Solitaire 2 and Solitaire Platinum Revascularization Device
Device Facts
| Record ID | K181060 |
|---|---|
| Device Name | Solitaire 2 and Solitaire Platinum Revascularization Device |
| Applicant | Medtronic Neurovascular |
| Product Code | POL · Neurology |
| Decision Date | Aug 24, 2018 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.5600 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The Solitaire™ 2 and Solitaire TM Platinum Revascularization Devices 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™ 2 and Solitaire TM Platinum Revascularization Devices 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 Story
Neurovascular mechanical thrombectomy device; used to restore blood flow in patients with acute ischemic stroke due to large intracranial vessel occlusion. Device consists of distal nitinol stent for clot retrieval; features Platinum/Iridium radiopaque markers. Operated by physicians in clinical settings. Input: mechanical engagement with thrombus; output: physical removal of clot. Subject device adds compatibility with alternative aspiration source (Riptide™ Aspiration System) to supplement standard 60 cc syringe. Healthcare providers use device under fluoroscopic guidance to navigate to occlusion site, deploy stent to capture thrombus, and retrieve clot. Benefits include restoration of blood flow and reduction of disability in stroke patients.
Clinical Evidence
Bench testing only. Simulated clot retrieval testing demonstrated equivalent performance between the subject device with the alternative aspiration source and the predicate device with a 60 cc syringe. A comprehensive review of relevant clinical literature was conducted to assess safety and effectiveness.
Technological Characteristics
Materials: Nitinol (stent, push wire), 90% Platinum/10% Iridium (radiopaque markers), PTFE (push-wire shrink tubing, introducer sheath), Grilamid (introducer sheath). Principle: Mechanical thrombectomy via stent retriever. Form factor: Stent-based retriever. Sterilization: Ethylene oxide. Connectivity: None.
Indications for Use
Indicated for patients with acute ischemic stroke, including those with persistent, proximal anterior circulation, large vessel occlusion, and smaller core infarcts (within 6 hours of onset, post-IV t-PA) or those with large intracranial vessel occlusion (within 8 hours of onset, if ineligible for or failed IV t-PA).
Regulatory Classification
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.
Special Controls
In combination with the general controls of the FD&C Act, the Neurovascular Mechanical Thrombectomy Device for Acute Ischemic Stroke Treatment is subject to the following special controls:
*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.
Predicate Devices
- Solitaire™ 2 Revascularization Device (K162539)
- Solitaire™ Platinum Devices (K153071, K160641, K161879)
Submission Summary (Full Text)
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August 24, 2018
Medtronic Neurovascular Amnon Talmor Principal Regulatory Affairs Specialist 9775 Toledo Way Irvine, California 92618
Re: K181060
Trade/Device Name: Solitaire 2TM and Solitaire™ Platinum Revascularization Devices 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: May 31, 2018 Received: June 1, 2018
Dear Amnon Talmor:
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.
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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 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).
Sincerely,
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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) K181060
Device Name
Solitaire™ 2 and Solitaire TM Platinum Revascularization Devices
#### Indications for Use (Describe)
1. The Solitaire™ 2 and Solitaire ™ Platinum Revascularization Devices is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute 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.
2. The Solitaire™ 2 and Solitaire TM Platinum Revascularization Devices 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.
| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|
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 - K181060
| 510(k)<br>Owner: | Medtronic Neurovascular<br>9775 Toledo Way<br>Irvine, CA 92618<br>Establishment Registration No. 2029214 |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Contact<br>Person: | Amnon Talmor<br>Principal Specialist, Regulatory Affairs<br>Telephone: (949) 297-9270<br>E-mail: amnon.talmor@medtronic.com |
| Date Summary<br>Prepared: | August 10, 2018 |
| Trade Name of<br>Device: | Solitaire™ 2 and Solitaire™ Platinum Revascularization Devices |
| Common Name<br>of Device: | Neurovascular Mechanical Thrombectomy Device for<br>Acute Ischemic Stroke Treatment; Catheter, thrombus retriever |
| Classification of<br>Device: | 21 CFR 882.5600 and 21 CFR 870.1250, Class II |
| Product Code: | POL, NRY |
| Primary<br>Predicate<br>Devices: | Solitaire™ 2 Revascularization Device<br>K162539 |
| Additional<br>PredicateDevices: | Solitaire™ Platinum Devices (K153071, K160641 and K161879) |
## Device Description:
The Solitaire™ 2 and Solitaire™ Platinum Revascularization Devices is designed to restore blood flow in patients experiencing ischemic stroke due to large intracranial vessel occlusion 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 subject device facilitates clot retrieval and has Platinum/Iridium radiopaque markers on the proximal and distal ends and, for some SKUs, at several locations along the body of the stent. The devices are supplied sterile and are intended for single-use only.
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The purpose of this submission is a labeling change to include an alternative aspiration source in addition to the 60 cc syringe when using the Solitaire™ 2 and Solitaire TM Platinum Revascularization Devices.
The indications for use for the subject device are as follows:
- 1. The Solitaire™ 2 and Solitaire TM Platinum Revascularization Devices 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.
- 2. The Solitaire™ 2 and Solitaire TM Platinum Revascularization Devices 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 Comparison:
Table 1 below provides a comparison between the subject, the primary predicate and additional predicate devices. All aspects of the design-including stent sizes, marker spacing, device and packaging materials, sterilization methods and how suppliedremain the same.
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| Table 1: Comparison between the proposed Solitaire™ 2 and Solitaire™ Platinum Revascularization Devices used with the alternative<br>aspiration source to the primary predicate and additional predicate Solitaire™ 2 and Solitaire™ Platinum Revascularization Devices | | | | | | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|---------|-------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Primary Predicate:<br>Solitaire™ 2<br>Revascularization Device<br>with syringe aspiration<br>(K162539) | Additional Predicate devices<br>(Solitaire™ Platinum<br>Revascularization Device) | | | Subject: Solitaire™ 2 and<br>Solitaire™ Platinum<br>Revascularization<br>Devices used with<br>Riptide™ Aspiration<br>System | Rationale for Difference<br>(if applicable) |
| | | K153071 | K161879 | K160641 | | |
| Product code | POL and NRY | NRY | | | Same as primary predicate<br>(K162539) | N/A |
| Indication for Use | The Solitaire™ 2<br>Revascularization Device<br>is indicated for use to<br>restore blood flow in the<br>neurovasculature by<br>removing thrombus for the<br>treatment of acute ischemic<br>stroke to reduce disability<br>in patients with a<br>persistent, proximal<br>anterior circulation, large<br>vessel occlusion, and<br>smaller core infarcts who<br>have first received<br>intravenous tissue<br>plasminogen activator (IV<br>t-PA). Endovascular<br>therapy with the device<br>should be started within 6<br>hours of symptom onset.<br>The Solitaire™<br>Revascularization Device<br>is indicated to restore | The Solitaire™ Platinum<br>Revascularization Device is<br>indicated to restore blood flow by<br>removing thrombus from a large<br>intracranial vessel in patients<br>experiencing ischemic stroke<br>within 8 hours of symptom onset.<br>Patients who are ineligible for IV t-<br>PA or who fail IV t-PA therapy are<br>candidates for treatment. | | | Same as primary predicate<br>(K162539) | N/A |
| Table 1: Comparison between the proposed Solitaire™ 2 and Solitaire ™ Platinum Revascularization Devices used with the alternative<br>aspiration source to the primary predicate and additional predicate Solitaire™ 2 and Solitaire ™ Platinum Revascularization Devices | | | | | | |
| | Primary Predicate:<br>Solitaire™ 2<br>Revascularization Device<br>with syringe aspiration<br>(K162539) | Additional Predicate devices<br>(Solitaire™ Platinum<br>Revascularization Device) | | | Subject: Solitaire™ 2 and<br>Solitaire ™ Platinum<br>Revascularization<br>Devices used with<br>Riptide™ Aspiration<br>System | Rationale for Difference<br>(if applicable) |
| | blood flow by removing<br>thrombus from a large<br>intracranial vessel in<br>patients experiencing<br>ischemic stroke within 8<br>hours of symptom onset.<br>Patients who are ineligible<br>for IV t-PA or who fail IV<br>t-PA therapy are<br>candidates for treatment. | K153071 | K161879 | K160641 | | |
| Principle of operation | The device is used in the<br>neurovasculature to restore<br>blood flow for treatment of<br>acute ischemic stroke<br>The device is used in the<br>neurovasculature to restore<br>blood flow by removing<br>thrombus | The device is used in the<br>neurovasculature to restore blood<br>flow by removing thrombus | | | Same as primary predicate<br>(K162539) | N/A |
| Procedural steps<br>aspiration source | Syringe | | | | Aspiration Device | Bench testing and a<br>review of relevant clinical<br>literature demonstrates the<br>alternative aspiration<br>source does not raise any |
| Table 1: Comparison between the proposed Solitaire™ 2 and Solitaire ™™ Platinum Revascularization Devices used with the alternative<br>aspiration source to the primary predicate and additional predicate Solitaire™ 2 and Solitaire ™™ Platinum Revascularization Devices | | | | | | |
| | Primary Predicate:<br>Solitaire™ 2<br>Revascularization Device<br>with syringe aspiration<br>(K162539) | Additional Predicate devices<br>(Solitaire™ Platinum<br>Revascularization Device) | | | Subject: Solitaire™ 2 and<br>Solitaire ™™ Platinum<br>Revascularization<br>Devices used with<br>Riptide™ Aspiration<br>System | Rationale for Difference<br>(if applicable) |
| | | K153071 | K161879 | K160641 | | |
| | | | | | | new issues of safety or<br>effectiveness. |
| Device sizes (mm) | 4x15 | 4x20 | 4x20x05 | 6x40x10 | 4x15 | The subject device scope<br>includes the primary<br>predicate and additional<br>predicate devices. The<br>sizes used in the<br>simulated clot retrieval<br>testing were identical to<br>the primary predicate<br>device and representative<br>of the additional predicate<br>devices. |
| | 4x20 | 4x40 | 6x24x06 | | 4x20 | |
| | 4x40 | 6x20 | | | 4x40 | |
| | 6x20 | | | | 6x20 | |
| | 6x30 | | | | 6x30 | |
| | | | | | 4x20x05 | |
| | | | | | 6x24x06 | |
| | | | | | 6x40x10 | |
| How supplied | Stored within dispenser coil, Tyvek pouch and shipping carton | | | | | N/A |
| Sterilization method | Ethylene oxide | | | | | N/A |
| Device materials | | | | | | |
| Stent | Nitinol | | | | | N/A |
| Push wire | Nitinol | | | | | |
| Radiopaque markers | 90% Platinum/10% Iridium | | | | | |
| Push-wire shrink Tubing | PTFE | | | | | |
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| Table 1: Comparison between the proposed Solitaire™ 2 and Solitaire™ Platinum Revascularization Devices used with the alternative<br>aspiration source to the primary predicate and additional predicate Solitaire™ 2 and Solitaire™ Platinum Revascularization Devices | | | | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|
| | Primary Predicate:<br>Solitaire™ 2<br>Revascularization Device<br>with syringe aspiration<br>(K162539) | Additional Predicate devices<br>(Solitaire™ Platinum<br>Revascularization Device) | Subject: Solitaire™ 2 and<br>Solitaire™ Platinum<br>Revascularization<br>Devices used with<br>Riptide™ Aspiration<br>System | Rationale for Difference<br>(if applicable) |
| Introducer Sheath | PTFE/Grilamid | K153071 K161879 K160641 | | |
| Shrink tubing | PTFE | | | |
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# Performance Data
Medtronic Neurovascular performed the following non-clinical bench tests to support the use of the alternative aspiration source with the Solitaire™ 2 and Solitaire™ Platinum Revascularization Devices:
| Test | Test Method Summary | Conclusions |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Vacuum pressure<br>testing | Purpose: Compare the ability of the<br>alternative aspiration device to deliver<br>vacuum pressure to the distal tip of the<br>catheter to a 60 cc syringe.<br>Method: The vacuum pressure was<br>measured at the distal tip of the aspiration<br>catheter when generated from the<br>alternative aspiration device at various<br>vacuum pressure settings, as well as from a<br>60 cc VacLok® Syringe. | Vacuum pressure delivered to<br>the distal tip of the catheter from<br>a 60 cc syringe exceeded the<br>pressure delivered from the<br>alternative aspiration device. |
| Simulated clot<br>retrieval testing | Purpose: Compare the clot retrieval<br>performance of the subject device when<br>used with the alternative aspiration source<br>to the cleared device use with a 60 cc<br>syringe. | Clot retrieval performance of the<br>subject device was equivalent to<br>the predicate performance. |
In addition to the above tests, Medtronic Neurovascular conducted a comprehensive review of relevant clinical literature to assess whether any issues of safety or effectiveness were raised by the clinical use of the alternative aspiration source with the Solitaire™ 2 and Solitaire™ Platinum Revascularization Devices.
## Conclusion
Non-clinical bench testing and a review of relevant literature demonstrate the subject device is substantially equivalent to the predicate Solitaire™ 2 and Solitaire™ Platinum Revascularization Devices and does not raise any new questions of safety and effectiveness.
