(175 days)
Not Found
No
The device description and performance studies focus on the mechanical aspects of a revascularization device and do not mention any AI or ML components or functionalities.
Yes
The device is indicated for restoring blood flow by removing thrombus for the treatment of acute ischemic stroke, which directly addresses a medical condition to improve health.
No
The device is a revascularization device designed to remove thrombus and restore blood flow in the neurovasculature, which is a therapeutic function, not a diagnostic one. Its purpose is treatment, not diagnosis. While it acts on a medical condition, it does not assess or identify a condition.
No
The device description clearly describes a physical, implantable medical device made of nitinol and platinum/iridium, designed for mechanical thrombus removal. The submission is for labeling modifications and accessory updates, not for a software component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Solitaire™ Platinum Revascularization Device is a physical device designed to be inserted into the neurovasculature to mechanically remove blood clots. It directly interacts with the patient's anatomy and does not analyze samples taken from the body.
- Intended Use: The intended use is to restore blood flow by removing thrombus, which is a therapeutic intervention, not a diagnostic test performed on a sample.
- Device Description: The description focuses on the physical characteristics and function of the device for clot retrieval within the blood vessels.
Therefore, the Solitaire™ Platinum Revascularization Device is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
- The Solitaire™ Platinum Revascularization Device is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion, and smaller core infarcts who have first received intravenous tissue plasminogen activator (IV t-PA). Endovascular therapy with the device should be started within 6 hours of symptom onset.
- The Solitaire™ Platinum Revascularization Device is indicated to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for IV t-PA or who fail IV t-PA therapy are candidates for treatment.
Product codes (comma separated list FDA assigned to the subject device)
POL, NRY
Device Description
The Solitaire™ Platinum Revascularization Device is designed to restore blood flow by removing thrombus 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, 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 features an "overlap-design." The Solitaire™ Platinum Revascularization Device is designed with Platinum/Iridium radiopaque markers on the proximal and distal ends. In addition, the Solitaire™ Platinum Revascularization Device features radiopaque markers along the circumference of the working length. The Solitaire™ Platinum Revascularization Device is supplied sterile and intended for single-use.
The purpose of this submission is to modify the labeling for the subject Solitaire™ Platinum Revascularization Device to increase the number of flow restoration recoveries per device, align the minimum recommended vessel diameter across all models, and to update the list of optional accessories to include a guide catheter (minimum 5F).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Neurovasculature; internal carotid artery, M1 and M2 segments of the middle cerebral artery, basilar, and the vertebral arteries.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Data - Bench:
- Durability – Multiple Resheathing Cycles: Durability is performed to demonstrate that the device is able to withstand multiple resheathing cycles through a clinically relevant model. The Solitaire™ Platinum Revascularization Device met the acceptance criteria for resheathing durability.
- Simulated-Use: Simulated-use is performed to ensure the device is subjected to testing (e.g., delivery force) through a clinically relevant model. The Solitaire™ Platinum Revascularization Device met the individual acceptance criteria for simulated-use.
- Tensile Strength (Total System and Marker Band): Tensile strength is performed to obtain a quantitative measurement for the strength of the total system and the body markers. The Solitaire™ Platinum Revascularization Device met the acceptance criteria for tensile strength.
- Simulated clot retrieval testing: Clot retrieval performance of the subject device with 5F guide catheter was evaluated on multiple clot morphologies in a clinically relevant model. Clot retrieval performance of the subject device with a 5F guide catheter was substantially equivalent to the predicate testing with balloon guide catheter.
Performance Data - Animal:
Non-clinical animal testing was performed to evaluate the safety and usability of the reference Solitaire™ Platinum Revascularization Device in comparison to the predicate Solitaire™ 2 Revascularization Device at both acute and chronic time points in a porcine model. Non-clinical animal testing was performed in accordance with 21 CFR Part 58 for Good Laboratory Practice (GLP) for Non-Clinical Laboratory Studies.
The subject Solitaire™ Platinum Revascularization Device shares same the fundamental scientific technology as the predicate Solitaire™ 2 Revascularization Device and reference Solitaire™ Platinum Revascularization Device. Therefore, additional non-clinical animal testing was not performed for the subject Solitaire™ Platinum Revascularization Device. An analysis of previous non-clinical animal testing was used to support the modified labeling.
Performance Testing - Clinical:
The subject Solitaire™ Platinum Revascularization Device does not change the fundamental scientific technology of the predicate Solitaire™ 2 Revascularization Device.
The subject Solitaire™ Platinum Revascularization Device is substantially equivalent to the predicate Solitaire™ 2 Revascularization Device and does not raise new questions of the safety and effectiveness. A subgroup analysis of the clinical data from SWIFT PRIME was summarized to provide further confirmatory support of the modified labeling.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K162539, K153071, K161879, K160641
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.5600 Neurovascular mechanical thrombectomy device for acute ischemic stroke treatment.
(a)
Identification. A neurovascular mechanical thrombectomy device for acute ischemic stroke treatment is a prescription device used in the treatment of acute ischemic stroke to improve clinical outcomes. The device is delivered into the neurovasculature with an endovascular approach, mechanically removes thrombus from the body, and restores blood flow in the neurovasculature.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The patient contacting components of the device must be demonstrated to be biocompatible.
(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including:
(i) Mechanical testing to demonstrate the device can withstand anticipated tensile, torsional, and compressive forces.
(ii) Mechanical testing to evaluate the radial forces exerted by the device.
(iii) Non-clinical testing to verify the dimensions of the device.
(iv) Non-clinical testing must demonstrate the device can be delivered to the target location in the neurovasculature and retrieve simulated thrombus under simulated use conditions.
(v) Non-clinical testing must demonstrate the device is radiopaque and can be visualized.
(vi) Non-clinical testing must evaluate the coating integrity and particulates under simulated use conditions.
(vii) Animal testing must evaluate the safety of the device, including damage to the vessels or tissue under anticipated use conditions.
(3) Performance data must support the sterility and pyrogenicity of the patient contacting components of the device.
(4) Performance data must support the shelf-life of the device by demonstrating continued sterility, package integrity, and device functionality over the specified shelf-life.
(5) Clinical performance testing of the device must demonstrate the device performs as intended for use in the treatment of acute ischemic stroke and must capture any adverse events associated with the device and procedure.
(6) The labeling must include:
(i) Information on the specific patient population for which the device is intended for use in the treatment of acute ischemic stroke, including but not limited to, specifying time from symptom onset, vessels or location of the neurovasculature that can be accessed for treatment, and limitations on core infarct size.
(ii) Detailed instructions on proper device preparation and use for thrombus retrieval from the neurovasculature.
(iii) A summary of the clinical testing results, including a detailed summary of the device- and procedure-related complications and adverse events.
(iv) A shelf life.
0
Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services logo. The logo on the right is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.
October 25, 2018
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Helen Chow. Ph.D., RAC Senior Specialist, Regulatory Affairs 9775 Toledo Way Irvine, California 92618
Re: K181186
Trade/Device Name: Solitaire Platinum Revascularization Device Regulation Number: 21 CFR 882.5600 Regulation Name: Neurovascular Mechanical Thrombectomy Device for Acute Ischemic Stroke Treatment Regulatory Class: Class II Product Code: POL, NRY Dated: September 25, 2018 Received: September 26, 2018
Dear Helen Chow, Ph.D., RAC:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Xiaolin Zheng -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
2
Indications for Use
510(k) Number (if known) K181186
Device Name Solitaire™ Platinum Revascularization Device
Indications for Use (Describe)
-
The Solitaire™ Platinum Revascularization Device is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion, and smaller core infarcts who have first received intravenous tissue plasminogen activator (IV t-PA). Endovascular therapy with the device should be started within 6 hours of symptom onset.
-
The Solitaire™ Platinum Revascularization Device is indicated to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for IV t-PA or who fail IV t-PA therapy are candidates for treatment.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary: K181186
| 510(k) Owner: | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | |
|---|---|---|
| 9775 Toledo Way | ||
| Irvine, CA 92618 | ||
| Establishment Registration No. 2029214 | ||
| Contact: | Helen Chow | |
| Senior Regulatory Affairs Specialist | ||
| Telephone: (949) 297-5474 | ||
| E-mail: helen.h.chow@medtronic.com | ||
| Date Summary | ||
| Prepared: | September 25, 2018 | |
| Trade Name of | ||
| Device: | Solitaire™ Platinum Revascularization Device | |
| Common Name of | ||
| Device: | Neurovascular Mechanical Thrombectomy Device for Acute | |
| Ischemic Stroke Treatment | ||
| Catheter, Thrombus Retriever | ||
| Classification of | ||
| Device: | 21 CFR 882.5600 – Class II | |
| 21 CFR 870.1250 – Class II | ||
| Product Code(s): | POL | |
| NRY | ||
| Primary Predicate | ||
| Device: | Solitaire™ 2 Revascularization Device | |
| 510(k)#: K162539 | ||
| Additional Predicate | ||
| Device(s): | Solitaire™ Platinum Revascularization Device | |
| 510(k)#: K153071 K161879 K160641 |
Device Description:
The Solitaire™ Platinum Revascularization Device is designed to restore blood flow by removing thrombus 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, 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 features an "overlap-design." The Solitaire™ Platinum Revascularization Device is designed with Platinum/Iridium radiopaque markers on the proximal and distal ends. In addition, the Solitaire™ Platinum Revascularization Device features radiopaque markers along the circumference of the working length. The Solitaire™ Platinum Revascularization Device is supplied sterile and intended for single-use.
The purpose of this submission is to modify the labeling for the subject Solitaire™ Platinum Revascularization Device to increase the number of flow restoration recoveries per device, align the minimum recommended vessel diameter across all models, and to update the list of optional accessories to include a guide catheter (minimum 5F).
Indications for Use:
4
-
- The Solitaire™ Platinum Revascularization Device is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion, and smaller core infarcts who have first received intravenous tissue plasminogen activator (IV t-PA). Endovascular therapy with the device should be started within 6 hours of symptom onset.
-
- The Solitaire™ Platinum Revascularization Device is indicated to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for IV t-PA or who fail IV t-PA therapy are candidates for treatment.
| | Primary Predicate
Solitaire™ 2
Revascularization Device | Additional Predicate
Solitaire™ Platinum
Revascularization Device | Subject
Solitaire™ Platinum
Revascularization Device |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|
| Device
Classification | Class II, POL/NRY | Class II, NRY | Same as Primary Predicate |
| Indication for
Use (IFU)
Statement | The Solitaire™
Revascularization Device is
indicated for use to restore
blood flow in the
neurovasculature by removing
thrombus for the treatment of
acute ischemic stroke to
reduce disability in patients
with a persistent, proximal
anterior circulation, large
vessel occlusion, and smaller
core infarcts who have first
received intravenous tissue
plasminogen activator (IV t-
PA). Endovascular therapy
with the device should be
started within 6 hours of
symptom onset.
The Solitaire™
Revascularization Device is
indicated to restore blood flow
by removing thrombus from a
large intracranial vessel in
patients experiencing ischemic
stroke within 8 hours of
symptom onset. Patients who
are ineligible for IV t-PA or
who fail IV t-PA therapy are
candidates for treatment. | 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. | Same as Primary Predicate |
Device Comparison:
5
| Method of
| Supply | Stored within dispenser coil, Tyvek pouch, and shipping carton | Same | Same |
|---|---|---|---|
| Sterilization | |||
| Method | Ethylene Oxide | Same | Same |
| Device Sizes | 4-15 | ||
| 4-20 | |||
| 4-40 | |||
| 6-20 | |||
| 6-30 | 4-20-10 | ||
| 4-40-10 | |||
| 6-20-10 | |||
| 4-20-05 | |||
| 6-24-06 | |||
| 6-40-10 | Same as Additional Predicate | ||
| Material | |||
| Push Wire | Nitinol | Same | Same |
| Shrink Tube | PTFE | Same | Same |
| Proximal Coil | Platinum/Iridium | Same | Same |
| Marker Band | Platinum/Iridium | Same | Same |
| Shrink Tube | PTFE | Same | Same |
| Introducer | |||
| Sheath | Grilamid PTFE | Same | Same |
| Stent | Nitinol | Same | Same |
| Distal Marker | |||
| Coil | Platinum/Iridium | Same | Same |
| Body Markers | N/A | Platinum/Iridium | Same as Additional predicate |
Aside from the modified labeling, there have been no changes to the subject Solitaire™ Platinum Revascularization Device from the additional predicate Solitaire™ Platinum Revascularization Device (K153071, K161879 and K160641). In addition, the design modifications implemented into the additional predicate Solitaire™ Platinum Revascularization Device have been determined to be substantially equivalent to the primary predicate Solitaire™ 2 Revascularization Device (K162539).
Since the device design, materials, and manufacturing were not changed in the subject 510(k) submission, biocompatibility, sterilization, shelf-life, bench performance data, animal performance data, and clinical performance data were leveraged from the primary and additional predicate devices.
Performance Data - Bench:
The following non-clinical bench testing was leveraged to support the modified labeling for the subject Solitaire™ Platinum Revascularization Device.
| Test | Test Method Summary | Results |
|---|---|---|
| Durability – Multiple | ||
| Resheathing Cycles | Durability is performed to | |
| demonstrate that the device is able to | ||
| withstand multiple resheathing cycles | ||
| through a clinically relevant model. | The Solitaire™ Platinum | |
| Revascularization Device met the | ||
| acceptance criteria for resheathing | ||
| durability. | ||
| Simulated-Use | Simulated-use is performed to ensure | |
| the device is subjected to testing (e.g., | The Solitaire™ Platinum | |
| Revascularization Device met the |
6
| Test | Test Method Summary | Results |
|---|---|---|
| delivery force) through a clinically | ||
| relevant model. | individual acceptance criteria for | |
| simulated-use. | ||
| Tensile Strength | ||
| (Total System and | ||
| Marker Band) | Tensile strength is performed to obtain | |
| a quantitative measurement for the | ||
| strength of the total system and the | ||
| body markers. | The Solitaire™ Platinum | |
| Revascularization Device met the | ||
| acceptance criteria for tensile | ||
| strength. | ||
| Simulated clot | ||
| retrieval testing | Clot retrieval performance of the | |
| subject device with 5F guide catheter | ||
| was evaluated on multiple clot | ||
| morphologies in a clinically relevant | ||
| model. | Clot retrieval performance of the | |
| subject device with a 5F guide | ||
| catheter was substantially | ||
| equivalent to the predicate testing | ||
| with balloon guide catheter |
Performance Data - Animal:
Non-clinical animal testing was performed to evaluate the safety and usability of the reference Solitaire™ Platinum Revascularization Device in comparison to the predicate Solitaire™ 2 Revascularization Device at both acute and chronic time points in a porcine model. Non-clinical animal testing was performed in accordance with 21 CFR Part 58 for Good Laboratory Practice (GLP) for Non-Clinical Laboratory Studies.
The subject Solitaire™ Platinum Revascularization Device shares same the fundamental scientific technology as the predicate Solitaire™ 2 Revascularization Device and reference Solitaire™ Platinum Revascularization Device. Therefore, additional non-clinical animal testing was not performed for the subject Solitaire™ Platinum Revascularization Device. An analysis of previous non-clinical animal testing was used to support the modified labeling.
Performance Testing - Clinical:
The subject Solitaire™ Platinum Revascularization Device does not change the fundamental scientific technology of the predicate Solitaire™ 2 Revascularization Device.
The subject Solitaire™ Platinum Revascularization Device is substantially equivalent to the predicate Solitaire™ 2 Revascularization Device and does not raise new questions of the safety and effectiveness. A subgroup analysis of the clinical data from SWIFT PRIME was summarized to provide further confirmatory support of the modified labeling.