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.

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.

AI/ML Overview

The VSI Micro-Introducer Kit's acceptance criteria and the study proving it meets these criteria are detailed below, based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria (What the device should achieve)	Reported Device Performance (What the device actually achieved)
Bench Tests
Dimensional	Not explicitly stated, but implies meeting design specifications.	Results met specified acceptance criteria and did not raise different questions of safety and effectiveness.
Visual Inspection	Not explicitly stated, but implies meeting visual quality standards.	Results met specified acceptance criteria and did not raise different questions of safety and effectiveness.
Dilator Protrusion	Not explicitly stated, but implies meeting design specifications for protrusion.	Results met specified acceptance criteria and did not raise different questions of safety and effectiveness.
Luer Taper	Not explicitly stated, but implies meeting connection standards.	Results met specified acceptance criteria and did not raise different questions of safety and effectiveness.
Guidewire Passage	Not explicitly stated, but implies smooth passage of guidewires up to 0.018 or 0.038 inches.	Results met specified acceptance criteria and did not raise different questions of safety and effectiveness.
Insertion Force	Not explicitly stated, but implies an acceptable force for insertion.	Results met specified acceptance criteria and did not raise different questions of safety and effectiveness.
Kink	Not explicitly stated, but implies resistance to kinking during use.	Results met specified acceptance criteria and did not raise different questions of safety and effectiveness.
Aspiration	Not explicitly stated, but implies effective aspiration capabilities.	Results met specified acceptance criteria and did not raise different questions of safety and effectiveness.
Liquid Leak	Not explicitly stated, but implies no leakage of liquids.	Results met specified acceptance criteria and did not raise different questions of safety and effectiveness.
Hub Tensile	Not explicitly stated, but implies sufficient strength of the hub connection.	Results met specified acceptance criteria and did not raise different questions of safety and effectiveness.
Leveraged Tests (from predicate device)
Ink Adhesion	Not explicitly stated, but implies durability of markings.	Considered met as the tests were performed on the predicate and leveraged.
Corrosion (stiffen dilator only)	Not explicitly stated, but implies resistance to corrosion.	Considered met as the tests were performed on the predicate and leveraged.
Radiopacity (Sheath)	Not explicitly stated, but implies visibility under imaging.	Considered met as the tests were performed on the predicate and leveraged.
Biocompatibility Tests (from predicate device)
Cytotoxicity	Not explicitly stated, but implies non-toxic to cells.	Considered met as the tests were performed on the predicate and leveraged.
Sensitization	Not explicitly stated, but implies low potential for allergic reactions.	Considered met as the tests were performed on the predicate and leveraged.
Irritation/Intracutaneous Reactivity	Not explicitly stated, but implies low potential for irritation.	Considered met as the tests were performed on the predicate and leveraged.
Acute Systemic Toxicity	Not explicitly stated, but implies low potential for systemic toxicity.	Considered met as the tests were performed on the predicate and leveraged.
Hemocompatibility	Not explicitly stated, but implies compatibility with blood.	Considered met as the tests were performed on the predicate and leveraged.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated. The document mentions "The results of the design verification tests," implying a test set was used, but does not quantify its size.
Data Provenance: The study was conducted by Vascular Solutions, Inc. for the VSI Micro-Introducer Kit. It is a prospective study in the sense that new tests were performed on the subject device. However, some tests were "leveraged" from the predicate device, K101604, meaning past data from that device was used to support the subject device, which could be considered retrospective in nature for those specific tests. The origin of the data is the U.S. (Minneapolis, MN, USA).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The study primarily involves bench testing and leveraging data from a predicate device, not clinical performance requiring expert ground truth establishment in a conventional sense (e.g., image interpretation).

4. Adjudication Method for the Test Set

This information is not applicable as the study described is primarily bench testing and direct comparison to a predicate device, not a human reader or diagnostic assessment where adjudication would typically be needed.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This submission focuses on engineering and biocompatibility comparisons to a predicate device and does not involve human readers assessing device performance in a clinical setting.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

This question is not applicable as the device is a VSI Micro-Introducer Kit, a physical medical device, not an algorithm or AI system.

7. The Type of Ground Truth Used

For the bench tests, the "ground truth" was established based on the engineering specifications and performance standards for medical devices of this type, verified through laboratory testing. For the leveraged tests, the "ground truth" was the previously established performance and biocompatibility data of the predicate device (K101604).

8. The Sample Size for the Training Set

This question is not applicable as the device is a physical medical device and not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established

This question is not applicable as the device is a physical medical device and not an AI/ML algorithm.

Summary

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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);

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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

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.

Regulation Number and Section

§ 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).