(76 days)
The Route 92 Medical Full Length 054 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 054 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 catheters are hydrophilically coated. The devices are provided sterile and non-pyrogenic and are intended for single use only.
The provided text describes the 510(k) premarket notification for the "Route 92 Medical Full Length 054 Access System." This document focuses primarily on the comparison of the new device to a predicate device and the results of non-clinical performance testing, rather than a study proving the device meets acceptance criteria through clinical or user-based performance.
Therefore, many of the requested details, particularly those related to AI-based device performance, human reader studies, and ground truth establishment for patient data, are not present in this document. The document focuses on physical properties and mechanical performance of the device itself.
Based on the provided text, here's the information that can be extracted about the acceptance criteria and the "study" (non-clinical performance testing):
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for each test were "pre-determined" and the performance was reported as "PASS" for all samples, indicating they met these criteria. The specific numerical values or ranges for the acceptance criteria are not provided in this summary.
| Test | Acceptance Criteria (Not Explicitly Stated, Implied "Pre-determined") | Reported Device Performance |
|---|---|---|
| Dimensional Verification | Conformance to specifications | PASS |
| Luer Integrity | Per ISO 80369-7:2016 | PASS |
| Tensile Strength | Maintain integrity of catheter sections and bonds | PASS |
| Kink Resistance | No kinking in defined bend diameter | PASS |
| Torsion Resistance | Maintain integrity after rotation | PASS |
| Tip Flexibility | Met flexibility requirements | 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 maintained up to specified pressures | PASS |
| Hydrophilic Coating Integrity | Coating integrity maintained after multiple 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 states "All samples met the pre-determined acceptance criteria" for each test. However, the specific number of samples used for each non-clinical test is not provided. The data provenance is laboratory testing of the device itself, not human or patient data. It is a non-clinical, bench-top study.
3. Number of Experts Used to Establish Ground Truth for Test Set and Qualifications
Not applicable for this type of non-clinical device testing. The "ground truth" here is adherence to engineering specifications and ISO standards, evaluated through physical measurements and mechanical tests, not expert interpretation of patient data.
4. Adjudication Method for the Test Set
Not applicable. This was not a study involving human interpretation or adjudication. The results were based on physical measurements and performance against established engineering and ISO standards.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, an MRMC comparative effectiveness study was not conducted. This is a non-clinical device clearance, not an AI or diagnostic imaging study.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, this is purely a mechanical/physical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical tests was based on pre-determined acceptance criteria derived from engineering specifications and international standards (e.g., ISO 80369-7:2016, ISO 10555-1:2013).
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device. There is no concept of a "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, there is no corresponding ground truth establishment process.
Summary of what the document does describe related to acceptance and proof:
The document demonstrates that the "Route 92 Medical Full Length 054 Access System" meets its non-clinical performance and safety requirements by successfully passing a series of mechanical and physical tests. These tests are conducted to ensure the device performs as intended and is equivalent to the predicate device in terms of function and safety, given its similar design and materials but different dimensions. The "acceptance criteria" are implied to be the specific thresholds or ranges for each test (e.g., tensile strength, leak rate) that the device must meet to be considered safe and effective, and all samples passed these "pre-determined" criteria.
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August 15, 2023
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 consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.
Route 92 Medical Kirsten Valley Chief Operating Officer 155 Bovet Road, Suite 100 San Mateo, California 94402
Re: K231583
Trade/Device Name: Route 92 Medical Full Length 054 Access System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP Dated: July 28, 2023 Received: July 28, 2023
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 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 -S
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) K231583
Device Name
Route 92 Medical Full Length 054 Access System
Indications for Use (Describe)
The Route 92 Medical Full Length 054 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.
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 K231583
| Sponsor: | Route 92 Medical155 Bovet Road, Suite 100San Mateo, CA 94402 |
|---|---|
| Contact: | Kirsten Valley(650) 581-1179 |
| Date Prepared: | August 14, 2023 |
| Device Name: | Route 92 Medical Full Length 054 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 070 Access SystemK222743 |
Device Description
The Route 92 Medical Full Length 054 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 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 054 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 054 Access System are equivalent or similar to the Predicate Device as shown in the following table.
| Attribute | Predicate DeviceRoute 92 Medical Full Length 070Access System (K222743) | Subject DeviceRoute 92 Medical Full Length 054Access System (K231583) |
|---|---|---|
| Indicationsfor Use | The Route 92 Medical Full Length070 Access System is indicated for | The Route 92 Medical Full Length054 Access System is indicated for |
| Attribute | Predicate DeviceRoute 92 Medical Full Length 070Access System (K222743) | Subject DeviceRoute 92 Medical Full Length 054Access System (K231583) |
| use with compatible guide catheters infacilitating the insertion and guidanceof microcatheters into a selectedblood vessel in the neurovascularsystem. | use with 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 | 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 |
| Sterilization | 100% ethylene oxide | Same |
| Shelf Life | 6 months | Same |
| Support Catheter | ||
| InnerDiameter | 0.070" | 0.054" |
| OuterDiameter | 0.084" | 0.066" |
| Length | 132 cm | 125 cm and 148 cm |
| Delivery Catheter | ||
| InnerDiameter | 0.019" | 0.015" |
| OuterDiameter | 0.062" | 0.048" |
| Length | 151 cm | 167 cm |
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Non-Clinical Testing
Biocompatibility Testing
The patient-contacting materials were unchanged compared to the predicate device; therefore, no additional biocompatibility testing was required.
Performance Testing
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The successful completion of the performance testing listed in the following table demonstrates that the Route 92 Medical Full Length 054 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 |
| HydrophilicCoating Integrity | The integrity of the hydrophiliccoating was evaluated aftermultiple insertion and withdrawalcycles. | PASSAll samples met the pre-determinedacceptance criteria |
| Test | Test Method | Results |
| 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 054 Access System has the same intended use, similar technological characteristics and the same method of action as the predicate device. Differences between the subject and predicate devices do not raise new questions of safety and effectiveness of the device. The successful completion of performance testing demonstrates that the Route 92 Medical Full Length 054 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).