MINDFRAME CAPTURE LP REVASCULARIZATION DEVICE
Device Facts
| Record ID | K141516 |
|---|---|
| Device Name | MINDFRAME CAPTURE LP REVASCULARIZATION DEVICE |
| Applicant | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular |
| Product Code | NRY · Cardiovascular |
| Decision Date | Feb 5, 2015 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1250 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The Capture™ LP 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
Capture™ LP Revascularization Device is a neurothrombectomy tool for ischemic stroke; used by interventional neuroradiologists in clinical settings. Device consists of a laser-cut nitinol stent attached to a nitinol push-wire; features radiopaque markers (Platinum-Iridium/Platinum-Tungsten) for visualization. Physician delivers device through a microcatheter to the occlusion site; stent expands to engage and retrieve thrombus. Output is the physical removal of the clot, restoring blood flow. Device is single-use and sterile. Clinical benefit is the restoration of cerebral perfusion in stroke patients.
Clinical Evidence
No clinical data. Evidence provided via bench testing (tensile, torque, radial force, kink resistance, durability, radiopacity, clot retrieval performance) and animal studies (acute, 30-day, and 90-day chronic studies in swine). Animal studies confirmed successful clot retrieval, sustained blood flow (TIMI 2/3), and comparable arterial response/histopathology to the predicate device.
Technological Characteristics
Laser-cut nitinol stent on nitinol push-wire. Distal markers: 92% Pt/8% W; Proximal markers: 90% Pt/10% Ir. Attachment via laser welding and solder (Gold/Tin). Introduction sheath: HDPE. Dimensions: 3x20mm, 3x30mm, 4x20mm, 4x30mm. Sterilization: Gamma irradiation (SAL 10^-6). Biocompatibility per ISO 10993. Mechanical testing per ASTM F2004-05 (DSC) and ASTM F2096-11 (packaging).
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, requiring thrombus removal from large intracranial vessels.
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™ 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
February 5, 2015
Micro Therapeutics, Inc., d/b/a ev3 Neurovascular Mr. Larry Boucher Senior Regulatory Affairs Specialist 9775 Toledo Way Irvine, California 92618
Re: K141516 Trade/Device Name: MindFrame Capture™ LP Revascularization Device Regulation Number: 21 CFR 870.1250 Regulation Name: Catheter, Thrombus Retriever Regulatory Class: Class II Product Code: NRY Dated: December 24, 2014 Received: January 5, 2015
Dear Mr. Boucher,
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
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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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,
Carlos L. Pena - 50/0
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) K141516
## Device Name
Capture™ LP Revascularization Device
#### Indications for Use (Describe)
The Capture™ LP 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-family: Arial, sans-serif;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: Arial, sans-serif;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |
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# 1. 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: | Larry Boucher<br>Senior Regulatory Affairs Specialist<br>Telephone: (949) 297-9781<br>E-mail: larry.boucher@covidien.com | | |
| Date Summary<br>Prepared: | 28 January 2015 | | |
| Trade Name of<br>Device: | Capture™ LP Revascularization Device | | |
| Common Name of<br>Device: | Catheter, Thrombus Retriever | | |
| Classification of<br>Device: | 21 CFR 870.1250 – Class II | | |
| Predicate Device: | Solitaire™ FR Revascularization Device 510(k)#: K113455 | | |
| Performance Data: | The following bench testing was performed in support of the Capture™ LP Revascularization Device:<br>A f Temperature Testing Radial Force Testing Radiopacity Testing Kink Resistance Testing Dimensional Testing Durability Testing Delivery Force Testing Re-sheathing (withdrawal) Force Testing Component and Attachment (Tensile) Integrity Testing Torque Strength Testing Performance (Clot Retrieval) Testing Physician Usability Testing | | |
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| | Biocompatibility testing, sterilization validation, and a 2-year<br>accelerated aging study were also performed. In addition, an acute and<br>30-day and 90-day chronic animal studies were performed. |
|-------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion: | The Capture™ LP device is substantially equivalent to the Solitaire™<br>FR device based on the successful completion of non-clinical bench and<br>animal testing as well as similar principles of design, operation and<br>indications for use. |
#### Device Description:
The Capture™ LP device is designed to restore blood flow in patients experiencing ischemic stroke due to large intracranial vessel occlusion within 8 hours of symptoms onset. It is indicated for subjects who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy. The distal nitinol portion of the device facilitates clot retrieval and has Platinum -Iridium and Platinum-Tungsten radiopaque markers on the proximal and distal ends respectively. The device is supplied sterile and is intended for single-use only by physicians trained in interventional neuroradiology and treatment of ischemic stroke.
#### Indications for Use:
The ev3 / Covidien Capture™ LP 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 Capture™ LP Revascularization Device and the Solitaire™ FR Revascularization Device.
| Characteristic | Solitaire™ FR | Capture™ LP | Rationale for Difference (If Present) |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use | The Solitaire™ FR 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. | The Capture™ LP 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. | N/A |
| Characteristic | Solitaire™ FR | Capture™ LP | Rationale for Difference (If Present) |
| Sizes Offered | 4x15mm<br>4x20mm<br>6x20mm<br>6x30mm | 3x20mm<br>3x30mm<br>4x20mm<br>4x30mm | The Capture™ LP device is designed to be delivered through a smaller ID (0.432 mm/0.017" inner diameter) micro catheter. |
| Device Design | Laser-cut stent attached to a nitinol push-wire | Laser-cut stent attached to a nitinol push-wire | N/A |
| Distal End Design | "Overlapping" design | Tubular design | The results of bench testing and animal testing establish the equivalency of the Capture™ LP device and the Solitaire™ FR device. |
| Materials | | | |
| Stent | Nitinol | Nitinol | N/A |
| Distal Marker | 90% Platinum/ 10% Iridium | 92% Platinum/ 8% Tungsten | The material used for the Capture™ LP device was shown to be biocompatible per ISO 10993 testing. In addition, the Radiopacity of the material was shown to be equivalent to that of the Solitaire™ FR device through design verification testing. |
| Proximal Marker | 90% Platinum/ 10% Iridium | 90% Platinum/ 10% Iridium | N/A |
| Tip Attachment | Mechanical/Dymax adhesive | Laser welded | The tensile strength of the attachment zone was shown to be equivalent to Solitaire™ FR through design verification testing. |
| Marker Attachment | Laser weld | Solder (Gold/Tin) | The material used for the Capture™ LP device was shown to be biocompatible per ISO 10993 testing. In addition, the tensile strength of the marker attachment was shown to be equivalent to that of the Solitaire™ FR device through design verification testing. |
| Pusher Wire | Nitinol | Nitinol | N/A |
| Introduction Sheath | PTFE | HDPE | The material used for the Capture™ LP device was shown to be biocompatible per ISO 10993 testing. |
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### Sterilization and Shelf Life
The packaged Capture™ LP Revascularization device will be sterilized using a validated gamma irradiation sterilization cycle. The sterilization cycle has been validated to ensure a sterility assurance level (SAL) of 10 ° in accordance with ISO 11137-1/-2, Sterilization of health care products - Radiation sterilization - Substantiation of 25 kGy as a sterilization dose - Method VDmax25.
Aging studies for the Capture™ LP Revascularization Device have established the product and packaging remain functional and maintain sterility for up to 2 years. Aging studies for packaging integrity (per ASTM F2096-11), seal strength and device functionality were performed and met all acceptance criteria.
### Biocompatibility
Biocompatibility testing for the Capture™ LP Revascularization Device was conducted to conform with FDA consensus standard, recognition number 2-156, AAMI/ANSI/ISO 10993-1:2009, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process. The table below summarizes the biocompatibility testing performed on the Capture™ LP device.
| Test | Result | Conclusion |
|----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| Cytotoxicity - L929<br>MEM Elution | The test article scored a "0" (no cytotoxic<br>reaction) at 24, 48, and 72±4 hours | Non -cytotoxic |
| Klingman Maximization<br>Test | No animal challenged with the test article<br>extracts were observed with a sensitization<br>response greater than "0." | Non-sensitizer |
| Intracutaneous Injection<br>Test | The differences between the mean test and<br>control scores of the extract dermal<br>observations were less than 1.0 | Non-irritant |
| Acute Systemic Injection<br>Test – ISO | None of the animals injected with the test<br>article extract show a significantly greater<br>biological reaction than animals treated with<br>the control extract vehicle. | Not systemically toxic |
| Rabbit Pyrogen Test | The difference between the individual<br>rabbit's maximum temperature and<br>baseline temperature was ≤0.5°C. | Non-pyrogenic |
| Complement Activation<br>C3a and SC5b-9 | Test article and control devices exhibited<br>similar activation respective of the<br>normalized C3a and SC5b concentration<br>produced by CVF | Levels of the compliments<br>C3a and SC5b complements<br>were similar for Capture LP<br>and control device |
| Hemolysis: Direct<br>Contact/Extract | The blood had a plasma free hemoglobin<br>level of 0.9455 mg/ml. | Non-hemolytic |
| In Vitro<br>Hemocompatibility/<br>Platelet and Leukocyte | The mean of the three readings for the<br>reference material, negative control,<br>comparison and test articles were within | No adverse effect on platelet<br>and leukocyte counts |
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| Test | Result | Conclusion |
|-------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| Count | ±25% of the respective average values | ±25% of the respective average values |
| Partial Thromboplastin<br>Time | The mean clotting time values for the test<br>article were 90% of the negative control. | No adverse effect on<br>prothrombin coagulation<br>time of human plasma. |
| Thrombosis (In Vivo) –<br>2 dog | Implantation of the test and control<br>devices in the jugular veins resulted in no<br>adverse effects or clinical signs | The Capture LP device and<br>control device have similar<br>thromboresistance<br>characteristics |
| Reverse Mutation Assay<br>(Ames) | None of the tester strains shoes an increase<br>in reversion rates when treated with the<br>test article | Non-mutagenic |
| In Vitro Mouse<br>Lymphoma Assay with<br>Extended Treatment | The mutant frequencies and cloning<br>efficiencies of preparations treated with<br>the test article were within the limits<br>defined for a negative response. | Non-mutagenic |
| In Vivo Mouse<br>Micronucleus Assay | There were no biologically significant<br>increases in mPCE production in the test<br>article treated groups. | Non-mutagenic |
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## Performance Data – Bench
A summary of the pre-clinical bench testing performed for the Capture™ LP Revascularization device is presented in the table below.
| Test | Method | Conclusions |
|----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Total Length | The total length of the device<br>was measured from distal tip to<br>proximal wire | All devices met acceptance<br>criteria. |
| Delivery and Re-sheathing Force<br>Testing | Delivery and re-sheathing force<br>were tested during simulated use<br>in a representative tortuous<br>anatomical model | Delivery and re-sheathing force<br>testing met acceptance criteria.<br>Delivery and re-sheathing force<br>same as predicate. |
| Durability Testing | Device was evaluated for<br>delivery and withdrawal beyond<br>the recommended number of<br>passes and re-sheathings<br>recommended in the IFU. | Devices demonstrated no damage<br>after delivery and withdrawal.<br>Durability same as predicate. |
| Differential Scanning<br>Calorimetry (DSC) Testing | Af Temperature measured using<br>DSC testing per ASTM F2004-<br>05 | The transformational temperature<br>is lowered as the size of the<br>device increases. |
| Kink Resistance Testing | Device was delivered through a<br>bend in a fixture of known radius<br>and then inspected in-place for<br>any kinks or poor wall<br>apposition. | Device was resistant to kinking<br>around small radii turns. Kink<br>radii smaller than predicate due<br>to smaller device size. |
| System Tensile Testing | Fully assembled devices were<br>tested to failure and peak tensile<br>strength recorded. | System tensile testing met<br>acceptance criteria. System<br>tensile strength same as<br>predicate. |
| Markercoil Tensile Strength<br>Testing | Device was tested to determine<br>the tensile strength of the bonds<br>of the distal radiopaque markers | The tensile strength of the distal<br>radiopaque markers met<br>acceptance criteria. The<br>markercoil tensile strength same<br>as predicate. |
| Torque Strength Testing | Device was torqued in a<br>representative tortuous model to<br>determine number of rotations to<br>separate device | Torque strength testing met<br>acceptance criteria. Torque<br>strength same as predicate. |
| Test | Method | Conclusions |
| Radial Force Testing | Radial force testing performed on<br>device within recommended<br>vessel diameters specified in<br>IFU. | Radial force testing of the<br>Capture™ LP device is<br>comparable to the predicate<br>device for the recommended<br>vessel diameters specified in<br>IFU. |
| Radiopacity | Angiography of device taken in<br>porcine model. | Radiopacity of Capture™ LP<br>device equivalent to that of the<br>predicate device. |
| Performance Test (Clot Retrieval<br>Bench Test) | Device was delivered through a<br>tortuous anatomical model to<br>evaluate the effectiveness of the<br>device to retrieve soft and hard<br>clots of various lengths and<br>diameters | Capture™ LP device restored<br>distal blood flow 100% of the<br>time. Performance testing better<br>than predicate device. |
| Physician Usability Testing | The device was delivered in a<br>tortuous benchtop model to assess<br>the users' ability reliably deploy and<br>use the neurothrombectomy device. | Capture™ LP rated similar to the<br>predicate device when used<br>with the Rebar-14 microcatheter. |
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#### Performance Data - Animal
An acute animal study was performed that assessed usability, effectiveness, and safety of the Capture™ LP device as compared to the predicate device. A total of six swine were evaluated for usability effectiveness and safety. Effectiveness was measured by placing manufactured clot in the animal pharyngeal artery and assessing the ability of the device to retrieve the clot and restore blood flow to the target vessel. Safety was assessed by passing the device multiple times through the chose vessel and conducting an angiographic and histopathological evaluation. A summary of the study results is presented in the table below.
| Test | Result | Conclusion |
|------------------------------------------------|--------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Successful Clot Retrieval | The device was deployed to retrieve<br>manufactured clot in the pharyngeal<br>artery of porcine model. | The Capture™ LP device was able<br>to retrieve the manufactured clot in<br>all test animals. Clot recovery is the<br>same as the predicate device. |
| Sustained Flow (TIMI 2 or 3) In<br>Clot Vessel | After clot retrieval, blood flow to the<br>target vessel and distal vasculature<br>was assessed. | Blood flow was assessed with a<br>TIMI score of 2 or 3 for all vessels<br>where the Capture™ LP device was<br>used to retrieve clot. Blood flow<br>restoration the same as that for the<br>predicate device. |
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| Average Number of Passes for Clot | The number of passes to | The number of passes for the |
|-----------------------------------|--------------------------------|----------------------------------------|
| Retrieval | successfully retrieve clot was | Capture™ LP to successfully |
| | evaluated. | retrieve clot from the target vessels |
| | | is equivalent to that of the predicate |
| | | device. |
| | | |
The histological findings observed for both the Capture™ LP and the predicate devices demonstrated that the artery response to neurothrombectomy was comparable between the two devices.
30-day and 90-day chronic animal studies were performed to evaluate the usability and safety of the Capture™ LP device. In each study, the device was deployed and recovered in the vasculature of the swine test subjects and angiographic and histopathologic assessments were performed for vessel damage, thrombus formation, and vasospasm. Angiographic visualization during the procedure and just prior to subject sacrifice demonstrated that there was no wall damage or thrombus formation during the treatment. Histopathologic evaluation demonstrated that the artery response to the neurothrombectomy procedure was considered to be comparable between the Capture™ LP device and the predicate device.
#### Performance Testing - Clinical
Substantial equivalence of the Capture™ LP Revascularization Device has been established to the predicate device through the results of bench and animal testing. Equivalence has also been established through an evaluation of the indications for use, performance specifications, packaging, and the fundamental scientific technology. Therefore, clinical data is not required for the Capture™ LP device.
