Route 92 Medical Full Length 070 Access System

K222743 · Route 92 Medical, Inc. · QJP · Oct 4, 2022 · Cardiovascular

Device Facts

• Record ID: K222743
• Device Name: Route 92 Medical Full Length 070 Access System
• Applicant: Route 92 Medical, Inc.
• Product Code: QJP · Cardiovascular
• Decision Date: Oct 4, 2022
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended 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.

Device Story

System comprises support catheter and delivery catheter; used by neurovascular interventional physicians in clinical settings. Devices facilitate insertion/guidance of microcatheters into neurovascular blood vessels. Support catheter is single-lumen, variable stiffness; delivery catheter is hubbed, single-lumen, variable stiffness. Both are hydrophilically coated. System provides access to neurovasculature; enables navigation of microcatheters to target sites. Benefits include improved access to neurovascular anatomy for interventional procedures.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including dimensional verification, luer integrity (ISO 80369-7:2016), tensile strength, kink/torsion resistance, tip flexibility, air/liquid leakage (ISO 10555-1:2013), burst testing, coating integrity, and simulated use in a neurovascular model.

Technological Characteristics

Single-lumen, variable stiffness, coil-reinforced catheters. Materials: polymers and metals. Hydrophilic coating. Sterilization: 100% ethylene oxide. Dimensions: Support catheter 0.070" ID, 0.084" OD; Delivery catheter 0.019" ID, 0.062" OD. Standards: ISO 80369-7:2016 (Luer), ISO 10555-1:2013 (Leakage/Burst).

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

• Route 92 Medical Full Length 088 Access System (K210635)

Reference Devices

• Route 92 Medical Delivery Catheter (K190431)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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 Medical<br>155 Bovet Road, Suite 100<br>San Mateo, CA 94402 |
|------------------------|---------------------------------------------------------------------------------|
| Contact: | Kirsten Valley<br>[phone] |
| 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 Code<br>QJP, 21 CFR 870.1250) |
| Device Classification: | Class II |
| Predicate Device: | Route 92 Medical Full Length 088 Access System<br>K210635 |
| Reference Device: | Route 92 Medical Delivery Catheter<br>K190431 |

### 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 Device<br>Route 92 Medical Full Length 088<br>Access System (K210635) | Subject Device<br>Route 92 Medical Full Length 070<br>Access System (K222743) |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Route 92 Medical Full Length<br>088 Access System is indicated for<br>use with compatible guide catheters in<br>facilitating the insertion and guidance<br>of microcatheters into a selected<br>blood vessel in the neurovascular<br>system. | The Route 92 Medical Full Length<br>070 Access System is indicated for<br>use with compatible guide catheters in<br>facilitating the insertion and guidance<br>of microcatheters into a selected<br>blood vessel in the neurovascular<br>system. |
| Device Description | Sterile, single-use, variable stiffness,<br>coil-reinforced catheter | Same |
| Targeted population | Patients requiring use of a<br>microcatheter in the neurovascular<br>system | Same |
| User | Physicians trained in neurovascular<br>interventional techniques | Same |
| Anatomical Sites | Neurovasculature only | Same |
| Materials | Polymers and metals commonly used<br>in 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"<br>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 |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|
| Dimensional<br>Verification | Device dimensions were measured<br>to confirm conformance to the<br>specifications | PASS<br>All samples met the pre-determined<br>acceptance criteria |
| Luer Integrity | Tested per ISO 80369-7:2016 | PASS<br>All samples met the pre-determined<br>acceptance criteria |
| Tensile Strength | The tensile strength of the catheter<br>sections and bonds was tested | PASS<br>All samples met the pre-determined<br>acceptance criteria |
| Kink Resistance | Test specimen segments were<br>formed into a defined bend<br>diameter to evaluate kink<br>resistance | PASS<br>All samples met the pre-determined<br>acceptance criteria |
| Torsion<br>Resistance | The test specimens were rotated to<br>evaluate integrity after rotation | PASS<br>All samples met the pre-determined<br>acceptance criteria |
| Tip Flexibility | Test specimens were tested for tip<br>flexibility | PASS<br>All samples met the pre-determined<br>acceptance criteria |
| Air Leakage | Tested per ISO 10555-1:2013<br>Annex D. | PASS<br>All samples met the pre-determined<br>acceptance criteria |
| Liquid Leakage | Tested per ISO 10555-1:2013<br>Annex C. | PASS<br>All samples met the pre-determined<br>acceptance criteria |
| Static Burst | Tested per ISO 10555-1:2013<br>Annex F. | PASS<br>All samples met the pre-determined<br>acceptance criteria |
| Dynamic Burst | Mechanical integrity was<br>maintained up to the specified<br>pressures | PASS<br>All samples met the pre-determined<br>acceptance criteria |
| Test | Test Method | Results |
| Hydrophilic<br>Coating Integrity | The integrity of the hydrophilic<br>coating was evaluated after<br>multiple insertion and withdrawal<br>cycles. | PASS<br>All samples met the pre-determined<br>acceptance criteria |
| Simulated Use<br>Testing | Deliverability and compatibility<br>with accessory devices were<br>evaluated in a neurovascular model | PASS<br>All samples met the pre-determined<br>acceptance 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.