VSI Micro-Introducer Kit

K180913 · Vascular Solutions, Inc. · DYB · May 9, 2018 · Cardiovascular

Device Facts

• Record ID: K180913
• Device Name: VSI Micro-Introducer Kit
• Applicant: Vascular Solutions, Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: May 9, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

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.

Device Story

VSI Micro-Introducer Kit facilitates vascular access; consists of sheath (10-30 cm length; 2.3F, 4F, or 5F O.D.; straight or angled tip) and dilator (regular or stiffened). Sheath and dilator feature high-density polyethylene shafts/hubs; stiffened dilator includes stainless steel hypotube. Rotating luer lock secures dilator to sheath. Used by clinicians in clinical settings for percutaneous entry; enables smooth transition for guidewire/catheter insertion into vascular system. Device provides access point for subsequent interventional procedures; benefits patient by minimizing trauma during initial vascular access.

Clinical Evidence

Bench testing only. No clinical data. Verification tests included dimensional verification, visual inspection, dilator protrusion, luer taper, guidewire passage, insertion force, kink, aspiration, liquid leak, and hub tensile strength. Biocompatibility (cytotoxicity, sensitization, irritation, acute systemic toxicity, hemocompatibility) and performance (ink adhesion, corrosion, radiopacity) were leveraged from the predicate device.

Technological Characteristics

Materials: High-density polyethylene (shaft/hub), stainless steel (stiffen dilator hypotube). Design: Sheath/dilator assembly with rotating luer lock. Dimensions: 10-30 cm length, 2.3F-5F O.D. Sterilization: Ethylene oxide. Connectivity: None (manual device).

Indications for Use

Indicated for percutaneous introduction of guidewires or catheters (up to 0.038 inch) into the vascular system following small gauge needle stick.

Regulatory Classification

Identification

A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

Predicate Devices

• VSI Micro Introducer Kit (K101604)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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: [phone] Fax: [phone]

## 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.