(29 days)
No
The document describes a mechanical device for clot retrieval and mentions only physical modifications and bench testing. There is no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended to restore blood flow by removing thrombus from a large intracranial vessel 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 describes a therapeutic, rather than a diagnostic, function.
No
The device description clearly outlines physical components made of materials like nitinol and PTFE tubing, and the performance studies involve bench testing of physical properties like tensile strength and torque. This indicates a hardware-based medical device, not a software-only one.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Solitaire™ 2 Revascularization Device is a physical device used inside the body to remove a thrombus (blood clot) from a blood vessel. It is a therapeutic device, not a diagnostic one that analyzes samples.
- Intended Use: The intended use is to "restore blood flow by removing thrombus," which is a direct intervention on the patient's anatomy, not an analysis of a biological sample.
The description clearly indicates it's a device used in a surgical or interventional procedure to treat a condition within the body.
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 (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
Product codes
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.
The following modifications have been made to the device in support of this application:
• The attachment zone has been redesigned for greater tensile strength.
• The marker band has been redesigned to aid the crimping process.
• The pushwire now contains a fluorosafe marker.
• The Solitaire™ 2 Device uses one piece of PTFE tubing.
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
Non-Clinical Bench Testing:
- Delivery Force
- Withdrawal Force
- Total System Length
- Fluoro Safe Marker Length
- Distal Tip to Fluoro Marker Length
- Durability
- Radiopacity
- Torque Response
- Torque Strength
- System Tensile
1-Year Accelerated Aging Study: - Delivery Force
- Withdrawal Force
- Durability
- Torque Response
- Torque Strength
- System Tensile Strength
The following tests were not performed as they are not related to the changes being made to the Solitaire™ 2 Revascularization Device:
Bench Testing: - Kink Resistance
- Marker Coil Tensile Strength
- Radial Force
In addition, no clinical or animal testing was performed as there is no change in the indications for use or the fundamental scientific technology of the device.
Key Metrics
Not Found
Predicate Device(s)
Solitaire™ FR Revascularization Device (K113455)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K123378
29 October 2012
NOV 3 0 2012
Solitaire™ 2 Revascularization Device
3. 510(k) Summary
ﺗ ,
| 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
Sr. Regulatory Affairs Specialist
Telephone: (949) 297-9781
E-mail: larry.boucher@covidien.com |
| Date Summary
Prepared: | 27 November 2012 |
| Trade Name of
Device: | Solitaire™ 2 Revascularization Device |
| Common Name of
Device: | Catheter, Thrombus Retriever |
| Classification of
Device: | 21 CFR 870.1250 - Class II |
| Predicate Device: | Solitaire™ FR Revascularization Device (K113455) |
| 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.
The following modifications have been made to the device in support of
this application:
• The attachment zone has been redesigned for greater tensile
strength.
• The marker band has been redesigned to aid the crimping
process.
• The pushwire now contains a fluorosafe marker.
• The Solitaire™ 2 Device uses one piece of PTFE tubing. |
| Intended 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. |
1
29 October 2012
Performance Data:
The following tests were performed to support the changes to the Solitaire™ 2 Revascularization Device:
Non-Clinical
Bench Testing:
- . Delivery Force
- Withdrawal Force .
- Total System Length .
- Fluoro Safe Marker Length ●
- . Distal Tip to Fluoro Marker Length
- Durability .
- . Radiopacity
- Torque Response
- Torque Strength .
- . System Tensile
1-Year Accelerated Aging Study
- Delivery Force .
- ◆ Withdrawal Force
- Durability .
- . Torque Response
- Torque Strength ●
- System Tensile Strength .
The following tests were not performed as they are not related to the changes being made to the Solitaire™ 2 Revascularization Device:
Bench Testing:
- . Kink Resistance
- Marker Coil Tensile Strength .
- . Radial Force
In addition, no clinical or animal testing was performed as there is no change in the indications for use or the fundamental scientific technology of the device.
Conclusion:
The Solitaire™ 2 device is substantially equivalent to the Solitaire™ FR Revascularization Device based on the successful completion of non-clinical testing as well as identical principles of operation, materials of construction, dimensions, packaging, and indications for use.
2
Image /page/2/Picture/0 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 symbol that resembles a caduceus, a traditional symbol of medicine, but with a more abstract and modern design.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
November 30, 2012
Micro Therapeutics DBA ev3 Neurovascular c/o Mr. Larry Boucher Senior Regulatory Affairs Specialist 9775 Toledo Way Irvine, CA 92618
Re: K123378
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: October 29, 2012 Received: November 1, 2012
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.
3
Page 2 - Mr. Larry Boucher in
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 device-related 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Quynh T. Hoang for: .
Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number: K123378
Device Name: Solitaire™ 2 Revascularization Device
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.
Prescription Use XX (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Quynh T. Hoang
(Division Sign Off) Division of Neurological and Physical Medicine Devices (DNPMD)
510(k) Number K123378
Page 1 of 1