Solitaire Platinum Revascularization Device
Device Facts
| Record ID | K153071 |
|---|---|
| Device Name | Solitaire Platinum Revascularization Device |
| Applicant | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular |
| Product Code | NRY · Cardiovascular |
| Decision Date | Dec 23, 2015 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 870.1250 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
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 Story
Solitaire™ Platinum is a neurovascular stent retriever designed to restore blood flow in ischemic stroke patients by removing thrombi from large intracranial vessels. The device consists of a nitinol stent with platinum-iridium radiopaque markers on the working cell length, proximal, and distal ends. It is delivered via microcatheter to the occlusion site; the stent expands to engage the thrombus, which is then retrieved. Used in clinical settings (e.g., neuro-interventional suites) by physicians (interventional neurologists/radiologists). The device provides enhanced radiopacity compared to the predicate Solitaire™ 2, allowing better visualization under fluoroscopy during navigation and deployment. This improved visibility assists the physician in precise placement and retrieval, potentially reducing procedure time and improving recanalization success, thereby benefiting patients by restoring cerebral perfusion.
Clinical Evidence
No clinical data provided. Substantial equivalence supported by non-clinical bench testing (delivery/re-sheathing force, durability, tensile strength, radial force, radiopacity verification) and animal usability testing performed by an interventional neurologist.
Technological Characteristics
Nitinol stent retriever with 90% Platinum/10% Iridium radiopaque markers. Dimensions: 4x15mm, 4x20mm, 6x20mm, 6x30mm. Delivery system includes microcatheter/guide catheter compatibility. Sterilization: Ethylene Oxide. Connectivity: None (mechanical device).
Indications for Use
Indicated for patients experiencing ischemic stroke within 8 hours of symptom onset who are ineligible for or failed IV t-PA therapy, for the purpose of restoring blood flow by removing thrombus from large intracranial vessels (internal carotid, M1/M2 middle cerebral, basilar, and vertebral arteries).
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™ 2 Revascularization Device (K123378, K141491)
- Solitaire™ FR Revascularization Device (K113455)
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
December 23, 2015
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Ms. Phuong Chau Senior Regulatory Affairs Product Specialist 9775 Toledo Way Irvine, California 92618
Re: K153071
Trade/Device Name: Solitaire™ Platinum Revascularization Device Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: November 23, 2015 Received: November 25, 2015
Dear Ms. Phuong Chau:
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
# William J. Heetderks -S
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) K153071
#### Device Name
Solitaire™ Platinum Revascularization Device
#### 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)
| <span style="font-size:16px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|------------------------------------------------------------------------------------|
| <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |
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# 510(k) Summary K153071
| 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: | Phuong Chau<br>Senior Regulatory Affairs Product Specialist<br>Telephone: (949) 297-5487<br>E-mail: phuong.chau@medtronic.com | |
| Date Summary Prepared: | December 14, 2015 | |
| Trade Name of Device: | Solitaire™ Platinum Revascularization Device | |
| Common Name of Device: | Catheter, Thrombus Retriever | |
| Classification of Device: | 21 CFR 870.1250 – Class II | |
| Product Code | NRY | |
| Predicate Device: | Solitaire™ 2 Revascularization Device<br>510(k)#: K123378 and K141491 | |
| | Solitaire™ FR Revascularization Device (Biocompatibility)<br>510(k)#: K113455 | |
| Performance Data: | The following bench testing was performed in support of the<br>Solitaire™ Platinum device:<br>Delivery Force Testing Re-sheathing Force Testing Multiple Re-sheathing Durability Body Finger Marker Tensile Body Markers Radiopacity Radial Force (in-process) The following test data was adopted from the predicate device: Total System Length Kink Resistance Total System Tensile | |
- Distal Marker Coil Tensile •
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- Clot Retrieval Bench and Device Recovery Durability
- Torque Response
- Torque Strength
- Radiopacity (Distal Markers)
- Fluorosafe Marker Location .
Biocompatibility, sterilization, and aging data were also adopted from the predicate device as there is no change to the materials of construction, design, manufacturing process, or packaging for the addition of this additional model.
An animal study to assess usability was performed. No animal testing for safety and efficacy or clinical studies were performed as there is no change to the indications for use or the fundamental scientific technology of the device.
- The Solitaire™ Platinum device is substantially equivalent to the Conclusion: currently cleared Solitaire™ 2 and Solitaire™ FR device based on the completion of non-clinical bench testing and animal usability testing as well as similar principles of design, operation and indications for use.
## Device Description:
The Solitaire™ Platinum device is designed to restore blood flow in patients experiencing ischemic stroke due to large intracranial vessel occlusion. The device is designed 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 device facilitates clot retrieval and has Pt-Ir radiopaque markers on the working cell length, proximal and distal ends. The Solitaire™ Platinum device is a modification to the currently cleared Solitaire™ 2 Revascularization Device to increase the working length radiopacity.
#### Indication 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 of the Solitaire™ Platinum device and the currently cleared Solitaire™ 2 Revascularization Device.
| | Solitaire FR<br>(K113455) | Solitaire™ 2<br>(K123378 &<br>K141491) | Solitaire™<br>Platinum | Rationale for<br>Difference<br>(if present) |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|
| Indication for<br>Use | The Solitaire™ FR<br>Revascularization | The Solitaire™ 2<br>Revascularization | Same | N/A |
| Solitaire FR<br>(K113455) | Solitaire™ 2<br>(K123378 &<br>K141491) | Solitaire™<br>Platinum | Rationale for<br>Difference<br>(if present) | |
| 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. | Device is intended<br>to restore blood flow<br>by removing<br>thrombus from a<br>large intracranial<br>vessel in patients<br>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)<br>or who fail IV t-PA<br>therapy are<br>candidates for<br>treatment. | Device is intended to<br>restore blood flow by<br>removing thrombus<br>from a large intracranial<br>vessel in patients experiencing<br>ischemic stroke within 8 hours of<br>symptom onset. Patients who are<br>ineligible for intravenous tissue<br>plasminogen activator (IV t-PA) or<br>who fail IV t-PA therapy are<br>candidates for treatment. | | |
| Stored within<br>dispenser coil, Tyvek<br>pouch, & shipping<br>carton | Stored within<br>dispenser coil,<br>Tyvek pouch, &<br>shipping carton | Same | N/A | |
| Ethylene Oxide | Ethylene Oxide | Same | N/A | |
| 4x15mm<br>4x20mm<br>6x20mm<br>6x30mm | 4x15mm<br>4x20mm<br>4x40mm<br>6x20mm<br>6x30mm | 4x20mm<br>4x40mm<br>6x20mm | The three sizes<br>are within the<br>range of sizes<br>cleared for<br>Solitaire 2 and<br>Solitaire FR. | |
| Materials | | | | |
| Stent | Nitinol | Same | N/A | |
| Push-wire | Nitinol | Same | N/A | |
| Distal Marker<br>Coils | 90% Platinum/ 10%<br>Iridium | Same | N/A | |
| Body Marker<br>Fingers & Coils | N/A | 90% Platinum/<br>10% Iridium Same<br>material as Distal<br>Marker Coils as<br>predicate. | Markers are<br>added to the<br>body of the stent<br>retriever to<br>increase<br>radiopacity.<br>Bench testing<br>has demonstrated<br>that this change<br>does not raise<br>new question on<br>the safety and<br>effectiveness of<br>the device. | |
| | Solitaire FR<br>(K113455) | Solitaire™ 2<br>(K123378 &<br>K141491) | Solitaire™<br>Platinum | Rationale for<br>Difference<br>(if present) |
| Shrink Tubing | | | | |
| Introducer<br>Sheath | PTFE/Grilamid | PTFE/Grilamid | Same | N/A |
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## Sterilization and Shelf Life
The packaged Solitaire™ Platinum device will be sterilized using a validated Ethylene Oxide sterilization cycle. The materials of construction, design, manufacturing process, and packaging are identical to the predicate device. Therefore no additional validation testing is required.
Aging studies for the Solitaire™ 2 Revascularization Device have established the product and packaging remain functional and maintain sterility for up to 2 years. Aging studies for packaging integrity, seal strength and device functionality were performed and met all acceptance criteria. The materials of construction, design, manufacturing process, and packaging of the Solitaire™ Platinum device are identical to the predicate device. Therefore the existing aging and packaging data has been adopted for the Solitaire™ Platinum.
#### Biocompatibility
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 Solitaire™ 2 Revascularization Device. The Solitaire™ Platinum does not introduce any new materials into the finished device or the manufacturing process. Therefore the existing biocompatibility testing data has been adopted for the Solitaire™ Platinum.
#### Performance Data - Bench
A summary of the bench testing performed for the Solitaire™ Platinum is summarized in the table below.
| Test | Method | Conclusion |
|--------------------|-----------------------------------------------------------------------------------------------|-----------------------------------------|
| Delivery Force | Peak delivery force was<br>measured through a<br>representative tortuous<br>anatomical model. | All devices met acceptance<br>criteria. |
| Re-sheathing Force | Retrieval force was measured<br>through a representative<br>tortuous anatomical model. | All devices met acceptance<br>criteria. |
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| Test | Method | Conclusion |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Multiple Re-sheathing<br>Durability | Samples were evaluated on<br>their ability to withstand<br>delivery and withdrawal<br>forces in a representative<br>tortuous model beyond the<br>recommended number of<br>passes and re-sheathings<br>allowed per the IFU | All devices showed no<br>irregularities, breaks, kinks,<br>marker coil migration, glue<br>separations, or other observed<br>defects after all attempts.<br>All devices met acceptance<br>criteria. |
| Body Finger Marker Tensile | Markercoil tensile strength<br>testing is performed to verify<br>the strength of the laser weld<br>of the Pt/Ir markercoil to the<br>Nitinol distal finger of the<br>device. | All devices met acceptance<br>criteria. |
| Radial Force | The radial force was measured<br>100% in-process. | Radial force was measured<br>100% in-process on test<br>builds. All devices met<br>acceptance criteria. |
| Body Markers Radiopacity | Verification analysis of body<br>markers. | All devices met acceptance<br>criteria. |
## Performance Data - Animal
Animal usability testing was performed and assessed by an interventional neurologist on the following attributes after each pass: delivery of the device through the microcatheter, the ability to deploy the retriever, the ability to resheath and redeploy the retriever, the ability to retrieve the device through the guide catheter, the device condition, and the fluoroscopic visibility of the radiopaque body markers.
## Performance Testing – Clinical
No clinical study was performed as there is no change to the indications for use or the fundamental scientific technology for the new model number.
