(94 days)
The Trevo XP ProVue Retriever (4x30mm) is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
The Trevo XP ProVue Retriever (4x30mm) consists of a flexible, tapered core wire with a shaped section at the distal end. It is designed to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke. Radiopaque platinum wires in the shaped section and radiopaque markers on the distal end allow fluoroscopic visualization. Retriever dimensions are indicated on the product label. The Retriever has a hydrophilic coating to reduce friction during use. A torque device is provided with the Retriever to facilitate manipulation. The torque device is used to lock the core wire to the microcatheter during the procedure. Locking of the torque device to the wire allows the microcatheter and Retriever to be retracted as a system during clot retrieval. An insertion tool is provided to introduce the Retriever into a microcatheter. The proximal end of the device is compatible with the Abbott guide wire extension to facilitate removal or exchange of a catheter while maintaining the Retriever position in the vessel.
The provided text describes a 510(k) premarket notification for the Trevo XP ProVue Retriever (4x30mm). This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria for a new clinical outcome. Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not explicitly present in the provided text as they are typically associated with de novo approvals or significant device modifications requiring new clinical evidence.
However, I can extract information related to the acceptance criteria for bench and animal testing, and the study methodologies employed to demonstrate substantial equivalence.
Here's the information derived from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for each test were "meets acceptance criteria." The device performance is generally stated as having met these unspecified criteria. The document emphasizes substantial equivalence to the predicate device through bench and animal testing.
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Dimensional Verification | Meets acceptance criteria | Dimensional verification meets acceptance criteria. |
| Retriever Mid Joint Tensile Strength | Meets acceptance criteria | Retriever Mid Joint Tensile Strength meets acceptance criteria. |
| Retriever Tip Tensile Strength | Meets acceptance criteria | Retriever Tip Tensile Strength meets acceptance criteria. |
| Retriever Shaped Section Radial Force | Meets acceptance criteria | Retriever Shaped Section Radial Force meets acceptance criteria. |
| Retriever / Vessel Interaction (Tip Flexibility) | Meets acceptance criteria | Retriever/Vessel Interaction (Tip Flexibility) meets acceptance criteria. |
| Retriever Torque Tensile Durability | Meets acceptance criteria | Retriever Torque Tensile Durability meets acceptance criteria. |
| Retriever Platinum Wire Joint Strength | Meets acceptance criteria | Retriever Platinum Wire Joint Strength meets acceptance criteria. |
| Retriever Platinum Wire and Joint Durability | Meets acceptance criteria | Retriever Platinum Wire and Joint Durability meet acceptance criteria. |
| Radiopacity | Meets acceptance criteria | Radiopacity meets acceptance criteria. (Due to same platinum weave wires and configuration as predicate). |
| Retriever / Microcatheter Deliverability | Meets acceptance criteria | Retriever/Microcatheter Deliverability meets acceptance criteria. |
| Particulate Evaluation | All samples meet acceptance criteria | All samples meet acceptance criteria. |
| Coating Integrity Evaluation | All samples meet acceptance criteria | All samples meet acceptance criteria. |
| Simulated Use | Meets acceptance criteria | Simulated Use meets acceptance criteria. |
| Animal Studies (Safety and Usability) | Met acceptance criteria | The safety and usability results from the animal studies met acceptance criteria. |
2. Sample Size Used for the Test Set and Data Provenance
- Bench Testing: The sample sizes for individual bench tests are not explicitly stated in the summary document. The phrasing "All samples meet acceptance criteria" suggests that a sufficient number of devices were tested per manufacturing and quality control standards, but the exact N is not provided.
- Animal Testing: The document mentions that a "larger diameter device (6x30mm) than the subject device (4x30mm)" was used for animal studies as a "worst case." The number of animals used is not specified.
- Data Provenance: The bench and animal studies were conducted by Concentric Medical, Inc. (the submitter). These are prospective studies performed specifically for this 510(k) submission. No country of origin for the data is explicitly mentioned beyond the submitter's location in Mountain View, California, USA.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Bench Testing: No external experts are mentioned for establishing ground truth for the bench tests. These tests are industrial performance evaluations against internal specifications.
- Animal Testing: The animal studies were conducted in compliance with GLP regulation (21 CFR Part 58), which implies qualified personnel (e.g., veterinarians, pathologists, study directors) were involved in the conduct and evaluation, but their specific number or qualifications are not detailed.
- Clinical Data: No clinical study was performed for this 510(k) submission (stated in the document as "No clinical study was performed as there is no change to the indications for use or the fundamental scientific technology for the subject device."). Therefore, no experts were used to establish ground truth from a clinical test set.
4. Adjudication Method for the Test Set
Not applicable, as no human-read test set or clinical study requiring adjudication is described. The evaluations were based on quantifiable bench tests and animal observations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical study was performed as there is no change to the indications for use or the fundamental scientific technology for the subject device."
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to a medical device in the context of hardware, specifically a "thrombus retriever" catheter. The concept of "standalone algorithm performance" is not applicable here as it is not an AI/software device.
7. The Type of Ground Truth Used
- Bench Testing: Ground truth for bench tests is based on engineering specifications and physical measurements, which are inherently objective and quantitative (e.g., tensile strength, radial force, dimensions).
- Animal Testing: Ground truth in animal studies would typically involve pathological examination and observations for adverse events (e.g., "evidence of arterial transmural dissection or perforation"). This is based on direct biological and histological assessment.
8. The Sample Size for the Training Set
Not applicable. This device is a physical medical instrument (thrombus retriever), not a machine learning algorithm requiring a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. This device is a physical medical instrument (thrombus retriever), not a machine learning algorithm.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of a human figure in profile, composed of three overlapping silhouettes. The silhouettes are arranged in a way that suggests movement or flow. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 12, 2015
Concentric Medical, Inc. Ms. Rhoda M. Santos Principal Regulatory Affairs Specialist 301 East Evelyn Avenue Mountain View, California 94041
Re: K150616
Trade/Device Name: Trevo XP ProVue Retriever (4x30mm) Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: May 8, 2015 Received: May 11, 2015
Dear Ms. 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. 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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Carlos L. Pena -S 同公
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K150616
Device Name Trevo XP ProVue Retriever (4x30mm)
Indications for Use (Describe)
The Trevo XP ProVue Retriever (4x30mm) is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
| Trade Name: | Trevo XP ProVue Retriever (4x30mm) |
|---|---|
| Common Name: | Catheter, Thrombus Retriever |
| Classification Name: | Thrombus Retriever, 21CFR 870.1250 Class II |
| Product Code: | NRY |
| Submitter: | Concentric Medical, Inc.301 E. Evelyn AvenueMountain View, CA 94041Tel 510-413-2148Fax 510-413-2558Facility Registration #2954917 |
| Contact: | Rhoda M. SantosPrincipal Regulatory Affairs Specialist |
| Date Prepared: | May 8, 2015 |
| Predicate Device: | Trevo XP ProVue Retriever (4x20mm) (K132641 |
Device Description
The Trevo XP ProVue Retriever (4x30mm) consists of a flexible, tapered core wire with a shaped section at the distal end. It is designed to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke. Radiopaque platinum wires in the shaped section and radiopaque markers on the distal end allow fluoroscopic visualization. Retriever dimensions are indicated on the product label. The Retriever has a hydrophilic coating to reduce friction during use. A torque device is provided with the Retriever to facilitate manipulation. The torque device is used to lock the core wire to the microcatheter during the procedure. Locking of the torque device to the wire allows the microcatheter and Retriever to be retracted as a system during clot retrieval. An insertion tool is provided to introduce the Retriever into a microcatheter. The proximal end of the device is compatible with the Abbott guide wire extension to facilitate removal or exchange of a catheter while maintaining the Retriever position in the vessel.
Indications for Use
The Trevo XP ProVue Retriever (4x30mm) is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
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Technological Characteristics and Product Feature Comparison
The Trevo XP ProVue Retriever (4x30mm) is substantially equivalent to the primary predicate device in terms of basic design, materials used, and function. A comparison of the subject device with Primary Predicate Trevo XP ProVue Retriever (4x20mm) is summarized in the below table. Additionally, shaped section measurements are also compared to the reference predicate device [Solitaire FR Revascularization Device SFR2-4-40 (4x40mm) (K141491)].
| Feature | Primary PredicateCleared Trevo XPProVue Retriever(4x20mm)(K132641) | Subject DeviceTrevo XP ProVueRetriever (4x30mm) | Rationale for difference(if applicable) |
|---|---|---|---|
| Indicationsfor Use | The Trevo XP ProVueRetriever is intended torestore blood flow in theneurovasculature byremoving thrombus inpatients experiencingischemic stroke within 8hours of symptom onset.Patients who are ineligiblefor intravenous tissueplasminogen activator (IVt-PA) or who fail IV t-PAtherapy are candidates fortreatment. | Same | N/A |
| Feature | Primary PredicateCleared Trevo XPProVue Retriever(4x20mm)(K132641) | Subject DeviceTrevo XP ProVueRetriever (4x30mm) | Rationale for difference(if applicable) |
| DeviceDescription | The Retriever consists of aflexible, tapered core wirewith a shaped section at thedistal end. Platinummarkers at the distal endallow fluoroscopicvisualization. In addition,the shaped section is alsoradiopaque. Retrieverdimensions are indicated onproduct label.The Retriever has ahydrophilic coating toreduce friction during use.The Retriever has a shaftmarker to indicateproximity of Retriever tiprelative to Microcathetertip. A torque device isprovided with the Retrieverto facilitate manipulation.An insertion tool isprovided to introduce theRetriever into a Trevo®Microcatheter. | Same with the exceptionthat the subject Retriever isintroduced via an ExcelsiorXT-27 Microcatheter(whereas the predicatedevice is introduced via aTrevo® Microcatheter) | The Excelsior XT-27 andTrevo Pro18 Microcathetersare compatible with the4x30mm device and will beindicated as such in theIFU.Bench testing hasdemonstrated that thecompatibility of ExcelsiorXT-27 with the 4x30mmdevice does not affect thesafety and effectiveness ofthe device. |
| TargetPopulation | Patients with symptoms ofan ischemic stroke | Same | N/A |
| AnatomicalSites | Neurovasculature | Same | N/A |
| AccessoryDevicesProvided(not in directcontact withpatient) | Insertion tool and torquedevice provided in productpackage | Same | N/A |
| Feature | Primary PredicateCleared Trevo XPProVue Retriever(4x20mm)(K132641) | Subject DeviceTrevo XP ProVueRetriever (4x30mm) | Rationale for difference(if applicable) |
| MicrocatheterCompatibility | Trevo Pro 18 Microcatheter | Excelsior XT-27Microcatheter and TrevoPro 18 Microcatheter | The Excelsior XT-27 andTrevo Pro18 Microcathetersare compatible with the4x30mm device and will beindicated as such in theIFU.Bench testing hasdemonstrated that thecompatibility of ExcelsiorXT-27 with the 4x30mmdevice does not affect thesafety and effectiveness ofthe device. |
| Materials | Core Wire Material: Nitinol(nickel titanium alloy)Distal Shaped SectionMaterial: NitinolCoil Material Distal toDistal Shaped Section :Platinum/TungstenShaped Section RadiopaqueWire: Platinum/TungstenCoil Material Proximal toShaped Section: 304Stainless SteelSolder: Gold/TinHydrophilic Coating:Sodium hyaluronatemixture | Same | N/A |
| DimensionalDrawing | Image: Dimensional Drawing of the 4x20mm Retriever | Image: Dimensional Drawing of the 4x30mm Retriever | Additional reference(Length of the non-taperedportion of shaped section(F)) allows customers todirectly compare the lengthof the 4x30mm retriever tothe labeling of competitivestentrievers. |
| OverallLength (A) | 180cm | Same | N/A |
| Total ShapedSectionLength(nominal) (B) | 32mm | 44mm | Shaped section has beenlengthened to meet userpreferences.Bench and animal testinghas demonstrated that thelonger shaped section doesnot affect the safety andeffectiveness of the device. |
| Feature | Primary PredicateCleared Trevo XPProVue Retriever(4x20mm)(K132641) | Subject DeviceTrevo XP ProVueRetriever (4x30mm) | Rationale for difference(if applicable) |
| ActiveShapedSectionLength(nominal) (C) | 20mm | 30mm | Shaped section has beenlengthened to meet userpreferences.Bench and animal testinghas demonstrated that thelonger shaped section doesnot affect the safety andeffectiveness of the device. |
| ShapedSectionDiameter(nominal) (D) | 4mm | Same | N/A |
| ProximalCore WireDiameter (E) | 0.0180in | Same | N/A |
| Length of thenon-taperedportion ofshapedsection (F) | Not provided in labeling | 35mm | Additional reference(Length of the non-taperedportion of shaped section(F)) allows customers todirectly compare the lengthof the 4x30mm retriever tothe labeling of competitivestentrievers. |
| Shapedsection | 4 rows and 4 rings of cells. | 4 rows and 7 rings of cells. | Shaped section has beenlengthened to meet userpreferences.Bench and animal testinghas demonstrated that thelonger shaped section doesnot affect the safety andeffectiveness of the device. |
| Hydrophiliccoatinglength | Coating extends from theproximal end of the corewire up to the proximalcoil. | Coating extends from apoint 80cm distal to theproximal end of the corewire up to the proximal coilto enable physician to holdthe device more securely. | The lubricious coating wasremoved from the proximalend of the core wire so thephysician can hold thedevice more securely.Bench testing hasdemonstrated that thechange in coating lengthdoes not affect the safetyand effectiveness of thedevice. |
| Feature | Primary PredicateCleared Trevo XPProVue Retriever(4x20mm)(K132641) | Subject DeviceTrevo XP ProVueRetriever (4x30mm) | Rationale for difference(if applicable) |
| Shapedsection distalplatinum coilmarkers | Platinum markers attachedto 3 distal tips of the distalend of the shaped section. | Same | N/A |
| Core wiremarker bandplacementand presence | Core wire marker bands at59.53" from the proximalend of the shaped section. | Core wire marker bands at57.56" from the proximalend of the shaped section.Location moved (~5cmmore distal) to allowcompatibility with the XT-27 Microcatheter. | The placement of the shaftmarkers (Core wire markerbands) was moved to allowthe Trevo XP ProVueRetriever (4x30mm) to becompatible with theExcelsior XT-27Microcatheter.Bench testing hasdemonstrated that thedifference in placement ofthe core wire marker bandsdoes not affect the safetyand effectiveness of thedevice. |
| 6 marker bands are presenton the core wire. | 4 marker bands are presenton the core wire. | Difference in number ofshaft markers (core wiremarker bands) to make sizeseasily identifiable inmanufacturing.Bench testing hasdemonstrated that thedifference in number ofshaft markers (core wiremarker bands) does notaffect the safety andeffectiveness of the device. |
Product Feature Comparison of Subject Device with Primary Predicate Device Trevo XP ProVue Retriever (4x20mm) (K132641)
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| Feature | Primary PredicateCleared Trevo XPProVue Retriever(4x20mm)(K132641) | Subject DeviceTrevo XP ProVueRetriever (4x30mm) | Rationale for difference(if applicable) |
|---|---|---|---|
| Radial Force | Radial Force at 1.5mmdiameter: 0.70 +0.15/-0.20N | Radial Force at 1.5mmdiameter: 0.95 +0.15 /-0.25N | The longer length of the4x30mm device resulted ina higher radial forcespecification.Bench and animal testinghas demonstrated that thehigher radial forcespecification does not affectthe safety and effectivenessof the device. No evidenceof vessel dissection orperforation demonstrated inanimal testing using TrevoXP ProVue retriever(6x30mm, as worst casesize for 4x30mm). |
| Radial Force at 3.0mmdiameter: $\u2264$ 0.5 N | Same | N/A | |
| PackagingMaterials andConfiguration | Polyethylene Hoop,polycarbonate mountingcard, Tyvek/Film Pouch,HDPE Tubing Clips,Chipboard carton | Same | N/A |
| SterilizationMethod | 100% EtO | Same | N/A |
| HowSupplied | Sterile/Single Use | Same | N/A |
Risk Assessment
Risk assessment of the modifications has been conducted in accordance with EN ISO 14971:2012. Concentric Medical, Inc. has determined the modifications to the predicate device raise no new questions of safety or effectiveness. Results of verification and validation testing are appropriate for use in determining that the Trevo XP ProVue Retriever (4x30mm) is substantially equivalent to the predicate device.
The modifications did not result in the identification of any new failure modes nor were there any changes to existing failure modes, including no change to severity or occurrence; and, therefore, no change to overall residual risk.
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Testing Summary
Performance Data – Bench
The results of verification and validation testing conducted on the Trevo XP ProVue Retriever (4x30mm) demonstrate that it performs as designed, and is suitable for its intended use. The verification and validation test results demonstrate that the Trevo XP ProVue Retriever (4x30mm) is substantially equivalent to the predicate device. Specifically, the following tests were performed on the subject device:
| Test | Test Method Summary | Conclusions |
|---|---|---|
| DimensionalVerification | Verified dimensions using specifiedmeasurement tool. | Dimensional verificationmeets acceptance criteria. |
| Retriever Mid JointTensile Strength | Identify joint and prepare sample fortest. Use Instron tensile tester todetermine applied peak tensile force.Record results. | Retriever Mid JointTensile Strength meetsacceptance criteria. |
| Retriever TipTensile Strength | Load sample. Use Instron tensile testerto determine applied peak tensileforce. Record results. Repeat untilremaining distal cells with markers aretested. Record results. | Retriever Tip TensileStrength meets acceptancecriteria. |
| Retriever ShapedSection RadialForce | Constrain shaped section of retrieverand release to specified diameter. UseInstron tensile tester and Blockwise RFiris fixture to determine applied force atthe specified diameter. Record results. | Retriever Shaped SectionRadial Force meetsacceptance criteria. |
| Retriever / VesselInteraction (TipFlexibility) | Load sample so that the distal tip willbe flexed. Use Instron tensile tester todetermine applied peakcompression/flex force. Record results. | Retriever/VesselInteraction (TipFlexibility) meetsacceptance criteria. |
| Retriever TorqueTensile Durability | Grip shape section and core wire.Apply two full rotations to core wiregrips to torque device. Instron pullsfive tensile cycles to 1.7lbs then sixthcycle to failure. Record results. | Retriever Torque TensileDurability meetsacceptance criteria. |
| Retriever PlatinumWire Joint Strength | Identify joint and cut platinum wire,freeing it from the shaped section fortest. Use Instron tensile tester todetermine applied peak tensile force onindividual platinum wire. Recordresults. | Retriever Platinum WireJoint Strength meetsacceptance criteria. |
| Test | Test Method Summary | Conclusions |
| Retriever PlatinumWire and JointDurability | Wrap and unwrap the entire length ofthe shaped section of the retriever(sheathed in its insertion tool) around a2.0 mm pin. Repeat for a total of6 wrap-unwrap cycles. Perform visualinspection and record results. Perform10 deploy/reload cycles into insertiontool. Perform visual inspection andrecord results. | Retriever Platinum Wireand Joint Durability meetacceptance criteria. |
| Radiopacity | Radiopacity is assessed based on visualassessment of the device being usedunder fluoroscopy per acceptancecriteria. | Same platinum weavewires (same diameter andcomposition) andconfiguration (weavedesign) as the predicatedevice (Trevo XP ProVue4x20), therefore previousdata remains valid.Radiopacity meetsacceptance criteria. |
| Retriever /MicrocatheterDeliverability | Measure the force to push the devicethrough a tortuous model in a 37degCwater bath. Record maximum forcefrom the first 5 cm push. | Retriever/MicrocatheterDeliverability meetsacceptance criteria. |
| ParticulateEvaluation | Measured total number of particulateand size of particulate generated duringthe simulated delivery, deployment andresheathing of the device. Particulatecounting was assessed for ≥10um,≥25µm, and ≥50µm size ranges | All samples meetacceptance criteria. |
| Coating IntegrityEvaluation | An assessment of coating lubricity anddurability using a test model to evaluatefriction encountered from fullcircumferential contact of the coatedcore wire with pads. The hydrated corewires (hydration simulates an aqueousenvironment) are pulled through therubber pads using a calibrated tensilemachine so that the resistance can bemeasured and recorded. | All samples meetacceptance criteria. |
| Test | Test Method Summary | Conclusions |
| Simulated Use | Simulated use testing uses aneurovascular model cast from actualhuman neurovascular arteries. Thisbench testing model replicates thetortuosity, diameter and location of thearteries in the neurovasculature. Themodel incorporates a re-circulatingwater bath at 37°C pressurized between2 – 2.5 psi (100 – 126mm Hg) tosimulate the human arterial circulation.All testing follows the proceduralinstructions outlined in the Instructionsfor Use. | Simulated Use meetsacceptance criteria. |
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Performance Data - Animal
Animal Studies (acute and chronic) were conducted to demonstrate safety of the Trevo XP ProVue Retriever using a larger diameter device (6x30mm) than the subject device (4x30mm). A Trevo XP ProVue Retriever 6x30mm test article was developed for use in animal testing. The 6x30mm Trevo XP ProVue Retriever test article is comparable in design (i.e., same materials and similar tip design, cell size and distal truncation) and coating material to the Trevo XP ProVue Retriever 4x30mm design, except for the diameter (and associated radial force) which were increased to allow for a "worst case." The 6x30mm devices are worst case devices for assessing retriever/vessel interaction because they have a higher radial force part specification than the subject device. Animal studies were conducted in compliance with applicable requirements in the GLP regulation (21 CFR Part 58). The 6x30mm devices were deployed and animals were evaluated for evidence of arterial transmural dissection or perforation. The safety and usability results from the animal studies met acceptance criteria and suggest that the subject device is safe, usable and is equivalent to the predicate device.
Performance Data - Clinical
No clinical study was performed as there is no change to the indications for use or the fundamental scientific technology for the subject device. Substantial equivalence of the subject device has been established to the predicate device through the results of bench and animal testing.
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Sterilization and Shelf life
The Trevo XP ProVue Retriever (4x30mm) is sterilized by 100% Ethylene Oxide using an identical method (including sterilization chamber) to the predicate device, Trevo ProVue Retriever (K132641) and to an earlier device iteration (Trevo ProVue Retriever). The materials of construction and packaging are identical to the predicate device. Therefore, the results from the Trevo ProVue sterilization are applicable to the subject device (Trevo XP ProVue Retriever 4x30mm) and no additional sterilization validation testing is required.
Ethylene oxide (EO) residual testing for the Trevo XP ProVue Retriever 4x30mm was adopted from the predicate device, Trevo ProVue Retriever (K132641) and an earlier device iteration (Trevo ProVue Retriever) as the materials and packaging are identical to the predicate device.
Aging studies for the Trevo XP ProVue Retriever (4x30mm) have established the product remains functional and maintains sterility through the proposed shelf life. Since the packaging materials and configuration are identical to the predicate device, aging studies previously conducted for packaging integrity remain valid and no new packaging testing is required for the Trevo XP ProVue Retriever (4x30mm).
Biocompatibility
The Trevo XP ProVue Retriever (4x30mm) was assessed for impact to biocompatibility. Materials used in the Trevo XP ProVue Retriever (4x30mm) are all the same materials used in the cleared Trevo ProVue Retriever (K132641). Both the Trevo XP ProVue Retriever (4x30mm) and the cleared Trevo ProVue Retriever meet biological safety requirements per ISO 10993-1 for externally communicating medical devices with circulating blood contact for less than 24 hours.
Summary of Substantial Equivalence
The Trevo XP ProVue Retriever (4x30mm) is substantially equivalent to the predicate device with regard to device design, materials, intended use, and patient population. The conclusions drawn from risk assessments and the verification and validation testing conducted using the Trevo XP ProVue Retriever (4x30mm) demonstrate that the device performs as designed, is suitable for its intended use and is substantially equivalent to the legally marketed predicate device.
§ 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).