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 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.

AI/ML Overview

This submission describes the Excelsior™ SL-10 Microcatheter. The manufacturer is seeking substantial equivalence to existing predicate devices based on in vitro performance testing.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly provide a table of acceptance criteria with specific thresholds. Instead, it states that "All testing indicates that the device is safe and performs according to its intended use." This is common for predicate device comparisons where the performance is expected to be at least equivalent to the predicate, rather than meeting a specific numerical benchmark.

However, based on the testing mentioned, we can infer the performance aspects evaluated:

Performance Aspect	Reported Device Performance
Dimensional Inspection	Performed, implied to meet specifications
Tensile Strength	Performed, implied to meet safety and function
Burst Pressure	Performed, implied to meet safety and function
Flow Rate	Performed, implied to meet efficacy requirements
Withdrawal Force Testing	Performed, implied to meet safety and function
Biocompatibility	Confirmed according to ISO-10993

2. Sample Size Used for the Test Set and the Data Provenance

The document does not specify the sample sizes used for the in vitro performance tests. The data provenance is not explicitly stated as retrospective or prospective, nor are countries of origin mentioned. However, since these are in vitro performance tests, they are typically conducted in a laboratory setting by the manufacturer.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. The ground truth for this device is established through objective in vitro measurements and comparison to predicate devices, rather than expert consensus on diagnostic interpretations.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the "ground truth" is based on objective measurements and established standards (like ISO-10993) and comparison to predicate devices, not subjective expert reviews requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This is a medical device (microcatheter), not an AI diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance claims is based on:

Objective Measurements: Results of the in vitro performance tests (dimensional, tensile, burst, flow rate, withdrawal force).
Established Standards: Biocompatibility verified according to ISO-10993.
Predicate Device Equivalence: The primary "ground truth" for regulatory clearance is substantial equivalence to the legally marketed predicate devices (Tracker-10 Microcatheter and Excelsior 1018 Microcatheter) in terms of functionality, intended use, design, materials, and method of operation.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI algorithm; therefore, there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set.

Summary

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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-10Microcatheter	23 March 1994

Special 510(k): Device Modification November 2001

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g. Device Description

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 MicrocatheterPredicate cleared underK925813	Excelsior SL-10MicrocatheterSubject device	Excelsior 1018MicrocatheterPredicate cleared underK994155
Intended Use	Tracker-10 Microcatheteris intended to assist in thedelivery of diagnosticagents, such as contrastmedia, and therapeuticagents, such as occlusioncoils, into the peripheral,coronary andneurovasculature.	Excelsior SL-10Microcatheter is intendedto assist in the delivery ofdiagnostic agents, such ascontrast media, andtherapeutic agents, such asocclusion coils, into theperipheral, coronary andneurovasculature.	Excelsior 1018Microcatheter is intendedto assist in the delivery ofdiagnostic agents, such ascontrast media, andtherapeutic agents, such asocclusion coils, into theperipheral, coronary andneurovasculature.
Design:
Size (French)	2 French	1.7 French	2 French
InsideDiameter (ID)	0.015" minimum	0.016" minimum	0.0185" minimum
OutsideDiameter(OD)	0.034"	0.031"	0.034"
Materials	Predominatelypolypropylene,polyethylene andpolycarbonate	Predominately polyamide,stainless steel and rubber	Predominately polyamide,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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Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with three tail feathers.

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 (301) 594-4586. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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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Image /page/7/Picture/0 description: The image shows the logo for Boston Scientific Target. The words "Boston Scientific" are stacked on top of each other in a serif font. There is a horizontal line underneath the words "Boston Scientific". The word "TARGET" is in a sans-serif font and is located underneath the horizontal line.

INDICATIONS FOR USE STATEMENT

KO13789 510(k) Number: __

Device Name: Excelsior SL-10 Microcatheter

Indications for Use:

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

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

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
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.(b)
Classification. Class II (performance standards).