Use (DFU). | The shelf carton contains one (1) sterile pouch containing a Delivery Catheter and one (1) Directions for Use (DFU). | | Sterilization | Ethylene Oxide | Same as cleared device | {4}------------------------------------------------ ## Performance Testing – Bench The successful completion of the performance testing listed in the following table demonstrates that the modified Route 92 Medical Delivery Catheter is suitable for its intended use. {5}------------------------------------------------ | Test | Test Method | Results | |------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------| | Package Integrity after Aging and Distribution | The test specimens were subjected to EO sterilization and environmental conditioning, mechanical transit challenges, visual inspection and bubble leak test and peel test per ASTM F2096 and ASTM F88. | PASS All samples met the pre-determined acceptance criteria | | Label Integrity after Aging and Distribution | The test specimens were subjected to EO sterilization and climatic conditioning per ASTM D4169. | PASS All samples met the pre-determined acceptance criteria | | Tensile Strength | The tensile strength of the catheter sections and bonds was tested | PASS All samples met the pre-determined acceptance criteria | | Kink Resistance | Test specimen segments were formed into a defined bend diameter to evaluate kink resistance | PASS All samples met the pre-determined acceptance criteria | | Torsion Resistance | The test specimens were rotated to evaluate integrity after rotation | PASS All samples met the pre-determined acceptance criteria | | Tip Flexibility | Test specimens were tested for tip flexibility | PASS All samples met the pre-determined acceptance criteria | | Air Leakage | Tested per ISO 10555-1:2013 Annex D. | PASS All samples met the pre-determined acceptance criteria | | Liquid Leakage | Tested per ISO 10555-1:2013 Annex C. | PASS All samples met the pre-determined acceptance criteria | | Hydrophilic Coating Integrity | The integrity of the hydrophilic coating was evaluated after multiple insertion and withdrawal cycles. | PASS All samples met the pre-determined acceptance criteria | | Particulate Recovery | After multiple insertion and withdrawal cycles, the effluent water rinsed and flushed from the devices and model was tested per USP <788>. | PASS All samples met the pre-determined acceptance criteria | | Catheter Burst Pressure (Static & Dynamic) | Tested per ISO 10555-1:2013 Annex F. | PASS All samples met the pre-determined acceptance criteria | | Catheter Flow Rate | Tested per ISO 10555-1:2013 Annex E. | PASS All samples met the pre-determined acceptance criteria | | Simulated Use Testing | Deliverability and compatibility with accessory devices was evaluated in a neurovascular model | PASS All samples met the pre-determined acceptance criteria | | Test | Test Method | Results | | Packaging Integrity | ISO 11607-1 Part 1 | PASS | | | ISO 11607-2 Part 2 | All samples met the pre-determined acceptance criteria | {6}------------------------------------------------ ## Biocompatibility Biocompatibility evaluations were not conducted using the modified Route 92 Medical Delivery Catheter because the materials of construction and manufacturing processes have not changed from the predicate device. Therefore, the biocompatibility evaluations performed using the predicate Route 92 Medical Delivery Catheter (K182512) can also support the biocompatibility profile of the subject device. ## Substantial Equivalence The modified Route 92 Medical Delivery Catheter has the same intended use, similar technological characteristics and same method of action as the predicate Route 92 Medical Delivery Catheter (K182512). The successful completion of performance testing demonstrates that the modified Route 92 Medical Delivery Catheter is substantially equivalent to the predicate Route 92 Medical Delivery Catheter.