Route 92 Medical Full Length 088 Access System

K210635 · Route 92 Medical, Inc. · QJP · Jul 27, 2021 · Cardiovascular

Device Facts

• Record ID: K210635
• Device Name: Route 92 Medical Full Length 088 Access System
• Applicant: Route 92 Medical, Inc.
• Product Code: QJP · Cardiovascular
• Decision Date: Jul 27, 2021
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The Route 92 Medical Full Length 088 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

The Route 92 Medical Full Length 088 Access System consists of a support catheter and a delivery catheter used by physicians trained in neurovascular interventional techniques. The system is designed to facilitate the insertion and guidance of microcatheters into neurovascular blood vessels. The support catheter is a single-lumen, variable stiffness, coil-reinforced device; the delivery catheter is a hubbed, single-lumen, variable stiffness device. Both catheters feature hydrophilic coatings. The system is provided sterile for single use. During clinical procedures, the physician uses the catheters to navigate the neurovascular anatomy, providing a pathway for microcatheters. The device's design allows for precise navigation, potentially improving procedural efficiency and patient outcomes by enabling access to target vessels for therapeutic interventions.

Clinical Evidence

Bench testing only. No clinical data. Biocompatibility testing (ISO 10993-1) confirmed non-cytotoxicity, non-sensitization, non-irritation, and non-pyrogenicity. Hemocompatibility testing (complement activation, PTT, hemolysis) showed no adverse effects. Performance testing (ISO 10555-1, ISO 80369-7, USP <788>) confirmed dimensional accuracy, luer integrity, tensile strength, kink/torsion resistance, tip flexibility, leak/burst pressure, coating integrity, and particulate levels met all pre-determined acceptance criteria.

Technological Characteristics

Single-lumen, variable stiffness, coil-reinforced catheters. Materials: polymers and metals. Hydrophilic coating. Dimensions: Support catheter ID 0.088", OD 0.101"; Delivery catheter ID 0.019", OD 0.080" (distal)/0.062" (proximal). Lengths: 132 cm and 125 cm. Sterilization: 100% ethylene oxide. Standards: ISO 10993-1 (biocompatibility), ISO 10555-1 (catheter performance), ISO 80369-7 (luer integrity), USP <788> (particulates), ISO 11607 (packaging).

Indications for Use

Indicated for patients requiring use of a microcatheter in the neurovascular system to facilitate insertion and guidance into a selected blood vessel.

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 088 Access System (K201518)

Submission Summary (Full Text)

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July 27, 2021

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, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in smaller blue letters below that.

Route 92 Medical Kirsten Valley Chief Operating Officer 155 Bovet Road. Suite 100 San Mateo, California 94402

Re: K210635

Trade/Device Name: Route 92 Medical Full Length 088 Access System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP Dated: June 28, 2021 Received: June 29, 2021

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

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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 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) K210635

Device Name

Route 92 Medical Full Length 088 Access System

Indications for Use (Describe)

The Route 92 Medical Full Length 088 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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# K210635 510(k) Summary

| Sponsor: | Route 92 Medical<br>155 Bovet Road, Suite 100<br>San Mateo, CA 94402<br>Phone: [phone] |
|------------------------|---------------------------------------------------------------------------------------------|
| Contact: | Kirsten Valley |
| Date Prepared: | July 20, 2021 |
| Device Name: | Route 92 Medical Full Length 088 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 088 Access System, K201518 |

#### Device Description

The Route 92 Medical Full Length 088 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 Route 92 Medical Full Length 088 Access System 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 Full Length 088 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 088 Access System are equivalent to the Predicate Device as shown in the following table.

| Attribute | Predicate Device<br>Route 92 Medical 088 Access System<br>(K201518) | Subject Device<br>Route 92 Medical Full Length 088<br>Access System (K210635) |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications<br>for Use | The Route 92 Medical 088 Access<br>System, 143 cm, is indicated for use | The Route 92 Medical Full Length<br>088 Access System is indicated for |
| | Predicate Device<br>Route 92 Medical 088 Access System<br>(K201518) | Subject Device<br>Route 92 Medical Full Length 088<br>Access System (K210635) |
| Attribute | 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. | 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<br>Description | Sterile, single-use, variable stiffness,<br>coil-reinforced catheter with proximal<br>control wire | Sterile, single-use, variable stiffness,<br>coil-reinforced catheter |
| Targeted<br>population | Patients requiring use of a<br>microcatheter in the neurovascular<br>system | Same |
| User | Physicians trained in neurovascular<br>interventional techniques | Same |
| Anatomical<br>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 | Same |
| Support Catheter | | |
| Inner<br>Diameter | 0.088" | Same |
| Outer<br>Diameter | Distal: 0.101"<br>Proximal: 0.105" | 0.101" |
| Length | 143 cm | 132 cm and 125 cm |
| Delivery Catheter | | |
| Inner<br>Diameter | 0.019" | Same |
| Outer<br>Diameter | Distal: 0.080"<br>Proximal: 0.062" | Same |
| Length | 151 cm | Same |

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# Non-Clinical Testing

# Biocompatibility Testing

The Route 92 Medical Full Length 088 Access System is constructed using the same materials as the predicate device. All patient contacting components have been evaluated for biocompatibility in

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accordance with ISO 10993-1 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing. The Route 92 Medical Full Length 088 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 | Results | Conclusions |
|--------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| Cytotoxicity - ISO<br>MEM Elution | The test article extract showed no evidence of<br>causing cell lysis or toxicity. The test article<br>extract met the requirements of the test as grade<br>was less than 2. | The test article is non-<br>cytotoxic. |
| Sensitization - ISO<br>Guinea Pig<br>Maximization<br>Sensitization Test<br>(Normal Saline and<br>Sesame Oil) | The test article extracts showed no evidence of<br>causing delayed dermal contact sensitization in<br>the guinea pig. The test article was not considered<br>a sensitizer in the test. | The test article did not<br>elicit a sensitization<br>response. |
| Irritation - ISO<br>Intracutaneous<br>Reactivity (Normal<br>Saline and Sesame Oil) | The test article met the requirements of the test<br>since the difference between each test article<br>extract overall mean score and corresponding<br>control extract overall mean score was 1.0 or less<br>for both sodium chloride and sesame oil test<br>article extracts. | Requirements of the<br>ISO intracutaneous<br>reactivity test have<br>been met for the test<br>article. |
| Acute Systemic<br>Toxicity - ISO Acute<br>Systemic Injection<br>(Normal Saline and<br>Sesame Oil) | There was no mortality or evidence of systemic<br>toxicity from the extracts injected into mice. | Requirements of the<br>ISO acute systemic<br>injection test have been<br>met for the test article. |
| Pyrogen - Material<br>Mediated Pyrogen<br>(Normal Saline) | No single animal showed a temperature rise of<br>0.5℃ or more above its baseline temperature. | The test article is non-<br>pyrogenic. |
| Hemocompatibility-<br>Complement<br>Activation (SC5b-9) | The concentration of SC5b-9 in the test sample<br>was lower than the concentration in the control<br>sample. | The test article would<br>not be expected to<br>result in adverse effects<br>in vivo. |
| Hemocompatibility -<br>Partial Thromboplastin<br>Time | The test article clotting time was not statistically<br>different as compared to the control article. | The test article is<br>considered to be a non-<br>activator of the intrinsic<br>coagulation pathway. |
| Hemocompatibility -<br>ASTM Hemolysis | Both the test article in direct contact with blood<br>and the test article extract were non-hemolytic. | The test article is<br>considered non-<br>hemolytic. |

### 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 088 Access System is suitable for its intended use.

ﺎ

| 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 |
| 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 |
| Test | Test Method | Results |
| Particulate<br>Recovery | After multiple insertion and<br>withdrawal cycles, the effluent<br>water rinsed and flushed from the<br>devices and model was tested per<br>USP <788>. Particulates were<br>characterized for size ranges ≥10<br>µm, ≥25 µm, ≥50 µm, ≥100 µm,<br>≥200 µm, ≥500 µm and ≥1000 µm | 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 |
| Packaging<br>Integrity | ISO 11607-1 Part 1<br>ISO 11607-2 Part 2 | PASS<br>All samples met the pre-determined<br>acceptance criteria |

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#### Conclusions

The Route 92 Medical Full Length 088 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 successful completion of biocompatibility testing and performance testing demonstrates that the Route 92 Medical Full Length 088 Access System is substantially equivalent to the predicate device.