(63 days)
Not Found
No
The device description and performance studies focus on the physical and functional characteristics of a microcatheter, with no mention of AI or ML capabilities.
No.
The device is intended to assist in the delivery of therapeutic agents, not to be a therapeutic agent itself. It is a delivery tool, not a treatment.
No
The device is a microcatheter intended to assist in the delivery of diagnostic and therapeutic agents, not to perform a diagnostic function itself.
No
The device description clearly outlines a physical medical device made of polymers, stainless steel, and coating, intended for insertion into the vasculature. It undergoes physical performance and biocompatibility testing, indicating it is a hardware device, not software-only.
Based on the provided information, the Stryker Neurovascular Excelsior XT-17 Microcatheter is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used 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." This describes a device used within the body for delivery purposes, not a device used to test samples outside the body to diagnose a condition.
- Device Description: The description details a catheter designed for insertion into blood vessels, with features like a lumen for delivery, shaft stiffness, a luer fitting for accessories, and a radiopaque tip for visualization during a procedure. These are characteristics of an invasive medical device used for interventional procedures, not an IVD.
- Anatomical Site: The device is intended for use in the "peripheral, coronary and neuro vasculature," which are locations within the human body. IVDs typically analyze samples taken from the body (like blood, urine, tissue) but the analysis itself happens in vitro (outside the body).
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples, detecting analytes, or providing diagnostic information based on testing samples.
In summary, the Excelsior XT-17 Microcatheter is an invasive medical device used for delivering substances within the body, which is distinct from the function of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Stryker Neurovascular's Excelsior XT-17 Microcatheters are 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.
Product codes (comma separated list FDA assigned to the subject device)
DQY
Device Description
Stryker Neurovascular Excelsior® XT-17™ Microcatheters are single lumen devices designed to aid the physician in accessing distal vasculature 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. A radiopaque tip facilitates fluoroscopic visualization. Stryker Neurovascular hydrophilically coated Excelsior XT-17 Microcatheters are coated on the outer surface with Hydrolene® Coating that reduces friction during manipulation in the vessel. The Excelsior XT-17 Microcatheter is a single use device made of polymers, stainless steel, and Hydrolene® Coating, sterilized with Ethylene Oxide (EO) gas. Patient contact duration is less than 24 hours, and patient contact materials are polymers and Hydrolene® Coating. The Excelsior XT-17 Microcatheter is used in health care facility/hospital by physicians trained in performing endovascular procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral, coronary and neuro vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care facility/hospital by physicians trained in performing endovascular procedures.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Design verification of the Excelsior XT-17 consisted of: Functional testing (T=0): Verification testing to assess: Tip Shape Retention, Tip steam shape shrinkage, Flexibility of the Distal Shaft, Softness of the Distal Tip, Tip shape retention (only applicable to Preshaped catheters), Surface defects along effective length, Surface extraneous matter along effective length, Static Rupture / Leakage under High Static Pressure, Dynamic Burst, Tensile Strength, Catheter Hub, Compatibility with DMSO, Compatibility with Peel-away introducer sheath, Proximal Fluoro-saver marker visibility. Shelf life testing (Product and Packaging). Distribution /shipping Challenge Conditioning and Testing. Packaging Verification Testing. Biocompatibility testing: The biocompatibility evaluation for the proposed Excelsior XT-17 Microcatheter was performed according to EN ISO10993-1:2009 + AC: 2010. The battery of testing comprised the following: Cytotoxicity, Hemolysis, Physiochemical Test, FTIR, Latex.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract image of three faces in profile, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 14, 2014
Stryker Neurovascular Ms. Yoko Enrile Principle Regulatory Affairs Specialist 47900 Bayside Parkway Fremont, CA 94538 US
Re: K142565
Trade/Device Name: Excelsior XT-17 Microcatheter, Excelsior XT-17 Flex Microcatheter, Excelsior XT-17 Pre-Shaped Microcatheter, Excelsior XT-17 Flex Pre-Shaped Microcatheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheters Regulatory Class: Class II Product Code: DQY Dated: September 11, 2014 Received: September 12, 2014
Dear Ms. Enrile:
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. 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.
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Carlos L. Pena -S
Carlos Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K142565
Device Name Excelsior XT -17 Microcatheter
Indications for Use (Describe)
Stryker Neurovascular's Excelsior XT -17 Microcatheters are 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.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the Stryker Neurovascular logo. The word "Stryker" is in a bold, sans-serif font on the top line. Below that, the word "Neurovascular" is in a smaller, sans-serif font. The logo is black and white.
510(k) Summary
| Summary Date | November 12, 2014 | |
|---|---|---|
| Submitter Name and | ||
| Address | Stryker Neurovascular | |
| 47900 Bayside Parkway | ||
| Fremont, CA. 94538 | ||
| Contact Person: | Yoko Y Enrile | |
| Principal Regulatory Affairs Specialist | ||
| Phone: 510-413-2619 | ||
| Fax: 510-413-2588 | ||
| Email: yoko.enrile@stryker.com | ||
| Trade Name: | Excelsior® XT-17TM Microcatheter | |
| Common Name: | Percutaneous Catheter; Microcatheter | |
| Classification Name: | Percutaneous catheters are currently classified as Class II devices | |
| per 21 CFR 870.1250. No performance standards have been | ||
| established under Section 514 of the Food, Drug and Cosmetic Act | ||
| for these devices. | ||
| Product Code: | DQY | |
| Legally Marketed | ||
| Predicate Device: | Reference (Clearance Date) | Device |
| K123452 (3 January 2013) | Tracker-17 Microcatheter |
4
Device Description and Characteristics:
| Stryker Neurovascular Excelsior® XT-17™ Microcatheters are | |
|---|---|
| single lumen devices designed to aid the physician in accessing distal | |
| vasculature 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. A radiopaque tip facilitates | |
| fluoroscopic visualization. Stryker Neurovascular hydrophilically | |
| coated Excelsior XT-17 Microcatheters are coated on the outer | |
| surface with Hydrolene® Coating that reduces friction during | |
| manipulation in the vessel. | |
| The Excelsior XT-17 Microcatheter is a single use device made of | |
| polymers, stainless steel, and Hydrolene® Coating, sterilized with | |
| Ethylene Oxide (EO) gas. Patient contact duration is less than 24 | |
| hours, and patient contact materials are polymers and Hydrolene® | |
| Coating. | |
| The Excelsior XT-17 Microcatheter is used in health care | |
| facility/hospital by physicians trained in performing endovascular | |
| procedures. | |
| Accessories: | The Excelsior XT-17 Microcatheter is packaged with an introducer |
| sheath and a steam shaping mandrel accessory. |
Indications for Use / Intended Use:
Stryker Neurovascular's Excelsior XT-17 Microcatheters are 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.
Principle of Operations:
The Excelsior XT-17 Microcatheter is used to access and navigate the vasculature as well as to deliver diagnostic and therapeutic agents. The Excelsior XT-17 Microcatheter is inserted with a guide catheter and guided through the vasculature with the aid of a guidewire (over-the-wire microcatheters).
5
Technological Characteristics and Product Feature Comparison:
Stryker Neurovascular's Excelsior XT-17 Microcatheter is equivalent to the predicate device in terms of:
- functionality ●
- method of operation
- intended use ●
- . indication for use
- biological safety .
A tabular comparison of the specific technological characteristics between the predicate device and the proposed device is provided below.
6
510(k) Summary (cont.)
Product feature comparison for the Excelsior® XT-17™ Microcatheter:
| Characteristics | Results |
|---|---|
| Outer Shaft Material (Prox.) | Same as predicate |
| Outer Shaft Material (Mid) | Same as predicate |
| Outer Shaft Material (Distal) | Same as predicate |
| Outer Shaft Material | |
| (1.5 cm fluorosaver marker) | Material same as predicate but without colorant |
| Inner Shaft Material | Same as predicate |
| Liner | Same as predicate |
| Hub/Luer | Internal hub dimension for XT-17 is slightly smaller |
| Shaft Design | • Offered with a fluorosaver marker |
| • Offered with pre-shaped distal tips | |
| Tip Marker (Proximal) | Same as predicate |
| Tip Marker (Distal) | Same material, smaller OD |
| Coating | Same as predicate |
| Distal Shaft Length | Same as predicate |
| Mid shaft length | Same as predicate |
| Mid transition length | Same as predicate |
| Prox. Shaft Length | Same as predicate |
| Proximal ID / OD | Same as predicate |
| Distal ID / OD | Same ID, smaller OD |
| Effective Length | Same as predicate |
| Hydrolene Uncoated Length/ | |
| Coated length | Same as predicate |
| Indications for Use | Same as predicate |
| Sterilization Method | Same as predicate |
| Packaging Pouch Materials | Offered with Nylon/PE |
| Packaging Carton | Same as predicate |
| Packaging Configuration | • Straight type (Same as Excelsior XT-27 Microcatheter) |
| • Pre-Shaped (Offered with new packaging design) | |
| Accessories | Introducer sheath added |
| Closure Strip | Same as predicate |
| DMSO Compatibility | DMSO compatibility information added |
Risk assessment of the modifications in the form of design and use failure modes and effects analysis (design and use FMEAs) has been conducted in accordance with EN ISO 14971:2012. Stryker Neurovascular has determined the modifications to the predicate device raise no new questions of safety or effectiveness.
7
Performance data: Design verification of the Excelsior XT-17 consisted of: Functional testing (T=0): Verification testing to assess: Tip Shape Retention ● ● Tip steam shape shrinkage . Flexibility of the Distal Shaft ● Softness of the Distal Tip . Tip shape retention (only applicable to Preshaped catheters)
- Surface defects along effective length
- Surface extraneous matter along effective length
- . Static Rupture / Leakage under High Static Pressure
- . Dynamic Burst
- . Tensile Strength
- Catheter Hub
- Compatibility with DMSO ●
- Compatibility with Peel-away introducer sheath ●
- Proximal Fluoro-saver marker visibility ●
Shelf life testing (Product and Packaging)
Distribution /shipping Challenge Conditioning and Testing
Packaging Verification Testing
Biocompatibility testing:
The biocompatibility evaluation for the proposed Excelsior XT-17 Microcatheter was performed according to EN ISO10993-1:2009 + AC: 2010. The battery of testing comprised the following.
- Cytotoxicity
- Hemolysis
- Physiochemical Test
- FTIR ●
- Latex ●
8
Conclusion: The subject modifications do not alter the intended use or indications for use, or the fundamental scientific technology of the predicate device Tracker-17 Microcatheter. The risk assessment of the modifications conducted in accordance with EN ISO 14971: 2012 and successful verification testing demonstrate that the proposed device Excelsior XT-17 Microcatheter was found to have a safety and effectiveness profile that is similar to the predicate device.