(108 days)
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 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.
The provided text describes bench testing and biocompatibility testing for the Trevo Trak™ 21 Microcatheter. It does not contain information about studies involving AI, human readers, or image analysis, thus many of the requested fields cannot be filled from the given text.
Here is the information that can be extracted from the provided FDA 510(k) summary regarding the acceptance criteria and the studies performed for the Trevo Trak™ 21 Microcatheter:
1. A table of acceptance criteria and the reported device performance:
| Test | Acceptance Criteria | Device Performance (Conclusions) |
|---|---|---|
| Dimensional Verification | Procedure and technique of making dimensional measurements using various measurement equipment; Verify dimensions using specified measurement tool. | Dimensional verification met acceptance criteria. |
| Tensile Strength | Based on EN ISO 10555-1; Identify peak tensile force of catheter joints (catheter to hub junction). | Tensile strength met acceptance criteria. |
| Air Leak Resistance | Meets freedom from leakage-air aspiration requirement of 4.7.2 of EN ISO 10555-1 and 4.2.2 of EN 1707 (no air bubbles upon aspiration). | Air leak resistance of catheter met acceptance criteria. |
| Liquid Leak Resistance | Meets freedom from leakage-liquid leak requirement 4.7.1 of EN ISO 10555-1 and 4.2.1 of EN 1707 (no leaks at 300-320 kPa for 30s). | Liquid leak resistance of catheter met acceptance criteria. |
| Burst Pressure | Resistant to rated burst pressure without leakage or damage per EN ISO 10555-1:2013, Annex F (maintain pressure for at least 2 seconds). | Burst pressure met acceptance criteria. |
| Particulate Characterization | Acceptable generation of particulates (measured in four size ranges ≥10μm, ≥25μm, ≥50μm, ≥100μm, and potentially ≥200μm, ≥500μm, ≥1000μm). | Particulate generation was acceptable. |
| Coating Integrity | Visually characterized before and after simulated use with sufficient magnification to identify defects associated with coating loss. | Coating integrity was acceptable. |
| Torsion Bond Strength | Strength of catheter shaft when torque is applied; Record maximum observed number of 360-degree rotations. | Torsional Bond Strength met acceptance criteria. |
| Kink Resistance | Measure the kink radius of catheter shafts. | Kink resistance met acceptance criteria. |
| Chemical Compatibility | Visual and dimensional integrity of catheter following exposure to saline and non-ionic contrast liquids. | Chemical compatibility met acceptance criteria. |
| Tip Flexibility | Measure the maximum force required to deflect test sample by 45°. | Tip Flexibility met acceptance criteria. |
| Distal Tip Shape | Smooth, rounded, tapered, or similarly finished to minimize trauma to vessels per EN ISO 10555-1. | Distal Tip Shape met acceptance criteria. |
| Surface Condition | External surface free from extraneous matter, process, or surface defects along the shaft (visual inspection ≥2.5x magnification). | Surface condition met acceptance criteria. |
| Distal Shaft Trackability | Force required to track catheter through a tortuous model; lubricity and durability (peak force during advance tracking at 6th cycle). | Distal shaft trackability met acceptance criteria. |
| Luer Testing per EN 1707 | Meets requirements 4.1 through 4.7 of EN 1707. | Luer testing meets acceptance criteria. |
| In-vitro Simulated Use Study | Interventional device delivery, durability, and integrity of the device in a tortuous anatomical model with multiple physician users. | All test samples met acceptance criteria. |
| Compatibility with Retrieval Devices | Able to resheath a retriever in good condition without a captured thrombus at least 2 times without functional impact and integrity to the tip. | Compatibility with Retrieval devices met acceptance criteria. |
| Product Integrity Post Removal | No damage to product following removal from packaging (inspect for kinks, stretches, crushing, RHV damage). | Product integrity post removal met acceptance criteria. |
| Hemolysis (ISO 10993-4) | Direct Contact: Hemolysis ≤ 5%; Extraction: Non-hemolytic (0.0%). | Pass |
| Thrombosis (ISO 10993-4) | Acceptable for clinical application. | Pass (with noted potential for complement activation and slight coagulation enhancement). |
| Cytotoxicity (ISO 10993-5) | No less than or equal to 50% cell viability. | Pass |
| Sensitization (ISO 10993-10) | Not a sensitizer. | Pass |
| Irritation (ISO 10993-10) | No significant irritation. | Pass |
| Material Mediated Pyrogenicity (ISO 10993-11) | No febrile reaction greater than 0.5°. | Pass |
| Acute Systemic Toxicity (ISO 10993-11) | No mortality or evidence of systemic toxicity. | Pass |
| Physicochemical (ISO 10993-18) | Non-volatile Residue ≤ 15 mg; Residue on Ignition ≤ 5 mg; Heavy Metals ≤ 1 ppm; Buffering Capacity ≤ 10.0 mL. | Pass |
| FTIR (ISO 10993-18) | No unexpected readings. | Pass |
| Latex (ISO 10993-18) | No detectable latex. | Pass |
| Shelf Life Testing | Met established criteria (for labeled shelf life of two years for product and packaging). | Met established criteria. |
| Sterilization | Sterility Assurance Level (SAL) of 10^-6; EO residuals per EN ISO 10993-7 for limited contact delivery system - externally communicating. | Demonstrated to meet SAL of 10^-6, met EO residuals. |
2. Sample size used for the test set and the data provenance:
- The document mentions "All test samples met acceptance criteria" for the In-vitro Simulated Use Study, but the specific sample size for each bench test is not provided in this summary.
- Data Provenance: The studies are described as "design verification and design validation testing conducted on the Trevo Trak 21 Microcatheter," "bench testing," and "biocompatibility testing." The methods refer to international standards (EN ISO, ASTM), suggesting the tests were conducted according to established laboratory protocols. No information is provided about data provenance in terms of country of origin or if it's retrospective/prospective, as these are bench and biocompatibility tests, not clinical studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For the bench testing and biocompatibility testing, "experts" in the sense of clinical reviewers establishing ground truth for diagnostic accuracy are not applicable. The 'In-vitro Simulated Use Study' mentions evaluation by "multiple physician users" for device delivery, durability, and integrity, but the specific number and qualifications are not detailed.
4. Adjudication method for the test set:
- Not applicable for bench testing and biocompatibility. The tests have predefined pass/fail criteria based on physical measurements, chemical analyses, or visual inspections against a standard.
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:
- No MRMC comparative effectiveness study was done. This is a medical device (microcatheter), not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used:
- For the performance data (bench testing), the "ground truth" is defined by pre-established specifications and international standards (e.g., ISO, EN). The device's performance is measured against these quantitative and qualitative criteria.
- For biocompatibility, the "ground truth" is established by biocompatibility testing results against predefined thresholds for biological response according to ISO 10993 standards.
8. The sample size for the training set:
- Not applicable. This is a physical medical device, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable. No training set was used.
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November 22, 2019
Stryker Neurovascular Rhoda Santos Senior Principal Regulatory Affairs Specialist 47900 Bayside Parkway Fremont, California 94538
Re: K192122
Trade/Device Name: Trevo Trak™ 21 Microcatheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: DQO, DQY Dated: November 7, 2019 Received: November 8, 2019
Dear Rhoda Santos:
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,
Xiaolin Zheng, Ph.D., M.S. Director (Acting) 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) K192122
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.
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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510(k) Summary K192122
| 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, 21CFR 870.1250 – Class II |
| Product Code: | DQY |
| Submitter: | Stryker Neurovascular |
| 47900 Bayside Parkway | |
| Fremont, CA 94538-6515 | |
| (FDA Registration Number: 3008853977) | |
| Contact: | Rhoda M. Santos |
| Senior Principal Regulatory Affairs Specialist | |
| Phone: 510-413-2269 | |
| Fax: 510-413-2724 | |
| Email: rhoda.santos@stryker.com | |
| Date Prepared: | November 20, 2019 |
Legally Marketed Predicate Devices
| Name of Predicate Device | Name ofManufacturer | 510(k)Number |
|---|---|---|
| Trevo® Pro 18Microcatheter | StrykerNeurovascular | K113260 |
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.
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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 Comparison
Stryker Neurovascular has demonstrated the Trevo Trak™ 21 Microcatheter is substantially equivalent to the Predicate device, Trevo Pro18 Microcatheter (K113260) based on the same or similar materials, similar 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 (K192122) | Predicate Device (K113260) |
|---|---|---|
| Manufacturer | Stryker Neurovascular | Stryker Neurovascular |
| 510(k) Number | K192122 | K113260 |
| Device Trade Name | Trevo TrakTM 21Microcatheter | Trevo® Pro 18 Microcatheter |
| Regulation Number | 21 CFR 870.1250 | Same |
| Regulation Name | Percutaneous Catheter | Same |
| Classification | II | Same |
| Product Code | DQY | Same |
| IntendedUse/Indication forUse | The Microcatheter is indicatedfor use in the selective placementof devices and/or fluids, such ascontrast media, into theperipheral, coronary, and neurovasculature during diagnosticand/or therapeutic procedures. | The Microcatheter is indicatedfor use in the selective placementof fluids and/or other devices oragents into the peripheral,coronary, and neuro vasculatureduring diagnostic and/ortherapeutic 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. The | 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 on the distal 100cm to reduce friction during |
| Detail | Subject Device (K192122) | Predicate Device (K113260) |
| radiopaque shaft and distalmarker(s) facilitate fluoroscopicvisualization.Device dimensions andconfiguration are shown on theproduct label. A rotatinghemostasis valve with side-armadapter is provided with eachmicrocatheter. | use. The radiopaque shaft anddistal marker(s) facilitatefluoroscopic visualization.Device dimensions andconfiguration are shown on theproductlabel. A rotating hemostasisvalve with side-arm adapter isprovided with eachmicrocatheter. | |
| 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 |
| Labeled Shaft OuterDiameter | 2.4F/2.0F | Same |
| Labeled Shaft InnerDiameter | .021" | Same |
| Effective Length | 162 cm | 150 cm |
| Packaging Materialsand Configuration | HDPE Packaging Hoop,Tyvek/Film Pouch, SBS Carton | HDPE Packaging Hoop, HDPEmounting card, Tyvek/FilmPouch, HDPE Tubing Clips, SBSCarton |
| Sterilization Method | EO Sterilization | Same |
| How Supplied | Single Use/Sterile | Same |
| Detail | Subject Device (K192122) | Predicate Device (K113260) |
| 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 |
Table 1. Product Feature Comparison of Subject Device to Predicate Device
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Testing Summary
Performance Data – Bench Testing
The results of design verification and design validation testing conducted on the Trevo Trak 21 Microcatheter demonstrates that it performs as designed, is suitable for the indication for use, and is substantially equivalent to the legally marketed Predicate device. The design verification and design validation bench testing are summarized in Table 2 below.
| Test | Test Method Summary | Conclusions |
|---|---|---|
| DimensionalVerification | Purpose: To describe the procedure and techniqueof making dimensional measurements usingvarious measurement equipment.Method: Verify dimensions using specifiedmeasurement tool. Record measurements. | Dimensionalverification metacceptance criteria. |
| Tensile Strength | Purpose: To determine tensile strength ofcatheters based on EN ISO 10555-1.Method: Identify catheter joints, includingcatheter to hub junction, and prepare sample fortest. Use tensile tester to apply tensile load tosample and identify peak tensile force. Recordresults. | Tensile strengthmet acceptancecriteria. |
| Air Leak Resistance | Purpose: To determine whether the device meetsthe freedom from leakage-air aspirationrequirement of 4.7.2 of EN ISO 10555-1 and4.2.2 of EN 1707.Method: Connect test hub sample to a partiallyfilled syringe. With the nozzle of the syringepointing down towards the ground, withdraw theplunger to the 10cc mark. Hold for 15 seconds | Air leak resistanceof catheter metacceptance criteria. |
| Test | Test Method Summary | Conclusions |
| and examine the water in the syringe for theformation of air bubbles. Record results. | ||
| Liquid LeakResistance | Purpose: To determine whether the device meetsthe freedom from leakage-liquid leak requirement4.7.1 of EN ISO 10555-1 and 4.2.1 of EN 1707. | Liquid leakresistance ofcatheter met |
| Method: Connect test hub sample to fixture andflush with water to expel air. Occlude distal tip.Apply pressure of 300 kPa to 320 kPa andmaintain pressure for 30s. Visually inspectcatheter/hub joint and catheter shaft for leaks.Record results. | acceptance criteria. | |
| Burst pressure | Purpose: To determine if the catheter can resist itsrated burst pressure without causing leakage ordamage to the catheter. This test is performed inaccordance with EN ISO 10555-1:2013, Annex F. | Burst pressure metacceptance criteria. |
| Method: Prepare test sample. Apply specifiedburst pressure (greater than the rated burstpressure) to test sample and maintain pressure forat least 2 seconds. Observe sample for anyleakage or damage. Record results. | ||
| Particulatecharacterization | Purpose: To characterize acute phase particulategenerated as a result of product specific simulateduse steps. | Particulategeneration wasacceptable. |
| Method: Measure the total number of particulatesgenerated during simulated use. Report in each offour size ranges ≥10μm, ≥25μm, ≥50μm, and≥100μm. | ||
| If >100μm are observed, complete particle countanalysis of bin sizes ≥200μm, ≥500μm and≥1000μm. Record results. | ||
| Coating Integrity | Purpose: Coated surface shall be visuallycharacterized before and after simulated use withsufficient magnification to identify any defectswhich could be associated with loss of coatingunder anticipated clinical use conditions. | Coating integritywas acceptable. |
| Method: Remove test sample from packaging andinspect for damage. Visually inspect externalsurface of test sample using minimum 10xmagnification for surface defects. Record results. | ||
| Test | Test Method Summary | Conclusions |
| Torsion BondStrength | Purpose: To measure the strength of a cathetershaft when torque is applied.Method: Prepare test sample and insert intotorsional bond strength test fixture with tortuouspath model. Apply torque to proximal end ofcatheter while distal end is fixed. Recordmaximum observed number of 360-degreerotations. | Torsional BondStrength metacceptance criteria. |
| Kink Resistance | Purpose: To measure the kink radius of a cathetershafts.Method: Prepare test sample. Position test samplein a loop and place within a vice ensuring loopapex is within the vice. Slowly close the vice untilthe test sample kinks. Measure distance betweenvice grips and record result. | Kink resistance metacceptance criteria. |
| ChemicalCompatibility | Purpose: To determine visual and dimensionalintegrity of catheter following exposure to salineand non-ionic contrast liquids.Method: Prepare sample for test. Flush samplewith water for 1 minute and then measure OD andID of test sample. Insert mandrel and take imagesof test sample for initial characterization. Dip testsample and mandrel into specified chemicals andhold for 1 minute. Remove test sample, measureOD, ID and cross-sectional area. Take images oftest sample for post-exposure characterization.Record results. | Chemicalcompatibility metacceptance criteria. |
| Tip Flexibility | Purpose: To measure the maximum force requiredto deflect test sample by 45°.Method: Prepare sample for test. Use Instron andappropriate fixtures to deflect test sample whilemeasuring force. Record maximum forceachieved. | Tip Flexibility metacceptance criteria. |
| Distal Tip Shape | Purpose: To verify that the catheter tip is smooth,rounded, tapered or similarly finished in order tominimize trauma to vessels during use per ENISO 10555-1.Method: Visually inspect distal tip to verify distaltip end is smooth, rounded, tapered or similarlyfinished. Record results. | Distal Tip Shapemet acceptancecriteria. |
| Test | Test Method Summary | Conclusions |
| Surface Condition | Purpose: To verify the external surface of thecatheter is free from extraneous matter, process orsurface defects along the shaft.Method: Visually inspect external surface of testsample using minimum 2.5x magnification forsurface defects. Record results. | Surface conditionmet acceptancecriteria. |
| Distal ShaftTrackability | Purpose: To evaluate the force required to trackthe catheter through a tortuous model as well asevaluate the lubricity and durability of thecatheter.Method: Prepare sample for test. Use track testerto measure the track force of the test samplethrough a tortuous model using a tri-axialapproach. Record the peak force during advancetracking at 6th cycle. | Distal shafttrackability metacceptance criteria. |
| Luer Testing per EN1707 | Purpose: To determine if microcatheter hub andaccessory meet requirements 4.1 through 4.7 ofEN 1707.Method: Test methods conforms with section 5 ofEN 1707. | Luer testing meetsacceptance criteria. |
| In-vitro SimulatedUse Study | Purpose: To evaluate interventional devicedelivery, durability and integrity of the Subjectdevice as a general access and delivery catheter ina tortuous anatomical model with multiplephysician users.Method: Perform a simulated interventionalprocedure by tracking the device to the target sitefor interventional device delivery using aneurovascular model that replicates the tortuosity,diameter and location of the arteries in theneurovasculature. Devices were visuallyinspected post testing. | All test samples metacceptance criteria. |
| Compatibility withRetrieval devices | Purpose: To ensure the microcatheter shall beable to resheath a retriever in good conditionwithout a captured thrombus after deployment ofthe entire shaped section into the vessel at least 2times without functional impact and integrity tothe tip. | Compatibility withRetrieval devicesmet acceptancecriteria. |
| Test | Test Method Summary | Conclusions |
| Method: Entire shaped section is deployed intothe vessel at least 2 times and inspected forfunctional impact and integrity of the tip.Integrity is defined as no missing material or tearsat the tip. Functional impact is defined as inabilityto resheath the shaped section. A deployment isdefined as the entire shaped section of theretriever is deployed into the vessel. | ||
| Product Integrity PostRemoval | Purpose: To determine damage to productfollowing removal of the catheter and itsaccessories from its packaging.Method: Prepare product and remove frompackaging per DFU, followed by-inspecting for kinks, stretches or crushing of thecatheter shaft.Self-evident inspection:-No damage on RHV. | Product integritypost removal metacceptance criteria. |
Table 2. Performance Data - Bench Testing
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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 two years. Shelf life testing (product and packaging) and Distribution Shipping Challenge Conditioning and testing were performed on the Subject device, and the results met established criteria.
Sterilization
The Trevo Trak 21 Microcatheter and accessory (RHV) are sterilized with 100% Ethylene Oxide. The Trevo Trak 21 Microcatheter and accessory are provided sterility assurance level (SAL) of 10 6 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.
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Biocompatibility
The Trevo Trak 21 Microcatheter was assessed for biocompatibility in accordance with EN ISO 10993-1, "Biological evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process". The Subject device is considered an externally communicating medical device with circulating blood contact for less than 24 hours. The Trevo Trak 21 Microcatheter passed all recommended biocompatibility testing. An overview of the biocompatibility testing is summarized below.
| Test | Acceptance Criteria | Conclusion | ||
|---|---|---|---|---|
| ISO10993-4 | Hemolysis | Direct Contact | Hemolysis is $\le$ 5%. | Pass |
| Extraction | Non-hemolytic(0.0%) | Pass | ||
| Thrombosis | Thromboresistance | Thrombosis is acceptable for clinicalapplication. | Pass | |
| ComplementActivation | Potential activator( $p$ < 0.05 versus negative and activatedcontrols, ~4% of positive control,~173% of negative control) | |||
| Coagulation | Slight potential enhancement ofcoagulation system(17% faster clotting versus negativecontrol) | |||
| ISO10993-5 | Cytotoxicity | No less than or equal to 50% cellviability. | Pass | |
| ISO10993-10 | Sensitization | Not a sensitizer. | Pass | |
| Irritation | No significant irritation. | Pass | ||
| ISO10993-11 | Material Mediated Pyrogenicity | No febrile reaction greater than 0.5°. | Pass | |
| Acute Systemic Toxicity | No mortality or evidence of systemictoxicity. | Pass | ||
| ISO10993-18 | Physicochemical(USP <661>) | Non-volatile Residue $\le$ 15 mgResidue on Ignition $\le$ 5 mgHeavy Metals $\le$ 1 ppmBuffering Capacity $\le$ 10.0 mL | Pass | |
| FTIR | No unexpected readings. | Pass | ||
| Latex(LEAP - ASTM D6499) | No detectable latex. | Pass |
| Table 3. Overview of Biocompatibility Studies Performed on the Subject Device |
|---|
| ------------------------------------------------------------------------------- |
Conclusion
Stryker Neurovascular has demonstrated the Trevo Trak 21 Microcatheter is substantially equivalent to the Predicate device (K113260) based on same intended use / indications for use, same or similar materials, same fundamental design, and the same operating principles. The conclusions drawn from 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 device Directions for Use. Stryker Neurovascular has demonstrated that the Trevo Trak 21 Microcatheter is substantially equivalent to the legally marketed Predicate device.
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).