Solitaire Platinum Revascularization Device
Device Facts
| Record ID | K161879 |
|---|---|
| Device Name | Solitaire Platinum Revascularization Device |
| Applicant | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular |
| Product Code | NRY · Cardiovascular |
| Decision Date | Sep 21, 2016 |
| 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
The Solitaire™ Platinum Revascularization Device is a catheter-based thrombus retriever used by physicians in clinical settings to treat ischemic stroke. The device is navigated through the neurovasculature to the site of a large intracranial vessel occlusion. Once positioned, the device is deployed to engage and remove the thrombus, thereby restoring blood flow. The device features radiopaque markers for fluoroscopic visualization during the procedure. It is designed for use in patients who are ineligible for or have failed IV t-PA therapy. The device is supplied sterile and is intended for single use. By mechanically removing the clot, the device aims to improve clinical outcomes for stroke patients.
Clinical Evidence
No clinical data was performed. Substantial equivalence is supported by non-clinical bench testing, including delivery force, re-sheathing force, multiple re-sheathing durability, body marker tensile strength, radiopacity, and radial force measurements, alongside leveraged biocompatibility data from the predicate device.
Technological Characteristics
The device consists of a Nitinol revascularization stent/retriever and push-wire. Materials include Nitinol, 90% Platinum/10% Iridium markers, PTFE shrink tubing, and Dymax 1128A-M-T adhesive. It is a catheter-based system for neurovascular use. Sterilization is via Ethylene Oxide. The device is designed for manual operation under fluoroscopic guidance.
Indications for Use
Indicated for patients experiencing ischemic stroke within 8 hours of symptom onset, specifically those ineligible for or failing IV t-PA therapy, requiring thrombus removal from large intracranial vessels (e.g., internal carotid, middle cerebral, basilar, or 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™ Platinum Revascularization Device (K153071)
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
September 21, 2016
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Mr. Ryan Kenney Product Specialist, Regulatory Affairs 9775 Toledo Way Irvine, California 92618
Re: K161879
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: August 19, 2016 Received: August 22, 2016
Dear Mr. Kenney:
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/Resourcesfor You/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.
# Michael J.Hoffmann -A
for Carlos L. Peña, Ph.D., M.S. 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) K161879
#### 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)
| | Prescription Use (Part 21 CFR 801 Subpart D) |
|--|----------------------------------------------|
| | Over-The-Counter Use (21 CFR 801 Subpart C) |
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#### K161879 510(k) Summary
| 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: | Ryan Kenney<br>Product Specialist, Regulatory Affairs<br>Telephone: (949) 297-5489<br>E-mail: ryan.j.kenney@medtronic.com |
| Date Summary<br>Prepared: | September 08, 2016 |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name of<br>Device: | Solitaire™ Platinum Revascularization Device |
| Common Name of<br>Device: | Catheter, Thrombus Retriever |
| Classification of<br>Device: | 21 CFR 870.1250 – Class II |
| Product Code: | NRY |
| Predicate Device: | Solitaire™ Platinum Revascularization Device<br>510(k)#: K153071 |
| Performance Data: | The following performance testing was performed to support the<br>subject 4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization<br>Devices:<br>Delivery Force Testing Re-Sheathing Force Testing Multiple Re-Sheathing Durability Body Marker Tensile Body Marker Radiopacity (in-process) Proximal Marker Band to Distal Marker Band (in-process) Af Temperature (in-process) Radial Force (in-process) The following performance testing was leveraged from the predicate<br>device: Total System Length Kink Resistance Distal Finger Marker Coil and Push-wire Tensile Clot Retrieval and Device Recovery Durability Torque Response Torque Strength Radiopacity (Fluoroscopic Visualization Distal Finger Marker Coil) Fluorosafe Marker Location |
| | Biocompatibility Particulate |
| | The materials of construction, design, and packaging process for this<br>portfolio expansion of the subject 4-20-05 and 6-24-06 SolitaireTM<br>Platinum Revascularization Devices (K161879) are equivalent to the<br>predicate SolitaireTM Platinum Revascularization Device (K153071). |
| | In addition, the manufacturing process of the subject 4-20-05 and 6-<br>24-06 SolitaireTM Platinum Revascularization Devices (K161879) is<br>equivalent to the predicate SolitaireTM Platinum Revascularization<br>Device (K153071). Therefore; no additional biocompatibility,<br>sterilization, packaging, or shelf life validations are required. |
| | Non-clinical bench testing confirmed that the portfolio expansion of<br>the subject 4-20-05 and 6-24-06 SolitaireTM Platinum<br>Revascularization Devices do not introduce new risks or increase<br>existing risks. |
| Conclusion: | The subject 4-20-05 and 6-24-06 SolitaireTM Platinum<br>Revascularization Devices (K161879) are substantially equivalent to<br>the predicate SolitaireTM Platinum Revascularization Device<br>(K153071) based on non-clinical bench testing, similarities in<br>design, principles of operation, and indications for use. |
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## Device Description:
The subject 4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization Devices are 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.
## 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 following table provides a comparative of the technological characteristics associated with the portfolio expansion of the subject 4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization Devices (K161879) and the predicate Solitaire™ Platinum Revascularization Device (K153071).
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| | Predicate Device | Subject Devices | Rationale for Difference<br>(if applicable) |
|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Solitaire™ Platinum<br>Revascularization<br>Device<br>(K153071) | 4-20-05 and 6-24-06<br>Solitaire™ Platinum<br>Revascularization<br>Devices<br>(K161879) | |
| Indication for Use | The Solitaire™ 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 as K153071. | N/A. |
| Method of<br>Supply | Stored within<br>dispenser coil, Tyvek<br>pouch, and shipping<br>carton. | Same as K153071. | N/A. |
| Sterilization<br>Method | Ethylene Oxide | Same as K153071. | N/A. |
| Device Size(s) | 4-20-10<br>4-40-10<br>6-20-10 | 4-20-05<br>6-24-06 | The subject devices share<br>identical technological<br>characteristics to the<br>predicate device. Non-<br>clinical bench testing has<br>demonstrated that the<br>devices do not raise<br>questions about the safety<br>and effectiveness. |
| Materials | | | |
| | Predicate Device<br>Solitaire™ Platinum<br>Revascularization<br>Device<br>(K153071) | Subject Devices<br>4-20-05 and 6-24-06<br>Solitaire™ Platinum<br>Revascularization<br>Devices<br>(K161879) | Rationale for Difference<br>(if applicable) |
| Solitaire™<br>Platinum Non-<br>Detachable EP | Nitinol | Same as K153071. | N/A |
| Push-wire | Nitinol | Same as K153071. | N/A |
| Proximal Coil | 90% Platinum/<br>10% Iridium | Same as K153071. | N/A |
| Body Marker | N/A | 90% Platinum/<br>10% Iridium. | Same material as the Body<br>Finger Marker Coil. |
| Body Finger<br>Marker Coil | 90% Platinum/<br>10% Iridium | N/A | Not a design feature of the<br>subject devices. |
| Distal Finger<br>Marker Coil | 90% Platinum/<br>10% Iridium | Same as K153071. | N/A |
| Push-wire<br>Shrink Tubing | PTFE | Same as K153071. | N/A |
| Dymax Glue | Dymax 1128A-M-T | Same as K153071. | N/A |
| Guidewire Clip | UV Curing Adhesive | Same as K153071. | N/A |
| Dispenser Coil | HDPE, ID Coated<br>with Hydro-Sil 2000 | Same as K153071. | N/A |
| Stent<br>Introducer<br>Sheath | PTFE/Grilamid | Same as K153071. | N/A |
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## Sterilization and Shelf Life:
The subject 4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization Devices are sterilized using the identical validated, Ethylene Oxide (EO) sterilization cycle as the predicate Solitaire™ Platinum Revascularization Device. The materials of construction, design, manufacturing process, sterilization load configuration and packaging process for this portfolio expansion of the subject 4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization Devices are equivalent to the predicate Solitaire™ Platinum Revascularization Device. The packaging of the subject 4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization Devices remains functional and maintain sterility for up to two (2) years. Therefore, no additional sterilization or shelf life validation testing is required for the subject 4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization Devices.
## Biocompatibility:
The subject 4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization Devices do not introduce any new materials into the finished device or the manufacturing process. The material of construction for the subject 4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization Devices are identical to the predicate Solitaire™ Platinum
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Revascularization Device. Biocompatibility was leveraged from the predicate Solitaire™ Platinum Revascularization Device in support of the subject 4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization Devices. A summary of the biocompatibility testing leveraged for the subject 4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization Devices is summarized in the table below.
| Test<br>Category | Test<br>Description | Method | Acceptance<br>Criteria | Conclusion |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Cytotoxicity | L929 MTT<br>Cytotoxicity | ISO 10993-5 | Viability is ≥70%. | The subject 4-20-05<br>and 6-24-06 devices<br>met the acceptance<br>criteria for ISO<br>10993-5 and are<br>substantially<br>equivalent to the<br>predicate device. |
| Sensitization | Guinea Pig<br>Maximization<br>Sensitization | ISO 10993-10 | Test article does not<br>elicit a sensitization<br>response. | The subject 4-20-05<br>and 6-24-06 devices<br>met the acceptance<br>criteria for ISO<br>10993-10 and are<br>substantially<br>equivalent to the<br>predicate device. |
| 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. | The subject 4-20-05<br>and 6-24-06 devices<br>met the acceptance<br>criteria for ISO<br>10993-10 and are<br>substantially<br>equivalent to the<br>predicate device. |
| Acute<br>Systemic<br>Toxicity | Acute Systemic<br>Injection Test<br>Materials<br>Mediated<br>Rabbit Pyrogen | ISO 10993-11 | No abnormal clinical<br>signs and weight loss<br>in excess of 10%.<br>Temperature rise<br>≥0.5°C | The subject 4-20-05<br>and 6-24-06 devices<br>met the acceptance<br>criteria for ISO<br>10993-11 and are<br>substantially<br>equivalent to the<br>predicate device. |
| 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 | The subject 4-20-05 and 6-24-06 devices met the acceptance criteria for ISO 10993-4 and are substantially equivalent to the predicate device. |
| | 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 | The subject 4-20-05 and 6-24-06 devices met the acceptance criteria for ISO 10993-3 and are substantially equivalent to the predicate device. |
| | <i>In-vitro</i> Mouse Lymphoma Assay | | Test article is considered non-mutagenic | |
| | <i>In-vivo</i> Mouse Micronucleus Assay | | Test article is considered non-mutagenic | |
| | | | | |
| Test Description | Method | Acceptance Criteria | Conclusion | |
| Delivery Force | Peak delivery force was<br>measured through a<br>representative tortuous<br>anatomical model. | Stent must be<br>below delivery<br>force specification. | The subject 4-20-05 and 6-24-<br>06 devices met the acceptance<br>criteria for delivery force and<br>are substantially equivalent to<br>the predicate device. | |
| Re-sheathing<br>Force | Retrieval force was<br>measured through a<br>representative tortuous<br>anatomical model. | Stent must be<br>below re-sheathing<br>force specification. | The subject 4-20-05 and 6-24-<br>06 devices met the acceptance<br>criteria for re-sheathing force<br>and are substantially<br>equivalent to the predicate<br>device. | |
| Multiple Re-<br>sheathing<br>Durability | Samples were<br>evaluated on their<br>ability to withstand<br>delivery and<br>withdrawal forces in a<br>representative tortuous<br>model beyond the<br>recommended number<br>of passes and re-<br>sheathings allowed per<br>the Instructions for Use<br>(IFU). | The subject 4-20-<br>05 and 6-24-06<br>devices must<br>reliably deploy and<br>resheath up to four<br>(4) times. | The subject 4-20-05 and 6-24-<br>06 devices showed no<br>irregularities, breaks, kinks,<br>body marker migration, glue<br>separations, or other observed<br>defects after all deployment<br>and resheathing attempts.<br>The subject 4-20-05 and 6-24-<br>06 devices met the acceptance<br>criteria for multiple re-<br>sheathing durability and are<br>substantially equivalent to the<br>predicate device. | |
| Body Marker<br>Tensile | Body Marker tensile<br>strength testing is<br>performed to verify the<br>strength of the laser<br>weld of the<br>Platinum/Iridium<br>markercoil to the<br>Nitinol distal finger of<br>the device. | Body marker<br>should be greater<br>than or equal to<br>existing tensile<br>strength<br>specification. | The subject 4-20-05 and 6-24-<br>06 devices met acceptance<br>criteria for body marker<br>tensile and are substantially<br>equivalent to the predicate<br>device. | |
| Test Description | Method | Acceptance<br>Criteria | Conclusion | |
| Body Marker<br>Radiopacity | Verification analysis of<br>body markers. | The radiopaque<br>body markers must<br>be visible using<br>standard catheter<br>laboratory<br>equipment | The subject 4-20-05 and 6-24-<br>06 devices met acceptance<br>criteria for body marker<br>radiopacity and are<br>substantially equivalent to the<br>predicate device. | |
| Proximal Marker<br>to Distal Marker | The length of the laser<br>cut and electro-<br>polished stents are<br>measured 100% in<br>process. | Length of stent<br>must meet all<br>inspection criteria | The subject 4-20-05 and 6-24-<br>06 devices met acceptance<br>criteria for proximal marker to<br>distal marker and are<br>substantially equivalent to the<br>predicate device. | |
| A f Temperature | In-process 100%<br>tracking of heat set<br>parameters used to set<br>final Af | Temperature<br>should be less than<br>or equal to existing<br>A f temperature<br>specification. | The subject 4-20-05 and 6-24-<br>06 Solitaire™ Platinum<br>Revascularization Devices<br>met acceptance criteria for Af<br>and are substantially<br>equivalent to the predicate<br>device. | |
| Radial Force | The radial force was<br>measured 100% in-<br>process. | Stent must be<br>within existing<br>radial force<br>specification. | Radial force was measured<br>100% in-process.<br>The subject 4-20-05 and 6-24-<br>06 devices met acceptance<br>criteria for radial force and<br>are substantially equivalent to<br>the predicate device. | |
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## Performance Data – Bench:
A summary of the bench testing performed for the subject 4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization Devices is summarized in the table below.
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## Performance Data – Animal:
The subject 4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization Devices do not change the indications for use or the fundamental scientific technology of the predicate Solitaire™ Platinum Revascularization Device. Therefore, no additional non-clinical animal testing was performed for the subject 4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization Devices.
#### Performance Testing - Clinical:
The subject 4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization Devices do not change the indications for use or the fundamental scientific technology of the predicate device. The subject 4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization Devices are substantially equivalent to the predicate Solitaire™ Platinum Revascularization Device and do not raise new questions of the safety and effectiveness of the subject 4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization Devices. Therefore, no additional clinical study was performed.
