(113 days)
Not Found
No
The description focuses on the physical construction and intended use of a support catheter, with no mention of AI or ML capabilities.
No
The device is intended to facilitate access and delivery of other agents or devices, not inherently to provide therapy itself. It is a support catheter for other interventional procedures.
Yes
The "Intended Use / Indications for Use" section states that the device "may be used to subselectively infuse/deliver diagnostic or therapeutic agents," explicitly mentioning diagnostic agents.
No
The device description clearly details a physical catheter with material components (polymeric outer layer, Nitinol middle layer, PTFE/polyimide inner layer, radiopaque markerband, stainless steel, luer hub, strain relief, torque device). This is a hardware medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used within the body (in vivo) to access and manipulate the arterial and/or coronary vasculature. It facilitates the placement of other devices and delivers agents directly into the body.
- Device Description: The description details a catheter designed for insertion into blood vessels, with features like a radiopaque tip for visualization during a medical procedure.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens outside the body (in vitro), such as blood, urine, or tissue samples, to provide information about a patient's health.
IVD devices are used to perform tests on samples taken from the body to diagnose, monitor, or screen for diseases or conditions. This device is a medical device used for interventional procedures within the body.
N/A
Intended Use / Indications for Use
The Gopher Support Catheter is intended to be used in conjunction with steerable guidewires in order to access discreet regions of the arterial and/or coronary vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and to subselectively infuse/deliver diagnostic or therapeutic agents.
Product codes (comma separated list FDA assigned to the subject device)
DQY, DOY
Device Description
The Gopher catheter is available in two sizes-2F and 3F. Each catheter assembly has a polymeric outer layer and Nitinol middle layer that extend the length of the catheter. a porfilerie oud, the Nitinol tubing is laser cut and is lined with a PTFE/polyimide inner layer. To provide a radiographic means of locating the tip, the 2F size has a radiopaque markerband near the distal tip and the 3F distal tip is a segment of threaded, radiopaque stainless steel. Each catheter has printed positioning marks at 95cm and 105cm from the catheter's distal tip, a luer hub and strain relief on the proximal end, and an adjustable torque device near the proximal end. Each Gopher catheter model is compatible with ≥6F guide catheters and ≤0.014" guidewires and has a working length of approximately 135cm.
The Gopher catheter is provided sterile and intended for a single use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
arterial and/or coronary 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)
Bench testing was conducted on the Gopher catheter, including the packaging, and included an assessment of the physical properties of the device and its ability to achieve its intended use. The results of the tests confirmed the suitability of the device for its intended use. Each bench test that was conducted is listed, below.
Visual Inspection
Guidewire Interface
Tortuosity
Catheter Kink Resistance
Guide Catheter Interface
Fluid Leak Under Pressure
Air Leak During Aspiration
Flow Rate
Catheter Integrity After Torquing
Torque Strength
Torque Device-to-shaft Interface
Hub-to-proximal shaft Bond Strength
Distal Shaft Bond Strength
Markerband Visibility (2F)
Radiopaque Distal Tip (3F)
Packaging-Pouch Visual Appearance after Distribution Testing
Packaging-Product Containment after Distribution Testing
Packaging-Product Visual Appearance after Distribution Testing
Packaging-Label Legibility after Distribution Testing
In addition, the biocompatibility of the Gopher catheter was assessed in accordance with ISO 10993, "Biological Evaluation of Medical Devices." The testing confirmed that the materials and processes used in the manufacture of the Gopher catheters are biocompatible. The tests that were conducted are listed, below.
Cytotoxicity
Sensitization
Intracutaneous Reactivity
Acute Systemic Toxicity
Material Mediated Pyrogen
Hemocompatibility, hemolysis
Hemocompatibility, Prothrombin Time
Hemocompatibility, Lee White Coagulation Test
Hemocompatibility, In vitro Hemocompatibility Assessment
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.
Skyway™ Support Catheter (K052258 and K060327), Tornus Support Catheter (K051772)
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
0. Lots
510(k) Summary (As required by 21 CFR 807.92(c))
JUN - 1 2007
K070372 510(k) Number: ____
Date Prepared
May 29, 2007
Submitter Information
| Submitter's Name: | Vascular Solutions, Inc. |
|---|---|
| Address: | 6464 Sycamore Court |
| Minneapolis, MN 55369 |
Julie Tapper Contact Person: Senior Regulatory Affairs Associate Phone 763-656-4228 Fax 763-656-4253
Device Information
| Trade Name: | Gopher™ Support Catheter |
|---|---|
| Common Name: | Percutaneous catheter |
| Class: | II |
| Classification Name: | Percutaneous catheter |
| (21 CFR 870.1250, Product Code DQY) |
Predicate Devices
Skyway™ Support Catheter (K052258 and K060327), manufactured by Vascular Solutions, Inc.
Tornus Support Catheter (K051772), manufactured by Asahi Intecc Co., Ltd.
Device Description
The Gopher catheter is available in two sizes-2F and 3F. Each catheter assembly has a polymeric outer layer and Nitinol middle layer that extend the length of the catheter. a porfilerie oud, the Nitinol tubing is laser cut and is lined with a PTFE/polyimide inner layer. To provide a radiographic means of locating the tip, the 2F size has a radiopaque markerband near the distal tip and the 3F distal tip is a segment of threaded, radiopaque stainless steel.
1
Each catheter has printed positioning marks at 95cm and 105cm from the catheter's distal tip, a luer hub and strain relief on the proximal end, and an adjustable torque device near the proximal end. Each Gopher catheter model is compatible with ≥6F guide catheters and ≤0.014" guidewires and has a working length of approximately 135cm.
The Gopher catheter is provided sterile and intended for a single use.
Intended Use/Indications for Use
The Gopher Support Catheter is intended to be used in conjunction with steerable guidewires in order to access discreet regions of the arterial and/or coronary vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and to subselectively infuse/deliver diagnostic or therapeutic agents.
Summary of Non-clinical Testing
Bench testing was conducted on the Gopher catheter, including the packaging, and included an assessment of the physical properties of the device and its ability to achieve its intended use. The results of the tests confirmed the suitability of the device for its intended use. Each bench test that was conducted is listed, below.
| Visual Inspection | Torque Device-to-shaft Interface |
|---|---|
| Guidewire Interface | Hub-to-proximal shaft Bond Strength |
| Tortuosity | Distal Shaft Bond Strength |
| Catheter Kink Resistance | Markerband Visibility (2F) |
| Guide Catheter Interface | Radiopaque Distal Tip (3F) |
| Fluid Leak Under Pressure | Packaging-Pouch Visual Appearance after Distribution Testing |
| Air Leak During Aspiration | Packaging-Product Containment after Distribution Testing |
| Flow Rate | Packaging-Product Visual Appearance after Distribution Testing |
| Catheter Integrity After Torquing | Packaging-Label Legibility after Distribution Testing |
| Torque Strength |
In addition, the biocompatibility of the Gopher catheter was assessed in accordance with ISO 10993, "Biological Evaluation of Medical Devices." The testing confirmed that the materials and processes used in the manufacture of the Gopher catheters are biocompatible. The tests that were conducted are listed, below.
| Cytotoxicity | Hemocompatibility, hemolysis |
|---|---|
| Sensitization | Hemocompatibility, Prothrombin Time |
| Intracutaneous Reactivity | Hemocompatibility, Lee White Coagulation Test |
| Acute Systemic Toxicity | Hemocompatibility, In vitro Hemocompatibility Assessment |
| Material Mediated Pyrogen |
Summary of Clinical Testing
Clinical evaluations were not required for this device.
2
K070372 p. 30f 3
Statement of Equivalence
The Gopher catheter is substantially equivalent to the currently marketed Skyway and Tornus catheters, based on comparisons of the device classifications, indications for use, technological characteristics, and sterilization methods.
Conclusion
The Gopher catheter is substantially equivalent to the currently marketed Skyway and Tornus catheters, based on comparisons of the device classifications, indications for use, technological characteristics, and sterilization methods. Bench tests confirmed the suitability of the device for its intended use.
3
Public Health Service
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 1 2007
Vascular Solutions, Inc. c/o Ms. Julie Tapper Senior Regulatory Affairs Associate 6464 Sycamore Court Minneapolis, MN 55369
Re: K070372
Gopher™ Support Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: II (two) Product Code: DOY Dated: May 16, 2007 Received: May 21, 2007
Dear Ms. Tapper:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
4
Page 2 - Ms. Julie Tapper
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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,
C.S.N.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
510(k) Number: ___ K070372
Device Name:
Gopher™ Support Catheter
Indications for Use:
The Gopher Support Catheter is intended to be used in conjunction with steerable guidewires in order to access discreet regions of the arterial and/or coronary vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and to subselectively infuse/deliver diagnostic or therapeutic agents.
Prescription Use X (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 CDRH, Office of Device Evaluation (ODE)
QSSM
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number K070372