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 (K182512).

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: Traditional).

What are the predicate devices for Route 92 Medical Delivery Catheter?

Route 92 Medical Delivery Catheter (K180201).

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

K182512 · Route 92 Medical, Inc. · DQY · Dec 10, 2018 · Cardiovascular

Device Facts

Record ID	K182512
Device Name	Route 92 Medical Delivery Catheter
Applicant	Route 92 Medical, Inc.
Product Code	DQY · Cardiovascular
Decision Date	Dec 10, 2018
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1250
Device Class	Class 2

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 catheter; features flexible tapered tip with two radiopaque markers; hydrophilic coating on distal shaft; proximal hypotube with luer hub and fluoro-saver marker. Used in neurovascular procedures; inserted through compatible access catheter; standard neurovascular guidewire inserted through lumen. Advanced to target location under fluoroscopy using standard endovascular techniques. Enables physician to navigate and deliver catheters to specific neurovascular sites; facilitates endovascular interventions.

Clinical Evidence

No clinical data. Bench testing only. Performance verified via dimensional analysis, luer integrity, tensile strength, kink/torsion resistance, tip flexibility, leakage testing, coating integrity, particulate recovery, corrosion resistance, burst pressure, flow rate, and simulated use in neurovascular models. Biocompatibility confirmed per ISO 10993-1.

Technological Characteristics

Materials: Pebax (distal shaft), PTFE-coated stainless steel (proximal shaft), polycarbonate (luer). Dimensions: 0.019" ID, 0.062" distal OD, 0.028" proximal OD, 143 cm length. Features: hydrophilic coating, radiopaque markers, fluoro-saver marker. Sterilization: Ethylene Oxide (SAL 10^-6). Standards: ISO 10993-1, ISO 80369-7, ISO 10555-1, ISO 11607, USP <788>.

Indications for Use

Indicated for use in the neurovascular system to facilitate insertion and guidance of catheters into selected blood vessels. Intended 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 (K180201)

Related Devices

K190431 — Route 92 Medical Delivery Catheter · Route 92 Medical, Inc. · Mar 21, 2019
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
K221930 — CEREGLIDE 71 Intermediate Catheter · Cerenovus, Inc. · Mar 9, 2023

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. December 10, 2018 Route 92 Medical Inc. Kathy Tansey Senior Director of Regulatory Affairs and Quality Assurance 1700 S. El Camino Real, Suite 206 San Mateo, California 94402 Re: K182512 Trade/Device Name: Route 92 Medical Delivery Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: September 10, 2018 Received: September 12, 2018 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's {1}------------------------------------------------ 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.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 mediation-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. 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}------------------------------------------------ ## K182512 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: | November 14, 2018 | | 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 | #### Device Description The Delivery Catheter is a single-lumen, variable stiffness catheter with a flexible, tapered tip delineated by two radiopaque markers. The distal shaft of the Delivery Catheter has a hydrophilic coating. On the proximal end is a hypotube attached to a luer hub for guidewire introduction. This proximal hypotube includes a fluoro-saver marker indicating when the tip of the catheter is about to exit a long femoral sheath/guide. 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 access catheter. The Delivery Catheter and access 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 Route 92 Medical Delivery Catheter are identical to the Delivery Catheter component of the Route 92 Medical Access System as shown in the following table. {3}------------------------------------------------ | Attribute | Predicate Delivery Catheter Provided as Part of the Route 92 Medical Access System (K180201) | Subject Route 92 Medical Delivery Catheter | |---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | The Route 92 Medical Access System is indicated for use with compatible guide catheters in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the neurovascular systems. | 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 Description | The Delivery Catheter is a sterile, single- use, single-lumen, hydrophilically coated, variable stiffness catheter with a flexible, tapered tip. | Same as predicate device | | User | Physicians trained in neurovascular interventional techniques | Same as predicate device | | Anatomical Sites | Neurovasculature only | Same as predicate device | | Materials | Biocompatible polymers and metals commonly used in the manufacture of medical devices | Same as predicate device | | | Distal shaft: varying durometers of Pebax | | | | Proximal shaft: PTFE coated stainless steel | | | | Luer: polycarbonate | | | Inner Diameter | 0.019'' | Same as predicate device | | Outer Diameter | Distal: 0.062" Proximal: 0.028" | Same as predicate device | | Device Working Length | 143 cm | Same as predicate device | | Hydrophilic Coating | Present on polymer section of the Delivery Catheter | Same as predicate device | | Accessories Included | No accessory included | Same as predicate device | | Packaging | Nylon/Tyvek pouch inside of an SBS shelf carton | Same as predicate device | | Sterilization Method | Ethylene Oxide | Same as predicate device | | Shelf Life | 8 months | Same as predicate device | | Sterility | Validated to achieve Sterility Assurance Level (SAL) of 10-6 | Same as predicate device | | Endotoxin Testing | Meets requirement for less or equal to 2.15 endotoxin units per device | Same as predicate device | | Attribute | Predicate Delivery Catheter Provided as Part of the Route 92 Medical Access System (K180201) | Subject Route 92 Medical Delivery Catheter | | Principle of Operation | During use, a standard neurovascular guidewire may be inserted through the Delivery Catheter. The Delivery Catheter is inserted through a compatible access catheter. The Delivery Catheter and access catheter are advanced to the targeted location under fluoroscopy using standard endovascular techniques. | Same as predicate device | {4}------------------------------------------------ ## Non-Clinical Testing #### Biocompatibility Testing The Route 92 Medical Delivery Catheter is constructed using materials that are commonly used in the medical device industry. All patient contacting components have been evaluated for biocompatibility in accordance with ISO 10993-1 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing. The Route 92 Medical Access System is classified per ISO 10993-1 as externally communicating with limited circulating blood contact (≤ 24 hours). The following biocompatibility testing was performed for the predicate Route 92 Medical Access System (K180201) and leveraged from the predicate device submission to support the biocompatibility profile of the subject device because the subject Route 92 Medical Delivery Catheter contains the same materials of construction, design, and manufacturing processes as the predicate device. | Test | Results | Conclusions | |-----------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------| | Cytotoxicity - ISO MEM Elution | Grade 0 at 24, 48, 72 ± 4 hrs | The test article is non- cytotoxic. | | Sensitization - ISO Guinea Pig Maximization Sensitization Test (Normal Saline and Sesame Oil) | Clinical Observations: none of the animals showed abnormal clinical signs during the test period. Main Test Results: Negative Control, grade =0 Normal Saline, grade = 0 Sesame Oil, grade = 0 | Test article did not elicit a sensitization response. | | Irritation - ISO Intracutaneous Reactivity (Normal Saline and Sesame Oil) | Dermal observations: Comparative Results Mean Test-Mean Control (Normal Saline) = 0 Mean Test-Mean Control (Sesame Oil) = 0.1 Differences between mean test and control scores were less than 1.0 | Requirements of the ISO intracutaneous reactivity test have been met for the test article. | | Acute Systemic Toxicity – ISO Acute Systemic Injection (Normal Saline and Sesame Oil) | None of the test article extract treated animals were observed with clinical signs consistent with toxicity. Body weight changes were within acceptable parameters. | Requirements of the ISO acute systemic injection test have been met for the test article. | | Pyrogen - Material Mediated Pyrogen (Normal Saline) | During the 3-hr observation period, none of the rabbits administered with the text article extract had a temperature rise ≥ 0.5℃ at the required observation time points. The response did not exceed the USP limits and meets the requirements for this test. | The test article is non- pyrogenic. | | Test | Results | Conclusions | | Hemocompatibility - Complement Activation (C3a & SC5b-9) | When compared to a legally US-marketed device, the minimal increase in complement activation noted in the test article would not be expected to result in adverse effects in vivo. | The test article would not be expected to result in adverse effects in vivo. | | Hemocompatibility - Partial Thromboplastin Time (PTT) | The PTT of the test article was 100% of the negative control. | The test article is considered to be a non- activator of the intrinsic coagulation pathway and passes the test. | | Hemocompatibility - ASTM Hemolysis | Blank corrected hemolytic index above the negative control: Direct Method: 0.0% Extract Method: 0.3% | The test article is considered non-hemolytic. | | Hemocompatibility - Thromboresistance | All test animals survived the general anesthesia and study observation interval without test article related complications. The combined data of blood test reports, pre- and post-implant weight differences, and the patency and thrombus scores were not subjectively different between the test and control articles. | The test devices appear to have similar thromboresistance characteristics as the control devices. | | Genotoxicity - ISO Bacterial Mutagenicity Test - Ames Assay (Normal Saline and Polyethylene Glycol) | The test article did not induce substantial increases in reversion rates of the type that are associated with mutagenesis and no substantial test article toxicity was noted that may have interfered with the ability of the test system to detect mutagens. | The test article is considered non-mutagenic. | | Genotoxicity - ISO In Vitro Mouse Lymphoma (Normal Saline and Polyethylene Glycol) | The test article did not cause notable changes in the typical growth pattern of the L5178Y cells in suspension culture during the growth and expression period. The cloning efficiencies of these preparations were within normal limits. | The test article is considered to be non- mutagenic and non- clastogenic. | {5}------------------------------------------------ {6}------------------------------------------------ ## Performance Testing - Bench The successful completion of the performance testing listed in the following table demonstrates that the Route 92 Medical Delivery Catheter is suitable for its intended use. The following performance (bench) tests, except the dimensional verification, were all leveraged from the predicate Route 92 Medical Access System (K180201) because the subject Route 92 Medical Delivery Catheter is identical in design to the same catheter component in the predicate device. | Test | Test Method | Results | |--------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------| | Dimensional Verification | Device dimensions were measured to confirm conformance to the specifications | PASS All samples met the pre-determined acceptance criteria | | Luer Integrity | Tested per ISO 80369-7:2016 | PASS All samples met the pre-determined acceptance criteria | | RHV Sealing | RHV sealing were tested | 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 | | Corrosion Resistance | Tested per ISO 10555-1:2013 Annex A. | 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 | | Test | Test Method | Results | | Simulated Use Testing | Deliverability and compatibility with accessory devices was evaluated in a neurovascular model | PASS All samples met the pre-determined acceptance criteria | | Packaging Integrity | ISO 11607-1 Part 1 ISO 11607-2 Part 2 | PASS All samples met the pre-determined acceptance criteria | | Radiopacity | Radiopacity of the device was evaluated in an animal model under fluoroscopy | PASS All samples met the pre-determined acceptance criteria | {7}------------------------------------------------ ## Substantial Equivalence The Route 92 Medical Delivery Catheter has the same intended use, the same technological characteristics and same method of action as the predicate Route 92 Medical Access System. Therefore, based on the identical design and materials of construction between the subject and predicate devices and the completed non-clinical testing, the subject Route 92 Medical Delivery Catheter is substantially equivalent to the predicate Route 92 Medical Access System (K180201). {8}------------------------------------------------ # Please wait... If this message is not eventually replaced by the proper contents of the document, your PDF viewer may not be able to display this type of document. You can upgrade to the latest version of Adobe Reader for Windows®, Mac, or Linux® by visiting http://www.adobe.com/go/reader_download. For more assistance with Adobe Reader visit http://www.adobe.com/go/acrreader. Windows is either a registered trademark of Microsoft Corporation in the United States and/or other countries. Mac is a trademark of Apple Inc., registered in the United States and other countries. Linux is the registered trademark of Linus Torvalds in the U.S. and other countries.