K Number

Device Name

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

Manufacturer

VASCULAR SOLUTIONS, INC.

Date Cleared

2010-12-16

(188 days)

Product Code

DQY DOY

Regulation Number

870.1250

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 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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K091345

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The 510(k) summary describes a mechanical microcatheter and its physical properties and performance testing. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities.

Therapeutic

No
The device is described as facilitating placement and exchange of guidewires and other interventional devices, and for subselectively infusing/delivering diagnostic and therapeutic agents. It is not itself a therapeutic agent or device.

Diagnostic

Yes
The 'Intended Use / Indications for Use' section states that the device "may be used to subselectively infuse/deliver diagnostic and therapeutic agents." The inclusion of "diagnostic agents" indicates a diagnostic purpose.

SaMD (Software as a Medical Device)

The device description clearly details a physical catheter with a braided shaft, marker band, hydrophilic coating, and luer-lock adapter, indicating it is a hardware medical device.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly describes a device used within the body (in vivo) to access and manipulate blood vessels, facilitate placement of other devices, and deliver agents. This is a therapeutic and interventional use, not a diagnostic test performed on samples outside the body (in vitro).
Device Description: The description details a catheter designed for insertion into the vasculature, compatible with guidewires, and having features like a hydrophilic coating and marker bands for navigation within the body. These are characteristics of an in vivo device.
Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on these samples, or providing diagnostic information based on such analysis.

Therefore, the SuperCross microcatheter is an interventional medical device used in vivo, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

DOY

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

coronary and/or peripheral vasculature

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K091345

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
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.(b)
Classification. Class II (performance standards).

Summary

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: 763.656.4317 (direct) Fax: 763.656.4253 Email: mnienstedt@vascularsolutions.com

Alternate Contact Person

Stacy Quellette Senior Regulatory Affairs Operations Associate Tel: 763.656.4217 (direct) Fax: 763.656.4253 Email: souellette@vascularsolutions.com

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

Intended Use / Indications

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

Substantial Equivalence and Summary of Studies

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.

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.

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 (800) 638-2041 or (301) 796-7100 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

Indications for Use

DEC 1 6 2010

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

Device Name: SuperCross microcatheter

Indications for Use:

. .

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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സി Cardiovascular Devices

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