Route 92 Medical Sheath System

K191717 · Route 92 Medical, Inc. · DQY · Jan 13, 2020 · Cardiovascular

Device Facts

• Record ID: K191717
• Device Name: Route 92 Medical Sheath System
• Applicant: Route 92 Medical, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Jan 13, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The Route 92 Medical Sheath System is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.

Device Story

The Base Camp Sheath System is a percutaneous catheter system used by physicians trained in endovascular techniques to provide vascular access. The system consists of a sheath, dilator, navigating catheter, and rotating hemostasis valve (RHV). The dilator facilitates percutaneous introduction into the femoral artery; the sheath and navigating catheter provide a reinforcing conduit for the delivery of other interventional devices to target sites in the peripheral and neuro vasculature. All catheters feature variable stiffness, radiopaque markers for fluoroscopic visualization, and a hydrophilic coating to reduce friction during navigation. The device is used in clinical settings to facilitate device tracking and placement, potentially improving procedural efficiency and patient outcomes during minimally invasive vascular interventions.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993-1 (cytotoxicity, sensitization, irritation, acute systemic toxicity, pyrogenicity, hemocompatibility). Performance testing included dimensional verification, luer integrity (ISO 80369-7), tensile strength, kink/torsion resistance, tip flexibility, air/liquid leakage (ISO 10555-1), hydrophilic coating integrity, particulate recovery (USP <788>), simulated use in vascular models, and radiopacity evaluation in an animal model.

Technological Characteristics

Single-lumen, variable stiffness catheters with hydrophilic coating. Materials include polymers and metals standard for medical devices. Radiopaque markers at distal ends. Sterilized via ethylene oxide. Packaging per ISO 11607. Connectivity: None (mechanical device).

Indications for Use

Indicated for the introduction of interventional devices into the peripheral and neuro vasculature in patients requiring endovascular procedures.

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

• TNI Manufacturing, Inc. Long Sheath (K152876)

Reference Devices

• Flexor Tuohy-Borst Side-Arm Introducer (K142819)

Submission Summary (Full Text)

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January 13, 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: K191717

Trade/Device Name: Base Camp™ Sheath System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: December 12, 2019 Received: December 13, 2019

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) K191717

Device Name Base Camp Sheath System

Indications for Use (Describe)

The Route 92 Medical Sheath System is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.

| 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

| Sponsor: | Route 92 Medical<br>1700 S. El Camino Real, Suite 206<br>San Mateo, CA 94022<br>Phone: [phone]<br>Fax: [phone] |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Contact: | Kathy Tansey |
| Date Prepared: | June 25, 2019 |
| Device Trade Name: | Base Camp™ Sheath System |
| Common Name: | Percutaneous Catheter |
| Classification Name: | Percutaneous Catheter (Product Code DQY, 21 CFR<br>870.1250) |
| Legally Marketed Predicate Device: | TNI Manufacturing, Inc. Long Sheath (K152876) |

#### Device Description

The Route 92 Medical Sheath System is comprised of a Sheath, a Dilator, a Navigating Catheter, and an RHV (rotating hemostasis valve). The Sheath is a single-lumen, variable stiffness catheter with a radiopaque marker on the distal end. The inner lumen of the catheter is compatible with 8F or smaller catheters. The Dilator may be placed within the Sheath to facilitate percutaneous introduction of the Sheath into a femoral artery. The Dilator has a radiopaque marker at the distal tip. The Navigating Catheter is a single-lumen, variable stiffness catheter with a radiopaque marker at the distal tip. The Navigating Catheter is compatible with the Sheath and has a shaped distal end to facilitate placement. All of the catheters are coated with hydrophilic coating.

#### Indications for Use

The Route 92 Medical Sheath System is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.

#### Comparison to Predicate Device

The intended use, method of action, design, and materials of the Route 92 Medical Sheath System are substantially equivalent to the TNI Manufacturing, Inc. Long Sheath (K152876) predicate device as shown in the following table.

| Attribute | TNI Manufacturing, Inc. Long Sheath, K152876<br>(Predicate Device) | Route 92 Medical Sheath<br>System<br>(Subject Device) |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| Indications for<br>Use | The Long Sheath is indicated for the<br>introduction of interventional devices into the<br>peripheral, coronary, and neuro vasculature. | The Route 92 Medical Sheath<br>System is indicated for the<br>introduction of interventional |

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| Attribute | TNI Manufacturing, Inc. Long Sheath, K152876<br>(Predicate Device) | Route 92 Medical Sheath<br>System<br>(Subject Device) |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|
| | | devices into the peripheral and<br>neuro vasculature. |
| Device<br>Description | A single-lumen flexible, variable stiffness<br>catheter with a hydrophilically-coated, shaft and<br>a radiopaque marker band on the distal end. | Same as predicate |
| User | Physicians trained in endovascular techniques | Same as predicate |
| Anatomical Sites | Peripheral, coronary and neuro vasculature | Peripheral and neuro<br>vasculature |
| Method of Action | Inserted at a vascular access point to provide<br>access to the target site and once in place,<br>provides a reinforcing conduit for other<br>intravascular devices. Includes component(s) to<br>facilitate percutaneous introduction and<br>intravascular tracking of the device. | Same as predicate device |
| Lubricious<br>Coating | Hydrophilic coating | Same as predicate device |
| Packaging | Tyvek pouch, packaging card and SBS carton | Same as predicate device |
| Sterilization | Ethylene oxide | Same as predicate device |
| Materials | Polymers and metals commonly used in the<br>manufacture of medical devices | Same as predicate device |
| Dimensions | | |
| Working<br>Length(s) | 70, 80, 90 cm | 90 cm |
| Inner Diameter<br>(min) | 0.088" | 0.106" |
| Outer Diameter | 0.109" | 0.122" |

## Non-Clinical Testing

## Biocompatibility Testing

The Route 92 Medical Sheath System 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 Sheath 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.

A reference device (Flexor Tuohy-Borst Side-Arm Introducer, K142819) was chosen as the control device for SC5b-9 Complement Activation Assay and in vivo Thromboresistance evaluation.

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| Test | Results | Conclusions |
|--------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|
| Cytotoxicity - ISO MEM<br>Elution | No cytotoxicity or cell lysis was noted in any<br>of the test wells (reactivity grade = 0). The<br>test article extract met the requirements of<br>the test as the grade was less than 2. | The test article is non-<br>cytotoxic. |
| Sensitization - ISO<br>Guinea Pig Maximization<br>Sensitization Test<br>(Sodium Chloride USP<br>Solution and Sesame Oil) | The test article extracts showed no evidence<br>of causing delayed dermal contact<br>sensitization in the guinea pig (no findings in<br>clinical observations and grade = 0 for<br>dermal reactions). The test article was not<br>considered a sensitizer in the test. | Test article did not elicit a<br>sensitization response. |
| Irritation - ISO<br>Intracutaneous Reactivity<br>(Sodium Chloride USP<br>Solution and Sesame Oil) | The test article met the requirements of the<br>test since the difference between each test<br>article extract overall mean score and<br>corresponding control extract overall mean<br>score was 0.0 and 0.0 for sodium chloride<br>and sesame oil test article extracts,<br>respectively. | Requirements of the ISO<br>intracutaneous reactivity<br>test have been met for the<br>test article. |
| Acute Systemic Toxicity<br>– ISO Acute Systemic<br>Injection (Sodium<br>Chloride USP Solution<br>and Sesame Oil) | There was no mortality or evidence of<br>systemic toxicity from the injected extracts.<br>All animals treated had were clinically<br>normal throughout the study as compared to<br>control mice. | Requirements of the ISO<br>acute systemic injection<br>test have been met for the<br>test article. |
| Material Mediated<br>Pyrogenicity | No single animal showed a temperature rise<br>of 0.5℃ or more above its baseline<br>temperature. The total rise of the rabbits'<br>temperature during 3 hours was 0.2 ℃. The<br>total rise of rabbit temperatures during the 3-<br>hour observation period was within<br>acceptable USP requirements. The test article<br>met the requirements for the absence of<br>pyrogens. | The test article met the<br>requirements for the<br>absence of pyrogens. |
| Hemocompatibility -<br>Partial Thromboplastin<br>Time | The test articles met the requirements of the<br>test and were not different statistically from<br>the negative control and the negative<br>reference material. | The test article is<br>considered to be a non-<br>activator of the intrinsic<br>coagulation pathway. |
| Hemocompatibility -<br>ASTM Hemolysis | Blank corrected hemolytic index above the<br>negative control:<br>Direct Method: 0.0%<br>Extract Method: 0.4% | The test article is<br>considered non-hemolytic. |
| Hemocompatibility -<br>Complement Activation<br>Assay | When compared to a legally US-marketed<br>device, the complement activation noted in<br>the test article would not be expected to<br>result in adverse effects in vivo. | The test article is<br>considered to be a low<br>potential activator of the<br>complement system. |
| Test | Results | Conclusions |
| Hemocompatibility - in-<br>vivo Thromboresistance | When compared to a legally US-marketed<br>device, the test articles and control articles<br>were comparable. No to minimal thrombus<br>formation was noted with both test and<br>control articles. | The test article is<br>comparable to a legally<br>US-marketed device. |

II

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### Performance Testing

The successful completion of the performance testing listed in the following table demonstrates that the Route 92 Medical Sheath 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 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 |

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| 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 flushed from the model was<br>tested per 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 vascular 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 |
| Radiopacity | Radiopacity of the device was<br>evaluated in an animal model under<br>fluoroscopy | PASS<br>All samples met the pre-determined<br>acceptance criteria |

### Substantial Equivalence

The Route 92 Medical Sheath System is substantially equivalent to the predicate TNI Manufacturing, Inc. Long Sheath (K152876) in intended use, design, principles of operation, technology and performance. The successful completion of biocompatibility testing and performance testing demonstrates that the Route 92 Medical Sheath System is safe and effective for its intended use and substantially equivalent to the predicate device.