EXCELSIOR SL-10 MICROCATHETER, MODELS 168581, 168381, 168181, 168189

K013789 · Boston Scientific, Target · DQY · Dec 6, 2001 · Cardiovascular

Device Facts

• Record ID: K013789
• Device Name: EXCELSIOR SL-10 MICROCATHETER, MODELS 168581, 168381, 168181, 168189
• Applicant: Boston Scientific, Target
• Product Code: DQY · Cardiovascular
• Decision Date: Dec 6, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Excelsior SL-10 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 SL-10 Microcatheter is a single-lumen device used by physicians to access distal vasculature. It functions as a conduit for delivering diagnostic contrast media or therapeutic occlusion coils. The device features a shaft with graded durometer materials, a stainless steel wire-reinforced body for torque transmission, and a hydrophilic-coated outer surface to reduce friction. A radiopaque tip allows for fluoroscopic visualization. The device is used in clinical settings (e.g., interventional suites) alongside guide catheters and guidewires. It includes a steam-shaping mandrel for tip customization. By facilitating precise navigation and delivery of agents/coils, the device assists in minimally invasive vascular procedures, potentially improving patient outcomes in neurovascular, coronary, or peripheral interventions.

Clinical Evidence

Bench testing only. In vitro performance testing included dimensional inspection, tensile strength, burst pressure, flow rate, and withdrawal force testing. Biocompatibility was verified according to ISO-10993 standards. No clinical data was required or provided.

Technological Characteristics

Single-lumen microcatheter; 1.7 French; 0.016" ID; 0.031" OD. Materials: polyamide, stainless steel, rubber. Features: hydrophilic coating, radiopaque tip, stainless steel wire reinforcement. Sterilization method not specified. No software or electronic components.

Indications for Use

Indicated for use in peripheral, coronary, and neurovasculature to assist in the delivery of diagnostic agents (e.g., contrast media) and therapeutic agents (e.g., occlusion coils).

Regulatory Classification

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.

Predicate Devices

• Excelsior 1018 Microcatheter (K994155)
• Tracker-10 Microcatheter (K925813)

Submission Summary (Full Text)

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## SECTION 2 -- 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

a. Date Prepared: November 09, 2001

K013789

# DEC 0 6 2001

b. Contact Person George J. Prendergast Regulatory Affairs Specialist II Boston Scientific Target 47900 Bayside Parkway Fremont, CA 94538

c. Trade Name ExcelsiorTMSL-10 Microcatheter

- d. Common Name Microcatheter
- e. Classification Name

Percutaneous Catheter (21 CFR Section 870.1250)

#### f. Identification of Predicate Devices

| Number | Description | Clearance Date |
|---------|------------------------------|----------------|
| K994155 | Excelsior 1018 Microcatheter | 03 August 2000 |
| K925813 | Tracker-10<br>Microcatheter | 23 March 1994 |

Special 510(k): Device Modification November 2001

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#### g. Device Description

The Excelsior SL-10 Microcatheter is a single lumen device designed to aid the physician in accessing distal vasculature when used with a guide catheter and guidewire. The device shaft is comprised of graded materials of varying durometers, from a flexible tip to a semirigid proximal end. Stainless steel wire reinforcement provides for strength during torque transmission while the inner liner provides for lubricity. The hub / strain reliefs provide for kink resistance from the proximal end. A luer fitting on the catheter hub is used for the attachment of accessories. The radiopaque tip with one or two markers allows for visualization under fluoroscopy. The outer surface is coated with a hydrophilic coating which reduces friction during navigation in the vasculature. A steam shaping mandrel accessory is packaged with the catheter.

The Excelsior SL-10 Microcatheter will be manufactured in varying lengths. Model numbers and a device drawing are included in Section 4 of this submission.

h. Intended Use

The Excelsior SL-10 Microcatheter's Indications For Use are as follows:

Excelsior SL-10 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.

The intended use of the modified device, as described in its labeling, has not changed as a result of the modifications.

Special 510(k): Device Modification November 2001

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#### i. Product Feature Comparison

| Feature | Tracker-10 Microcatheter<br>Predicate cleared under<br>K925813 | Excelsior SL-10<br>Microcatheter<br>Subject device | Excelsior 1018<br>Microcatheter<br>Predicate cleared under<br>K994155 |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Tracker-10 Microcatheter<br>is intended to assist in the<br>delivery of diagnostic<br>agents, such as contrast<br>media, and therapeutic<br>agents, such as occlusion<br>coils, into the peripheral,<br>coronary and<br>neurovasculature. | Excelsior SL-10<br>Microcatheter is intended<br>to assist in the delivery of<br>diagnostic agents, such as<br>contrast media, and<br>therapeutic agents, such as<br>occlusion coils, into the<br>peripheral, coronary and<br>neurovasculature. | Excelsior 1018<br>Microcatheter is intended<br>to assist in the delivery of<br>diagnostic agents, such as<br>contrast media, and<br>therapeutic agents, such as<br>occlusion coils, into the<br>peripheral, coronary and<br>neurovasculature. |
| Design: | | | |
| Size (French) | 2 French | 1.7 French | 2 French |
| Inside<br>Diameter (ID) | 0.015" minimum | 0.016" minimum | 0.0185" minimum |
| Outside<br>Diameter<br>(OD) | 0.034" | 0.031" | 0.034" |
| Materials | Predominately<br>polypropylene,<br>polyethylene and<br>polycarbonate | Predominately polyamide,<br>stainless steel and rubber | Predominately polyamide,<br>stainless steel and rubber |

#### j. Comparison of Technological Characteristics

Excelsior SL-10 Microcatheter is substantially equivalent to Boston Scientific Target 's Tracker-10 Microcatheter and Excelsior 1018 Microcatheter. Excelsior SL-10 Microcatheter is substantially equivalent to the predicate devices in terms of functionality, intended use, design, materials and method of operation.

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#### k. Testing

In vitro performance testing of Excelsior SL-10 Microcatheter included dimensional inspection, tensile strength, burst pressure, flow rate and withdrawal force testing. All testing indicates that the device is safe and performs according to its intended use.

Biocompatibility testing was verified according to ISO-10993, Biological Evaluation of Medical Devices. Test results confirm biocompatibility of the Excelsior SL-10 Microcatheter.

#### l. Summary of Substantial Equivalence

Boston Scientific Target's determination of substantial equivalence to Tracker-10 Microcatheter and Excelsior 1018 Microcatheter predicate devices is based on the following.

The subject catheter is substantially equivalent to Tracker – 10 Microcatheter with respect to the following:

- size
- intended use .
- labeling .
- biocompatibility ●
- packaging
- sterilization methods ●

The subject catheter is substantially equivalent to Excelsior 1018 Microcatheter with respect to the following:

- materials
- intended use ●
- size
- . labeling
- biocompatibility .
- packaging ●
- sterilization methods .

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Based on the above information provided in this submission, Boston Scientific's Excelsior SL-10 Microcatheter is substantially equivalent to Boston Scientific's Excelsior 1018 Microcatheter and Tracker–10 Microcatheter.

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#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 0 6 2001

Mr. George J. Prendergast Regulatory Affairs Specialist II Boston Scientific Target 47900 Bayside Parkway Fremont, CA 94538

Re: K013789

> Excelsior™ SL-10 Microcatheter Regulation Number: 870.1250 Regulation Name: Percutaneous catheter. Regulatory Class: Class II Product Code: DQY Dated: November 9, 2001 Received: November 14, 2001

Dear Mr. Prendergast:

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 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.

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#### Page 2 - Mr. George J. Prendergast

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,

Dada Tule

Bram Zuckerman, M.D. Acting 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

KO13789 510(k) Number: __

Device Name: Excelsior SL-10 Microcatheter

Indications for Use:

The Excelsior SL-10 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.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ***_***
(Per 21 CFR 801.109)
OR
Over The Counter Use **_**

Division of Cardiovascular & Respiratory Devices
510(k) Number **__**R013787