The Silk Road Access Catheter is a sterile, non-pyrogenic, single-use access catheter indicated for introduction of interventional devices into the peripheral vasculature. The Silk Road Access Catheter is a single-lumen, coil-reinforced shaft, variable stiffness catheter in a range of diameters and working lengths to accommodate target anatomy. All sizes contain a radiopaque marker on the distal end and a catheter hub on the proximal end. The catheter shaft has a hydrophilic coating on its distal portion to reduce friction during use. The catheter is offered with a dilator. The Silk Road Access Catheter is a limited duration (<24 hours), externalcommunicating device, contacting circulating blood.

AI/ML Overview

This document is a 510(k) Pre-market Notification for a medical device called the Silk Road Access Catheter. It focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving novel performance against acceptance criteria for a new type of device.

Therefore, the specific information requested in the prompt about acceptance criteria, detailed study results, sample sizes for test and training sets, expert qualifications, adjudication methods, and standalone/MRMC studies is not directly applicable or available in this document.

This document describes a regulatory submission where the goal is to show the new device (Subject Device) is as safe and effective as an existing, legally marketed device (Predicate Device), not to establish new performance benchmarks.

However, I can extract information regarding the performance testing conducted to support the substantial equivalence claim.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table with explicit acceptance criteria and corresponding numerical performance results for the Subject Device. Instead, it lists the types of tests performed and states that these tests demonstrate "substantial equivalence." For biocompatibility, it states "The battery of tests included the following tests," and for animal studies, it mentions "the safety acceptance criteria for the studies were met." This implies the tests were successfully passed, but specific quantitative criteria and results are not detailed.

2. Sample size used for the test set and the data provenance:

Biocompatibility Tests: The document lists various biocompatibility tests (e.g., Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Hemocompatibility, Genotoxicity, Pyrogenicity). However, it does not specify the sample sizes used for these tests.
Bench Testing: A comprehensive list of bench tests is provided (e.g., Visual Inspection, Coating Particulate, Leakage, Kink Resistance, Burst, Radiopacity, Shelf Life). Again, no sample sizes for these tests are mentioned.
Animal Studies: A "GLP animal study was previously performed to evaluate the safety, performance and handling of the Predicate Device in the canine model." The sample size for this animal study is not specified.
Data Provenance: The studies were internal testing, likely conducted by the manufacturer or contracted labs, as part of the regulatory submission process. The document does not specify country of origin for the data or whether the data was retrospective or prospective, though regulatory testing like this is typically prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. The document refers to "acceptance criteria" being met for the animal study, but does not detail how ground truth for any of the non-clinical tests was established by experts.

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

This information is not provided in the document.

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:

No, an MRMC comparative effectiveness study was not done. This is a non-clinical device that does not involve "human readers" or "AI assistance" in the context of diagnostic interpretation.

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

This is not an AI/algorithm-based device. Therefore, this type of standalone performance study is not applicable and was not performed.

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

For Biocompatibility, ground truth is typically assessed against established ISO standards and biological responses (e.g., cell viability, immune reaction indicators, blood compatibility parameters).
For Bench Testing, ground truth is based on engineering specifications and performance limits defined by relevant standards (e.g., ISO 10555-1) and internal design requirements.
For Animal Studies, ground truth for safety and performance was based on "pathology and histopathology results" and "performance and handling observations" by a clinician in the canine model.

8. The sample size for the training set:

This information is not applicable as this is not an AI/machine learning device that requires a training set.

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

This information is not applicable as this is not an AI/machine learning device that requires a training set.

Summary of Device and Performance Testing:

The Silk Road Access Catheter is a sterile, single-use percutaneous catheter. The regulatory submission (K143459) aims to demonstrate its substantial equivalence to a previously cleared predicate device (K130649).

The performance data to support this claim includes:

Biocompatibility Testing: Conducted according to FDA Blue Book Memorandum #G-95-1 and ISO 10993-1, covering Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Hemocompatibility, Genotoxicity, and Pyrogenicity. The document states that the device is considered an externally communicating medical device with circulating blood contact for less than 24 hours. No specific quantitative results or sample sizes are provided for these tests, only that an evaluation was conducted.
Bench Testing: A comprehensive set of engineering tests were performed, including Visual Inspection, Dimensional Verification, Coating Particulate, Coating Integrity, Liquid Leakage, Air Leakage, Kink Resistance, Torsion, Guidewire Advancement and Withdrawal Force, Burst, Bending Stiffness, Aspiration Rate, Flush Rate, Tensile Test, Corrosion, Radiopacity, Simulated Preparation and Use, and Shelf Life. These tests aim to verify the physical and mechanical properties of the device. No specific quantitative results or sample sizes are provided.
Animal Studies: A GLP animal study was "previously performed to evaluate the safety, performance and handling of the Predicate Device in the canine model." The document states that based on pathology and histopathology results, "the safety acceptance criteria for the studies were met," and "No untoward observations were found by the clinician." The rationale is that since the subject device has the same basic design and fundamental technology as the predicate, the predicate's animal study results are applicable. No specific sample size for the animal study is mentioned.
Clinical Performance Testing: The document explicitly states, "The Predicate Device was cleared based on the results of only non-clinical testing, therefore, only non-clinical testing was required to support substantial equivalence." No clinical performance testing was conducted or required for this 510(k) submission.

In conclusion, this regulatory document focuses on establishing substantial equivalence through non-clinical testing (biocompatibility, bench testing, and reliance on previous animal studies for the predicate device). It does not provide the detailed acceptance criteria and performance data in a format suitable for the requested table, nor does it involve the types of studies (MRMC, standalone AI) or expert-based ground truth establishment typically associated with diagnostic AI/software devices.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling three human profiles facing to the right, stacked on top of each other, creating a sense of depth and connection.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 1, 2015

Silk Road Medical. Inc. Ric Ruedy Vice President, RA/CA/QA 735 North Pastoria Ave. Sunnyvale, CA 94085

Re: K143459

Trade/Device Name: Silk Road Access Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DOY Dated: February 13, 2015 Received: February 18, 2015

Dear Mr. Ruedy:

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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kenneth J. Cavanaugh -S

for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known): K143459

Silk Road® Access Catheter Device Name:

Indications for Use:

The Silk Road® Access Catheter is indicated for the introduction of interventional devices into the peripheral vasculature.

Prescription Use _ _ X Or Over-The-Counter Use _______________ (per 21 CFR 801.109)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

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510(k) Summary

l. SUBMITTER

Silk Road Medical, Inc. 735 North Pastoria Avenue Sunnyvale, CA 94085 Phone: (408) 720-9002 Fax: (408) 720-9013

Contact Person: Richard M. Ruedy Executive Vice President, RA/CA/QA (408) 828-7281 ric@silkroadmed.com

Alternate Contact: Linda Ruedy Sr. Director, Clinical and Regulatory Affairs (408) 857-6754 lruedy@silkroadmed.com

Date Prepared: March 17, 2015

ll. DEVICE

Name of the Device: Silk Road® Access Catheter Common or Usual Name: Percutaneous Catheter Classification Name: Percutaneous Catheter (21 CFR§ 870.1250) Regulatory Class: Class II Product Code: DQY

lll. PREDICATE

Silk Road Medical, Inc. Silk Road® Access Catheter (K130649) This predicate has not been subject to a design-related recall.

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IV. DEVICE DESCRIPTION

V. INDICATIONS FOR USE

The Silk Road® Access Catheter is indicated for the introduction of interventional devices into the peripheral vasculature.

TECHNOLOGICAL CHARACTERISTICS VI. COMPARISON or WITH THE PREDICATE DEVICE

The Subject Device and Predicate Device are identical with respect to the following:

. Sterile, non-pyrogenic disposable, single-use devices
Intended for use to provide an access conduit for the introduction of . interventional devices
. Indicated for use in introduction of interventional devices into the peripheral vasculature
. Target anatomical site is the peripheral vasculature
. Single-lumen, coil-reinforced shaft, variable stiffness catheter in a range of diameters and working lengths to accommodate target anatomy. All sizes contain a radiopaque marker on the distal end and a catheter hub on the proximal end. The catheter shaft has a hydrophilic coating on its distal portion to reduce friction during use. The catheter is offered with a dilator.

The following technological differences exist between the Subject Device and Predicate Device:

Use of additional polymer in catheter shaft .
Use of different material for catheter shaft support .
Use of tensile reinforcement for catheter shaft ●

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The technological characteristics and principles of operation of the Silk Road Access Catheter are substantially equivalent to the named Predicate Device.

VII. PERFORMANCE DATA

The following performance testing was conducted on the Silk Road Access Catheter to support a determination of substantial equivalence to the Predicate Device.

Biocompatibility

The biocompatibility evaluation for the Silk Road Access Catheter was conducted in accordance with the FDA Blue Book Memorandum #G-95-1 "Use of International Standard ISO 10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices- Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The battery of tests included the following tests:

Cytotoxicity: MEM Elution L-929 ISO/USP
Sensitization: Guinea Pig Maximization Sensitization Test ●
Irritation: ISO Intracutaneous Reactivity Test
Systemic Toxicity: ISO Acute Systemic Injection ●
. Hemocompatibility:
- Four Hour Thromboresistance Evaluation in Dogs O
- Complement Activation C3a and SC5b-9 O
- Platelet and Leukocyte Count O
- Partial Thromboplastin Time о
- Hemolysis O
Genotoxicity: .
- Bacterial Mutagenicity Test- Ames Assay с
- in vitro Mouse Lymphoma Assay O
- in vivo Mouse Micronucleus Assay o
Pvrogenicitv ●
- Material Mediated Pyrogen

The Silk Road Access Catheter is considered to be an externally communicating medical device with circulating blood contact for less than 24 hours. Exceptions include the non-patient contacting components, which are assembled encapsulated with the blood-contacting layers of the catheter and include the catheter radiopaque marker band, catheter axial reinforcement members and adhesives.

Bench Testing

Visual Inspection and Dimensional Verification .
. Coating Particulate (USP 788)
Coating Integrity .
Liquid Leakage (ISO 10555-1)

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Air Leakage (ISO 10555-1) ●
Kink Resistance ●
Torsion ●
Guidewire Advancement and Withdrawal Force ●
Burst ●
Bending Stiffness Characterization
Aspiration Rate Characterization
Flush Rate Characterization
Tensile Test (ISO 10555-1)
. Corrosion (ISO 10555-1)
Radiopacity ●
Simulated Preparation and Use ●
Shelf Life ●

Animal Studies

A GLP animal study was previously performed to evaluate the safety, performance and handling of the Predicate Device in the canine model. Based on pathology and histopathology results, the safety acceptance criteria for the studies were met. Performance and handling observations were made based on detailed characteristics of the device. No untoward observations were found by the clinician. The in vivo performance testing of the Predicate Device Silk Road Access Catheter, demonstrating that the product is safe for its labeled indications, is applicable to the Subject Device because the basic design and fundamental technology is unchanged.

Clinical Performance Testing

The Predicate Device was cleared based on the results of only non-clinical testing, therefore, only non-clinical testing was required to support substantial equivalence.

VIII. CONCLUSIONS

The conclusions drawn from non-clinical tests demonstrate the Subject Device is substantially equivalent to the Predicate Device in its intended use.

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).