The Excelsior XT-27 Microcatheter and Excelsior XT-27 Flex Microcatheter are intended to assist in the delivery of embolization particles, diagnostic agents (such as contrast media), and interventional devices (such as stents) that are indicated for use in the neurovasculature and with a catheter of 0.027 inches in inner diameter.

The Excelsior XT-27 Pre-Shaped Microcatheter and Excelsior XT-27 Flex Pre-Shaped Microcatheter are intended to assist in the delivery of embolization particles, diagnostic agents (such as contrast media), and interventional devices (such as stents) that are indicated for use in the neurovasculature and with a catheter of 0.027 inches in inner diameter.

Device Description

The subject devices hereafter referred to as Excelsior® XT-27® Microcatheters are sterile, single lumen, 0.027 inch inner diameter (ID) microcatheters with one tip marker designed to aid the physician in accessing distal neurovasculature when used with a guide 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. A luer fitting located on the microcatheter hub is used for the attachment of accessories. One radiopaque tip marker is positioned at the distal tip of the device to facilitate fluoroscopic visualization® XT-27® Microcatheters are coated on the outer surface with Hydrolene™ coating which reduces friction during manipulation in the vessel.

The Excelsior® XT-27® Microcatheters are available in effective lengths of both 135 cm (53.1 inch) and 150 cm (59.1 inch), with two distal shaft configurations achieved through distal shaft lengths of 6 cm (XT-27 model) and 18 cm (XT-27 Flex model). Both straight tip and pre-shaped versions are available.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (Excelsior XT-27 Microcatheters) and details its acceptance criteria and the study performed to demonstrate substantial equivalence, but it does not describe an AI/ML device. Therefore, the questions related to AI/ML specific criteria (such as sample sizes for test and training sets, number of experts for ground truth, adjudication methods, multi-reader multi-case studies, standalone performance, and data provenance) are not applicable to this document.

However, I can provide the acceptance criteria and study information that is available for this mechanical microcatheter from the document.

1. Table of acceptance criteria and the reported device performance:

Test	Acceptance Criteria (Inferred from "Pass")	Reported Device Performance
Guide Catheter Compatibility with 1.17 mm (0.046") ID	Maximum forces required to completely deliver and retrieve the microcatheter inside a 0.046" ID guide catheter with worst-case sized ancillary devices must be acceptable/pass.	Pass
Tensile Strength for Joints and Marker Band	Tensile strength after preconditioning by simulated use with worst-case sized ancillary and interventional devices must be acceptable/pass.	Pass
Particulate and Coating Integrity	Hydrophilic coating integrity and particulate generation under simulated use conditions with a 0.046" ID guide catheter, and comparison to cleared comparator devices, must be acceptable/pass.	Pass

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

Sample Size for Test Set: The document does not specify the exact number of samples (e.g., number of microcatheters tested) used for each bench test. It mentions testing with "ancillary devices that represent worst-case sizes" for the Guide Catheter Compatibility test and "worst-case sized ancillary devices and interventional devices" for the Tensile Strength test.
Data Provenance: The study is described as "Bench testing," indicating it was conducted in a laboratory setting. There is no information regarding country of origin or whether it was retrospective or prospective, as these terms are typically applied to clinical studies involving human or animal subjects.

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 as this is a mechanical device performance study, not an AI/ML diagnostic or prognostic study requiring expert opinion for ground truth. The "ground truth" here is the physical performance of the device against engineering specifications.

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

Not applicable for the same reason as point 3. Bench testing results are typically adjudicated by meeting predefined engineering specifications and criteria, not by expert consensus in the same way as diagnostic reads.

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:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This type of study is relevant for AI-assisted diagnostic devices, which is not what this device is.

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

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

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

The "ground truth" in this context is based on engineering specifications and performance criteria for the physical device. For example, for tensile strength, the ground truth would be a defined minimum force the joints and marker band must withstand without failure. For compatibility, it would be the ability to successfully deliver and retrieve the microcatheter within the specified guide catheter with acceptable force.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device, so there is no training set.

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

Not applicable for the same reason as point 8.

Summary

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March 21, 2025

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in a smaller font size.

Stryker Neurovascular Manmeet Chawla Senior Project Manager Regulatory Affairs 47900 Bayside Parkway Fremont, California 94538

Re: K242289

Trade/Device Name: Excelsior XT-27 Microcatheter, Excelsior XT-27 Flex Microcatheter, Excelsior XT-27 Pre-Shaped Microcatheter, Excelsior XT-27 Flex Pre-Shaped Microcatheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP, KRA Dated: February 21, 2025 Received: February 21, 2025

Dear Manmeet Chawla:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory

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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Naira Muradyan -S

Naira Muradyan, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional, and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K242289

Device Name

Excelsior XT-27 Microcatheter, Excelsior XT-27 Flex Microcatheter,

Excelsior XT-27 Pre-Shaped Microcatheter, Excelsior XT-27 Flex Pre-Shaped Microcatheter

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/4/Picture/1 description: The image shows the logo for Stryker Neurovascular. The word "stryker" is in bold, black, sans-serif font. Below it, the word "Neurovascular" is in a smaller, black, sans-serif font. There is a registered trademark symbol to the right of the word "stryker".

K242289

510(k) Summary

Submitter:	Stryker Neurovascular47900 Bayside ParkwayFremont, CA 94538Phone: 510-423-2500
Contact:	Manmeet ChawlaE-mail: manmeet.chawla@stryker.com
Date Prepared:	March 20, 2025
Device Name:	Excelsior® XT-27® Microcatheter, Excelsior® XT-27® Flex Microcatheter,Excelsior® XT-27® Pre-Shaped Microcatheter, Excelsior® XT-27® Flex Pre-Shaped Microcatheter
Common Name:	Percutaneous catheter
Classification Name:	Catheter, Percutaneous, Neurovasculature (21 CFR 870.1250, QJP) andCatheter, Continuous Flush (21 CFR 870.1210, KRA)
Device Classification:	Class II
Product Code:	QJP and KRA
Predicate Device:	Excelsior® XT-27® Microcatheter (K113778, cleared 20-April-2012)

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Image /page/5/Picture/1 description: The image shows the logo for Stryker Neurovascular. The word "stryker" is in bold, sans-serif font, with the "s" in lowercase and the rest of the letters in uppercase. To the right of the "r" is the registered trademark symbol. Below "stryker" is the word "Neurovascular" in a smaller, sans-serif font.

DEVICE DESCRIPTION:

Product Description	UPN	Effective Length (cm) /Tip Length (cm)
Excelsior® XT-27®, Straight	M003XT2735810	135 / 6
Excelsior® XT-27®, Pre-Shaped	M003XT2735910	135 / 6
Excelsior® XT-27®, Straight	M003XT2750810	150 / 6
Excelsior® XT-27®, Pre-Shaped	M003XT2750910	150 / 6
Excelsior® XT-27®, Flex, Straight	M003XT2735820	135 / 18
Excelsior® XT-27®, Flex, Pre-Shaped	M003XT2735920	135 / 18
Excelsior® XT-27®, Flex, Straight	M003XT2750820	150 / 18
Excelsior® XT-27®, Flex, Pre-Shaped	M003XT2750920	150 / 18

		Table 1. Excelsior® XT-27® Microcatheter Types
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Please note that all Excelsior® XT-27® Microcatheters referenced in this submission are considered the subject device.

The subject Excelsior® XT-27® Microcatheters are a modification to the predicate device, Excelsior® XT-27 Microcatheter (K113778), for the labeling change to recommend the use of the Excelsion® XT-27 % Microcatheters with guide catheters with a minimum ID of 0.046 inch (1.17 mm). The technological characteristics and principles of operation remain unchanged except for the Excelsior® XT-27% Microcatheters with guide catheters with a minimum ID of 0.046 inch (1.17 mm). The device design, materials, manufacturing, packaging, and sterilization methods, biocompatibility data, bench-top data, and stability are directly applicable from the predicate device (K113778) and from other changes made since that did not require a 510(k) submission.

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Image /page/6/Picture/1 description: The image shows the logo for Stryker Neurovascular. The word "stryker" is written in a bold, sans-serif font, with the letters closely spaced together. Below the word "stryker" is the word "Neurovascular", written in a smaller, sans-serif font. There is a registered trademark symbol to the right of the word "stryker".

Accessories

Each Excelsion® XT-27® Microcatheter is provided with a shaping mandrel and peel away introducer sheath within a separate inner Tyvek™ pouch (accessory pouch) for straight configurations and inside a pre-shaped tray for the pre-shaped configurations. The Excelsior® XT- 27® Microcatheters are available in a single pack (one unit per package) only. The device pouch, Instruction for Use (IFU), and pointer page are provided inside a shelf carton.

INTENDED USE /INDICATIONS FOR USE:

The indications for use are similar between the predicate Excelsior® XT-27® Microcatheter (K113778) and subject Excelsion® XT-27® Microcatheters. Minor modifications for clarity were made to the indications for use (refer to comparison in Table 2). Changes do not impact the intended use of the device.

Indications for Use for Excelsior® XT-27® Microcatheter and Excelsion® XT-27® Flex Microcatheter:

The Excelsior® XT-27® Microcatheter and Excelsior® XT-27® Flex Microcatheter are intended to assist in the delivery of embolization particles, diagnostic agents (such as contrast media), and interventional devices (such as stents) that are indicated for use in the neurovasculature and with a catheter of 0.027 inches in inner diameter.

Indications for Use for Excelsior® XT-27® Pre-Shaped Microcatheter and Excelsior® XT-27® Flex (Pre-Shaped Microcatheter:

The Excelsion® XT-27® Pre-Shaped Microcatheter and Excelsior® XT-27® Flex Pre-Shaped Microcatheter are intended to assist in the delivery of embolization particles, diagnostic agents (such as contrast media), and interventional devices (such as stents) that are indicated for use in the neurovasculature and with a catheter of 0.027 inches in inner diameter.

TECHNOLOGICAL CHARACTERISTICS AND COMPARISON TO THE PREDICATE DEVICE:

Stryker Neurovascular has demonstrated that the subject Excelsior® XT-27® Microcatheters are substantially equivalent to the predicate Excelsior® XT-27® Microcatheter (K113778) based on the same intended use, same or similar materials, similar design, and the same fundamental operating principles.

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Image /page/7/Picture/1 description: The image shows the logo for Stryker Neurovascular. The word "stryker" is in bold, sans-serif font, with the "s" slightly overlapping the "t". Below "stryker" is the word "Neurovascular" in a smaller, sans-serif font. A registered trademark symbol is located to the right of the "r" in "stryker".

A comparison of the subject and predicate devices is summarized in Table 2 below.

Characteristic	Predicate DeviceExcelsior® XT-27® Microcatheter(K113778)	Subject DeviceExcelsior® XT-27® Microcatheters(K242289)
Manufacturer	Stryker	Same
Device Type	Percutaneous Catheter	Same
Regulation/Class	870.1250, Class II870.1210, Class II	Same
Product Code	DQY, KRA	QJP, KRA
IntendedUse/Indicationsfor Use	The Excelsior XT-27 Microcatheter isintended to assist in the delivery ofdiagnostic agents (such as contrastmedia), therapeutic agents, and non-liquid interventional devices (such asstents) that are indicated for use in theneurovasculature and with a catheter of0.027 inches in inner diameter.	The Excelsior XT-27 Microcatheter andExcelsior XT-27 Flex Microcatheter areintended to assist in the delivery ofembolization particles, diagnostic agents(such as contrast media), andinterventional devices (such as stents)that are indicated for use in theneurovasculature and with a catheter of0.027 inches in inner diameter.The Excelsior XT-27 Pre-ShapedMicrocatheter and Excelsior XT-27 FlexPre-Shaped Microcatheter are intendedto assist in the delivery of embolizationparticles, diagnostic agents (such ascontrast media), and interventionaldevices (such as stents) that are indicatedfor use in the neurovasculature and witha catheter of 0.027 inches in innerdiameter.

Table 2. Comparison of the Subject Devices with the Predicate Device

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Stryker Neurovascular Premarket Notification, Special 510(k)

Excelsior® XT-27® and Excelsior® XT-27® Flex (Straight Microcatheters)
Excelsior® XT-27® and Excelsior® XT-27® Flex (Pre-Shaped Microcatheters)

Characteristic	Predicate DeviceExcelsior® XT-27® Microcatheter(K113778)	Subject DeviceExcelsior® XT-27® Microcatheters(K242289)
How Supplied	Single use, sterile, non-pyrogenic	Same
Method ofSterilization	Ethylene Oxide (EtO) gas	Same
Materials	PTFE, Pebax, Stainless Steel wire,Nylon, Santoprene	Same
Features
Tip Configuration	Straight tip Pre-Shaped tip Option for secondary steam shapingby physician prior to use.	Same
Effective Lengths	135 cm, 150 cm	Same
Proximal OD/Distal OD	Proximal OD (outer diameter): 2.9FDistal OD: 2.7F	Same
ID	0.027 inch	Same
HydrophilicCoating Length	80 cm	Same
Tip Length/DistalShaft Length	6 cm, 18 cm	Same
Tip Marker	Platinum (90%) / Iridium (10%) alloy	Same
MetalReinforcement	304 Stainless Steel	Same
Coating	Hydrophilic Polymer	Same

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Image /page/9/Picture/1 description: The image shows the logo for Stryker Neurovascular. The word "stryker" is written in a bold, sans-serif font, with the "r" having a registered trademark symbol next to it. Below "stryker" is the word "Neurovascular" in a smaller, sans-serif font.

RISK ASSESSMENT:

Risk assessment of the subject modified Excelsior® XT-27® Microcatheters has been conducted in accordance with EN ISO 14971 and Stryker Neurovascular risk management procedures. Stryker Neurovascular has determined that the change in the minimum recommended guide catheter ID as outlined in the compatibility table of the Excelsior® XT-27® Microcatheters IFU raises no new questions of safety or effectiveness. The risk assessment conducted on the subject device did not result in any new hazards or harms.

PERFORMANCE DATA:

Non-clinical tests were performed to demonstrate the subject device performs as intended and substantial equivalence. Bench testing that was performed is summarized in Table 3.

Test	Test Method Summary	Results
Guide Catheter Compatibilitywith 1.17 mm (0.046") ID	A track and Pull Back study was conducted toevaluate the maximum forces required to completelydeliver and retrieve an Excelsior® XT-27®Microcatheter inside a 0.046" ID guide catheter withancillary devices that represent worst-case sizes.	Pass
Tensile Strength for Joints andMarker Band	Tensile strength tested after preconditioning bysimulated use with worst-case sized ancillarydevices and interventional devices.	Pass
Particulate and CoatingIntegrity	Hydrophilic coating integrity and particulategeneration were evaluated under simulated useconditions with Excelsior® XT-27® Microcathetersused with 0.046" ID guide catheter, with comparisonto cleared comparator devices.	Pass

Table 3. Bench Testing Summary

CONCLUSION:

The subject device is substantially equivalent to the predicate device based on similar intended use/indications for use, same or similar materials, same fundamental design, and the same operating principles. The non-clinical testing data support the subject device performs as intended.

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).