PIGGYBACK WIRE CONVERTER

K090977 · Vascular Solutions, Inc. · DQY · Jun 18, 2009 · Cardiovascular

Device Facts

• Record ID: K090977
• Device Name: PIGGYBACK WIRE CONVERTER
• Applicant: Vascular Solutions, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Jun 18, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PIGGYBACK wire converter is intended to be used with guide wires to access the peripheral vasculature and to facilitate placement of interventional devices.

Device Story

PiggyBack wire converter is a 0.035" outer-diameter support catheter compatible with 0.014" guide wires; used to access peripheral vasculature and facilitate interventional device placement. Device features hydrophilic shaft coating for ease of advancement and distal radiopaque marker band for visualization. Proximal end includes locking mechanism to secure catheter onto guide wire while remaining outside patient. Used by clinicians in interventional settings. Benefits include improved support and navigation during vascular procedures.

Clinical Evidence

Bench testing only; no clinical data.

Technological Characteristics

0.035" outer-diameter support catheter; hydrophilic shaft coating; radiopaque distal marker band; locking mechanism for 0.014" guide wires; available in 80 cm, 120 cm, and 145 cm lengths.

Indications for Use

Indicated for use with guide wires to access peripheral vasculature and facilitate placement of interventional devices in patients requiring peripheral vascular intervention.

Regulatory Classification

Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Predicate Devices

• Skyway OTW support catheter (K083784)

Submission Summary (Full Text)

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Vascular Solutions, Inc.

#### 510(k) Summary 2

JUN 18 2009

## Date Prepared: March 31, 2009

#### Submitter's Name / Contact Person

#### Manufacturer

Vascular Solutions, Inc. 6464 Sycamore Court Minneapolis, MN 55369 USA Establishment Registration # 2134812

#### Contact Person

Charmaine Sutton, RAC Acting VP of Regulatory Tel: [phone] (direct); Fax: [phone] Email: [e-mail]

# General Information

| Trade Name | PiggyBack™ wire converter |
|---------------------|----------------------------------------------------------------|
| Common / Usual Name | Percutaneous catheter |
| Classification Name | 870.1250 Catheter, percutaneous |
| Predicate Device | K083784 Skyway OTW support catheter (Vascular Solutions, Inc.) |

#### Device Description

The PiggyBack wire converter is a 0.035" outer-diameter support catheter that is compatible with standard 0.014" guide wires. The shaft has a hydrophilic coating to facilitate ease of advancement into the vasculature. The distal tip of the PiggyBack has a radiopaque marker band. The proximal end of the catheter, which remains outside of the patient, has a locking mechanism that secures the PiggyBack onto the 0.014" guide wire. The PiggyBack is provided in three working lengths: 80 cm, 120 cm, and 145 cm.

#### Intended Use / Indications

The PiggyBack wire converter is intended to be used with guide wires to access the peripheral vasculature and to facilitate placement of interventional devices.

#### Substantial Equivalence and Summary of Studies

The PiggyBack wire converter is substantially equivalent in intended use and indications to the predicate device. Technological differences in design and materials have been qualified through biomaterial assessments and verification testing, the results of which did not raise any new safety or performance questions.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wings, representing health, human services, and the USA. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

# JUN 18 2009

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Vascular Solutions, Inc. c/o Ms. Charmaine Sutton 6464 Sycamore Ct. Minneapolis, MN 55369

Re: K090977

Trade/Device Name: PiggyBack Wire Converter Regulation Number: 21 CFR 870.1250 Regulation Name: Catheter, Percutaneous Regulatory Class: Class II (two) Product Code: DQY Dated: April 2, 2009 Received: April 6, 2009

## Dear Ms. Sutton:

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 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.

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Page 2 - Ms. Charmaine Sutton

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21. CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 vours.

Dunia R. Voolmer

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Device Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K090977

Device Name: PiggyBackTM wire converter

Indications for Use:

The PIGGYBACK wire converter is intended to be used with guide wires to access the peripheral vasculature and to facilitate placement of interventional devices.

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Posted November 13, 2003)

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(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_K0909 77