Route 92 Medical 088 Access System, 110 cm

K200121 · Route 92 Medical, Inc. · QJP · Apr 18, 2020 · Cardiovascular

Device Facts

• Record ID: K200121
• Device Name: Route 92 Medical 088 Access System, 110 cm
• Applicant: Route 92 Medical, Inc.
• Product Code: QJP · Cardiovascular
• Decision Date: Apr 18, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The Route 92 Medical 088 Access System, 110 cm, 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 088 Access System is a sterile, single-use neurovascular catheter system consisting of a Support Catheter and a Delivery Catheter. It is used by physicians trained in neurovascular interventional techniques in a clinical setting. The device is inserted into the neurovasculature to facilitate the guidance of microcatheters. The Support Catheter features a variable stiffness, coil-reinforced design with a proximal stainless-steel control wire; the Delivery Catheter is a hubbed, variable stiffness catheter. Both components are hydrophilically coated. The system is used under fluoroscopic guidance. By providing a stable access path, the device assists the physician in navigating microcatheters to target sites, potentially improving procedural efficiency and patient outcomes during neurovascular interventions.

Clinical Evidence

Bench testing only. Biocompatibility evaluated per ISO 10993-1 (cytotoxicity, sensitization, irritation, acute systemic toxicity, pyrogenicity, hemocompatibility). Performance testing included dimensional verification, luer integrity (ISO 80369-7), RHV sealing, tensile strength, kink/torsion resistance, tip flexibility, air/liquid leakage (ISO 10555-1), burst testing, coating integrity, particulate recovery (USP <788>), simulated use in neurovascular models, radiopacity, contrast delivery, and in vivo thromboresistance in a swine model. All tests met pre-determined acceptance criteria.

Technological Characteristics

Sterile, single-use, variable stiffness, coil-reinforced catheters with proximal stainless-steel control wire. Hydrophilic coating. Materials: polymers and metals. Dimensions: Support Catheter (0.088" ID, 0.101"-0.105" OD), Delivery Catheter (0.019" ID, 0.062"-0.080" OD). Length: 110 cm. Standards: ISO 10993-1 (biocompatibility), ISO 80369-7 (luer), ISO 10555-1 (leakage), USP <788> (particulates), ISO 11607 (packaging).

Indications for Use

Indicated for patients requiring microcatheter use in the neurovascular system to facilitate insertion and guidance 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 Access System (K180201)
• Imperative Care Inc. EagleRay Long Sheath (K180169)

Submission Summary (Full Text)

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April 18, 2020

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: K200121

Trade/Device Name: Route 92 Medical 088 Access System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP Dated: January 17, 2020 Received: January 21, 2020

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/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,

Xiaolin Zheng, Ph.D., M.S. 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) K200121

Device Name Route 92 Medical 088 Access System

Indications for Use (Describe)

The Route 92 Medical 088 Access System, 110 cm, 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 <i>one</i> or <i>both</i> , 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

# 510(k) Summary

| Sponsor: | Route 92 Medical<br>1700 S. El Camino Real, Suite 206<br>San Mateo, CA 94022<br>Phone: [phone] |
|----------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| Contact: | Kathy Tansey |
| Date Prepared: | January 17, 2019 |
| Device Name: | Route 92 Medical 088 Access System |
| Common Name: | Percutaneous Catheter |
| Classification Name: | Percutaneous Catheter (Product Code OJP, 21 CFR<br>870.1250) |
| Primary Predicate Device:<br>Secondary Predicate Device: | Route 92 Medical Access System, K180201<br>Imperative Care Inc. EagleRay Long Sheath, K180169 |

#### Device Description

The Route 92 Medical 088 Access System, 110 cm, is comprised of a Support Catheter and a Delivery Catheter. The distal portion of the Support Catheter is a single-lumen, variable stiffness catheter. Like the predicate device, the proximal portion is a stainless-steel control wire. The Delivery Catheter is a hubbed, single-lumen variable stiffness catheter. Both catheters are hydrophilically coated. The Route 92 Medical Access System, 110 cm, 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 088 Access System, 110 cm, 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 088 Access System, 110 cm, are equivalent to the Predicate Devices as shown in the following table.

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| Attribute | Primary Predicate<br>Route 92 Medical Access<br>System (K180201) | Secondary Predicate<br>Imperative Care Inc.<br>EagleRay Long Sheath<br>(K180169) | Subject<br>Route 92 Medical 088<br>Access System, 110 cm |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications<br>for Use | The Route 92 Medical<br>Access System is indicated<br>for use with compatible<br>guide catheters in facilitating<br>the insertion and guidance of<br>microcatheters into a<br>selected blood vessel in the<br>neurovascular system. | The EagleRay Long<br>Sheath and EagleRay<br>Access Catheter are<br>indicated for the<br>introduction of<br>interventional devices into<br>the peripheral, coronary,<br>and neuro vasculature. | The Route 92 Medical 088<br>Access System, 110 cm, is<br>indicated for use with<br>compatible guide catheters<br>in facilitating the insertion<br>and guidance of<br>microcatheters into a<br>selected blood vessel in the<br>neurovascular system. |
| Device<br>Description | Sterile, single-use, variable<br>stiffness, coil-reinforced<br>catheter with proximal<br>control wire | Sterile, single-use,<br>variable stiffness, wire-<br>reinforced catheter | Sterile, single-use, variable<br>stiffness, coil-reinforced<br>catheter with proximal<br>control wire |
| Targeted<br>population | Patients requiring use of a<br>microcatheter in the<br>neurovascular system | Patients requiring use of a<br>microcatheter in the<br>peripheral, coronary or<br>neurovascular systems | Patients requiring use of a<br>microcatheter in the<br>neurovascular system |
| User | Physicians trained in<br>neurovascular interventional<br>techniques | Physicians trained in<br>interventional techniques | Physicians trained in<br>neurovascular interventional<br>techniques |
| Anatomical<br>Sites | Neurovasculature only | Peripheral, coronary or<br>neurovascular systems | Neurovasculature only |
| Materials | Polymers and metals<br>commonly used in the<br>manufacture of medical<br>devices | Polymers and metals<br>commonly used in the<br>manufacture of medical<br>devices | Polymers and metals<br>commonly used in the<br>manufacture of medical<br>devices |
| Support Catheter | | | |
| Inner<br>Diameter | 0.070" | .088" | 0.088" |
| Outer<br>Diameter | Distal: 0.082"<br>Proximal: 0.087" | Distal: 0.106"<br>Proximal: 0.108" | Distal: 0.101"<br>Proximal: 0.105" |
| Length | 136cm | 80cm -110cm | 110cm |
| Inner<br>Diameter | 0.019" | N/A | 0.019" |
| Outer<br>Diameter | 0.062" | N/A | Distal: 0.080"<br>Proximal: 0.062" |
| Length | 143cm | N/A | 151cm |

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## Non-Clinical Testing

### Biocompatibility Testing

The Route 92 Medical 088 Access System, 110 cm, 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). A summary of the biocompatibility testing is provided below.

| Test | Conclusions |
|-----------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| Cytotoxicity – ISO MEM Elution | The test article is non-cytotoxic. |
| Sensitization – ISO Guinea Pig<br>Maximization Sensitization Test<br>(Normal Saline and Sesame Oil) | The test article did not elicit a<br>sensitization response. |
| Irritation – ISO Intracutaneous<br>Reactivity (Normal Saline and<br>Sesame Oil) | Requirements of the ISO<br>intracutaneous reactivity test have been<br>met for the test article. |
| Acute Systemic Toxicity – ISO<br>Acute Systemic Injection (Normal<br>Saline and Sesame Oil) | Requirements of the ISO acute<br>systemic injection test have been met<br>for the test article. |
| Pyrogen – Material Mediated<br>Pyrogen (Normal Saline) | The test article is non-pyrogenic. |
| Hemocompatibility – Complement<br>Activation (SC5b-9) | The test article would not be expected<br>to result in adverse effects in vivo. |
| Hemocompatibility – Partial<br>Thromboplastin Time | The test article is considered to be a<br>non-activator of the intrinsic<br>coagulation pathway. |
| Hemocompatibility – ASTM<br>Hemolysis | The test article is considered non-<br>hemolytic. |
| Hemocompatibility –<br>Thromboresistance | The test articles have similar<br>thromboresistance characteristics as<br>the control devices. |

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## Performance Testing

The successful completion of the performance testing listed in the following table demonstrates that the Route 92 Medical 088 Access System, 110 cm, 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 |
| RHV Sealing | RHV sealing around the catheter<br>shafts was tested | 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 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 /<br>Static Burst | Tested per ISO 10555-1:2013<br>Annex C. | 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 |
| 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>. | PASS<br>All samples met the pre-determined<br>acceptance criteria |
| Simulated Use<br>Testing | Deliverability and compatibility<br>with accessory devices was<br>evaluated in a neurovascular model | PASS<br>All samples met the pre-determined<br>acceptance criteria |
| Radiopacity | Radiopacity of the device was<br>evaluated in an animal model<br>under fluoroscopy | PASS<br>All samples met the pre-determined<br>acceptance criteria |
| Contrast Delivery | Contrast delivery using the<br>device was evaluated in an<br>animal model under fluoroscopy | PASS<br>All samples met the pre-determined<br>acceptance criteria |
| In Vivo<br>Thromboresistance | Thromboresistance was evaluated<br>under clinical conditions in the<br>swine 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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## Substantial Equivalence

The Route 92 Medical 088 Access System, 110 cm, has the same intended use, the same technological characteristics and same method of action as the Predicate Devices. The successful completion of biocompatibility testing and performance testing demonstrates that the Route 92 Medical 088 Access System, 110 cm, is substantially equivalent to the Predicate Devices.