(89 days)
No
The device description and performance studies focus on the mechanical aspects of a revascularization device for stroke treatment, with no mention of AI or ML capabilities.
Yes
The device is indicated for restoring blood flow by removing thrombus in acute ischemic stroke patients, which is a direct therapeutic action to improve patient health.
No
The device description indicates that the Solitaire™ 4 Revascularization Device is designed to restore blood flow by removing thrombus, which is a therapeutic action, not a diagnostic one.
No
The device description clearly states it is a physical device made of nitinol with radiopaque markers, designed for mechanical clot retrieval. It is not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Solitaire™ Revascularization Device is a physical device used inside the body (in the neurovasculature) to mechanically remove blood clots. It does not analyze biological specimens.
- Intended Use: The intended use is to restore blood flow by removing thrombus, a physical intervention, not a diagnostic test performed on a sample.
The description clearly indicates it's a medical device used for a therapeutic procedure within the patient's body.
N/A
Intended Use / Indications for Use
- 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.
Product codes
POL, NRY
Device Description
The Solitaire™ 4 Revascularization Device is designed to restore blood flow in patients experiencing ischemic stroke due to large intracranial vessel occlusion. The Solitaire™ 4 Revascularization Device is designed for use in the neurovasculature such as the Internal Carotid Artery (ICA), M1 and M2 segments of the middle cerebral artery, basilar, and the vertebral arteries. The distal nitinol portion of the Solitaire™ 4 Revascularization Device facilitates clot retrieval and has Platinum/Iridium radiopaque markers on the proximal and distal ends. The Solitaire™ 4 Revascularization Device also features radiopaque markers along the circumference of the working length of the device. The devices are supplied sterile and are intended for single-use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
neurovasculature, Internal Carotid Artery (ICA), M1 and M2 segments of the middle cerebral artery, basilar, and the vertebral arteries, large intracranial vessel
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
Bench tests were performed.
Test: Total System Length, Fluorosafe Marker Length, Delivery Force, Re-Sheathing Force, Particulate, Durability, System Tensile, Torque, Marker Tensile.
Results: Acceptance criteria met for all tests.
No animal or clinical testing was performed.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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January 29, 2019
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Helen Chow, PhD, RAC Senior Specialist. Regulatory Affairs 9775 Toledo Way Irvine, California 92618
Re: K183022
Trade/Device Name: Solitaire™ 4 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: December 21, 2018 Received: December 26, 2018
Dear Helen Chow:
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.
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
1
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 (QS) 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 (Sections 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).
Sincerelv.
Image /page/1/Picture/5 description: The image shows the name "Xiaolin Zheng" in a large, clear font. Below the name, there is a "-S" written in a smaller font size. The background of the image is a light blue color, with a faint FDA logo.
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) K183022
Device Name Solitaire™ 4 Revascularization Device
Indications for Use (Describe)
-
The Solitaire™ Revascularization Device is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ische 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.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary - K183022
| 510(k) Owner: | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
9775 Toledo Way
Irvine, CA 92618
Establishment Registration No. 2029214 |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Helen Chow
Sr. Specialist, Regulatory Affairs
Telephone: (949) 297-5474
E-mail: helen.h.chow@medtronic.com |
| Date Summary Prepared: | October 30, 2018 |
| Trade Name of Device: | Solitaire™ 4 Revascularization Device |
| Common Name of Device: | Neurovascular Mechanical Thrombectomy Device for Acute
Ischemic Stroke Treatment;
Catheter, Thrombus Retriever |
| Classification of Device: | Class II, 21 CFR 882.5600; 21 CFR 870.1250 |
| Product Code: | POL; NRY |
| Predicate Device: | Solitaire™ Platinum Revascularization Device (K181186) |
Device Description:
The Solitaire™ 4 Revascularization Device is designed to restore blood flow in patients experiencing ischemic stroke due to large intracranial vessel occlusion. The Solitaire™ 4 Revascularization Device is designed for use in the neurovasculature such as the Internal Carotid Artery (ICA), M1 and M2 segments of the middle cerebral artery, basilar, and the vertebral arteries. The distal nitinol portion of the Solitaire™ 4 Revascularization Device facilitates clot retrieval and has Platinum/Iridium radiopaque markers on the proximal and distal ends. The Solitaire™ 4 Revascularization Device also features radiopaque markers along the circumference of the working length of the device. The devices are supplied sterile and are intended for singleuse only.
Indications for Use:
-
- 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
4
8 hours of symptom onset. Patients who are ineligible for IV t-PA or who fail IV t-PA therapy are candidates for treatment.
Device Comparison:
A comparison of the technological characteristics of the subject Solitaire™ 4 Revascularization Device and the predicate Solitaire™ Platinum Revascularization Device (K181186) is provided in Table 1. The Solitaire™ 4 Revascularization Device is a design modification of the delivery system to Solitaire™ Platinum. Modifying the delivery system allows for all of the sizes (diameters and lengths) of Solitaire™ 4 to fit through a 0.021'' inner diameter microcatheter.
| Table 1: Device Comparison | |||
|---|---|---|---|
| Predicate Solitaire™ | |||
| Platinum | |||
| Revascularization Device | |||
| (K181186) | Subject Solitaire™ 4 | ||
| Revascularization | |||
| Device | Rationale for Difference | ||
| (if applicable) | |||
| Indication for | |||
| Use | 1. 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. | Same | N/A |
| Principles of
Operation | The device is used in the
neurovasculature to restore | Same | N/A |
| Table 1: Device Comparison | | | |
| | Predicate Solitaire™
Platinum
Revascularization Device
(K181186) | Subject Solitaire™ 4
Revascularization
Device | Rationale for Difference
(if applicable) |
| | blood flow for treatment of
acute ischemic stroke | | |
| Dimensions and Materials | | | |
| Device Size(s) | 4-20-05 mm
4-20-10 mm
4-40-10 mm
6-20-10 mm
6-24-06 mm
6-40-10 mm | 4-20-05 mm
4-20-10 mm
4-40-10 mm
6-20-10 mm
6-24-06 mm
6-40-10 mm | Same |
| Device
Materials | Stent: Nitinol
Pushwire: Nitinol
Markers: 90% Platinum/
10% Iridium
Push-wire shrink Tubing:
PTFE
Introducer Sheath:
PTFE/Grilamid | Same | N/A |
| Sterilization and Packaging | | | |
| Packaging
Materials | Stored within dispenser coil,
Tyvek pouch, and shipping
carton. | Stored within dispenser
coil, Tyvek/Nylon
pouch, and shipping
carton. | The pouch is the only
change in the key packaging
materials. The Nylon/Tyvek
pouch maintains sterility for
the labeled shelf of the
Solitaire™ 4 device. |
| Sterilization
Method | Ethylene Oxide | Same | N/A |
| How Supplied | Sterile, Single Use | Same | N/A |
5
Performance Data:
Biocompatibility:
Solitaire™ 4 does not introduce any new materials into the finished device nor the manufacturing processes. The material of the subject Solitaire™ 4 is identical to the material of the predicate Solitaire™ Platinum (K181186). Therefore, no new biocompatibility evaluations were conducted on the subject device. The prior completed biocompatibility evaluations on the predicate device were used to support the biocompatibility profile of the subject device.
The following non-clinical bench tests were performed to support the Solitaire™ 4 device.
| Test | Test Method Summary | Conclusions |
|---|---|---|
| Total System Length | Total System Length was | |
| measured from the distal tip | ||
| of the distal marker to the | ||
| proximal tip of the delivery | ||
| system. | Acceptance criteria met | |
| Test | Test Method Summary | Conclusions |
| Fluorosafe Marker Length | Fluorosafe marker length | |
| was measured from the | ||
| measurement of the length | ||
| from the distal tip of the | ||
| device to distal end of the | ||
| marker. | Acceptance criteria met | |
| Delivery Force | Delivery force was | |
| measured through a | ||
| representative tortuous | ||
| anatomical model. | Acceptance criteria met | |
| Re-Sheathing Force | Retrieval force was measured | |
| through a representative | ||
| tortuous anatomical model. | Acceptance criteria met | |
| Particulate | Particulate was evaluated for | |
| generation under simulated | ||
| use in a representative | ||
| tortuous anatomical model. | Acceptance criteria met | |
| Durability | Durability was evaluated on | |
| the ability to withstand | ||
| simulated use of the device, | ||
| including delivery, | ||
| resheathing and retrieval in a | ||
| representative tortuous model | ||
| with the appropriate ancillary | ||
| devices. | Acceptance criteria met | |
| System Tensile | Following simulated use, the | |
| tensile force testing is | ||
| performed to verify the | ||
| amount of force it takes to | ||
| detach the device meets the | ||
| acceptance criteria. | Acceptance criteria met | |
| Torque | Torque testing is performed | |
| to verify the stent joint | ||
| withstands a minimum of one | ||
| rotation on the proximal wire | ||
| following simulated use. | Acceptance criteria met | |
| Marker Tensile | Marker tensile strength | |
| testing is performed to verify | ||
| the strength of the laser weld | ||
| of the Pt/Ir marker coil to | ||
| the Nitinol distal finger of | ||
| the device. | Acceptance criteria met |
6
7
Performance Data - Animal, Clinical:
No clinical or animal testing was performed on the subject device because there is no change in the indications for use or the fundamental scientific technology of the device.
Conclusion:
Bench testing confirmed that the modifications to Solitaire™ 4 met product specifications and do not raise new questions on the safety and effectiveness of the device. Additionally, there are no changes to the indications for use or the fundamental scientific technology of the device. Therefore, the subject Solitaire™ 4 Revascularization Device is substantially equivalent to the predicate Solitaire™ Platinum Revascularization Device.