TRACKER EXCEL -14 PRE-SHAPED MICROCATHETER

K050599 · Boston Scientific Corp · DQY · Jun 3, 2005 · Cardiovascular

Device Facts

• Record ID: K050599
• Device Name: TRACKER EXCEL -14 PRE-SHAPED MICROCATHETER
• Applicant: Boston Scientific Corp
• Product Code: DQY · Cardiovascular
• Decision Date: Jun 3, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Boston Scientific's Tracker™ Excel™-14 Pre-Shaped 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 neuro vasculature.

Device Story

Single lumen microcatheter designed for distal vasculature access; used with guiding catheter and steerable guidewire. Features graded shaft stiffness, hydrophilic coating, and radiopaque tip for fluoroscopic visualization. Pre-shaped tips facilitate navigation; secondary shaping allowed. Operated by physicians in clinical settings. Facilitates delivery of contrast media or therapeutic occlusion coils; aids in navigating complex anatomy. Benefits patient by enabling precise placement of diagnostic/therapeutic agents in peripheral, coronary, and neuro vasculature.

Clinical Evidence

Bench testing only. No clinical data presented. In-vitro testing included tip shape retention, appearance, dimensions, static rupture, tensile strength, buckling test, and compatibility with coils, guidewires, and guide catheters.

Technological Characteristics

Single lumen microcatheter; hydrophilic coated outer diameter; radiopaque tip. Features graded shaft stiffness. Offered with pre-shaped tips. Compatible with GDC™ coils. No software or electronic components.

Indications for Use

Indicated for use in peripheral, coronary, and neuro vasculature 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

• Tracker™ Excel™-14 Microcatheter (K994155)

Reference Devices

• Guglielmi Detachable Coils (K962503)
• Guglielmi Detachable Coils (K001083)

Submission Summary (Full Text)

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Special 510(k): Modification -Boston Scientific's Tracker™ -14 Pre-Shaped Microcatheter

K050599

## 510(K) Summary of Safety and Effectiveness

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.

Date prepared: March 7, 2005 Contact Person: Victor Ham Regulatory Affairs Project Manager Boston Scientific 47900 Bayside Parkway Fremont, CA 94538 Tel: [phone]

Device Name: Tracker™ ExcelTM_J4 Pre-Shaped Microcatheter, Class II

Common name: Microcatheters Classification name: Percutaneous Catheters

Product Code: DQY

### Device Description:

Doney Dosenbarm.
The Tracker™ Excel™-14 Pre-Shaped 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 astifiess ranging from a highly flexible tip to a semi-rigid proximal section aids the physician in tracking over selectively placed guidewires. 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 individually with a variety of pre-shaped tips.

#### Indications for Use:

Like the predicate devices, Boston Scientific's Tracker™ Excel™-14 Pre-Shaped 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 neuro vasculature.

Predicate Device(s): Tracker™ Excel™-14 Microcatheter (510(k) # K994155 cleared August 3, 2000)

## Testing in Support of Substantial Equivalence Determination

The predicate device which was originally cleared for straight steam-shapeable tip was modified to include pre-shaped tips. The modification is made for ease of use to the physicians. The modification involves a new tip shaping process and the necessary packaging modifications to protect the new tip shapes.

The results of in-vitro testing (tip shape retention, appearance of the tip, tip dimensions, static rupture, tensile strength of tip, buckling test, and coil, guidewire and guide catheter compatibility) and biological safety testing support the claim of substantial equivalence.

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# Technological Characteristics and Product Feature Comparison

Tracker™ Excel™-14 Pre-Shaped Microcatheter is substantially equivalent to the predicate device in terms of functionality, materials, method of operation, intended use, indications for use, and biological safety.

## Product Feature Comparison for the

## Tracker™ Excel™-14 Pre-Shaped Microcatheter

| Characteristic | Results |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------|
| Shaft Materials | Same as predicate* device |
| Shaft Design | Same as predicate* device |
| Distal Shaft Length | Same as predicate* device |
| Proximal ID / OD | Same as predicate* device |
| Distal ID / OD | Same as predicate* device |
| Tip Markers | Same as predicate* device |
| Coating | Same as predicate* device |
| Effective Length | Same as predicate* device |
| **GDC™ Compatibility | Same as predicate* device |
| Tip Configuration | Offered with Pre-Shaped Tips<br>with the option of secondary<br>shaping for proper adjustment to<br>the anatomy prior to use. |
| | As compared to the predicate<br>which was cleared with straight<br>tip, steam shapeable by physician<br>prior to use |

* Tracker Excel -14 Microcatheter cleared under K994155 on August 3, 2000 **Boston Scientific's Guglielmi Detachable Coils, K962503 & K001083

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### 510(K) Summary of Safety and Effectiveness

Results of the performance and biocompatibility testing, as presented in this Special 510(K), demonstrate that the Pre-Shaped devices are substantially equivalent to the respective predicate unmodified devices.

The subject catheters with Pre-Shaped tips are substantially equivalent to their respective predicate devices with respect to the following:

- . functionality
- intended use ◆
- indications for use .
- materials ●
- method of operation .
- biological safety .

Based on the above information provided in this submission, Boston Scientific's Tracker™ Excel™ 14 Pre-Shaped Microcatheter is substantially equivalent to Boston Scientific's Tracker™ Excel™ 14 Microcatheter.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle head in profile, facing right, with three parallel lines extending from the back of its head, resembling feathers or wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and country.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 3 - 2005

Boston Scientific c/o Mr. Victor Ham Regulatory Affairs Project Manager 47900 Bayside Parkway Fremont, CA 94538

Re: K050599

Trade/Device Name: Tracker™ Excel™-14 Pre-Shaped Microcatheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: II Product Code: DQY Dated: May 3, 2005 Received: May 4, 2005

Dear Mr. Ham:

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

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Page 2 - Mr. Victor Ham

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic for the quality systems (Sections (Sections 531-542 of the Act); 21 CFR 1000-1050. product launtion control provisions (seting your device as described in your Section 510(k) This letter will anow you to begin maing of substantial equivalence of your device to a legally premarket notification. The PDA maining of basification 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 If you dealer specific da reliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Duna P. Lachner

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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K050599

### INDICATIONS FOR USE STATEMENT

K650599 510(k) Number:

Device Name:

Tracker™ Excel™-14 Pre-Shaped Microcatheter

Indications for Use:

Boston Scientific's Tracker™ Excel™-14 Pre-Shaped 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 neuro vasculature.

Prescription Use X (Per 21 CFR 801.109)

OR

Over The Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Deanna P. Vachner

(Division of Cardiovascular Devices

510(k) number k050594

Boston Scientific March, 2005