Route 92 Medical 088 Access System

K201518 · Route 92 Medical · QJP · Aug 14, 2020 · Cardiovascular

Device Facts

• Record ID: K201518
• Device Name: Route 92 Medical 088 Access System
• Applicant: Route 92 Medical
• Product Code: QJP · Cardiovascular
• Decision Date: Aug 14, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The Route 92 Medical 088 Access System, 143 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 (143 cm) is a neurovascular access device consisting of a support catheter and a delivery catheter. The support catheter features a variable stiffness, single-lumen design with a stainless-steel proximal control wire; the delivery catheter is a hubbed, single-lumen, variable stiffness catheter. Both are hydrophilically coated. Used in clinical settings by physicians trained in neurovascular interventional techniques, the system is inserted into the neurovasculature to facilitate the navigation and placement of microcatheters. The device is provided sterile for single use. By providing a stable access pathway, it assists clinicians in reaching target vessels, thereby enabling subsequent interventional procedures. Performance is monitored via fluoroscopy.

Clinical Evidence

No human clinical data provided. Evidence consists of bench testing (dimensional verification, tensile strength, kink/torsion resistance, burst testing, coating integrity, particulate recovery per USP <788>) and an acute swine model study evaluating safety, performance, radiopacity, and contrast delivery under fluoroscopy with angiographic and histological assessments.

Technological Characteristics

Variable stiffness, coil-reinforced, single-lumen catheters with hydrophilic coating and stainless-steel proximal control wire. Materials are polymers and metals standard for medical devices. Biocompatibility per ISO 10993-1. Mechanical testing per ISO 10555-1:2013 and ISO 80369-7:2016. Sterile, single-use. No software or electronic components.

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 088 Access System, 110 cm (K200121)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.

Route 92 Medical Kathy Tansey Senior Director of Regulatory Affairs and Quality Assurance 155 Bovet Road, Suite 100 San Mateo, California 94402

August 14, 2020

## Re: K201518

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: June 5, 2020 Received: June 8, 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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Naira Muradyan, Ph.D. Assistant Director (Acting) 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) K201518

Device Name Route 92 Medical 088 Access System

Indications for Use (Describe)

The Route 92 Medical 088 Access System, 143 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 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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K201518

# 510(K) SUMMARY

# 510(k) Summary

| Sponsor: | Route 92 Medical<br>155 Bovet Road, Suite 100<br>San Mateo, CA 94402<br>Phone: [phone] |
|----------------------|---------------------------------------------------------------------------------------------|
| Contact: | Kathy Tansey |
| Date Prepared: | June 05, 2020 |
| Device Name: | Route 92 Medical 088 Access System |
| Common Name: | Percutaneous Catheter |
| Classification Name: | Percutaneous Catheter (Product Code QJP, 21 CFR<br>870.1250) |
| Predicate Device: | Route 92 Medical 088 Access System, 110 cm, K200121 |

#### Device Description

The Route 92 Medical 088 Access System, 143 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, 143 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, 143 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, 143 cm, are equivalent to the Predicate Device as shown in the following table.

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| Attribute | Predicate Device<br>Route 92 Medical 088 Access<br>System, 110 cm (K200121) | Subject Device<br>Route 92 Medical 088 Access<br>System, 143 cm |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications<br>for Use | The Route 92 Medical Access<br>System, 110 cm, is indicated for use<br>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 088 Access<br>System, 143 cm, is indicated for use<br>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 | Same |
| 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 |
| Support Catheter | | |
| Inner<br>Diameter | 0.088" | Same |
| Outer<br>Diameter | Distal: 0.101"<br>Proximal: 0.105" | Same |
| Length | 110 cm | 143 cm |
| Delivery Catheter | | |
| Inner<br>Diameter | 0.019" | Same |
| Outer<br>Diameter | Distal: 0.080"<br>Proximal: 0.062" | Same |
| Length | 151 cm | Same |

## Non-Clinical Testing

## Biocompatibility Testing

The Route 92 Medical 088 Access System, 143 cm, is constructed using the same materials as the predicate device. 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.

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

# Performance Testing

The successful completion of the performance testing listed in the following table demonstrates that the Route 92 Medical 088 Access System, 143 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 |
| Test | Test Method | Results |
| 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 /<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 |
| 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>. 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 was<br>evaluated in a neurovascular model | PASS<br>All samples met the pre-determined<br>acceptance criteria |
| Test | Test Method | Results |
| 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 device<br>was evaluated in an animal model<br>under fluoroscopy | PASS<br>All samples met the pre-determined<br>acceptance criteria |
| Animal Study | Safety and device performance<br>were both evaluated under clinical<br>conditions using an acute swine<br>model with angiographic and<br>histological assessements. The<br>subject device was compared to a<br>predicate control device to<br>demonstrate substantial<br>equivalence. | 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, 143 cm, has the same intended use, the same technological characteristics and same method of action as the predicate device. The successful completion of biocompatibility testing and performance testing demonstrates that the Route 92 Medical 088 Access System, 143 cm, is substantially equivalent to the predicate device.