(154 days)
Not Found
No
The device description and intended use focus on the physical properties and function of a support catheter, with no mention of AI or ML capabilities.
No.
The device facilitates the placement and exchange of guidewires and other interventional devices and can be used to subselectively infuse/deliver therapeutic agents, but it does not inherently treat a condition. It is a tool for delivering therapies or other devices.
No
Explanation: The device is a support catheter intended to facilitate the placement and exchange of guidewires and other interventional devices, and to deliver therapeutic agents. Its purpose is interventional/therapeutic, not diagnostic.
No
The device description clearly details a physical catheter with various material components (polyethylene tube, hub, strain relief, marker bands, hydrophilic coating) and physical properties (tapering shaft, dimensions). The performance studies section also describes bench testing of the physical properties of the device. This indicates it is a hardware medical device, not software-only.
Based on the provided information, 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 the arterial and/or coronary vasculature) to facilitate procedures and deliver therapeutic agents. IVDs are used to examine specimens from the body (like blood, urine, tissue) to diagnose or monitor conditions.
- Device Description: The description details a catheter designed for insertion into blood vessels, with features like a shaft, hub, marker bands, and a hydrophilic coating for navigation within the body. This is consistent with an invasive medical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with in vitro diagnostics.
Therefore, the Minnie support catheter is an invasive medical device used for interventional procedures, not an IVD.
N/A
Intended Use / Indications for Use
The Minnie support catheters are 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. The Minnie support catheters also may be used to subselectively infuse/deliver therapeutic agents.
Product codes (comma separated list FDA assigned to the subject device)
DQY
Device Description
The Minnic Support Catheter is available in nine models. Each Minnie catheter is a single lumen polycthylenc tube that comprises the catheter shaft. To create a lower crossing profile, the shaft tapers at the distal end. A polyethylene hub is overmolded onto the shaft and each catheter has a printed strain relief component that is just distal of the hub. To confirm position and aid in estimating geometries in the vasculature, each device has three evenly-spaced, radiopaque marker bands at the distal end-the distal-most marker band is approximately 2.5mm from the distal tip. The 5700 and 5701 models have printed-positioning markers at 95cm and 105cm from the distal tip. A hydrophilic coating is applied to the distal-most 40cm of the shaft to provide a lubricious outer surface. Each Minnie catheter is compatible with >=5F introducer sheaths and >=6F guide catheters.
The Minnie catheter is provided sterile and intended for a single-patient 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 Minnie catheter, 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. Bench tests that were conducted were: Visual inspection for sharp edges, Radiopacity, Hydrophilic coating (lubricity), Visual inspection for excessive hydrophilic coating, Hydrophilic coating integrity, Hydrophilic coating integrity—Congo Red Dye, Tortuosity, Kink resistance, Flow rate, Turbidity, Hub-to-shaft bond strength, Distal shaft strength, Liquid leak under pressure, Air leak during aspiration, Corrosion resistance, Total marker integrity, Torque strength, Dynamic pressure, Static pressure, Distal outer diameter measurement, Marker band spacing, Hub luer compliance, Guidewire compatibility, Guide catheter compatibility, Introducer sheath compatibility, Temperature and humidity conditioning. Clinical evaluations were not required for this device.
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.
K991059, K022138, K033678, K072750, K052258, K060327
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
510(k) Summary (As required by 21 CFR 807.92(c))
510(k) Number: K082337
Date Prepared
August 13, 2008
Submitter Information
Submitter's Name: Address:
Vascular Solutions, Inc. 6464 Sycamore Court Minneapolis, MN 55369
Contact Person:
Julic Tapper Senior Regulatory Affairs Associate Phone 763-656-4228 Fax 763-656-4250
Device Information
| Trade Name: | Minnic™ Support Catheter |
|---|---|
| Common Name: | Percutaneous catheter |
| Class: | II |
| Classification Name: | Percutaneous catheter (21 CFR 870.1250, Product Code DOY) |
Predicate Devices
Quick-Cross® Support2 Catheters (K991059, K022138, K033678, and K072750), manufactured by Spectranetics Corporation.
Skyway™ Support Catheter (K052258 and K060327), manufactured by Vascular Solutions, Inc.
1
Device Description
The Minnic Support Catheter is available in nine models. A summary of the nine models is provided in the following table:
| Model Number | Guidewire Compatibility | Working Length | Proximal OD | Distal OD |
|---|---|---|---|---|
| 5700 | .014" | 135cm | 0.0390" | 0.0260" |
| 5701 | .014" | 150cm | 0.0390" | .0260" |
| 5702 | .018" | 90cm | .0440" | .0300" |
| 5703 | .018" | 135cm | .0440" | .0300" |
| 5704 | .018" | 150cm | .0440" | .0300" |
| 5705 | .035" | 65cm | .0630" | .0500" |
| 5706 | .035" | 90cm | .0630" | .0500" |
| 5707 | .035" | 135cm | .0630" | .0500" |
| 5708 | .035" | 150cm | .0630" | .0500" |
Each Minnie catheter is a single lumen polycthylenc tube that comprises the catheter shaft. To create a lower crossing profile, the shaft tapers at the distal end. A polyethylene hub is overmolded onto the shaft and each catheter has a printed strain relief component that is just distal of the hub. To confirm position and aid in estimating geometries in the vasculature, each device has three evenly-spaced, radiopaque marker bands at the distal end-the distal-most marker band is approximately 2.5mm from the distal tip. The 5700 and 5701 models have printed-positioning markers at 95cm and 105cm from the distal tip. A hydrophilic coating is applied to the distal-most 40cm of the shaft to provide a lubricious outer surface. Each Minnie catheter is compatible with ≥5F introducer sheaths and ≥6F guide catheters.
The Minnie catheter is provided sterile and intended for a single-patient use.
Intended Use/Indications for Use
The Minnie support catheters are 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. The Minnie support catheters also may be used to subselectively infuse/deliver therapeutic agents.
2
Summary of Non-clinical Testing
Bench testing was conducted on the Minnie catheter, 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. Fach bench test that was conducted is listed, below.
| Visual inspection for sharp edges | Corrosion resistance |
|---|---|
| Radiopacity | Positioning marker integrity |
| Hydrophilic coating (lubricity) | Torque strength |
| Visual inspection for excessive hydrophilic coating | Dynamic pressure |
| Hydrophilic coating integrity | Static pressure |
| Hydrophilic coating integrity—Congo Red Dye | Distal outer diameter measurement |
| Tortuosity | Marker band spacing |
| Kink resistance | Hub luer compliance |
| Flow rate | Guidewire compatibility |
| Hub-to-shaft bond strength | Guide catheter compatibility |
| Distal shaft strength | Introducer sheath compatibility |
| Liquid leak under pressure | Temperature and humidity conditioning |
| Air leak during aspiration |
Summary of Clinical Testing
Clinical evaluations were not required for this device.
Statement of Equivalence
The Minnie catheter is substantially equivalent to the currently marketed Quick-Cross and Skyway catheters, based on comparisons of the device classifications, indications 4 for use, technological characteristics, and sterilization methods.
Conclusion
The Minnie catheter is substantially equivalent to the currently marketed Quick-Cross and Skyway catheters, based on comparisons of the device classifications, indications for use, technological charactcristics, and sterilization methods. Bench tests confirmed the suitability of the device for its intended usc.
3
Image /page/3/Picture/1 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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The background is white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 5 2009
Re: K082337
Vascular Solutions, Inc.
c/o Ms. Charmaine Sutton 6464 Sycamore Court Minneapolis, MN 55369
Trade/Device Name: Minnie™ Support Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: November 26, 2008 Received: December 1, 2008
ﮩﮯ
Dear Ms. Sutton:
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.
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 (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.
4
Page 2 - Ms. Charmaine Sutton
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,
er R. buchner
Sram 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: K082337
Device Name: Minnie™ Support Catheter
Indications for Use:
The Minnie support catheters are 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. The Minnie support catheters also may be used to subselectively infuse/deliver therapeutic agents.
Prescription Use X (Part 21 CFR 801 Subpart D)
ಕ್ಕೆ ಸ
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)
ing R. V. Lines
(Division Sign-Off) (Division of Cardiovascular Devices
510(k) Number_KO 8