(17 days)
- The Trevo Retriever is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion, and smaller core infarcts who have first received intravenous tissue plasminogen activator (IV t-PA). Endovascular therapy with the device should start within 6 hours of symptom onset.
- The Trevo Retriever 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 Retriever is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion of the internal carotid artery (ICA) or middle cerebral artery (MCA)-M1 segments with smaller core infarcts (0-50 cc for age < 80 years, 0-20 cc for age ≥ 80 years). Endovascular therapy with the device should start within 6-24 hours of time last seen well in patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy.
The Trevo Retriever consists of a flexible, tapered core wire with a shaped section at the distal end. Platinum markers at the distal end allow fluoroscopic visualization. In addition, the shaped section is also radiopaque. Retriever dimensions are indicated on product label. The Retriever delivery wire has a hydrophilic coating on the distal 101cm length to reduce friction during use. The Retriever has a shaft marker to indicate proximity of Retriever tip relative to Microcatheter tip. A Torque Device is provided with the Retriever to facilitate manipulation and retrieval. The Retriever comes preloaded in an insertion tool to introduce the Retriever into a Microcatheter.
This document is an FDA 510(k) Summary for the Stryker Neurovascular Trevo NXT ProVue Retriever, seeking to demonstrate its substantial equivalence to a previously cleared predicate device (K192207). It explicitly states that there are no changes to the device's intended use or indications for use. The core of the submission revolves around the fact that the only change made to the device is a re-naming convention for stent size, referring to "cell coverage length" instead of the previous naming convention. Therefore, the performance data presented is minimal and specifically targets this labeling change.
Because the device itself, its materials, manufacturing, and intended use are unchanged from a predicate device, and the only change is in how a dimension is described for labeling purposes, the study design for proving acceptance is significantly different from what would be expected for a novel device or a device with new functionalities.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Test Purpose/Method) | Reported Device Performance/Conclusion |
|---|---|
| Dimensional Verification (Cell Coverage Length) | Purpose: To describe the procedure and technique of making dimensional measurements using various measurement equipment. |
| Method: Verify dimensions using specified measurement tool. Record measurements. | (Specific measurements are not provided in this summary, but the conclusion states they meet criteria.) |
(Note: The document explicitly states "There are no changes to the device intended use or indications for use statement. Other than the addition of cell coverage length as a new design input and associated labeling change, there are no changes in the device design, materials, manufacturing, packaging and sterilization methods; therefore, biocompatibility data, bench performance data, sterilization and stability data from the predicate device (K192207) are directly applicable to the subject device." This means the acceptance criteria for most performance aspects are implicitly met by referencing the predicate device's prior approval.)
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated for the "Dimensional Verification" test. This type of bench testing typically involves testing a statistically significant number of units; however, the exact number is not provided in this summary.
- Data Provenance: The study is a bench test conducted by the manufacturer, Stryker Neurovascular, based in Fremont, California, USA. The data would be prospective, as it's a verification test for a specific change.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. For this submission, the "ground truth" for the acceptance criteria is a direct engineering/dimensional measurement, not a clinical or interpretive assessment requiring expert consensus. The acceptance is based on whether the measured "cell coverage length" falls within engineering specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. As this is a bench test verifying a dimensional specification, there is no need for expert adjudication. The measurement results are compared against predefined engineering tolerances.
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. An MRMC study was not done. This device is a mechanical thrombectomy device, not an AI/imaging diagnostic device. The submission explicitly states "No animal or clinical studies were conducted as there is no change to the indications for use or the fundamental scientific technology."
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 a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The ground truth for the "Dimensional Verification" was engineering specifications/tolerances for the newly defined "cell coverage length."
8. The sample size for the training set
- Not Applicable. This is a hardware device, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
- Not Applicable. This is a hardware device, not an AI algorithm requiring a training set.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 7, 2020
Stryker Neurovascular Germaine Fu, Ph.D. Regulatory Project Manager 47900 Bayside Parkway Fremont, California 94538
Re: K200117
Trade/Device Name: Trevo NXT ProVue Retriever Regulation Number: 21 CFR 882.5600 Regulation Name: Neurovascular Mechanical Thrombectomy Device for Acute Ischemic Stroke Treatment Regulatory Class: Class II Product Code: POL, NRY Dated: January 20, 2020 Received: January 21, 2020
Dear Dr. Germaine Fu:
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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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 (OS) 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 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) K200117
Device Name Trevo NXT ProVue Retriever
Indications for Use (Describe)
-
The Trevo Retriever is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion, and smaller core infarcts who have first received intravenous tissue plasminogen activator (IV t-PA). Endovascular therapy with the device should start within 6 hours of symptom onset.
-
The Trevo Retriever 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 Retriever is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion of the internal carotid artery (ICA) or middle cerebral artery (MCA)-M1 segments with smaller core infarcts (0-50 cc for age < 80 years, 0-20 cc for age ≥ 80 years). Endovascular therapy with the device should start within 6-24 hours of time last seen well in patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy.
| 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 K200117
Introduction:
According to the requirements of 21 CFR 807.92, the following information provides sufficient details to understand the basis for a determination of substantial equivalence.
Submitter Name, Address and Content:
| Submitter: | Stryker Neurovascular47900 Bayside ParkwayFremont, CA 94538-6515(FDA Registration Number: 3008853977) |
|---|---|
| Contact: | Germaine Fu, Ph.D.Regulatory Project ManagerPhone: 510-413-2862Fax: 510-413-2588Email: germaine.fu@stryker.com |
| Date Prepared: | February 5, 2020 |
Device Name and Classification:
| Trade/Proprietary Name: | Trevo NXT TM ProVue Retriever |
|---|---|
| Common Name: | Trevo Retriever |
| Classification Name: | Neurovascular Mechanical Thrombectomy Device for Acute IschemicStroke Treatment, 21 CFR 882.5600, Class IIPercutaneous Catheter, 21 CFR 870.1250 – Class II |
| Product Code: | POL, NRY |
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Legally Marketed Predicate Device
| Name of Predicate Device | Name ofManufacturer | 510(k)Number |
|---|---|---|
| Trevo NXT™ ProVueRetriever | StrykerNeurovascular | K192207 |
Device Description
The Trevo Retriever consists of a flexible, tapered core wire with a shaped section at the distal end. Platinum markers at the distal end allow fluoroscopic visualization. In addition, the shaped section is also radiopaque. Retriever dimensions are indicated on product label. The Retriever delivery wire has a hydrophilic coating on the distal 101cm length to reduce friction during use. The Retriever has a shaft marker to indicate proximity of Retriever tip relative to Microcatheter tip. A Torque Device is provided with the Retriever to facilitate manipulation and retrieval. The Retriever comes preloaded in an insertion tool to introduce the Retriever into a Microcatheter.
Indications for Use
-
- The Trevo Retriever is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion, and smaller core infarcts who have first received intravenous tissue plasminogen activator (IV t-PA). Endovascular therapy with the device should start within 6 hours of symptom onset.
-
- The Trevo Retriever 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 Retriever is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion of the internal carotid artery (ICA) or middle cerebral artery (MCA)-M1 segments with smaller core infarcts (0-50 cc for age < 80 years, 0-20 cc for age ≥ 80 years). Endovascular therapy with the device
{5}------------------------------------------------
should start within 6-24 hours of time last seen well in patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy.
Technological Characteristics and Product Feature Comparison
Stryker Neurovascular has demonstrated the Trevo NXT ProVue Retriever is substantially equivalent to the Predicate device, Trevo NXT ProVue Retriever (K192207) based on the same indications for use, device design, materials, manufacturing, packaging and sterilization methods. A comparison of the Subject device with the Predicate device is summarized in Table 1 below.
| Feature | Predicate DeviceTrevo NXT ProVue Retriever | Subject DeviceTrevo NXT ProVue Retriever |
|---|---|---|
| RegulationNumber | • 21 CFR 882.5600• 21 CFR 870.1250 | Same |
| RegulationName | • Neurovascular MechanicalThrombectomy Device for AcuteIschemic Stroke Treatment• Percutaneous Catheter | Same |
| Classification | Class II | Same |
| Product Code | • POL• NRY | Same |
| Intended Use | Neurovascular mechanical thrombectomydevice for acute ischemic stroke treatmentused in the treatment of acute ischemicstroke to improve clinical outcomes. | Same |
| Indications forUse | 1. The Trevo Retriever is indicated for useto restore blood flow in theneurovasculature by removing thrombusfor the treatment of acute ischemicstroke to reduce disability in patientswith a persistent, proximal anteriorcirculation, large vessel occlusion, andsmaller core infarcts who have firstreceived intravenous tissue plasminogenactivator (IV t-PA). Endovasculartherapy with the device should startwithin 6 hours of symptom onset.2. The Trevo Retriever is intended torestore blood flow in theneurovasculature by removing thrombusin patients experiencing ischemic strokewithin 8 hours of symptom onset.Patients who are ineligible forintravenous tissue plasminogen activator | Same |
| Feature | Predicate DeviceTrevo NXT ProVue Retriever | Subject DeviceTrevo NXT ProVue Retriever |
| (IV t-PA) or who fail IV t-PA therapyare candidates for treatment.3. The Trevo Retriever is indicated for useto restore blood flow in theneurovasculature by removing thrombusfor the treatment of acute ischemicstroke to reduce disability in patientswith a persistent, proximal anteriorcirculation, large vessel occlusion of theinternal carotid artery (ICA) or middlecerebral artery (MCA)-M1 segments withsmaller core infarcts (0-50 cc for age < 80years, 0-20 cc for age ≥ 80 years).Endovascular therapy with the deviceshould start within 6-24 hours of timelast seen well in patients who areineligible for intravenous tissueplasminogen activator (IV t-PA) or whofail IV t-PA therapy. | ||
| TargetPopulation | Patients experiencing acute ischemic stroke | Same |
| AnatomicalSites | Neurovasculature | Same |
| TECHNOLOGICAL CHARACTERISTICS | ||
| DeviceDescription | The Retriever consists of a flexible, taperedcore wire with a shaped section at the distalend. Platinum markers at the distal end allowfluoroscopic visualization. In addition, theshaped section is also radiopaque. Retrieverdimensions are indicated on product label.The Retriever delivery wire has ahydrophilic coating on the distal 101cm toreduce friction during use. The Retriever hasa shaft marker to indicate proximity ofRetriever tip relative to Microcatheter tip. Atorque device is provided with the Retrieverto facilitate manipulation and retrieval. TheRetriever comes preloaded in an insertiontool to introduce the Retriever into aMicrocatheter. | Same |
| Principle ofOperation | The Trevo Retriever is delivered to thethrombus using a microcatheter. TheMicrocatheter is then retracted to deploy theshaped section of the Retriever. If using anAspiration Catheter, remove Microcatheter.Advance Aspiration Catheter over proximalsection of Retriever while applyingaspiration using a 60 mL syringe or anaspiration pump. The Retriever withMicrocatheter or Aspiration Catheter are | Same |
Table 1. Product Feature Comparison of Subject Device to Predicate Device
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| Feature | Predicate DeviceTrevo NXT ProVue Retriever | Subject DeviceTrevo NXT ProVue Retriever | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| pulled back to capture the thrombus. TheRetriever, thrombus, and Microcatheter orAspiration Catheter are removed as a unitfrom the body. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| ProceduralStepsAspirationSource | Syringe, Aspiration pump | Same | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| AccessoryDevices | Insertion tool and torque device providedwithin product package | Same | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Sizes | 3x25mm4x21mm4x35mm6x30mm | 3x32mm4x28mm4x41mm6x37mmNote: The subject device stent design has notchanged but the naming convention of thestent size has changed to refer to the “cellcoverage length”. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Compatibility | Retriever Size Trevo Pro14Microcatheter Trevo Trak 21Microcatheter* Trevo Pro18Microcatheter Excelsior® XT-27Microcatheter(REF XT275081) RecommendedMinimumVessel ID (mm) TrevoNXT 3x25 √ √ √ √ TrevoNXT 4x21 √ √ √ TrevoNXT 4x35 √ √ √ 2.5 TrevoNXT 6x30 √ √ √ | Retriever Size Trevo Pro14Microcatheter Trevo Trak 21Microcatheter* Trevo Pro18Microcatheter Excelsior® XT-27Microcatheter(REF XT275081) RecommendedMinimumVessel ID (mm) TrevoNXT 3x32 √ √ √ √ TrevoNXT 4x28 √ √ √ TrevoNXT 4x41 √ √ √ 2.5 TrevoNXT 6x37 √ √ √ | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| MATERIALS | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Core Wire | Nitinol (nickel titanium alloy) | Same | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shaped Section | Nitinol | Same | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Distal Coil | Platinum/Tungsten | Same | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shaped SectionRadiopaqueWire | Platinum/Tungsten | Same | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Mid Coil | 304 Stainless Steel | Same | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Proximal Coil | Pebax | Same | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Solder | Gold/Tin | Same | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| HydrophilicCoating | Sodium hyaluronate mixture | Same |
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| Feature | Predicate DeviceTrevo NXT ProVue Retriever | Subject DeviceTrevo NXT ProVue Retriever |
|---|---|---|
| DIMENSIONAL DRAWING | ||
| DimensionalDrawing | All Retriever sizes:Image: Dimensional Drawing A, B, C, D, E | All Retriever sizes:Image: Dimensional Drawing A, B, C, D, E, F |
| Overall Length(A) | 200 cm | Same |
| Total ShapedSection Length(B) | 32, 36, 40, 44 mm | Same |
| Full DiameterLength (C) | 21, 25, 30, 35 mm | Same |
| Shaped SectionDiameter (D) | 3, 4, 6 mm | Same |
| Delivery CoreWire OuterDiameter (E) | 0.015, 0.019" | Same |
| Cell CoverageLength (F) | Not Applicable | 28, 32, 37, 41 mm |
| PACKAGING | ||
| Materials andConfiguration | Polyethylene Hoop, polycarbonate mountingcard, Tyvek/Film Pouch, Chipboard carton | Same |
| SterilizationMethod | 100% EtO | Same |
| How Supplied | Sterile/Single Use | Same |
The differences between the devices are not critical as demonstrated above and through the testing referenced below.
Risk Assessment
Risk assessment of the Trevo NXT ProVue Retriever has been conducted in accordance with EN ISO 14971. Stryker Neurovascular has determined that the labeling changes to the Trevo NXT ProVue Retriever raise no new questions of safety or effectiveness. Results of testing are appropriate for determining that the Trevo NXT ProVue Retriever is substantially equivalent to the legally marketed Predicate device.
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Testing Summary
There are no changes to the device intended use or indications for use statement. Other than the addition of cell coverage length as a new design input and associated labeling change, there are no changes in the device design, materials, manufacturing, packaging and sterilization methods; therefore, biocompatibility data, bench performance data, sterilization and stability data from the predicate device (K192207) are directly applicable to the subject device. Relevant testing data supporting the subject device are summarized as follows.
Performance Data – Bench Testing
Testing on the subject device was conducted only for the cell coverage length specification. The results of design verification testing conducted on the Trevo NXT ProVue Retriever demonstrates that it is substantially equivalent to the legally marketed Predicate device. The design verification bench testing is summarized in Table 2 below.
| Test | Test Method Summary | Conclusions |
|---|---|---|
| Dimensional Verification(Cell Coverage Length) | Purpose: To describe the procedure andtechnique of making dimensionalmeasurements using variousmeasurement equipment.Method: Verify dimensions usingspecified measurement tool. Recordmeasurements. | Dimensional verificationmeets acceptancecriteria. |
Table 2. Performance Data - Design Verification Bench Testing
Performance Data - Animal, Clinical
No animal or clinical studies were conducted as there is no change to the indications for use or the fundamental scientific technology. Substantial equivalence of the Subject device has been established to the Predicate devices through the results of bench testing.
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Shelf Life Testing
Shelf life testing previously conducted for the Trevo NXT ProVue Retriever was used to support the changes to the device and can be found in K192207. Shelf life testing was not performed on the Subject device since there was no impact to device material, design, or safety and efficacy as a result of the labeling changes. As with the Predicate device, the Subject device is labeled with a 2-year shelf life.
Sterilization
Sterilization evaluation previously conducted for the Trevo NXT ProVue Retriever was used to support the labeling changes to the device and can be found in K192207. The Trevo NXT ProVue Retrievers are sterilized with 100% Ethylene Oxide and provided sterility assurance level (SAL) of 106 has been demonstrated. The Trevo NXT Pro Vue Retrievers meet EO residuals per EN ISO 10993-7 for limited contacting, externally communicated devices. The Trevo NXT ProVue Retrievers are for single use only.
Biocompatibility
Biocompatibility testing previously conducted for the Trevo NXT ProVue Retriever was used to support the labeling changes to the device and can be found in K192207. The results of biocompatibility testing, and biological safety evaluation of the Trevo NXT ProVue Retrievers demonstrate that the devices meet biological safety requirements per ISO 10993-1 for externally communicating medical devices with circulating blood contact for less than 24 hours. The Trevo NXT ProVue Retrievers are considered to have no residual risk of biological hazards. Also, the devices and its packaging do not contain detectable latex. Therefore, the Trevo NXT ProVue Retriever devices, accessories, and primary packaging are considered biocompatible for their intended use.
Conclusion
Based on the conclusions drawn from risk assessment and the bench testing results summarized above, the Subject device demonstrates substantial equivalence to the legally marketed Predicate device (K192207).
§ 882.5600 Neurovascular mechanical thrombectomy device for acute ischemic stroke treatment.
(a)
Identification. A neurovascular mechanical thrombectomy device for acute ischemic stroke treatment is a prescription device used in the treatment of acute ischemic stroke to improve clinical outcomes. The device is delivered into the neurovasculature with an endovascular approach, mechanically removes thrombus from the body, and restores blood flow in the neurovasculature.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The patient contacting components of the device must be demonstrated to be biocompatible.
(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including:
(i) Mechanical testing to demonstrate the device can withstand anticipated tensile, torsional, and compressive forces.
(ii) Mechanical testing to evaluate the radial forces exerted by the device.
(iii) Non-clinical testing to verify the dimensions of the device.
(iv) Non-clinical testing must demonstrate the device can be delivered to the target location in the neurovasculature and retrieve simulated thrombus under simulated use conditions.
(v) Non-clinical testing must demonstrate the device is radiopaque and can be visualized.
(vi) Non-clinical testing must evaluate the coating integrity and particulates under simulated use conditions.
(vii) Animal testing must evaluate the safety of the device, including damage to the vessels or tissue under anticipated use conditions.
(3) Performance data must support the sterility and pyrogenicity of the patient contacting components of the device.
(4) Performance data must support the shelf-life of the device by demonstrating continued sterility, package integrity, and device functionality over the specified shelf-life.
(5) Clinical performance testing of the device must demonstrate the device performs as intended for use in the treatment of acute ischemic stroke and must capture any adverse events associated with the device and procedure.
(6) The labeling must include:
(i) Information on the specific patient population for which the device is intended for use in the treatment of acute ischemic stroke, including but not limited to, specifying time from symptom onset, vessels or location of the neurovasculature that can be accessed for treatment, and limitations on core infarct size.
(ii) Detailed instructions on proper device preparation and use for thrombus retrieval from the neurovasculature.
(iii) A summary of the clinical testing results, including a detailed summary of the device- and procedure-related complications and adverse events.
(iv) A shelf life.