(195 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a catheter, with no mention of AI or ML capabilities.
No.
The device description and intended use clearly state that the Echo Intracranial Base Catheter is designed for the introduction and guidance of other interventional devices, not to directly provide therapy itself.
No
Explanation: The device is a catheter designed for the introduction and guidance of interventional devices, not for diagnosing medical conditions. Its function is to facilitate therapeutic procedures by providing access to the neurovasculature for other devices.
No
The device description clearly outlines a physical catheter with hardware components (lumen, radiopaque marker, luer hub, coating, dilator, valves). The performance studies also focus on physical properties and biological interactions, not software performance.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body (in vitro).
- Device Function: The Echo Intracranial Base Catheter is a device used inside the body (in vivo) to facilitate the introduction and guidance of other interventional devices into the neurovasculature. It is a tool for accessing and navigating within the blood vessels of the brain.
- Lack of Diagnostic Testing: The description does not mention any form of testing performed on biological samples or any diagnostic output. Its purpose is purely procedural and interventional.
Therefore, based on the provided information, the Echo Intracranial Base Catheter is an interventional medical device, not an IVD.
N/A
Intended Use / Indications for Use
The Echo Intracranial Base Catheter is indicated for the introduction of interventional devices into the neurovasculature.
Product codes (comma separated list FDA assigned to the subject device)
OJP
Device Description
The Echo Intracranial Base Catheter is a single lumen, flexible, variable stiffness catheter with a 0.100 inch inner diameter, designed for use in facilitating the insertion and guidance of appropriately sized interventional devices into the neurovascular system. It has a radiopaque marker band on the distal end a luer hub at the proximal end. The distal catheter shaft has a 14 cm lubricious coating to reduce friction during use. It is packaged with a dilator and two rotating hemostatic valves. The Echo Intracranial Base Catheter is compatible with introducer sheaths with an inner diameter of 9F or greater. The Echo Intracranial Base Catheter is supplied sterile, non-pyrogenic, and intended for single use only.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Data- Bench Testing:
Tests performed include Dimensional Verification, Tensile Strength, Torque Strength, Particulate, Coating Integrity, Liquid Leak, Air Leak, Kink Resistance, Burst Strength, Liner Lamination, Tip Stiffness, Frictional Force, Chemical Compatibility, Product Integrity Post-Removal, and Simulated Use Testing.
Conclusion: All samples met established acceptance criteria or were comparable to the predicate device.
Performance Data- Animal Safety Testing:
Study Type: Subacute animal study
Sample Size: Two (2) animals (swine), three (3) passes per device in each vessel.
Data Source: In-house study
Annotation Protocol: Compliance with Good Laboratory Practice (GLP) regulation (21 CFR Part 58). Evaluation included angiography, necropsy, and histopathology.
Key Results: Success criteria for all study end points were met. The subject device performed comparably to both control devices in terms of device safety, vessel injury, and tissue response, demonstrating vascular safety.
Biocompatibility:
Tests performed include Extract and Direct Hemolysis (ISO 10993-4), Thromboresistance (ISO 10993-4), SC5b-9 Complement Activation Assay (ISO 10993-4), ASTM Partial Thromboplastin Time (ISO 10993-4), Cytotoxicity Study Using the ISO Elution Method (ISO 10993-5), ISO Maximization Sensitization Study (ISO 10993-10), ISO Acute Systemic Toxicity (ISO 10993-11), Material Mediated Pyrogenicity (USP ), and ISO Intracutaneous Reactivity Study - Extract (ISO 10993-23).
Conclusion: All tests demonstrated favorable results (Non-hemolytic, Non-thrombogenic, Non-activator, No enhancement or inhibition of coagulation system, Non-cytotoxic, No evidence of sensitization, No mortality or evidence of acute systemic toxicity, Non-pyrogenic reactivity, Non-irritant).
Sterilization and Shelf Life:
Sterilization Method: 100% Ethylene Oxide to a sterility assurance level (SAL) of 10-4. Meets EO residuals per EN ISO 10993-7.
Labeled Shelf Life: 1-year.
Key Results: Shelf-life testing (product and packaging) and Distribution Shipping Challenge Conditioning testing met established criteria.
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.
AXS Infinity LS® Plus Long Sheath (K193034)
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
December 19, 2024
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Stryker Neurovascular Shameena Segui Senior Staff Regulatory Affairs Specialist Stryker Neurovascular 47900 Bayside Pkwy Fremont, California 94538
Re: K241637
Trade/Device Name: Echo™ Intracranial Base Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: OJP Dated: June 6, 2024 Received: November 15, 2024
Dear Shameena Segui:
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.
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"
1
(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 OS 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 Rue"). 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-devices/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 mediation-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-regulatoryassistance/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).
2
Sincerely,
Michael Mcknight -S
for 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) K241637
Device Name Echo™ Intracranial Base Catheter
Indications for Use (Describe)
The Echo Intracranial Base Catheter is indicated for the introduction of interventional devices into the neurovasculature.
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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4
Stryker Neurovascular Premarket Notification, Traditional 510(k) Echo™ Intracranial Base Catheter K241637
Image /page/4/Picture/1 description: The image shows the Stryker Neurovascular logo. The word "Stryker" is in a bold, sans-serif font, with the "s" connected to the "t". The word "Neurovascular" is in a smaller, sans-serif font, and is located below the word "Stryker". There is a registered trademark symbol to the right of the word "Stryker".
Echo™ Intracranial Base Catheter
510(k) Summary
5
510(k) Summary
| Trade/Proprietary Name: | Echo™ Intracranial Base Catheter |
|---|---|
| Common Name: | Percutaneous Catheter |
| Classification Name: | Catheter, Percutaneous, Neurovasculature, |
| 21CFR870.1250 – Class II | |
| Product Code: | QJP |
| Submitter: | Stryker Neurovascular |
| 47900 Bayside Parkway | |
| Fremont, CA 94538-6515 | |
| (FDA Registration Number: 3008853977) | |
| Contact: | Shameena Segui |
| Date Prepared: | December 18, 2024 |
| Predicate Device: | AXS Infinity LS® Plus Long Sheath (K193034) |
Device Description
The Echo Intracranial Base Catheter is a single lumen, flexible, variable stiffness catheter with a 0.100 inch inner diameter, designed for use in facilitating the insertion and guidance of appropriately sized interventional devices into the neurovascular system. It has a radiopaque marker band on the distal end a luer hub at the proximal end. The distal catheter shaft has a 14 cm lubricious coating to reduce friction during use. It is packaged with a dilator and two rotating hemostatic valves. The Echo Intracranial Base Catheter is compatible with introducer sheaths with an inner diameter of 9F or greater. The Echo Intracranial Base Catheter is supplied sterile, non-pyrogenic, and intended for single use only.
6
Indications for Use
The Echo Intracranial Base Catheter is indicated for the introduction of interventional devices into the neurovasculature.
Technological Characteristics and Product Feature Comparison
Stryker Neurovascular has demonstrated the Echo Intracranial Base Catheter is substantially equivalent to the Predicate Device, AXS Infinity LS Plus (K193034) based on the same or similar materials, similar design, and the same fundamental operating principles. The Echo Intracranial Base Catheter indication for use is limited to use in the neurovasculature, while the Predicate Device AXS Infinity LS Plus is indicated for use in the peripheral, coronary, and neurovasculature. A comparison of the Subject Device with the Predicate Device is summarized in Table 1 below.
| Detail | Subject Device | Predicate Device |
|---|---|---|
| Device Trade Name | Echo™ Intracranial Base Catheter | AXS Infinity LS® Plus Long Sheath |
| Regulation Number | 21 CFR 870.1250 | Same |
| Classification | II | Same |
| FDA Product Code | QJP | DQY |
| 510(k) Number | K241637 | K193034 |
| Intended Use/ Indications | ||
| for Use | The Echo Intracranial Base Catheter is The AXS Infinity LS Plus is indicated | |
| indicated for the introduction of | ||
| interventional devices into the | ||
| neurovasculature. | for the introduction of interventional | |
| devices into the peripheral, coronary, | ||
| and neurovasculature. | ||
| Materials | Commonly used medical grade | |
| plastics & metals. | Same | |
| Coating | Hydrophilic coating | Same |
| Reinforcement | Stainless Steel Hypotube | Stainless Steel Coil |
| Outer Diameter | 0.118 in. | 0.109 in. |
| Inner Diameter | 0.100 in. | 0.091 in. |
| Effective Length(s) | 100, 105 cm | 70, 80, 90 cm |
| Sterilization Method | EO Sterilization | Same |
| How Supplied | Single Use/Sterile | Same |
| Accessory Devices | ||
| Provided | 2 Hemostasis Valves, 1 Dilator | 1 Hemostasis Valves, 1 Dilator |
Table 1: Comparison of Subject and Predicate Device
7
| Packaging | Tyvek/Nylon Pouch, Polyethylene
Support Tube, Packaging Card, SBS
Carton | Same |
| ----------- | -------------------------------------------------------------------------------- | ------ |
|---|
Risk Assessment
Risk assessment of the Echo Intracranial Base Catheter has been conducted in accordance with EN ISO 14971 and Stryker Neurovascular risk management procedures. Stryker Neurovascular has determined that the Echo Intracranial Base Catheter 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, and no significant changes to the occurrences of harm were identified when compared with the Predicate Device.
Performance Data- Bench Testing
The results of verification and validation testing conducted on the Subject Device demonstrate that it performs as designed and is suitable for its intended use. Table 2 provides a summary of testing performed on the Subject Device:
| Test | Test Method Summary | Conclusions |
|---|---|---|
| Dimensional Verification | Verification of critical dimensions. | Pass - Samples met established |
| acceptance criteria | ||
| Tensile Strength | Tensile strength tested per ISO 10555-1. | Pass - Samples met established |
| acceptance criteria | ||
| Torque Strength | Measurement of torque strength. | Pass - Samples met established |
| acceptance criteria | ||
| Particulate | Particulate was collected from simulated use in | |
| a tortuous model, characterized by size and | ||
| particulate type, and compared to | ||
| commercially available product. | Pass - Device comparable to | |
| predicate | ||
| Coating Integrity | Hydrophilic coating was inspected before and | |
| after simulated use in a tortuous model. | Pass - Device comparable to | |
| predicate | ||
| Liquid Leak | Liquid leak tested per ISO 10555-1. | Pass - Samples met established |
| acceptance criteria | ||
| Air Leak | Air leak tested per ISO 10555-1. | Pass - Samples met established |
| acceptance criteria | ||
| Kink Resistance | Measurement of catheter kink radius. | Pass - Samples met established |
| acceptance criteria | ||
| Burst Strength | Burst strength was tested per ISO 10555-1. | Pass - Samples met established |
| acceptance criteria | ||
| Liner Lamination | Verification of inner liner adherence. | Pass - Samples met established |
| acceptance criteria | ||
| Tip Stiffness | Measurement of distal tip stiffness. | Pass - Device comparable to |
| predicate | ||
| Frictional Force | Measurement of coating frictional force. | Pass - Device comparable to |
| predicate |
Table 2: Performance Data- Bench Testing
8
| Chemical Compatibility | Catheter was measured and visually inspected
before and after exposure to various clinically
relevant chemicals. | Pass - Samples met established
acceptance criteria |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|
| Product Integrity Post-Removal | Catheter and accessories were inspected
following removal from packaging. | Pass - Samples met established
acceptance criteria |
| Simulated Use Testing | Simulated use testing in a bench anatomical
model with femoral artery access. | Pass - Samples met established
acceptance criteria |
Performance Data- Animal Safety Testing
A subacute animal study was conducted in compliance with applicable requirements in the Good Laboratory Practice (GLP) regulation (21 CFR Part 58) to evaluate safety of the Echo Intracranial Base Catheter in clinically relevant vessel sizes of healthy swine. Two (2) animals were utilized to complete the study, and in each vessel, three (3) passes were conducted per device. Angiography, necropsy and histopathology of the Echo Intracranial Base Catheter were evaluated and compared to two (2) control devices. The vessels evaluated in the swine model included the renal, lingual, and internal maxillary arteries. Success criteria for all study end points were met. In regard to device safety, vessel injury and tissue response, the subject device performed comparably to both controls, demonstrating vascular safety of the Echo Intracranial Base Catheter.
Biocompatibility
The Echo Intracranial Base Catheter is categorized as a limited exposure (≤24 hours), externally communicating device with circulating blood contact in accordance with ISO 10993-1 and FDA Guidance, "Use of International ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation of testing within a risk management process." All patient contacting components used in the Echo Intracranial Base Catheter have a history of safe clinical use throughout the medical device industry and/or within Stryker Neurovascular and have supporting biocompatibility data. The results of the biocompatibility testing are summarized in Table 3 below.
| Test | Test Method Summary | Conclusion |
|---|---|---|
| Extract and Direct Hemolysis | ||
| (performed separately) | ISO 10993-4 | Non-hemolytic |
| Thromboresistance | ISO 10993-4 | Non-thrombogenic |
| SC5b-9 Complement Activation | ||
| Assay | ISO 10993-4 | Non-activator |
| ASTM Partial Thromboplastin | ||
| Time | ISO 10993-4 | No enhancement or inhibition of |
| coagulation system | ||
| Cytotoxicity Study Using the ISO | ||
| Elution Method | ISO 10993-5 | Non-cytotoxic |
Table 3: Biocompatibility Tests and Results
9
| ISO Maximization Sensitization
| Study | ISO 10993-10 | No evidence of sensitization |
|---|---|---|
| ISO Acute Systemic Toxicity | ISO 10993-11 | No mortality or evidence of acute |
| systemic toxicity | ||
| Material Mediated Pyrogenicity | USP | Non-pyrogenic reactivity |
| ISO Intracutaneous Reactivity | ||
| Study - Extract | ISO 10993-23 | Non-irritant |
Sterilization and Shelf Life
The Echo Intracranial Base Catheter and all device accessories are sterilized with 100% Ethylene Oxide to a sterility assurance level (SAL) of 104. The subject device and accessories meet EO residuals per EN ISO 10993-7 for a limited contact delivery system - externally communicating. The Echo Intracranial Base Catheter and accessories are provided for single use only.
The labeled shelf life for the Echo Intracranial Base Catheter is 1-year. Shelf-life testing (product and packaging) and Distribution Shipping Challenge Conditioning testing were performed on the Subject Device, and the results met established criteria.
Conclusion
The Echo Intracranial Base Catheter is substantially equivalent to the Predicate Device (K193034) based on similar intended use / indications for use, same or similar materials, same fundamental design, and the same operating principles. The conclusions drawn from risk assessments, the bench testing conducted using the Subject Device compared to the Predicate Device, and an animal safety study demonstrate that the Subject Device is suitable for the indication for use with the associated QJP Product Code. Additionally, the testing results summarized above along with the risk assessment demonstrate that the benefits of the device outweigh any residual risks when used in accordance with device Instructions for Use.
Stryker Neurovascular has demonstrated that the Echo Intracranial Base Catheter is substantially equivalent to the legally marketed Predicate device.