EXCELSIOR 1018 MICROCATHETER

K994155 · Boston Scientific, Target · KRA · Aug 3, 2000 · Cardiovascular

Device Facts

• Record ID: K994155
• Device Name: EXCELSIOR 1018 MICROCATHETER
• Applicant: Boston Scientific, Target
• Product Code: KRA · Cardiovascular
• Decision Date: Aug 3, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1210
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Excelsior 1018 Microcatheter is intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils, into the peripheral, coronary, and neurovasculature.

Device Story

Excelsior 1018 Microcatheter is a single-lumen catheter designed for distal vasculature access. Device features graded shaft stiffness, hydrophilic coating for friction reduction, and radiopaque tip for fluoroscopic visualization. Operated by physicians in clinical settings to track over guidewires. Used to deliver diagnostic contrast media or therapeutic occlusion coils (e.g., GDC-10, GDC-18). Output is the successful placement of agents within the target vasculature, facilitating minimally invasive procedures. Benefits include improved navigation and delivery of therapeutic/diagnostic materials to distal sites.

Clinical Evidence

Bench testing only. Performance testing included tensile strength, coefficient of friction, static rupture, tip buckling, dimensional inspection, critical bend radius, particulate analysis, and coil compatibility. Biocompatibility testing was also performed.

Technological Characteristics

Single-lumen, metal-reinforced thermoplastic shaft; hydrophilic polymer coating; platinum-iridium tip markers. Dimensions: 0.0185" ID, 0.025"-0.034" OD. Length: 105-150 cm. Compatible with GDC-10 and GDC-18 coils.

Indications for Use

Indicated for patients requiring delivery of diagnostic contrast media or therapeutic occlusion coils into peripheral, coronary, or neurovasculature.

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

• TurboTracker-18 Infusion Catheter (K960806)

Reference Devices

• Guglielmi Detachable Coils (K962503)

Submission Summary (Full Text)

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This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

## Contact Person:

Linda Guthrie Senior Regulatory Affairs Specialist Boston Scientific Target 47900 Bayside Parkway Fremont, CA 94538

Device Name: Excelsior™ 1018 Microcatheter, Class II

## Device Description:

The Excelsior 1018 Microcatheter is a single lumen device designed to aid the physician in accessing the distal vasculature when used with a guiding catheter and steerable guidewire. Graded shaft stiffness ranging from a highly flexible tip to a semi-rigid proximal section aids the physician in tracking over selectively placed guidewires without displacement of the wire. A luer fitting located on the catheter hub is used for the attachment of accessories. A radiopaque tip facilitates fluoroscopic visualization. The outer diameter is coated with a hydrophilic surface that reduces friction during manipulation in the vessel. The catheter is packaged with a steam shaping mandrel accessory.

## Indications for Use:

Like the predicate TurboTracker-18 Infusion Catheter device, the Excelsior 1018 Microcatheter is intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils, into the peripheral, coronary, and neurovasculature.

# Predicate Device:

TurboTracker®-18 Infusion Catheter K960806, cleared May 2, 1996

# Testing in Support of Substantial Equivalence Determination

The Excelsior 1018 Microcatheter has different technological characteristics. However, the results of performance testing (tensile strength, coefficient of friction, static rupture, tip buckling, dimensional inspection, critical bend radius, particulate analysis, and coil compatibility) and biocompatibility testing support this claim of substantial equivalence. Results of the performance and biocompatibility testing, as presented in this pre-market notification, demonstrate that the Excelsior 1018 Microcatheter is substantially equivalent to the predicate TurboTracker-18 Infusion Catheter device. See Table 1 for a comparison of the technological characteristics.

Boston Scientific Target Section 2, Page 2 of 3

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# 510(K) Summary of Safety and Effectiveness

| Characteristic | *Predicate Device | Excelsior 1018<br>Microcatheter |
|----------------------|---------------------|---------------------------------|
| Shaft Materials | Thermoplastic | Thermoplastic |
| Shaft Design | Metal reinforced | Metal reinforced |
| Distal Shaft Length | 0 - 80 cm | 6 cm |
| Proximal ID / OD | 0.020" / 0.038" | 0.0185" / 0.034" |
| Distal ID / OD | 0.020" / 0.033" | 0.0185" / 0.025" |
| Tip Markers | Platinum Iridium | Platinum Iridium |
| Coating | Hydrophilic Polymer | Hydrophilic Polymer |
| Effective Length | 15 - 200 cm | 105 cm - 150 cm |
| **GDC® Compatibility | GDC-18 | GDC-10 & GDC-18 |

| Section 2 - Table 1, Technological Characteristics Summary | |
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* TurboTracker-18 Infusion Catheter (K960806, May 1996)

**Boston Scientific Target's Guglielmi Detachable Coils (K962503, September 1996)

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### Public Health Service

3 2000 AUG

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 .

Ms. Roxanne K. Baxter Manager, Regulatory Affairs Boston Scientific Target 47900 Bayside Parkway Fremont, CA 94538

K994155 Re : Excelsior 1018 Microcatheter Trade Name: Regulatory Class: II KRA Product Code: May 4, 2000 Dated: Received: May 8, 2000

Dear Ms. Baxter:

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 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). 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 regulations 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 assumptions. Failure to comply with the GMP regulation may result in 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. Roxanne K. Baxter

This letter will allow you to begin marketing your device as described.
The FDA to between to sectification - The FDA finding of substantial This letter will allow you to begin marketing your arrantial
in your 510(k) premarket notification. The Finding of substantial in your 510(k) premarket notification. The sted predicate device equivalence of your device to a regarly markedd provided to be
results in a classification for your device and thus, permits your
results in a classification tor your device device to proceed to the market.

If you desire specific advice for your device on our labeling
and the success of the 001 and additionally 809.10 for in vi If you desire specific advice for your actles of a for in vitro regulation (21 CFR Part 801 and additionariy oost compliance at (301)
diagnostic devices), please contact the office of Compliance and diagnostic devices), please contact the order promotion and 594–4586. Additionally, tor questions on the pffice of Compliance at
advertising of your device, please contact the office of compliance at our device, prease ocher gulation entitled, [phone]. (301) 594–4639. Also, prease note coldidation" (21CPR 807.97).
"Misbranding by reference to premarket notification" (21CPR 807.97) "Misbranding by reference to premarker nochilities under the Act may
Other general information of Small Manufacturers Assistance at i Other general information of Small Manufacturers Assistance at its internet be obtained from the Division of Smart Manufaceae on at its internet
toll-free number [phone] or (301) 443–6597 or at its internet toll-free number [phone] 02 - 11 - 11 - 11 - 11 - 11 - 11 - 14 - 14 - 14 - 14 - 14 - 14 - 14 - 14 - 14 - 1

Sincerely yours,

James E. Dillard III

James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# INDICATIONS FOR USE STATEMENT

510(k) Number:

K994155

Device Name: Excelsior ™ 1018 Microcatheter Catheter

Indications for Use:

The Excelsior 1018 Microcatheter is intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils, into the peripheral, coronary, and neurovasculature.

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) | | |
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| Prescription Use | OR | Over The Counter Use |
| (Per 21 CFR 801.109) | | |

| Excelsior 1018 Microcatheter 510(k)<br>December, 1999 | (Division Sign-Off)<br>Division of Cardiovascular, Respiratory,<br>and Neurological Devices<br>510(k) Number Section 1. Page 8 of 8 |
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