(366 days)
4-40 Solitaire™ 2
No
The summary describes a mechanical revascularization device for clot retrieval and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is intended to restore blood flow by removing thrombus from an intracranial vessel, which directly treats the ischemic stroke condition.
No
The device is described as a revascularization device intended to restore blood flow by removing thrombus, which is a therapeutic function, not a diagnostic one.
No
The device description clearly describes a physical medical device made of nitinol and platinum iridium, intended for mechanical clot retrieval. It is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is intended to restore blood flow by physically removing thrombus from a blood vessel within the body. This is a therapeutic intervention performed in vivo (within a living organism).
- Device Description: The description details a physical device designed to be inserted into the neurovasculature to retrieve a clot. This is consistent with an in vivo medical device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is clearly designed for use in vivo to treat a medical condition.
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 (comma separated list FDA assigned to the subject device)
NRY
Device Description
The subject 6-40-10 Solitaire™ Platinum Revascularization Device is designed to restore blood flow 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 (ICA), M1 and M2 segments of the middle cerebral artery, basilar, and the vertebral arteries. The distal nitinol portion of the Solitaire™ Platinum Revascularization Device facilitates clot retrieval. The Solitaire™ Platinum Revascularization Device has Platinum Iridium radiopaque markers on the working cell length, proximal and distal ends. The subject Solitaire™ Platinum Revascularization Device is a portfolio expansion to the predicate Solitaire™ Platinum Revascularization Device (K153071).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
large intracranial vessel, neurovasculature such as the Internal Carotid Artery (ICA), 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
A clinical study was not performed for the subject 6-40-10 Solitaire™ Platinum Revascularization Device. Confirmatory clinical data using the cleared 4x40 Solitaire devices (predicate 4-40-10 Solitaire™ Platinum and reference 4-40 Solitaire™ 2) was leveraged to support substantial equivalence of the subject 6-40-10 Solitaire™ Platinum Revascularization Device. Leveraging of the 4x40 Solitaire device confirmatory clinical data is appropriate as the subject 6-40-10 Solitaire™ Platinum Revascularization Device is within the existing ranges of the 4x40 Solitaire devices for device length, radial outward force and delivery / resheathing forces. The confirmatory 4x40 Solitaire clinical data was collected as part of the Systematic Evaluation of Patients TReated with Neurothrombectomy Devices for AcuTe IschemicStroke (STRATIS) Registry.
STRATIS Registry Design: A prospective, multi-center, non-randomized, observational registry evaluating the use of Covidien market-released neurothrombectomy devices in patients diagnosed with an acute ischemic stroke due to large intracranial vessel occlusion. The study used an independent Clinical Events Committee for adverse event adjudication and an independent Core Lab for procedural image assessment.
Sample Size: Under the STRATIS Registry, 984 patients were enrolled that were treated with a Medtronic neurothrombectomy device at the discretion of treating physicians and as part of hospital standard practice at 55 sites within the United States. Of the 984 patients treated, a total of 296 were treated using only the cleared 4x40 device. Major patient eligible criteria for consent and enrollment into the Registry were to be treated with the Solitaire device within 8 hours of symptom onset.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- Non-clinical bench testing: Multiple tests were performed on the subject 6-40-10 Solitaire™ Platinum Revascularization Device, including Total System Length, Marker-to-Marker Length, Delivery Force, Resheathing Force, Multiple Resheathing Durability, Body Finger Marker Coil Tensile, Radial Force, Radiopacity, Ease of Use (Fluorosafe Marker Location), and Particulate. All tests met acceptance criteria.
- Non-clinical animal testing: Performed on the subject 6-40-10 Solitaire™ Platinum Revascularization Device in an in-vivo Yorkshire cross swine model. Four of eight proposed target sites were evaluated, at 0-day (acute) and 30-day (chronic) time points. The testing was designed to show non-inferiority between the control 6-30 Solitaire™ 2 Revascularization Device and the test 6-40-10 Solitaire™ Platinum Revascularization Device, evaluating biological responses such as Luminal Thrombus, Endothelial Cell Coverage, Inflammation, Fibrin, Medial Smooth Muscle Cell (SMC) Loss, Disruption of the Internal Elastic Lamina (IEL) and External Elastic Lamina (EEL), Adventitia, Neointimal Hyperplasia, Elastic Fiber Separation, and Lumen Area Reduction.
- Clinical Performance (leveraged data): Confirmatory clinical data leveraged from the STRATIS Registry 4x40 group (n=296) included baseline demographics, safety data, and performance data.
- Baseline Demographics: Age (years) 66.4 ± 15.2 (296), NIHSS at baseline 16.8 ± 5.5 (296), Male Gender 51.4% (152/296).
- Safety Data: Symptomatic ICH 2.8% (7/252), Mortality at 90 days 16.2% (48/296), Study Device-Related SAEs 0.3% (1/296) - specifically, Subarachnoid hemorrhage.
- Performance Data: Successful revascularization (TICI 2b-3) 90.4% (227/251), Functional Independence (mRS 0-2) at 90 days 60.3% (167/277).
- Key Results: Non-clinical bench, animal testing and the confirmatory clinical data demonstrated that the subject 6-40-10 Solitaire™ Platinum Revascularization Device is substantially equivalent to the predicate Solitaire™ Platinum Revascularization Device (K153071) and does not raise new questions of the safety and effectiveness of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Symptomatic ICH: 2.8% (7/252)
- Mortality at 90 days: 16.2% (48/296)
- Successful revascularization (TICI 2b-3): 90.4% (227/251)
- Functional Independence (mRS 0-2) at 90 days: 60.3% (167/277)
- Study Device-Related SAEs: 0.3% (1/296)
Predicate Device(s)
SolitaireTM Platinum Revascularization Device (K153071)
Reference Device(s)
4-40 Solitaire™ 2
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
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 stylized image of an eagle with three heads, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The eagle is depicted in black and white, and the text is in a simple, sans-serif font.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 8, 2017
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Jennifer Correa Senior Regulatory Affairs Specialist 9775 Toledo Way Irvine, California 92618
Re: K160641
Trade/Device Name: Solitaire™ Platinum Revascularization Device (6x40 mm) Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: February 16, 2017 Received: February 21, 2017
Dear Ms. Correa:
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
Digitally signed by William J. Heetderks -
DN: c=US, o=U.S. Government, ou=HHS,
ou=FDA, ou=People,
0.9.2342.19200300.100.1.1=0010149848
cn=William J. Heetderks -S
Date: 2017.03.08 16:48:39-05'00'
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) K160641
Device Name
Solitaire™ Platinum Revascularization Device (6x40 mm)
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 | K160641 |
|---|---|
| 510(k) Owner: | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular |
| 9775 Toledo Way | |
| Irvine, CA 92618 | |
| Establishment Registration No. 2029214 | |
| Contact Person: | Jennifer Correa |
| Senior Specialist, Regulatory Affairs | |
| Telephone: (949) 297-9563 | |
| E-mail: Jennifer.L.Correa@medtronic.com | |
| Date Summary | |
| Prepared: | March 1, 2017 |
| Trade Name of | |
| Device: | SolitaireTM Platinum Revascularization Device (6x40 mm) |
| Common Name of | |
| Device: | Catheter, Thrombus Retriever |
| Classification of | |
| Device: | 21 CFR 870.1250 - Class II |
| Product Code: | NRY |
| Predicate Device: | SolitaireTM Platinum Revascularization Device |
| 510(k)#: K153071 | |
| Performance Data: | The following non-clinical bench testing and confirmatory |
| clinical data supports the subject 6-40-10 SolitaireTM Platinum | |
| Revascularization Device: | |
| • Total System Length | |
| • Marker-to-Marker Length | |
| • Delivery Force | |
| • Resheathing Force | |
| • Multiple Resheathing Durability | |
| • Body Finger Marker Coil Tensile | |
| • Radial Force | |
| • Radiopacity | |
| • Ease of Use (Fluorosafe Marker Location) | |
| • Particulate | |
| • Leveraged confirmatory clinical data using the cleared | |
| 4x40 Solitaire devices | |
| Conclusion: | The materials of construction, design, and manufacturing/ |
| packaging processes for the subject 6-40-10 SolitaireTM Platinum | |
| Revascularization Device are identical to the predicate SolitaireTM | |
| Platinum Revascularization Device (K153071) therefore; | |
| biocompatibility, sterilization, packaging, and shelf life | |
| validations have been leveraged or adopted. Non-clinical animal | |
| testing was performed to demonstrate safety, effectiveness, and |
4
usability of the subject 6-40-10 Solitaire™ Platinum Revascularization Device. Non-clinical bench and animal testing confirmed that the subject 6-40-10 Solitaire™ Platinum Revascularization Device does not introduce new risks or increase existing risks. Confirmatory clinical data using the cleared 4x40 Solitaire devices (predicate 4-40-10 Solitaire™ Platinum and reference 4-40 Solitaire™ 2) was leveraged to support substantial equivalence of the subject 6-40-10 Solitaire™ Platinum Revascularization Device. The subject Solitaire™ Platinum Revascularization Device should be determined to be substantially equivalent to the predicate Solitaire™ Platinum Revascularization Device (K153071) based on non-clinical bench and animal testing, confirmatory clinical data, similarities in design, principles of operation, and indications for use.
Device Description:
The subject 6-40-10 Solitaire™ Platinum Revascularization Device is designed to restore blood flow 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 (ICA), M1 and M2 segments of the middle cerebral artery, basilar, and the vertebral arteries. The distal nitinol portion of the Solitaire™ Platinum Revascularization Device facilitates clot retrieval. The Solitaire™ Platinum Revascularization Device has Platinum Iridium radiopaque markers on the working cell length, proximal and distal ends. The subject Solitaire™ Platinum Revascularization Device is a portfolio expansion to the predicate Solitaire™ Platinum Revascularization Device (K153071).
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.
Device Comparison:
The table below provides a comparison of the technological characteristics associated with the portfolio expansion of the subject 6-40-10 Solitaire™ Platinum Revascularization Device and the predicate Solitaire™ Platinum Revascularization Device (K153071).
5
| | Predicate Device
Solitaire™ Platinum
Revascularization
Device (K153071) | Subject Device
6-40-10 Solitaire™
Platinum
Revascularization
Device | Rationale for Difference
(if applicable) |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | Same | N/A |
| Principles of
Operation | The device is used in
the neurovasculature
to restore blood flow
by removing
thrombus. | Same | N/A |
| Method of
Supply | Stored within
dispenser coil, Tyvek
pouch, and shipping
carton. | Same | N/A |
| Sterilization
Method | Ethylene Oxide | Same | N/A |
| | Predicate Device
Solitaire™ Platinum
Revascularization
Device (K153071) | Subject Device
6-40-10 Solitaire™
Platinum
Revascularization
Device | Rationale for Difference
(if applicable) |
| Device Size(s) | 4-20-10
4-40-10
6-20-10 | 6-40-10 | The subject 6-40-10
Solitaire™ Platinum
Revascularization Device
shares similar technological
characteristics to the
predicate 6-20-10 (6 mm
stent diameter) and the 4-40-
10 (40 mm stent length) of
the predicate Solitaire™
Platinum Revascularization
Devices. Bench testing has
demonstrated that the subject
6-40-10 Solitaire™ Platinum
Revascularization Device is
within the existing ranges of
the 4x40 Solitaire devices for
device length, radial outward
force and delivery /
resheathing forces. |
| | | | |
| Stent | Nitinol. | Same | N/A |
| Push-wire | Nitinol. | Same | N/A |
| Distal Marker
Coil | 90% Platinum/
10% Iridium | Same | N/A |
| Body Finger
Marker Coil | 90% Platinum/
10% Iridium | Same | N/A |
| Push-wire
Shrink Tubing | PTFE | Same | N/A |
| Introducer
Sheath | PTFE/Grilamid | Same | N/A |
6
Sterilization and Shelf Life:
The subject 6-40-10 Solitaire™ Platinum Revascularization Device is sterilized using the identical validated, Ethylene Oxide (EO) sterilization cycle as the predicate Solitaire™ Platinum Revascularization Device (K153071). The materials of construction, design, manufacturing process, packaging, and sterile load configurations are identical to the predicate Solitaire™ Platinum Revascularization Device (K153071). Therefore, no additional sterilization validation testing is required.
The subject 6-40-10 Solitaire™ Platinum Revascularization Device and subsequent packaging remain functional and maintain sterility for up to two (2) years. The materials
7
of construction, design, manufacturing process, packaging, and sterile load configurations are identical to the predicate Solitaire™ Platinum Revascularization Device (K153071). Therefore, no additional shelf life validation testing is required.
Biocompatibility:
The subject 6-40-10 Solitaire™ Platinum Revascularization Device does not introduce any new materials into the finished device nor the manufacturing processes. The material of the subject 6-40-10 Solitaire™ Platinum Revascularization Device is identical to the material of the predicate Solitaire™ Platinum Revascularization Device (K153071). 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 subject 6-40-10 Solitaire™ Platinum Revascularization Device. A summary of the biocompatibility testing completed for the Solitaire™ FR Revascularization Device includes:
| Test
Category | Test
Description | Method | Acceptance Criteria | Conclusion |
|-------------------------------|---------------------------------------------|--------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| Cytotoxicity | L929 MTT
Cytotoxicity | ISO 10993-5 | Viability is $\geq$ 70%. | Acceptance criteria
met |
| Sensitization | Guinea Pig
Maximization
Sensitization | ISO 10993-10 | Test article does not
elicit a sensitization
response. | Acceptance criteria
met |
| Irritation | Intracutaneous
Irritation Test | ISO 10993-10 | Differences in the
mean test and control
scores of the extract
dermal observations
are $