(161 days)
The Trevo XP ProVue Retriever (6x25 mm) 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 (6x25mm) consists of a flexible, tapered core 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 and an insertion tool are provided with the Retriever. 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 the Trevo XP ProVue Retriever (6x25 mm) and summarizes the testing conducted to support its substantial equivalence to a predicate device (Trevo XP ProVue Retriever (4x20mm)). However, it does not contain specific acceptance criteria for each test or detailed performance metrics in the format of a table comparing criteria to reported performance. Instead, it generally states that tests "meet acceptance criteria" or provides qualitative conclusions.
Therefore, for aspects requiring quantitative acceptance criteria and reported device performance (like a comparative table), a direct answer cannot be fully generated as that level of detail is not explicitly present. Similarly, information regarding sample size for test sets, data provenance, expert involvement for ground truth, adjudication methods, MRMC studies, standalone performance with specific metrics, or training set details are not provided in the given document.
Based on the available information, here's what can be inferred and stated:
1. A table of acceptance criteria and the reported device performance
The document lists various tests and provides a "Conclusions" column for each, generally stating that the device "meets acceptance criteria." It does not provide the numerical acceptance criteria themselves or quantitative reported device performance in most cases.
| Test | Acceptance Criteria (Not explicitly stated quantitatively in the document for most tests) | Reported Device Performance (Qualitative conclusions) |
|---|---|---|
| Dimensional Verification | Not specified quantitatively | Dimensional verification meets acceptance criteria. |
| Retriever Mid Joint Tensile Strength | Not specified quantitatively | Retriever Mid Joint Tensile Strength meets acceptance criteria. |
| Retriever Tip Tensile Strength | Not specified quantitatively | Retriever Tip Tensile Strength meets acceptance criteria. |
| Retriever Shaped Section Radial Force | Not specified quantitatively | Retriever Shaped Section Radial Force meets acceptance criteria. |
| Retriever/Vessel Interaction (Tip Flexibility) | Not specified quantitatively | Retriever/Vessel Interaction (Tip Flexibility) meets acceptance criteria. |
| Retriever Torque Tensile Durability | Not specified quantitatively | Retriever Torque Tensile Durability meets acceptance criteria. |
| Retriever Platinum Wire Joint Strength | Not specified quantitatively | Retriever Platinum Wire Joint Strength meets acceptance criteria. |
| Retriever Platinum Wire and Joint Durability | Not specified quantitatively | Retriever Platinum Wire and Joint Durability meet acceptance criteria. |
| Radiopacity | Visual assessment of device under fluoroscopy. | Radiopacity meets acceptance criteria. |
| Retriever / Microcatheter Deliverability | Not specified quantitatively | Retriever/Microcatheter Deliverability meets acceptance criteria. |
| Particulate Evaluation | Maximum allowable number/size of particulates generated during simulated use. | All samples meet acceptance criteria (i.e., total number and size of particulates generated were within limits for ≥10µm, ≥25µm, and ≥50µm size ranges). |
| Coating Integrity Evaluation | No delamination at coating edges, minimal defects along coating length after tracking. | Neither Baseline nor Post-tracking test articles exhibited delamination at coating edges. Baseline showed no defects; Post-tracking showed minimal defects. Coating functions as intended and exhibited appropriate integrity. |
| Simulated Use | Successful removal of simulated thrombus, no adverse events. | Simulated Use meets acceptance criteria (i.e., device successfully retrieved simulated thrombus in a neurovascular model). |
| Animal Studies (Acute) | No arterial transmural dissection or perforation due to Stentriever use. | Histopathology consistent with arterial healing after routine catheterization. Angiography showed no evidence of vessel dissection, perforation, or thrombosis. |
| Animal Studies (Chronic) | No arterial transmural dissection or perforation; no stenosis, vessel irregularity, or pseudoaneurysm at treatment sites. | Histopathology consistent with arterial healing. No evidence of vessel dissection or perforation. Angiography showed no evidence of dissection, perforation, stenosis, vessel irregularity, intimal flap, or pseudoaneurysm at Day 0 and Day 30. Animal studies meet acceptance criteria and are comparable to the predicate device. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated for most tests.
- For Animal Studies: 12 test articles (devices) were deployed (4 per animal) across 6 treatment runs in both internal maxillary arteries (IMAs) of animals, resulting in the assessment of 6 arteries (2 per animal) for both acute and chronic studies.
- Data Provenance:
- Simulated Use: Conducted using a silicone neurovascular model cast from actual human neurovascular arteries.
- Animal Studies: Conducted in swine, in compliance with GLP regulation (21 CFR Part 58). This is prospective animal data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The tests primarily involve engineering performance metrics, simulated use outcomes, and animal study observations (angiography, histopathology) conducted by unspecified personnel. There is no mention of external human experts establishing ground truth for the test set in the context of diagnostic interpretation or similar tasks.
4. Adjudication method for the test set
This information is not provided in the document. The tests described are primarily physical/mechanical performance tests, simulated use, and animal studies. Adjudication methods like "2+1" or "3+1" are typically used for establishing ground truth in clinical or image-based diagnostic studies involving human interpretation.
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
There is no mention of an MRMC comparative effectiveness study, AI assistance, or human reader performance improvement in this document. The device is a mechanical thrombectomy retriever, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a medical instrument (thrombectomy retriever) and not an algorithm or AI system. Its performance is inherent to the device itself (mechanical, physical, and biocompatibility characteristics), not an algorithm that operates standalone. The animal and simulated use studies demonstrate its "standalone" performance as a device.
7. The type of ground truth used
- For physical/mechanical tests (e.g., tensile strength, radial force, deliverability, particulate evaluation): The "ground truth" is defined by established engineering specifications and physical measurements, and compliance with these objective criteria.
- For Radiopacity: Visual assessment under fluoroscopy.
- For Coating Integrity: Visual assessment, comparison of test articles, and consideration of other correlated tests (lubricity, durability, particulate generation).
- For Simulated Use: The ability to retrieve simulated thrombus in a physical model, guided by procedural instructions derived from the Instructions for Use.
- For Animal Studies: Histopathology and angiography results are used to assess vessel response, dissection, perforation, thrombosis, stenosis, etc., against predefined safety criteria.
8. The sample size for the training set
This information is not provided and is not applicable to the type of device (a medical instrument). Training sets are typically associated with machine learning or AI models, which this device is not.
9. How the ground truth for the training set was established
This information is not provided and is not applicable for the same reasons as #8.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of a stylized caduceus, which is a symbol of medicine and health. The caduceus is composed of three intertwined snakes and a staff.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 6, 2015
Concentric Medical, Inc. Mr. Bill Hyatt Regulatory Affairs Manager 301 East Evelyn Avenue Mountain View, California 94041
Re: K143077
Trade/Device Name: Trevo XP ProVue Retriever (6x25 mm) Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: March 3, 2015 Received: March 6, 2015
Dear Mr. Hyatt:
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
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) K143077
Device Name Trevo XP ProVue Retriever (6x25 mm)
Indications for Use (Describe)
The Trevo XP ProVue Retriever (6x25 mm) 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 (6x25 mm) | |
|---|---|---|
| Common Name: | Catheter, Thrombus Retriever | |
| Classification Name: | Percutaneous Catheter, 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: | Bill HyattManager, Regulatory Affairs | |
| Date Prepared: | April 2, 2015 | |
| Predicate Device: | Trevo XP ProVue Retriever (4x20mm) (K132641) |
Device Description
The Trevo XP ProVue Retriever (6x25mm) consists of a flexible, tapered core 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 and an insertion tool are provided with the Retriever. 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 (6x25mm) 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.
Technological Characteristics and Product Feature Comparison
The Trevo XP ProVue Retriever (6x25mm) 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.
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| Feature | Primary PredicateCleared Trevo XP ProVue Retriever (4x20mm) (K132641) | Subject DeviceTrevo XP ProVue Retriever (6x25mm) | |
|---|---|---|---|
| Indications for Use | The Trevo XP ProVue Retrieveris intended to restore blood flowin the neurovasculature byremoving thrombus in patientsexperiencing ischemic strokewithin 8 hours of symptomonset. Patients who are ineligiblefor intravenous tissueplasminogen activator (IV t-PA)or who fail IV t-PA therapy arecandidates for treatment. | Same as K132641 | |
| DeviceDescription | The Retriever consists of aflexible, tapered core wire with ashaped section at the distal end.Platinum markers at the distal endallow fluoroscopic visualization.In addition, the shaped section isalso radiopaque. Retrieverdimensions are indicated onproduct label.The Retriever has a hydrophiliccoating to reduce friction duringuse. The Retriever has a shaftmarker to indicate proximity ofRetriever tip relative toMicrocatheter tip. A torque deviceis provided with the Retriever tofacilitate manipulation. Aninsertion tool is provided tointroduce the Retriever into aTrevo® Microcatheter. | Same as K132641 with theexception that the subjectRetriever is introduced via anXT-27 Microcatheter (whereasthe predicate device isintroduced via a Trevo®Microcatheter) | |
| Target Population | Patients with symptoms of anischemic stroke | Same as K132641 | |
| Anatomical Sites | Neurovasculature | Same as K132641 | |
| Feature | Primary PredicateCleared Trevo XP ProVueRetriever (4x20mm)(K132641) | Subject DeviceTrevo XP ProVue Retriever(6x25mm) | |
| Accessory DevicesProvided(not in directcontact withpatient) | Insertion tool and torque deviceprovided in product package | Same as K132641 | |
| MicrocatheterCompatibility | Trevo Pro 18 Microcatheter | Excelsior XT-27Microcatheter | |
| Materials | Core Wire Material: Nitinol(nickel titanium alloy)Distal Shaped Section Material:NitinolCoil Material Distal to DistalShaped Section :Platinum/TungstenShaped Section RadiopaqueWire: Platinum/TungstenCoil Material Proximal toShaped Section: 304 StainlessSteelSolder: Gold/TinHydrophilic Coating: Sodiumhyaluronate mixture | Same as K132641 | |
| DimensionalDrawing | ED | ||
| Overall Length(A) | 180cm | 180cm | |
| Total ShapedSection Length(nominal) (B) | 32mm | 40mm | |
| Active ShapedSection Length(nominal) (C) | 20mm | 25mm | |
| Shaped SectionDiameter(nominal) (D) | 4mm | 6mm | |
| Feature | Primary PredicateCleared Trevo XP ProVueRetriever (4x20mm)(K132641) | Subject DeviceTrevo XP ProVue Retriever(6x25mm) | |
| Proximal CoreWire Diameter (E) | 0.0180in | Same as K132641 | |
| Length of the non-tapered portion ofshaped section (F) | Not provided in labeling | 30mm | |
| Shaped section | 4 rows and 4 rings of cells. | 5 rows and 5 rings of cells. | |
| Hydrophiliccoating length | Coating extends from theproximal end of the core wire upto the proximal coil. | Coating extends from a point80cm distal to the proximalend of the core wire up to theproximal coil to enablephysician to hold the devicemore securely. | |
| Shaped sectiondistal platinumcoil markers | Platinum markers attached to 3distal tips of the distal end of theshaped section. | Platinum markers attached to 3distal tips of the distal end of theshaped section. | |
| Radiopaqueplatinum wirewoven into shapedsection | Three platinum wires woven onshaped section struts. | Four platinum wires woven onshaped section struts. | |
| Core wire markerband placementand presence | Core wire marker bands at59.53" from the proximal end ofthe shaped section.6 marker bands are present onthe core wire. | Core wire marker bands at57.56" from the proximal endof the shaped section. (~5cmmore distal) to allow | |
| PackagingMaterials andConfiguration | Polyethylene Hoop,polycarbonate mounting card,Tyvek/Film Pouch, HDPETubing Clips, Chipboard carton | Same as K132641 | |
| SterilizationMethod | 100% EtO | Same as K132641 | |
| How Supplied | Sterile/Single Use | Same as K132641 |
Product Feature Comparison of Subject Device with Primary Predicate Device Trevo XP ProVue Retriever (4x20mm) (K132641)
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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 (6x25mm) 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.
Testing Summarv
The results of verification and validation testing conducted on the Trevo XP ProVue Retriever (6x25mm) 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 (6x25mm) is substantially equivalent to the predicate device. Specifically, the following tests were performed on the proposed device:
| Test | Test Method Summary | Conclusions | |
|---|---|---|---|
| 1. | DimensionalVerification | Verified dimensions usingspecified measurement tool. | Dimensionalverification meetsacceptance criteria. |
| 2. | Retriever Mid JointTensile Strength | Identified joint and cutsample for test. Recordedpeak tensile force results. | Retriever Mid JointTensile Strength meetsacceptance criteria. |
| 3. | Retriever Tip TensileStrength | Loaded sample. Recordedpeak tensile force results. | Retriever Tip TensileStrength meetsacceptance criteria. |
| 4. | Retriever ShapedSection Radial Force | Constrained and releasedshaped section of retriever tospecified diameter. Recordedradial force results. | Retriever ShapedSection Radial Forcemeets acceptancecriteria. |
| 5. | Retriever/VesselInteraction (TipFlexibility) | Loaded sample so that thedistal tip was flexed.Recorded peakcompression/flex forceresults. | Retriever/VesselInteraction (TipFlexibility) meetsacceptance criteria. |
| 6. | Retriever TorqueTensile Durability | Gripped device and appliedrotations to torque device.Pulled tensile cycles to a maxload then last cycle to failure.Recorded results. | Retriever TorqueTensile Durabilitymeets acceptancecriteria. |
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| Test | Test Method Summary | Conclusions | |
|---|---|---|---|
| 7. | Retriever PlatinumWire Joint Strength | Identified joint and cut sample for test. Recorded peak tensile force results for each individual platinum wire. | Retriever Platinum Wire Joint Strength meets acceptance criteria. |
| 8. | Retriever PlatinumWire and JointDurability | Wrapped and unwrapped the entire length of the shaped section of the retriever (sheathed in insertion tool) around a pin and repeat.Performed visual inspection and recorded results.Performed deploy/reload cycles into insertion tool.Performed visual inspection and recorded results. | Retriever Platinum Wire and Joint Durability meet acceptance criteria. |
| 9. | Radiopacity | Radiopacity was assessed based on visual assessment of the device being used under fluoroscopy. | Radiopacity meets acceptance criteria. |
| 10. | Retriever /MicrocatheterDeliverability | Measured the force to push the device through a tortuous model. | Retriever/Microcatheter Deliverability meets acceptance criteria. |
| 11. | Particulate Evaluation | Measured total number of particulate and size of particulate generated during the simulated delivery, deployment and resheathing of the device. Particulate counting was assessed for $≥10µm$ , $≥25µm$ , and $≥50µm$ size ranges | All samples meet acceptance criteria. |
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| Test | Test Method Summary | Conclusions | |
|---|---|---|---|
| 12. | Coating IntegrityEvaluation | A visual assessment of thecoating integrity of thesubject device was performedbefore (baseline) and aftertracking through a tortuouspath fixture representative ofclinical conditions (simulateduse). The visual assessmentevaluation included acomparison of the visualassessment using highermagnification and a dye toassess the adhesion of thecoating. Proximal and distalcoating edges were evaluatedto determine if the coatingwas intact. The entirecoating length of the devicewas evaluated for defects(visible voids or scratches). | Neither the Baselinetest articles nor thePost-tracking testarticles exhibited anydelamination at coatingedges (either proximalor distal). The Baselinetest articles did notexhibit any coatingdefects (voids orscratches). The Posttracking devicesexhibited minimaldefects along the 75cmcoating length. Whenconsidered inconjunction withcoating lubricity anddurability results andthe particulategeneration results, thecoating functions asintended and hasexhibited appropriateintegrity (via visualassessment) postsimulated use. |
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| Test | Test Method Summary | Conclusions | |
|---|---|---|---|
| 13. | Simulated Use | Simulated use testing used asilicone neurovascular modelcast from actual humanneurovascular arteries. Thisbench testing modelreplicates the tortuosity,diameter and location of thearteries in theneurovasculature includingthe internal carotid artery(ICA) siphon. The modelends at the mid carotidarteries and proximal supportis provided by a guidecatheter. The modelincorporates a re-circulatingwater bath at 37°Cpressurized between 2 – 2.5psi (100 - 126 mm Hg) tosimulate the human arterialcirculation. All testingfollows the proceduralinstructions outlined in theInstructions for Use.Simulated thrombus is usedto assess the devices ability toretrieve clot | Simulated Use meetsacceptance criteria. |
| Test | Test Method Summary | Conclusions | |
| 14. | Animal studies (acuteand chronic) | Animal studies consisting ofan acute animal (swine) studyand a chronic animal (swine)study were performed usingdevices representative of theTrevo XP ProVue Retriever(6x25mm) and wereconducted in compliance withapplicable requirements inthe GLP regulation (21 CFRPart 58).In both the acute and thechronic animal studies: | Acute Animal StudyResults: -Histopathology wasconsistent with arterialhealing after routinecatheterizationcommonly seen withguidewires / catheters.Angiography revealedNo evidence of vesseldissection orperforation orthrombosis. |
| 12 test articles (4 per animal) were deployed 6 test article treatment runs were conducted successfully in both internal maxillary arteries (IMAs) of animals which resulted in the assessment of 6 arteries (2 per animal). Safety (vessel response) was assessed based on the presence or absence of arterial transmural dissection or perforation due to Stentriever use in the treated vessels.Device/vessel interaction is considered acceptable (pass) if there is no evidence of arterial transmural dissection or perforation due to Stentriever use in the treated vessels based on results of angiography and histopathology. | Chronic Animal StudyResults: -Histopathology wasconsistent with arterialhealing after routinecatheterizationcommonly seen withguidewires / cathetersNo evidence of vesseldissection orperforationAngiography revealedno evidence of vesseldissection orperforation at Day 0,and no angiographicevidence of stenosis,vessel irregularity,intimal flap orpseudoaneurysm wasobserved at treatmentsites at Day 30Conclusion: Animalstudies meetacceptance criteria andare comparable topredicate device |
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Biocompatibility
The Trevo XP ProVue Retriever (6x25mm) was assessed for impact to biocompatibility. Materials used in the Trevo XP ProVue Retriever (6x25mm) are all the same materials used in the cleared Trevo ProVue Retriever (K132641). Both the Trevo XP ProVue Retriever (6x25mm) 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 (6x25mm) 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 (6x25mm) 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).