(120 days)
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 is a sterile, single lumen 0.027 in ID device with one tip marker 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. One radiopaque tip marker is positioned at the distal tip of the device to facilitate fluoroscopic visualization. The Excelsior XT-27 Microcatheter is 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 135cm (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.
This document describes the Stryker Neurovascular Excelsior® XT-27™ Microcatheter and its 510(k) submission for market clearance. The submission relies on demonstrating substantial equivalence to predicate devices through a series of bench tests.
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Excelsior XT-27 Microcatheter are largely based on demonstrating equivalence to the predicate devices (K000177, Renegade™ Hi-Flo™ Microcatheter and K042568, Excelsior® SL-10 Pre-Shaped Microcatheter). The "Result" column explicitly states "Met same criteria as predicate," indicating that the performance of the Excelsior XT-27 Microcatheter was found to be comparable to or better than the predicate devices for these specific tests.
| Test / Performance Metric | Acceptance Criteria (Implicitly based on Predicate) | Reported Device Performance |
|---|---|---|
| Visual Inspection | ||
| Durable Hydrophilic Coating | Performance comparable to predicate device | Met same criteria as predicate |
| Surface Defects | Performance comparable to predicate device | Met same criteria as predicate |
| Surface-Extraneous matter | Performance comparable to predicate device | Met same criteria as predicate |
| Dimensional Measurement | ||
| Kink Radius of Curvature / Proximal Shaft Kink | Performance comparable to predicate device | Met same criteria as predicate |
| Distal OD Reduction | Performance comparable to predicate device | Met same criteria as predicate |
| Tip Configuration | Performance comparable to predicate device | Met same criteria as predicate |
| Catheter Hub | Performance comparable to predicate device | Met same criteria as predicate |
| Corrosion Resistance | Performance comparable to predicate device | Met same criteria as predicate |
| Simulated Use: | ||
| Introduction | Performance comparable to predicate device in simulated use | Met same criteria as predicate |
| Tracking | Performance comparable to predicate device in simulated use | Met same criteria as predicate |
| Reposition / Deployment | Performance comparable to predicate device in simulated use | Met same criteria as predicate |
| Detachment | Performance comparable to predicate device in simulated use | Met same criteria as predicate |
| Overall Performance | Performance comparable to predicate device in simulated use | Met same criteria as predicate |
| Advancement / Retraction Force | Performance comparable to predicate device | Met same criteria as predicate |
| Biocompatibility Testing: | ||
| In-vitro Cytotoxicity, MEM Elution | Non-cytotoxic | Non-cytotoxic |
| Intracutaneous reactivity | Non-irritating | Non-irritating |
| Acute systemic toxicity, Injection | Non-toxic | Non-toxic |
| Sensitization, Guinea Pig Maximization | Non-sensitizing | Non-sensitizing |
| Hemocompatibility (Direct Contact; Complement Activation C3a and SC5b-9; PTT; blood cell counts and hemoglobin / hematocrit levels) | Non-hemolytic | Non-hemolytic |
| Materials Mediated Pyrogen levels, Rabbit test | Non-pyrogenic | Non-pyrogenic |
| USP impurities, <661> | No significant impurities / Comparable to predicate | None |
| Latex test, ELISA Inhibition | No latex present / Comparable to predicate | None |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each of the bench tests. It also does not provide information about data provenance in terms of country of origin or whether the tests were retrospective or prospective. Given the nature of bench testing for a medical device, it is typically prospective, with samples of the device being manufactured and then tested in controlled laboratory environments.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
This information is not provided in the document. For bench testing, "ground truth" is typically established through adherence to test methodologies and specifications, often informed by engineering standards and regulatory guidance, rather than expert consensus on individual cases.
4. Adjudication Method for the Test Set
This information is not provided. As mentioned above, bench testing relies on objective measurements and predefined acceptance criteria rather than expert adjudication in the way clinical studies might.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance
This information is not applicable and not provided. The Excelsior XT-27 Microcatheter is a physical medical device (microcatheter), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance would not be relevant to its evaluation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable and not provided. As it is a physical medical device, there is no "algorithm only" performance to be evaluated in a standalone manner.
7. The Type of Ground Truth Used
The ground truth for most of these tests is established by:
- Engineering Specifications and Design Requirements: For dimensional measurements, kink radius, advancement/retraction force.
- Established Biomedical Test Standards: For biocompatibility tests (cytotoxicity, irritation, systemic toxicity, sensitization, hemocompatibility, pyrogenicity, USP impurities, latex). These standards define the methods and acceptance criteria for classifying a material as non-toxic, non-irritating, etc.
- Comparison to Predicate Device Performance: For many performance characteristics (e.g., visual inspection, simulated use), the "ground truth" for the new device is that its performance must be equivalent or superior to the already legally marketed predicate devices.
8. The Sample Size for the Training Set
This information is not applicable and not provided. As a physical medical device, there is no "training set" in the context of machine learning or AI. The design and manufacturing processes are refined through engineering iterations, but this is distinct from an algorithmic training process.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided for the same reasons as point 8.
In Summary:
The document focuses on demonstrating substantial equivalence of the Excelsior® XT-27™ Microcatheter to its predicate devices through comprehensive bench testing. The acceptance criteria for most tests are implicitly or explicitly that the new device must perform comparably to (or better than) the predicate devices, or meet established safety and performance standards (especially for biocompatibility). The study design is largely a series of controlled laboratory tests performed on samples of the device. Aspects related to AI, human readers, or large-scale data training sets are not relevant to this type of device submission and therefore not included.
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APR 2 0 2012
Stryker Neurovascular Traditional 510(k) Submission Excelsior® XT-27™ Microcatheter
i
. '•
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
.
| Trade Name: | Excelsior® XT-27™ Microcatheter |
|---|---|
| Generic Name: | Percutaneous Catheter, Microcatheter |
| Classification: | CLASS II, 21 CFR 870.1250 |
| Submitted By: | Stryker Neurovascular47900 Bayside ParkwayFremont, CA 94538-6515 |
| Contact: | Yoko Y Enrile |
| Predicate Device: | K000177, Renegade™ Hi-Flo™ MicrocatheterK042568, Excelsior® SL-10 Pre-Shaped Microcatheter |
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.
Device Description: The Excelsior® XT-27™ Microcatheter is a sterile, single lumen 0.027 in
ID device with one tip marker 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. One radiopaque tip marker is positioned
at the distal tip of the device to facilitate fluoroscopic visualization. The
Excelsior XT-27 Microcatheter is 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 135cm (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.
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Accessories: Each Excelsior XT-27 Microcatheter is provided with accessories (a shaping mandrel, and peel away introducer) within a separate inner Tyvek™ pouch (Accessory pouch). The Excelsior XT-27 Microcatheter is available in a single pack (one unit per package) only. The device pouch and Directions for Use (DFU) are both provided inside a shelf carton.
Summary Differences in Technological Characteristics: The Excelsior XT-27 Microcatheters introduce several enhanced design features:
- a) The OD profile of the Excelsior XT-27 Microcatheter is smaller than the Renegade Hi-Flo Microcatheter.
- b) The Excelsior XT-27 Microcatheter has up to five zones of polymer stiffness which vary from the distal to proximal shaft and help to enhance the trackability and pushability of the catheter.
- c) The Excelsior XT-27 Microcatheter has a more supportive double helix winding reinforcement compared to the Renegade Hi-Flo Microcatheter.
Bench Test Summary:
| Test | Result |
|---|---|
| Visual Inspection:Durable Hydrophilic CoatingSurface DefectsSurface-Extraneous matter | Met same criteria aspredicate |
| Dimensional Measurement:Kink Radius of Curvature / ProximalShaft KinkDistal OD ReductionTip ConfigurationCatheter Hub | Met same criteria aspredicate |
| Corrosion Resistance | Met same criteria aspredicate |
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| Simulated use: | Met same criteria as predicate |
|---|---|
| * Introduction | |
| * Tracking | |
| * Reposition / Deployment | |
| * Detachment | |
| * Overall Performance | |
| Advancement / Retraction Force | Met same criteria as predicate |
| In-vitro Cytotoxicity, MEM Elution | Non-cytotoxic |
| Intracutaneous reactivity | Non-irritating |
| Acute systemic toxicity, Injection | Non-toxic |
| Sensitization, Guinea PigMaximization | Non- sensitizing |
| Hemocompatibility, Direct Contact;Complement Activation C3a andSC5b-9; PTT; blood cell counts andhemoglobin / hematocrit levels | Non-hemolytic |
| Materials Mediated Pyrogen levels,Rabbit test | Non-pyrogenic |
| USP impurities, <661> | None |
| Latex test, ELISA Inhibition | None |
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| Predicate / Subject | Product Feature Comparison for Excelsior® SL-10 Pre-Shaped |
|---|---|
| Device | Microcatheter (K042568) and Renegade™ Hi-Flo™ Microcatheter(K000177) |
| Comparison: | (K000177) |
| Feature | K042568Excelsior® SL-10Pre-ShapedMicrocatheter | K000177Renegade™ Hi-Flo™Microcatheter | Subject Device |
|---|---|---|---|
| Materials | PTFE, Pebax,Stainless Steelwire, Nylon,Santoprene | PTFE, Pebax,Vectran Fiber andPt/Ir wire, Nylon,Santoprene | PTFE, Pebax,Stainless Steelwire, Nylon,Santoprene |
| Tip shape | Preshaped | Straight | Offers both shapes(Straight andPreshaped) |
| Option of steamshaping byphysician forproper adjustmentto the anatomyprior to use | Option of steamshaping byphysician forproper adjustmentto the anatomyprior to use | Option of steamshaping byphysician forproper adjustmentto the anatomyprior to use | |
| EffectiveLengths | 150 cm | 135 cm, 150 cm | 135 cm, 150 cm |
| Proximal/Distal OD | Proximal OD 2.4FDistal OD 1.7F | Proximal OD 3FDistal OD 2.8F | Proximal OD: 2.9FDistal OD: 2.7F |
| ID | 0.0165 inch | 0.027inch | 0.027inch |
| HydrophilicCoatingLength | 100 cm | 60 cm | 80 cm |
| Tip Length | 6cm | 10cm and 20cm | 6cm and 18cm |
| Tip Markers | 90%Pt-10%Ir | 90%Pt-10%Ir | 90%Pt-10%Ir |
| Coating | Polyvinylpyrrolidone Polyacrylamide | HydropassHydrophilicCoating | Polyvinylpyrrolidone Polyacrylamide |
| Method ofsupply | Sterile, single-use,non-pyrogenic | Sterile, single-use,non-pyrogenic | Sterile, single-use,non-pyrogenic |
Summary of Substantial Equivalence: The Excelsior XT-27 Microcatheter subject of this submission is substantially equivalent to the predicate devices with regard to design, materials, sterilization, principle of operation, performance, and indications for use.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's commitment to promoting health, well-being, and human services. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Stryker Neurovascular c/o Ms. Tina Lochner DEKRA Certification. Inc. 4377 County Line Road Chalfont, PA 18914
APR 2 0 2012
Re: K113778
Trade/Device Name: Excelsior XT-27 Microcatheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY, KRA Dated: March 16, 2012 Received: March 22, 2012
Dear Ms. Lochner:
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 r ou may, thereforey issues 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 fray be subject to additions, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Ms. Tina Lochner
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 forth in the quality systems (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely vours.
Ea. Hemm
Malvina B. Eydelman, MD Director Division of Ophthalmic, Neurological, and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K113778
Device Name: . . . . . _ _ _ Excelsior® XT-27™ Microcatheter
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.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Quyuh Hoang
(Division Sign-Off)
Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number_
Page 1 of 1
§ 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).