(176 days)
No
The device description and performance studies focus on the mechanical and material properties of a catheter, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as a catheter used for directing and supporting guidewires, and for delivering saline or contrast agents. Its function is primarily to facilitate diagnostic or interventional procedures, not to provide a therapeutic effect on its own.
No
The device is primarily intended for directing, steering, controlling, and supporting a guidewire, and for manual delivery of saline solution or diagnostic contrast agents. While it can deliver contrast agents, its main function is not to perform a diagnostic assessment itself; it's an accessory for diagnostic or interventional procedures.
No
The device description clearly details a physical catheter with a deflectable tip, control handle, and lumens, indicating 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 states the device is for "directing, steering, controlling, and supporting a guidewire to access discrete regions of the coronary and peripheral vasculature." This describes a device used within the body for interventional procedures, not for testing samples outside the body.
- Device Description: The description details a catheter with a deflectable tip designed for use with a guidewire in the vasculature. This aligns with an interventional device, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing. The OTW version's use for delivering saline or contrast agents is for imaging or flushing, not for in vitro diagnostic testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely procedural and interventional.
N/A
Intended Use / Indications for Use
The Venture 0.014" catheters are indicated for directing, steering, controlling, and supporting a guidewire to access discrete regions of the coronary and peripheral vasculature. The OTW version (Model 5821) may also be used for manual delivery of saline solution or diagnostic contrast agents.
Product codes (comma separated list FDA assigned to the subject device)
DQY
Device Description
The Venture 0.014" catheters are single lumen catheters with a radiopaque deflectable distal tip designed to provide guidewire support during interventional procedures in the coronary and peripheral vasculature. The Venture 0.014" catheters are compatible with 0.014" guidewires and are available in two configurations. The rapid exchange configuration consists of a hypotube shaft with a rapid exchange (RX) lumen and deflectable tip on the distal segment. The over the wire configuration consists of an over-the-wire (OTW) lumen that runs the entire length of the catheter with a deflectable tip. The Venture 0.014" catheter tips are deflectable 90° by rotating a deflection knob on the control handle of the proximal end and a hydrophilic coating on the distal end of the catheter enhances deliverability to the target vasculature. The Venture 0.014" catheters are sterilized with ethylene oxide.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary and 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)
Performance Testing - Bench: The device design was verified through tests including: Deliver, Deflect, and Retract; Guidewire Steerability; Tip Deflection Angle; Tip Rebound; Tip Rotation; Tip Tensile; Surface Defects; Guidewire Movement; Torque Robustness; Luer to Extension Tensile; Extension to Back Handle Tensile; Liquid Leakage from Fitting Assembly under Pressure; Static Pressure; Coating Lubricity/Durability; Throw Length; Particulates; HPC Fluid Drops; Therapeutic Agent Conditioning; Dynamic Pressure. The results met specified acceptance criteria.
Biocompatibility Testing: Evaluation conducted in accordance with ISO 10993-1. Tests included: Cytotoxicity, Sensitization, Irritation, Material Mediated Pyrogenicity, Hemolysis, Complement Activation, Acute Systemic Toxicity, Thrombogenicity. Passing results demonstrated the device is noncytotoxic, non-sensitizing, non-irritating, non-systemically toxic, non-hemolytic, not an activator of the complement system, and thromboresistant.
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.
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).
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March 13, 2019
Vascular Solutions, LLC Becky Astrup Regulatory Affairs Specialist 6464 Sycamore Court North Minneapolis. Minnesota 55369
Re: K182570
Trade/Device Name: Venture 0.014" Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: DOY Dated: February 8, 2019 Received: February 11, 2019
Dear Becky Astrup:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn
(http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
| Lydia S. | Digitally signed by
Lydia S. Glaw -S |
|----------|-----------------------------------------|
| Glaw -S | Date: 2019.03.13
15:26:36 -04'00' |
for Bram 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
510(k) Number (if known)
Device Name Venture 0.014" Catheter
Indications for Use (Describe)
The Venture 0.014" catheters are indicated for directing, steering, controlling, and supporting a guidewire to access discrete regions of the coronary and peripheral vasculature. The OTW version (Model 5821) may also be used for manual delivery of saline solution or diagnostic contrast agents.
| Type of Use (Select one or both, as applicable) |
|---|
| Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image is a logo for Vascular Solutions. The logo features the word "Vascular" in a bold, serif font, with the word "SOLUTIONS" in a smaller, sans-serif font underneath. Above the text is a square shape in a light brown color, with a pattern of black squares that fade out towards the top, creating a visual effect of movement or flow.
510(k) Summary
[As required by 21 CFR 807.92]
510(k) Number: K182570
SUBMITTER AND DEVICE
| Submitter: | Vascular Solutions, LLC
6464 Sycamore Court North
Minneapolis, MN 55369 USA |
|-----------------------------|-----------------------------------------------------------------------------------|
| Establishment Registration: | 2134812 |
| Phone: | 763-656-4300 |
| Fax: | 763-656-4253 |
| Contact Person: | Becky Astrup,
Regulatory Product Specialist |
| Date Prepared: | September 14th, 2018 |
| Name of Device: | Venture 0.014" Catheter |
| Common or Usual Name: | Catheter |
| Classification Name: | Catheter, Percutaneous
(21 CFR 870.1250) |
| Regulatory Class: | II |
| Product Code: | DQY |
PREDICATE DEVICES
The legally marketed devices to which substantial equivalence is claimed is:
Primary Predicate Device: Vascular Solutions, Venture Wire Control Catheter, K042910 - cleared November 22, 2004.
Predicate Device: Vascular Solutions, Venture Wire Control Catheter, K061843 - cleared August 1, 2006.
The Vascular Solutions Turnpike Catheter, K142065- cleared November 25, 2014 and the Vascular Solutions Venture 038 Catheter, K171335- cleared June 7, 2017 are included as reference devices for this submission.
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DEVICE DESCRIPTION
The Venture 0.014" catheters are single lumen catheters with a radiopaque deflectable distal tip designed to provide guidewire support during interventional procedures in the coronary and peripheral vasculature. The Venture 0.014" catheters are compatible with 0.014" guidewires and are available in two configurations. The rapid exchange configuration consists of a hypotube shaft with a rapid exchange (RX) lumen and deflectable tip on the distal segment. The over the wire configuration consists of an over-the-wire (OTW) lumen that runs the entire length of the catheter with a deflectable tip. The Venture 0.014" catheter tips are deflectable 90° by rotating a deflection knob on the control handle of the proximal end and a hydrophilic coating on the distal end of the catheter enhances deliverability to the target vasculature. The Venture 0.014" catheters are sterilized with ethylene oxide.
INDICATIONS FOR USE
The Venture 0.014" catheters are indicated for directing, steering, controlling, and supporting a guidewire to access discrete regions of the coronary and peripheral vasculature. The OTW version (Model 5821) may also be used for manual delivery of saline solution or diagnostic contrast agents.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES
The Venture 0.014" catheter included in this Special 510(k) submission is a modification of the current Venture Wire Control Catheter. Modifications include a change in distal tip jacket material and, applicable to the OTW configuration only, an additional material processing step for the manufacturing of the liner component and removal of the proximal positioning marks. A comparison of technological differences between the subject and predicate devices is provided below.
| Characteristic | Predicate Devices:
Venture Wire Control Catheter
K042910, K061843 | Subject Device:
Venture 0.014" Catheter |
|-------------------------|-------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Principles of Operation | Deflectable tip is actuated by turning the knob on the proximal handle. | |
| Anatomical Location | Coronary and peripheral vasculature | |
| Guidewire Compatibility | 0.014" | |
| Working Length | K061843 (RX)
145 cm
K042910 (OTW)
140 cm | Model 5820 (RX):
144.5 cm
Model 5821 (OTW):
139.5 cm |
| Proximal Markers | Markers on the shaft for 90 cm and
100 cm guides. | Model 5820 (RX):
Markers on the shaft for 90 cm and
100 cm guides.
Model 5821 (OTW):
NA- No positioning marks |
| Tip Deflection | 90° from catheter axis. | |
| Lubricious Coating | Hydrophilic Coating | |
| Sterility | Ethylene Oxide (EO) – Sterility Assurance Level (SAL) 10-6 | |
| Biocompatibility | Meets ISO 10993-1 | |
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PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Performance Testing - Bench
The technological differences between the subject and predicate devices have been evaluated through bench tests to provide evidence that the Venture 0.014" catheter is substantially equivalent to the predicate devices. The device design was verified through the following tests:
- Deliver, Deflect, and Retract ●
- Guidewire Steerability
- Tip Deflection Angle ●
- Tip Rebound ●
- Tip Rotation ●
- Tip Tensile
- Surface Defects ●
- Guidewire Movement
- Torque Robustness ●
- Luer to Extension Tensile
- Extension to Back Handle Tensile ●
- Liquid Leakage from Fitting ● Assembly under Pressure
- Static Pressure
- Coating Lubricity/Durability ●
- Throw Length ●
- Particulates ●
- HPC Fluid Drops ●
- Therapeutic Agent Conditioning ●
- Dynamic Pressure ●
The results of the verification tests met the specified acceptance criteria and did not raise different questions of safety and effectiveness.
Biocompatibility Testing
The biocompatibility evaluation for the Venture 0.014" catheter was conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The Venture 0.014" catheter is considered an externally communicating device in contact with circulating blood and tissue for a limited period of time (