SUPERCROSS MICROCATHETER (130 CM), SUPERCROSS MICROCATHETER (150 CM) MODEL 5300, 5301

K101659 · Vascular Solutions, Inc. · DQY · Dec 16, 2010 · Cardiovascular

Device Facts

• Record ID: K101659
• Device Name: SUPERCROSS MICROCATHETER (130 CM), SUPERCROSS MICROCATHETER (150 CM) MODEL 5300, 5301
• Applicant: Vascular Solutions, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Dec 16, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The SuperCross microcatheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the coronary and/or peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and to subselectively infuse/deliver diagnostic and therapeutic agents.

Device Story

SuperCross microcatheter is a single-lumen, braided-shaft catheter for coronary and peripheral vascular access. Used with 0.014-inch steerable guidewires; facilitates guidewire/interventional device placement and exchange; enables subselective infusion of diagnostic/therapeutic agents. Features include radiopaque distal marker band, hydrophilic coating on distal 40 cm, and positioning marks. Operated by physicians in clinical settings. Device provides a pathway for guidewires and agents; aids navigation through small, tortuous anatomy. Benefits include improved deliverability and access to target vasculature.

Clinical Evidence

Bench testing only. No clinical data. Verification testing included simulated anatomy/concomitant device use, hydrophilic coating integrity, liquid leak, kink, static pressure, air aspiration, tensile, torque, dimensional verification, radiopacity, and comprehensive biocompatibility (cytotoxicity, sensitization, irritation, acute systemic toxicity, material-mediated pyrogens, hemocompatibility).

Technological Characteristics

Single-lumen catheter; braided stainless steel backbone with thermoplastic shaft; hydrophilic coating; radiopaque distal marker; 0.014-inch guidewire compatible; ISO 594-1/594-2 compliant luer hub; 300 psi injection pressure rating; ethylene oxide sterilization.

Indications for Use

Indicated for patients requiring access to discrete regions of coronary or peripheral vasculature for guidewire placement/exchange or subselective infusion of diagnostic/therapeutic agents.

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

• Gopher™ Gold catheter (K091345)

Submission Summary (Full Text)

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DEC 16 2010

## 2 510(k) Summary

[As required by 21 CFR 807.92]

510(k) Number: K101659

#### Submitter's Information / Contact Person

#### Manufacturer

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

#### Date Prepared: December 13, 2010

#### Contact Person

Matt Nienstedt Regulatory Affairs Associate Tel: [phone] (direct) Fax: [phone] Email: [e-mail]

#### Alternate Contact Person

Stacy Quellette Senior Regulatory Affairs Operations Associate Tel: [phone] (direct) Fax: [phone] Email: [e-mail]

#### General Information

| Trade Name | SuperCross™ microcatheter |
|---------------------|------------------------------------------------------------|
| Common / Usual Name | microcatheter |
| Classification Name | 21 CFR 870.1250, Catheter, Percutaneous |
| Predicate Device | Gopher™ Gold catheter (K091345 - Vascular Solutions, Inc.) |

#### Device Description

The SuperCross™ microcatheter (SuperCross) is a single-lumen catheter designed for use in the coronary and peripheral vasculature. The SuperCross tubing consists of a braided shaft that tapers distally to create a low profile. SuperCross is compatible with a 0.014 inch diameter guidewire with a minimum length of 180 cm. The SuperCross has a single gold marker band located 0.035 inch (0.89 mm) from the distal tip of the catheter. The distal 40 cm of the SuperCross has a hydrophilic coating to enhance deliverability to the target vasculature. The device has positioning marks located at 95 cm and 105 cm from the distal tip, respectively. The proximal end of the catheter incorporates a strain relief and a luer-lock adapter for flushing, wire insertion, and accessory attachment.

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#### Intended Use / Indications

The SuperCross microcatheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the coronary and/or peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and to subselectively infuse/deliver diagnostic and therapeutic agents.

### Technological Characteristics

The SuperCross microcatheter is substantially equivalent in device design and performance to the predicate device. The SuperCross and predicate Gopher Gold devices have the following characteristics in common:

- . Compatibility with 0.014 inch guidewires
- . Shaft configuration - The shafts of the SuperCross and Gopher Gold are both constructed from a braided stainless steel backbone and several thermoplastics bonded together that taper from larger, proximal inner and outer diameters to smaller, distal inner and outer diameters.
- Radiopaque distal tips .
- . Positioning marks
- . Similar inner and outer diameters
- Tapered distal tips The SuperCross and predicate Gopher Gold are both designed with . tapered distal tips to aid in navigating small, tortuous anatomy.
- . Hub configuration - Both the predicate and subject device have proximal hubs (with strain reliefs) that are compatible with ISO 594-1 and ISO 594-2 compliant luer fittings.
- . Rated to 300 psi injection pressure
- . Sterilized by ethylene oxide
- Packaged in identical sterile pouch and retail box .

The SuperCross and Gopher Gold devices differ in the following:

- Specific catheter shaft and hub materials and construction .
- "Hydrophilic coating SuperCross has a hydrophilic coating and the predicate Gopher Gold . does not.
- Torque device and threaded tip The predicate Gopher Gold device features a threaded distal tip and is supplied with a torque device while the SuperCross does not contain these features

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#### Substantial Equivalence and Summary of Studies

The SuperCross microcatheter is substantially equivalent to the specified predicate device based on comparisons of the device functionality, technological characteristics, and indications for use. The device design was qualified through the following tests:

- Simulated anatomy/concomitant device use .
- Hydrophilic coating integrity and particulates .
- Liquid leak .
- . Kink
- Static pressure .
- Air aspiration .
- . Tensile
- Torque ●
- Dimensional verification .
- Radiopacity .
- . Biocompatibility
- o Cytotoxicity
- Sensitization O
- o Irritation/intracutaneous reactivity
- Acute systemic toxicity o
- Material mediated pyrogens o
- Hemocompatibility o
- Hemolysis ■
- Coagulation
- . Prothrombin time
- Hemotological parameters
- Complement activation 트
- 피 Thrombogenicity

Results of the verification testing and biomaterial assessments met the specified acceptance criteria and did not raise new safety or performance questions.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002

DEC 16 2010

Vascular Solutions, Inc. c/o Mr. Matt Nienstedt Regulatory Affairs Associate 6464 Sycamore Court Minneapolis, MN 55369

Re: K101659

Trade/Device Name: SuperCross™ Microcatheter Common Name: Catheter, Percutaneous Regulation Number: 21 CFR 870.1250 Regulatory Class: II Product Code: DOY Dated: December 3, 2010 Received: December 6, 2010

#### Dear Mr. Nienstedt:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed four becaused the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use sured in the encreate) to tegary coment date of the Medical Device Amendments, or to commerce pror to May 20, 1977, are eccordance 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 I ou may, dicierore, manol the Act include requirements for annual registration, listing of general oonly of over in the practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability adulteration. Trease note: CDTCF Good not over be truthful and not misleading.

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Page 2 - Mr. Matt Nienstedt

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 (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); 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/MedicalDevices/Safety/ReportaProblem/default.htm 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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours,

Dina R. Vahner

Image /page/4/Picture/8 description: The image shows a black and white drawing of a symbol. The symbol is a stylized letter, possibly a cursive 'f' or 's', with a loop at the bottom and a curved line extending to the right. The drawing is simple and lacks any shading or texture.

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

DEC 1 6 2010

# 510(k) Number (if known): K | 0 | 659

Device Name: SuperCross microcatheter

Indications for Use:

. .

.

- -

The SuperCross microcatheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the coronary and/or peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and to subselectively infuse/deliver diagnostic and therapeutic agents.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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)

R. dehner

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