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.
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 of the internal carotid artery (ICA) or middle cerebral artery (MCA)-M1 segments with smaller core infarcts (< 70 cc by CTA or MRA, < 25 cc by MR-DWI). Endovascular therapy with the device should start within 6-16 hours of time last seen well in patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy.

Device Description

The Solitaire™ Revascularization Device is designed to restore blood flow in patients experiencing ischemic stroke due to large intracranial vessel occlusion. The Solitaire™ Revascularization 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 distal nitinol portion of the Solitaire™ Revascularization Device facilitates clot retrieval and has Platinum/Iridium radiopaque markers on the proximal and distal ends and also features radiopaque markers along the circumference of the working length of the devices are supplied sterile and are intended for single-use only.

AI/ML Overview

The prompt asks to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, based on the provided text.

Based on the provided information, the submission is for a labeling modification to reduce the recommended minimum vessel diameter for the Solitaire™ Revascularization Device, 4 mm device models. The core device design and Indications for Use remain unchanged from the predicate devices. Therefore, the performance criteria and studies focus on demonstrating that this labeling modification does not introduce new safety or effectiveness concerns.

Here's the breakdown of the information as requested:

1. Table of acceptance criteria and the reported device performance:

Acceptance Criteria (Implied)	Reported Device Performance
Bench Testing:
Durability: Ability to withstand simulated use (delivery, resheathing, retrieval) in a representative tortuous model.	Acceptance criteria met. (The test demonstrates the device can endure the mechanical stresses under simulated use with the reduced vessel diameter.)
Radial Force: Maintain sufficient radial force at the minimum vessel diameter.	Acceptance criteria met. (The test confirms appropriate interaction with the vessel wall even in smaller diameters.)
Clinical Performance & Safety (for reduced vessel diameter): Equivalent clinical performance and safety profile in vessels down to 1.5-2.0mm compared to the predicate device in its approved vessel sizes.	Retrospective subgroup analysis of the STRATIS registry data demonstrated that the subject Solitaire™ Revascularization 4 mm device, with vessel diameters of 1.5 to 2.0 mm, has similar clinical performance and safety profile compared to the predicate Solitaire™ Revascularization 4 mm device. This indicates the device continues to meet expected safety and effectiveness when used in smaller vessels within the new recommended range.

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

Test Set Sample Size: The exact sample size for the retrospective analysis of the STRATIS registry data is not explicitly stated in the provided text. It mentions "a retrospective subgroup analysis."
Data Provenance: The data is from the STRATIS registry, described as a retrospective analysis. The country of origin is not specified, but STRATIS (Stroke TreAtment with a Solitaire stent-retriever and Intravenous t-PA) is an international registry, so the data likely encompasses multiple countries.

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

This information is not provided in the text. The STRATIS registry would have had various clinical endpoints and adjudication processes, but the details of experts establishing ground truth for the specific retrospective subgroup analysis are not described.

4. Adjudication method for the test set:

This information is not provided in the text.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No MRMC study was performed. The device is a mechanical thrombectomy device, not an AI-assisted diagnostic tool.

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

No standalone algorithm performance was done as this is a medical device (thrombectomy device), not an imaging or diagnostic algorithm.

7. The type of ground truth used:

For the clinical performance, the ground truth would be based on patient outcomes data collected as part of the STRATIS registry (e.g., successful reperfusion rates, clinical disability scores, adverse event rates), as adjudicated in the original registry study design. For the bench tests, the ground truth is based on engineering measurements against predefined specifications.

8. The sample size for the training set:

Training Set Sample Size: The concept of a "training set" in the context of device approval (especially for a physical medical device and a labeling modification) is not applicable in the same way it would be for an AI/ML algorithm. The device design and previous iterations would have been "trained" through extensive R&D and prior clinical trials for predicate devices, but there isn't a "training set" in the computational sense.
The "retrospective analysis of subject vessel size was performed using the STRATIS registry data" to support the labeling modification, implying that this existing clinical data was used for validation rather than for "training" a new device or algorithm.

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

As above, the concept of a "training set" with ground truth establishment in the AI/ML sense is not applicable for this device submission. The existing clinical data from the STRATIS registry, which includes patient outcomes, would serve as the "ground truth" for evaluating the clinical performance of the device in smaller vessels. The establishment of this ground truth would have been defined by the STRATIS registry protocol, including clinical assessments and imaging.

Summary

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November 20, 2020

Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Jennifer Correa, MS, RAC Program Manager, Regulatory Affairs 9775 Toledo Way Irvine, California 92618

Re: K193576

Trade/Device Name: Solitaire Platinum Revascularization Device, Solitaire X Revascularization Device (Solitaire 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: October 26, 2020 Received: October 27, 2020

Dear Jennifer Correa:

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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Naira Muradyan, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K193576

Device Name

Solitaire™ Platinum Revascularization Device, Solitaire™ X Revascularization Device (Solitaire™ 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 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.
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 of the internal carotid artery (ICA) or middle cerebral artery (MCA)-M1 segments with smaller core infarcts (< 70 cc by CTA or MRA, < 25 cc by MR-DWI). Endovascular therapy with the device should start within 6-16 hours of time last seen well in patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

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

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510(K) Summary	K193576
510(k) Owner:	Micro Therapeutics, Inc. d/b/a ev3 Neurovascular9775 Toledo WayIrvine, CA 92618Establishment Registration No. 2029214
Contact Person:	Jennifer CorreaProgram Manager, Regulatory AffairsTelephone: (949) 297-5494E-mail: Jennifer.L.Correa@medtronic.com
Date SummaryPrepared:	November 18, 2020
Trade Name ofDevice:	Solitaire™ Platinum Revascularization Device,Solitaire™ X Revascularization Device(Solitaire™ Revascularization Device)
Common Name ofDevice:	Neurovascular MechanicalThrombectomy Device for AcuteIschemic Stroke Treatment	Catheter, Thrombus Retriever
Classification:	Class II, 21 CFR 882.5600	Class II, 21 CFR 870.1250
Product Code:	POL	NRY
Primary PredicateDevices:	Solitaire™ Platinum Revascularization Device (K181186);Solitaire™ 4 Revascularization Device (K183022)
AdditionalPredicate Devices:	Solitaire™ Platinum Revascularization Device and Solitaire™ 2Revascularization Device (K181807)

Device Description:

Indications for Use:

The Solitaire™ Revascularization Device is indicated for use to restore blood flow in the 1. 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.

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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 8 hours of symptom onset. Patients who are ineligible for IV t-PA or who fail IV t-PA therapy are candidates for treatment.
1. The Solitaire™M 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 of the internal carotid artery (ICA) or middle cerebral artery (MCA)-M1 segments with smaller core infarcts (< 70 cc by CTA or MRA, < 25 cc by MR-DWI). Endovascular therapy with the device should start within 6-16 hours of time last seen well in patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy.

Device Comparison:

A comparison of the technological characteristics of the subject Solitaire™ Revascularization Device and the predicate Solitaire™ 2 Revascularization Device (Solitaire™ Platinum Revascularization Device K181807, K181186; Solitaire™ 4 Revascularization Device K183022) is provided in Table 1. This 510(k) is for a labeling modification to reduce the recommended minimum vessel diameter for the subject Solitaire™ Revascularization Device, 4 mm device models. The Indications for Use (IFU) of the subject Solitaire™ Revascularization Device remain unchanged and are identical to the legally marketed additional predicate device. The subject Solitaire™ Revascularization device is identical to the primary predicate Solitaire™ Revascularization Devices, apart from these labeling modifications.

Table 1: Device Comparison
Indication for Use	Primary Predicate SolitaireTMRevascularization Device(K181186, K183022)	Additional Predicate SolitaireTMRevascularization Device(K181807)	Subject SolitaireTMRevascularization Device
	1. The SolitaireTM RevascularizationDevice is indicated for use to restoreblood flow in the neurovasculature byremoving thrombus for the treatment ofacute ischemic stroke to reducedisability in patients with a persistent,proximal anterior circulation, largevessel occlusion, and smaller coreinfarcts who have first receivedintravenous tissue plasminogenactivator (IV t-PA). Endovasculartherapy with the device should bestarted within 6 hours of symptomonset.2. The SolitaireTM RevascularizationDevice is indicated to restore bloodflow by removing thrombus from alarge intracranial vessel in patientsexperiencing ischemic stroke within 8hours of symptom onset. Patients whoare ineligible for IV t-PA or who fail IV	1. The SolitaireTM RevascularizationDevice is indicated for use to restoreblood flow in the neurovasculature byremoving thrombus for the treatment ofacute ischemic stroke to reducedisability in patients with a persistent,proximal anterior circulation, largevessel occlusion, and smaller coreinfarcts who have first receivedintravenous tissue plasminogenactivator (IV t-PA). Endovasculartherapy with the device should bestarted within 6 hours of symptomonset.2. The SolitaireTM RevascularizationDevice is indicated to restore bloodflow by removing thrombus from alarge intracranial vessel in patientsexperiencing ischemic stroke within 8hours of symptom onset. Patients whoare ineligible for IV t-PA or who fail IV	Same asadditionalpredicate
	Table 1: Device Comparison
	Primary Predicate Solitaire™Revascularization Device(K181186, K183022)		Additional Predicate Solitaire™Revascularization Device(K181807)	SubjectSolitaire™RevascularizationDevice
	t-PA therapy are candidates fortreatment.	t-PA therapy are candidates fortreatment.3. The Solitaire™ RevascularizationDevice is indicated for use to restoreblood flow in the neurovasculature byremoving thrombus for the treatment ofacute ischemic stroke to reducedisability in patients with a persistent,proximal anterior circulation, largevessel occlusion of the internal carotidartery (ICA) or middle cerebral artery(MCA)-M1 segments with smaller coreinfarcts (< 70 cc by CTA or MRA, < 25cc by MR-DWI). Endovascular therapywith the device should start within 6-16hours of time last seen well in patientswho are ineligible for intravenoustissue plasminogen activator (IV t-PA)or who fail IV t-PA therapy.
PrinciplesofOperation	The device is used in the neurovasculatureto restore blood flow for treatment of acuteischemic stroke	Same		Same
Vessel Size	2.0 to 4.0 mm (4 mm device)2.0 to 5.5 mm (6 mm device)	Same		1.5 to 4.0 mm (4mm device)2.0 to 5.5 mm (6mm device)
		Dimensions and Materials
DeviceSize(s)	4-20-05 mm4-20-10 mm4-40-10 mm6-20-10 mm6-24-06 mm6-40-10 mm	4-15 mm4-20 mm4-40 mm6-20 mm6-30 mm	4-20-05 mm4-20-10 mm4-40-10 mm6-20-10 mm6-24-06 mm6-40-10 mm	Same as PrimaryPredicate
DeviceMaterials	Stent: NitinolPushwire: NitinolMarkers: 90% Platinum/ 10% IridiumPush-wire shrink Tubing: PTFEIntroducer Sheath: PTFE/Grilamid	Same	Same	Same
	Sterilization and Packaging
PackagingMaterials	Stored within dispenser coil, pouch, andshipping carton.	Same		Same
SterilizationMethod	Ethylene Oxide	Same		Same
HowSupplied	Sterile, Single Use	Same	Same	Same

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Performance Testing - Bench:

The subject Solitaire™ Revascularization device is identical to the primary predicate Solitaire™ Revascularization Devices including device design, materials, manufacturing, packaging, sterilization, and shelf-life. Therefore, previously conducted biocompatibility tests, sterilization validation, and shelf-life were leveraged from the predicate devices. The following non-clinical bench test was performed to support the labeling modification:

Test	Test Method Summary	Conclusions
Durability	Durability was 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	Acceptance criteria met
Radial Force	Radial force measured at a minimum vessel diameter.	Acceptance criteria met

Performance Testing - Animal:

No additional animal testing was performed or required to support the labeling modification. Previously conducted animal studies included vessels of appropriate size to support the labeling modifications for minimum recommended vessel diameter.

Performance Testing - Clinical:

To support substantial equivalence of the subject Solitaire™ Revascularization Device, a retrospective analysis of subject vessel size was performed using the STRATIS registry data. This retrospective subgroup analysis demonstrates that the subject Solitaire™ Revascularization 4 mm device, with vessel diameters of 1.5 to 2.0 mm, has similar clinical performance and safety profile compared to the predicate Solitaire™ Revascularization 4 mm device.

Summary of Substantial Equivalence:

There is no change to the Indication for Use Statements or design for the Solitaire™ Revascularization Device in comparison to the legally marketed predicate device. The additional bench testing, existing animal testing and the retrospective vessel diameter analysis demonstrates that the labeling modification does not raise any new or different questions of safety or effectiveness of the Solitaire™ Revascularization Device. The information provided in this submission supports a determination of substantial equivalence for the Solitaire™ 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.