(118 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a catheter, with no mention of AI or ML.
No.
The device is used to introduce other interventional devices, rather than directly treating a condition itself.
No
The device is an access catheter used to introduce interventional devices into the peripheral vasculature, not to diagnose a condition. Its function is to facilitate a medical procedure, not to identify a disease or medical state.
No
The device description clearly describes a physical catheter with a shaft, radiopaque marker, hub, and hydrophilic coating, indicating it is a hardware device.
Based on the provided information, the Silk Road® Access Catheter is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the "introduction of interventional devices into the peripheral vasculature." This describes a device used within the body for a procedural purpose, not for examining specimens outside the body to diagnose a condition.
- Device Description: The description details a catheter designed for insertion into blood vessels. It mentions contact with "circulating blood," which is part of its function within the body, not for analyzing blood samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), reagents, or any diagnostic purpose. The focus is entirely on facilitating access for other interventional devices.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The Silk Road® Access Catheter does not fit this description.
N/A
Intended Use / Indications for Use
The Silk Road® Access Catheter is indicated for the introduction of interventional devices into the peripheral vasculature.
Product codes
DQY
Device Description
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 (
§ 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).
0
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
1
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
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 (