(235 days)
Not Found
No
The summary describes a physical access catheter and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is an access catheter used to introduce other interventional devices into the peripheral vasculature, rather than providing therapy itself.
No
Explanation: The device, an access catheter, is used to introduce other interventional devices into the peripheral vasculature. Its purpose is to facilitate access for treatment, not to diagnose a condition.
No
The device description clearly outlines a physical catheter with a shaft, radiopaque marker, hub, and hydrophilic coating. It also mentions non-clinical performance data related to physical properties and animal studies, indicating a hardware device.
Based on the provided information, the Silk Road™ Access Catheter is not an In Vitro Diagnostic (IVD) 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 testing samples outside the body.
- Device Description: The description details a catheter designed for insertion into blood vessels, with features like a coil-reinforced shaft, radiopaque marker, and hydrophilic coating. These are characteristics of devices used for accessing and navigating within the circulatory system.
- Contact with Circulating Blood: The description explicitly states it's an "external-communicating devices, contacting circulating blood." IVDs typically analyze samples of blood or other bodily fluids outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information based on testing bodily fluids.
In summary, the Silk Road Access Catheter is a medical device used for accessing the peripheral vasculature during interventional procedures, which is distinct from the function of an In Vitro Diagnostic device.
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, KRA
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 in all but the smallest size (SR-045-AC). 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
Traditional 510(k) Silk Road™ Access Catheter
510(k) Summary
NOV 0 1 2013
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
A. Name and Address of Applicant Silk Road Medical, Inc. 735 North Pastoria Avenue Sunnyvale, CA 94085 Phone: (408) 720-9002 . Fax: (408) 720-9013
B. Contact Person
Richard M. Ruedy Vice President, RA/CA/QA (408) 828-7281 ric@silkroadmed.com
Alternate Contact: Diana DeGregorio Lincé Consulting Regulatory Affairs Consultant (925) 980-8047 dianadegregorio@comcast.net
C. Date Prepared
October 23, 2013
D. Device Name
| Trade Name: | Silk Road™ Access Catheter |
|---|---|
| Common Name: | Percutaneous Catheter |
| Classification Name: | Percutaneous Catheter |
E. Device Classification
Classification: Product Code: Device Class:
21 CFR§870.1250 DQY, KRA Class II
1
F. Predicate Device
Silk Road Medical, Inc. submits that the subject Silk Road™ Access Catheter is substantially equivalent to the predicate, Penumbra Neuron™ Intracranial Access System (K070970, K082290).
G. 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 in all but the smallest size (SR-045-AC). The Silk Road Access Catheter is a limited duration (In Vitro Mouse
Lymphoma Assay | The test article passes if the mutant frequency is less than 1.8 fold higher than that of the concurrent negative control groups. | Results - The controls for the assay performed as required; qualifying both the assay and cell culture system as valid. The mutant frequencies and cloning efficiencies of preparations treated with test article were within the limits defined for a negative response.
Conclusion - The test article is considered to be non-mutagenic (non-genotoxic and non-clastogenic) in this test system. |
| Genotoxicity:
In Vivo Mouse
Micronucleus
Assay | The test article passes if it does not show a significant increase in the number of micronucleated polychromatic erythrocytes. | Result - In general there were no apparent gross manifestations of toxicity nor biologically significant erythropoietic disturbances |
| Attribute | Acceptance Criteria | Result |
| | | Furthermore, there were no
biologically significant increases
in mPCE production in the test
article treated groups as
compared to the concurrent
negative controls.
Conclusion - The test article is
considered non-mutagenic in this
test system. |
| Packaging Validation | Packaging must maintain product
sterility and protect the product
during shipment and storage. | Pass |
| Sterilization Validation | Silk Road Access Catheter must be
validated ISO 11135-1:2007 | Pass |
| Shelf Life | Silk Road Access Catheter must
perform to specification and the
package must maintain a sterile
barrier during the shelf-life period as
labeled on the product label. | Pass |
6
Safety and Performance Testing - Animal
A GLP animal study was performed to evaluate the safety, performance and handling of the Silk Road Access Catheter as compared to a control device. Based on pathology and histopathology results, the safety acceptance criteria for the study were met. Performance and handling observations were made based on detailed characteristics of the device. No untoward observations were found by the clinician.
The physical, mechanical and in vitro and in vivo performance testing of the subject Silk Road Access Catheter demonstrate that the product is safe and effective for its labeled indications and is Substantially Equivalent to the currently marketed predicate.
K. Conclusions
The Silk Road Access Catheter has been carefully compared to legally marketed devices with respect to intended use and technological characteristics. In addition, nonclinical testing was conducted to validate the performance of the device and ensure the Silk Road Access Catheter functions as intended and meets design specifications. The comparison and non-clinical results demonstrate that the device is substantially equivalent to the predicate device for its intended use.
7
Image /page/7/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three arms reaching upwards, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 1, 2013
Silk Road Medical. Inc. % Mr. Richard M. Ruedy Vice President, RA/CA/QA 735 North Pastoria Avenue Sunnyvale, CA 94085
Re: K130649
Trade/Device Name: Silk Road™ Access Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY, KRA Dated: September 20, 2013 Received: September 23, 2013
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
8
Page 2 - Mr. Richard M. Ruedy
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/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 Small Manufacturers, International and Consumer Assistance 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 vours.
Victor Krauthamer -A
Victor Krauthamer, Ph.D. Acting Division Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
9
Indications for Use
510(k) Number (if known): K130649
Device Name: Silk Road™ Access Catheter
Indications For Use:
The Silk Road™ Access Catheter is indicated for the introduction of interventional devices into the peripheral vasculature.
Prescription Use _ V (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
Victor Krau 2013.11.01
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