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.

AI/ML Overview

Here's a summary of the acceptance criteria and study findings for the Solitaire™ FR Revascularization Device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the non-inferiority study design comparing the Solitaire FR device to the predicate Merci Retriever.

Metric (Implied Acceptance Criterion)	Predicate Device (Merci Retriever) Performance	Solitaire™ FR Device Performance	Conclusion (Does it meet acceptance criteria?)
Primary Effectiveness Endpoint: Successful recanalization measured by TIMI flow without symptomatic hemorrhage (non-inferiority to Merci)	24.1% (13/54)	60.7% (34/56)	Yes, met non-inferiority (p<0.0001)
Primary Safety Endpoint: Device- and/or procedure-related Serious Adverse Events (SAEs) (implied to be comparable or better than Merci)	40.0%	22.4%	Yes, observed to be lower and overall safety profile "similar"
Mortality Rate (implied to be comparable or better than Merci)	38.2%	17.2%	Yes, lower than Merci
Rate of Symptomatic Intracranial Hemorrhage (implied to be comparable or better than Merci)	10.9%	1.7%	Yes, lower than Merci
Rate of All Intracranial Hemorrhage (implied to be comparable or better than Merci)	38.2%	17.2%	Yes, lower than Merci
Time to achieve initial recanalization (implied to be comparable or better than Merci)	58.7 minutes	47.0 minutes	Yes, statistically significant difference (p=0.0376, faster)
Good Neurological Outcome (GNO) at Day 30 (implied to be comparable or better than Merci)	33.3%	50.9%	Yes, higher than Merci
Good Neurological Outcome (GNO) at Day 90 (implied to be comparable or better than Merci)	33.3%	58.2%	Yes, higher than Merci

Note: The document specifies non-inferiority for the primary effectiveness endpoint. For safety and secondary outcomes, the "acceptance criteria" are implied by the comparative study demonstrating comparable or superior performance to the predicate device.

Bench Testing - In Vitro Clot Retrieval

Metric	Predicate Device (Merci Retriever) Performance	Solitaire™ FR Device Performance	Conclusion (Does it meet acceptance criteria?)
Successful clot retrieval	80%	96.2%	Yes, higher than Merci

2. Sample Size Used for the Test Set and Data Provenance

Sample Size (Clinical Trial - ITT randomized population):
- Solitaire FR arm: 58 subjects
- Merci arm: 55 subjects
- Total ITT randomized population: 113 subjects (The total ITT population including roll-in subjects was 144, but comparative analyses were based solely on the randomized population).
Data Provenance: The study was a "multi-center, IDE, randomized, prospectively controlled Study" (SWIFT trial). The specific countries of origin are not mentioned, but "multi-center" implies data from multiple clinical sites.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document states: "Post study device use angiographic data was used to assess the primary endpoint by the Core Lab (blinded to treatment assignment)."

Number of experts: Not specified (refers to a "Core Lab").
Qualifications of experts: Not specified, but a "Core Lab" typically implies a team of qualified medical professionals specializing in interpreting such data (e.g., neuroradiologists).

4. Adjudication Method for the Test Set

The document does not explicitly state an adjudication method for disagreements among experts, if multiple experts were involved in the Core Lab. It only mentions that the Core Lab was "blinded to treatment assignment" for primary endpoint assessment.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No, an MRMC comparative effectiveness study involving AI assistance for human readers was not done. This study compares two medical devices (Solitaire FR vs. Merci Retriever) for stroke treatment, not the performance of human readers with or without AI.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, this device is a physical medical device (thrombus retriever), not an AI algorithm. Therefore, a standalone algorithm performance study is not applicable. The device's performance is measured directly in clinical use.

7. The Type of Ground Truth Used

Clinical Outcomes/Composite Endpoint: The primary effectiveness endpoint was "successful recanalization measured by TIMI flow without symptomatic hemorrhage." This is a composite clinical outcome determined by post-procedure angiography (TIMI flow) and clinical assessment for symptomatic hemorrhage.
Expert Angiographic Review: Post-study device use angiographic data was assessed by a Core Lab (blinded to treatment assignment) to determine the TIMI flow.
Clinical Assessment: Neurological outcomes (mRS, Barthel Index, NIHSS), mortality, and adverse events were assessed by clinical personnel during follow-up visits.

8. The Sample Size for the Training Set

This device is a physical medical device and its performance was evaluated through preclinical and clinical studies, not through AI model training. Therefore, there is no "training set" in the context of an AI algorithm. The "roll-in" Solitaire FR subjects (31 subjects) in the clinical trial were not randomized and likely served to familiarize sites with the device and procedures, but not as an AI training set.

9. How the Ground Truth for the Training Set Was Established

As explained in point 8, there is no AI training set for this physical medical device.

Summary

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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:

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Intended Use:

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 torestore blood flow in theneurovasculature by removing thrombusin patients experiencing ischemic stroke.Patients who are ineligible for treatmentwith intravenous tissue plasminogenactivator (IV t-PA) or who fail IV t-PAtherapy are candidates for treatment. TheMerci Retriever is also indicated for usein the retrieval of foreign bodiesmisplaced during interventionalradiological procedures in the neuro,peripheral and coronary vasculature.	The Solitaire™ FR RevascularizationDevice is intended to restore blood flowby removing thrombus from a largeintracranial vessel in patientsexperiencing ischemic stroke within 8hours of symptom onset. Patients whoare ineligible for intravenous tissueplasminogen activator (IV t-PA) or whofail IV t-PA therapy are candidates fortreatment.
Materials	Nitinol core wirePlatinum distal coilPolymer filamentsHydrophilic coating	Nitinol device and push wire90% Platinum/ 10% Iridium distalmarker coilsStainless steel wire, Parylene coatedDymax adhesivePTFE push wire shrink tubingPTFE/Grilamid introducer sheath
Bench Testing	Overall rate of successful clot retrievalwas 80% in an in vitro tortuousanatomical model.	Overall rate of successful clot retrievalwas 96.2% in an in vitro tortuousanatomical model.
Acute Animalstudy	Successful clot retrieval was 66.7% (4/6).Arterial histological response wassubstantially equivalent to the Solitairedevices.	Successful clot retrieval was 100% (6/6).Arterial histological response wassubstantially equivalent to the Mercidevices.
Chronic AnimalStudy	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 was50% (4/8).Arterial histological response wassubstantially equivalent to the Solitairedevices.	Acute results:Successful clot retrieval andrecanalization was 100% (6/6).Chronic results:Successful clot retrieval was 87.5%(7/8); recanalization after chronic periodwas 75% (6/8).Arterial histological response wassubstantially equivalent to the Mercidevices.
Clinical trialSWIFT(G090082)	Merci group success rate for the primaryeffectiveness endpoint = 24.1% (13/54)	Solitaire group success rate for theprimary effectiveness endpoint = 60.7%(34/56)

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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 postexposure 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 testarticle and control was 0.0	Non-irritant
Systemic Injection Test - ISO	No animals injected with test article showedsignificantly greater biological reaction thananimals treated with control	Not systemicallytoxic
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 inRats via SubcutaneousImplantation	Bioreactivity rating at 90 days = 0.7	Not locally orsystemically toxic
Intramuscular ImplantationTest - ISO 4 weekImplantation	Bioreactivity rating at 4 weeks = 2.1	Non-reactive
Intramuscular ImplantationTest - ISO 13 weekImplantation	Bioreactivity rating at 13 weeks = 0.0	Non-reactive
Salmonella Typhimurium andEscherichia Coli ReverseMutation Assay - ISO	A statistically significant increase was notobserved with test articles as compared tocontrols	Non-mutagenic
In Vitro Mouse LymphomaAssay with ExtendedTreatment	Non-mutagenic; acceptable negative and positivecontrols results for CE and MF	Non-mutagenic
Rodent Bone MarrowMicronucleus Assay (90Animals) - ISO	Non-clastogenic; no statistically significantincrease (p ≥ 0.05)	Non-clastogenic
Unactivated PartialThromboplastin Time Assay- ISO Indirect Contact	UPTT of plasma exposed to test article was notsignificantly decreased when compared tocontrols	No adverse effect onclotting time ofhuman plasma
Prothrombin Time Assay -ISO Indirect Contact	Difference < 1 sec	No adverse effect onprothrombincoagulation time ofhuman plasma
Hemolysis - Rabbit Blood -ASTM Indirect Contact	Test article = 0.0% hemolysis	Non-hemolytic
Test	Results	Conclusion
In Vitro HemocompatibilityAssay - ISO Indirect Contact	Test article had no adverse effects on anyhematological parameters tested (complete bloodcount, hematocrit, erythrocyte indices, andplatelet count)	No adverse effects onhematologicalparameters of humanblood
In-Vivo ThrombogenicityAssay (Dog)	Vessel Patency ≤ 1Thrombus ≤ 1Pulmonary Thromboembolism = 0	The Solitaire FR testdevices have similarthromboresistancecharacteristics as thecontrol devices(Merci)
Complement Activation C3a	Solitaire 1.7% as compared to activation bypositive controlMerci 1.7% as compared to activation by positivecontrol	The level of C3acomplementactivation induced bySolitaire FR wassimilar to the controldevice (Merci)
Complement ActivationSC5b-9	Solitaire 0.0% as compared to activation bypositive controlMerci 0.2% as compared to activation by positivecontrol	The level of SC5b-9complementactivation induced bySolitaire FR wassimilar to the controldevice (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 anyobservations	Pass
Af Temperature	N = 23; all devices within Af temperaturespecification	Pass
Kink Resistance	N = 62; all devices deployed to intended locationand resisted kinking	Pass
System Tensile Strength	N = 30; all devices above tensile strengthspecification	Pass
Markercoil Tensile Strength	N = 123; all devices above tensile strengthspecification	Pass
Torque Response	N = 60; all devices within torque responsespecification	Pass
Torque Strength	N = 60; all devices within torque strengthspecification	Pass
Radial Force	N = 67; all devices within radial forcespecification	Pass
Radiopacity	N = 2; all markerbands visualized effectivelywith tissue and bone simulation	Pass

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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

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. 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

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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

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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 PreferredTerm	Roll-in(allSOLITAIRE™FR device)	RandomizedSOLITAIRE™ FRdevice	RandomizedConcentricMedicalMERCI™ 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 LymphaticSystem 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 FailureCongestive	3.2% (1/31) [1]	5.2% (3/58) [3]	3.6% (2/55) [2]	4.2% (6/144) [6]	1.000
GastrointestinalDisorders	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
GastrointestinalHaemorrhage	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 andAdministration SiteConditions	9.7% (3/31) [3]	24.1% (14/58) [15]	16.4% (9/55) [10]	18.1% (26/144) [28]	0.355
Catheter SiteHaematoma	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 PreferredTerm	Roll-in(allSOLITAIRE™FR device)	RandomizedSOLITAIRE™ FRdevice	RandomizedConcentricMedicalMERCI™ device	All Enrolled	Rand. p-value
Units	% (pts/N) [AEs]	% (pts/N) [AEs]	% (pts/N) [AEs]	% (pts/N) [AEs]
SubarachnoidHaemorrhage	3.2% (1/31) [1]	5.2% (3/58) [3]	14.5% (8/55) [8]	8.3% (12/144) [12]	0.118
Respiratory, Thoracicand MediastinalDisorders	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
PneumoniaAspiration	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 VeinThrombosis	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

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Page 9 of 10

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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.

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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.

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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

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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

Regulation Number and Section

§ 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).