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 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.

AI/ML Overview

The provided text describes a 510(k) submission for the Excelsior™ 1018 Microcatheter, focusing on its substantial equivalence to a predicate device, the TurboTracker-18 Infusion Catheter. The submission primarily details performance testing and biocompatibility to support this claim, rather than a clinical study with traditional acceptance criteria for a new AI/software device.

Therefore, many of the requested categories for AI/ML device studies (such as MRMC studies, ground truth establishment for training sets, number of experts for ground truth, sample sizes for test/training sets, data provenance, and adjudication methods) are not applicable to this 510(k) summary, as it pertains to a physical medical device.

1. A table of acceptance criteria and the reported device performance

Since this is a submission for a physical microcatheter, the "acceptance criteria" are related to established engineering and biocompatibility standards rather than clinical performance metrics typical of an AI device. The document states that "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."

While specific numerical acceptance criteria and reported performance values for each of these tests are not provided in the given text, the submission states that the results "demonstrate that the Excelsior 1018 Microcatheter is substantially equivalent to the predicate TurboTracker-18 Infusion Catheter device." This implies that the Excelsior 1018 Microcatheter met the necessary performance and safety standards to be considered equivalent to the predicate device.

Test Type	Acceptance Criteria (Implied)	Reported Device Performance (Implied)
Tensile Strength	Met established engineering standards for medical catheters and was comparable to predicate.	Met.
Coefficient of Friction	Met established engineering standards for medical catheters and was comparable to predicate.	Met.
Static Rupture	Met established engineering standards for medical catheters and was comparable to predicate.	Met.
Tip Buckling	Met established engineering standards for medical catheters and was comparable to predicate.	Met.
Dimensional Inspection	Conformed to specified dimensions and was comparable to predicate.	Met.
Critical Bend Radius	Met established engineering standards for medical catheters and was comparable to predicate.	Met.
Particulate Analysis	Met established safety standards for particulate matter in medical devices.	Met.
Coil Compatibility	Compatible with target coils (GDC-10 & GDC-18).	Met.
Biocompatibility	Met ISO 10993 standards for biological evaluation of medical devices.	Met.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable to this type of device submission. Performance testing usually involves a defined number of units per test, but these are engineering tests, not clinical studies with "test sets" in the AI/ML sense. Data provenance would be from internal lab testing at Boston Scientific.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. Ground truth in this context refers to established engineering specifications and biocompatibility standards, not expert assessments of clinical data for AI performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are used in clinical studies, particularly for AI, to resolve discrepancies in ground truth labeling. This submission relies on objective engineering measurements and standard biocompatibility assessments.

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 not an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the performance testing is based on established engineering specifications, industry standards (e.g., for biocompatibility), and comparison to the predicate device's characteristics. For coil compatibility, the "ground truth" is whether the microcatheter can successfully deliver the specified GDC coils.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

Not applicable.

Summary

{0}------------------------------------------------

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:

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

{1}------------------------------------------------

510(K) Summary of Safety and Effectiveness

Characteristic	*Predicate Device	Excelsior 1018Microcatheter
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
------------------------------------------------------------	--

TurboTracker-18 Infusion Catheter (K960806, May 1996)

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

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services-USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

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.

{3}------------------------------------------------

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, (301) 594-4639. (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 (800) 638-2041 or (301) 443–6597 or at its internet toll-free number (600) 056 2011 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

{4}------------------------------------------------

INDICATIONS FOR USE STATEMENT

510(k) Number:

K994155

Device Name: Excelsior ™ 1018 Microcatheter Catheter

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	OR	Over The Counter Use
(Per 21 CFR 801.109)

Excelsior 1018 Microcatheter 510(k)December, 1999	(Division Sign-Off)Division of Cardiovascular, Respiratory,and Neurological Devices510(k) Number Section 1. Page 8 of 8
-------------------------------------------------------	-------------------------------------------------------------------------------------------------------------------------------------

Regulation Number and Section

§ 870.1210 Continuous flush catheter.

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