Who is the manufacturer of Route 92 Medical Access System?

Route 92 Medical, Inc. filed the 510(k) submission for Route 92 Medical Access System (K180201).

What is the FDA product code for Route 92 Medical Access System?

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 Access System?

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

Who can help prepare an FDA 510(k) submission like Route 92 Medical Access System?

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 Access System

Q: What are the predicate devices for Route 92 Medical Access System?

MIVI Mi-EXT Catheter (K163233).

K180201 · Route 92 Medical, Inc. · DQY · May 23, 2018 · Cardiovascular

Device Facts

Record ID	K180201
Device Name	Route 92 Medical Access System
Applicant	Route 92 Medical, Inc.
Product Code	DQY · Cardiovascular
Decision Date	May 23, 2018
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1250
Device Class	Class 2

Intended 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 system.

Device Story

System comprises Access Catheter and Delivery Catheter; used to facilitate insertion/guidance of microcatheters into neurovascular blood vessels. Access Catheter features distal single-lumen variable stiffness design with proximal stainless-steel control wire; Delivery Catheter is hubbed, single-lumen, variable stiffness. Both are hydrophilically coated. Operated by physicians trained in neurovascular interventional techniques in clinical settings. Device provides lumen for microcatheter introduction; delivered through guide catheter. Output is physical access path for microcatheters; aids clinical decision-making by enabling navigation to target neurovascular sites. Benefits include improved access to neurovasculature for interventional procedures.

Clinical Evidence

Bench testing only. No clinical data. Testing included biocompatibility (ISO 10993-1), dimensional verification, luer integrity (ISO 80369-7), RHV sealing, tensile strength, kink/torsion resistance, tip flexibility, air/liquid leakage (ISO 10555-1), flow rates, hydrophilic coating integrity, particulate recovery (USP <788>), corrosion resistance, simulated use in neurovascular models, and radiopacity.

Technological Characteristics

Materials: polymers and metals common to medical devices. Design: variable stiffness, coil-reinforced, hydrophilically coated catheters. Access Catheter: 0.070" ID, 0.082"-0.087" OD. Delivery Catheter: 0.019" ID, 0.062" OD. Connectivity: none. Sterilization: sterile, non-pyrogenic. Standards: ISO 10993-1 (biocompatibility), ISO 80369-7 (luer), ISO 10555-1 (leakage/corrosion), USP <788> (particulates), ISO 11607 (packaging).

Indications for Use

Indicated for patients requiring use of a microcatheter in the neurovascular system to facilitate insertion and guidance of microcatheters into selected blood vessels.

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

MIVI Mi-EXT Catheter (K163233)

Related Devices

K203043 — Route 92 Medical 070 Access System · Route 92 Medical, Inc. · Nov 11, 2020
K222743 — Route 92 Medical Full Length 070 Access System · Route 92 Medical, Inc. · Oct 4, 2022
K210635 — Route 92 Medical Full Length 088 Access System · Route 92 Medical, Inc. · Jul 27, 2021
K200121 — Route 92 Medical 088 Access System, 110 cm · Route 92 Medical, Inc. · Apr 18, 2020
K242420 — pNOVUS 21 Microcatheter · Phenox, Ltd. · Nov 12, 2024

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text. May 23, 2018 Route 92 Medical, Inc. Kirsten Valley Senior VP QA/RA/CA 1700 South El Camino Real, Suite 206 San Mateo, California 94402 Re: K180201 Trade/Device Name: Route 92 Medical Access System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: April 23, 2018 Received: April 24, 2018 Dear Kirsten Valley: 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. 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 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); {1}------------------------------------------------ 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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. # Carlos L. Pena -S 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) K180201 Device Name Route 92 Medical Access System #### Indications for Use (Describe) 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 system. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| X Prescription Use (Part 21 CFR 801 Subpart D) | 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}------------------------------------------------ ## K180201 ## 510(K) SUMMARY ## 510(k) Summary | Sponsor: | Route 92 Medical 1700 S. El Camino Real, Suite 206 San Mateo, CA 94022 Phone: 650-581-1179 Fax: 650-343-5827 | |------------------------------------|--------------------------------------------------------------------------------------------------------------------------| | Contact: | Kirsten Valley | | Date Prepared: | May 3, 2018 | | Device Name: | Route 92 Medical Access System | | Common Name: | Percutaneous Catheter | | Classification Name: | Percutaneous Catheter (Product Code DQY, 21 CFR 870.1250) | | Legally Marketed Predicate Device: | MIVI Mi-EXT Catheter (K163233) | #### Device Description The Route 92 Medical Access System is comprised of an Access Catheter and a Delivery Catheter. The distal portion of the Access Catheter is a single-lumen, variable stiffness catheter. Like the predicate device, the proximal portion is a stainless-steel control wire. The Delivery Catheter is a hubbed, singlelumen variable stiffness catheters are hydrophilically coated. The Route 92 Medical Access System is intended for use with compatible guide catheters in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the neurovascular system. The devices are provided sterile and non-pyrogenic and are intended for single use only. #### 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 system. #### Comparison to Predicate Device The method of action, design, and materials of the Route 92 Medical Access System are equivalent to the MIVI Mi-EXT Catheter as shown in the following table. | Attribute | Predicate MIVI Mi-EXT Catheter (K163233) | Subject Route 92 Medical Access System | |------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | The MIVI 6F Guide Catheter is indicated for use with compatible guide catheters | The Route 92 Medical Access System is indicated for use with compatible | | Attribute | Predicate MIVI Mi-EXT Catheter (K163233) | Subject Route 92 Medical Access System | | | in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the peripheral, coronary and neuro vascular systems. | guide catheters in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the neurovascular system. | | Device Description | Sterile, single-use, variable stiffness, coil-reinforced catheter with proximal control wire | Same as predicate device. | | Targeted population | Patients requiring use of a microcatheter in the peripheral, coronary or neurovascular systems | Patients requiring use of a microcatheter in the neurovascular system | | User | Physicians trained in interventional techniques | Physicians trained in neurovascular interventional techniques | | Anatomical Sites | Peripheral, coronary or neurovascular systems | Neurovasculature only | | Method of Action | Delivered through a guide catheter with support of a microcatheter/delivery catheter, the device provides a lumen for the introduction of microcatheters. | Same as predicate device | | Materials | Polymers and metals commonly used in the manufacture of medical devices | Same as predicate device | | Access Catheter | | | | Inner Diameter | 0.069" | 0.070" (minimum) | | Outer Diameter | Distal: 0.081" Proximal: 0.087" | Distal: 0.082" Proximal: 0.087" | | Length | 140 - 153cm | 136cm | | Delivery Catheter | | | | Inner Diameter | N/A | 0.019" | | Outer Diameter | N/A | 0.062" | | Length | N/A | 150cm | {4}------------------------------------------------ ### Non-Clinical Testing ## Biocompatibility Testing The Route 92 Medical Access System 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). A summary of the biocompatibility testing is provided below. {5}------------------------------------------------ | 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°C 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. | | 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 | The PPT 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 test devices appear to have similar thromboresistance characteristics as the | | | 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. | 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. | = {6}------------------------------------------------ #### Performance Testing The successful completion of the performance testing listed in the following table demonstrates that the Route 92 Medical Access System is suitable for its intended use. | 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 around the catheter shafts was 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 | | Test | Test Method | Results | | 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 / Static Burst | Tested per ISO 10555-1:2013 Annex C. | PASS All samples met the pre-determined acceptance criteria | | Dynamic Burst | Mechanical integrity was maintained up to the specified pressures | PASS All samples met the pre-determined acceptance criteria | | Flow | Contrast media flow rates were measured and found to be equivalent to predicate devices | 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 | | 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 | | Test | Test Method | Results | | Radiopacity | Radiopacity of the device was evaluated in an animal model under fluoroscopy | PASS All samples met the pre-determined acceptance criteria | {7}------------------------------------------------ = {8}------------------------------------------------ #### Substantial Equivalence The Route 92 Medical Access System has the same intended use, the same technological characteristics and same method of action as the predicate MIVI Mi-EXT Catheter. The successful completion of biocompatibility testing and performance testing demonstrates that the Route 92 Medical Access System is substantially equivalent to MIVI Mi-EXT Catheter.