8F Modified Sheath System

K240529 · Route 92 Medical, Inc. · QJP · Oct 2, 2024 · Cardiovascular

Device Facts

• Record ID: K240529
• Device Name: 8F Modified Sheath System
• Applicant: Route 92 Medical, Inc.
• Product Code: QJP · Cardiovascular
• Decision Date: Oct 2, 2024
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The 8F Modified Sheath System is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.

Device Story

The 8F Modified Sheath System is a percutaneous catheter system used by physicians trained in endovascular techniques to provide vascular access. The system consists of a sheath, a navigating catheter, a dilator, and a rotating hemostasis valve (RHV). The sheath acts as a conduit for interventional devices; the dilator facilitates percutaneous entry into the femoral artery; the navigating catheter assists in placement. All catheters feature variable stiffness, radiopaque markers for visualization, and hydrophilic coatings to reduce friction. The device is used in clinical settings to provide a stable pathway for other intravascular tools. By providing a reinforced conduit, the system facilitates the delivery of interventional devices to target sites in the peripheral and neuro vasculature, potentially improving procedural efficiency and patient outcomes during endovascular interventions.

Clinical Evidence

No clinical data or animal testing was required. Substantial equivalence was established through non-clinical bench testing, including biocompatibility (sensitization, irritation, systemic toxicity, pyrogenicity, cytotoxicity, and hemocompatibility assays) and mechanical performance testing (dimensional verification, luer integrity, tensile strength, kink/torsion resistance, leakage, coating integrity, and simulated use).

Technological Characteristics

Single-lumen, variable stiffness catheters; hydrophilic coating; radiopaque marker bands. Materials: polymers and metals standard for medical devices. Dimensions: 8F inner diameter, 90cm/80cm working lengths. Connectivity: N/A. Sterilization: Ethylene oxide (EtO) per ISO 11135. No software or electronic components.

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

• Base Camp® Sheath System (K191717)

Submission Summary (Full Text)

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Image /page/0/Picture/0 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

October 2, 2024

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

Re: K240529

Trade/Device Name: 8F Modified Sheath System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP, DQY Dated: August 29, 2024 Received: September 3, 2024

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 (the 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 available 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory

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assistance/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 -S

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) K240529

Device Name 8F Modified Sheath System

Indications for Use (Describe)

The 8F Modified Sheath System is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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## K240529 510(k) Summary

| Sponsor: | Route 92 Medical, Inc.<br>155 Bovet Road, Suite 100<br>San Mateo, CA 94402 |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Kirsten Valley<br>650-581-1179 |
| Date Prepared: | September 30, 2024 |
| Device Name: | 8F Modified Sheath System |
| Common Name: | Percutaneous Catheter |
| Classification Name: | Catheter, Percutaneous, Neurovasculature (Product Code<br>QJP, 21 CFR 870.1250)<br>Catheter, Percutaneous (Product Code DQY, 21 CFR<br>870.1250) |
| Legally Marketed Predicate Device: | Base Camp® Sheath System (K191717, Route 92 Medical) |

#### Device Description

The 8F Modified Sheath System is comprised of a Sheath, 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 singlelumen, 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 8F Modified 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 8F Modified Sheath System are substantially equivalent to the K191717 predicate device as shown in the following table.

| Attribute | Base Camp Sheath System,<br>K191717 (Predicate Device) | 8F Modified Sheath System,<br>K240529 (Subject Device) |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory<br>Classification | Catheter, Percutaneous, 21 CFR 870.1250 | Catheter, Percutaneous,<br>Neurovasculature, 21 CFR<br>870.1250 |
| Attribute | Base Camp Sheath System,<br>K191717 (Predicate Device) | 8F Modified Sheath System,<br>K240529 (Subject Device) |
| | | Catheter, Percutaneous, 21<br>CFR 870.1250 |
| Product Code | DQY, Catheter, Percutaneous | QJP, Catheter, Percutaneous,<br>Neurovasculature |
| | | DQY, Catheter, Percutaneous |
| Indications for<br>Use | The Route 92 Medical Sheath is indicated for<br>the introduction of interventional devices into<br>the peripheral and neuro vasculature. | The 8F Modified Sheath<br>System is indicated for the<br>introduction of interventional<br>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 device |
| User | Physicians trained in endovascular techniques | Same as predicate device |
| Anatomical Sites | Peripheral and neuro vasculature | Same as predicate device |
| 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 |
| How Supplied | Sterile, single-use | Same as predicate device |
| Packaging | Tyvek pouch, packaging card, and SBS carton | Same as predicate device |
| Sterilization | Ethylene oxide (EtO) | Same as predicate device |
| Shelf-Life | 8 months | 6 months |
| Accessories<br>Included | Dilator, Navigating Catheter, and Rotating<br>Hemostasis Valve | Same as predicate device |
| Dimensions | | |
| Sheath | | |
| Working<br>Length(s) | 90 cm | 90 cm and 80 cm |
| Overall Length | 96 cm | 96 cm and 86 cm |
| Coating Length | 8 cm | Same as predicate device |
| Inner Diameter | 0.106" | Same as predicate device |
| Outer Diameter | 0.122" | Same as predicate device |
| | | |

1

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| Attribute | Base Camp Sheath System,<br>K191717 (Predicate Device) | 8F Modified Sheath System,<br>K240529 (Subject Device) | | |
|--------------------------------|----------------------------------------------------------------------------|--------------------------------------------------------|--|--|
| Tip<br>Configuration/<br>Shape | Straight | Straight | | |
| Materials | Polymers and metals commonly used in the<br>manufacture of medical devices | Same as predicate device | | |
| Marker Band | Yes | Yes | | |
| Dilator | | | | |
| Working<br>Length(s) | 103 cm | Same as predicate device | | |
| Overall Length | 106 cm | Same as predicate device | | |
| Coating Length | 15 cm | Same as predicate device | | |
| Inner Diameter<br>(Distal) | 0.040" | Same as predicate device | | |
| Inner Diameter<br>(Proximal) | 0.044" | Same as predicate device | | |
| Outer Diameter<br>(Distal) | 0.050" | Same as predicate device | | |
| Outer Diameter<br>(Proximal) | 0.102" | Same as predicate device | | |
| Tip<br>Configuration/<br>Shape | Straight | Same as predicate device | | |
| Materials | Polymers and metals commonly used in the<br>manufacture of medical devices | Same as predicate device | | |
| Marker Band | Yes | Same as predicate device | | |
| Navigating Catheter | | | | |
| Working<br>Length(s) | 113 cm | Same as predicate device | | |
| Overall Length | 116 cm | Same as predicate device | | |
| Coating Length | 40 cm | Same as predicate device | | |
| Inner Diameter | 0.040" | Same as predicate device | | |
| Outer Diameter<br>(Distal) | 0.070" | Same as predicate device | | |
| Outer Diameter<br>(Proximal) | 0.104" | Same as predicate device | | |

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| Attribute | Base Camp Sheath System,<br>K191717 (Predicate Device) | 8F Modified Sheath System,<br>K240529 (Subject Device) |
|--------------------------------|----------------------------------------------------------------------------|--------------------------------------------------------|
| Tip<br>Configuration/<br>Shape | Angled | Same as predicate device |
| Materials | Polymers and metals commonly used in the<br>manufacture of medical devices | Same as predicate device |
| Marker Band | Yes | Same as predicate device |

#### Non-Clinical Testing

### Biocompatibility Testing

The 8F Modified 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 Dilator, Navigating Catheter, and Rotating Hemostasis Valve are identical in materials and manufacturing to those previously cleared in K191717.

The 8F Modified Sheath is classified per ISO 10993-1 as externally communicating with limited circulating blood contact (<24 hours). A summary of the biocompatibility testing conducted on the 8F Modified Sheath is provided below.

| Test | Results | Conclusions |
|--------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| 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. The test<br>article was not considered a sensitizer in the<br>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 were not greater than 1.0 for sodium<br>chloride and sesame oil test article extracts. | 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 were clinically normal<br>throughout the study as compared to control<br>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 rabbits'<br>temperatures during the 3-hour observation<br>period was within acceptable USP<br>requirements. | The test article met the<br>requirements for the<br>absence of pyrogens. |

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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. The test article extract met<br>the requirements of the test as the grade was<br>less than 2. | The test article is non-<br>cytotoxic. |
| Hemocompatibility –<br>ASTM Hemolysis | The test articles (via the direct contact<br>method and indirect contact method) were<br>both rated non-hemolytic. | The test article is<br>considered non-hemolytic. |
| Hemocompatibility -<br>Thrombogenicity: ASTM<br>Partial Thromboplastin<br>Time Assay | The test article average clotting time was not<br>lower and was not statistically significant<br>when compared to the negative control.<br>The test article average clotting time was not<br>lower and was not statistically significant<br>when compared to the vehicle control. | The test article met the<br>requirements of the test. |
| Hemocompatibility -<br>Complement Activation<br>Assay | The SC5b-9 concentration of the test article<br>was not statistically higher than the activated<br>normal human serum, the negative control,<br>or the comparator test article. | The test article is a non-<br>activator of the<br>complement system. |
| Hemocompatibility -<br>Thrombogenicity: ASTM<br>Platelet/Leukocyte Count | The test article average platelet count was<br>similar to the comparator test article, 80 to<br>120% of the vehicle control, and at least 30%<br>above the positive control. | The test article met the<br>requirements of the test. |
| Hemocompatibility -<br>Thrombogenicity:<br>Comparative Surface<br>Assessment | 40x magnification images taken of the<br>subject device and predicate device show<br>comparable surface morphologies. | The test article does not<br>have any features that<br>would increase<br>thrombogenicity risk. |

### Performance Testing

The successful completion of the performance testing listed in the following table demonstrates that the 8F Medical Modified Sheath System is suitable for its intended use.

| Test | Test Method | Results |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|
| Dimensional<br>Verification | Device dimensions were measured to<br>confirm conformance to the<br>specifications. | PASS<br>The pre-determined acceptance criteria<br>were met. |
| Luer Integrity | Tested per ISO 80369-7:2016. | PASS<br>The pre-determined acceptance criteria<br>were met. |
| Test | Test Method | Results |
| Tensile Strength | The tensile strength of the catheter<br>sections and bonds was tested. | PASS<br>The pre-determined acceptance criteria<br>were met. |
| Kink Resistance | Test specimen segments were formed<br>into a defined bend diameter to evaluate<br>kink resistance. | PASS<br>The pre-determined acceptance criteria<br>were met. |
| Torsion<br>Resistance | The test specimens were rotated to<br>evaluate integrity after rotation. | PASS<br>The pre-determined acceptance criteria<br>were met. |
| Tip Flexibility | Test specimens were tested for tip<br>flexibility. | PASS<br>The pre-determined acceptance criteria<br>were met. |
| Air Leakage | Tested per ISO 10555-1:2013 Annex D. | PASS<br>The pre-determined acceptance criteria<br>were met. |
| Liquid Leakage | Tested per ISO 10555-1:2013 Annex C. | PASS<br>The pre-determined acceptance criteria<br>were met. |
| Hydrophilic<br>Coating Integrity | The integrity of the hydrophilic coating<br>was evaluated after multiple insertion<br>and withdrawal cycles in a vascular<br>model. | PASS<br>The pre-determined acceptance criteria<br>were met. |
| Simulated Use<br>Testing | Deliverability and compatibility with<br>accessory devices were evaluated in a<br>vascular model. | PASS<br>The pre-determined acceptance criteria<br>were met. |
| Static Burst<br>Pressure Testing | Tested per ISO 10555-1:2013 Annex F. | PASS<br>The pre-determined acceptance criteria<br>were met. |
| Particulate<br>Testing | The size and quantity of particulate<br>matter generated during simulated use<br>testing were determined. | PASS<br>The pre-determined acceptance criteria<br>were met. |
| Delivery/Retrieval<br>Force Testing | The forces to deliver and retrieve the<br>subject device in an anatomical model<br>were measured. | PASS |

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### Clinical Data and Animal Testing

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Substantial equivalence was established based on non-clinical bench performance data. Clinical and animal testing data were not deemed necessary.

### Sterilization

The 8F Modified Sheath System is sterilized using a validated EtO process with a sterility assurance level of 1x10 · validated per the overkill method in accordance with ISO 11135, "Sterilization of Health-Care Products - Ethylene Oxide - Requirements for the Development, Validation, and Routine Control of a Sterilization Process for Medical Devices".

### Substantial Equivalence

The 8F Modified Sheath System is substantially equivalent to the predicate Route 92 Medical's Base Camp Sheath System (K191717) in intended use, design, principles of operation, technology, and performance. The successful completion of biocompatibility testing and performance testing demonstrates that the 8F Modified Sheath System is safe and effective for its intended use and substantially equivalent to the predicate device.