(67 days)
The Route 92 Medical 088 Access System, 143 cm, 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.
The Route 92 Medical 088 Access System, 143 cm, is comprised of a Support Catheter and a Delivery Catheter. The distal portion of the Support 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, single-lumen variable stiffness catheter. Both catheters are hydrophilically coated. The Route 92 Medical Access System, 143 cm, 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.
This document describes the premarket notification for a medical device, the Route 92 Medical 088 Access System, 143 cm, a percutaneous catheter designed to facilitate the insertion and guidance of microcatheters in the neurovascular system.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The document categorizes performance testing into Biocompatibility Testing and Engineering Performance Testing. The acceptance criteria for all tests are implicitly stated as "met the pre-determined acceptance criteria," and the results are uniformly "PASS."
| Test Category | Specific Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | Cytotoxicity - ISO MEM Elution | Non-cytotoxic | The test article is non-cytotoxic. |
| Sensitization – ISO Guinea Pig Maximization | No sensitization response | The test article did not elicit a sensitization response. | |
| Irritation - ISO Intracutaneous Reactivity | Requirements of the ISO intracutaneous reactivity test met | Requirements of the ISO intracutaneous reactivity test have been met for the test article. | |
| Acute Systemic Toxicity – ISO Acute Systemic Injection | Requirements of the ISO acute systemic injection test met | Requirements of the ISO acute systemic injection test have been met for the test article. | |
| Pyrogen - Material Mediated Pyrogen | Non-pyrogenic | The test article is non-pyrogenic. | |
| Hemocompatibility – Complement Activation | No expected adverse effects in vivo | The test article would not be expected to result in adverse effects in vivo. | |
| Hemocompatibility – Partial Thromboplastin Time | Non-activator of intrinsic coagulation pathway | The test article is considered to be a non-activator of the intrinsic coagulation pathway. | |
| Hemocompatibility – ASTM Hemolysis | Non-hemolytic | The test article is considered non-hemolytic. | |
| Hemocompatibility – Thromboresistance | Similar thromboresistance characteristics as control devices | The test articles have similar thromboresistance characteristics as the control devices. | |
| Performance | Dimensional Verification | Conformance to specifications | PASS - All samples met the pre-determined acceptance criteria |
| Luer Integrity | Per ISO 80369-7:2016 | PASS - All samples met the pre-determined acceptance criteria | |
| RHV Sealing | Sealing around catheter shafts maintained | PASS - All samples met the pre-determined acceptance criteria | |
| Tensile Strength | Catheter sections and bonds maintain tensile strength | PASS - All samples met the pre-determined acceptance criteria | |
| Kink Resistance | No kinking when formed into defined bend diameter | PASS - All samples met the pre-determined acceptance criteria | |
| Torsion Resistance | Integrity maintained after rotation | PASS - All samples met the pre-determined acceptance criteria | |
| Tip Flexibility | Appropriate tip flexibility | PASS - All samples met the pre-determined acceptance criteria | |
| Air Leakage | Per ISO 10555-1:2013 Annex D | PASS - All samples met the pre-determined acceptance criteria | |
| Liquid Leakage / Static Burst | Per ISO 10555-1:2013 Annex C | PASS - All samples met the pre-determined acceptance criteria | |
| Dynamic Burst | Mechanical integrity maintained up to specified pressures | PASS - All samples met the pre-determined acceptance criteria | |
| Hydrophilic Coating Integrity | Integrity maintained after multiple insertion/withdrawal cycles | PASS - All samples met the pre-determined acceptance criteria | |
| Particulate Recovery | Particulates within acceptable limits per USP <788> | PASS - All samples met the pre-determined acceptance criteria | |
| Simulated Use Testing | Deliverability and compatibility in neurovascular model | PASS - All samples met the pre-determined acceptance criteria | |
| Radiopacity | Visible under fluoroscopy in animal model | PASS - All samples met the pre-determined acceptance criteria | |
| Contrast Delivery | Successful contrast delivery in animal model | PASS - All samples met the pre-determined acceptance criteria | |
| Animal Study | Safety and performance comparable to predicate in acute swine model (angiographic and histological assessments) | PASS - All samples met the pre-determined acceptance criteria | |
| Packaging Integrity | Per ISO 11607-1 Part 1 & ISO 11607-2 Part 2 | PASS - All samples met the pre-determined acceptance criteria |
2. Sample Sizes Used for the Test Set and Data Provenance:
The document consistently states "All samples met the pre-determined acceptance criteria" for the performance tests, implying that the sample size for each specific test was sufficient to demonstrate compliance. However, the exact numerical sample size for each performance test is not explicitly provided.
- Data Provenance:
- Biocompatibility: In-vitro and in-vivo tests aligned with ISO 10993-1 standards.
- Performance Testing: In-vitro bench testing, and in-vivo animal model testing (acute swine model). No specific country of origin is mentioned for the data, but the testing standards (ISO, USP, ASTM) are international.
- Retrospective/Prospective: The testing described is prospective, specifically designed to evaluate the new device against established standards and a predicate device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This document is for a medical device (catheter), not an AI/imaging device requiring expert interpretation of results. Therefore, the concept of "experts establishing ground truth for a test set" in the context of image interpretation or clinical diagnosis is not directly applicable.
The ground truth for the device's performance is established by:
- Engineering specifications and validated test methods (e.g., ISO, ASTM, USP standards).
- Performance in animal models, assessed by researchers and potentially, but not explicitly stated, veterinary or interventional specialists.
4. Adjudication Method for the Test Set:
Not applicable in the typical sense of a human-in-the-loop AI study. The "adjudication" is inherent in the quantitative and qualitative PASS/FAIL results generated by the standardized test methods.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
No, an MRMC study was not conducted. This type of study is primarily relevant for diagnostic imaging AI devices where human readers interpret medical images. This document describes a physical medical device (catheter) and its mechanical/biocompatibility performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
This question is not applicable. This is not an AI algorithm. The device's "standalone" performance is evaluated through the detailed bench testing, biocompatibility testing, and animal studies, which assess the device's intrinsic properties and function without human intervention during the measurement of performance metrics.
7. The Type of Ground Truth Used:
The ground truth for this device's performance is based on:
- Validated Standard Test Methods: International standards (ISO, ASTM, USP) for medical device performance and biocompatibility.
- Predicate Device Comparison: The new device is compared to a legally marketed predicate device (Route 92 Medical 088 Access System, 110 cm, K200121) to demonstrate substantial equivalence, implying the predicate's performance serves as a comparative "ground truth."
- Pre-determined Acceptance Criteria: Internal specifications and performance limits set by the manufacturer based on regulatory requirements and engineering principles.
- Animal Model Observations: Direct observation of device safety and performance in an acute swine model, including angiographic and histological assessments.
8. The Sample Size for the Training Set:
Not applicable. This is a physical medical device, not an AI model that requires a "training set."
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no training set for a physical medical device.
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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" in blue, and the word "ADMINISTRATION" in a smaller font size below.
Route 92 Medical Kathy Tansey Senior Director of Regulatory Affairs and Quality Assurance 155 Bovet Road, Suite 100 San Mateo, California 94402
August 14, 2020
Re: K201518
Trade/Device Name: Route 92 Medical 088 Access System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP Dated: June 5, 2020 Received: June 8, 2020
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Naira Muradyan, Ph.D. Assistant Director (Acting) DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K201518
Device Name Route 92 Medical 088 Access System
Indications for Use (Describe)
The Route 92 Medical 088 Access System, 143 cm, 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)
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510(K) SUMMARY
510(k) Summary
| Sponsor: | Route 92 Medical155 Bovet Road, Suite 100San Mateo, CA 94402Phone: 650-581-1179 |
|---|---|
| Contact: | Kathy Tansey |
| Date Prepared: | June 05, 2020 |
| Device Name: | Route 92 Medical 088 Access System |
| Common Name: | Percutaneous Catheter |
| Classification Name: | Percutaneous Catheter (Product Code QJP, 21 CFR870.1250) |
| Predicate Device: | Route 92 Medical 088 Access System, 110 cm, K200121 |
Device Description
The Route 92 Medical 088 Access System, 143 cm, is comprised of a Support Catheter and a Delivery Catheter. The distal portion of the Support 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, single-lumen variable stiffness catheter. Both catheters are hydrophilically coated. The Route 92 Medical Access System, 143 cm, 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 088 Access System, 143 cm, 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 the Predicate Device
The method of action, design, and materials of the Route 92 Medical 088 Access System, 143 cm, are equivalent to the Predicate Device as shown in the following table.
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| Attribute | Predicate DeviceRoute 92 Medical 088 AccessSystem, 110 cm (K200121) | Subject DeviceRoute 92 Medical 088 AccessSystem, 143 cm |
|---|---|---|
| Indicationsfor Use | The Route 92 Medical AccessSystem, 110 cm, is indicated for usewith compatible guide catheters infacilitating the insertion and guidanceof microcatheters into a selectedblood vessel in the neurovascularsystem. | The Route 92 Medical 088 AccessSystem, 143 cm, is indicated for usewith compatible guide catheters infacilitating the insertion and guidanceof microcatheters into a selectedblood vessel in the neurovascularsystem. |
| DeviceDescription | Sterile, single-use, variable stiffness,coil-reinforced catheter with proximalcontrol wire | Same |
| Targetedpopulation | Patients requiring use of amicrocatheter in the neurovascularsystem | Same |
| User | Physicians trained in neurovascularinterventional techniques | Same |
| AnatomicalSites | Neurovasculature only | Same |
| Materials | Polymers and metals commonly usedin the manufacture of medical devices | Same |
| Support Catheter | ||
| InnerDiameter | 0.088" | Same |
| OuterDiameter | Distal: 0.101"Proximal: 0.105" | Same |
| Length | 110 cm | 143 cm |
| Delivery Catheter | ||
| InnerDiameter | 0.019" | Same |
| OuterDiameter | Distal: 0.080"Proximal: 0.062" | Same |
| Length | 151 cm | Same |
Non-Clinical Testing
Biocompatibility Testing
The Route 92 Medical 088 Access System, 143 cm, is constructed using the same materials as the predicate device. 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.
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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.
| Test | Conclusions |
|---|---|
| Cytotoxicity - ISO MEM Elution | The test article is non-cytotoxic. |
| Sensitization – ISO Guinea PigMaximization Sensitization Test (NormalSaline and Sesame Oil) | The test article did not elicit a sensitizationresponse. |
| Irritation - ISO Intracutaneous Reactivity(Normal Saline and Sesame Oil) | Requirements of the ISO intracutaneousreactivity test have been met for the testarticle. |
| Acute Systemic Toxicity – ISO AcuteSystemic Injection (Normal Saline andSesame Oil) | Requirements of the ISO acute systemicinjection test have been met for the test article. |
| Pyrogen - Material Mediated Pyrogen(Normal Saline) | The test article is non-pyrogenic. |
| Hemocompatibility – ComplementActivation (SC5b-9) | The test article would not be expected to resultin adverse effects in vivo. |
| Hemocompatibility – Partial ThromboplastinTime | The test article is considered to be a non-activator of the intrinsic coagulation pathway. |
| Hemocompatibility – ASTM Hemolysis | The test article is considered non-hemolytic. |
| Hemocompatibility – Thromboresistance | The test articles have similarthromboresistance characteristics as thecontrol devices. |
Performance Testing
The successful completion of the performance testing listed in the following table demonstrates that the Route 92 Medical 088 Access System, 143 cm, is suitable for its intended use.
| Test | Test Method | Results |
|---|---|---|
| DimensionalVerification | Device dimensions were measuredto confirm conformance to thespecifications | PASSAll samples met the pre-determinedacceptance criteria |
| Luer Integrity | Tested per ISO 80369-7:2016 | PASSAll samples met the pre-determinedacceptance criteria |
| RHV Sealing | RHV sealing around the cathetershafts was tested | PASSAll samples met the pre-determinedacceptance criteria |
| Test | Test Method | Results |
| Tensile Strength | The tensile strength of the cathetersections and bonds was tested | PASSAll samples met the pre-determinedacceptance criteria |
| Kink Resistance | Test specimen segments wereformed into a defined benddiameter to evaluate kinkresistance | PASSAll samples met the pre-determinedacceptance criteria |
| TorsionResistance | The test specimens were rotated toevaluate integrity after rotation | PASSAll samples met the pre-determinedacceptance criteria |
| Tip Flexibility | Test specimens were tested for tipflexibility | PASSAll samples met the pre-determinedacceptance criteria |
| Air Leakage | Tested per ISO 10555-1:2013Annex D. | PASSAll samples met the pre-determinedacceptance criteria |
| Liquid Leakage /Static Burst | Tested per ISO 10555-1:2013Annex C. | PASSAll samples met the pre-determinedacceptance criteria |
| Dynamic Burst | Mechanical integrity wasmaintained up to the specifiedpressures | PASSAll samples met the pre-determinedacceptance criteria |
| HydrophilicCoating Integrity | The integrity of the hydrophiliccoating was evaluated aftermultiple insertion and withdrawalcycles. | PASSAll samples met the pre-determinedacceptance criteria |
| ParticulateRecovery | After multiple insertion andwithdrawal cycles, the effluentwater rinsed and flushed from thedevices and model was tested perUSP <788>. Particulates werecharacterized for size ranges ≥10µm, ≥25 µm, ≥50 µm, ≥100 µm,≥200 µm, ≥500 µm and ≥1000 µm | PASSAll samples met the pre-determinedacceptance criteria |
| Simulated UseTesting | Deliverability and compatibilitywith accessory devices wasevaluated in a neurovascular model | PASSAll samples met the pre-determinedacceptance criteria |
| Test | Test Method | Results |
| Radiopacity | Radiopacity of the device wasevaluated in an animal modelunder fluoroscopy | PASSAll samples met the pre-determinedacceptance criteria |
| Contrast Delivery | Contrast delivery using the devicewas evaluated in an animal modelunder fluoroscopy | PASSAll samples met the pre-determinedacceptance criteria |
| Animal Study | Safety and device performancewere both evaluated under clinicalconditions using an acute swinemodel with angiographic andhistological assessements. Thesubject device was compared to apredicate control device todemonstrate substantialequivalence. | PASSAll samples met the pre-determinedacceptance criteria |
| PackagingIntegrity | ISO 11607-1 Part 1ISO 11607-2 Part 2 | PASSAll samples met the pre-determinedacceptance criteria |
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Substantial Equivalence
The Route 92 Medical 088 Access System, 143 cm, has the same intended use, the same technological characteristics and same method of action as the predicate device. The successful completion of biocompatibility testing and performance testing demonstrates that the Route 92 Medical 088 Access System, 143 cm, is substantially equivalent to the predicate device.
§ 870.1250 Percutaneous catheter.
(a)
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.(b)
Classification. Class II (performance standards).