RENEGADE STC 18 MICROCATHETER

K023681 · Boston Scientific Corp · DQO · Nov 26, 2002 · Cardiovascular

Device Facts

• Record ID: K023681
• Device Name: RENEGADE STC 18 MICROCATHETER
• Applicant: Boston Scientific Corp
• Product Code: DQO · Cardiovascular
• Decision Date: Nov 26, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Renegade STC™ 18 is 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. The Renegade™ STC-18 Microcatheter is a sterile, single-use catheter and is available in lengths of 105 cm, 130 cm, and 150cm.

Device Story

Renegade STC-18 is a sterile, single-use microcatheter; used in neuro, peripheral, and coronary vasculature. Device tracks coaxially over steerable guidewires to reach distal, tortuous vessels. Once positioned, enables controlled, selective infusion of diagnostic, embolic, or therapeutic agents. Operated by physicians in clinical settings. Benefits include improved access to difficult-to-reach vascular regions for targeted therapy or diagnostics.

Clinical Evidence

Bench testing only; biocompatibility testing performed per ISO 10993.

Technological Characteristics

Sterile, single-use microcatheter; available in 105 cm, 130 cm, and 150 cm lengths. Biocompatibility verified per ISO 10993.

Indications for Use

Indicated for general intravascular use in neuro, peripheral, and coronary vasculature. Used for coaxial tracking over steerable guidewires to access distal, tortuous vessels and for 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™ Hi-Flo Microcatheter
• Renegade™ Fiber Braided Microcatheter
• Excelsior™ 1018 Microcatheter
• Tracker® Excel™ 14

Submission Summary (Full Text)

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16023681

Special 510(k) Renegade™ STC-18 Microcatheter
October 31, 2002

| General<br>Provisions | Trade Name: Renegade STC™ 18 Microcatheter<br>Classification Name: Diagnostic Intravascular Catheter |
|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name of<br>Predicate<br>Devices | Renegade™ Hi-Flo Microcatheter, Renegade™ Fiber Braided Microcatheter,<br>Excelsior™ 1018 Microcatheter and Tracker® Excel™ 14 |
| Classification | Class II |
| Performance<br>Standards | Performance Standards have not been established by FDA under Section 514<br>of the Food, Drug and Cosmetic Act |
| Intended Use<br>and Device<br>Description | The Renegade STC™ 18 is intended for general intravascular use, including<br>neuro, peripheral and coronary vasculature. The catheter can be coaxially<br>tracked over a steerable guidewire in order to access distal, tortuous<br>vasculature. Once the subselective region has been accessed, the catheter can<br>be used for controlled and selective infusion of diagnostic, embolic, or<br>therapeutic materials into vessels. The Renegade™ STC-18 Microcatheter is a<br>sterile, single-use catheter and is available in lengths of 105 cm, 130 cm, and<br>150cm. |
| Biocompatibility | The Renegade STC-18™ Microcatheter has been tested for biocompatibility<br>per ISO 10993. All data demonstrate this device is biocompatible for its<br>intended use. |
| Summary of<br>Substantial<br>Equivalence | The Renegade STC™ 18 Microcatheter has been tested and compared to the<br>predicate device. All data gathered demonstrate this device as substantially<br>equivalent. No new issues of safety or efficacy have been raised. |

# Summary of Safety and Effectiveness

NOV 2 6 2002

0 0 0 0 5 2

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Boston Scientific Corporation Ms. Christine M. Cameron Regulatory Affairs Specialist One Boston Scientific Place Natick, MA 01760-1537

Re: K023681

> Renegade STCTM 18 Microcatheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter. Regulatory Class: II Product Code: DOO Dated: October 31, 2002 Received: November 1, 2002

Dear Ms. Cameron:

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 mav 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. Christine M. Cameron

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 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,

Wh

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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Special 510(k) Renegade ™ STC-18 Microcatheter October 31, 2002 100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000

**Indications For Use**

| 510(k) Number (if known) | Unknown<br>K023681 |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Renegade STC ^TM 18 Microcatheter |
| Indications for Use | The Renegade STC ^TM 18 Microcatheter is 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. |

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Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Cardiovascular & Respiratory Devices
510(k) Number K029681

| Prescription Use | <div>✓</div> |
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OR

| Over-The Counter Use | |
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Confidential Boston Scientific Corporation