The ENROUTE Enflate™ Transcarotid RX Balloon Dilatation Catheter is intended for percutaneous transluminal angioplasty and post-dilatation of self-expanding stents in the carotid arteries.

Device Description

The Silk Road Medical ENROUTE Enflate™ Transcarotid RX Balloon Dilatation Catheter is a standard rapid exchange (RX) 0.014" Percutaneous Transluminal Angioplasty (PTA) catheter with a proximal single lumen and distal coaxial lumen tubing with a dilatation balloon, and an atraumatic, tapered tip. The proximal luer lock hub allows for connection with a balloon inflation device for inflation with diluted contrast medium. The second lumen in the distal shaft permits the use of an 0.014" guidewire to facilitate advancement of the catheter to and through the stenosis to be dilated. The balloon has two radiopaque marker bands to aid in positioning the balloon in the stenosis, located either 25 or 35 mm apart as indicated on the package label. An external position marker is located 32.5 cm from the distal tip to indicate the relative position of the catheter tip to the guiding catheter/introducer sheath. The total working length of the catheter is 75 cm. The Silk Road Medical ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter will complement the TCAR procedure.

AI/ML Overview

The provided text describes a medical device called the ENROUTE Enflate™ Transcarotid RX Balloon Dilatation Catheter and its substantial equivalence submission to the FDA. The document outlines acceptance criteria and the studies conducted to prove the device meets these criteria.

Here's the breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document details various tests performed and states that the device "met all established requirements" and "all tests passed successfully." While specific quantitative acceptance criteria or exact performance values are not explicitly listed in a comparative table within the provided text, the document indicates that the device met the pre-determined acceptance criteria for each test.

Acceptance Criteria Category	Reported Device Performance
Biocompatibility	Successfully conducted per BS EN ISO 10993-1, compliant with ISO 10993-1 guidelines for limited exposure (< 24 hours), external communicating device with circulating blood contact. Studies were GLP compliant.
Cytotoxicity	Passed
Intracutaneous reactivity	Passed
Sensitization	Passed
Acute systemic toxicity	Passed
Hemocompatibility	Passed (Direct and Indirect Contact, Complement activation, In vivo thromboresistance)
Pyrogenicity	Passed
Design Verification (Bench-Top Testing)	All tests passed successfully according to FDA draft guidance "Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions" and "Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters- Class II Special Controls Guidance for Industry and FDA," using standard test methods and pre-determined acceptance criteria.
Visual and Dimensional Inspection	Passed
Balloon Fatigue	Passed
Balloon Fatigue (Without Stent)	Passed
Balloon Rated Burst Pressure	Passed
Simulated Use	Passed
Balloon Rated Burst Pressure (Without Stent)	Passed
Balloon Fatigue (In Stent)	Passed
Balloon Compliance	Passed
Catheter Bond Strength	Passed
Tip Pull Test	Passed
Flexibility and Kink Test	Passed
Torque Strength	Passed
Radiopaci	No specific pass/fail explicitly stated, but implied to meet requirements as part of overall successful testing.
Balloon Rated Burst Pressure (In Stent)	Passed
Balloon Inflation and Deflation Time	Passed
Sterilization, Packaging Validation, and Shelf Life	Compliant with relevant ISO standards and established shelf life.
Sterilization	Compliant with ISO 11135:2014
Packaging Validation	Per ISO 11607-1 & ISO 11607-2
Shelf Life	Established through design verification testing on accelerated aged devices.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The text does not specify the sample sizes used for the test sets in any of the biocompatibility, design verification, sterilization, packaging validation, or shelf life studies. It also does not provide information about the country of origin or whether the data was retrospective or prospective, as these were all bench-top and lab-based tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and not provided in the document. The studies conducted (biocompatibility, bench-top engineering tests, sterilization/packaging validation) do not involve expert interpretation or ground truth establishment in the way clinical studies or image analysis algorithms would. The "ground truth" for these tests is based on established scientific and engineering principles, and validated test methods.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and not provided. Adjudication methods are typically relevant for clinical studies or studies involving human readers/interpreters, which is not the nature of the tests described for this device.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study, nor any evaluation of human reader improvement with or without AI assistance. This device is a physical medical device (balloon dilatation catheter), not an AI-powered diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This information is not applicable. The device is a physical medical device, not an algorithm. Therefore, "standalone" algorithm-only performance is not relevant to this submission.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the tests performed is based on established scientific principles, consensus standards (e.g., ISO, FDA guidance documents), and engineering specifications. For biocompatibility, it's the biological response to materials; for design verification, it's the physical and mechanical performance characteristics against predefined specifications; for sterilization, it's the efficacy of the sterilization process according to standards. It is not expert consensus, pathology, or outcomes data in the clinical sense.

8. The sample size for the training set

This information is not applicable and not provided. The development and testing of this physical medical device do not involve "training sets" in the context of machine learning or AI. The design and manufacturing processes are validated against specifications and standards, not "trained" on data.

9. How the ground truth for the training set was established

This information is not applicable for the reasons stated in point 8.

Summary

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September 2, 2022

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

Re: K221414

Trade/Device Name: ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: May 12, 2022 Received: May 16, 2022

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.

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

Sincerely,

Gregory O'Connell 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

Enclosure

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Indications for Use

510(k) Number (if known) K221414

Device Name

ENROUTE Enflate™ Transcarotid RX Balloon Dilatation Catheter

Indications for Use (Describe)

The ENROUTE Enflate™ Transcarotid RX Balloon Dilatation Catheter is intended for percutaneous transluminal angioplasty and post-dilatation of self-expanding stents in the carotid arteries.

Type of Use (Select one or both, as applicable)
[X] Prescription Use (Part 21 CFR 801 Subpart D)[ ] Over-The-Counter Use (21 CFR 807 Subpart C)	[X] Prescription Use (Part 21 CFR 801 Subpart D)	[ ] Over-The-Counter Use (21 CFR 807 Subpart C)
[X] Prescription Use (Part 21 CFR 801 Subpart D)	[ ] Over-The-Counter Use (21 CFR 807 Subpart C)

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

[as required by 21 CFR 807.92.(c)]

Pursuant to Section 12, Part (a)(i)(3A) of the Safe Medical Devices Act of 1990, Silk Road Medical is providing the summary of Substantial Equivalence for the ENROUTE Enflate™ Transcarotid RX Balloon Dilatation Catheter.

1.1. Sponsor/Applicant

Silk Road Medical 1213 Innsbruck Drive Sunnyvale, CA 94089

1.2. Sponsor Contact

Primary Contact	Alternate Contact
Denise Aycox	Kym Rupp
Sr. Regulatory Affairs Specialist.	Manager, Regulatory Affairs
Ph: 408-585-2156	(407) 756-0035
Email: daycox@silkroadmed.com	Email: krupp@silkroadmed.com

1.3. Date of Preparation of 510(k)Summary

May 12, 2022

1.4. Device Trade or Proprietary Name

Trade Name ENROUTE Enflate™ Transcarotid RX Balloon Dilatation Catheter

1.5. Device Classification

Regulatory Class	II
Classification Panel	Cardiovascular
Classification Name	Percutaneous Catheter
Common Name	PTA balloon dilatation catheter
ClassificationRegulation	870.1250
Product Code	LIT

1.6. Predicate Device

Predicate Device
510(k) Number / Clearance Date	Name of Device	Name of Manufacturer
K071189 Cleared on May 16, 2007	AVIATOR PLUS PTA BalloonDilatation Catheter	Cordis Europa, N.VOosteinde 8Roden, NL NI-9301 Lj

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1.7. Predicate Comparison

Predicate Comparison
Device Name	Predicate Device	Subject Device	For any differences, justification of substantial equivalence
510(k) No.	K071189	TBD	N/A
Classification	Class II		SAME
ClassificationRegulation	870.1250		SAME
Product Code	LIT		SAME
Indication for Use	The Cordis AVIATORPLUS PTA BalloonDilatation Catheteris indicated forPercutaneousTransluminalAngioplasty in theperipheralvasculature,including iliac,femoral, ilia-femoral, popliteal,infra popliteal,renal, and carotidarteries, and for thetreatment ofobstructive lesionsof native orsyntheticarteriovenousdialysis fistulae. Thisdevice · 1s alsoindicated for post-dilatation ofballoon-expandableand self-expandingstents in theperipheralvasculature.	The ENROUTEEnflateTM TranscarotidRX Balloon DilatationCatheter is intendedfor percutaneoustransluminalangioplasty and post-dilatation of self-expanding stents in thecarotid arteries.	Both products are intended fortransluminal angioplasty andpost-dilatation of self-expanding stents in the carotidarteries. The predicate,AVIATOR PLUS, has anexpanded indication while theENROUTE Enflate has a morelimited indication particularlyfor use in the carotid arteries.
Balloon Characteristics
Catheter Type	Rapid Exchange (RX)		SAME
Shaft	RX Coaxial	SAME
Construction
GuidewireCompatibility	.014"	SAME
SheathCompatibility	4 or 5F(4F (up to 6mm), 5F for7mm)	SAME(4F for 4-5.5 mmdiameters, 5F for 6 mmdiameter)	Both the subject and predicateare compatible with 4F or 5Fsheaths depending on theballoon diameter.
Nominal Pressure	10 atm	8 atm	The Nominal pressure is similarto the predicate and isconsistent with other PTAballoons.
Rated BurstPressure	14 atm (for diametersup to 6mm), 12 atm for7mm	14 atm	The RBP for both the subjectand predicate are 14 atm forballoon diameters up to 6mm.The 12atm RBP is for a 7mmdiameter which is not anoffered diameter size for thesubject
Contrast Infusion	No		SAME
Coating	None		SAME
Marker band #	2		SAME
Balloon Material	Duralyn	Nylon	The ENROUTE Enflate Catheteris constructed of materialscommonly used for semi-compliant PTA balloons.
Dimensions
Catheter WorkingLength	142cm	75cm	The shorter working lengthwas selected to accommodatethe TCAR procedure. Theproduct is designed to havedirect access to the carotidartery rather than femoralartery access.
Catheter ShaftOuter Diameter	1.10mm	1.14mm	The OD of the catheter shaft issimilar to the predicate andfalls in-line with other clearedPTA catheters.
Balloon Length	15mm, 20mm, 30mmor 40mm	25mm or 35mm	These lengths are similar toother cleared PTA ballooncatheters for use in the carotidarteries.
Balloon Diameter	4.0, 4.5, 5.0, 5.5, 6.0 or7.0 mm at nominalpressure	4.0, 4.5, 5.0, 5.5, or 6.0mm at nominalpressure	The diameter sizes areidentical to the predicate withthe exception of the 7.0mmsize. These diameters are
			consistent with other clearedPTA balloon catheters for usein the carotid arteries.
Packaging and Sterilization
PackagingConfiguration	Balloon and flushingneedle provided inTyvek pouch. Theballoon is packaged in aprotective hoop.	Balloon packaged in aprotective hoop in aTyvek pouch	The Packaging configuration isidentical to the predicateexcept a flushing needle is notincluded.
SterilizationMethod	EO	SAME

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1.8. Device Description:

1.9. Indications for Use:

The ENROUTE Enflate™ Transcarotid RX Balloon Dilatation Catheter is intended for percutaneous transluminal angioplasty and post-dilatation of self-expanding stents in the carotid arteries.

1.10. 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 performed on the subject ENROUTE Enflate™ Transcarotid RX Balloon Dilatation Catheter to support substantial equivalence to the predicate device:

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

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The subject, ENROUTE ENROUTE Enflate™ Transcarotid RX Balloon Dilatation Catheter met all established requirements.

1.10.1. Biocompatibility Testing

The subject ENROUTE Enflate™ Transcarotid RX Balloon Dilatation Catheter uses equivalent materials, processing, and identical sterilization methods as those in the predicate device, AVIATOR PLUS PTA Balloon Dilatation Catheter [K071189].

Biocompatibility testing was successfully conducted per BS EN ISO 10993-1. The studies 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
Intracutaneous reactivity (Irritation)
. Sensitization
Acute systemic toxicity
Hemocompatibility
- o Direct and Indirect Contact
- O Complement activation
- In vivo thromboresistance O
Pyrogenicity

1.10.2. Design Verification - Bench-top Testing

The physical and mechanical properties of the ENROUTE Enflate™ Transcarotid RX Balloon Dilatation Catheter were assessed in accordance with FDA draft guidance "Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions" and the guidance "Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters- Class II Special Controls Guidance for Industry and FDA. Standard test methods and pre-determined acceptance criteria were used. The following tests were performed and all tests passed successfully:

. Visual and Dimensional Inspection
. Balloon Fatigue
Balloon Fatigue (Without Stent)
Balloon Rated Burst Pressure

Simulated Use

Balloon Rated Burst Pressure (Without Stent)
. Balloon Fatigue (In Stent)
Balloon Compliance
I Catheter Bond Strength
l Tip Pull Test
Flexibility and Kink Test
l Torque Strength

■

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Radiopaci

l Balloon Rated Burst Pressure (In Stent)
. Balloon Inflation and Deflation Time

1.10.3. 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.

1.11. Summary of Substantial Equivalence

The subject, ENROUTE Enflate™ Transcarotid RX Balloon Dilatation Catheter is substantially equivalent to the predicate device with regard to intended use, operating principle, design concept, materials, shelf-life, packaging and sterilization processes. 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 Enflate™ Transcarotid RX Balloon Dilatation Catheter met the acceptance criteria, is adequate for the intended use, and is substantially equivalent to the predicate.

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).