K Number

Device Name

ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter

Manufacturer

Silk Road Medical, Inc.

Date Cleared

2022-09-02

(109 days)

Product Code

LIT

Regulation Number

870.1250

Intended 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.

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K071189

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical characteristics and mechanical performance of a balloon catheter, with no mention of software, algorithms, or data processing that would indicate AI/ML.

Therapeutic

Yes
The device is used for percutaneous transluminal angioplasty and post-dilatation of self-expanding stents in the carotid arteries, which are therapeutic interventions.

Diagnostic

This device is a balloon dilatation catheter used for therapeutic angioplasty and post-dilatation of stents, not for diagnosing a condition. Its function is to treat a stenosis by dilating it, rather than to identify or characterize it.

SaMD (Software as a Medical Device)

The device description clearly details a physical catheter with a balloon, lumens, and marker bands, indicating it is a hardware device, not software only.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
Device Function: The ENROUTE Enflate™ Transcarotid RX Balloon Dilatation Catheter is a physical device used within the body (in vivo) to perform a medical procedure (angioplasty and stent post-dilatation). It does not analyze samples taken from the body.
Intended Use: The intended use clearly describes a therapeutic procedure performed directly on the carotid arteries, not a diagnostic test on a specimen.

Therefore, based on the provided information, the ENROUTE Enflate™ Transcarotid RX Balloon Dilatation Catheter is a therapeutic medical device, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

LIT

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

carotid arteries

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Design Verification (Bench-Top Testing) .

Visual and Dimensional Inspection
Balloon Fatigue
Balloon Fatigue (Without Stent)
Balloon Rated Burst Pressure
Balloon Rated Burst Pressure (Without Stent)
Balloon Fatigue (In Stent)
Balloon Compliance
Catheter Bond Strength
Tip Pull Test
Flexibility and Kink Test
Torque Strength
Balloon Inflation and Deflation Time

Biocompatibility

Cytotoxicity
Intracutaneous reactivity (Irritation)
Sensitization
Acute systemic toxicity
Hemocompatibility
Direct and Indirect Contact
Complement activation
In vivo thromboresistance
Pyrogenicity

Sterilization, Packaging Validation, and Shelf Life

All established requirements were met, and all tests passed successfully.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K071189

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

Summary

Image /page/0/Picture/0 description: The image contains 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

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

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
Classification
Regulation	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 Balloon
Dilatation Catheter	Cordis Europa, N.V
Oosteinde 8
Roden, 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
Classification
Regulation	870.1250		SAME
Product Code	LIT		SAME
Indication for Use	The Cordis AVIATOR
PLUS PTA Balloon
Dilatation Catheter
is indicated for
Percutaneous
Transluminal
Angioplasty in the
peripheral
vasculature,
including iliac,
femoral, ilia-
femoral, popliteal,
infra popliteal,
renal, and carotid
arteries, and for the
treatment of
obstructive lesions
of native or
synthetic
arteriovenous
dialysis fistulae. This
device · 1s also
indicated for post-
dilatation of
balloon-expandable
and self-expanding
stents in the
peripheral
vasculature.	The ENROUTE
EnflateTM Transcarotid
RX Balloon Dilatation
Catheter is intended
for percutaneous
transluminal
angioplasty and post-
dilatation of self-
expanding stents in the
carotid arteries.	Both products are intended for
transluminal angioplasty and
post-dilatation of self-
expanding stents in the carotid
arteries. The predicate,
AVIATOR PLUS, has an
expanded indication while the
ENROUTE Enflate has a more
limited indication particularly
for use in the carotid arteries.
Balloon Characteristics
Catheter Type	Rapid Exchange (RX)		SAME
Shaft	RX Coaxial	SAME
Construction
Guidewire
Compatibility	.014"	SAME
Sheath
Compatibility	4 or 5F
(4F (up to 6mm), 5F for
7mm)	SAME
(4F for 4-5.5 mm
diameters, 5F for 6 mm
diameter)	Both the subject and predicate
are compatible with 4F or 5F
sheaths depending on the
balloon diameter.
Nominal Pressure	10 atm	8 atm	The Nominal pressure is similar
to the predicate and is
consistent with other PTA
balloons.
Rated Burst
Pressure	14 atm (for diameters
up to 6mm), 12 atm for
7mm	14 atm	The RBP for both the subject
and predicate are 14 atm for
balloon diameters up to 6mm.
The 12atm RBP is for a 7mm
diameter which is not an
offered diameter size for the
subject
Contrast Infusion	No		SAME
Coating	None		SAME
Marker band #	2		SAME
Balloon Material	Duralyn	Nylon	The ENROUTE Enflate Catheter
is constructed of materials
commonly used for semi-
compliant PTA balloons.
Dimensions
Catheter Working
Length	142cm	75cm	The shorter working length
was selected to accommodate
the TCAR procedure. The
product is designed to have
direct access to the carotid
artery rather than femoral
artery access.
Catheter Shaft
Outer Diameter	1.10mm	1.14mm	The OD of the catheter shaft is
similar to the predicate and
falls in-line with other cleared
PTA catheters.
Balloon Length	15mm, 20mm, 30mm
or 40mm	25mm or 35mm	These lengths are similar to
other cleared PTA balloon
catheters for use in the carotid
arteries.
Balloon Diameter	4.0, 4.5, 5.0, 5.5, 6.0 or
7.0 mm at nominal
pressure	4.0, 4.5, 5.0, 5.5, or 6.0
mm at nominal
pressure	The diameter sizes are
identical to the predicate with
the exception of the 7.0mm
size. These diameters are
			consistent with other cleared
PTA balloon catheters for use
in the carotid arteries.
Packaging and Sterilization
Packaging
Configuration	Balloon and flushing
needle provided in
Tyvek pouch. The
balloon is packaged in a
protective hoop.	Balloon packaged in a
protective hoop in a
Tyvek pouch	The Packaging configuration is
identical to the predicate
except a flushing needle is not
included.
Sterilization
Method	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 (