(30 days)
Not Found
No
The device description and performance studies focus on the physical components and mechanical properties of a micro-introducer kit, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is used for introducing guidewires/catheters into the vascular system, which is a preparatory step for other procedures, not a therapeutic action itself.
No
The device is described as an introducer kit used for percutaneous introduction of guidewires or catheters, and the "Intended Use / Indications for Use" section does not mention any diagnostic functions.
No
The device description clearly outlines physical components like sheaths, dilators, and hypotubes, and the performance studies involve bench tests on these physical components. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "percutaneous introduction of up to a 0.018 inch guidewire or catheter into the vascular system." This describes a procedure performed on the patient's body, not a test performed on a sample taken from the patient.
- Device Description: The device is a physical introducer kit consisting of a sheath and dilator. This is a surgical/interventional tool, not a reagent, instrument, or system used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a tool used to facilitate a medical procedure.
N/A
Intended Use / Indications for Use
VSI Micro-Introducer Kits are intended for use in percutaneous introduction of up to a 0.018 inch guidewire or catheter into the vascular system following a small gauge needle stick.
Product codes
DYB
Device Description
The VSI micro-introducer kits consist of a sheath and are available in lengths of 10 cm to 30 cm. The sheath is available with either a 2.3 F, 4 F or 5 F outer diameter (O.D.) and with a straight or angled tip. The dilator is available with regular flexibility or in a 'stiffen' version. The sheath and dilator consist of a high-density polyethylene shaft and hub; the sheath shaft has a tapered distal tip that provides a smooth transition to the distal tip of the dilator. A rotating luer lock on the distal end of the dilator hub can be locked on to the sheath hub. The stiffen dilator shaft contains a stainless steel hypotube.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vascular system
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 device have been evaluated through bench tests to provide evidence of VSI Micro-Introducer Kit substantial equivalence. The VSI Micro-Introducer Kit is substantially equivalent to the specified predicate device based on comparisons of the device functionality, technological characteristics, and indications for use. The results of the design verification tests met the specified acceptance criteria and did not raise different questions of safety and effectiveness.
The device design has been verified through the following tests:
- . Dimensional Verification
- . Visual Inspection
- Dilator Protrusion ●
- Luer Taper ●
- Guidewire Passage ●
- Insertion Force
- Kink
- Aspiration
- Liquid Leak
- Hub Tensile
The following design verification tests were performed on the predicate device and leveraged for the subject device:
- . Ink Adhesion
- Corrosion (stiffen dilator only) ●
- Radiopacity (Sheath)
The following biocompatibility tests were performed on the predicate device and leveraged for the subject device:
- . Cytotoxicity
- Sensitization ●
- Irritation/intracutaneous reactivity ●
- Acute systemic toxicity ●
- Hemocompatibility ●
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health and Human Services logo on the left and the FDA acronym and full name on the right. The Department of Health and Human Services logo is a stylized representation of a human figure, while the FDA acronym and full name are written in blue.
May 9, 2018
Vascular Solutions, Inc % Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, Minnesota 55313
Re: K180913
Trade/Device Name: VSI Micro-Introducer Kit Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer Regulatory Class: Class II Product Code: DYB Dated: April 4, 2018 Received: April 9, 2018
Dear Mark Job:
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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-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,
Kenneth J. Cavanaugh -S
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) K180913
Device Name VSI Micro-Introducer Kit
Indications for Use (Describe)
VSI Micro-Introducer Kits are intended for use in percutaneous introduction of up to a 0.018 inch guidewire or catheter into the vascular system following a small gauge needle stick.
Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
[As required by 21 CFR 807.92]
Date Prepared: 03/23/2018
K180913 510(k) Number: _
Submitter's Name / Contact Person
Manufacturer
Vascular Solutions, Inc. 6464 Sycamore Court North Minneapolis, MN 55369 USA Establishment Registration # 2134812
Contact Person
Nancy Frame Sr. Regulatory Product Specialist Tel: 763-656-4230 Fax: 763-656-4253
General Information
| Trade Name | VSI Micro-Introducer Kit |
|---|---|
| Common / Usual Name | Catheter introducer |
| Classification Product Code | DYB |
| Classification Name | 21 CFR 870.1340 |
| Predicate Device | K101604, VSI Micro Introducer Kit, Vascular Solutions, Inc |
Device Description
The VSI micro-introducer kits consist of a sheath and are available in lengths of 10 cm to 30 cm. The sheath is available with either a 2.3 F, 4 F or 5 F outer diameter (O.D.) and with a straight or angled tip. The dilator is available with regular flexibility or in a 'stiffen' version. The sheath and dilator consist of a high-density polyethylene shaft and hub; the sheath shaft has a tapered distal tip that provides a smooth transition to the distal tip of the dilator. A rotating luer lock on the distal end of the dilator hub can be locked on to the sheath hub. The stiffen dilator shaft contains a stainless steel hypotube.
Intended Use
VSI Micro-Introducer Kits are intended for use in percutaneous introduction of up to a 0.018 inch or 0.038 inch guidewire or catheter into the vascular system following a small gauge needle stick.
Technological Characteristics Comparison
This submission proposes minor specifications to improve manufacturability and robustness for the 4F and 5F models. The subject VSI Micro-Introducer Kit has equivalent design components and materials, and is similar in components and dimensions to the predicate device. The subject and predicate devices consist of a sheath and a dilator, are available in the same nominal O.D.s, and utilize identical patient contacting materials of construction. Like the predicate device, the subject VSI Micro-Introducer Kits are compatible with guidewires and catheters with a maximum O.D. of 0.038". Both the subject VSI Micro-Introducer Kit and the predicate device are sterilized in an ethylene oxide process, and have identical sterile barrier packaging materials.
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Substantial Equivalence and Summary of Studies
The technological differences between the subject and predicate device have been evaluated through bench tests to provide evidence of VSI Micro-Introducer Kit substantial equivalence. The VSI Micro-Introducer Kit is substantially equivalent to the specified predicate device based on comparisons of the device functionality, technological characteristics, and indications for use. The results of the design verification tests met the specified acceptance criteria and did not raise different questions of safety and effectiveness.
The device design has been verified through the following tests:
- . Dimensional Verification
- . Visual Inspection
- Dilator Protrusion ●
- Luer Taper ●
- Guidewire Passage ●
- Insertion Force
- Kink
- Aspiration
- Liquid Leak
- Hub Tensile
The following design verification tests were performed on the predicate device and leveraged for the subject device:
- . Ink Adhesion
- Corrosion (stiffen dilator only) ●
- Radiopacity (Sheath)
The following biocompatibility tests were performed on the predicate device and leveraged for the subject device:
- . Cytotoxicity
- Sensitization ●
- Irritation/intracutaneous reactivity ●
- Acute systemic toxicity ●
- Hemocompatibility ●
Conclusions
The technological differences between the subject VSI Micro-Introducer Kit and the predicate device do not raise different questions of safety and effectiveness. The subject VSI Micro-Introducer Kit is identical to the predicate device in its indications for use and materials, and is substantially equivalent in technology and performance to the predicate device. Performance data demonstrate that the subject VSI
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Micro-Introducer Kit is as safe, as effective, and performs as well as the predicate device. Therefore, it can be concluded that the subject VSI Micro-Introducer Kit is substantially equivalent to the predicate device.