(37 days)
Not Found
No
The provided text describes a standard catheter and does not mention any AI or ML components or functionalities.
No
The device facilitates the delivery of therapeutic agents but is not a therapeutic agent itself.
Yes
The "Intended Use / Indications for Use" states that the device may be used to "subselectively infuse/deliver diagnostic and therapeutic agents," indicating its role in diagnostic procedures.
No
The device description clearly describes a physical catheter, which is a hardware component, not a software-only device.
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 about a person's health. This testing is done outside of the body (in vitro).
- Gopher Gold Catheter Function: The description clearly states the Gopher Gold catheter is used within the body (in vivo) to access and navigate blood vessels, facilitate device placement, and deliver agents. It is a tool for intervention and diagnosis within the patient, not for testing samples from the patient.
The intended use and device description are consistent with a device used for interventional procedures within the circulatory system, not for laboratory testing of biological samples.
N/A
Intended Use / Indications for Use
The Gopher Gold catheter is intended to be used in conjunction with steerable guidewires to access discreet regions of the coronary and/or peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and to subselectively infuse/deliver diagnostic and therapeutic agents.
Product codes (comma separated list FDA assigned to the subject device)
DOY
Device Description
The Gopher Gold catheter is a 3F catheter that is compatible with standard 0.014" guidewires and 6F guide catheters. The Gopher Gold is a single-lumen catheter with a working length of 135 cm with printed positioning marks at 95 cm and 105 cm. The Gopher Gold catheter is packaged in a dispenser coil and is sealed within a single sterile barrier pouch. The Gopher Gold catheter is sterilized by ethylene oxide and intended for single use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary and/or peripheral vasculature
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)
Technological differences in design and materials have been qualified through biomaterial assessments and other design verification testing, the results of which did not raise any new safety or performance questions.
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.
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
§ 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
Vascular Solutions, Inc.
Special 510(k) Premarket Notification Gopher Gold Catheter
510(k) Summary 2
Date Prepared: April 15, 2009
Submitter's Name / Contact Person
Manufacturer
Vascular Solutions, Inc. 6464 Sycamore Court Minneapolis, MN 55369 USA Establishment Registration # 2134812
Contact Person
Loucinda Bjorklund Senior Regulatory Affairs Associate Tcl: 763.656.4208 (direct); Fax: 763.656.4253 Email: 1bjorklund@vascularsolutions.com
General Information
Gopher™ Gold catheter Trade Name Common / Usual Name Classification Name Predicate Device
Percutaneous catheter 870.1250 Catheter, percutaneous K070372 Gopher catheter (Vascular Solutions, Inc.)
Device Description
The Gopher Gold catheter is a 3F catheter that is compatible with standard 0.014" guidewires and 6F guide catheters. The Gopher Gold is a single-lumen catheter with a working length of 135 cm with printed positioning marks at 95 cm and 105 cm. The Gopher Gold catheter is packaged in a dispenser coil and is sealed within a single sterile barrier pouch. The Gopher Gold catheter is sterilized by ethylene oxide and intended for single use.
Intended Use / Indications
The Gopher Gold catheter is intended to be used in conjunction with steerable guidewires to access discreet regions of the coronary and/or peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and to subselectively infuse/deliver diagnostic and therapeutic agents
Substantial Equivalence and Summary of Studies
The Gopher gold catheter is substantially equivalent in intended use and indications to the predicate device. Technological differences in design and materials have been qualified through biomaterial assessments and other design verification testing, the results of which did not raise any new safety or performance questions.
JUN 1 2 2009
1
Image /page/1/Picture/1 description: The image contains the text "Public Health Service". The text is written in a simple, sans-serif font and is horizontally aligned. The words are stacked on a single line and are easily readable.
Image /page/1/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized abstract design resembling an eagle or bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the design.
2 2009 JUL
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Vascular Solutions, Inc. c/o Ms. Loucinda Bjorklund Senior Regulatory Affairs Associate 6464 Sycamore Court Minneapolis. MN 55369
Re: K091345
Trade/Device Name: Gopher™ Gold Catheter Common Name: Catheter, Percutaneous Regulation Number: 21 CFR 870.1250 Regulatory Class: II Product Code: DOY Dated: May 5, 2009 Received: May 13, 2009
Dear Ms. Bjorklund:
This letter corrects our substantially equivalent letter of June 12, 2009.
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
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
2
Page 2 - Ms. Loucinda Bjorklund
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 forth in the quality systems (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Duna R. Lechner
Image /page/2/Picture/6 description: The image shows the name and title of Bram D. Zuckerman, M.D. He is the Director of the Division of Cardiovascular Devices. The division is part of the Office of Device Evaluation. The office is part of the Center for Devices and Radiological Health.
Enclosure
3
Indications for Use
K091345 510(k) Number (if known): Device Name: Gopher™ Gold catheter Indications for Use: The Gopher Gold catheter is intended to be used in conjunction with steerable guidewires to access discreet regions of the coronary and/or peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and to subselectively infuse/deliver diagnostic and therapeutic agents. Prescription Use __ Over-The-Counter Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1 (Posted November 13, 2003)
iovascular Devices
510(k) Number K0911345