(154 days)
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.
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.
The provided 510(k) summary is for the Minnie™ Support Catheter, a medical device. This type of device is not an AI/ML-driven product, but rather a physical catheter used in interventional procedures. Therefore, many of the requested criteria related to AI/ML device studies (such as sample sizes for test/training sets, ground truth establishment methods, expert panel details, MRMC studies, and standalone performance) are not applicable to this submission.
However, I can extract and present the information related to the acceptance criteria and the study that proves the device meets them, based on the provided document.
Minnie™ Support Catheter Acceptance Criteria and Performance Study
1. A table of acceptance criteria and the reported device performance
The document lists various bench tests conducted to assess the physical properties and intended use suitability of the Minnie™ Support Catheter. For each of these tests, the "reported device performance" is implicitly stated as having "confirmed the suitability of the device for its intended use" and "Bench tests confirmed the suitability of the device for its intended use." Specific quantitative acceptance criteria or detailed performance results for each test are not provided in this summary.
| Acceptance Criteria (Bench Test Category) | Reported Device Performance (Implicit) |
|---|---|
| Visual inspection for sharp edges | Suitability for intended use confirmed |
| Radiopacity | Suitability for intended use confirmed |
| Hydrophilic coating (lubricity) | Suitability for intended use confirmed |
| Visual inspection for excessive hydrophilic coating | Suitability for intended use confirmed |
| Hydrophilic coating integrity | Suitability for intended use confirmed |
| Hydrophilic coating integrity—Congo Red Dye | Suitability for intended use confirmed |
| Tortuosity | Suitability for intended use confirmed |
| Kink resistance | Suitability for intended use confirmed |
| Flow rate | Suitability for intended use confirmed |
| Hub-to-shaft bond strength | Suitability for intended use confirmed |
| Distal shaft strength | Suitability for intended use confirmed |
| Liquid leak under pressure | Suitability for intended use confirmed |
| Air leak during aspiration | Suitability for intended use confirmed |
| Corrosion resistance | Suitability for intended use confirmed |
| Positioning marker integrity | Suitability for intended use confirmed |
| Torque strength | Suitability for intended use confirmed |
| Dynamic pressure | Suitability for intended use confirmed |
| Static pressure | Suitability for intended use confirmed |
| Distal outer diameter measurement | Suitability for intended use confirmed |
| Marker band spacing | Suitability for intended use confirmed |
| Hub luer compliance | Suitability for intended use confirmed |
| Guidewire compatibility | Suitability for intended use confirmed (explicitly states compatibility) |
| Guide catheter compatibility | Suitability for intended use confirmed (explicitly states compatibility) |
| Introducer sheath compatibility | Suitability for intended use confirmed (explicitly states compatibility) |
| Temperature and humidity conditioning | Suitability for intended use confirmed |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: This information is not provided in the document. The tests conducted are "bench tests," implying laboratory testing of device samples. The exact number of samples tested for each criterion is not specified.
- Data Provenance: The tests are "bench testing," meaning in-vitro laboratory evaluations, not tests on human data. No country of origin for data is relevant in this context, nor is retrospective or prospective classification.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This is not applicable. The "ground truth" for a physical medical device in bench testing is determined by established engineering and material science standards and measurement techniques, not by expert medical opinion in the same way an AI model's output might be adjudicated.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods involving multiple expert readers are relevant for subjective interpretations of data (e.g., medical images) or algorithm outputs, not for objective physical bench tests of a device.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. The Minnie™ Support Catheter is a physical medical device, not an AI/ML-driven system that would assist human readers in interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. The Minnie™ Support Catheter is a physical medical device and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the bench tests would have been established by objective measurements against predefined engineering specifications and industry standards. For example, "Distal outer diameter measurement" would have a specified tolerance, and the ground truth is whether the measured diameter falls within that tolerance. Similarly for "Flow rate" or "Kink resistance," there would be measurable standards.
8. The sample size for the training set
This is not applicable. There is no "training set" for a physical medical device in the context of this 510(k) submission.
9. How the ground truth for the training set was established
This is not applicable for the reasons stated above.
Summary of Study for the Minnie™ Support Catheter:
The study proving the Minnie™ Support Catheter meets its acceptance criteria was comprised solely of bench testing. These tests assessed the physical properties and functionality of the device against internal specifications, engineering standards, and performance expectations for its intended use. Clinical evaluations were explicitly stated as "not required" for this device. The conclusion of the submission is based on the findings from these bench tests, affirming the device's suitability for its intended use, and its substantial equivalence to predicate devices (Quick-Cross® Support2 Catheters and Skyway™ Support Catheter) based on classifications, indications, technological characteristics, and sterilization methods.
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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.
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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.
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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.
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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.
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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
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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
§ 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).