(25 days)
The Route 92 Medical Full Length 070 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.
The Route 92 Medical Full Length 070 Access System is comprised of a Support Catheter and a Delivery Catheter. The Support Catheter is a single-lumen, variable stiffness catheter. The Delivery Catheter is a hubbed, single-lumen variable stiffness catheter. Both catheters are hydrophilically coated. The devices are provided sterile and non-pyrogenic and are intended for single use only.
The Route 92 Medical Full Length 070 Access System is a medical device that facilitates the insertion and guidance of microcatheters in the neurovascular system. The provided document focuses on demonstrating the substantial equivalence of the device to a predicate device (Route 92 Medical Full Length 088 Access System, K210635) through non-clinical performance testing.
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes various performance tests conducted, with the general acceptance criterion being that "All samples met the pre-determined acceptance criteria." While specific numerical acceptance criteria are not detailed in this summary, the results consistently indicate "PASS" for all tests.
| Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Dimensional Verification | Conformance to specifications | PASS |
| Luer Integrity | Per ISO 80369-7:2016 | PASS |
| Tensile Strength | Sufficient strength of catheter sections/bonds | PASS |
| Kink Resistance | Resistance to kinking at defined bend diameter | PASS |
| Torsion Resistance | Integrity after rotation | PASS |
| Tip Flexibility | Acceptable tip flexibility | PASS |
| Air Leakage | Per ISO 10555-1:2013 Annex D | PASS |
| Liquid Leakage | Per ISO 10555-1:2013 Annex C | PASS |
| Static Burst | Per ISO 10555-1:2013 Annex F | PASS |
| Dynamic Burst | Mechanical integrity up to specified pressures | PASS |
| Hydrophilic Coating Integrity | Integrity after multiple insertion/withdrawal cycles | PASS |
| Simulated Use Testing | Deliverability and compatibility in neurovascular model | PASS |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the numerical sample size used for each test. Instead, it generally refers to "All samples." The provenance of the data is not specified regarding country of origin or whether it was retrospective or prospective. Given that it's non-clinical performance testing for a 510(k) submission, it's highly probable these were controlled laboratory tests conducted prospectively by the manufacturer.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This section is not applicable to this document. The study described is non-clinical performance testing of a physical medical device, not a study involving human interpretation of medical data where expert ground truth would be required. The "ground truth" for these tests are the established engineering specifications and international standards (e.g., ISO standards).
4. Adjudication Method for the Test Set:
This section is not applicable for the same reasons as point 3. Testing involves objective measurements against pre-defined engineering and performance criteria, not expert adjudication of subjective findings.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:
No, an MRMC comparative effectiveness study was not done. The submission focuses on demonstrating substantial equivalence through non-clinical performance testing of the device itself, not on evaluating the performance of human readers with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This section is not applicable. The device is a physical catheter system, not an algorithm or AI system.
7. The Type of Ground Truth Used:
The "ground truth" for the non-clinical performance tests conducted for the Route 92 Medical Full Length 070 Access System is based on pre-determined acceptance criteria derived from established engineering specifications and relevant international standards (e.g., ISO standards). For example, Luer integrity was tested per ISO 80369-7:2016, and air/liquid leakage and static burst per ISO 10555-1:2013. Simulated use testing evaluated deliverability and compatibility against expected performance in a neurovascular model.
8. The Sample Size for the Training Set:
This section is not applicable. There is no "training set" as this is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established:
This section is not applicable for the same reasons as point 8.
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October 4, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Route 92 Medical Kirsten Valley Chief Operating Officer 155 Bovet Road, Suite 100 San Mateo, California 94402
Re: K222743
Trade/Device Name: Route 92 Medical Full Length 070 Access System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP Dated: September 8, 2022 Received: September 9, 2022
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. 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 mediation-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 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) K222743
Device Name
Route 92 Medical Full Length 070 Access System
Indications for Use (Describe)
The Route 92 Medical Full Length 070 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)
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510(k) Summary K222743
| Sponsor: | Route 92 Medical155 Bovet Road, Suite 100San Mateo, CA 94402 |
|---|---|
| Contact: | Kirsten Valley(650) 581-1179 |
| Date Prepared: | October 3, 2022 |
| Device Name: | Route 92 Medical Full Length 070 Access System |
| Common Name: | Percutaneous Catheter |
| Classification Name: | Catheter, Percutaneous, Neurovasculature (Product CodeQJP, 21 CFR 870.1250) |
| Device Classification: | Class II |
| Predicate Device: | Route 92 Medical Full Length 088 Access SystemK210635 |
| Reference Device: | Route 92 Medical Delivery CatheterK190431 |
Device Description
The Route 92 Medical Full Length 070 Access System is comprised of a Support Catheter and a Delivery Catheter. The Support Catheter is a single-lumen, variable stiffness catheter. The Delivery Catheter is a hubbed, single-lumen variable stiffness catheter. Both catheters are hydrophilically coated. The devices are provided sterile and non-pyrogenic and are intended for single use only.
Indications for Use
The Route 92 Medical Full Length 070 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 the Predicate Device
The method of action, design, and materials of the Route 92 Medical Full Length 070 Access System are equivalent to the Predicate Device as shown in the following table.
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| Attribute | Predicate DeviceRoute 92 Medical Full Length 088Access System (K210635) | Subject DeviceRoute 92 Medical Full Length 070Access System (K222743) |
|---|---|---|
| Indications for Use | The Route 92 Medical Full Length088 Access System is indicated foruse with compatible guide catheters infacilitating the insertion and guidanceof microcatheters into a selectedblood vessel in the neurovascularsystem. | The Route 92 Medical Full Length070 Access System is indicated foruse with compatible guide catheters infacilitating the insertion and guidanceof microcatheters into a selectedblood vessel in the neurovascularsystem. |
| Device Description | Sterile, single-use, variable stiffness,coil-reinforced catheter | Same |
| Targeted population | Patients requiring use of amicrocatheter in the neurovascularsystem | Same |
| User | Physicians trained in neurovascularinterventional techniques | Same |
| Anatomical Sites | Neurovasculature only | Same |
| Materials | Polymers and metals commonly usedin the manufacture of medical devices | Same |
| Sterilization | 100% ethylene oxide | Same |
| Shelf Life | 8 months | 6 months |
| Support Catheter | ||
| Inner Diameter | 0.088" | 0.070" |
| Outer Diameter | 0.101" | 0.084" |
| Length | 132 cm and 125 cm | 132 cm |
| Delivery Catheter | ||
| Inner Diameter | 0.019" | Same |
| Outer Diameter | Distal: 0.080"Proximal: 0.062" | 0.062" |
| Length | 151 cm | Same |
Non-Clinical Testing
Biocompatibility Testing
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The patient-contacting materials were unchanged compared to the predicate device; therefore, no additional biocompatibility testing was required.
Performance Testing
The successful completion of the performance testing listed in the following table demonstrates that the Route 92 Medical Full Length 070 Access System 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 |
| 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 | Tested per ISO 10555-1:2013Annex C. | PASSAll samples met the pre-determinedacceptance criteria |
| Static Burst | Tested per ISO 10555-1:2013Annex F. | PASSAll samples met the pre-determinedacceptance criteria |
| Dynamic Burst | Mechanical integrity wasmaintained up to the specifiedpressures | PASSAll samples met the pre-determinedacceptance criteria |
| Test | Test Method | Results |
| HydrophilicCoating Integrity | The integrity of the hydrophiliccoating was evaluated aftermultiple insertion and withdrawalcycles. | PASSAll samples met the pre-determinedacceptance criteria |
| Simulated UseTesting | Deliverability and compatibilitywith accessory devices wereevaluated in a neurovascular model | PASSAll samples met the pre-determinedacceptance criteria |
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Conclusions
The Route 92 Medical Full Length 070 Access System has the same intended use, the same technological characteristics and same method of action as the predicate device. Differences between the subject and predicate devices do not raise new concerns of safety and effectiveness of the device. The successful completion of performance testing demonstrates that the Route 92 Medical Full Length 070 Access System 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).