(30 days)
No
The description focuses on the mechanical and material properties of a catheter, with no mention of AI or ML for image processing, data analysis, or control.
No
The device is described as a catheter used for directing, steering, controlling, and supporting a guidewire, and for delivering saline or contrast agents, which are diagnostic or interventional support functions, not therapeutic actions.
No
The primary indications for use of the Venture 038 catheter are for directing, steering, controlling, and supporting a guidewire, or for manual delivery of saline solution or diagnostic contrast agents. While it can deliver diagnostic contrast agents, the device itself does not perform any diagnostic function.
No
The device description clearly details a physical catheter with a deflectable tip, control handle, and various material properties and dimensions. The performance studies also focus on physical and material testing, not software validation.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Venture 038 catheter is a medical device used within the body (in vivo) to assist in accessing and navigating the peripheral vasculature. Its function is mechanical (directing, steering, controlling, supporting a guidewire) and for delivering substances (saline, contrast agents).
- Lack of Diagnostic Testing: The description does not mention any testing of biological samples or the generation of diagnostic information from such samples.
Therefore, based on the provided information, the Venture 038 catheter is a therapeutic and interventional medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Venture 038 catheter is indicated for directing, steering, controlling, and supporting a guidewire to access discrete regions of the peripheral vasculature. It may also be used for manual delivery of saline solution or diagnostic contrast agents.
Product codes
DQY
Device Description
The Venture 038 catheter is an over-the-wire single lumen catheter with a radiopaque deflectable distal tip. The deflectable distal tip is actuated by rotating a knob on the control handle of the proximal end of the catheter. The Venture 038 catheter has a working length of 120 cm or 70 cm and has a hydrophilic coating on the distal 45 cm of the catheter. The Venture 038 catheter provides support to 0.035" guidewires and is compatible with 6F introducer sheaths and 8F guide catheters.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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
The technological differences between the subject and predicate devices have been evaluated through biocompatibility and bench tests to provide evidence that the Venture 038 catheter is substantially equivalent to the predicate device. The Venture 038 catheter is substantially equivalent to the specified predicate device based on comparisons of the device functionality, technological characteristics, and indications for use. The device design has been verified through the following tests:
- Simulated Use
- Kink Radius
- Visual Inspection ●
- . Tip Deflection
- Tip Rotation
- Tensile Strength ●
- . Liquid Leak
- Liquid Leak Under Pressure
- Injection Pressure
- Aspiration
- Corrosion
- Particulate Count ●
Device samples passed the following biocompatibility tests performed in accordance with ISO 10993-1:
- . Cytotoxicity
- Sensitization
- Irritation
- Acute Systemic Toxicity
- Pyrogenicity ●
- Hemolysis
- Complement Activation
- In Vitro Hemocompatibility
- Coagulation ●
- Thrombogenicty
The results of the verification tests met the specified acceptance criteria and did not raise new safety or performance issues. Therefore, the Venture 038 catheter is substantially equivalent to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a series of human profiles.
June 7, 2017
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Vascular Solutions, Inc. Ms. Beka Vite Sr. Regulatory Product Specialist 6464 Sycamore Court North Minneapolis, MN 55369
Re: K171335
Trade/Device Name: Venture 038 catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: May 5, 2017 Received: May 8, 2017
Dear Ms. Vite:
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. 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
1
related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Fernando
Aguel-S
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name Venture 038 catheter
Indications for Use (Describe)
The Venture 038 catheter is indicated for directing, steering, controlling, and supporting a guidewire to access discrete regions of the peripheral vasculature. It 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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3
510(k) Summary
[As required by 21 CFR 807.92]
Date Prepared: May 5, 2017
510(k) Number: K171335
Submitter's Name / Contact Person
| Manufacturer | Contact Person |
|---|---|
| Vascular Solutions, Inc. | Beka Vite |
| 6464 Sycamore Court North | Sr. Regulatory Product Specialist |
| Minneapolis, MN | |
| 55369 USA | Tel: 763-656-4300 |
| Establishment Registration # 2134812 | Fax: 763-656-4253 |
General Information
| Trade Name | Venture 038 catheter |
|---|---|
| Common / Usual Name | Catheter, Percutaneous |
| Classification Name | Class II |
| Predicate Device | K040922 and K042910 - 0.014" Venture Wire Control Catheter, Velocimed Inc. |
| Reference Device | K142065 - Turnpike Catheter, Vascular Solutions, Inc. |
Device Description
The Venture 038 catheter is an over-the-wire single lumen catheter with a radiopaque deflectable distal tip. The deflectable distal tip is actuated by rotating a knob on the control handle of the proximal end of the catheter. The Venture 038 catheter has a working length of 120 cm or 70 cm and has a hydrophilic coating on the distal 45 cm of the catheter. The Venture 038 catheter provides support to 0.035" guidewires and is compatible with 6F introducer sheaths and 8F guide catheters.
Indications for Use
The Venture 038 catheter is indicated for directing, steering, controlling, and supporting a guidewire to access discrete regions of the peripheral vasculature. It may also be used for manual delivery of saline solution or diagnostic contrast agents.
Technological Characteristics Comparison
A comparison of technological differences between the subject and predicate device is provided below.
| Characteristic | Subject Device | Predicate Device |
|---|---|---|
| Intended Use | Directing, steering, controlling, and supporting a guidewire to access discrete regions of the vasculature | Directing, steering, controlling, and supporting a guidewire to access discrete regions of the vasculature |
| Anatomical Location | Peripheral vasculature | Coronary and peripheral vasculature |
| Venture 038 Catheter | Venture Wire Control Catheter |
4
| Characteristic | Subject Device | Predicate Device |
|---|---|---|
| Venture 038 Catheter | Venture Wire Control Catheter | |
| Working Length | 120 cm and 70 cm | 140 cm and 70 cm |
| Guidewire | ||
| Compatibility | 0.035" or 0.038" | 0.014" |
| Lubricous Coating | Hydrophilic coating | |
| Sterility | Ethylene Oxide (EO) – Sterility Assurance Level (SAL) 10-6 |
Substantial Equivalence and Summary of Studies
The technological differences between the subject and predicate devices have been evaluated through biocompatibility and bench tests to provide evidence that the Venture 038 catheter is substantially equivalent to the predicate device. The Venture 038 catheter is substantially equivalent to the specified predicate device based on comparisons of the device functionality, technological characteristics, and indications for use. The device design has been verified through the following tests:
- Simulated Use
- Kink Radius
- Visual Inspection ●
- . Tip Deflection
- Tip Rotation
- Tensile Strength ●
- . Liquid Leak
- Liquid Leak Under Pressure
- Injection Pressure
- Aspiration
- Corrosion
- Particulate Count ●
Device samples passed the following biocompatibility tests performed in accordance with ISO 10993-1:
- . Cytotoxicity
- Sensitization
- Irritation
- Acute Systemic Toxicity
- Pyrogenicity ●
- Hemolysis
- Complement Activation
- In Vitro Hemocompatibility
- Coagulation ●
- Thrombogenicty
The results of the verification tests met the specified acceptance criteria and did not raise new safety or performance issues. Therefore, the Venture 038 catheter is substantially equivalent to the predicate device.