The Solitaire™ Revascularization Device is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion, and smaller core infarcts who have first received intravenous tissue plasminogen activator (IV t-PA). Endovascular therapy with the device should be started within 6 hours of symptom onset.
The Solitaire™ Revascularization Device is indicated 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 IV t-PA or who fail IV t-PA therapy are candidates for treatment.

Device Description

The Solitaire™ 4 Revascularization Device is designed to restore blood flow in patients experiencing ischemic stroke due to large intracranial vessel occlusion. The Solitaire™ 4 Revascularization Device is designed for use in the neurovasculature such as the Internal Carotid Artery (ICA), M1 and M2 segments of the middle cerebral artery, basilar, and the vertebral arteries. The distal nitinol portion of the Solitaire™ 4 Revascularization Device facilitates clot retrieval and has Platinum/Iridium radiopaque markers on the proximal and distal ends. The Solitaire™ 4 Revascularization Device also features radiopaque markers along the circumference of the working length of the device. The devices are supplied sterile and are intended for single-use only.

AI/ML Overview

The provided text is a 510(k) Summary for the Solitaire™ 4 Revascularization Device, which is a medical device for treating acute ischemic stroke. It describes the device, its indications for use, comparison to a predicate device, and performance data.

However, the questions posed in your request (Acceptance Criteria, Study Details, Sample Size, Expert Ground Truth, Adjudication, MRMC Study, Standalone Performance, Ground Truth Type, Training Set Details) are typically associated with the evaluation of AI/ML-driven medical devices that require demonstration of algorithmic performance against a defined ground truth.

The Solitaire™ 4 Revascularization Device is a physical mechanical thrombectomy device. The performance data provided in this document focuses on bench testing (non-clinical) to ensure the device's physical properties, such as length, force, particulate generation, durability, and tensile strength, meet specifications. It explicitly states:

"No clinical or animal testing was performed on the subject device because there is no change in the indications for use or the fundamental scientific technology of the device."
"Bench testing confirmed that the modifications to Solitaire™ 4 met product specifications and do not raise new questions on the safety and effectiveness of the device."

Therefore, most of the information requested, which pertains to AI/ML device validation, is not applicable to this traditional medical device submission.

Here's a breakdown of what can be extracted from the document based on your questions, and what cannot:

1. A table of acceptance criteria and the reported device performance:

The document provides a summary of non-clinical bench tests. It states that "Acceptance criteria met" for each test, but it does not specify the numerical acceptance criteria themselves or the reported performance values. It only confirms that the device passed.

Test	Test Method Summary	Acceptance Criteria Met	Reported Device Performance
Total System Length	Measured from the distal tip of the distal marker to the proximal tip of the delivery system.	Yes	Not specified
Fluorosafe Marker Length	Measured from the measurement of the length from the distal tip of the device to distal end of the marker.	Yes	Not specified
Delivery Force	Measured through a representative tortuous anatomical model.	Yes	Not specified
Re-Sheathing Force	Measured through a representative tortuous anatomical model.	Yes	Not specified
Particulate	Evaluated for generation under simulated use in a representative tortuous anatomical model.	Yes	Not specified
Durability	Evaluated on the ability to withstand simulated use of the device, including delivery, resheathing and retrieval in a representative tortuous model with the appropriate ancillary devices.	Yes	Not specified
System Tensile	Following simulated use, the tensile force testing is performed to verify the amount of force it takes to detach the device meets the acceptance criteria.	Yes	Not specified
Torque	Performed to verify the stent joint withstands a minimum of one rotation on the proximal wire following simulated use.	Yes	Not specified
Marker Tensile	Performed to verify the strength of the laser weld of the Pt/Ir marker coil to the Nitinol distal finger of the device.	Yes	Not specified

2. Sample sized used for the test set and the data provenance:

The document doesn't provide specific sample sizes (e.g., number of devices tested) for the bench tests. It also does not discuss data provenance in terms of country of origin or retrospective/prospective, as this is laboratory bench data, not clinical patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. Ground truth as typically understood for AI/ML models (e.g., medical image annotations) is not relevant for the bench testing of a physical device. The "ground truth" here is engineering specifications and physical measurements.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. This is not a process that requires multi-reader adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done:

No, an MRMC study was explicitly not done. The document states: "No clinical or animal testing was performed on the subject device because there is no change in the indications for use or the fundamental scientific technology of the device."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

The "ground truth" for the bench tests is the engineering specifications and performance standards set for the device's physical properties. For example, a "System Tensile" test has a pre-defined acceptance criterion for the amount of force the device must withstand.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established:

Not applicable.

Summary

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January 29, 2019

Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Helen Chow, PhD, RAC Senior Specialist. Regulatory Affairs 9775 Toledo Way Irvine, California 92618

Re: K183022

Trade/Device Name: Solitaire™ 4 Revascularization Device Regulation Number: 21 CFR 882.5600 Regulation Name: Neurovascular Mechanical Thrombectomy Device for Acute Ischemic Stroke Treatment Regulatory Class: Class II Product Code: POL. NRY Dated: December 21, 2018 Received: December 26, 2018

Dear Helen Chow:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803). please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerelv.

Image /page/1/Picture/5 description: The image shows the name "Xiaolin Zheng" in a large, clear font. Below the name, there is a "-S" written in a smaller font size. The background of the image is a light blue color, with a faint FDA logo.

for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K183022

Device Name Solitaire™ 4 Revascularization Device

Indications for Use (Describe)

The Solitaire™ Revascularization Device is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ische to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion, and smaller core infarcts who have first received intravenous tissue plasminogen activator (IV t-PA). Endovascular therapy with the device should be started within 6 hours of symptom onset.
The Solitaire™ Revascularization Device is indicated 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 IV t-PA or who fail IV t-PA therapy are candidates for treatment.

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary - K183022

510(k) Owner:	Micro Therapeutics, Inc. d/b/a ev3 Neurovascular9775 Toledo WayIrvine, CA 92618Establishment Registration No. 2029214
Contact Person:	Helen ChowSr. Specialist, Regulatory AffairsTelephone: (949) 297-5474E-mail: helen.h.chow@medtronic.com
Date Summary Prepared:	October 30, 2018
Trade Name of Device:	Solitaire™ 4 Revascularization Device
Common Name of Device:	Neurovascular Mechanical Thrombectomy Device for AcuteIschemic Stroke Treatment;Catheter, Thrombus Retriever
Classification of Device:	Class II, 21 CFR 882.5600; 21 CFR 870.1250
Product Code:	POL; NRY
Predicate Device:	Solitaire™ Platinum Revascularization Device (K181186)

Device Description:

Indications for Use:

1. The Solitaire™ Revascularization Device is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion, and smaller core infarcts who have first received intravenous tissue plasminogen activator (IV t-PA). Endovascular therapy with the device should be started within 6 hours of symptom onset.
1. The Solitaire™ Revascularization Device is indicated to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke within

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8 hours of symptom onset. Patients who are ineligible for IV t-PA or who fail IV t-PA therapy are candidates for treatment.

Device Comparison:

A comparison of the technological characteristics of the subject Solitaire™ 4 Revascularization Device and the predicate Solitaire™ Platinum Revascularization Device (K181186) is provided in Table 1. The Solitaire™ 4 Revascularization Device is a design modification of the delivery system to Solitaire™ Platinum. Modifying the delivery system allows for all of the sizes (diameters and lengths) of Solitaire™ 4 to fit through a 0.021'' inner diameter microcatheter.

Table 1: Device Comparison
	Predicate Solitaire™PlatinumRevascularization Device(K181186)	Subject Solitaire™ 4RevascularizationDevice	Rationale for Difference(if applicable)
Indication forUse	1. The Solitaire™Revascularization Deviceis indicated for use torestore blood flow in theneurovasculature byremoving thrombus forthe treatment of acuteischemic stroke to reducedisability in patients witha persistent, proximalanterior circulation, largevessel occlusion, andsmaller core infarcts whohave first receivedintravenous tissueplasminogen activator(IV t-PA). Endovasculartherapy with the deviceshould be started within6 hours of symptomonset.2. The Solitaire™Revascularization Deviceis indicated to restoreblood flow by removingthrombus from a largeintracranial vessel inpatients experiencingischemic stroke within 8hours of symptom onset.Patients who areineligible for IV t-PA orwho fail IV t-PA therapyare candidates fortreatment.	Same	N/A
Principles ofOperation	The device is used in theneurovasculature to restore	Same	N/A
Table 1: Device Comparison
	Predicate Solitaire™PlatinumRevascularization Device(K181186)	Subject Solitaire™ 4RevascularizationDevice	Rationale for Difference(if applicable)
	blood flow for treatment ofacute ischemic stroke
Dimensions and Materials
Device Size(s)	4-20-05 mm4-20-10 mm4-40-10 mm6-20-10 mm6-24-06 mm6-40-10 mm	4-20-05 mm4-20-10 mm4-40-10 mm6-20-10 mm6-24-06 mm6-40-10 mm	Same
DeviceMaterials	Stent: NitinolPushwire: NitinolMarkers: 90% Platinum/10% IridiumPush-wire shrink Tubing:PTFEIntroducer Sheath:PTFE/Grilamid	Same	N/A
Sterilization and Packaging
PackagingMaterials	Stored within dispenser coil,Tyvek pouch, and shippingcarton.	Stored within dispensercoil, Tyvek/Nylonpouch, and shippingcarton.	The pouch is the onlychange in the key packagingmaterials. The Nylon/Tyvekpouch maintains sterility forthe labeled shelf of theSolitaire™ 4 device.
SterilizationMethod	Ethylene Oxide	Same	N/A
How Supplied	Sterile, Single Use	Same	N/A

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Performance Data:

Biocompatibility:

Solitaire™ 4 does not introduce any new materials into the finished device nor the manufacturing processes. The material of the subject Solitaire™ 4 is identical to the material of the predicate Solitaire™ Platinum (K181186). Therefore, no new biocompatibility evaluations were conducted on the subject device. The prior completed biocompatibility evaluations on the predicate device were used to support the biocompatibility profile of the subject device.

The following non-clinical bench tests were performed to support the Solitaire™ 4 device.

Test	Test Method Summary	Conclusions
Total System Length	Total System Length wasmeasured from the distal tipof the distal marker to theproximal tip of the deliverysystem.	Acceptance criteria met
Test	Test Method Summary	Conclusions
Fluorosafe Marker Length	Fluorosafe marker lengthwas measured from themeasurement of the lengthfrom the distal tip of thedevice to distal end of themarker.	Acceptance criteria met
Delivery Force	Delivery force wasmeasured through arepresentative tortuousanatomical model.	Acceptance criteria met
Re-Sheathing Force	Retrieval force was measuredthrough a representativetortuous anatomical model.	Acceptance criteria met
Particulate	Particulate was evaluated forgeneration under simulateduse in a representativetortuous anatomical model.	Acceptance criteria met
Durability	Durability was evaluated onthe ability to withstandsimulated use of the device,including delivery,resheathing and retrieval in arepresentative tortuous modelwith the appropriate ancillarydevices.	Acceptance criteria met
System Tensile	Following simulated use, thetensile force testing isperformed to verify theamount of force it takes todetach the device meets theacceptance criteria.	Acceptance criteria met
Torque	Torque testing is performedto verify the stent jointwithstands a minimum of onerotation on the proximal wirefollowing simulated use.	Acceptance criteria met
Marker Tensile	Marker tensile strengthtesting is performed to verifythe strength of the laser weldof the Pt/Ir marker coil tothe Nitinol distal finger ofthe device.	Acceptance criteria met

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Performance Data - Animal, Clinical:

No clinical or animal testing was performed on the subject device because there is no change in the indications for use or the fundamental scientific technology of the device.

Conclusion:

Bench testing confirmed that the modifications to Solitaire™ 4 met product specifications and do not raise new questions on the safety and effectiveness of the device. Additionally, there are no changes to the indications for use or the fundamental scientific technology of the device. Therefore, the subject Solitaire™ 4 Revascularization Device is substantially equivalent to the predicate Solitaire™ Platinum Revascularization Device.

Regulation Number and Section

§ 882.5600 Neurovascular mechanical thrombectomy device for acute ischemic stroke treatment.

(a)
Identification. A neurovascular mechanical thrombectomy device for acute ischemic stroke treatment is a prescription device used in the treatment of acute ischemic stroke to improve clinical outcomes. The device is delivered into the neurovasculature with an endovascular approach, mechanically removes thrombus from the body, and restores blood flow in the neurovasculature.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The patient contacting components of the device must be demonstrated to be biocompatible.
(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including:
(i) Mechanical testing to demonstrate the device can withstand anticipated tensile, torsional, and compressive forces.
(ii) Mechanical testing to evaluate the radial forces exerted by the device.
(iii) Non-clinical testing to verify the dimensions of the device.
(iv) Non-clinical testing must demonstrate the device can be delivered to the target location in the neurovasculature and retrieve simulated thrombus under simulated use conditions.
(v) Non-clinical testing must demonstrate the device is radiopaque and can be visualized.
(vi) Non-clinical testing must evaluate the coating integrity and particulates under simulated use conditions.
(vii) Animal testing must evaluate the safety of the device, including damage to the vessels or tissue under anticipated use conditions.
(3) Performance data must support the sterility and pyrogenicity of the patient contacting components of the device.
(4) Performance data must support the shelf-life of the device by demonstrating continued sterility, package integrity, and device functionality over the specified shelf-life.
(5) Clinical performance testing of the device must demonstrate the device performs as intended for use in the treatment of acute ischemic stroke and must capture any adverse events associated with the device and procedure.
(6) The labeling must include:
(i) Information on the specific patient population for which the device is intended for use in the treatment of acute ischemic stroke, including but not limited to, specifying time from symptom onset, vessels or location of the neurovasculature that can be accessed for treatment, and limitations on core infarct size.
(ii) Detailed instructions on proper device preparation and use for thrombus retrieval from the neurovasculature.
(iii) A summary of the clinical testing results, including a detailed summary of the device- and procedure-related complications and adverse events.
(iv) A shelf life.