(153 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 (0-50cc for age <80 years, 0-20cc 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.
The acceptance criteria for the Trevo NXT ProVue Retriever are not explicitly stated in numerical thresholds within the provided text. However, the document asserts that the device is substantially equivalent to its predicate device (K210502) and that the performance is "similar" to established safety and performance profiles. The primary change supported by this submission is a labeling modification concerning the minimum vessel diameter for certain models.
Here's an attempt to structure the information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document does not provide specific quantitative acceptance criteria or numerical performance metrics for the Trevo NXT ProVue Retriever. Instead, it relies on demonstrating substantial equivalence to a predicate, particularly in the context of a labeling change for compatibility. The "performance" assessment is qualitative, focusing on "similar performance and safety profile".
| Acceptance Criteria (Inferred from Substantial Equivalence and Clinical Analysis Goal) | Reported Device Performance (from Retrospective Analysis) |
|---|---|
| Demonstrated similar performance and safety profile in smaller vessels. | Use of Trevo NXT ProVue Retriever 3 mm and 4 mm models in vessels with diameters of 1.5 to 2.5 mm has a similar performance and safety profile using available procedural data compared to their use in vessels with diameters ≥ 2.5 mm. (This is the key finding to support the labeling change). |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Description: A "retrospective analysis of device performance per vessel size" was conducted.
- Sample Size: Not explicitly stated. The analysis was performed "using The ASSIST Registry data." The number of cases or patients included in this retrospective subgroup analysis is not provided.
- Data Provenance: Retrospective. The country of origin of "The ASSIST Registry" data is not specified in the provided text.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- The document does not mention the use of experts to establish ground truth for "The ASSIST Registry data" specifically for this retrospective analysis. The data from "The ASSIST Registry" would presumably have its own established ground truth generated during data collection, but this is not detailed here. The submission focuses on analyzing existing data.
4. Adjudication Method for the Test Set
- Not applicable/Not mentioned. The study involved a retrospective analysis of registry data, not a new dataset requiring expert adjudication for ground truth.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or described. The study was a retrospective analysis of an existing registry.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. The device is a mechanical thrombectomy device, not an algorithm or AI. The "performance" refers to the clinical effectiveness of the physical device.
7. The Type of Ground Truth Used
- For the retrospective analysis of "The ASSIST Registry data," the ground truth would be the clinical outcomes data and procedural data recorded within that registry. For example, successful recanalization (restoring blood flow), reduction in disability, and safety events (as mentioned in "similar performance and safety profile").
8. The Sample Size for the Training Set
- Not applicable. The device is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. (See #8)
{0}------------------------------------------------
March 29, 2023
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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.
Stryker Neurovascular Heli Chambi Staff Regulatory Affairs Specialist 47900 Bayside Parkway Fremont, California 94538
Re: K223305
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: February 21, 2023 Received: February 23, 2023
Dear Heli Chambi:
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
{1}------------------------------------------------
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,
Naira Muradyan -S
Naira Muradyan, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K223305
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 (0-50cc for age <80 years, 0-20cc 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) |
| CONTINUE ON A SEPARATE PAGE IF NEEDED |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
510(k) Summary K223305
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 Contact:
| Submitter: | Stryker Neurovascular47900 Bayside ParkwayFremont, CA 94538-6515(FDA Registration Number: 3008853977) |
|---|---|
| Contact: | Heli ChambiStaff Regulatory Affairs SpecialistPhone: 239-366-6826Fax: 510-413-2588Email: heli.chambi@stryker.com |
| Date Prepared: | March 29, 2023 |
Device Name and Classification:
| Trade/Proprietary Name: | Trevo NXT ProVue Retriever |
|---|---|
| Common Name: | Trevo Retriever |
| Classification Name: | Neurovascular Mechanical Thrombectomy Device for Acute IschemicStroke Treatment, 21 CFR 882.5600, Class IICatheter, Thrombus Retriever, 21 CFR 870.1250 – Class II |
| Product Code: | POL, NRY |
Legally Marketed Predicate Device
| Name of Predicate Device | Name ofManufacturer | 510(k)Number |
|---|---|---|
| Trevo NXT ProVueRetriever | StrykerNeurovascular | K210502 |
{4}------------------------------------------------
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 (0-50cc for age <80 years, 0-20cc 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.
{5}------------------------------------------------
Technological Characteristics and Product Feature Comparison
There are no differences in the technological characteristics between the subject device and predicate device because they both have the same indications for use, device design, materials, manufacturing, packaging, and sterilization methods. The changes made to the subject device are solely labeling changes to update compatibility information in the Instructions for Use (IFU).
The differences between the subject and predicate devices are summarized in Table 1 below.
| Feature | Predicate Device | Subject Device |
|---|---|---|
| Trevo NXT ProVue Retriever (K210502) | Trevo NXT ProVue Retriever | |
| Regulation Number | 21 CFR 882.5600 21 CFR 870.1250 | Same |
| Regulation Name | Neurovascular Mechanical Thrombectomy Device for Acute Ischemic Stroke Treatment Percutaneous Catheter | Same |
| Classification | Class II | Same |
| Product Code | POL NRY | Same |
| Intended Use | Neurovascular mechanical thrombectomy device for acute ischemic stroke treatment used in the treatment of acute ischemic stroke to improve clinical outcomes. | Same |
| Indications for Use | 1. 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.2. 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 | Same |
| Feature | Predicate Device | Subject Device |
| Trevo NXT ProVue Retriever (K210502) | Trevo NXT ProVue Retriever | |
| t-PA) or who fail IV t-PA therapy arecandidates for treatment. | ||
| 3. The Trevo Retriever is indicated for useto restore blood flow in the neurovasculatureby removing thrombus for the treatment ofacute ischemic stroke to reduce disability inpatients with a persistent, proximal anteriorcirculation, large vessel occlusion of theinternal carotid artery (ICA) or middlecerebral artery (MCA)-M1 segments withsmaller core infarcts (0-50cc for age <80years, 0-20cc for age ≥80 years).Endovascular therapy with the device shouldstart within 6-24 hours of time last seen wellin patients who are ineligible for intravenoustissue plasminogen activator (IV t-PA) orwho fail IV t-PA therapy. | ||
| TargetPopulation | Patients experiencing acute ischemic stroke | Same |
| Anatomical Sites | Neurovasculature | Same |
| 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. TheRetriever delivery wire has a hydrophiliccoating on the distal 101cm to reduce frictionduring use. The Retriever has a shaft markerto indicate proximity of Retriever tip relativeto Microcatheter tip. A torque device isprovided with the Retriever to facilitatemanipulation and retrieval. The Retrievercomes preloaded in an insertion tool tointroduce the Retriever into a Microcatheter. | 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 applying aspirationusing a 60 mL syringe or an aspiration pump.The Retriever with Microcatheter or | Same |
Table 1. Product Feature Comparison of Subject Device to Predicate Device
{6}------------------------------------------------
{7}------------------------------------------------
| Feature | Predicate Device | Subject Device | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Trevo NXT ProVue Retriever (K210502) | Trevo NXT ProVue Retriever | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Aspiration Catheter are pulled back to capture the thrombus. The Retriever, thrombus, and Microcatheter or Aspiration Catheter are removed as a unit from the body. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Procedural StepsAspiration Source | Syringe, Aspiration pump | Same | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Accessory Devices | Insertion tool and torque device provided within product package | Same | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Sizes | 3x32mm4x28mm4x41mm6x37mm | Same | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Compatibility | Retriever Size Trevo Pro14 Microcatheter Trevo Trak 21 Microcatheter* Trevo Pro18 Microcatheter Excelsior® XT-27 Microcatheter (REF XT275081) Recommended Minimum Vessel ID (mm) Trevo NXT 3x32 √ √ √ √ Trevo NXT 4x28 √ √ √ 2.5 Trevo NXT 4x41 √ √ √ Trevo NXT 6x37 √ √ √ | Retriever Size Trevo Pro14 Microcatheter Trevo Trak 21 Microcatheter* Trevo Pro18 Microcatheter Excelsior® XT-27 Microcatheter (REF XT275081) Recommended Minimum Vessel ID (mm) Trevo NXT 3x32 √ √ √ √ Trevo NXT 4x28 √ √ √ 1.5 Trevo NXT 4x41 √ √ √ Trevo NXT 6x37 √ √ √ 2.5 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Balloon Guide Catheters and Aspiration Catheters (commercially available aspiration catheters with minimum inner diameter 0.046 inches (1.17mm)) are recommended for use during thrombus removal procedures. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Core Wire | Nitinol (nickel titanium alloy) | Same | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shaped Section | Nitinol | Same | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Distal Coil | Platinum/Tungsten | Same | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shaped Section Radiopaque Wire | Platinum/Tungsten | Same | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Mid Coil | 304 Stainless Steel | Same |
{8}------------------------------------------------
| Feature | Predicate Device | Subject Device |
|---|---|---|
| Trevo NXT ProVue Retriever (K210502) | Trevo NXT ProVue Retriever | |
| Proximal Coil | Pebax | Same |
| Solder | Gold/Tin | Same |
| HydrophilicCoating | Sodium hyaluronate mixture | Same |
| DimensionalDrawing | All Retriever sizes:Image: [Dimensional Drawing] | Same |
| 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 inches | Same |
| Cell CoverageLength (F) | 28, 32, 37, 41 mm | Same |
| PackagingMaterials andConfiguration | Polyethylene Hoop, Polycarbonate MountingCard, Tyvek/Film Pouch, Chipboard Carton | Same |
| SterilizationMethod | 100% EtO | Same |
| How Supplied | Sterile/Single Use | Same |
{9}------------------------------------------------
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 with the modified IFU is substantially equivalent to the legally marketed Predicate device.
Testing Summary
There are no changes to the device intended use or indications for use statement. Other than the proposed labeling changes regarding compatibility, 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 (K210502) are directly applicable. Relevant testing data supporting the subject device are summarized as follows.
Performance Data – Bench Testing
There are no changes to the device intended use or indications for use statement. Other than the labeling modification to recommend use of some Trevo retriever models in vessels with minimum diameter of 1.5 mm, there are no changes to the device design, materials, manufacturing and packaging and sterilization methods; therefore, biocompatibility data, bench performance data, sterilization and stability data from the predicate device (K210502) are directly applicable.
Performance Data – Clinical
To support the labeling modifications for the subject Trevo NXT ProVue Retriever 3 mm and 4 mm models, a retrospective analysis of device performance per vessel size was performed using The ASSIST Registry data. This retrospective subgroup analysis demonstrates that use of the subject Trevo NXT ProVue Retriever 3 mm and 4 mm models in vessels with diameters of 1.5 to 2.5 mm has a similar performance and safety profile using available procedural data compared to their use in vessels with diameters ≥ 2.5 mm.
Shelf-Life Testing
Shelf-life testing previously conducted for the Trevo NXT ProVue Retriever was leveraged to support the labeling changes to the device. Shelf-life testing was not performed on the subject device
{10}------------------------------------------------
since there was no impact to device material, design, or safety and efficacy as a result of the labeling changes.
Sterilization
Sterilization evaluation previously conducted for the Trevo NXT ProVue Retriever was leveraged to support the labeling changes to the device. The Trevo NXT ProVue Retrievers are sterilized with 100% Ethylene Oxide (EO) and provided sterile. A sterility assurance level (SAL) of 10 6 has been demonstrated. The Trevo NXT ProVue 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 leveraged to support the labeling changes to the device. 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 Pro Vue Retriever devices, accessories, and primary packaging are considered biocompatible for their intended use.
Conclusion
Based on the conclusions drawn from the risk assessment and the analysis of clinical data from The ASSIST Registry, the subject demonstrates substantial equivalence to the legally marketed predicate device (K210502).
§ 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.