(139 days)
Not Found
No
The summary describes a mechanical device for clot retrieval and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML. The focus is on the physical characteristics and performance of the device itself.
Yes.
The device is intended to restore blood flow by removing thrombus in patients experiencing ischemic stroke, which directly treats a medical condition.
No
The device is described as a "Revascularization Device" intended to "restore blood flow by removing thrombus." This indicates a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a physical device ("distal nitinol portion," "Pt-Ir radiopaque markers") used for clot retrieval, and the performance studies involve bench testing and animal studies on a physical device.
Based on the provided text, the Solitaire™ 2 Revascularization 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™ 2 Revascularization Device is a medical device used inside the body to physically remove a thrombus (blood clot) from a blood vessel. It is an interventional device, not a diagnostic test performed on a sample.
- Intended Use: The intended use clearly states it is for "restor[ing] blood flow by removing thrombus from a large intracranial vessel." This is a therapeutic intervention, not a diagnostic process.
Therefore, the Solitaire™ 2 Revascularization Device falls under the category of a therapeutic medical device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Solitaire™ 2 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 (IVt-PA) or fail IVt-PA therapy are candidates for treatment.
Product codes (comma separated list FDA assigned to the subject device)
NRY
Device Description
The Solitaire™ 2 device is designed to restore blood flow in subjects experiencing ischemic stroke due to large intracranial vessel occlusion within 8 hours of symptom 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 Pt-Ir radiopaque markers on the proximal and distal ends.
This purpose of this application is to add one (1) new model number (SFR2-4-40) to the Solitaire™ 2 Revascularization Device family. The additional model will be identical to the currently cleared Solitaire™ 2 4x20 (SFR2-4-20) model, with the exception of a longer retriever length.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench Testing:
- Total System Length: Samples were measured from the proximal tip of the push-wire to the distal-most tip of the finger marker coils. All devices met acceptance criteria.
- Distal Tip to Fluoro Safe Marker Length: Samples were measured from the distal tip of the device to the distal side of the proximal fluoro safe marker. All devices met acceptance criteria.
- Delivery Force: Peak delivery force was measured through a representative tortuous anatomical model. All devices met acceptance criteria. Delivery force same as the predicate device.
- Retrieval Force: Retrieval force was measured through a representative tortuous anatomical model. All devices met acceptance criteria. Retrieval force same as the predicate device.
- Radial Force: The radial force was measured 100% in-process. Radial force was measured 100% in-process on DVT builds.
- Durability: Samples were evaluated on their ability to withstand delivery and withdrawal forces in a representative tortuous model beyond the recommended number of passes and re-sheathings allowed per the IFU. All devices showed no irregularities, breaks, kinks, marker coil migration, glue separations, or other observed defects after all attempts. Durability same as the predicate device.
- Performance: Test samples were evaluated for their ability to restore blood flow and retrieve soft clot from a 4mm vessel and hard clot in a 2mm vessel in a representative tortuous model. All devices successfully retrieved the soft and firm clots from the respective vessels. Performance is the same as the predicate device.
Animal Study:
- Study type: Acute and 30 day animal study.
- Sample size: A total of twelve swine were evaluated, with six (6) swine used for the acute study and six (6) swine used for the chronic 30 day study. A total of 4 vessels per animal were treated with two (2) vessels receiving the control device and two (2) vessels treated with the test device.
- Key results: Histological findings demonstrated that the vessel response to neurothrombectomy was comparable between the two devices with no histological remarkable difference in the vessel in regards to tissue injury, hemorrhagic evaluation and thrombogenic evaluation. Usability was assessed by an interventionalist, and the safety and usability results suggest that the Solitaire™ 2 4x40 device is safe, usable and is equivalent to the predicate device.
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.
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
§ 870.1250 Percutaneous catheter.
(a)
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.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with medicine and healthcare, featuring a staff with a serpent entwined around it.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 22, 2014
Micro Therapeutics, Inc. d/b/a Ev3 Neurovascular Mr. Larry Boucher Sr. Regulatory Affairs Specialist 9775 Toledo Way Irvine, CA 92618
Re: K141491 Trade/Device Name: Solitaire 2 Revascularization Device Regulation Number: 21 CFR 870.1250 Regulation Name: Catheter, Thrombus Retriever Regulatory Class: Class II Product Code: NRY Dated: August 20, 2014 Received: August 21, 2014
Dear Mr. Larry 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
1
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 -SFD/A
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) K141491
Device Name Solitaire 2 Revascularization Device
Indications for Use (Describe)
The Solitaire™ 2 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 (IVt-PA) or fail IVt-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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3
510(k) Summary
| 510(k) Owner: | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
9775 Toledo Way
Irvine, CA 92618
Establishment Registration No. 2029214 |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Larry Boucher
Senior Regulatory Affairs Specialist
Telephone: (949) 297-9781
E-mail: larry.boucher@covidien.com |
| Date Summary
Prepared: | 20 August 2014 |
| Trade Name of
Device: | Solitaire™ 2 Revascularization Device, 4x40mm |
| Common Name of
Device: | Catheter, Thrombus Retriever |
| Classification of
Device: | 21 CFR 870.1250 – Class II |
| Predicate Device: | Solitaire™ 2 Revascularization Device, 510(k)#: K123378
Solitaire™ FR Revascularization Device (Biocompatibility)
510(k)#: K113455 |
| Performance Data: | The following bench testing was performed in support of the
Solitaire™ 2 4x40 device and to establish substantial equivalence to the
Solitaire™ 2 Revascularization Device:
Dimensional Testing Delivery Force Testing Retrieval Force Testing Durability Testing Performance (Clot Retrieval) Testing Radial Force (in-process) The following test data was adopted from the predicate device:
Af Temperature Testing Kink Resistance Testing System Tensile Testing |
4
- . Distal Marker Testing
- Torque Response Testing
- Radiopacity Testing
Biocompatibility, sterilization, and aging data were also adopted from the predicate device as there is no change to the materials of construction, design, manufacturing process, or packaging for the addition of this additional model.
Animal studies were performed to assess the safety and usability of the Solitaire™ 2 4x40 device compared to the previously cleared Solitaire™ 2 4x20 device. No clinical studies were performed as there is no change to the indications for use or the fundamental scientific technology of the device.
- Conclusion: The Solitaire™ 2 4x40 device is substantially equivalent to the currently cleared Solitaire™ 2 device based on the successful completion of non-clinical bench and animal testing as well as similar principles of design, operation and indications for use.
Device Description:
The Solitaire™ 2 device is designed to restore blood flow in subjects experiencing ischemic stroke due to large intracranial vessel occlusion within 8 hours of symptom 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 Pt-Ir radiopaque markers on the proximal and distal ends.
This purpose of this application is to add one (1) new model number (SFR2-4-40) to the Solitaire™ 2 Revascularization Device family. The additional model will be identical to the currently cleared Solitaire™ 2 4x20 (SFR2-4-20) model, with the exception of a longer retriever length.
Indications for Use:
The Solitaire™ 2 Revascularization Device is intended to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
Device Comparison
The table below provides a comparison of the technological characteristics of the Solitaire™ 2 4x40 model and the currently cleared Solitaire™ 2 Revascularization Device.
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| | Solitaire™ 2
(K123378) | Solitaire™ FR
(K113455) | Solitaire™ 2 4x40 | Rationale for
Difference (if
applicable) |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for
Use | The Solitaire™ 2
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 | Same | N/A |
| Method of
Supply | Stored within
dispenser coil, Tyvek
pouch, & shipping
carton | Same | Same | N/A |
| Sterilization
Method | Ethylene Oxide | Same | Same | N/A |
| Device Sizes | 4x15mm
4x20mm
6x20mm
6x30mm | Same | 4x40mm | The difference in size
is due to the extra
working length of the
device. Bench and
animal testing have
demonstrated that the
extra working length
does not affect the
safety and
effectiveness of the
device. |
| Materials | | | | |
| Stent | Nitinol | Same | Same | N/A |
| Push-wire | Nitinol | Same | Same | N/A |
| Markers | 90% Platinum/ 10%
Iridium | Same | Same | N/A |
| Push-wire Shrink
Tubing | PTFE | Same | Same | N/A |
| Introducer Sheath | PTFE/Grilamid | Same | Same | N/A |
6
Sterilization and Shelf Life
The currently cleared Solitaire™ 2 Revascularization Device into the EO sterilization cycle originally cleared under K1113455 for the Solitaire™ FR Revascularization Device. The materials of construction, design, manufacturing process, and packaging are identical to the predicate device. Therefore no additional validation testing is required.
Residual testing for the Solitaire™ 2 4x40mm device was adopted from the Solitaire™ 2 Revascularization Device as the materials of constructions and the manufacturing process are identical to the currently cleared Solitaire™ 2 device. In addition, the surface area of the Solitaire™ 2 4x40mm device is 5.2% less than the currently cleared Solitaire™ 2 6x30mm device.
Aging studies for the Solitaire™ 2 Revascularization Device have established the product and packaging remain functional and maintain sterility for 2 years. Aging studies for packaging integrity (per ASTM F2096-11), seal strength and device functionality were performed and met all acceptance criteria. The materials of construction, design, manufacturing process, and packaging of the Solitaire™ 2 4x40mm device are identical to the predicate device. Therefore the existing aging and packaging data has been adopted for the new model number.
Biocompatibility
Biocompatibility data for the Solitaire device family was tested for the Solitaire™ FR Revascularization device. The biocompatibility data for the Solitaire™ FR device has been adopted for the Solitaire™ 2 4x40mm device as no new materials have been introduced into the manufacturing process or the finished device.
Performance Data – Bench
A summary of the non-clinical bench testing performed for the Solitaire™ 2 4x40mm model is presented in the table below.
| Test | Method | Conclusion |
|---|---|---|
| Total System Length | Samples were measured from | |
| the proximal tip of the push- | ||
| wire to the distal-most tip of | ||
| the finger marker coils. | All devices met acceptance | |
| criteria. | ||
| Distal Tip to Fluoro Safe | ||
| Marker Length | Samples were measured from | |
| the distal tip of the device to | ||
| the distal side of the proximal | ||
| fluoro safe marker. | All devices met acceptance | |
| criteria. |
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| Test | Method | Conclusion |
|---|---|---|
| Delivery Force | Peak delivery force was | |
| measured through a | ||
| representative tortuous | ||
| anatomical model. | All devices met acceptance | |
| criteria. Delivery force same | ||
| as the predicate device. | ||
| Retrieval Force | Retrieval force was measured | |
| through a representative | ||
| tortuous anatomical model. | All devices met acceptance | |
| criteria. Retrieval force same | ||
| as the predicate device. | ||
| Radial Force | The radial force was measured | |
| 100% in-process. | Radial force was measured | |
| 100% in-process on DVT | ||
| builds. | ||
| Durability | Samples were evaluated on | |
| their ability to withstand | ||
| delivery and withdrawal forces | ||
| in a representative tortuous | ||
| model beyond the | ||
| recommended number of | ||
| passes and re-sheathings | ||
| allowed per the IFU | All devices showed no | |
| irregularities, breaks, kinks, | ||
| marker coil migration, glue | ||
| separations, or other observed | ||
| defects after all attempts. | ||
| Durability same as the | ||
| predicate device. | ||
| Performance | Test samples were evaluated | |
| for their ability to restore | ||
| blood flow and retrieve soft | ||
| clot from a 4mm vessel and | ||
| hard clot in a 2mm vessel in a | ||
| representative tortuous model. | All devices successfully | |
| retrieved the soft and firm | ||
| clots from the respective | ||
| vessels. Performance is the | ||
| same as the predicate device. |
Performance Data - Animal
An acute and 30 day animal study was performed that assessed safety and usability of the Solitaire™ 2 4x40 device as compared to the Solitaire 2 4x20 predicate device. A total of twelve swine were evaluated with a total of 3 passes and 6 resheathings across selected sections of vessels, with six (6) swine used for the acute study and six (6) swine used for the chronic 30 day study. A total of 4 vessels per animal were treated with two (2) vessels receiving the control device and two (2) vessels treated with the test device. Safety was evaluated for tissue damage, hemorrhage, and thrombi using angiographic images and histopathological evaluation.
Histological findings of the Solitaire™ 2 4x40 and the predicate device for the acute and chronic study demonstrated that the vessel response to neurothrombectomy was comparable between the two devices with no histological remarkable difference in the vessel in regards to tissue injury, hemorrhagic evaluation and thrombogenic evaluation.
8
Usability for the acute and chronic study were assessed by an interventionalist on the following attributes after each pass: delivery through catheter, ability to position stent retriever at intended target zone, ability to deploy retriever, ability to re-sheath and reposition, ability to retrieve the device through a guide catheter and device condition. The safety and usability results from the acute and 30-day animal studies suggest that the Solitaire™ 2 4x40 device is safe, usable and is equivalent to the predicate device.
Performance Testing - Clinical
No clinical study was performed as there is no change to the indications for use or the fundamental scientific technology for the new model number. Substantial equivalence of the Solitaire™ 2 4x40 device has been established to the predicate device through the results of bench and animal testing.