GREBSET MICRO-INTRODUCER KIT, MODELS 7950, 7951

K081846 · Vascular Solutions, Inc. · DQO · Jan 28, 2009 · Cardiovascular

Device Facts

• Record ID: K081846
• Device Name: GREBSET MICRO-INTRODUCER KIT, MODELS 7950, 7951
• Applicant: Vascular Solutions, Inc.
• Product Code: DQO · Cardiovascular
• Decision Date: Jan 28, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1200
• Device Class: Class 2

Intended Use

The GrebSet micro-introducer kit is intended to facilitate the percutaneous placement of guidewires in the vascular system and for delivery of contrast media to vascular sites.

Device Story

GrebSet micro-introducer kit facilitates vascular access and contrast media delivery. Components include access needle (21G echogenic or 20G Trocar), 0.018" guidewire, dilator, and catheter with radiopaque marker band. Compatible with guidewires ≤0.038"/0.965mm. Used by clinicians in clinical settings to gain vascular access. Device enables guidewire placement and contrast injection, aiding diagnostic or interventional procedures. Benefits include reliable vascular access and visualization via radiopaque marker.

Clinical Evidence

No clinical evaluations were conducted. Substantial equivalence is supported by bench testing, including aspiration, corrosion resistance, leakage, curve retention, pressure testing, kink testing, tortuosity, coating performance, torque, and fluoroscopic visualization.

Technological Characteristics

Kit includes access needle, 0.018" guidewire, dilator, and catheter with radiopaque marker band. Compatible with guidewires up to 0.038". Features hydrophilic coating. Bench testing verified mechanical integrity (torque, kink, pressure, aspiration). No software or electronic components.

Indications for Use

Indicated for patients requiring percutaneous guidewire placement in the vascular system and delivery of contrast media to vascular sites.

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

• InnerChange Micro-Introducer Catheter (K073585)
• AccuStick II (K unknown)
• Neff Percutaneous Access Set (K unknown)

Submission Summary (Full Text)

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# 510(k) Summary

JAN 2 8 2009

## 510(k) Number: K081846

## Date Prepared

September 8, 2008

### Submitter Information

Submitter's Name: Address:

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

Establishment Registration 2134812

Contact Person:

Julie Tapper, Senior Regulatory Affairs Associate [e-mail] 763-656-4300

# Device Information

Trade Name: Classification Name: Product Code: Regulation:

GrebSet micro-introducer kit Diagnostic Intravascular Catheter DOO 21 CFR 870.1200

#### Predicate Devices

Vascular Solutions: InnerChange Micro-Introducer Catheter (K073585) Boston Scientific; AccuStick II (K unknown) Cook Medical; Neff Percutaneous Access Set (K unknown)

# Device Description

The GrebSet micro-introducer kit is designed to gain access and deliver contrast media to selected vascular sites. The GrebSet catheter is compatible with ≤0.038"/.965mm guidewires. Each GrebSet kit consists of the following components:

- Access needle (21G echogenic percutaneous entry needle OR 20G echogenic Trocar . needle)
- 0.018" guidewire .
- Dilator .
- Catheter with radiopaque marker band located on distal tip ●

#### Intended Use/Indications for Use

The GrebSet micro-introducer kit is intended to facilitate the percutaneous placement of guidewires in the vascular system and for delivery of contrast media to vascular sites.

# Summary of Non-Clinical Testing

Testing conducted included assessments of the design verification of the GrebSet catheter along with biocompatibility assessments and shelf life testing to ensure that the device would

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perform as intended. The results of this testing confirmed the suitability of the GrebSet Catheter for its intended use. Each bench test that was conducted is listed, as follows:

| Aspiration Testing | Corrosion Resistance |
|-----------------------------------------|----------------------------------|
| Catheter Liquid Leakage Under Pressure | GrebSet Catheter Curve Retention |
| Static & Dynamic High Pressure Catheter | GrebSet Catheter Tortuosity |
| Testing | |
| Catheter Kink Testing | Hydrophilic Coating Performance |
| Fluoroscopic Visualization Test | Catheter Torque Test |
| Catheter Flow Rate Test | Force At Break |

# Summary of Clinical Testing

No clinical evaluations of this product have been conducted.

### Statement of Equivalence

The GrebSet micro-introducer kit has similar intended for use and functions as the predicate device.

#### Conclusion

Through the data and information presented, Vascular Solutions considers the GrebSet micro-introducer kit to be substantially equivalent to the predicate device. The testing performed confirms that the GrebSet Catheter will perform as intended.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract emblem resembling an eagle or bird in flight, composed of three curved lines representing the wings and a stylized head and body.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Vascular Solutions, Inc. c/o Ms. Julie Tapper Senior Regulatory Affairs Associate 6464 Sycamore Court Minneapolis, MN 55369

JAN 2 8 2009

Re: K081846

> Trade/Device Name: GrebSet™ Micro-introducer Kit Common Name: Diagnostic Intravascular Catheter Regulation Number: 21 CFR 870.1200 Regulatory Class: II Product Code: DQO Dated: December 23, 2008 Received: December 24, 2008

Dear Ms. Tapper:

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. Drue, 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

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#### Page 2 - Ms. Julie Tapper

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. 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 Biometrics' (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 may 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,

K//C/
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: K081846

Device Name:

. GrebSet™ Micro-introducer Kit

#### Indications for Use:

The GrebSet micro-introducer kit is intended to facilitate the percutaneous placement of guidewires in the vascular system and for delivery of contrast media to vascular sites.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

# (PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Cardiovascellar Devices 510(k) Number

Vascular Solutions, Inc. K081846 FDA Deficiency Letter Response