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.

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.

AI/ML Overview

The provided text describes the regulatory filing for the Trevo Trak 21 Microcatheter (K211594), which is a device intended for selective placement of devices and/or fluids in vasculature. This submission focuses on demonstrating substantial equivalence to a previously cleared predicate device (K192122), particularly concerning a change in the recommended minimum inner diameter of the guide catheter.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria specified are primarily related to general device performance and safety rather than a specific algorithmic output, as this is a physical medical device (microcatheter) and not an AI/ML powered device. The "reported device performance" refers to the results of bench testing.

Test	Acceptance Criteria Statement (Implied/Explicit)	Reported Device Performance
Simulated Use/Compatibility	The user will assess Trevo Trak™ 21 Microcatheter with a worst-case compatible guide catheter in the in vitro simulated use model. (Implicit: Device must function acceptably and compatibly within the simulated use environment, particularly with the new 0.046 inch ID guide catheter).	Simulated Use testing met acceptance criteria.
Particulate Characterization	Use light obscuration particle counting to measure the total number of particulates generated during simulated use. (Implicit: Particulate generation must be within acceptable limits and comparable to the predicate device to ensure safety).	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. (Implicit: Coating integrity must be maintained before and after simulated use to prevent embolization or other issues).	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. (Implicit: The device must have an acceptable track force, indicating ease and safety of navigation through the vasculature, especially with the changed guide catheter diameter).	Track Testing results met acceptance criteria.
Shelf-Life	Product shelf-life testing was performed and results met established criteria. (Implied: Device must maintain its functional and safety characteristics for its labeled shelf-life of six months).	Product shelf-life testing met established criteria.
Sterilization	Sterility assurance level (SAL) of $10^{-6}$ demonstrated. Meets EO residuals per EN ISO 10993-7 for limited contact delivery system – externally communicating. (Implied: Device must be sterile and have acceptable residual levels of sterilant).	SAL of $10^{-6}$ demonstrated. Meets EO residuals per EN ISO 10993-7.
Biocompatibility	Meets biological safety requirements per EN ISO 10993-1 for an externally communicating medical device with circulating blood contact for less than 24 hours. (Implied: Device materials must be safe for human contact).	Meets biological safety requirements per EN ISO 10993-1.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the numerical sample sizes for each bench test conducted on the Trevo Trak 21 Microcatheter (K211594). It mentions that the testing was performed to assess compatibility with a 0.046 inch inner diameter (ID) guide catheter.

Test Set Sample Size: Not explicitly stated for K211594's current submission. The wording "User will assess Trevo Trak™ 21 Microcatheter with a worst case compatible guide catheter" suggests a focus on representative scenarios but not a specific 'n' number.
Data Provenance: The bench testing appears to be prospective and conducted by Stryker Neurovascular themselves, as part of their submission for K211594. The location of the testing is not specified, but the manufacturer is based in Fremont, California, USA. The shelf-life, sterilization, and biocompatibility data referenced previous testing in K192122, suggesting retrospective use of that data for the current submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This section is not applicable as the device is a physical medical instrument, not an AI/ML algorithm requiring expert interpretation of results for ground truth establishment. The "ground truth" for the performance tests relies on established engineering and materials science principles and validated test methods.

4. Adjudication Method for the Test Set

This is not applicable for the same reasons as point 3. The assessment of bench test results involves direct measurements, visual inspections, and adherence to predefined engineering specifications, not expert consensus or adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. The Trevo Trak 21 Microcatheter is a physical medical device, not an AI/ML diagnostic or assistive technology. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was conducted.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This is not applicable as the device is a physical medical device and does not involve any algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's performance is based on engineering specifications, recognized national/international standards (e.g., ISO 14971 for risk assessment, ISO 10993-1 for biocompatibility), and validated test methods. The successful meeting of these criteria serves as the basis for claiming safety and effectiveness.

8. The sample size for the training set

This is not applicable as this is a physical medical device, not an AI/ML system requiring a training set.

9. How the ground truth for the training set was established

This is not applicable for the same reasons as point 8.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K211594

Device Name Trevo Trak™ 21 Microcatheter

Indications for Use (Describe)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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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 Neurovascular47900 Bayside ParkwayFremont, CA 94538-6515(FDA Registration Number: 3008853977)
Contact:	Shivani H. PatelSenior Staff Regulatory Affairs SpecialistPhone: 341-465-2199Fax: 510-413-2724Email: Shivani.Pate12@stryker.com
Date Prepared:	November 18, 2021

Legally Marketed Predicate Devices

Name of Predicate Device	Name ofManufacturer	510(k)Number
Trevo Trak™ 21Microcatheter	StrykerNeurovascular	K192122

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Device Description

Indications for Use

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™ 21Microcatheter	Same
Regulation Number	21 CFR 870.125021 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 foruse in the selective placement ofdevices and/or fluids, such ascontrast media, into the	Same
Detail	Subject Device	Predicate Device (K192122)
	peripheral, coronary, and neurovasculature during diagnosticand/or therapeutic procedures.
Device Description	The Microcatheter is a single-lumen, braided shaft, variablestiffness catheter with radiopaquemarker(s) on the distal end and aLuer hub on the proximal end.The catheter shaft has ahydrophilic coating to reducefriction during use. Theradiopaque shaft and distalmarker(s) facilitate fluoroscopic	Same
Accessory DevicesProvided (not indirect contact withpatient)	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 OuterDiameter	2.4F/2.0F	Same
Labeled Shaft InnerDiameter	.021"	Same
Effective Length	162 cm	Same
Packaging Materialsand 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 ofOperation	The device is advanced into thevasculature over an appropriatelysized guide wire. Once themicrocatheter is inserted, thecatheter can be advanced throughthe vasculature to the desiredlocation.	Same
Recommendedminimuminnerdiameter of guidecatheter	0.046 inch inner diameter	0.058 inch inner diameter

Table 1. Product Feature Comparison of Subject Device to Predicate Device

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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.

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Test	Test Method Summary	Conclusions
SimulatedUse/Compatibility	User will assess Trevo Trak™ 21 Microcatheterwith a worst case compatible guide catheter in thein vitro simulated use model.	Simulated Usetesting metacceptance criteria.
ParticulateCharacterization	Use light obscuration particle counting tomeasure the total number of particulatesgenerated during simulated use.	Particulategeneration wasacceptable andcomparable tothe predicatedevice.
Coating Integrity	Use visual inspection to identify the location,size, and number of occurrences of anomalies onthe coated surface of the Trevo Trak™ 21Microcatheter beforeand after simulated use.	Coating integritywas acceptable bothbefore and aftersimulated use.
Track Force Testing	Use a Track Tester Model to measure the TrevoTrak™ 21 Microcatheter track force through aguide catheter during simulated use.	Track Testingresults metacceptance 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.

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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.

Regulation Number and Section

§ 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).