(126 days)
Not Found
No
The summary describes a mechanical thrombectomy device and does not mention any AI or ML components or capabilities.
Yes.
The device is intended to restore blood flow and remove thrombus in patients experiencing ischemic stroke, which directly treats a medical condition.
No
The Trevo Retriever is a thrombectomy device designed to restore blood flow by removing blood clots in stroke patients. It is a therapeutic device, not a diagnostic one. While it uses diagnostic angiographic data, it does not itself perform diagnosis.
No
The device description clearly indicates it is a physical medical device (flexible, tapered core wire, radiopaque coil, hydrophilic coating, torque device, insertion tool) used for mechanical thrombectomy, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Trevo Retriever Function: The description clearly states that the Trevo Retriever is a device intended to be inserted into the neurovasculature to physically remove a thrombus (blood clot). It is a mechanical device used within the body to restore blood flow.
- Lack of Sample Analysis: There is no mention of the device analyzing any biological samples taken from the patient. Its function is entirely based on physical interaction within the blood vessels.
The information provided describes a medical device used for interventional procedures, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
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-tPA) or who fail IV-tPA therapy are candidates for treatment.
Product codes
NRY
Device Description
Like the predicate device, the Trevo Retriever consists of a flexible, tapered core wire with a shaped section at the distal end and is designed to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke. A radiopaque coil at the distal end allows fluoroscopic visualization. Retriever dimensions are indicated on the product label. The Retriever has a hydrophilic coating to reduce friction during use. A torque device and an insertion tool are provided with the Retriever. The proximal end of the device is compatible with the Abbott guide wire extension to facilitate removal or exchange of a catheter while maintaining the Retriever position in the vessel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Neurovasculature
Indicated Patient Age Range
Age 18-85 (has had 18th birthday, but not yet had 86th birthday)
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
To demonstrate substantial equivalence, a randomized, multi-center, prospectively controlled IDE clinical trial (TREVO 2) was conducted comparing the efficacy of the subject Trevo Retriever to the predicate Merci Retriever for removing occlusive thrombi in patients experiencing an ischemic stroke.
A total of 178 patients were randomized, 88 to treatment with the Trevo device and 90 to the Merci device. On review by the Core Lab, 81 subjects randomized to Trevo and 82 subjects randomized to Merci met all angiographic entry criteria. An attempt to treat with the device was made in 79 Trevo and 81 Merci subjects. The population for analysis of the primary effectiveness and safety endpoints includes these 160 subjects were treated with the device to which they were randomized. There were no subjects with missing endpoint data.
Statistical Analysis: Analysis of the primary efficacy endpoint (successful revascularization of the target occlusion, using the TICI score as the metric) was performed using a one-sided test per Blackwelder's formulation of the primary efficacy non-inferiority hypothesis at the 0.025 level of significance. The primary safety endpoint of the study was the incidence of procedure-related serious adverse events (PRSAEs) through 24 hours post procedure. These events were adjudicated by an independent clinical events committee per protocol. There was no statistical hypothesis related to the primary safety endpoint.
Key Results:
Primary Efficacy Endpoint:
Post-Device Revascularization Success (TICI >=2a) for Trevo (N=79): 87.3% (69/79) [95% CI: 78.0%, 93.8%]
Post-Device Revascularization Success (TICI >=2a) for Merci (N=81): 58.0% (47/81) [95% CI: 46.5%, 68.9%]
Difference: 29.3% [15.0%, 42.4%], p-value =2a) for Trevo (N=79): 79.7% (63/79) [95% CI: 69.2%, 88.0%]
Post-Device Revascularization Success (TICI >=2a) for Merci (N=81): 49.4% (40/81) [95% CI: 38.1%, 60.7%]
Difference: 30.4% [15.0%, 44.1%], p-value
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
0
3 2012 AUG
510(K) SUMMARY
| Trade Name: | Trevo Retriever |
|---|---|
| Common Name: | Catheter, Thrombus Retriever |
| Classification: | Catheter, Thrombus Retriever, 21CFR 870.1250 - Class II |
| Submitter: | Concentric Medical, Inc. |
| 301 E. Evelyn Avenue | |
| Mountain View, CA 94041 | |
| Tel 650-938-2100 | |
| Fax 650-237-5230 | |
| Facility Registration #2954917 | |
| Contact: | Kirsten Valley |
| Vice President, Technology & Regulatory Affairs | |
| Date Prepared: | July 27, 2012 |
| 1 64 6 4 4 4 4 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 | Uly ( ( ) ( LV LL | |
|---|---|---|
| Predicate Device: | Merci® Retriever (K063774 |
Device Description
Like the predicate device, the Trevo Retriever consists of a flexible, tapered core wire with a shaped section at the distal end and is designed to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke. A radiopaque coil at the distal end allows fluoroscopic visualization. Retriever dimensions are indicated on the product label. The Retriever has a hydrophilic coating to reduce friction during use. A torque device and an insertion tool are provided with the Retriever. The proximal end of the device is compatible with the Abbott guide wire extension to facilitate removal or exchange of a catheter while maintaining the Retriever position in the vessel.
Indications for Use
The Indications for Use are as follows:
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. This is comparable to the predicate device's Indications for Use and does not impact the intended therapeutic use of the device in patients experiencing ischemic stroke or raise different issues of safety and effectiveness. As a result, the safety and effectiveness of the device are not impacted when used as indicated.
Technological Characteristics
There are technological differences between Trevo and the predicate device. The effect of these differences on safety and effectiveness has been addressed in a clinical study which supports that the clinical performance of the two devices is substantially equivalent. Table 1 provides a comparison between the Trevo device and the predicate Merci device.
1
| Attribute | Predicate Merci Retriever Device (K063774) | Subject Trevo Retriever |
|---|---|---|
| Device Description | The Retriever consists of a flexible, tapered core wire with a shaped section at the distal end. A platinum coil allows fluoroscopic visualization. The Retriever has a hydrophilic coating to reduce friction. The Retriever has a shaft marker to indicate proximity of Retriever tip relative to Microcatheter tip. A torque device and insertion tool are provided with the Retriever. | Same as the predicate device |
| Distal End (shaped section) Configuration | Image: Distal End Configuration of Merci Retriever Device | Image: Distal End Configuration of Trevo Retriever Device |
| Anatomical Sites | Neurovasculature | Same as cleared device |
| Target Population | Patients with symptoms of an ischemic stroke | Same as cleared device |
| Single/Multiple Use | Single Use | Same as cleared device |
| Materials | ||
| Core Wire Material | Nitinol (nickel titanium alloy) | Same as cleared device |
| Distal Shaped Section Material | Nitinol | Same as cleared device |
| Coil Material Distal to Distal Shaped Section | Platinum/Tungsten | Same as cleared device |
| Coil Material Proximal to Shaped Section | 304 Stainless Steel | Same as cleared device |
| Solder | Gold/Tin | Same as cleared device |
| Nominal Design Attributes | ||
| Proximal Core Wire Diameter | 0.0137" | 0.0180" |
| Shaped Section Diameter (nominal) | Variable along length ranging from 3mm-1.5mm | 4 mm |
| Shaped Section Length (nominal) | 7 mm | 20 mm |
| Distal Tip Length (nominal) | 7 mm | 4 mm |
| Accessory Devices | ||
| Provided (not in direct | ||
| contact with patient) | Insertion tool and torque device provided | |
| in product package | Same as cleared device | |
| Packaging | ||
| Materials and | ||
| Configuration | Polyethylene Hoop, polycarbonate | |
| mounting card, Tyvek/Film Pouch, MDPE | ||
| Tubing Clips, Chipboard carton | ||
| Image: packaging | Same as cleared device | |
| Sterilization Method | 100% EtO | Same as cleared device |
| How Supplied | Sterile/Single Use | Same as cleared device |
2
Testing Summary
Bench Testing
The results of verification and validation conducted on the Trevo Retriever demonstrate that it performs as designed, is suitable for its intended use and is substantially equivalent to the predicate device. Specifically, the following tests were performed on the proposed device:
- Simulated Use Testing: the device's ability to be used in a neurovascular model per . procedural instructions outlined in the Instructions for Use was successfully evaluated.
- Tensile Testing: the device's mechanical integrity under tensile loads was successfully . evaluated.
- Radial Force Testing: the resulting radial force when the device is constrained radially 0 was successfully evaluated.
- . Tip Deflection Force Testing: the force to deflect the distal tip of the device was successfully evaluated.
- 0 Torque/Tensile Durability: the ability of the device to withstand torque and tensile load cycles without fracture was successfully evaluated.
- Kink Resistance: the ability of the device shaft to resist kinking was successfully . evaluated.
- Device safety (vessel response) was successfully evaluated in an animal model .
Clinical Testing
To demonstrate substantial equivalence, a randomized, multi-center, prospectively controlled IDE clinical trial (TREVO 2) was conducted comparing the efficacy of the subject Trevo Retriever to the predicate Merci Retriever for removing occlusive thrombi in patients experiencing an ischemic stroke.
3
A total of 178 patients were randomized, 88 to treatment with the Trevo device and 90 to the Merci device. On review by the Core Lab, 81 subjects randomized to Trevo and 82 subjects randomized to Merci met all angiographic entry criteria. An attempt to treat with the device was made in 79 Trevo and 81 Merci subjects. The population for analysis of the primary effectiveness and safety endpoints includes these 160 subjects were treated with the device to which they were randomized. There were no subjects with missing endpoint data. Statistical Analysis
Analysis of the primary efficacy endpoint (successful revascularization of the target occlusion, using the TICI score as the metric) was performed using a one-sided test per Blackwelder's formulation of the primary efficacy non-inferiority hypothesis at the 0.025 level of significance. The primary safety endpoint of the study was the incidence of procedure-related serious adverse events (PRSAEs) through 24 hours post procedure. These events were adjudicated by an independent clinical events committee per protocol. There was no statistical hypothesis related to the primary safety endpoint.
Study Procedures
Diagnostic angiographic data was obtained at baseline (prior to patient randomization), again at the conclusion of revascularization attempts with the assigned study device, and post procedure. 24-hour post-procedure follow-up included CT or MR imaging and NIHSS examination. Follow-up at day 7-10 (or discharge if earlier) and at day 90 (+/-14 days) included NIHSS exam and modified Rankin Scale (mRS).
Inclusion Criteria
- Patient presenting with clinical signs and symptoms consistent with a diagnosis of Acute . Ischemic Stroke, and:
- o a. Patient has failed IV t-PA therapy
- Or
- b. Patient is contraindicated for IV t-PA administration o
- o a. Patient has failed IV t-PA therapy
- Age 18-85 (has had 18th birthday, but not yet had 86th birthday) ●
- . NIHSS 8 8 400 mg / dL (22.20 mmol)
- . Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR > 3.0
- Treated with Heparin within 48 hours with a PTT greater than 2 times the lab normal .
- Baseline platelet count 185 mm Hg or DBP>110 mm Hg) .
KIZOq
4
NOTE: If the blood pressure can be successfully reduced and maintained at the acceptable level using medication, the patient can be enrolled
- . Pregnancy
- Patient participating in another investigational drug or device study .
- CT showing hypodensity or MR showing hyperintensity involving greater than 1/3 of the ● MCA territory. For non-MCA strokes, CT showing hypodensity or MR showing hyperintensity involving > 100cc of tissue.
- . Baseline CT/MR evidence of significant mass effect with midline shift
- . Baseline CT evidence of hemorrhage
- . Baseline CT/MR evidence of intracranial tumor (except small meningioma)
- . Angiographic evidence of vasculitis or arterial dissection
- . Stenosis in a proximal vessel that requires treatment or that prevents access to the thrombus with the assigned study device
- � Angiographic evidence of excessive arterial tortuosity that would preclude the assigned study device from reaching the thrombus
- . Bilateral stroke
| Reason for Exclusion | Number of
Subjects |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|
| Angiographic evidence of vasculitis or arterial dissection | 0 |
| Angiographic evidence of excessive arterial tortuosity that would
preclude the assigned study device from reaching the thrombus | 1 |
| Vessel too small | 1 |
| No angiographic evidence of a persistent large vessel occlusion in the
internal carotid, middle cerebral (M1 and/or M2 segments), basilar
and/or vertebral arteries | 26* |
| CT showing hypodensity or MR showing hyperintensity involving
greater than 1/3 of the MCA territory (discovery concurrent with
angiography) | 1 |
| Stenosis in a proximal vessel that requires treatment or that prevents
access to the thrombus with the assigned study device | 3* |
Table 2: Summary of Reasons for Frelusion during Angiographic Screening
*1 subject had 2 exclusion criteria
Primary Efficacy Endpoint
Primary Efficacy was assessed by the independent Core Lab. Revascularization as measured by TICI was determined for each subject following the use of the assigned study device. Use of any IA lytic or treatment of a proximal carotid stenosis was automatically counted as a revascularization failure regardless of the subjects's revascularization status after use of the device (Table 3a). In an additional analysis, subjects were counted as revascularization failures if any adjunctive therapy was used at the site of an occlusion regardless of revascularization status after the use of the assigned study device (Table 3b). Subjects with a baseline TICI 2a by Core Lab and subjects in whom the device was never attempted were excluded from both analyses. The test for non-inferiority is highly significant and establishes that the Trevo Retriever is non-inferior and substantially equivalent to the Merci Retriever.
5
| Lab), With Study Device Attempted, Any IA lytic Considered as Treatment Failure | ||||
|---|---|---|---|---|
| Primary Effectiveness | ||||
| Endpoint | Trevo (N=79) | |||
| % (n/N) | ||||
| [95% CI]a | Merci (N=81) | |||
| % (n/N) | ||||
| [95% CI]a | Difference | |||
| [95% CI]b | p-value | |||
| Post-Device Revascularization | ||||
| Success (TICI ≥2a) | 87.3% (69/79) | |||
| [78.0%, 93.8%] | 58.0% (47/81) | |||
| [46.5%, 68.9%] | 29.3% | |||
| [15.0%, 42.4%] | AUG 3 2012 |
Concentric Medical, Inc. c/o Ms. Kirsten Valley Vice President, Technology & Regulatory Affairs 301 East Evelyn Avenue Mountain View, CA 94041
Re: K120961
Trade/Device Name: Trevo Retriever Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: July 30, 2012 Received: July 31, 2012
Dear Ms. Valley:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
10
Page 2 - Ms. Kirsten Valley
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
-Malvina B. Evdelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
11
Indications for Use
510(k) Number (if known):
Device Name: Trevo Retriever
Indications for Use:
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-tPA) or who fail IV-tPA therapy are candidates for treatment.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
JOE HVTTER
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
KI20961
510(k) Number.