(89 days)
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.
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.
This document describes the premarket notification (510(k)) for the Route 92 Medical Delivery Catheter. The submission aims to demonstrate substantial equivalence to a predicate device, not to perform a comparative effectiveness study or validate an AI/ML algorithm. Therefore, many of the requested elements for describing AI-related studies are not applicable.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for each test are typically "PASS," meaning the samples met pre-determined criteria. The document states "All samples met the pre-determined acceptance criteria" for nearly all non-clinical performance tests. Specific quantitative acceptance criteria are not provided within this summary for most tests, but they would have been defined in the full test protocols.
| Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Biocompatibility Testing | ||
| Cytotoxicity - ISO MEM Elution | Grade 0 | Grade 0 at 24, 48, 72 ± 4 hrs (Non-cytotoxic) |
| Sensitization - ISO Guinea Pig Maximization Sensitization Test | No sensitization response | No sensitization response |
| Irritation - ISO Intracutaneous Reactivity | Mean Test-Mean Control < 1.0 | Mean Test-Mean Control (Normal Saline) = 0; Mean Test-Mean Control (Sesame Oil) = 0.1 |
| Acute Systemic Toxicity – ISO Acute Systemic Injection | No clinical signs consistent with toxicity, body weight within acceptable parameters | None observed, within acceptable parameters |
| Pyrogen - Material Mediated Pyrogen | Temperature rise < 0.5℃ | No temperature rise ≥ 0.5℃ |
| Hemocompatibility - Complement Activation (C3a & SC5b-9) | Minimal increase not expected to result in adverse effects in vivo | Minimal increase noted, not expected to result in adverse effects in vivo |
| Hemocompatibility - Partial Thromboplastin Time (PTT) | PTT of test article = 100% of negative control | PTT of test article was 100% of the negative control |
| Hemocompatibility - ASTM Hemolysis | Non-hemolytic | Direct Method: 0.0%; Extract Method: 0.3% (non-hemolytic) |
| Hemocompatibility - Thromboresistance | Similar thromboresistance characteristics as control devices | Similar thromboresistance characteristics as control devices |
| Genotoxicity - ISO Bacterial Mutagenicity Test - Ames Assay | No substantial increases in reversion rates or toxicity interfering with mutagen detection | No substantial increases in reversion rates, no substantial toxicity |
| Genotoxicity - ISO In Vitro Mouse Lymphoma | No notable changes in typical growth pattern, cloning efficiencies within normal limits | No notable changes, cloning efficiencies within normal limits |
| Performance Testing - Bench | ||
| Dimensional Verification | Conformance to specifications | PASS |
| Luer Integrity | Met pre-determined acceptance criteria | PASS |
| RHV Sealing | Met pre-determined acceptance criteria | PASS |
| Tensile Strength | Met pre-determined acceptance criteria | PASS |
| Kink Resistance | Met pre-determined acceptance criteria | PASS |
| Torsion Resistance | Met pre-determined acceptance criteria | PASS |
| Tip Flexibility | Met pre-determined acceptance criteria | PASS |
| Air Leakage | Meets ISO 10555-1:2013 Annex D requirements | PASS |
| Liquid Leakage | Meets ISO 10555-1:2013 Annex C requirements | PASS |
| Hydrophilic Coating Integrity | Met pre-determined acceptance criteria | PASS |
| Particulate Recovery | Meets USP <788> requirements | PASS |
| Corrosion Resistance | Meets ISO 10555-1:2013 Annex A requirements | PASS |
| Catheter Burst Pressure (Static & Dynamic) | Meets ISO 10555-1:2013 Annex F requirements | PASS |
| Catheter Flow Rate | Meets ISO 10555-1:2013 Annex E requirements | PASS |
| Simulated Use Testing | Deliverability and compatibility met pre-determined acceptance criteria | PASS |
| Packaging Integrity | Meets ISO 11607-1 Part 1 & ISO 11607-2 Part 2 requirements | PASS |
| Radiopacity | Met pre-determined acceptance criteria | PASS |
2. Sample Size for Test Set and Data Provenance
This submission is for a medical device (catheter) and relies on non-clinical (bench and biocompatibility) testing, not a clinical study involving human patient data or a "test set" in the context of an AI/ML algorithm.
- Sample Size (Test Set): The specific number of samples for each bench test is not provided in this summary. For biocompatibility, animal testing (Guinea Pig Maximization, Acute Systemic Injection, Pyrogen, Thromboresistance in animal model) was performed, but the exact number of animals per test is not detailed.
- Data Provenance (e.g., country of origin, retrospective/prospective): Not applicable for bench and biocompatibility testing of a physical device. Biocompatibility data was leveraged from the predicate device (K180201), indicating it was previously generated.
3. Number of Experts Used to Establish Ground Truth for Test Set and Qualifications
Not applicable. Ground truth, in the context of expert consensus, is typically used for AI/ML image analysis or diagnostic devices. This submission involves physical device performance and safety testing.
4. Adjudication Method for the Test Set
Not applicable, as there is no "test set" requiring adjudication by experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not a diagnostic device or an AI/ML algorithm being compared to human readers. It is a delivery catheter.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This is not an AI/ML algorithm.
7. Type of Ground Truth Used
The "ground truth" for this device's performance is established by:
- Pre-defined technical specifications and engineering requirements.
- International standards (e.g., ISO 10993-1, ISO 80369-7, ISO 10555-1, ISO 11607-1/2, USP <788>).
- Laboratory measurements and observations during bench testing.
- Biological responses observed in animal models (for biocompatibility).
8. Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI/ML algorithm requiring a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no training set for this device.
Study Proving Device Meets Acceptance Criteria:
The study that proves the device meets the acceptance criteria is a combination of Biocompatibility Testing and Performance Testing - Bench.
- Biocompatibility Testing: Evaluated the biological safety of the device materials. These tests were leveraged from the predicate device (Route 92 Medical Access System, K180201) because the subject device is identical in materials, design, and manufacturing processes. The tests included Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Pyrogen, Hemocompatibility (Complement Activation, PTT, Hemolysis, Thromboresistance), and Genotoxicity (Bacterial Mutagenicity, In Vitro Mouse Lymphoma). All tests reported "PASS" or conclusions indicating the device is safe and biocompatible within accepted medical device standards.
- Performance Testing - Bench: Evaluated the physical and mechanical performance characteristics of the catheter. Most of these tests were also leveraged from the predicate device (K180201) due to identical design. Tests included Dimensional Verification, Luer Integrity, RHV Sealing, Tensile Strength, Kink Resistance, Torsion Resistance, Tip Flexibility, Air Leakage, Liquid Leakage, Hydrophilic Coating Integrity, Particulate Recovery, Corrosion Resistance, Catheter Burst Pressure, Catheter Flow Rate, Simulated Use Testing, Packaging Integrity, and Radiopacity. All tests reported "PASS," indicating that the samples met their pre-determined acceptance criteria.
The summary concludes that: "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." And "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)."
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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
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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
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K182512 510(k) Summary
| 510(k) Summary | |
|---|---|
| Sponsor: | Route 92 Medical1700 S. El Camino Real, Suite 206San Mateo, CA 94022Phone: 408-391-6536Fax: 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 CFR870.1250) |
| 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.
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| Attribute | Predicate Delivery Catheter Providedas Part of the Route 92 Medical AccessSystem (K180201) | Subject Route 92 Medical DeliveryCatheter |
|---|---|---|
| Indications forUse | The Route 92 Medical Access System isindicated for use with compatible guidecatheters in facilitating the insertion andguidance of microcatheters into aselected blood vessel in theneurovascular systems. | The Route 92 Medical DeliveryCatheter is indicated for use withcompatible catheters in facilitating theinsertion and guidance of cathetersinto a selected blood vessel in theneurovascular system. |
| DeviceDescription | The Delivery Catheter is a sterile, single-use, single-lumen, hydrophilicallycoated, variable stiffness catheter with aflexible, tapered tip. | Same as predicate device |
| User | Physicians trained in neurovascularinterventional techniques | Same as predicate device |
| Anatomical Sites | Neurovasculature only | Same as predicate device |
| Materials | Biocompatible polymers and metalscommonly used in the manufacture ofmedical devices | Same as predicate device |
| Distal shaft: varying durometers ofPebax | ||
| Proximal shaft: PTFE coated stainlesssteel | ||
| Luer: polycarbonate | ||
| Inner Diameter | 0.019'' | Same as predicate device |
| Outer Diameter | Distal: 0.062"Proximal: 0.028" | Same as predicate device |
| Device WorkingLength | 143 cm | Same as predicate device |
| HydrophilicCoating | Present on polymer section of theDelivery Catheter | Same as predicate device |
| AccessoriesIncluded | No accessory included | Same as predicate device |
| Packaging | Nylon/Tyvek pouch inside of an SBSshelf carton | Same as predicate device |
| SterilizationMethod | Ethylene Oxide | Same as predicate device |
| Shelf Life | 8 months | Same as predicate device |
| Sterility | Validated to achieve Sterility AssuranceLevel (SAL) of 10-6 | Same as predicate device |
| Endotoxin Testing | Meets requirement for less or equal to2.15 endotoxin units per device | Same as predicate device |
| Attribute | Predicate Delivery Catheter Providedas Part of the Route 92 Medical AccessSystem (K180201) | Subject Route 92 Medical DeliveryCatheter |
| Principle ofOperation | During use, a standard neurovascularguidewire may be inserted through theDelivery Catheter. The DeliveryCatheter is inserted through a compatibleaccess catheter. The Delivery Catheterand access catheter are advanced to thetargeted location under fluoroscopyusing standard endovascular techniques. | Same as predicate device |
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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 MEMElution | Grade 0 at 24, 48, 72 ± 4 hrs | The test article is non-cytotoxic. |
| Sensitization - ISOGuinea Pig MaximizationSensitization Test(Normal Saline andSesame Oil) | Clinical Observations: none of the animalsshowed abnormal clinical signs during thetest period.Main Test Results:Negative Control, grade =0Normal Saline, grade = 0Sesame Oil, grade = 0 | Test article did not elicit asensitization response. |
| Irritation - ISOIntracutaneous Reactivity(Normal Saline andSesame Oil) | Dermal observations:Comparative Results Mean Test-MeanControl (Normal Saline) = 0Mean Test-Mean Control (Sesame Oil) = 0.1Differences between mean test and controlscores were less than 1.0 | Requirements of the ISOintracutaneous reactivitytest have been met for thetest article. |
| Acute Systemic Toxicity– ISO Acute SystemicInjection (Normal Salineand Sesame Oil) | None of the test article extract treatedanimals were observed with clinical signsconsistent with toxicity. Body weightchanges were within acceptable parameters. | Requirements of the ISOacute systemic injectiontest have been met for thetest article. |
| Pyrogen - MaterialMediated Pyrogen(Normal Saline) | During the 3-hr observation period, none ofthe rabbits administered with the text articleextract had a temperature rise ≥ 0.5℃ atthe required observation time points. Theresponse did not exceed the USP limits andmeets the requirements for this test. | The test article is non-pyrogenic. |
| Test | Results | Conclusions |
| Hemocompatibility -ComplementActivation (C3a &SC5b-9) | When compared to a legally US-marketeddevice, the minimal increase in complementactivation noted in the test article would notbe expected to result in adverse effects invivo. | The test article would notbe expected to result inadverse effects in vivo. |
| Hemocompatibility -Partial ThromboplastinTime (PTT) | The PTT of the test article was 100% of thenegative control. | The test article isconsidered to be a non-activator of the intrinsiccoagulation pathway andpasses the test. |
| Hemocompatibility -ASTM Hemolysis | Blank corrected hemolytic index above thenegative control:Direct Method: 0.0%Extract Method: 0.3% | The test article isconsidered non-hemolytic. |
| Hemocompatibility -Thromboresistance | All test animals survived the generalanesthesia and study observation intervalwithout test article related complications.The combined data of blood test reports, pre-and post-implant weight differences, and thepatency and thrombus scores were notsubjectively different between the test andcontrol articles. | The test devices appear tohave similarthromboresistancecharacteristics as thecontrol devices. |
| Genotoxicity - ISOBacterial MutagenicityTest - Ames Assay(Normal Saline andPolyethylene Glycol) | The test article did not induce substantialincreases in reversion rates of the type thatare associated with mutagenesis and nosubstantial test article toxicity was noted thatmay have interfered with the ability of thetest system to detect mutagens. | The test article isconsidered non-mutagenic. |
| Genotoxicity - ISO InVitro Mouse Lymphoma(Normal Saline andPolyethylene Glycol) | The test article did not cause notable changesin the typical growth pattern of the L5178Ycells in suspension culture during the growthand expression period. The cloningefficiencies of these preparations were withinnormal limits. | The test article isconsidered to be non-mutagenic and non-clastogenic. |
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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 |
|---|---|---|
| DimensionalVerification | Device dimensions weremeasured to confirm conformanceto the specifications | PASSAll samples met the pre-determined acceptance criteria |
| Luer Integrity | Tested per ISO 80369-7:2016 | PASSAll samples met the pre-determined acceptance criteria |
| RHV Sealing | RHV sealing were tested | PASSAll samples met the pre-determined acceptance criteria |
| Tensile Strength | The tensile strength of thecatheter sections and bonds wastested | PASSAll samples met the pre-determined acceptance criteria |
| Kink Resistance | Test specimen segments wereformed into a defined benddiameter to evaluate kinkresistance | PASSAll samples met the pre-determined acceptance criteria |
| Torsion Resistance | The test specimens were rotatedto evaluate integrity after rotation | PASSAll samples met the pre-determined acceptance criteria |
| Tip Flexibility | Test specimens were tested for tipflexibility | PASSAll samples met the pre-determined acceptance criteria |
| Air Leakage | Tested per ISO 10555-1:2013Annex D. | PASSAll samples met the pre-determined acceptance criteria |
| Liquid Leakage | Tested per ISO 10555-1:2013Annex C. | PASSAll samples met the pre-determined acceptance criteria |
| HydrophilicCoating Integrity | The integrity of the hydrophiliccoating was evaluated aftermultiple insertion and withdrawalcycles. | PASSAll samples met the pre-determined acceptance criteria |
| ParticulateRecovery | After multiple insertion andwithdrawal cycles, the effluentwater rinsed and flushed from thedevices and model was tested perUSP <788>. | PASSAll samples met the pre-determined acceptance criteria |
| CorrosionResistance | Tested per ISO 10555-1:2013Annex A. | PASSAll samples met the pre-determined acceptance criteria |
| Catheter BurstPressure (Static &Dynamic) | Tested per ISO 10555-1:2013Annex F. | PASSAll samples met the pre-determined acceptance criteria |
| Catheter Flow Rate | Tested per ISO 10555-1:2013Annex E. | PASSAll samples met the pre-determined acceptance criteria |
| Test | Test Method | Results |
| Simulated UseTesting | Deliverability andcompatibility with accessorydevices was evaluated in aneurovascular model | PASSAll samples met the pre-determined acceptancecriteria |
| PackagingIntegrity | ISO 11607-1 Part 1ISO 11607-2 Part 2 | PASSAll samples met the pre-determined acceptancecriteria |
| Radiopacity | Radiopacity of the device wasevaluated in an animal modelunder fluoroscopy | PASSAll samples met the pre-determined acceptancecriteria |
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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).
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§ 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).