(231 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a microcatheter, with no mention of AI or ML capabilities.
No.
The device is described as a microcatheter intended to assist in the delivery of other agents and devices, but it does not directly provide therapy itself.
No.
The device is a microcatheter intended to assist in the delivery of diagnostic agents, not to perform diagnostics itself.
No
The device description clearly describes a physical microcatheter with specific dimensions, materials, and features like a luer fitting and radiopaque tip marker. This is a hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for assisting in the delivery of various agents and devices within the neurovasculature. This is an in vivo (within a living organism) application, not an in vitro (outside of a living organism, typically in a lab) diagnostic test.
- Device Description: The description details a microcatheter designed for navigating blood vessels, which is consistent with an in vivo interventional device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device's function is purely mechanical delivery.
Therefore, the Excelsior XT-27 Microcatheter and its variations are considered medical devices for interventional procedures, not IVDs.
N/A
Intended Use / Indications for Use
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.
Product codes
QJP, KRA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
neurovasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Non-clinical tests were performed to demonstrate the subject device performs as intended and substantial equivalence. Bench testing was performed for Guide Catheter Compatibility with 1.17 mm (0.046") ID, Tensile Strength for Joints and Marker Band, and Particulate and Coating Integrity. For Guide Catheter Compatibility, a track and Pull Back study was conducted to evaluate the maximum forces required to completely deliver and retrieve an Excelsior® XT-27® Microcatheter inside a 0.046" ID guide catheter with ancillary devices that represent worst-case sizes. The result was Pass. For Tensile Strength for Joints and Marker Band, tensile strength was tested after preconditioning by simulated use with worst-case sized ancillary devices and interventional devices. The result was Pass. For Particulate and Coating Integrity, hydrophilic coating integrity and particulate generation were evaluated under simulated use conditions with Excelsior® XT-27® Microcatheters used with 0.046" ID guide catheter, with comparison to cleared comparator devices. The result was Pass.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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.
1
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
2
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
3
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)
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.
| 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".
510(k) Summary
| Submitter: | Stryker Neurovascular
47900 Bayside Parkway
Fremont, CA 94538
Phone: 510-423-2500 |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Manmeet Chawla
E-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) and
Catheter, 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) |
5
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:
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. Refer to Table 1.
| 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 | |||
|---|---|---|---|
| -- | -- | ------------------------------------------------ | -- |
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.
6
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 Device
Excelsior® XT-27® Microcatheter
(K113778) | Subject Device
Excelsior® XT-27® Microcatheters
(K242289) |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Stryker | Same |
| Device Type | Percutaneous Catheter | Same |
| Regulation/Class | 870.1250, Class II
870.1210, Class II | Same |
| Product Code | DQY, KRA | QJP, KRA |
| Intended
Use/Indications
for Use | The Excelsior XT-27 Microcatheter is
intended to assist in the delivery of
diagnostic agents (such as contrast
media), therapeutic agents, and non-
liquid 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 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. |
Table 2. Comparison of the Subject Devices with the Predicate Device
8
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 Device
Excelsior® XT-27® Microcatheter
(K113778) | Subject Device
Excelsior® XT-27® Microcatheters
(K242289) |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|
| How Supplied | Single use, sterile, non-pyrogenic | Same |
| Method of
Sterilization | 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 shaping
by physician prior to use. | Same |
| Effective Lengths | 135 cm, 150 cm | Same |
| Proximal OD/
Distal OD | Proximal OD (outer diameter): 2.9F
Distal OD: 2.7F | Same |
| ID | 0.027 inch | Same |
| Hydrophilic
Coating Length | 80 cm | Same |
| Tip Length/Distal
Shaft Length | 6 cm, 18 cm | Same |
| Tip Marker | Platinum (90%) / Iridium (10%) alloy | Same |
| Metal
Reinforcement | 304 Stainless Steel | Same |
| Coating | Hydrophilic Polymer | Same |
9
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 Compatibility | ||
| with 1.17 mm (0.046") ID | A track and Pull Back study was conducted to | |
| evaluate the maximum forces required to completely | ||
| deliver and retrieve an Excelsior® XT-27® | ||
| Microcatheter inside a 0.046" ID guide catheter with | ||
| ancillary devices that represent worst-case sizes. | Pass | |
| Tensile Strength for Joints and | ||
| Marker Band | Tensile strength tested after preconditioning by | |
| simulated use with worst-case sized ancillary | ||
| devices and interventional devices. | Pass | |
| Particulate and Coating | ||
| Integrity | Hydrophilic coating integrity and particulate | |
| generation were evaluated under simulated use | ||
| conditions with Excelsior® XT-27® Microcatheters | ||
| used with 0.046" ID guide catheter, with comparison | ||
| to 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.