(100 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 artely (ICA) or middle cerebral artely (MCA)-Ml 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.
The provided document is a 510(k) summary for the Trevo NXT ProVue Retriever, a neurovascular mechanical thrombectomy device. It describes the device, its intended use, and a comparison to predicate devices, primarily focusing on non-clinical performance and biocompatibility data to establish substantial equivalence.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and the Reported Device Performance:
The document provides a table of various performance tests, their methods, and conclusions. The acceptance criteria themselves are explicitly stated for biocompatibility tests, but for performance tests, the conclusion is generally "meets acceptance criteria," implying that specific thresholds were defined internally and met.
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Performance Testing | ||
| Dimensional Verification | (Implied specific measurements and tolerances) | Dimensional verification meets acceptance criteria. |
| Retriever Delivery Wire Kink Resistance | (Implied: no damage after three retrieval attempts in tortuous model per IFU) | Retriever Delivery Wire Kink Resistance meets acceptance criteria. |
| Tip Flexibility | (Implied: device withstands applied peak compression/flex force) | Tip Flexibility meets acceptance criteria. |
| Retriever Shaped Section Radial Force | (Implied: meets specified force at specified diameters) | Retriever Shaped Section Radial Force meets acceptance criteria. |
| Corrosion Resistance | No signs of corrosion after immersion in saline bath per EN ISO 10555-1. | Corrosion Resistance meets acceptance criteria. |
| Particulate Characterization | Acceptable number of particulates in specified size ranges (≥10µm, ≥25µm, ≥50µm, ≥100µm; and ≥200µm, ≥500µm, ≥1000µm if >100µm observed). | Particulate characterization was acceptable. |
| Coating Integrity Characterization | (Implied: no significant coating damage after simulated use in tortuous model) | Coating Integrity was acceptable. |
| ISO Fracture | No fractures after winding around a cylindrical former per EN ISO 11070, Annex F. | ISO Fracture meets acceptance criteria. |
| ISO Flexure | No damage or flaking of coating after 20 cycles of reverse bending and straightening per EN ISO 11070, Annex G. | ISO Flexure meets acceptance criteria. |
| Reloadability into Insertion Tool | (Implied: no damage after three retrieval attempts in tortuous model per IFU) | Reloadability into Insertion Tool meets acceptance criteria. |
| Coating Lubricity/Durability | (Implied: average frictional force at 6th cycle is within acceptable limits) | Coating Lubricity/Durability meets acceptance criteria. -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Retriever / Microcatheter Deliverability (Track Test-First Push) | (Implied: maximum force from first 5cm push is within acceptable limits) | Retriever/Microcatheter Deliverability meets acceptance criteria. -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Retriever In-Vivo Resheathability Into Microcatheter | (Implied: no damage after three retrieval attempts in tortuous model per IFU) | Retriever In-Vivo Resheathability into Microcatheter meets acceptance criteria. -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Retractability of Retriever into BGC | (Implied: no damage after three retrieval attempts in tortuous model per IFU) | Retractability of Retriever into BGC meets acceptance criteria. -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Retrievability of Retriever with Intermediate Catheter | (Implied: no damage after three retrieval attempts in tortuous model per IFU) | Retractability of Retriever with Intermediate Catheter meets acceptance criteria. -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Product Integrity Post Removal | No kinks inspected on delivery wire or retriever after removal from packaging per IFU. | Product Integrity Post Removal meets acceptance criteria. -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Stent Containment in Insertion Tool | Proper position of stent retriever within insertion tool after removal from packaging per IFU. | Stent Containment in Insertion Tool meets acceptance criteria. |
| Design Validation | (Implied: device performance successful in neurovascular model under simulated clinical conditions) | Design Validation testing met acceptance criteria. All Users observed that the Trevo NXT ProVue Retrievers successfully met all the design attribute evaluations defined in the design validation protocol. No additional risks identified. Adequately met customer needs. |
| Biocompatibility Testing | ||
| ISO 10993-4: Hemolysis | Hemolysis is ≤ 5%. | Acceptance criteria met. |
| ISO 10993-4: Thrombosis | Thrombosis is acceptable for clinical application. | Acceptance criteria met. |
| ISO 10993-5: Cytotoxicity | Not less than or equal to 50% cell viability. | Acceptance criteria met. |
| ISO 10993-10: Sensitization | Not a sensitizer. | Acceptance criteria met. |
| ISO 10993-10: Irritation | No significant irritation. | Acceptance criteria met. |
| ISO 10993-11: Material Mediated Pyrogenicity | No febrile reaction greater than 0.5°C. | Acceptance criteria met. -------------------------------------------------------------------------------------------------------------------------- |
| ISO 10993-11: Acute Systemic Toxicity | No mortality or evidence of systemic toxicity. | Acceptance criteria met. -------------------------------------------------------------------------------------------------------------------------- |
| ISO 10993-18: Physicochemical (USP <661>) | Non-volatile Residue ≤ 15 mg; Residue on Ignition ≤ 5 mg; Heavy Metals ≤ 1 ppm; Buffering Capacity ≤ 10.0 mL. | Acceptance criteria met. -------------------------------------------------------------------------------------------------------------------------- |
| FTIR | No unexpected readings. | Acceptance criteria met. -------------------------------------------------------------------------------------------------------------------------- |
| Latex (LEAP - ASTM D6400) | No detectable latex. | Acceptance criteria met. -------------------------------------------------------------------------------------------------------------------------- |
| Sterilization Assurance Level | SAL of 10⁻⁶. | Achieved. |
| EO Residuals | Met per EN ISO 10993-7 for limited contacting, externally communicated devices. | Achieved. |
| Shelf Life | Packaging remains functional and maintains sterility for 2 years. | Met all acceptance criteria. |
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 for Test Set: Not explicitly mentioned for each specific performance test. The design validation states "All Users observed that the Trevo NXT ProVue Retrievers successfully met all the design attribute evaluations...". For biocompatibility, standard ISO tests were performed, which usually involve specific numbers of samples or animals as per the standard.
- Data Provenance: The studies are non-clinical (bench testing and in vitro simulated-use studies) and biocompatibility tests. They are not clinical studies involving human patient data, so concepts like country of origin or retrospective/prospective are not applicable in this context. The simulated-use studies were conducted internally for device verification and validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not explicitly stated. The design validation study mentions "Users evaluated the device in a simulated use tortuous anatomical model". It doesn't specify if these "Users" are experts in establishing ground truth, nor their number or qualifications as one would typically see in a clinical study where expert consensus might establish ground truth for a diagnostic device. In this context of a mechanical device, performance is evaluated against defined physical and functional criteria rather than expert interpretation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable as this is a device performance study focusing on physical and functional attributes, not a study requiring adjudication of clinical outcomes or interpretations.
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:
- Not applicable. This is a non-clinical evaluation of a mechanical thrombectomy device, not an AI-assisted diagnostic or decision support system.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a mechanical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For performance testing, the "ground truth" (or reference standard) is based on defined engineering specifications, industry standards (e.g., ISO, ASTM), and predetermined functional requirements. For example, a successful test means the device's dimension falls within a specified range, or it withstands a certain force, or it shows no damage after simulated use.
- For biocompatibility testing, the ground truth is established by the criteria outlined in recognized international standards (ISO 10993-x), which define acceptable biological responses (e.g., hemolysis ≤ 5%, not a sensitizer).
8. The sample size for the training set:
- Not applicable. This is a non-clinical evaluation of a mechanical thrombectomy device, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable.
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
November 22, 2019
Stryker Neurovascular Rhoda Santos Senior Principal Regulatory Affairs Specialist 47900 Bayside Parkway Fremont, California 94538
Re: K192207
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: October 22, 2019 Received: October 23, 2019
Dear Rhoda Santos:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
{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,
Xiaolin Zheng -S
Xiaolin Zheng, Ph.D., M.S. Director (Acting) DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K192207
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 artely (ICA) or middle cerebral artely (MCA)-Ml 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.
| CONTINUE ON A SEPARATE PAGE IF NEEDED | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
| Type of Use (Select one or both, as applicable) |
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510(k) Summary K192207
| Trade Name:Common Name:Classification Name: | Trevo NXT ProVue RetrieverTrevo Retriever- Neurovascular Mechanical Thrombectomy Device for AcuteIschemic Stroke Treatment, 21 CFR 882.5600, Class II- Percutaneous Catheter, 21CFR 870.1250, Class II |
|---|---|
| Product Code: | POL, NRY |
| Submitter: | Stryker Neurovascular47900 Bayside ParkwayFremont, CA 94538Tel 510-413-2269Fax 510-413-2724Facility Registration #3008853977 |
| Contact: | Rhoda M. SantosSenior Principal Regulatory Affairs Specialist |
| Date Prepared: | October 22, 2019 |
| Primary Predicate Device: | Trevo XP ProVue Retriever (K190779, cleared June 25, 2019) |
| Reference PredicateDevice: | AXS Catalyst Distal Access Catheter (K173841 cleared March 18,2018)AXS Catalyst 7 Distal Access Catheter, (K183464 cleared March13, 2019) |
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.
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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.
Comparison of Technological Characteristics with the Primary Predicate Device:
The intended use remains as a neurovascular mechanical thrombectomy device for acute ischemic stroke treatment used in the treatment of acute ischemic stroke to improve clinical outcomes. The technological characteristics and principles of operation remain unchanged. Refer to table below for comparison of technological characteristics associated with Subject Device and Primary Predicate Device.
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| Feature | Primary Predicate DeviceTrevo XP ProVue Retriever (K190779) | Subject DeviceTrevo NXT ProVue Retriever (K192207) | Subject DeviceSubstantiallyEquivalent toPredicateDevice(s)? |
|---|---|---|---|
| Intended Use | Neurovascular mechanical thrombectomy devicefor acute ischemic stroke treatment used in thetreatment of acute ischemic stroke to improveclinical outcomes. | Same | NA |
| Indications for Use | 1. The Trevo Retriever is indicated for use torestore blood flow in the neurovasculature byremoving thrombus for the treatment of acuteischemic stroke to reduce disability in patientswith a persistent, proximal anterior circulation,large vessel occlusion, and smaller coreinfarcts who have first received intravenoustissue plasminogen activator (IV t-PA).Endovascular therapy with the device shouldstart within 6 hours of symptom onset.2. The Trevo Retriever is intended to restore bloodflow in the neurovasculature by removingthrombus in patients experiencing ischemicstroke within 8 hours of symptom onset.Patients who are ineligible for intravenoustissue plasminogen activator (IV t-PA) or whofail IV t-PA therapy are candidates fortreatment. | Same | NA |
| Feature | Primary Predicate DeviceTrevo XP ProVue Retriever (K190779) | Subject DeviceTrevo NXT ProVue Retriever (K192207) | Subject DeviceSubstantiallyEquivalent toPredicateDevice(s)? |
| 3. The Trevo Retriever is indicated for use torestore blood flow in the neurovasculature byremoving thrombus for the treatment of acuteischemic stroke to reduce disability in patientswith a persistent, proximal anterior circulation,large vessel occlusion of the internal carotidartery (ICA) or middle cerebral artery (MCA)-M1 segments with smaller core infarcts (0-50ccfor age <80 years, 0-20cc for age ≥80 years).Endovascular therapy with the device shouldstart within 6-24 hours of time last seen well inpatients who are ineligible for intravenoustissue plasminogen activator (IV t-PA) or whofail IV t-PA therapy. | |||
| Regulation Number/Name/ Class/Product Code | 21 CFR 882.5600, Neurovascular MechanicalThrombectomy Device for Acute Ischemic StrokeTreatment, Class II, POL21 CFR 870.1250, Percutaneous Catheter, Class II,NRY | Same | NA |
| Target Population | Patients experiencing acute ischemic stroke | Same | NA |
| Anatomical Sites | Neurovasculature | Same | NA |
| Feature | Primary Predicate DeviceTrevo XP ProVue Retriever (K190779) | Subject DeviceTrevo NXT ProVue Retriever (K192207) | Subject DeviceSubstantiallyEquivalent toPredicateDevice(s)? |
| Device Description | The Retriever consists of a flexible, tapered corewire with a shaped section at the distal end.Platinum markers at the distal end allowfluoroscopic visualization. In addition, the shapedsection is also radiopaque. Retriever dimensionsare indicated on product label. The Retriever has ahydrophilic coating to reduce friction during use.The Retriever has a shaft marker to indicateproximity of Retriever tip relative to Microcathetertip. A torque device is provided with the Retrieverto facilitate manipulation. The torque device isused to lock the core wire to the microcatheterduring the procedure. Locking of the torque deviceto the wire allows the microcatheter and Retrieverto be retracted as a system during clot retrieval. Aninsertion tool is provided to introduce the Retrieverinto a Microcatheter. The Insertion Tool is a sheathin which the Retriever comes preloaded. Once halfthe retriever's length is inserted into themicrocatheter, the insertion tool is removed.Retrievers have a modified proximal end thatpermits attachment of the Abbott Vascular DOCGuide Wire Extension (REF 22260). Joining GuideWire Extension to Retriever facilitates removal orexchange of a catheter while maintaining Retrieverposition in anatomy. After exchange has beencompleted, the extension can be detached. | The Retriever consists of a flexible, tapered corewire with a shaped section at the distal end.Platinum markers at the distal end allowfluoroscopic visualization. In addition, the shapedsection is also radiopaque. Retriever dimensionsare indicated on product label. The Retrieverdelivery wire has a hydrophilic coating on thedistal 101cm to reduce friction during use. TheRetriever has a shaft marker to indicate proximityof Retriever tip relative to Microcatheter tip. Atorque device is provided with the Retriever tofacilitate manipulation and retrieval. The Retrievercomes preloaded in an insertion tool to introducethe Retriever into a Microcatheter. | Yes.Revised for clarityand brevity fordescription of torquedevice usage. Alsoidentifies length ofhydrophilic coating.Reference to AbbottVascular DOCGuide WireExtension (REF22260) has beendeleted as thisfeature has beenremoved as part ofthe modificationsfor the Trevo NXTProVue Retriever. |
| Feature | Primary Predicate DeviceTrevo XP ProVue Retriever (K190779) | Subject DeviceTrevo NXT ProVue Retriever (K192207) | Subject DeviceSubstantiallyEquivalent toPredicateDevice(s)? |
| Principle ofOperation | The Trevo Retriever is delivered to the thrombususing a microcatheter. The Microcatheter is thenretracted to deploy the shaped section of theRetriever. If using an Aspiration Catheter, removeMicrocatheter. Advance Aspiration Catheter overproximal section of Retriever while applyingaspiration using a 60 mL syringe or an aspirationpump. The Retriever with Microcatheter orAspiration Catheter are pulled back to capture thethrombus. The Retriever, thrombus, andMicrocatheter or Aspiration Catheter are removedas a unit from the body. | Same | NA |
| Procedural StepsAspiration Source | Syringe, Aspiration pump | Same | NA |
| Sizes | 3x20mm4x20mm4x30mm6x25mm | 3x25mm4x21mm4x35mm6x30mm | Yes.Modification basedon customerpreference.As there are nochanges to the actualdesign of the shapedsection, safety andeffectiveness of thedevice is unaffected. |
| Accessory Devices | Insertion tool and torque device provided withinproduct package | Same | NA |
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{9}------------------------------------------------
| Feature | Primary Predicate DeviceTrevo XP ProVue Retriever (K190779) | Subject DeviceTrevo NXT ProVue Retriever (K192207) | Subject DeviceSubstantiallyEquivalent toPredicateDevice(s)? | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Compatibility | Retriever Size | Trevo Pro14Microcatheter | Trevo Pro18Microcatheter | Excelsior® XT-27®(150cm x 6cmstraight REFXT275081) | RecommendedMinimumVessel ID (mm) | Retriever Size | Trevo Pro14Microcatheter | Trevo Trak 21Microcatheter* | Trevo Pro18Microcatheter | Excelsior® XT-27(REF XT275081)Microcatheter | RecommendedMinimumVessel ID (mm) | Yes.Trevo Trak 21Microcatheter iscurrently pendingFDA review underK192122. |
| Trevo XP ProVue3X20mm | √ | √ | TrevoNXT 3x25 | √ | √ | √ | √ | |||||
| Trevo XP ProVue4X20mm | √ | √ | TrevoNXT 4x21 | √ | √ | √ | ||||||
| Trevo ProVue4X20mm | √ | 2.5 | TrevoNXT 4x35 | √ | √ | √ | 2.5 | |||||
| Trevo XP ProVue4X30mm | √ | √ | √ | TrevoNXT 6x30 | √ | √ | √ | |||||
| Trevo XP ProVue6X25mm | √ | |||||||||||
| Materials | ||||||||||||
| Core Wire | Nitinol (nickel titanium alloy) | Same | NA | |||||||||
| Shaped Section | Nitinol | Same | NA | |||||||||
| Distal Coil | Platinum/Tungsten | Same | NA | |||||||||
| Shaped SectionRadiopaque Wire | Platinum/Tungsten | Same | NA | |||||||||
| Mid Coil | 304 Stainless Steel | Same | NA |
{10}------------------------------------------------
| Feature | Primary Predicate DeviceTrevo XP ProVue Retriever (K190779) | Subject DeviceTrevo NXT ProVue Retriever (K192207) | Subject DeviceSubstantiallyEquivalent toPredicateDevice(s)? |
|---|---|---|---|
| Proximal Coil /Proximal Support /Length | 304 Stainless Steel | Pebax | Yes.Biocompatibilityand bench testinghas demonstratedthat the change inthe proximal coilmaterial does notaffect the safety andperformance of thedevice. |
| Solder | Gold/Tin | Same | NA |
| Hydrophilic Coating | Sodium hyaluronate mixture | Same except with updated formulation | Yes.Biocompatibilityand bench testinghas demonstratedthat the change inthe hydrophiliccoating formulationdoes not affect thesafety andperformance of thedevice. |
{11}------------------------------------------------
| Feature | Primary Predicate DeviceTrevo XP ProVue Retriever (K190779) | Subject DeviceTrevo NXT ProVue Retriever (K192207) | Subject DeviceSubstantiallyEquivalent toPredicateDevice(s)? |
|---|---|---|---|
| DimensionalDrawing | 3x20, 4x20mm Retriever sizes:Image: Dimensional drawing of 3x20, 4x20mm Retriever sizes4x30, 6x25mm Retriever sizes:Image: Dimensional drawing of 4x30, 6x25mm Retriever sizes | All Retriever sizes:Image: Dimensional drawing of All Retriever sizes | Yes.Modification basedon customerpreference.As there are nochanges to theactual design of theshaped section,safety andeffectiveness of thedevice isunaffected. |
{12}------------------------------------------------
| Feature | Primary Predicate DeviceTrevo XP ProVue Retriever (K190779) | Subject DeviceTrevo NXT ProVue Retriever (K192207) | Subject DeviceSubstantiallyEquivalent toPredicateDevice(s)? |
|---|---|---|---|
| Overall Length | 180, 190cm | 200cm | Yes.Increased length ofthe delivery corewire allows forcompatibility withlonger devices.Bench testing hasdemonstrated thatthe change in thedelivery core wirelength does notaffect the safety andeffectiveness of thedevice. |
| Total Shaped SectionLength (nominal) | 32, 36, 40, 44mm | Same | NA |
| Active ShapedSection Length | 20, 25, 30mm | Same | NA |
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| Feature | Primary Predicate DeviceTrevo XP ProVue Retriever (K190779) | Subject DeviceTrevo NXT ProVue Retriever (K192207) | Subject DeviceSubstantially Equivalent toPredicate Device(s)? | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Full Diameter Length(nominal) | 4x30, 6x25mm Retriever sizes:Retriever Size (mm) Dimension C (mm) 3x20 NA 4x20 NA 4x30 35 6x25 30 | All Retriever sizes:Retriever Size (mm) Dimension C (mm) 3x25 25 4x21 21 4x35 Same 6x30 Same | Yes.Labeling changes to replace the Active Shaped Section Length with Full Diameter Length is based on customer preference.As there are no changes to the actual design of the shaped section, safety and effectiveness of the device is unaffected. | ||||||||||||||||||||||
| Shaped Section Diameter (nominal) | 3, 4, 6mm | Same | NA | ||||||||||||||||||||||
| Proximal Core WireDiameter | Retriever Size (mm) Dimension E (inches) 3x20 0.015 4x20 0.018Retriever Size (mm) Dimension F (inches) 4x30 0.018 6x25 0.018 | Retriever Size (mm) Dimension E (inches) 3x20 0.015 4x20 0.019 4x30 0.019 6x25 0.019 | Yes.Modification accommodates SNV procedures.As there are no actual changes to the delivery core wire outer diameter, the safety and effectiveness of the device is unaffected. |
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| Feature | Primary Predicate DeviceTrevo XP ProVue Retriever (K190779) | Subject DeviceTrevo NXT ProVue Retriever (K192207) | Subject DeviceSubstantiallyEquivalent toPredicateDevice(s)? |
|---|---|---|---|
| Materials andConfiguration | Polyethylene Hoop, polycarbonate mounting card,Tyvek/Film Pouch, HDPE Tubing Clips,Chipboard carton | Longer Polyethylene Hoop, polycarbonatemounting card, Tyvek/Film Pouch, Chipboardcarton | Yes.Hoop was modifiedto accommodatelonger devicelength, andsterilizationvalidation has beencompleted. |
| Sterilization Method | 100% EtO | Same | NA |
| How Supplied | Sterile/Single Use | Same | NA |
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Performance Data – Non-Clinical
The following performance data were provided in support of the substantial equivalence determination.
Performance Testing:
To confirm that the performance of the Subject device, Trevo NXT ProVue Retriever, is substantially equivalent to the performance of the Primary Predicate, device verification and validation testing was conducted on those aspects of the devices that could be affected by the differences between the Primary Predicate device and the Subject device.
Validation:
In accordance with FDA's guidance, "Pre-Clinical and Clinical Studies for Neurothrombectomy Devices," issued June 18, 2007, an in vitro Simulated-use study was completed to assess the usability of the subject device, Trevo NXT ProVue Retriever. Users evaluated the device in a simulated use tortuous anatomical model under simulated clinical conditions per the proposed Directions for Use (DFU).
All Users observed that the Trevo NXT ProVue Retrievers successfully met all the design attribute evaluations defined in the Trevo NXT ProVue Retriever design validation protocol, when utilized in simulated use tortuous anatomy. There were no additional risks identified by the Users. All Trevo NXT ProVue Retrievers used in testing adequately met the customer needs defined in internal documentation.
Leveraged Non-Clinical Data:
Data supporting the performance characteristics that were not impacted by the proposed modifications were leveraged from the Primary Predicate device. Previous data remains valid as there are no changes to the design / geometry of the shaped section associated with the proposed modifications for the Trevo NXT ProVue Retrievers. As there are no changes to the design of the shaped section, the following tests and associated data were leveraged as listed below:
- Dimensional Verification ●
- Retriever Shape Section Radial Force ●
- Retriever Torque/Tensile Durability
- Retriever Mid Joint Tensile Strength ●
- Retriever Tip Tensile Strength
- Retriever Wire Joint Tensile Strength
- . Retriever Wire and Joint Durability
- Simulated Use ●
Non-Clinical Data:
In accordance with FDA's guidance, "Pre-Clinical and Clinical Studies for
Neurothrombectomy Devices," issued June 18, 2007, additional design verification and validation testing conducted on the Trevo NXT ProVue Retriever demonstrates that it performs as designed and is suitable for its intended use. The test results are appropriate to support a determination of substantial equivalence to the Primary Predicate device.
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| Test | Test Method Summary | Conclusions |
|---|---|---|
| DimensionalVerification | Verified dimensions using specified measurement tool. | Dimensionalverification meetsacceptance criteria. |
| Retriever DeliveryWire KinkResistance | Using appropriate simulated use model in 37°Cwater/saline bath, complete retrieval procedure per IFUfor three retrieval attempts. Remove device from themodel and inspect delivery core wire for damage.Record results. | Retriever Delivery WireKink Resistance meetsacceptance criteria. |
| Tip Flexibility | Load sample so that the distal tip will be flexed. UseInstron tensile tester to determine applied peakcompression/flex force. Record results. | Tip Flexibility meetsacceptance criteria. |
| Retriever ShapedSection Radial Force | Constrain shaped section of retriever and release tospecified diameter. Use Instron tensile tester andBlockwise RF iris fixture to determine applied force atthe specified diameters. Record results. | Retriever ShapedSection Radial Forcemeets acceptancecriteria. |
| Corrosion Resistance | Immerse test sample in saline bath per EN ISO 10555-1.Remove test sample and allow to dry at roomtemperature. Inspect sample for signs of corrosion.Record results. | Corrosion Resistancemeets acceptancecriteria. |
| ParticulateCharacterization | Measure the total number of particulates generatedduring simulated use. Report in each of four size ranges≥10µm, ≥25µm, ≥50µm, and ≥100µm.If >100µm are observed, complete particle countanalysis of bin sizes ≥200µm, ≥500µm and ≥1000µm.Record results. | Particulatecharacterization wasacceptable. |
| Coating IntegrityCharacterization | Inspect the device coating prior to simulated use. Runthe device through a clinically relevant tortuous model.Visually inspect the device coating after simulated use.Record results. | Coating Integrity wasacceptable. |
| ISO Fracture | Wind retriever wire around a cylindrical former for atleast eight complete turns, then unwind and examine forfractures per EN ISO 11070, Annex F. Visually inspectsample for fractures. Record results. | ISO Fracture meetsacceptance criteria. |
| ISO Flexure | The retriever delivery core wire is subjected to 20 cyclesof repeated reverse bending and straightening per ENISO 11070, Annex G. Visually inspect sample fordamage and flaking of (PTFE) coating. Record results. | ISO Flexure meetsacceptance criteria. |
| Reloadability intoInsertion Tool | Using appropriate simulated use model in 37°Cwater/saline bath, complete retrieval procedure per IFUfor three retrieval attempts. Remove device from themodel and inspect for damage. Record results. | Reloadability intoInsertion Tool meetsacceptance criteria. |
| CoatingLubricity/Durability | Prepare sample for test. Use friction tester to measurethe frictional force of the device sample when pulledbetween two clamped pads. Record the averagefrictional force at 6th cycle. | CoatingLubricity/Durabilitymeets acceptancecriteria. |
| Test | Test Method Summary | Conclusions |
| Retriever /MicrocatheterDeliverability (TrackTest- First Push) | Measure the force to push the device through a tortuousmodel in a 37°C water bath. Record maximum forcefrom the first 5cm push. | Retriever/MicrocatheterDeliverability meetsacceptance criteria. |
| Retriever In-VivoResheathability IntoMicrocatheter | Using appropriate simulated use model in 37°Cwater/saline bath, complete retrieval procedure per IFUfor three retrieval attempts. Remove device from themodel and inspect for damage. Record results. | Retriever In-VivoResheathability intoMicrocatheter meetsacceptance criteria. |
| Retractability ofRetriever into BGC | Using appropriate simulated use model in 37°Cwater/saline bath, complete retrieval procedure per IFUfor three retrieval attempts. Remove device from themodel and inspect for damage. Record results. | Retractability ofRetriever into BGCmeets acceptancecriteria. |
| Retrievability ofRetriever withIntermediateCatheter | Using appropriate simulated use model in 37°Cwater/saline bath, complete retrieval procedure per IFUfor three retrieval attempts. Remove device from themodel and inspect for damage. Record results. | Retractability ofRetriever withIntermediate Cathetermeets acceptancecriteria. |
| Product IntegrityPost Removal | Remove product from packaging hoop per IFU. Visuallyinspect product for kinks on delivery wire or retriever.Record results. | Product Integrity PostRemoval meetsacceptance criteria. |
| Stent Containment inInsertion Tool | Remove product from packaging hoop per IFU. Visuallyinspect position of stent retriever within insertion tool.Record results. | Stent Containment inInsertion Tool meetsacceptance criteria. |
| Design Validation | Design Validation testing utilized a neurovascular modelwith a re-circulating water bath at 37°C to simulate thehuman arterial circulation and assess deviceperformance. | Design Validationtesting met acceptancecriteria. |
The performance bench testing performed are listed below:
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Results of verification and validation testing are appropriate for use in determining that the Trevo NXT ProVue Retriever devices are substantially equivalent to the Primary Predicate and Reference devices. Based on the successful completion of the verification and validation testing on accelerated aged devices, the Subject device has met all the pre-specified requirements and is safe for clinical use.
Biocompatibility:
The biocompatibility evaluation for the Trevo® NXT ProVue Retrievers was conducted in accordance with the FDA guidance, "Use of International Standard ISO-10993-1, 'Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process, " and International Standard ISO 10993-1 as recognized by FDA.
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| Test Method, Category, and Description | Acceptance Criteria | Conclusion | ||
|---|---|---|---|---|
| ISO 10993-4 | Hemolysis | Direct Contact | Hemolysis is ≤ 5%. | Acceptance criteria met |
| Extraction | Acceptance criteria met | |||
| ISO 10993-4 | Thrombosis | Thromboresistance | Thrombosis is acceptable for clinicalapplication. | Acceptance criteria met |
| Complement Activation(sC5b-9) | Acceptance criteria met | |||
| Coagulation(Partial Thromboplastin Time) | Acceptance criteria met | |||
| ISO 10993-5 | Cytotoxicity(L929 MEM Elution) | No less than or equal to 50% cell viability. | Acceptance criteria met | |
| ISO 10993-10 | Sensitization(Guinea Pig Maximization) | Not a sensitizer. | Acceptance criteria met | |
| ISO 10993-10 | Irritation(Rabbit Intracutaneous [Intradermal]) | No significant irritation. | Acceptance criteria met | |
| ISO 10993-11 | Material Mediated Pyrogenicity | No febrile reaction greater than 0.5°C. | Acceptance criteria met | |
| ISO 10993-11 | Acute Systemic Toxicity | No mortality or evidence of systemictoxicity. | Acceptance criteria met | |
| ISO 10993-18 | Physicochemical(USP <661>) | Non-volatile Residue ≤ 15 mgResidue on Ignition ≤ 5 mgHeavy Metals ≤ 1 ppmBuffering Capacity ≤ 10.0 mL | Acceptance criteria met | |
| FTIR | No unexpected readings. | Acceptance criteria met | ||
| Latex(LEAP - ASTM D6400) | No detectable latex. | Acceptance criteria met |
A summary of the biocompatibility testing completed follows:
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.
Sterilization and Shelf Life:
The Trevo® NXT ProVue Retrievers are sterilized with 100% Ethylene Oxide and provided sterile. A sterility assurance level (SAL) of 1066 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.
Aging studies for the Subject device demonstrate that the device packaging remains functional and maintains sterility for shelf life of 2 years. Aging studies for packaging integrity, seal strength and device functionality met all acceptance criteria.
Performance Data - Animal, Clinical
No clinical or animal testing was performed on the Subject device 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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Conclusions:
Based on the supporting documentation provided in this submission, Stryker Neurovascular believes the Subject devices demonstrated substantial equivalence to the listed Predicate devices.
§ 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.