(186 days)
Not Found
No
The summary describes a physical microcatheter and its performance characteristics, with no mention of AI/ML in the device description, intended use, or performance studies.
Yes
The device is indicated for use in "therapeutic procedures," meaning it is used to treat a condition.
Yes
The "Intended Use / Indications for Use" section states: "The Microcatheter is indicated for use in the selective placement of devices and/or fluids, such as contrast media, into the peripheral, coronary, and neuro vasculature during diagnostic and/or therapeutic procedures." The mention of "diagnostic . . . procedures" directly indicates its use in diagnostics.
No
The device description clearly describes a physical catheter with a braided shaft, radiopaque markers, and a Luer hub, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The description clearly states the Microcatheter is used for the "selective placement of devices and/or fluids... into the peripheral, coronary, and neuro vasculature." This is an invasive procedure performed inside the body.
- Lack of Specimen Analysis: There is no mention of the device being used to analyze any biological specimens. Its purpose is to deliver or place other items within the body's vascular system.
Therefore, based on the provided information, the Trevo Trak 21 Microcatheter is a medical device used for interventional procedures within the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Microcatheter is indicated for use in the selective placement of devices and/or fluids, such as contrast media, into the peripheral, coronary, and neuro vasculature during diagnostic and/or therapeutic procedures.
Product codes
QJP, DQY, DQO
Device Description
The Trevo Trak 21 Microcatheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker(s) on the distal end and a Luer hub on the proximal end. The catheter shaft has a hydrophilic coating to reduce friction during use. The radiopaque shaft and distal marker(s) facilitate fluoroscopic visualization.
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
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
Bench testing was performed:
- Simulated Use/Compatibility: User will assess Trevo Trak 21 Microcatheter with a worst case compatible guide catheter in the in vitro simulated use model. Conclusions: Simulated Use testing met acceptance criteria.
- Particulate Characterization: Use light obscuration particle counting to measure the total number of particulates generated during simulated use. Conclusions: Particulate generation was acceptable and comparable to the predicate device.
- Coating Integrity: Use visual inspection to identify the location, size, and number of occurrences of anomalies on the coated surface of the Trevo Trak 21 Microcatheter before and after simulated use. Conclusions: Coating integrity was acceptable both before and after simulated use.
- Track Force Testing: Use a Track Tester Model to measure the Trevo Trak 21 Microcatheter track force through a guide catheter during simulated use. Conclusions: Track Testing results met acceptance criteria.
No animal study or clinical study was conducted.
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
November 26, 2021
Image /page/0/Picture/1 description: The image shows the logo of 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 in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
Stryker Neurovascular Shivani H. Patel Senior Staff Regulatory Affairs Specialist 47900 Bayside Parkway Fremont, California 94538
Re: K211594
Trade/Device Name: Trevo Trak 21 Microcatheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP, DQY, DQO Dated: November 9, 2021 Received: November 10, 2021
Dear Shivani H. Patel:
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. 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 located 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.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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).
Sincerely,
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
2
Indications for Use
510(k) Number (if known) K211594
Device Name Trevo Trak™ 21 Microcatheter
Indications for Use (Describe)
The Microcatheter is indicated for use in the selective placement of devices and/or fluids, such as contrast media, into the peripheral, coronary, and neuro vasculature during diagnostic and/or therapeutic procedures.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary K211594
| Trade/Proprietary Name: | Trevo Trak™ 21 Microcatheter |
|---|---|
| Common Name: | Catheter, Percutaneous, Neurovasculature |
| Regulation Name: | Percutaneous Catheter, 21 CFR 870.1250 - Class II |
| Product Code: | QJP |
| Trade/Proprietary Name: | Trevo Trak™ 21 Microcatheter |
| Common Name: | Catheter, Intravascular, Diagnostic |
| Regulation Name: | Catheter, Intravascular, Diagnostic, 21 CFR 870.1200 - Class II |
| Product Code: | DQO |
| Trade/Proprietary Name: | Trevo Trak™ 21 Microcatheter |
| Common Name: | Percutaneous Catheter |
| Regulation Name: | Percutaneous Catheter, 21 CFR 870.1250 - Class II |
| Product Code: | DQY |
| Submitter: | Stryker Neurovascular |
| 47900 Bayside Parkway | |
| Fremont, CA 94538-6515 | |
| (FDA Registration Number: 3008853977) | |
| Contact: | Shivani H. Patel |
| Senior Staff Regulatory Affairs Specialist | |
| Phone: 341-465-2199 | |
| Fax: 510-413-2724 | |
| Email: Shivani.Pate12@stryker.com | |
| Date Prepared: | November 18, 2021 |
Legally Marketed Predicate Devices
| Name of Predicate Device | Name of
Manufacturer | 510(k)
Number |
|---------------------------------|--------------------------|------------------|
| Trevo Trak™ 21
Microcatheter | Stryker
Neurovascular | K192122 |
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Device Description
The Trevo Trak 21 Microcatheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker(s) on the distal end and a Luer hub on the proximal end. The catheter shaft has a hydrophilic coating to reduce friction during use. The radiopaque shaft and distal marker(s) facilitate fluoroscopic visualization.
Indications for Use
The Microcatheter is indicated for use in the selective placement of devices and/or fluids, such as contrast media, into the peripheral, coronary, and neuro vasculature during diagnostic and/or therapeutic procedures.
Technological Characteristics and Product Feature Comnarison
Stryker Neurovascular has demonstrated the Trevo Trak™ 21 Microcatheter is substantially equivalent to the Predicate device, Trevo Trak 21 Microcatheter (K192122), based on the same materials, same design, and the same fundamental operating principles. A comparison of the Subject device with the Predicate device is summarized in Table 1 below.
| Detail | Subject Device | Predicate Device (K192122) |
|---|---|---|
| Manufacturer | Stryker Neurovascular | Same |
| 510(k) Number | K211594 | K192122 |
| Device Trade Name | Trevo Trak™ 21 | |
| Microcatheter | Same | |
| Regulation Number | 21 CFR 870.1250 | |
| 21 CFR 870.1200 | Same | |
| Regulation Name | Percutaneous Catheter | Same |
| Classification | II | Same |
| Product Code | QJP, DQO, DQY | DQO, DQY |
| Indication for Use | The Microcatheter is indicated for | |
| use in the selective placement of | ||
| devices and/or fluids, such as | ||
| contrast media, into the | Same | |
| Detail | Subject Device | Predicate Device (K192122) |
| peripheral, coronary, and neuro | ||
| vasculature during diagnostic | ||
| and/or therapeutic procedures. | ||
| Device Description | The Microcatheter is a single- | |
| lumen, braided shaft, variable | ||
| stiffness catheter with radiopaque | ||
| marker(s) on the distal end and a | ||
| Luer hub on the proximal end. | ||
| The catheter shaft has a | ||
| hydrophilic coating to reduce | ||
| friction during use. The | ||
| radiopaque shaft and distal | ||
| marker(s) facilitate fluoroscopic | ||
| Same | ||
| Accessory Devices | ||
| Provided (not in | ||
| direct contact with | ||
| patient) | Rotating Hemostasis Valve | |
| (RHV) packaged within device | Same | |
| Outer Jacket | Polymeric microcatheter | Same |
| Shaft Braid | Stainless Steel | Same |
| Strain Relief | Polyolefin | Same |
| Inner Layer | PTFE | Same |
| Catheter Hub | Polyurethane | Same |
| Marker Band | Platinum/Iridium | Same |
| Adhesive | Acrylic (Acrylated Urethane) | Same |
| Outer Jacket Coating | Hydrophilic Coating | Same |
| Detail | Subject Device | Predicate Device (K192122) |
| Labeled Shaft Outer | ||
| Diameter | 2.4F/2.0F | Same |
| Labeled Shaft Inner | ||
| Diameter | .021" | Same |
| Effective Length | 162 cm | Same |
| Packaging Materials | ||
| and Configuration | HDPE Packaging Hoop, | |
| Tyvek/Film Pouch, SBS Carton | Same | |
| Sterilization Method | EO Sterilization | Same |
| How Supplied | Single Use/Sterile | Same |
| Shelf-Life | 6 months | 2 years |
| Principles of | ||
| Operation | The device is advanced into the | |
| vasculature over an appropriately | ||
| sized guide wire. Once the | ||
| microcatheter is inserted, the | ||
| catheter can be advanced through | ||
| the vasculature to the desired | ||
| location. | Same | |
| Recommended | ||
| minimum | ||
| inner | ||
| diameter of guide | ||
| catheter | 0.046 inch inner diameter | 0.058 inch inner diameter |
Table 1. Product Feature Comparison of Subject Device to Predicate Device
5
6
The differences between the devices do not raise new questions of safety and effectiveness.
Risk Assessment
A risk assessment of the Trevo Trak 21 Microcatheter has been conducted in accordance with EN ISO 14971. Stryker Neurovascular has determined that the labeling changes to the Trevo Trak 21 Microcatheter raise no new questions of safety and effectiveness. The results of testing demonstrate that the Trevo Trak 21 Microcatheter with the modified labeling is substantially equivalent to the legally marketed Predicate device.
Testing Summary
Performance Data – Bench Testing
Stryker Neurovascular performed the following non-clinical bench testing to assess the compatibility of the Trevo Trak 21 Microcatheter with 0.046 inch inner diameter (ID) guide catheters. The bench testing is summarized in Table 2 below.
7
| Test | Test Method Summary | Conclusions |
|---|---|---|
| Simulated | ||
| Use/Compatibility | User will assess Trevo Trak™ 21 Microcatheter | |
| with a worst case compatible guide catheter in the | ||
| in vitro simulated use model. | Simulated Use | |
| testing met | ||
| acceptance criteria. | ||
| Particulate | ||
| Characterization | Use light obscuration particle counting to | |
| measure the total number of particulates | ||
| generated during simulated use. | Particulate | |
| generation was | ||
| acceptable and | ||
| comparable to | ||
| the predicate | ||
| device. | ||
| Coating Integrity | Use visual inspection to identify the location, | |
| size, and number of occurrences of anomalies on | ||
| the coated surface of the Trevo Trak™ 21 | ||
| Microcatheter before | ||
| and after simulated use. | Coating integrity | |
| was acceptable both | ||
| before and after | ||
| simulated use. | ||
| Track Force Testing | Use a Track Tester Model to measure the Trevo | |
| Trak™ 21 Microcatheter track force through a | ||
| guide catheter during simulated use. | Track Testing | |
| results met | ||
| acceptance criteria. |
Table 2. Performance Data - Bench Testing
Performance Data – Animal Study. Clinical Study
No animal study or clinical study was conducted as bench testing was determined sufficient for verification and validation purposes.
Shelf Life Testing
The labeled shelf life for the Trevo Trak 21 Microcatheter is six-months. Product shelf-life testing was performed on the Subject device and the results met established criteria. The packaging shelf-life and Distribution Shipping Challenge Conditioning and testing was performed on the Predicate device and test results were reviewed and cleared in K192122.
8
Sterilization
The sterilization evaluation previously conducted for the Trevo Trak 21 Microcatheter was used to support the subject device and can be found in K192122. The Trevo Trak 21 Microcatheter is sterilized with 100% Ethylene Oxide. The Trevo Trak 21 Microcatheter and accessory are provided sterile. A sterility assurance level (SAL) of 106 has been demonstrated. The Trevo Trak 21 Microcatheter and accessory meet EO residuals per EN ISO 10993-7 for a limited contact delivery system – externally communicating. The Trevo Trak 21 Microcatheter and accessory are for single use only.
Biocompatibility
The biocompatibility testing previously conducted for the Trevo Trak 21 Microcatheter was used to support the subject device and can be found in K192122. The results of biocompatibility testing and biological safety evaluation of the Trevo Trak 21 Microcatheter demonstrate that the device meets the biological safety requirements per EN ISO 10993-1, "Biological evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process" for an externally communicating medical device with circulating blood contact for less than 24 hours. Therefore, the Trevo Trak 21 Microcatheter, accessory, and primary packaging are considered biocompatible for their intended use.
Conclusion
Stryker Neurovascular has demonstrated the Trevo Trak 21 Microcatheter is substantially equivalent to the Predicate device (K192122) based on same intended use / indications for use, same materials, same fundamental design, and the same operating principles. The conclusions drawn from the risk assessment and the bench testing results summarized above demonstrate that the benefits of the device outweigh any residual risks when used in accordance with the device Instructions for Use. Stryker Neurovascular has demonstrated that the Trevo Trak 21 Microcatheter is substantially equivalent to the legally marketed Predicate device.