(62 days)
Not Found
No
The summary describes a mechanical device for clot retrieval and does not mention any software or algorithms that would incorporate AI/ML.
Yes
The device is intended to restore blood flow by removing thrombus in patients experiencing ischemic stroke, which is a direct treatment for a medical condition.
No
This device is designed to treat ischemic stroke by removing thrombus and restoring blood flow, which is a therapeutic function, not a diagnostic one.
No
The device description clearly describes a physical, implantable medical device made of nitinol with radiopaque markers, intended for mechanical clot retrieval. It is not software.
Based on the provided information, the Solitaire™ Platinum 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™ Platinum device is a mechanical device designed to physically remove a thrombus (blood clot) from a blood vessel within the body. It is used in vivo (within the living organism) to restore blood flow.
- Intended Use: The intended use clearly states it's for restoring blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke. This is a therapeutic intervention, not a diagnostic test performed on a sample outside the body.
Therefore, the Solitaire™ Platinum Revascularization Device falls under the category of a medical device used for treatment, not an in vitro diagnostic device used for diagnosis.
N/A
Intended Use / Indications for Use
The Solitaire™ Platinum Revascularization Device is intended to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
Product codes
NRY
Device Description
The Solitaire™ Platinum device is designed to restore blood flow in patients experiencing ischemic stroke due to large intracranial vessel occlusion. The device is designed for use in the neurovasculature such as the internal carotid artery, M1 and M2 segments of the middle cerebral artery, basilar, and the vertebral arteries. The distal nitinol portion of the device facilitates clot retrieval and has Pt-Ir radiopaque markers on the working cell length, proximal and distal ends. The Solitaire™ Platinum device is a modification to the currently cleared Solitaire™ 2 Revascularization Device to increase the working length radiopacity.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
large intracranial vessel, 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: The following bench testing was performed in support of the Solitaire™ Platinum device: Delivery Force Testing Re-sheathing Force Testing Multiple Re-sheathing Durability Body Finger Marker Tensile Body Markers Radiopacity Radial Force (in-process) The following test data was adopted from the predicate device: Total System Length Kink Resistance Total System Tensile - Distal Marker Coil Tensile • Clot Retrieval Bench and Device Recovery Durability - Torque Response - Torque Strength - Radiopacity (Distal Markers) - Fluorosafe Marker Location . 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. An animal study to assess usability was performed. No animal testing for safety and efficacy or clinical studies were performed as there is no change to the indications for use or the fundamental scientific technology of the device.
Bench Study Results:
- Delivery Force: Peak delivery force was measured through a representative tortuous anatomical model. All devices met acceptance criteria.
- Re-sheathing Force: Retrieval force was measured through a representative tortuous anatomical model. All devices met acceptance criteria.
- Multiple Re-sheathing 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. All devices met acceptance criteria.
- Body Finger Marker Tensile: Markercoil tensile strength testing is performed to verify the strength of the laser weld of the Pt/Ir markercoil to the Nitinol distal finger of the device. All devices met acceptance criteria.
- Radial Force: The radial force was measured 100% in-process. Radial force was measured 100% in-process on test builds. All devices met acceptance criteria.
- Body Markers Radiopacity: Verification analysis of body markers. All devices met acceptance criteria.
Animal Study: Animal usability testing was performed and assessed by an interventional neurologist on the following attributes after each pass: delivery of the device through the microcatheter, the ability to deploy the retriever, the ability to resheath and redeploy the retriever, the ability to retrieve the device through the guide catheter, the device condition, and the fluoroscopic visibility of the radiopaque body markers.
Clinical Study: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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" around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with 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
December 23, 2015
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Ms. Phuong Chau Senior Regulatory Affairs Product Specialist 9775 Toledo Way Irvine, California 92618
Re: K153071
Trade/Device Name: Solitaire™ Platinum Revascularization Device Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: November 23, 2015 Received: November 25, 2015
Dear Ms. Phuong Chau:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices. good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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,
William J. Heetderks -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) K153071
Device Name
Solitaire™ Platinum Revascularization Device
Indications for Use (Describe)
The Solitaire™ Platinum Revascularization Device is intended to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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 K153071
| 510(k) Owner: | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
9775 Toledo Way
Irvine, CA 92618
Establishment Registration No. 2029214 | |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Contact Person: | Phuong Chau
Senior Regulatory Affairs Product Specialist
Telephone: (949) 297-5487
E-mail: phuong.chau@medtronic.com | |
| Date Summary Prepared: | December 14, 2015 | |
| Trade Name of Device: | Solitaire™ Platinum Revascularization Device | |
| Common Name of Device: | Catheter, Thrombus Retriever | |
| Classification of Device: | 21 CFR 870.1250 – Class II | |
| Product Code | NRY | |
| Predicate Device: | Solitaire™ 2 Revascularization Device
510(k)#: K123378 and K141491 | |
| | Solitaire™ FR Revascularization Device (Biocompatibility)
510(k)#: K113455 | |
| Performance Data: | The following bench testing was performed in support of the
Solitaire™ Platinum device:
Delivery Force Testing Re-sheathing Force Testing Multiple Re-sheathing Durability Body Finger Marker Tensile Body Markers Radiopacity Radial Force (in-process) The following test data was adopted from the predicate device: Total System Length Kink Resistance Total System Tensile | |
- Distal Marker Coil Tensile •
4
- Clot Retrieval Bench and Device Recovery Durability
- Torque Response
- Torque Strength
- Radiopacity (Distal Markers)
- Fluorosafe Marker Location .
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.
An animal study to assess usability was performed. No animal testing for safety and efficacy or clinical studies were performed as there is no change to the indications for use or the fundamental scientific technology of the device.
- The Solitaire™ Platinum device is substantially equivalent to the Conclusion: currently cleared Solitaire™ 2 and Solitaire™ FR device based on the completion of non-clinical bench testing and animal usability testing as well as similar principles of design, operation and indications for use.
Device Description:
The Solitaire™ Platinum device is designed to restore blood flow in patients experiencing ischemic stroke due to large intracranial vessel occlusion. The device is designed for use in the neurovasculature such as the internal carotid artery, M1 and M2 segments of the middle cerebral artery, basilar, and the vertebral arteries. The distal nitinol portion of the device facilitates clot retrieval and has Pt-Ir radiopaque markers on the working cell length, proximal and distal ends. The Solitaire™ Platinum device is a modification to the currently cleared Solitaire™ 2 Revascularization Device to increase the working length radiopacity.
Indication for Use:
The Solitaire™ Platinum Revascularization Device is intended to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
Device Comparison
The table below provides a comparison of the technological characteristics of the Solitaire™ Platinum device and the currently cleared Solitaire™ 2 Revascularization Device.
| | Solitaire FR
(K113455) | Solitaire™ 2
(K123378 &
K141491) | Solitaire™
Platinum | Rationale for
Difference
(if present) |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|
| Indication for
Use | The Solitaire™ FR
Revascularization | The Solitaire™ 2
Revascularization | Same | N/A |
| Solitaire FR
(K113455) | Solitaire™ 2
(K123378 &
K141491) | Solitaire™
Platinum | Rationale for
Difference
(if present) | |
| 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 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 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. | | |
| Stored within
dispenser coil, Tyvek
pouch, & shipping
carton | Stored within
dispenser coil,
Tyvek pouch, &
shipping carton | Same | N/A | |
| Ethylene Oxide | Ethylene Oxide | Same | N/A | |
| 4x15mm
4x20mm
6x20mm
6x30mm | 4x15mm
4x20mm
4x40mm
6x20mm
6x30mm | 4x20mm
4x40mm
6x20mm | The three sizes
are within the
range of sizes
cleared for
Solitaire 2 and
Solitaire FR. | |
| Materials | | | | |
| Stent | Nitinol | Same | N/A | |
| Push-wire | Nitinol | Same | N/A | |
| Distal Marker
Coils | 90% Platinum/ 10%
Iridium | Same | N/A | |
| Body Marker
Fingers & Coils | N/A | 90% Platinum/
10% Iridium Same
material as Distal
Marker Coils as
predicate. | Markers are
added to the
body of the stent
retriever to
increase
radiopacity.
Bench testing
has demonstrated
that this change
does not raise
new question on
the safety and
effectiveness of
the device. | |
| | Solitaire FR
(K113455) | Solitaire™ 2
(K123378 &
K141491) | Solitaire™
Platinum | Rationale for
Difference
(if present) |
| Shrink Tubing | | | | |
| Introducer
Sheath | PTFE/Grilamid | PTFE/Grilamid | Same | N/A |
5
6
Sterilization and Shelf Life
The packaged Solitaire™ Platinum device will be sterilized using a validated Ethylene Oxide sterilization cycle. The materials of construction, design, manufacturing process, and packaging are identical to the predicate device. Therefore no additional validation testing is required.
Aging studies for the Solitaire™ 2 Revascularization Device have established the product and packaging remain functional and maintain sterility for up to 2 years. Aging studies for packaging integrity, seal strength and device functionality were performed and met all acceptance criteria. The materials of construction, design, manufacturing process, and packaging of the Solitaire™ Platinum device are identical to the predicate device. Therefore the existing aging and packaging data has been adopted for the Solitaire™ Platinum.
Biocompatibility
Biocompatibility data for the Solitaire device family was tested for the Solitaire™ FR Revascularization Device. The biocompatibility data for the Solitaire™ FR was adopted for the Solitaire™ 2 Revascularization Device. The Solitaire™ Platinum does not introduce any new materials into the finished device or the manufacturing process. Therefore the existing biocompatibility testing data has been adopted for the Solitaire™ Platinum.
Performance Data - Bench
A summary of the bench testing performed for the Solitaire™ Platinum is summarized in the table below.
| Test | Method | Conclusion |
|---|---|---|
| Delivery Force | Peak delivery force was | |
| measured through a | ||
| representative tortuous | ||
| anatomical model. | All devices met acceptance | |
| criteria. | ||
| Re-sheathing Force | Retrieval force was measured | |
| through a representative | ||
| tortuous anatomical model. | All devices met acceptance | |
| criteria. |
7
| Test | Method | Conclusion |
|---|---|---|
| Multiple Re-sheathing | ||
| 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. | ||
| All devices met acceptance | ||
| criteria. | ||
| Body Finger Marker Tensile | Markercoil tensile strength | |
| testing is performed to verify | ||
| the strength of the laser weld | ||
| of the Pt/Ir markercoil to the | ||
| Nitinol distal finger of the | ||
| device. | All devices met acceptance | |
| criteria. | ||
| Radial Force | The radial force was measured | |
| 100% in-process. | Radial force was measured | |
| 100% in-process on test | ||
| builds. All devices met | ||
| acceptance criteria. | ||
| Body Markers Radiopacity | Verification analysis of body | |
| markers. | All devices met acceptance | |
| criteria. |
Performance Data - Animal
Animal usability testing was performed and assessed by an interventional neurologist on the following attributes after each pass: delivery of the device through the microcatheter, the ability to deploy the retriever, the ability to resheath and redeploy the retriever, the ability to retrieve the device through the guide catheter, the device condition, and the fluoroscopic visibility of the radiopaque body markers.
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.