Solitaire Platinum Revascularization Device, 6x40 mm

K160641 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · NRY · Mar 8, 2017 · Cardiovascular

Device Facts

• Record ID: K160641
• Device Name: Solitaire Platinum Revascularization Device, 6x40 mm
• Applicant: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
• Product Code: NRY · Cardiovascular
• Decision Date: Mar 8, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Solitaire™ Platinum Revascularization Device is intended to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.

Device Story

Device is a neurovascular thrombus retriever; used to restore blood flow in large intracranial vessels (ICA, M1/M2 segments, basilar, vertebral arteries). Input: physician-guided delivery via microcatheter to occlusion site. Operation: distal nitinol stent-like component expands to engage/remove thrombus; platinum-iridium markers provide radiopacity for fluoroscopic guidance. Output: mechanical removal of clot. Used in clinical/hospital settings by physicians. Benefits: revascularization in acute ischemic stroke patients. Device is a portfolio expansion of predicate; identical materials/design/manufacturing.

Clinical Evidence

No new clinical study performed. Leveraged confirmatory data from the prospective, multi-center, non-randomized STRATIS Registry (n=296 patients treated with 4x40 Solitaire). Primary endpoints: safety (symptomatic ICH 2.8%, 90-day mortality 16.2%) and performance (successful revascularization TICI 2b-3 90.4%, functional independence mRS 0-2 60.3% at 90 days). Device-related SAEs were 0.3%.

Technological Characteristics

Nitinol stent and push-wire; 90% Platinum/10% Iridium radiopaque markers; PTFE push-wire shrink tubing; PTFE/Grilamid introducer sheath. Sterilization: Ethylene Oxide. Connectivity: None (mechanical). Dimensions: 6-40-10 mm. No software/algorithm.

Indications for Use

Indicated for patients experiencing ischemic stroke within 8 hours of symptom onset due to large intracranial vessel occlusion, who are ineligible for or failed IV t-PA therapy.

Regulatory Classification

Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Predicate Devices

• Solitaire™ Platinum Revascularization Device (K153071)

Reference Devices

• 4-40 Solitaire™ 2

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 8, 2017

Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Jennifer Correa Senior Regulatory Affairs Specialist 9775 Toledo Way Irvine, California 92618

Re: K160641

Trade/Device Name: Solitaire™ Platinum Revascularization Device (6x40 mm) Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: February 16, 2017 Received: February 21, 2017

Dear Ms. 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. 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 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 devicerelated 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

William J.
Heetderks -S
Digitally signed by William J. Heetderks -
DN: c=US, o=U.S. Government, ou=HHS,
ou=FDA, ou=People,
0.9.2342.19200300.100.1.1=0010149848
cn=William J. Heetderks -S
Date: 2017.03.08 16:48:39-05'00'

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) K160641

#### Device Name

Solitaire™ Platinum Revascularization Device (6x40 mm)

#### Indications for Use (Describe)

The Solitaire™ Platinum 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.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| <div> <span> × Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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| 510(k) Summary | K160641 |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Owner: | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular<br>9775 Toledo Way<br>Irvine, CA 92618<br>Establishment Registration No. 2029214 |
| Contact Person: | Jennifer Correa<br>Senior Specialist, Regulatory Affairs<br>Telephone: [phone]<br>E-mail: [e-mail] |
| Date Summary<br>Prepared: | March 1, 2017 |
| Trade Name of<br>Device: | SolitaireTM Platinum Revascularization Device (6x40 mm) |
| Common Name of<br>Device: | Catheter, Thrombus Retriever |
| Classification of<br>Device: | 21 CFR 870.1250 - Class II |
| Product Code: | NRY |
| Predicate Device: | SolitaireTM Platinum Revascularization Device<br>510(k)#: K153071 |
| Performance Data: | The following non-clinical bench testing and confirmatory<br>clinical data supports the subject 6-40-10 SolitaireTM Platinum<br>Revascularization Device:<br>• Total System Length<br>• Marker-to-Marker Length<br>• Delivery Force<br>• Resheathing Force<br>• Multiple Resheathing Durability<br>• Body Finger Marker Coil Tensile<br>• Radial Force<br>• Radiopacity<br>• Ease of Use (Fluorosafe Marker Location)<br>• Particulate<br>• Leveraged confirmatory clinical data using the cleared<br>4x40 Solitaire devices |
| Conclusion: | The materials of construction, design, and manufacturing/<br>packaging processes for the subject 6-40-10 SolitaireTM Platinum<br>Revascularization Device are identical to the predicate SolitaireTM<br>Platinum Revascularization Device (K153071) therefore;<br>biocompatibility, sterilization, packaging, and shelf life<br>validations have been leveraged or adopted. Non-clinical animal<br>testing was performed to demonstrate safety, effectiveness, and |

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usability of the subject 6-40-10 Solitaire™ Platinum Revascularization Device. Non-clinical bench and animal testing confirmed that the subject 6-40-10 Solitaire™ Platinum Revascularization Device does not introduce new risks or increase existing risks. Confirmatory clinical data using the cleared 4x40 Solitaire devices (predicate 4-40-10 Solitaire™ Platinum and reference 4-40 Solitaire™ 2) was leveraged to support substantial equivalence of the subject 6-40-10 Solitaire™ Platinum Revascularization Device. The subject Solitaire™ Platinum Revascularization Device should be determined to be substantially equivalent to the predicate Solitaire™ Platinum Revascularization Device (K153071) based on non-clinical bench and animal testing, confirmatory clinical data, similarities in design, principles of operation, and indications for use.

#### Device Description:

The subject 6-40-10 Solitaire™ Platinum Revascularization Device is designed to restore blood flow in patients experiencing ischemic stroke due to large intracranial vessel occlusion. The Solitaire™ Platinum 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™ Platinum Revascularization Device facilitates clot retrieval. The Solitaire™ Platinum Revascularization Device has Platinum Iridium radiopaque markers on the working cell length, proximal and distal ends. The subject Solitaire™ Platinum Revascularization Device is a portfolio expansion to the predicate Solitaire™ Platinum Revascularization Device (K153071).

### Indications for Use:

The Solitaire™ Platinum Revascularization Device is intended to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.

### Device Comparison:

The table below provides a comparison of the technological characteristics associated with the portfolio expansion of the subject 6-40-10 Solitaire™ Platinum Revascularization Device and the predicate Solitaire™ Platinum Revascularization Device (K153071).

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| | Predicate Device<br>Solitaire™ Platinum<br>Revascularization<br>Device (K153071) | Subject Device<br>6-40-10 Solitaire™<br>Platinum<br>Revascularization<br>Device | Rationale for Difference<br>(if applicable) |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for<br>Use | The Solitaire™<br>Platinum<br>Revascularization<br>Device is intended to<br>restore blood flow by<br>removing thrombus<br>from a large<br>intracranial vessel in<br>patients experiencing<br>ischemic stroke<br>within 8 hours of<br>symptom onset.<br>Patients who are<br>ineligible for<br>intravenous tissue<br>plasminogen<br>activator (IV t-PA) or<br>who fail IV t-PA<br>therapy are<br>candidates for<br>treatment. | Same | N/A |
| Principles of<br>Operation | The device is used in<br>the neurovasculature<br>to restore blood flow<br>by removing<br>thrombus. | Same | N/A |
| Method of<br>Supply | Stored within<br>dispenser coil, Tyvek<br>pouch, and shipping<br>carton. | Same | N/A |
| Sterilization<br>Method | Ethylene Oxide | Same | N/A |
| | Predicate Device<br>Solitaire™ Platinum<br>Revascularization<br>Device (K153071) | Subject Device<br>6-40-10 Solitaire™<br>Platinum<br>Revascularization<br>Device | Rationale for Difference<br>(if applicable) |
| Device Size(s) | 4-20-10<br>4-40-10<br>6-20-10 | 6-40-10 | The subject 6-40-10<br>Solitaire™ Platinum<br>Revascularization Device<br>shares similar technological<br>characteristics to the<br>predicate 6-20-10 (6 mm<br>stent diameter) and the 4-40-<br>10 (40 mm stent length) of<br>the predicate Solitaire™<br>Platinum Revascularization<br>Devices. Bench testing has<br>demonstrated that the subject<br>6-40-10 Solitaire™ Platinum<br>Revascularization Device is<br>within the existing ranges of<br>the 4x40 Solitaire devices for<br>device length, radial outward<br>force and delivery /<br>resheathing forces. |
| | | | |
| Stent | Nitinol. | Same | N/A |
| Push-wire | Nitinol. | Same | N/A |
| Distal Marker<br>Coil | 90% Platinum/<br>10% Iridium | Same | N/A |
| Body Finger<br>Marker Coil | 90% Platinum/<br>10% Iridium | Same | N/A |
| Push-wire<br>Shrink Tubing | PTFE | Same | N/A |
| Introducer<br>Sheath | PTFE/Grilamid | Same | N/A |

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## Sterilization and Shelf Life:

The subject 6-40-10 Solitaire™ Platinum Revascularization Device is sterilized using the identical validated, Ethylene Oxide (EO) sterilization cycle as the predicate Solitaire™ Platinum Revascularization Device (K153071). The materials of construction, design, manufacturing process, packaging, and sterile load configurations are identical to the predicate Solitaire™ Platinum Revascularization Device (K153071). Therefore, no additional sterilization validation testing is required.

The subject 6-40-10 Solitaire™ Platinum Revascularization Device and subsequent packaging remain functional and maintain sterility for up to two (2) years. The materials

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of construction, design, manufacturing process, packaging, and sterile load configurations are identical to the predicate Solitaire™ Platinum Revascularization Device (K153071). Therefore, no additional shelf life validation testing is required.

## Biocompatibility:

The subject 6-40-10 Solitaire™ Platinum Revascularization Device does not introduce any new materials into the finished device nor the manufacturing processes. The material of the subject 6-40-10 Solitaire™ Platinum Revascularization Device is identical to the material of the predicate Solitaire™ Platinum Revascularization Device (K153071). Biocompatibility data for the Solitaire device family was tested for the Solitaire™ FR Revascularization Device. The biocompatibility data for the Solitaire™ FR was adopted for the subject 6-40-10 Solitaire™ Platinum Revascularization Device. A summary of the biocompatibility testing completed for the Solitaire™ FR Revascularization Device includes:

| Test<br>Category | Test<br>Description | Method | Acceptance Criteria | Conclusion |
|-------------------------------|---------------------------------------------|--------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| Cytotoxicity | L929 MTT<br>Cytotoxicity | ISO 10993-5 | Viability is $\geq$ 70%. | Acceptance criteria<br>met |
| Sensitization | Guinea Pig<br>Maximization<br>Sensitization | ISO 10993-10 | Test article does not<br>elicit a sensitization<br>response. | Acceptance criteria<br>met |
| Irritation | Intracutaneous<br>Irritation Test | ISO 10993-10 | Differences in the<br>mean test and control<br>scores of the extract<br>dermal observations<br>are $<$ 1.0. | Acceptance criteria<br>met |
| Acute<br>Systemic<br>Toxicity | Acute Systemic<br>Injection Test | ISO 10993-11 | No abnormal clinical<br>signs and weight loss<br>in excess of 10%.<br>Temperature rise<br>$\geq$ 0.5°C | Acceptance criteria<br>met |
| | Materials<br>Mediated<br>Rabbit Pyrogen | | | |
| Test<br>Category | Test<br>Description | Method | Acceptance Criteria | Conclusion |
| Hemo-<br>compatibility | Hemolysis | ISO 10993-4 | No significant differences between the test article extract and negative control article results. The test article is considered non-hemolytic | Acceptance criteria met |
| | Partial Thromboplastin Time | | Clotting times are similar to the negative control and the reference material (HDPE) indicating the device materials are not an activator of the intrinsic coagulation pathway. | |
| | Platelet and Leukocyte Count | | Test article does not adversely affect the platelet and leukocyte components of the blood compared to the reference material. | |
| | Complement Activation C3a and SC5b-9 Assay | | Levels of C3a and SC5b-9 are comparable and less than the positive control. | |
| | Thrombosis | | Thrombo-resistance properties are acceptable in clinical use. | |
| Genotoxicity | Bacterial Mutagenicity Test | ISO 10993-3 | Test article is considered non-mutagenic | Acceptance criteria met |
| | In-vitro Mouse Lymphoma Assay | | Test article is considered non-mutagenic | |
| | In-vivo Mouse Micronucleus Assay | | Test article is considered non-mutagenic | |

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# Performance Data – Bench:

A summary of the non-clinical bench testing performed for the subject 6-40-10 Solitaire™ Platinum Revascularization Device is summarized in the table below.

| Test Description | Method | Acceptance Criteria | Conclusion |
|---------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|-------------------------|
| Total System Length | Total system length was measured from the distal tip of the distal marker to the proximal tip of the delivery system. | The stent length should be adequate for its intended use for delivery via standard microcatheters. | Acceptance criteria met |
| Marker-to-Marker Length | Marker-to-marker length is representative of the total stent length. Total stent length was measured 100% in process. | The stent length should be adequate for its intended use for delivery via standard microcatheters. | Acceptance criteria met |
| Delivery Force | Delivery force was measured through a representative tortuous anatomical model. | The stent must be below delivery force specification. | Acceptance criteria met |
| Resheathing Force | Resheathing force was measured through a representative tortuous anatomical model. | The stent must be below re-sheathing force specification. | Acceptance criteria met |
| Multiple Resheathing Durability | Multiple resheathing durability was evaluated on the ability to withstand delivery and withdrawal forces in a representative tortuous model beyond the recommended number of passes and re-sheathings allowed per the Instructions for Use. | The stent must be able to be deployed and resheathed up to four times. | Acceptance criteria met |
| Body Finger Marker Coil Tensile | Body finger marker coil tensile was performed to verify the strength of the laser weld of the Platinum/Iridium marker coil to the Nitinol body finger. | The body finger marker coil tensile should be greater than or equal to existing tensile strength specification. | Acceptance criteria met |
| Test Description | Method | Acceptance Criteria | Conclusion |
| Radial Force | Radial force was measured 100% in process. | The stent must be within existing radial force specification. | Acceptance criteria met |
| Radiopacity | Radiopacity was verified by both a material and dimensional analyses. | The radiopaque body markers must be visible using standard catheter laboratory equipment. | Acceptance criteria met |
| Ease of Use<br>(Fluorosafe Marker Location) | Ease of use (fluorosafe marker location) was measured from the distal tip of the distal marker to the distal end of the fluorosafe marker. | Less required fluoroscopy is better than more required fluoroscopy. | Acceptance criteria met |
| Particulate | Particulate was evaluated for generation under simulated use in a representative tortuous anatomical model. | The stent must not generate clinically unacceptable particulate. | Acceptance criteria met |

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## Performance Data - Animal:

Non-clinical animal testing was conducted to verify the performance of the subject 6-40-10 Solitaire™ Platinum Revascularization Device. Non-clinical animal testing was conducted to verify the subject 6-40-10 Solitaire™ Platinum Revascularization Device is safe and effective in an in-vivo Yorkshire cross swine model. Four (4) of the following eight (8) proposed target sites were evaluated:

- Right Vertebral ●
- Left Vertebral ●
- Right Internal Thoracic ●
- Left Internal Thoracic ●
- Right Costocervical ●
- Left Costocervical ●
- Renal ●
- Ascending Pharyngeal

Please note the renal and ascending pharyngeal are considered alternative back-up sites depending on the size of the swine, distal target zone diameter, length, consistency of vessel diameter, and the ability to harvest the vessel post procedure.

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Non-clinical animal testing was evaluated at 0-day (acute) and 30-day (chronic) time points. The non-clinical animal testing was designed to show no-clinical inferiority between the control 6-30 Solitaire™ 2 Revascularization Device and the test 6-40-10 Solitaire™ Platinum Revascularization Device. Non-clinical animal testing evaluated the following biological responses of vascular tissue specific to safety:

- . Luminal Thrombus
- Endothelial Cell Coverage
- Inflammation
- Fibrin
- Medial Smooth Muscle Cell (SMC) Loss ●
- Disruption of the Internal Elastic Lamina (IEL) and External Elastic Lamina (EEL)
- . Adventitia
- Neointimal Hyperplasia
- Elastic Fiber Separation ●
- . Lumen Area Reduction

## Performance Testing - Clinical:

## Type of data

A clinical study was not performed for the subject 6-40-10 Solitaire™ Platinum Revascularization Device. Confirmatory clinical data using the cleared 4x40 Solitaire devices (predicate 4-40-10 Solitaire™ Platinum and reference 4-40 Solitaire™ 2) was leveraged to support substantial equivalence of the subject 6-40-10 Solitaire™ Platinum Revascularization Device. Leveraging of the 4x40 Solitaire device confirmatory clinical data is appropriate as the subject 6-40-10 Solitaire™ Platinum Revascularization Device is within the existing ranges of the 4x40 Solitaire devices for device length, radial outward force and delivery / resheathing forces. The confirmatory 4x40 Solitaire clinical data was collected as part of the Systematic Evaluation of Patients TReated with Neurothrombectomy Devices for AcuTe IschemicStroke (STRATIS) Registry.

## STRATIS Registry Design

A prospective, multi-center, non-randomized, observational registry evaluating the use of Covidien market-released neurothrombectomy devices in patients diagnosed with an acute ischemic stroke due to large intracranial vessel occlusion. The study used an independent Clinical Events Committee for adverse event adjudication and an independent Core Lab for procedural image assessment.

### Sample Size

Under the STRATIS Registry, 984 patients were enrolled that were treated with a Medtronic neurothrombectomy device at the discretion of treating physicians and as part of hospital standard practice at 55 sites within the United States. Of the 984 patients treated, a total of 296 were treated using only the cleared 4x40 device. Major patient eligible criteria for consent and enrollment into the Registry were to be treated with the Solitaire device within 8 hours of symptom onset.

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## Confirmatory Clinical Data

The confirmatory clinical data leveraged from the STRATIS Registry 4x40 group included baseline demographics, safety data and performance data and showed that the cleared 4x40 Solitaire device has a similar clinical performance and safety profile to other cleared Solitaire device dimensions.

| STRATIS Registry 4x40 Subgroup | |
|----------------------------------------------------|----------------------------------------|
| Confirmatory Clinical Data | |
| Baseline Demographics | |
| Age (years) | 66.4 ± 15.2 (296)<br>67.0 (58.0, 77.0) |
| NIHSS at baseline | 16.8 ± 5.5 (296)<br>16.0 (12.0, 21.0) |
| Male Gender | 51.4% (152/296) |
| Safety Data | |
| Symptomatic ICH | 2.8% (7/252) |
| Mortality at 90 days | 16.2% (48/296) |
| Performance Data | |
| Successful<br>revascularization<br>(TICI 2b-3) | 90.4% (227/251) |
| Functional<br>Independence (mRS 0-2)<br>at 90 days | 60.3% (167/277) |

## Device Related Serious Adverse Events (SAEs)

| STRATIS Registry 4x40 Subgroup<br>Device-Related SAEs | |
|-------------------------------------------------------|--------------------|
| Study Device-Related<br>SAEs | 0.3% (1/296) [1]** |

** Subarachnoid hemorrhage

### Conclusion

Non-clinical bench, animal testing and the confirmatory clinical data demonstrated that the subject 6-40-10 Solitaire™ Platinum Revascularization Device is substantially equivalent to the predicate Solitaire™ Platinum Revascularization Device (K153071) and does not raise new questions of the safety and effectiveness of the device. Additionally, there are no changes to the indications for use or the fundamental scientific technology of the Solitaire™ Platinum Revascularization Device.