MODIFICATION TO RENEGADE FIBER BRAIDED MICROCATHETER

K020012 · Boston Scientific/Medi-Tech · DQO · Jan 29, 2002 · Cardiovascular

Device Facts

• Record ID: K020012
• Device Name: MODIFICATION TO RENEGADE FIBER BRAIDED MICROCATHETER
• Applicant: Boston Scientific/Medi-Tech
• Product Code: DQO · Cardiovascular
• Decision Date: Jan 29, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Renegade™ Fiber Braided Microcatheters are intended for general intravascular use, including neuro, peripheral and coronary vasculature. The catheter can be coaxially tracked over a steerable guidewire in order to access distal, tortuous vasculature. Once the subselective region has been accessed, the catheter can be used for controlled and selective infusion of diagnostic, embolic, or therapeutic materials into vessels.

Device Story

Renegade™ Fiber Braided Microcatheter is a diagnostic intravascular catheter designed for navigation through distal, tortuous vasculature. The device is used by clinicians in clinical settings to access subselective regions via coaxial tracking over a steerable guidewire. Once positioned, it facilitates the controlled infusion of diagnostic, embolic, or therapeutic agents. The device benefits patients by enabling targeted delivery of materials to specific vascular sites, potentially improving therapeutic outcomes in neuro, peripheral, and coronary procedures.

Clinical Evidence

Bench testing only; biocompatibility testing performed per ISO 10993.

Technological Characteristics

Fiber-braided microcatheter construction; biocompatible materials per ISO 10993; designed for coaxial tracking over steerable guidewires.

Indications for Use

Indicated for general intravascular use in neuro, peripheral, and coronary vasculature for accessing distal, tortuous vessels and for the controlled, selective infusion of diagnostic, embolic, or therapeutic materials.

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

• Renegade™ Fiber Braided Microcatheter

Submission Summary (Full Text)

{0}------------------------------------------------

K020012

JAN 2 9 2002

## Summary of Safety and Effectiveness

| General Provisions | Trade Name: Renegade™ Fiber Braided Microcatheter |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Classification Name: Diagnostic Intravascular Catheter |
| Name of Predicate Devices | Renegade™ Fiber Braided Microcatheter |
| Classification | Class II |
| Performance Standards | Performance Standards have not been established by FDA under Section 514 of the Food, Drug and Cosmetic Act |
| Intended Use and Device Description | The Renegade™ Fiber Braided Microcatheters are intended for general intravascular use, including neuro, peripheral and coronary vasculature. The catheter can be coaxially tracked over a steerable guidewire in order to access distal, tortuous vasculature. Once the subselective region has been accessed, the catheter can be used for controlled and selective infusion of diagnostic, embolic, or therapeutic materials into vessels. |
| Biocompatibility | The Renegade™ Fiber Braided Microcatheters have been tested for biocompatibility per ISO 10993. All data demonstrate this device is biocompatible for its intended use. |
| Summary of Substantial Equivalence | The Renegade™ Fiber Braided Microcatheters have been tested and compared to the predicate device. All data gathered demonstrate this device as substantially equivalent. No new issues of safety or efficacy have been raised. |

0036

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. 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 symbol resembling an abstract caduceus or a representation of the human form, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 9 2002

Ms. Jodi Lynn Greenizen Regulatory Affairs Project Manager Boston Scientific Scimed, Inc. One Scimed Place Maple Grove MN 55311

Re: K020012

> Trade/Device Name: Renegade™ Fiber Braided Microcatheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter. Regulatory Class: Class II Product Code: DQO Dated: December 31, 2001 Received: January 3, 2002

Dear Ms. Greenizen:

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

{2}------------------------------------------------

Page 2 - Ms. Jodi Lynn Greenizen

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Brom Zuckerman, M.D.

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

Enclosure

{3}------------------------------------------------

## Indications For Use

| 510(k) Number (if known) | Unknown k 020012 |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Renegade™ Fiber Braided Microcatheter |
| Indications for Use | The Renegade™ Fiber Braided Microcatheters are intended for general intravascular use, including neuro, peripheral and coronary vasculature. The catheter can be coaxially tracked over a steerable guidewire in order to access distal, tortuous vasculature. Once the subselective region has been accessed, the catheter can be used for controlled and selective infusion of diagnostic, embolic, or therapeutic materials into vessels. |

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

| Concurrence of CDRH (Office of Device Evaluation) (ODE) | |
|---------------------------------------------------------|--|
| Division of Cardiovascular & Respiratory Devices | |
| 510(k) Number | |

| Prescription Use<br>(Per 21 CFR 801.109) | | OR | Over-The Counter Use<br>(Optional Format 1-2-96) | |
|------------------------------------------|--|----|--------------------------------------------------|--|
|------------------------------------------|--|----|--------------------------------------------------|--|

1

: