RENEGADE FIBER BRAIDED MICROCATHETER

K973645 · Boston Scientific Corp · KRA · Nov 19, 1997 · Cardiovascular

Device Facts

• Record ID: K973645
• Device Name: RENEGADE FIBER BRAIDED MICROCATHETER
• Applicant: Boston Scientific Corp
• Product Code: KRA · Cardiovascular
• Decision Date: Nov 19, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1210
• Device Class: Class 2

Intended Use

The Renegade Fiber Braided Microcatheter is intended for general intravascular use, including neuro, peripheral, and coronary vasculature. The catheter can be coaxially tracked over a steerable quidewire in order to access distal, tortuous vasculature. Once the subselective region has been accessed, the catheter can be used for the controlled and selective infusion of diagnostic, embolic, or therapeutic materials into vessels. Diagnostic, embolic, or therapeutic agents to be used in accordance with specifications outlined by the manufacturer.

Device Story

Renegade Fiber Braided Microcatheter is a single-lumen intravascular catheter; used for accessing distal, tortuous vasculature in neuro, peripheral, and coronary systems. Device is tracked coaxially over a steerable guidewire. Once positioned, it enables controlled, selective infusion of diagnostic (e.g., contrast media), embolic, or therapeutic agents. Operated by clinicians in clinical settings. Benefits include improved access to difficult-to-reach vessels for targeted delivery of therapeutic or diagnostic materials.

Clinical Evidence

No clinical data; substantial equivalence supported by mechanical, biocompatibility, and animal testing.

Technological Characteristics

3.0F/2.5F single-lumen catheter; progressively softer shaft from proximal to distal ends; hydrophilic coating on outer surface; available in 130 cm and 150 cm lengths with 10 cm, 20 cm, and 30 cm distal segments; ethylene oxide sterilization.

Indications for Use

Indicated for patients requiring access to distal, tortuous neuro, peripheral, and coronary vasculature for the infusion of diagnostic, embolic, or therapeutic agents.

Regulatory Classification

Identification

A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.

Predicate Devices

• Evolution Microcatheter
• Eddy Infusion
• TurboTracker Infusion Catheter
• Venture II™ Intravascular Infusion catheters

Submission Summary (Full Text)

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# NOV 19 1997

### SUMMARY OF SAFETY AND EFFECTIVENESS K973645

Pursuant to §513(i)(3)(A) of the Food, Drug, and cosmetic Act, Boston Scientific Corporation submits this summary of safety and effectiveness.

#### A. GENERAL INFORMATION

| Owner Operator Submitting | Boston Scientific Corporation |
|------------------------------|--------------------------------------------|
| this Premarket Notification: | One Boston Scientific Place |
| | Natick, MA 01757 |
| | [phone] |
| Contact Person: | Wanda M. Carpinella |
| | Regulatory Affairs Department |
| Device Generic Name: | Intravascular Infusion Catheter |
| Device Classification: | 74 DQO Catheter, Intravascular, Diagnostic |

#### B. INDICATIONS FOR USE

The Renegade Fiber Braided Microcatheter is intended for general intravascular use, including neuro, peripheral, and coronary vasculature. The catheter can be coaxially tracked over a steerable quidewire in order to access distal, tortuous vasculature. Once the subselective region has been accessed, the catheter can be used for the controlled and selective infusion of diagnostic, embolic, or therapeutic materials into vessels. Diagnostic, embolic, or therapeutic agents to be used in accordance with specifications outlined by the manufacturer.

#### C. DESCRIPTIVE CHARACTERISTICS

The device is a 3.0F/2.5F, single lumen catheter constructed with progressively softer shaft characteristics from its proximal to its distal ends. The device is tracked coaxially over a selectively placed guide wire. To facilitate catheter introduction, the device incorporates a hydrophilic coating applied to the outer sufface of the shaft. Once the subselective region has been accessed, the lumen of the catheter can be used for infusion of diagnostic agents, such as contrast medium, and therapeutic materials. The device is available in useable lengths of 130 cm and 150 cm and in distal segment lengths of 10cm, 20cm, and 30cm.

#### D. SUBSTANTIAL EQUIVALENCE

The proposed microcatheter is substantially equivalent to the Evolution Microcatheter, and the Eddy Infusion, TurboTracker Infusion Catheter and Venture II™ Intravascular Infusion catheters. Where dimensional and material differences exist between the proposed device and the predicate devices, mechanical, biocompatibility and animal testing demonstrated that these differences do not adversely affect safety and effectiveness.

#### E. PACKAGING, STERILIZATION, AND PYROGENICITY

The proposed catheter is packaged in a heat-sealed Tyvek/mylar pouch. The product is sterilized using ethylene oxide gas.

#### F. CONCLUSION

Based on the information presented, Boston Scientific Corporation believes that the proposed infusion catheter meets the minimum requirements that are considered acceptable for its intended use and is substantially equivalent to other currently marketed intravscular infusion catheters.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 9 1997

Ms. Wanda M. Carpinella Boston Scientific Corporation One Boston Scientific Place Natick, Massachusetts 01760-1537

K973645 Re: Fiber-braided Microcatheter Requlatory Class: II (two) Product Code: 74 KRA Dated: September 22, 1997 Received: September 24, 1997

Dear Ms. Carpinella:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Wanda M. Carpinella

This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K973645

Renegade™ Fiber Braided Microcatheter with Device Name: Hydropass™ Ccating

The Renegade Fiber Braided Microcatheter is Indications for Use: 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 the controlled and selective infusion of diagnostic, embolic, or therapeutic materials into vessels. Diagnostic, embolic, or therapeutic agents to be used in accordance with specifications outlined by the manufacturer.

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Concurrence of CDRH, Office of Device Evaluaiton (ODE)

(Division Sign-Off) Division of Cardiovascular, Respiratory, nd Neurological Device : Number

Prescription Use (Per 21 CRF 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)