INNERCHANGE MICRO-INTRODUCER CATHETER, MODELS 7900, 7901, 7902, 7903, 7904 AND 7905

K073585 · Vascular Solutions, Inc. · DQO · Apr 17, 2008 · Cardiovascular

Device Facts

• Record ID: K073585
• Device Name: INNERCHANGE MICRO-INTRODUCER CATHETER, MODELS 7900, 7901, 7902, 7903, 7904 AND 7905
• Applicant: Vascular Solutions, Inc.
• Product Code: DQO · Cardiovascular
• Decision Date: Apr 17, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1200
• Device Class: Class 2

Intended Use

The INNERCHANGE micro-introducer catheter is intended for use in accessing the vascular system through a small gauge needle stick and for delivering radiopaque media to selected sites in the vascular system in conjunction with routine diagnostic procedures.

Device Story

The InnerChange Micro-Introducer Catheter is a diagnostic intravascular device used to obtain vascular access and deliver radiopaque contrast media. The system includes a 21G percutaneous entry needle, a 0.018" guidewire, a dilator, and a hydrophilically coated diagnostic catheter with an attached stopcock. It is designed for use by clinicians in a clinical setting. The device is compatible with guidewires up to 0.038"/965mm. By facilitating access through a small gauge needle, the device allows for diagnostic imaging procedures, aiding clinicians in visualizing the vascular system to inform clinical decision-making and patient management.

Clinical Evidence

No clinical data; bench testing only. Testing included radiopacity, visual inspection of coating, catheter/dilator assembly, guidewire passage, tortuosity, flow rate, dynamic pressure, kink radius, liquid leak, and shaft strength.

Technological Characteristics

Diagnostic intravascular catheter with hydrophilic coating. Components include 21G percutaneous entry needle, 0.018" guidewire, dilator, and catheter with stopcock. Compatible with ≤0.038" guidewires. Mechanical device; no energy source or software.

Indications for Use

Indicated for patients requiring vascular access via small gauge needle stick for the delivery of radiopaque media during routine diagnostic procedures.

Regulatory Classification

Identification

An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.

Predicate Devices

• Vascular Solutions, Inc. InnerChange Micro-Introducer Catheter (K062627)

Submission Summary (Full Text)

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# 510(k) Summary

510(k) Number: K073585

## Date Prepared

December 19, 2007

#### Submitter Information

Submitter's Name/ Address:

Vascular Solutions, Inc. 6464 Sycamore Court Minneapolis, MN 55369

Establishment Registration 2134812

Contact Person:

Alternative contact:

Alyssa Malinski 763-656-4300 [e-mail] Doralie Poganski 763-656-4300 dpoganski(@)vascularsolutions.com

#### Device Information

Trade Name: InnerChange™ Micro-Introducer Catheter Common Name: Diagnostic Intravascular Catheter Classification Name: Diagnostic Intravascular Catheter Product Code: DQO Regulation: Class II, 21 CFR 870.1200

#### Predicate Device(s)

- Vascular Solutions, Inc. InnerChange Micro-Introducer Catheter (K062627) .

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## Device Description

The INNERCHANGE micro-introducer catheter combines a micro-introducer kit for obtaining vascular access with a hydrophilically coated diagnostic catheter. The INNERCHANGE catheter is designed to be used for delivering radiopaque media to selected sites in the vascular system in conjunction with routine diagnostic procedures. The INNERCHANGE micro-introducer catheter is compatible with ≤0.038" / 965mm guidewires. Each INNERCHANGE micro-introducer catheter consists of the following components:

- . 21G percutaneous entry needle
- 0.018" guidewire .
- Dilator .
- Catheter with selected tip shape and attached stopcock .

#### Intended Use/Indications for Use

The INNERCHANGE micro-introducer catheter is intended for use in accessing the vascular system through a small gauge needle stick and for delivering radiopaque media to selected sites in the vascular system in conjunction with routine diagnostic procedures.

#### Summary of Non-Clinical Testing

Testing conducted included assessments of the design verification of the InnerChange Micro-Introducer Catheter along with biocompatibility assessments and shelf life testing. The results of this testing confirmed the suitability of the InnerChange Micro-Introducer Catheter for its intended use. Each bench test that was conducted is listed:

- Radiopacity .
- . Visual inspection (lubricious coating)
- . Visual inspection of catheter/dilator
- Catheter Curve retention .
- Dilator passage .
- � Dilator/catheter tapered tip assembly
- Guidewire passage .
- 4 Catheter Tortuosity test
- Hydrophilic coating inspection after tortuosity .
- . Flow rate with contrast
- Dynamic pressure test (catheter only)
- . Kink radius
- Liquid leak test (catheter only) .
- Proximal to distal shaft strength .

#### Summary of Clinical Testing

No clinical evaluations of this product have been conducted.

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#### Statement of Equivalence

The InnerChange Micro-Introducer Catheter has the exact intended use and function as the Vascular Solutions InnerChange Catheters (K062627).

## Conclusion

Through the data and information presented, Vascular Solutions considers the InnerChange Micro-Introducer Catheter to be substantially equivalent to the Vascular Solutions InnerChange Catheters (K062627). The testing performed confirms that the InnerChange Micro-Introducer Catheter will perform as intended.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem resembling an eagle or bird in flight, with three curved lines representing the wings and a wavy line representing the body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# APR 1 7 2008

Vascular Solutions c/o Ms. Alyssa Malinski 6464 Sycamore Court Minneapolis, MN 55369

Re: K073585

> Trade Name: InnerChange Micro-Introducer Catheter (Models 7900, 7901, 7902, 7903, 7904, 7905) Regulation Number 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: Class II Product Code: DQO Dated: April 11, 2008 Received: April 14, 2008

Dear Ms. Malinski:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality

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Page 2 -- Ms. Alyssa Malinski

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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You mav obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

buma R. bohner

S

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 Statement

# 510(k) Number (if known): K07 35 85

Device Name: InnerChange™ Micro-Introducer Catheter

#### Indications for Use:

The INNERCHANGE micro-introducer catheter is intended for use in accessing the vascular system through a small gauge needle stick and for delivering radiopaque media to selected sites in the vascular system in conjunction with routine diagnostic procedures.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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#### Concurrence of CDRH, Office of Device Evaluation (ODE)

sumna D. de Aunes

510(k) Number K023585

⁽Division Sign-Off) (Division Sign-Off)
Division of Cardiovascular Devices