The ENROUTE Transcarotid Neuroprotection System is intended to provide transcarotid vascular access, introduction of diagnostic agents and therapeutic devices, and embolic protection during carotid artery angioplasty and stenting procedures for patients diagnosed with carotid artery stenosis and who have appropriate anatomy described below:

· Adequate femoral venous access
Common carotid artery reference diameter of at least 6mm
· Carotid bifurcation is a minimum of 5 cm above the clavicle as measured by duplex Doppler ultrasound (DUS) or computerized axial tomopgraphy (CT) angiography or magnetic resonance (MR) angiography.

Device Description

The ENROUTE® Transcarotid Neuroprotection System (Modified) is designed to provide direct transcarotid arterial access to the common carotid artery (CCA), provide introduction of diagnostic agents and therapeutic devices, and provide embolic protection during carotid artery angioplasty and stenting procedures for patients diagnosed with carotid artery stenosis. The ENROUTE Transcarotid NPS (Modified) is designed to transport emboli away from the carotid artery circulation by reversing blood flow at the treatment site prior to crossing a lesion in the carotid artery and during lesion manipulation. It has an integrated filter used to capture and contain embolic material liberated during the procedure.

The ENROUTE Transcarotid NPS (Modified) consists of four primary components: the Transcarotid Arterial Sheath with Dilator, the Venous Return Sheath with Dilator, the Flow Controller and a 0.035" Extra Support J-Tip Guidewire. When assembled and inserted into the patient, the components of the ENROUTE Transcarotid NPS (Modified) create an arteriovenous shunt. When used in conjunction with occlusion of the proximal common carotid artery, the ENROUTE Transcarotid NPS (Modified) reverses the direction of blood flow in the internal carotid artery (ICA), shunting embolic particles away from the cerebral circulation, and into the venous circulation. Flow through the arteriovenous shunt is regulated by the Flow Controller.

AI/ML Overview

The provided text is a 510(k) summary for the ENROUTE® Transcarotid Neuroprotection System (Modified). It describes the device, its intended use, and the testing conducted to demonstrate its substantial equivalence to a predicate device. However, the document does not contain any information about a study involving an AI/Machine Learning device or human readers.

Therefore, I cannot extract the information required to answer your questions regarding acceptance criteria for an AI device, sample sizes for test/training sets, expert qualifications, ground truth establishment, MRMC studies, or standalone algorithm performance.

The document entirely focuses on the substantial equivalence of a mechanical medical device (a catheter system) based on:

Biocompatibility testing: Ensuring materials are safe for patient contact.
Design Verification (Bench-Top Testing): Evaluating physical and mechanical properties.
Sterilization, Packaging Validation, and Shelf Life: Ensuring the device remains sterile and functional over time.

It explicitly states: "The subject, ENROUTE® Transcarotid Neuroprotection System (Modified) met all established requirements." but these requirements are related to the physical and biological performance of the mechanical device, not AI performance.

Summary

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April 11, 2023

Silk Road Medical Denise Aycox Senior Regulatory Affairs Specialist 1213 Innsbruck Drive Sunnyvale, California 94089

Re: K230402

Trade/Device Name: ENROUTE® Transcarotid Neuroprotection System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NTE Dated: February 14, 2023 Received: February 15, 2023

Dear Denise Aycox:

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.

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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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Misti L. Malone -S

Misti Malone, PhD Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K230402/S001

Device Name

Enroute Transcarotid Neuroprotection System

Indications for Use (Describe)

· Adequate femoral venous access
Common carotid artery reference diameter of at least 6mm
· Carotid bifurcation is a minimum of 5 cm above the clavicle as measured by duplex Doppler ultrasound (DUS) or computerized axial tomopgraphy (CT) angiography or magnetic resonance (MR) angiography.

Type of Use (Select one or both, as applicable)
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☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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1. 510(k) Summary

1.1. Date of Preparation of 510(k)Summary

February 14, 2023

1.2. Device Trade or Proprietary Name

1.3. Device Trade or Proprietary Name

Enroute Transcarotid Neuroprotection System

1.4. Device Classification

Regulatory Class: II Classification Panel: Cardiovascular Classification Name: Temporary Carotid Catheter for Embolic Capture Commun Name: Percutaneous Catheter Classification Regulation: 870.1250 Product Code: NTE

1.5. Predicate Device

510K Number & Date: K153485 on March 10, 2016 Device Name: Enroute Transcarotid Neuroprotection System

Predicate Device
510(k) Number/ ClearanceDate	Name of Device	Name of Manufacturer
K153485 cleared on March 10,2016	ENROUTE® TranscarotidNeuroprotection System	Silk Road Medical1213 Innsbruck Dr. Sunnyvale,CA 94089

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1.6. Predicate Device Comparison

Predicate Comparison
	Predicate Device	Subject Device
Device Name	ENROUTE® TranscarotidNeuroprotectionSystem	ENROUTE® Transcarotid Neuroprotection System(Modified)
Indications ForUse	The ENROUTETranscarotidNeuroprotection System(ENROUTE TranscarotidNPS) is intended toprovide transcarotidvascular access,introduction ofdiagnostic agents andtherapeutic devices, andembolic protectionduring carotid arteryangioplasty and stentingprocedures for patientsdiagnosed with carotidartery stenosis and whohave appropriateanatomy describedbelow:• Adequate femoralvenous access• Common carotidartery referencediameter of at least6 mm• Carotid bifurcation isa minimum of 5 cmabove the clavicle asmeasured by duplexDoppler ultrasound(DUS) orcomputerized axialtomography (CT)angiography ormagnetic resonance(MR) angiography.	SAME
Device Characteristics
Single Use	Yes	SAME
Arterial andVenous Sheathreinforcement	Sheath body isreinforced with a ribboncoil	SAME
Predicate Comparison
Device Name	Predicate Device	Subject Device
Arterial andVenous Sheathconstruction	Sheath body outerjacket is mostlyconstructed ofthermoplastic polymerlayers of variousdensities to enhanceflexibility	SAME
Arterial SheathConfiguration	• Straight• Angled-Tip	Angled-Tip
Sheath StopperDesign	• Removable• Large Distal Foot• Suture Grooves• Positive Lock to theSheath	SAME
Venous ReturnSheathcomponents	• Sheath• Hemostasis Valve• Flow Line withStopcock and QuickConnect• Dilator	All return sheath components remain the sameexcept that the stopcock now provides indexedtactile feedback.
Arterial SheathComponents	• Sheath• Hemostasis Valve• Extension Tubing• Arterial Stopcock• Dilator	All sheath components remain the same exceptthat the stopcock now provides indexed tactilefeedback.
GuidewireConstruction	• Core wire 0.035" OD• 90 cmPTFE-coated Nitinolwith stainless steel coilJ-Tip.	SAME
Dimensions
Transcarotid Arterial Sheath
Working Length	11 cm	SAME
Total Length	33.2 cm	SAME
Inner Diameter	8 Fr (2.6 mm)	SAME
Outer Diameter	10.5 Fr (3.5 mm)	SAME
Venous Return Sheath
Working Length	11 cm	K230402/S001Page 1 of 8SAME
Total Length	13.6 cm	SAME
Inner Diameter	8 Fr (2.6 mm)	SAME
Predicate Comparison
Device Name	Predicate Device	Subject Device
	ENROUTE® TranscarotidNeuroprotectionSystem	ENROUTE® Transcarotid Neuroprotection System(Modified)

Outer Diameter	10.5 Fr (3.5 mm)	SAME
Arteriovenous Shunt
Total Length	102 cm ± 2 cm	SAME
Packaging and Sterilization
Packaging	Paperboard cardNylon/Tyvek pouchPaperboard shelf carton	Thermoformed, Plastic trayNylon/Tyvek pouchPaperboard shelf carton
Sterilization	Ethylene Oxide (EO)SAL: 10-6	SAME
Shelf Life	6 months at originalsubmission (now labeledfor 3-years)	6 months

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1.7. Device Description:

1.8. Indications for Use:

The ENROUTE Transcarotid Neuroprotection System (ENROUTE Transcarotid NPS) is intended to provide transcarotid vascular access, introduction of diagnostic agents and therapeutic devices, and embolic protection during carotid artery angioplasty and stenting procedures for patients diagnosed with carotid artery stenosis and who have appropriate anatomy described below:

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Adequate femoral venous access
Common carotid artery reference diameter of at least 6 mm
Carotid bifurcation is a minimum of 5 cm above the clavicle as measured by duplex Doppler ultrasound (DUS) or computerized axial tomography (CT) angiography or magnetic resonance (MR) angiography.

1.9. Summary of Performance Data

As required under Section 12, Part (a)(i)(3A) of the Safe Medical Devices Act of 1990, a summary of any information regarding substantial equivalence of the device follows. Included in this section are descriptions of the testing, which substantiates the safe and effective performance of the subject, ENROUTE® Transcarotid Neuroprotection System (Modified) as well its substantial equivalence to the predicate device:

Biocompatibility
. Design Verification (Bench-Top Testing)
Sterilization, Packaging Validation, and Shelf Life

The subject, ENROUTE® Transcarotid Neuroprotection System (Modified) met all established requirements.

1.9.1. Biocompatibility Testing

The purpose of biocompatibility testing is to demonstrate an absence of harmful effects of patient-contact materials in the subject device, ENROUTE® Transcarotid Neuroprotection System (Modified).

The materials used in the subject, ENROUTE® Transcarotid Neuroprotection System (Modified) are the same as those utilized in the currently marketed predicate device, ENROUTE® Transcarotid Neuroprotection System, with the exception of the new packaging tray. The ENROUTE® Transcarotid Neuroprotection System (Modified) device is manufactured in the same environment as the ENROUTE® Transcarotid Neuroprotection System and uses equivalent manufacturing processes.

Biocompatibility testing was successfully conducted per ISO 10993-1. The studies completed for the ENROUTE® Transcarotid Neuroprotection System (Modified) were selected in accordance with ISO 10993-1 guidelines (Biological Evaluation of Medical Devices) for a limited exposure (< 24 hours), external communicating device with circulating blood contact. Studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices (GLP) and included:

Cytotoxicity
Hemocompatibility
- o Direct and Indirect Contact

All other biocompatibility risks were mitigated through successful completion of prior biocompatibility testing per EN ISO 10993-1:2009/AC: 2010, which was provided in the original 510k for the predicate device (K153485) and will be leveraged for the ENROUTE® Transcarotid

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Neuroprotection System (Modified). Therefore, no further biocompatibility testing was required.

Cytotoxicity and Hemocompatibility (Direct and indirect hemolysis) testing were successfully completed on final, finished Arterial Sheath components of the full device. All tests received passing scores. Thus, the ENROUTE® Transcarotid Neuroprotection System (Modified) is considered biocompatible and meet the requirements of ISO 10993-1:2018: Biological evaluation of medical devices – Part 1.

1.9.2. Design Verification - Bench-top Testing

Design Verification testing was conducted to mitigate risks for the subject device, ENROUTE® Transcarotid Neuroprotection System (Modified), and to demonstrate substantial equivalence to the predicate. Testing was based on the design specifications, risk analysis, SOPs, Work Instructions, and available guidance/standards documents.

Design Verification testing was conducted to evaluate the physical and mechanical properties of the subject, ENROUTE® Transcarotid Neuroprotection System (Modified). All studies were conducted using good scientific practices and statistical sampling methods as required by Silk Road Medical Design Control procedures. All testing met the pre-determined acceptance criteria.

Performance testing for the subject device was performed in accordance with the standards with the following guidance:

. Guidance for Industry and Food and Drug Administration Staff Coronary and Carotid Embolic Protection Devices Premarket Notification [510(k)] Submissions
To support the modifications made, the subject ENROUTE® Transcarotid Neuroprotection System (Modified) device underwent the following performance testing:
Visual Inspection and Dimensional Verification
. DilatorSnap Force
Air Leakage During Aspiration
. Liquid Leakage Under Pressure
- Dilator Peak Tensile Force
. Junction Tensile Strength

. ISO 80369-7 Small Bore Connector Dimensional and Functional Testing
. Simulated Use/Usability
l Shelf-Life
Packaging Testing

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1.9.3. Sterilization, Packaging Validation, and Shelf Life

Sterility testing demonstrated that the device is compliant with ISO 11135:2014 "Sterilization of health care products – Ethylene oxide - Requirements for development, validation, and routine control of a sterilization process for medical devices".

Packaging validation conducted in accordance with ISO 11607-1 & ISO 11607-2, and design verification testing performed on accelerated aged devices were used to establish shelf life.

1.10. Summary of Substantial Equivalence

The subject device, ENROUTE® Transcarotid Neuroprotection System (Modified), is substantially equivalent to the predicate device, The ENROUTE® Transcarotid Neuroprotection System (K153485) in indications for use, operating principle, technology, design, materials, dimensions, physician use, single use, sterilization, and device biocompatibility.

The differences in design between the subject and predicate devices do not impact the overall principles of operation, how the device is used and where the device is used.

Substantial equivalence was demonstrated with non-clinical performance tests, which complied with the requirements specified in the international and FDA-recognized consensus standards. The results of these tests demonstrate that ENROUTE® Transcarotid Neuroprotection System (Modified) met the acceptance criteria and is adequate for the intended use and does not raise new issues of safety and effectiveness.

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
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.(b)
Classification. Class II (performance standards).