Who is the manufacturer of SOLITAIRE FR REVASCULARIZATION DEVICE?

Micro Therapeutics Dba Ev3 Neurovascular filed the 510(k) submission for SOLITAIRE FR REVASCULARIZATION DEVICE (K113455).

What is the FDA product code for SOLITAIRE FR REVASCULARIZATION DEVICE?

NRY. It is classified under 21 CFR 870.1250 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for SOLITAIRE FR REVASCULARIZATION DEVICE?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like SOLITAIRE FR REVASCULARIZATION DEVICE?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

SOLITAIRE FR REVASCULARIZATION DEVICE

Q: What are the predicate devices for SOLITAIRE FR REVASCULARIZATION DEVICE?

Merci Retrievers (K062046, K063774, K070521, K071172, K081305, K082034, K090085).

K113455 · Micro Therapeutics Dba Ev3 Neurovascular · NRY · Mar 2, 2012 · Cardiovascular

Device Facts

Record ID	K113455
Device Name	SOLITAIRE FR REVASCULARIZATION DEVICE
Applicant	Micro Therapeutics Dba Ev3 Neurovascular
Product Code	NRY · Cardiovascular
Decision Date	Mar 2, 2012
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1250
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Solitaire™ FR Revascularization Device is intended to restore blood flow by removing thrombus from a large intracranial vessel 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.

Device Story

Solitaire FR is a nitinol self-expanding, stent-based revascularization device designed for mechanical thrombectomy in large intracranial vessels. It is used in interventional neuroradiology suites by trained physicians. The device is delivered via catheter to the site of occlusion; upon deployment, the stent-like structure engages the thrombus, allowing for retrieval and restoration of blood flow. It features Pt-Ir radiopaque markers for fluoroscopic visualization. The device is single-use and sterile. By removing the clot, it aims to improve neurological outcomes in acute ischemic stroke patients who are ineligible for or failed IV t-PA therapy. Clinical benefit is demonstrated by higher recanalization rates and improved neurological outcomes compared to traditional coil-based retrievers.

Clinical Evidence

Evidence from the SWIFT multi-center, randomized, prospective controlled trial (n=144). Primary endpoint: successful recanalization (TIMI 2/3) without symptomatic intracranial hemorrhage. Solitaire FR success rate 60.7% vs. Merci 24.1% (p<0.0001). Secondary outcomes: Solitaire FR showed faster recanalization (47.0 vs 58.7 min, p=0.0376), higher good neurological outcomes at 90 days (58.2% vs 33.3%), and lower mortality (17.2% vs 38.2%). Safety profile was favorable with fewer device/procedure-related SAEs.

Technological Characteristics

Nitinol self-expanding stent-based design; 90% Platinum/10% Iridium distal marker coils; stainless steel wire with Parylene coating; PTFE push wire shrink tubing; Dymax adhesive. Sensing/visualization via radiopaque markers. Single-use, sterile. Mechanical actuation principle. No software or electronic components.

Indications for Use

Indicated for patients aged 22-85 experiencing acute ischemic stroke with NIHSS >8 and <30, having TIMI 0 or 1 flow in M1/M2 segments of MCA, ICA, basilar, or vertebral arteries, treatable within 8 hours of symptom onset. Contraindicated for patients with NIHSS ≥30, coma, rapidly improving symptoms, pregnancy, contrast sensitivity, uncontrolled hypertension, warfarin use (INR >3.0), platelet count <30,000, glucose <50 mg/dL, severe arterial tortuosity, life expectancy <90 days, or specific imaging findings (hemorrhage, large infarcts, mass effect, or carotid dissection).

Regulatory Classification

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.

Predicate Devices

Merci Retrievers (K062046, K063774, K070521, K071172, K081305, K082034, K090085)

Related Devices

K161879 — Solitaire Platinum Revascularization Device · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · Sep 21, 2016
K203358 — Solitaire X Revascularization Device · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · Mar 1, 2021
K153071 — Solitaire Platinum Revascularization Device · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · Dec 23, 2015
K183022 — Solitaire 4 Revascularization Device · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · Jan 29, 2019
K141491 — SOLITAIRE 2 REVASCULARIZATION DEVICE · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · Oct 22, 2014

Submission Summary (Full Text)

{0}------------------------------------------------ # MAR - 2 2017 <113455 27 February 2012 ## 510(k) Summary 510(k) Owner: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular 9775 Toledo Way Irvine, CA 92618 Establishment Registration No. 2029214 Contact Person: Laura Heaton Senior Manager Regulatory Affairs Telephone: (949) 680-1241 E-mail: Theaton@ev3.net Date Summary Prepared: 27 February 2012 Trade Name of Device: Solitaire™ FR Revascularization Device Common Name of Device: Catheter, Thrombus Retriever Classification of Device: 21 CFR 870.1250 - Class II #### Predicate Device: Merci® Retrievers (K062046, K063774, K070521, K071172, K081305, K082034, K090085) #### Device Description: The Solitaire™ FR Revascularization Device is intended to restore blood flow by removing thrombus from a large intracranial vessel 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 device is intended for use in the neurovasculature such as the internal carotid artery, M1 and M2 segments of the middle cerebral artery, basilar, and the vertebral arteries. The device is a nitinol self-expanding, fully retrievable, stent-based design that allows for clot retrieval when deployed in occluded target vessels after acute ischemic stroke. The distal nitinol portion of the device facilitates clot retrieval and has Pt-Ir radiopaque markers for visualization on the proximal and distal ends. The device is supplied sterile and is intended for single-use only by physicians trained in interventional neuroradiology and treatment of ischemic stroke. {1}------------------------------------------------ ## Intended Use: The Solitaire™ FR Revascularization Device is intended to restore blood flow by removing thrombus from a large intracranial vessel 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. ## Comparison of Technological Characteristics to Predicate Device The Solitaire FR device is substantially equivalent to the Merci Retriever based on the successful completion of non-clinical bench and animal testing, clinical testing, and similar principles of operation and indications for use. | | Merci Retriever | Solitaire FR | |--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indication for Use | The Merci Retriever is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke. Patients who are ineligible for treatment with intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment. The Merci Retriever is also indicated for use in the retrieval of foreign bodies misplaced during interventional radiological procedures in the neuro, peripheral and coronary vasculature. | The Solitaire™ FR Revascularization Device is intended to restore blood flow by removing thrombus from a large intracranial vessel 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. | | Materials | Nitinol core wire Platinum distal coil Polymer filaments Hydrophilic coating | Nitinol device and push wire 90% Platinum/ 10% Iridium distal marker coils Stainless steel wire, Parylene coated Dymax adhesive PTFE push wire shrink tubing PTFE/Grilamid introducer sheath | | Bench Testing | Overall rate of successful clot retrieval was 80% in an in vitro tortuous anatomical model. | Overall rate of successful clot retrieval was 96.2% in an in vitro tortuous anatomical model. | | Acute Animal study | Successful clot retrieval was 66.7% (4/6). Arterial histological response was substantially equivalent to the Solitaire devices. | Successful clot retrieval was 100% (6/6). Arterial histological response was substantially equivalent to the Merci devices. | | Chronic Animal Study | Acute results: Successful clot retrieval was 66.7% (4/6) and recanalization was 83.3% (5/6). Chronic results: Successful clot retrieval was 100% (8/8); recanalization after chronic period was 50% (4/8). Arterial histological response was substantially equivalent to the Solitaire devices. | Acute results: Successful clot retrieval and recanalization was 100% (6/6). Chronic results: Successful clot retrieval was 87.5% (7/8); recanalization after chronic period was 75% (6/8). Arterial histological response was substantially equivalent to the Merci devices. | | Clinical trial SWIFT (G090082) | Merci group success rate for the primary effectiveness endpoint = 24.1% (13/54) | Solitaire group success rate for the primary effectiveness endpoint = 60.7% (34/56) | {2}------------------------------------------------ ## Preclinical Performance Data: Non-clinical bench and animal testing as well as a multi-center, randomized, prospectively controlled clinical trial comparing the performance of Solitaire FR to the Merci Retriever were performed. The Solitaire FR devices met test specifications and the non-inferior outcome measures of the clinical protocol. ' | Test | Results | Conclusion | |--------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------| | L929 MEM Elution Test - ISO | Grade 0 reactivity observed 48 hours post exposure to test article extract | Non-cytotoxic | | L929 MTT Cytotoxicity Test (1 concentration) – ISO | Test article viability = 83% | Non-cytotoxic | | Kligman Maximization Test - ISO | 0% (Grade 1), weak allergenic potential | Non-sensitizer | | Intracutaneous Injection Test - ISO | Difference of overall mean score between test article and control was 0.0 | Non-irritant | | Systemic Injection Test - ISO | No animals injected with test article showed significantly greater biological reaction than animals treated with control | Not systemically toxic | | Rabbit Pyrogen Test (Material Mediated) - ISO | Temperature increases for test animals were 0.0, 0.0, and 0.0ºC. Control = 0.0ºC | Non-pyrogenic | | 90-Day Systemic Toxicity in Rats via Subcutaneous Implantation | Bioreactivity rating at 90 days = 0.7 | Not locally or systemically toxic | | Intramuscular Implantation Test - ISO 4 week Implantation | Bioreactivity rating at 4 weeks = 2.1 | Non-reactive | | Intramuscular Implantation Test - ISO 13 week Implantation | Bioreactivity rating at 13 weeks = 0.0 | Non-reactive | | Salmonella Typhimurium and Escherichia Coli Reverse Mutation Assay - ISO | A statistically significant increase was not observed with test articles as compared to controls | Non-mutagenic | | In Vitro Mouse Lymphoma Assay with Extended Treatment | Non-mutagenic; acceptable negative and positive controls results for CE and MF | Non-mutagenic | | Rodent Bone Marrow Micronucleus Assay (90 Animals) - ISO | Non-clastogenic; no statistically significant increase (p ≥ 0.05) | Non-clastogenic | | Unactivated Partial Thromboplastin Time Assay - ISO Indirect Contact | UPTT of plasma exposed to test article was not significantly decreased when compared to controls | No adverse effect on clotting time of human plasma | | Prothrombin Time Assay - ISO Indirect Contact | Difference < 1 sec | No adverse effect on prothrombin coagulation time of human plasma | | Hemolysis - Rabbit Blood - ASTM Indirect Contact | Test article = 0.0% hemolysis | Non-hemolytic | | Test | Results | Conclusion | | In Vitro Hemocompatibility Assay - ISO Indirect Contact | Test article had no adverse effects on any hematological parameters tested (complete blood count, hematocrit, erythrocyte indices, and platelet count) | No adverse effects on hematological parameters of human blood | | In-Vivo Thrombogenicity Assay (Dog) | Vessel Patency ≤ 1 Thrombus ≤ 1 Pulmonary Thromboembolism = 0 | The Solitaire FR test devices have similar thromboresistance characteristics as the control devices (Merci) | | Complement Activation C3a | Solitaire 1.7% as compared to activation by positive control Merci 1.7% as compared to activation by positive control | The level of C3a complement activation induced by Solitaire FR was similar to the control device (Merci) | | Complement Activation SC5b-9 | Solitaire 0.0% as compared to activation by positive control Merci 0.2% as compared to activation by positive control | The level of SC5b-9 complement activation induced by Solitaire FR was similar to the control device (Merci) | | Total Length | N = 62; all devices within specification | Pass | | Delivery Force | N = 61; all devices below peak force specification | Pass | | Re-sheathing Force | N = 61; all devices below peak force specification | Pass | | Durability | N = 60; all devices completed delivery, deployment and recovery without any observations | Pass | | Af Temperature | N = 23; all devices within Af temperature specification | Pass | | Kink Resistance | N = 62; all devices deployed to intended location and resisted kinking | Pass | | System Tensile Strength | N = 30; all devices above tensile strength specification | Pass | | Markercoil Tensile Strength | N = 123; all devices above tensile strength specification | Pass | | Torque Response | N = 60; all devices within torque response specification | Pass | | Torque Strength | N = 60; all devices within torque strength specification | Pass | | Radial Force | N = 67; all devices within radial force specification | Pass | | Radiopacity | N = 2; all markerbands visualized effectively with tissue and bone simulation | Pass | {3}------------------------------------------------ : · ・ . . . : . . ・ : ・ : . : {4}------------------------------------------------ ## Clinical Performance Data Study Design: The SWIFT (Solitaire™ FR with the Intention for Thrombectomy) Study is a multi-center. IDE, randomized, prospectively controlled Study comparing the performance of the Solitaire™ FR Revascularization Device with a commercially available Merci® Retriever. Randomization to the Solitaire FR arm or Merci arm occurred on a 1:1 basis. Assessments for the primary efficacy endpoint were done post procedure and subjects were followed for up to 90 days (±15days) for neurological outcomes and safety assessments. ## Sample Size: A total of 144 Subjects contributed to the ITT (intention-to-treat) population of which 31 (21.5%) were Solitaire FR roll-in (non-randomized). 58 (40.3%) were randomized to Solitaire FR and 55 (38.2%) were randomized to Merci. Comparative analyses for the purpose of study endpoints were based solely upon the ITT randomized study population. ### Statistical Analysis: All subjects who were consented and randomized were included in the ITT population. The ITT population included all subjects with data for a given endpoint; results were assessed according to randomized assignment regardless of the treatment actually received. The per-protocol (PP) population excluded those subjects who failed to meet all inclusion criteria or who did not receive treatment with the randomly assigned device. The primary efficacy analysis (successful recanalization measured by TIMI flow without symptomatic hemorrhage) was performed using a one-sided test under Blackwelder's method of testing non-inferiority at the 0.025 level of significance. The primary safety endpoint of device- and/or procedure-related Serious Adverse Events (SAEs) was evaluated descriptively. Additional analyses included subgroup and interim analyses. Subgroup analyses, based on the vessel site treated and baseline NIHSS, were performed to assess homogeneity of the primary efficacy endpoint. An interim analysis was performed, after enrolling 144 roll-in and randomized subjects, to obtain a statistical look for efficacy and forms the basis for this report. #### Study Procedures: Angiographic data obtained during the study included a baseline angiogram (prior to device deployment). A post study device use angiogram was conducted immediately after completion of study device use, i.e. after achievement of TIMI 2 or 3 reperfusion or 3 passes of the study arm device without recanalization. If any rescue therapy was employed, a final post all procedures angiogram was done. Post study device use angiographic data was used to assess the primary endpoint by the Core Lab (blinded to treatment assignment). Follow up evaluations included a 24 hours) follow-up visit that included an NIHSS examination and CT or MRI imaging. Subsequent follow-up visits occurred at 7-10 days (or discharge if earlier), 30 days (±15days), and 90 days (±15days) in which the modified Rankin Scale (mRS) assessing global disability, the Barthel Index assessing instrumental activities of daily living, and the NIHSS exam assessing neurologic deficit were performed. #### Inclusion Criteria: - Subject or subject's legally authorized representative has signed and dated an Informed Consent Form . - Age 22 85 . - Clinical signs consistent with acute ischemic stroke . - NIHSS > 8 and < 30 . - Thrombolysis in Myocardial Infarction (TIMI) 0 or TIMI 1 flow in the M1 or M2 of MCA, ICA, . basilar or vertebral arteries confirmed by angiography that is accessible to the Solitaire FR or Merci Device {5}------------------------------------------------ - . Subject is able to be treated within 8 hours of stroke symptoms onset with minimum of one deployment of the Solitaire FR or Merci Device. - . Subiect who is ineligible or failed intravenous tissue plasminogen activator (1-PA) therapy given at local institutions or within national practice. (Note: Failed IV t-PA is defined as subjects with occlusion present 61 minutes or more after start of IV therapy.) - . Subject is willing to conduct follow-up visits. ## Exclusion Criteria: - NIHSS ≥ 30 or coma . - . Neurological signs that are rapidly improving prior to or at time of treatment - Females who are pregnant or lactating . - Known serious sensitivity to radiographic contrast agents . - Current participation in another investigation drug or device study . - . Uncontrolled hypertension defined as systolic blood pressure > 185 or diastolic blood pressure > 110 that cannot be controlled except with continuous parenteral antihypertensive medication - . Use of warfarin anticoagulation with INR > 3.0 - Platelet count < 30,000 . - Glucose < 50 mg/dL - Arterial tortuosity that would prevent the device from reaching the target vessel � - . Life expectancy of less than 90 days - Additionally, subjects were also considered ineligible for study participation if they met any of the . following imaging exclusion criteria - CT or MRI evidence of hemorrhage on presentation . - CT showing hypodensity or MR showing hyperintensity involving greater than 1/3 of the middle ● cerebral artery (MCA) territory (or in other territories, >100 cc of tissue) on presentation - . CT or MRI evidence of mass effect or intracranial tumor (except small meningioma) - Angiographic evidence of carotid dissection, complete cervical carotid occlusions, or vasculitis i {6}------------------------------------------------ | Reason for Screen Failure | Occurrence | |---------------------------------------------------------|------------| | Angiographic | 91 | | No occlusion on angiogram | 35 | | Complete cervical carotid occlusion | 28 | | Occlusion located in ineligible vessel | 16 | | Vessel tortuosity | 7 | | Vessel dissection | 5 | | Clinical | 234 | | NIHSS does not qualify for study | 81 | | Age | 38 | | Neurological signs improvement | 34 | | Stroke onset time unknown | 29 | | Time from stroke onset exceed 8 hrs | 23 | | Exclusion criteria not documented | 11 | | Unable to consent | 11 | | No intervention per physician | 2 | | INR exceed required limit | 2 | | Uncontrolled hypertension | 1 | | Subject presented comatose | 1 | | Pre-existing condition, tumor | 1 | | Imaging | 55 | | CT/MRI showing infarct | 23 | | Hemorrhage present at baseline | 22 | | Imaging exclusion specific not listed | 5 | | Infarct involving greater than 1/3 of the MCA territory | 4 | | No mismatch on MRI | 1 | | Other | 11 | | Total | 391 | ### Primary Safety and Efficacy Outcomes: Analysis of the primary efficacy endpoint showed statistically significant evidence that Solitaire FR was non-inferior to the Merci device in the arterial recanalization of occluded target vessels without any presence of symptomatic intracranial hemorthage. The Solitaire FR group success rate was 60.7% (34/56) compared to 24.1% (13/54) for the Merci group. The criterior for non-inferiority was met with an associated p<0.0001. . ### Key Secondary Outcomes: - Time to achieve initial recanalization: A statistically significant difference between the two devices . was observed (Solitaire FR 47.0 minutes vs. Merci 58.7 minutes), p=0.0376. - Assessment of neurological outcomes at Day 30 and Day 90: . - At day 30, GNO (good neurological outcome) with Solitaire FR (50.9%) was higher than o Merci (33.3%). - At day 90, GNO with Solitaire FR (58.2%) was higher than Merci (33.3%). 0 {7}------------------------------------------------ - The overall mortality rate for the subjects randomized to Merci was 38.2%, which was higher o than the mortality rate for the subjects randomized to Solitaire FR, 17.2%. The mortality profile of the roll-in Solitaire FR subjects was similar to that of randomized Solitaire FR subjects at 16.1%. There was one device related death observed in the study attributed to the Merci device and none attributed to the Solitaire FR device. - The rate of symptomatic intracranial hemorrhage was 10.9% in the Merci group and 1.7% in o the Solitaire FR group and the rate of all intracranial hemorrhage was 38.2% in the Merci group and 17.2% in the Solitaire FR group. ## Important Safety Results: The nominal overall device- and/or procedure-related serious adverse event rate for Solitaire FR subjects was observed to be lower than for Merci subjects (22.4% vs. 40.0%). This pattern persisted in devicerelated events only, while the event rate point estimates for procedure-related events were comparable between randomized groups. | Adverse Events occurring at an incidence of 5% or more in any group in the SWIFT Trial | | | | | | |----------------------------------------------------------------------------------------|---------------------------------------------|---------------------------------------|------------------------------------------------------|-----------------------|-------------------| | MedDRA Preferred Term | Roll-in (all SOLITAIRE™ FR device) | Randomized SOLITAIRE™ FR device | Randomized Concentric Medical MERCI™ device | All Enrolled | Rand. p- value | | Units | % (pts/N) [AEs] | % (pts/N) [AEs] | % (pts/N) [AEs] | % (pts/N) [AEs] | | | TOTAL Adverse Events (AE) | 83.9% (26/31) [115] | 94.8% (55/58) [267] | 92.7% (51/55) [262] | 91.7% (132/144) [644] | 0.430 | | Blood and Lymphatic System Disorders | 22.6% (7/31) [8] | 24.1% (14/58) [17] | 16.4% (9/55) [9] | 20.8% (30/144) [34] | 0.355 | | Anaemia | 19.4% (6/31) [6] | 20.7% (12/58) [13] | 12.7% (7/55) [7] | 17.4% (25/144) [26] | 0.318 | | Thrombocytopenia | 3.2% (1/31) [1] | 6.9% (4/58) [4] | 1.8% (1/55) [1] | 4.2% (6/144) [6] | 0.365 | | Cardiac Disorders | 22.6% (7/31) [7] | 39.7% (23/58) [28] | 32.7% (18/55) [22] | 33.3% (48/144) [57] | 0.557 | | Atrial Fibrillation | 16.1% (5/31) [5] | 19.0% (11/58) [12] | 9.1% (5/55) [5] | 14.6% (21/144) [22] | 0.179 | | Bradycardia | 0.0% (0/31) [0] | 1.7% (1/58) [1] | 5.5% (3/55) [3] | 2.8% (4/144) [4] | 0.355 | | Cardiac Arrest | 0.0% (0/31) [0] | 0.0% (0/58) [0] | 5.5% (3/55) [4] | 2.1% (3/144) [4] | 0.112 | | Cardiac Failure Congestive | 3.2% (1/31) [1] | 5.2% (3/58) [3] | 3.6% (2/55) [2] | 4.2% (6/144) [6] | 1.000 | | Gastrointestinal Disorders | 16.1% (5/31) [7] | 20.7% (12/58) [16] | 21.8% (12/55) [18] | 20.1% (29/144) [41] | 1.000 | | Dysphagia | 0.0% (0/31) [0] | 5.2% (3/58) [3] | 7.3% (4/55) [4] | 4.9% (7/144) [7] | 0.712 | | Gastrointestinal Haemorrhage | 9.7% (3/31) [3] | 1.7% (1/58) [1] | 1.8% (1/55) [2] | 3.5% (5/144) [6] | 1.000 | | Nausea | 6.5% (2/31) [2] | 1.7% (1/58) [1] | 10.9% (6/55) [8] | 6.3% (9/144) [11] | 0.057 | | General Disorders and Administration Site Conditions | 9.7% (3/31) [3] | 24.1% (14/58) [15] | 16.4% (9/55) [10] | 18.1% (26/144) [28] | 0.355 | | Catheter Site Haematoma | 9.7% (3/31) [3] | 5.2% (3/58) [3] | 1.8% (1/55) [1] | 4.9% (7/144) [7] | 0.619 | | Pyrexia | 0.0% (0/31) [0] | 12.1% (7/58) [7] | 10.9% (6/55) [6] | 9.0% (13/144) [13] | 1.000 | | Adverse Events occurring at an incidence of 5% or more in any group in the SWIFT Trial | | | | | | | MedDRA Preferred Term | Roll-in (all SOLITAIRE™ FR device) | Randomized SOLITAIRE™ FR device | Randomized Concentric Medical MERCI™ device | All Enrolled | Rand. p-value | | Units | % (pts/N) [AEs] | % (pts/N) [AEs] | % (pts/N) [AEs] | % (pts/N) [AEs] | | | Infections and Infestations | 41.9% (13/31) [16] | 43.1% (25/58) [29] | 34.5% (19/55) [32] | 39.6% (57/144) [77] | 0.441 | | Pneumonia | 9.7% (3/31) [3] | 3.4% (2/58) [2] | 12.7% (7/55) [7] | 8.3% (12/144) [12] | 0.089 | | Sepsis | 0.0% (0/31) [0] | 5.2% (3/58) [3] | 3.6% (2/55) [2] | 3.5% (5/144) [5] | 1.000 | | Urinary Tract Infection | 32.3% (10/31) [10] | 25.9% (15/58) [15] | 21.8% (12/55) [13] | 25.7% (37/144) [38] | 0.664 | | Metabolism and Nutrition Disorders | 12.9% (4/31) [5] | 20.7% (12/58) [16] | 21.8% (12/55) [24] | 19.4% (28/144) [45] | 1.000 | | Electrolyte Imbalance | 0.0% (0/31) [0] | 5.2% (3/58) [3] | 3.6% (2/55) [2] | 3.5% (5/144) [5] | 1.000 | | Hyperglycaemia | 6.5% (2/31) [2] | 3.4% (2/58) [2] | 7.3% (4/55) [5] | 5.6% (8/144) [9] | 0.430 | | Hypernatraemia | 0.0% (0/31) [0] | 3.4% (2/58) [2] | 5.5% (3/55) [3] | 3.5% (5/144) [5] | 0.674 | | Hypocalcaemia | 3.2% (1/31) [1] | 3.4% (2/58) [2] | 5.5% (3/55) [3] | 4.2% (6/144) [6] | 0.674 | | Hypokalaemia | 3.2% (1/31) [1] | 0.0% (0/58) [0] | 7.3% (4/55) [5] | 3.5% (5/144) [6] | 0.053 | | Musculoskeletal and Connective Tissue Disorders | 12.9% (4/31) [5] | 13.8% (8/58) [8] | 7.3% (4/55) [4] | 11.1% (16/144) [17] | 0.363 | | Musculoskeletal Pain | 6.5% (2/31) [3] | 1.7% (1/58) [1] | 3.6% (2/55) [2] | 3.5% (5/144) [6] | 0.612 | | Nervous System Disorders | 58.1% (18/31) [30] | 55.2% (32/58) [51] | 74.5% (41/55) [70] | 63.2% (91/144) [151] | 0.048 | | Brain Oedema | 6.5% (2/31) [2] | 5.2% (3/58) [3] | 1.8% (1/55) [1] | 4.2% (6/144) [6] | 0.619 | | Cerebral Gas Embolism | 0.0% (0/31) [0] | 1.7% (1/58) [1] | 5.5% (3/55) [3] | 2.8% (4/144) [4] | 0.355 | | Cerebral Haematoma | 12.9% (4/31) [4] | 10.3% (6/58) [6] | 18.2% (10/55) [10] | 13.9% (20/144) [20] | 0.286 | | Cerebrovascular Accident | 19.4% (6/31) [6] | 12.1% (7/58) [7] | 25.5% (14/55) [14] | 18.8% (27/144) [27] | 0.091 | | Cerebrovascular Spasm | 6.5% (2/31) [2] | 5.2% (3/58) [3] | 7.3% (4/55) [4] | 6.3% (9/144) [9] | 0.712 | | Haemorrhagic Cerebral Infarction | 25.8% (8/31) [8] | 12.1% (7/58) [7] | 9.1% (5/55) [5] | 13.9% (20/144) [20] | 0.763 | | Headache | 9.7% (3/31) [3] | 10.3% (6/58) [6] | 3.6% (2/55) [2] | 7.6% (11/144) [11] | 0.273 | | Intracranial Pressure Increased | 0.0% (0/31) [0] | 6.9% (4/58) [4] | 5.5% (3/55) [3] | 4.9% (7/144) [7] | 1.000 | | Intraventricular Haemorrhage | 0.0% (0/31) [0] | 3.4% (2/58) [2] | 5.5% (3/55) [3] | 3.5% (5/144) [5] | 0.674 | | Ischaemic Stroke | 6.5% (2/31) [2] | 3.4% (2/58) [2] | 12.7% (7/55) [7] | 7.6% (11/144) [11] | 0.089 | | Adverse Events occurring at an incidence of 5% or more in any group in the SWIFT Trial | | | | | | | MedDRA Preferred Term | Roll-in (all SOLITAIRE™ FR device) | Randomized SOLITAIRE™ FR device | Randomized Concentric Medical MERCI™ device | All Enrolled | Rand. p- value | | Units | % (pts/N) [AEs] | % (pts/N) [AEs] | % (pts/N) [AEs] | % (pts/N) [AEs] | | | Subarachnoid Haemorrhage | 3.2% (1/31) [1] | 5.2% (3/58) [3] | 14.5% (8/55) [8] | 8.3% (12/144) [12] | 0.118 | | Respiratory, Thoracic and Mediastinal Disorders | 25.8% (8/31) [12] | 37.9% (22/58) [32] | 41.8% (23/55) [29] | 36.8% (53/144) [73] | 0.704 | | Atelectasis | 0.0% (0/31) [0] | 6.9% (4/58) [4] | 3.6% (2/55) [2] | 4.2% (6/144) [6] | 0.680 | | Hypoxia | 0.0% (0/31) [0] | 10.3% (6/58) [6] | 1.8% (1/55) [1] | 4.9% (7/144) [7] | 0.114 | | Pleural Effusion | 9.7% (3/31) [3] | 0.0% (0/58) [0] | 7.3% (4/55) [4] | 4.9% (7/144) [7] | 0.053 | | Pneumonia Aspiration | 3.2% (1/31) [1] | 10.3% (6/58) [6] | 5.5% (3/55) [3] | 6.9% (10/144) [10] | 0.491 | | Pulmonary Oedema | 0.0% (0/31) [0] | 5.2% (3/58) [3] | 10.9% (6/55) [6] | 6.3% (9/144) [9] | 0.313 | | Respiratory Failure | 9.7% (3/31) [3] | 8.6% (5/58) [5] | 14.5% (8/55) [8] | 11.1% (16/144) [16] | 0.385 | | Vascular Disorders | 32.3% (10/31) [11] | 27.6% (16/58) [24] | 32.7% (18/55) [21] | 30.6% (44/144) [56] | 0.682 | | Deep Vein Thrombosis | 12.9% (4/31) [4] | 5.2% (3/58) [3] | 9.1% (5/55) [5] | 8.3% (12/144) [12] | 0.482 | | Hypertension | 0.0% (0/31) [0] | 10.3% (6/58) [7] | 1.8% (1/55) [1] | 4.9% (7/144) [8] | 0.114 | | Hypotension | 9.7% (3/31) [3] | 10.3% (6/58) [7] | 10.9% (6/55) [6] | 10.4% (15/144) [16] | 1.000 | | Vasospasm | 9.7% (3/31) [3] | 5.2% (3/58) [3] | 5.5% (3/55) [3] | 6.3% (9/144) [9] | 1.000 | {8}------------------------------------------------ • . Page 9 of 10 . {9}------------------------------------------------ ## Conclusion: The data from this study demonstrate that the Solitaire FR device is non-inferior (p<0.000) to the Merci device in achieving arterial recanalization of the occluded target vessel without any presence of symptomatic intracranial hemorrhage. At 30 and 90 days, Solitaire FR had higher rates of GNO compared to Merci. Further, mortality rates and rate of intracranial hemorrhage within the Solitaire FR treated group were lower than those seen in the Merci treated group. The overall safety profile of the two devices, as measured by the rate of device-related and procedure-related SAEs, was similar between the two groups. Data from this study demonstrate that the Solitaire FR device is safe, effective, and non-inferior to Merci for arterial recanalization of occluded target vessels after acute ischemic stroke in subjects who are ineligible for or have failed IV t-PA therapy. {10}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/10/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Micro Therapeutics, Inc. d/b/a/ ev3 Neurovascular c/o Ms. Laura Heaton Senior Manager Regulatory Affairs 9775 Toledo Way Irvine, CA 92618 - 2 2012 MAR Re: K113455 Trade/Device Name: Solitaire™ FR Revascularization Device Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: NRY Dated: January 27, 2012 Received: January 30, 2012 Dear Ms. Heaton: 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. {11}------------------------------------------------ Page 2 - Ms. Laura Heaton 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/ReportalProblem/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/ResourcesforYou/Industry/default.htm. Sincerely yours, Eile. Thm, M.D. Malvina B. Eydelman/M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {12}------------------------------------------------ ## Indications for Use ## 510(k) Number (if known): K113455 Device Name: Solitaire™ FR Revascularization Device Indications for Use: The Solitaire™ FR Revascularization Device is intended to restore blood manuficults to: 030. The betware - arge intracranial vessel in patients experiencing ischemic strow by removing incomous now a wast. Patients who are ineligible for intravenous tissue Stroke willing of bythphone who fail IV t-PA therapy are candidates for treatment. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) # Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1 Jeffrey Toy (Division Sign-Off) (Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices 510(k) Number K113455