(100 days)
No
The device description and performance studies focus on the mechanical aspects of the retriever and its physical interaction with thrombus, with no mention of AI/ML for image analysis, decision support, or other functions.
Yes.
The device is used to restore blood flow and remove thrombus for the treatment of acute ischemic stroke, which are therapeutic interventions.
No
The device description and intended use clearly state that the Trevo Retriever is designed for removing thrombus to restore blood flow in the neurovasculature, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly outlines physical components like a core wire, platinum markers, a hydrophilic coating, a shaft marker, a Torque Device, and an insertion tool. These are hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The Trevo Retriever is a mechanical device designed to be inserted into the neurovasculature to physically remove blood clots (thrombus) in patients experiencing acute ischemic stroke. It directly interacts with the patient's anatomy and is used for a therapeutic intervention (restoring blood flow), not for analyzing biological samples outside the body.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological specimens. The device description focuses on its physical structure, materials, and mechanism for retrieving clots.
Therefore, the Trevo Retriever is a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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 ), FTIR, Latex) met acceptance criteria. 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 devices are considered to have no residual risk of biological hazards and do not contain detectable latex.
Sterilization and Shelf Life:
- Study Type: Sterilization and aging studies.
- Key Results: Sterilized with 100% Ethylene Oxide with a sterility assurance level (SAL) of 10-6. Meets EO residuals per EN ISO 10993-7. Shelf life of 2 years demonstrated through aging studies for packaging integrity, seal strength and device functionality.
Animal, Clinical Performance Data:
- Study Type: No clinical or animal testing was performed.
- Key Results: Not applicable, as substantial equivalence was based on bench testing due to no change in indications for use or fundamental scientific technology.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Trevo XP ProVue Retriever (K190779, cleared June 25, 2019)
Reference Device(s)
AXS Catalyst Distal Access Catheter (K173841 cleared March 18, 2018), AXS Catalyst 7 Distal Access Catheter (K183464 cleared March 13, 2019)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
2
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 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 K192207
| Trade Name:
Common Name:
Classification Name: | Trevo NXT ProVue Retriever
Trevo Retriever
- Neurovascular Mechanical Thrombectomy Device for Acute
Ischemic Stroke Treatment, 21 CFR 882.5600, Class II - Percutaneous Catheter, 21CFR 870.1250, Class II |
|-----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code: | POL, NRY |
| Submitter: | Stryker Neurovascular
47900 Bayside Parkway
Fremont, CA 94538
Tel 510-413-2269
Fax 510-413-2724
Facility Registration #3008853977 |
| Contact: | Rhoda M. Santos
Senior Principal Regulatory Affairs Specialist |
| Date Prepared: | October 22, 2019 |
| Primary Predicate Device: | Trevo XP ProVue Retriever (K190779, cleared June 25, 2019) |
| Reference Predicate
Device: | AXS Catalyst Distal Access Catheter (K173841 cleared March 18,
AXS Catalyst 7 Distal Access Catheter, (K183464 cleared March
13, 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.
4
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 100µm are observed, complete particle count
analysis of bin sizes ≥200µm, ≥500µm and ≥1000µm.
Record results. | Particulate
characterization was
acceptable. |
| Coating Integrity
Characterization | Inspect the device coating prior to simulated use. Run
the device through a clinically relevant tortuous model.
Visually inspect the device coating after simulated use.
Record results. | Coating Integrity was
acceptable. |
| ISO Fracture | Wind retriever wire around a cylindrical former for at
least eight complete turns, then unwind and examine for
fractures per EN ISO 11070, Annex F. Visually inspect
sample for fractures. Record results. | ISO Fracture meets
acceptance criteria. |
| ISO Flexure | The retriever delivery core wire is subjected to 20 cycles
of repeated reverse bending and straightening per EN
ISO 11070, Annex G. Visually inspect sample for
damage and flaking of (PTFE) coating. Record results. | ISO Flexure meets
acceptance criteria. |
| Reloadability into
Insertion Tool | Using appropriate simulated use model in 37°C
water/saline bath, complete retrieval procedure per IFU
for three retrieval attempts. Remove device from the
model and inspect for damage. Record results. | Reloadability into
Insertion Tool meets
acceptance criteria. |
| Coating
Lubricity/Durability | Prepare sample for test. Use friction tester to measure
the frictional force of the device sample when pulled
between two clamped pads. Record the average
frictional force at 6th cycle. | Coating
Lubricity/Durability
meets acceptance
criteria. |
| Test | Test Method Summary | Conclusions |
| Retriever /
Microcatheter
Deliverability (Track
Test- First Push) | Measure the force to push the device through a tortuous
model in a 37°C water bath. Record maximum force
from the first 5cm push. | Retriever/Microcatheter
Deliverability meets
acceptance criteria. |
| Retriever In-Vivo
Resheathability Into
Microcatheter | Using appropriate simulated use model in 37°C
water/saline bath, complete retrieval procedure per IFU
for three retrieval attempts. Remove device from the
model and inspect for damage. Record results. | Retriever In-Vivo
Resheathability into
Microcatheter meets
acceptance criteria. |
| Retractability of
Retriever into BGC | Using appropriate simulated use model in 37°C
water/saline bath, complete retrieval procedure per IFU
for three retrieval attempts. Remove device from the
model and inspect for damage. Record results. | Retractability of
Retriever into BGC
meets acceptance
criteria. |
| Retrievability of
Retriever with
Intermediate
Catheter | Using appropriate simulated use model in 37°C
water/saline bath, complete retrieval procedure per IFU
for three retrieval attempts. Remove device from the
model and inspect for damage. Record results. | Retractability of
Retriever with
Intermediate Catheter
meets acceptance
criteria. |
| Product Integrity
Post Removal | Remove product from packaging hoop per IFU. Visually
inspect product for kinks on delivery wire or retriever.
Record results. | Product Integrity Post
Removal meets
acceptance criteria. |
| Stent Containment in
Insertion Tool | Remove product from packaging hoop per IFU. Visually
inspect position of stent retriever within insertion tool.
Record results. | Stent Containment in
Insertion Tool meets
acceptance criteria. |
| Design Validation | Design Validation testing utilized a neurovascular model
with a re-circulating water bath at 37°C to simulate the
human arterial circulation and assess device
performance. | Design Validation
testing met acceptance
criteria. |
- 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 100µm are observed, complete particle count
The performance bench testing performed are listed below:
17
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.
18
| 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 clinical | |
| application. | 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 systemic | ||
| toxicity. | Acceptance criteria met | |||
| ISO 10993-18 | Physicochemical | |||
| (USP ) | 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 |
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.