(59 days)
No
The summary describes a mechanical thrombectomy device and its clinical trial results. There is no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is indicated for restoring blood flow by removing thrombus in acute ischemic stroke patients, which is a direct treatment for a medical condition.
No
The Solitaire™ 2 Revascularization Device is indicated for the treatment of acute ischemic stroke by removing thrombus to restore blood flow, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a physical device ("distal nitinol portion," "Iridium radiopaque markers") designed to be used within the neurovasculature for 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/Indications for Use: The device is used to physically remove thrombus (blood clots) from blood vessels in the brain to restore blood flow. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The description details a physical device designed for insertion into the neurovasculature for clot retrieval.
- 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) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
The device is a medical device used for a therapeutic procedure, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
-
The Solitaire™ 2 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 (comma separated list FDA assigned to the subject device)
POL, NRY
Device Description
The Solitaire™ 2 Revascularization Device is designed to restore blood flow in patients experiencing ischemic stroke due to large intracranial vessel occlusion. The Solitaire™ 2 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™ 2 Revascularization Device facilitates clot retrieval and has Iridium radiopaque markers on the proximal and distal ends. 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
CT or MR angiography, CT or MRI scan, Baseline non-contrast CT or DWI MRI
Anatomical Site
Neurovasculature, Internal Carotid Artery (ICA), M1 and M2 segments of the middle cerebral artery, basilar, and the vertebral arteries, large intracranial vessel, anterior circulation
Indicated Patient Age Range
18 - 80
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 Performance Testing:
- Study Type: Bench testing under simulated use conditions
- Sample Size: Not specified for individual tests, but various tests were performed.
- Key Results: All acceptance criteria were met for delivery force, re-sheathing force, total system length, fluorosafe marker length, multiple re-sheathing durability, body marker tensile strength, body marker radiopacity, proximal marker to distal marker length, torque response, torque strength, system tensile, Af temperature, radial force, kink resistance, clot removal in a simulated neurovascular model, and particulate generation under simulated use conditions. The device demonstrated usability and effectiveness comparable to the predicate device for clot removal.
Animal Performance Testing:
- Study Type: Acute and 30-day animal study
- Sample Size: Not explicitly stated, but compared the Solitaire™ 2 device to a predicate device.
- Key Results:
- Evaluated safety (tissue damage, hemorrhage, thrombi) using angiographic images and histopathological evaluation.
- Histological findings for both devices showed comparable vessel response with no remarkable histological differences in tissue injury, hemorrhagic evaluation, and thrombogenic evaluation.
- Usability was assessed by an interventionalist on attributes like delivery through catheter, ability to position stent retriever at target, deployment ability, re-sheathing and repositioning ability, retrieval ability, and device condition.
- Safety and usability results indicate the Solitaire™ 2 device is safe, usable, and equivalent to the predicate device.
Clinical Performance Testing:
- Study Type: SWIFT PRIME (Solitaire™ FR or Solitaire™ 2 With the Intention For Thrombectomy as Primary Endovascular Treatment for Acute Ischemic Stroke) - a global, multicenter, two-arm, prospective, randomized, open, blinded endpoint (PROBE) clinical Investigation Device Exemption (IDE) study.
- Sample Size:
- Total randomized: 196 subjects (98 in each group).
- Analysis cohort (IV t-PA within 3 hours): 161 subjects (84 in IV t-PA plus Solitaire™ group, 77 in IV t-PA only).
- Primary and secondary efficacy endpoint analysis cohort: 144 subjects (17 subjects excluded from IV t-PA plus Solitaire™ group).
- Key Results:
- Primary Effectiveness Endpoint: 90-day global disability assessed via modified Rankin Scale (mRS). The proportion of patients functionally independent (mRS 0-2) at 90 days was significantly higher in the IV t-PA plus Solitaire™ device group (62.7%) compared to the IV t-PA only group (36.8%). (p-value: 0.0007)
- Primary Safety Variables:
- Any Serious Adverse Event*: IV t-PA Only: 33.8% (26/77), IV t-PA + Solitaire: 31.0% (26/84). Odds Ratio: 0.88 (0.45-1.70).
- Symptomatic ICH at 27 hours**: IV t-PA Only: 3.9% (3/77), IV t-PA + Solitaire: 0.0% (0/84).
- Secondary Clinical Efficacy Endpoints:
- Mortality at 90 days: IV t-PA Only: 13.2% (10/76), IV t-PA + Solitaire: 9.0% (6/67). Odds Ratio: 0.65 (0.22-1.89), p-value: 0.596.
- Functional Independence (mRS 0-2) at 90 days: IV t-PA Only: 36.8% (28/76), IV t-PA + Solitaire: 62.7% (42/67). Odds Ratio: 2.88 (1.46-5.68), p-value: 0.003.
- Change in NIHSS at 27 hours Post randomization: Mean +/- SD: IV t-PA Only: -4.3 +/- 6.4, IV t-PA + Solitaire: -9.9 +/- 7.2. Median: IV t-PA Only: -3.0, IV t-PA + Solitaire: -9.5. p-value:
§ 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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 10, 2016
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Jennifer Correa Sr. Regulatory Affairs Product Specialist 9775 Toledo Way Irvine, California 92618
Re: K162539
Trade/Device Name: Solitaire 2 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: September 9, 2016 Received: September 12, 2016
Dear Ms. Jennifer 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
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,
Carlos L. Pena -SFD/△
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) K162539
Device Name Solitaire™ 2 Revascularization Device
Indications for Use (Describe)
-
The Solitaire™ 2 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.
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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| 510(K) Summary | K162539 |
|---|---|
| 510(k) Owner: | |
| Contact Person: | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular |
| 9775 Toledo Way | |
| Irvine, CA 92618 | |
| Establishment Registration No. 2029214 | |
| Jennifer Correa | |
| Senior Specialist, Regulatory Affairs | |
| Telephone: (949) 297-9563 | |
| E-mail: jennifer.l.correa@medtronic.com | |
| Date Summary | |
| Prepared: | |
| Trade Name of | |
| Device: | October 28, 2016 |
| Solitaire™ 2 Revascularization Device | |
| Common Name of | |
| Device: | |
| Classification of | |
| Device: | Neurovascular Mechanical Thrombectomy Device for Acute |
| Ischemic Stroke Treatment | |
| Class II, 21 CFR 882.5600, 21 CFR 870.1250 | |
| Product Code: | |
| Predicate Devices: | POL, NRY |
| Trevo XP ProVue Retriever | |
| DEN150049 | |
| Clinical Data: | A global, multicenter, two-arm, prospective, randomized, open, |
| blinded endpoint (PROBE) clinical study (SWIFT PRIME, IDE | |
| G120142) comparing neurological disability outcomes (defined by | |
| mRS) in Acute Ischemic Stroke (AIS) patients who are treated | |
| with either IV t-PA alone or IV t-PA in combination with Solitaire | |
| mechanical thrombectomy intervention was performed. The data | |
| from the SWIFT PRIME study in comparison to the data from the | |
| Trevo clinical study demonstrate that the use of the Solitaire | |
| Revascularization device is safe and is substantially equivalent to | |
| the predicate device for reducing 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) for acute ischemic stroke. | |
| Conclusion: | The Solitaire™ 2 Revascularization Device is substantially |
| equivalent to the Trevo XP ProVue Retriever based on comparison | |
| of the Trevo clinical data to the SWIFT PRIME clinical study data. | |
| In addition, the Solitaire™ 2 Revascularization Device is | |
| substantially equivalent to the Trevo XP ProVue Retriever in terms | |
| of fundamental scientific technology, including similarities in | |
| design, principles of operation, and indications for use. |
4
Device Description:
The Solitaire™ 2 Revascularization Device is designed to restore blood flow in patients experiencing ischemic stroke due to large intracranial vessel occlusion. The Solitaire™ 2 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™ 2 Revascularization Device facilitates clot retrieval and has Iridium radiopaque markers on the proximal and distal ends. The devices are supplied sterile and are intended for single-use only.
There have been no changes to the Solitaire™ 2 Revascularization Device from the currently cleared Solitaire devices (K113455, K123378 and K141491) to support the proposed additional indication. Indication for Use #2 is the same indication as the currently cleared Solitaire Devices under product code NRY (K113355, K123378 and K141491). The currently cleared Solitaire™ 2 Revascularization device is used as a reference device for Indication for Use, previously completed bench, animal, and clinical data.
Indications for Use:
-
- The Solitaire™ 2 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.
Device Comparison:
The table below provides a comparison of the technological characteristics of the Solitaire™ 2 Revascularization Device and the predicate Trevo XP ProVue Retriever (DEN150049).
| | Predicate Device
Trevo XP ProVue
Retriever (DEN150049) | Subject Device
Solitaire™ 2
Revascularization Device | Rationale for
Difference
(if applicable) |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication
for Use | The Trevo ProVue and
XP ProVue Retrievers are
intended to restore blood
flow in the neurovascular
by removing thrombus for
treatment of acute
ischemic stroke to reduce
disability in patients with | 1. The Solitaire™ 2
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 | Indication 1:
N/A, same as
predicate
device
Indication 2:
N/A, same as
reference |
| | Predicate Device
Trevo XP ProVue | Subject Device
Solitaire™ 2 | Rationale for
Difference
(if applicable) |
| | Retriever (DEN150049) | Revascularization Device | |
| | a persistent, proximal
anterior circulation, large
vessel occlusion, and
small core infarcts who
have first received
intravenous tissue
plasminogen activator (IV
t-PA). Endovascular
therapy with the device
should start within 6 hours
of symptom onset. | 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. | predicate
device
(K113455,
K123378 and
K141491
cleared under
product code
NRY) |
| Principles of
Operation | The device is used in the
neurovasculature to
restore blood flow for
treatment of acute
ischemic stroke | Same | N/A |
| Dimensions and Materials | | | |
| Device
Size(s) | 3x20 mm
4x20 mm
4x30 mm
6x25 mm | 4x15 mm
4x20 mm
4x40 mm
6x20 mm
6x30 mm | Both devices
are offered in a
variety of sizes
designed to be
used in the
neurovasculature
to restore
blood flow. |
| Device
Materials | Core Wire Material:
Nitinol (nickel titanium
alloy) | Stent: Nitinol
Pushwire: Nitinol
Markers: 90% Platinum/
10% Iridium | Both device
materials are
biocompatible, |
| | Predicate Device
Trevo XP ProVue
Retriever (DEN150049) | Subject Device
Solitaire™ 2
Revascularization Device | Rationale for
Difference
(if applicable) |
| | Distal Shaped Section
Material: Nitinol
Coil Material Distal to
Distal
Shaped Section :
Platinum/Tungsten
Shaped Section
Radiopaque Wire:
Platinum/Tungsten
Coil Material Proximal to
Shaped Section: 304
Stainless Steel
Solder: Gold/Tin
Hydrophilic Coating:
Sodium hyaluronate
mixture | 10% Iridium
Push-wire shrink Tubing:
PTFE
Introducer Sheath:
PTFE/Grilamid | designed to be
used in the
neurovasculatu
re, and contain
radiopaque
materials for
visualization. |
| | Sterilization and Packaging | | |
| Packaging
Materials | Polyethylene Hoop,
polycarbonate mounting
card, Tyvek/Film Pouch,
HDPE Tubing Clips,
Chipboard carton | Stored within dispenser
coil, Tyvek pouch, and
shipping carton. | Packaging
materials are
similar and
typical for
medical
devices. Both
packaging
configurations
maintain a
sterility of the
device through
the shelf life. |
| Sterilization
Method | Ethylene Oxide | Same | N/A |
| How
Supplied | Sterile, Single Use | Same | N/A |
5
6
Sterilization and Shelf Life:
The Solitaire™ 2 Revascularization Device is sterilized using a validated, Ethylene Oxide (EO) sterilization cycle. The sterilization cycle has been validated to ensure a sterility assurance level (SAL) of 106 in accordance with ISO 11135-1:2007, Sterilization of health care products - Ethylene oxide - Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices. There have been no changes to device sterilization in support of this submission. Therefore, no additional sterilization validation testing is required.
7
Aging studies for the Solitaire™ 2 Revascularization Device have established the Solitaire™ 2 Revascularization Device packaging remains functional and maintains sterility for up to two years. Aging studies for packaging integrity, seal strength and device functionality were performed and met all acceptance criteria. There have been no changes to the materials of construction, design, manufacturing process, packaging, or sterile load configurations in support of this submission. Therefore, no additional shelf life validation testing is required.
Biocompatibility:
Biocompatibility data for the Solitaire device family was tested for the reference Solitaire™ FR Revascularization Device. The biocompatibility data for the Solitaire™ FR was adopted for the Solitaire™ 2 Revascularization Device. The Solitaire™ Revascularization Device is biocompatible and has been tested in accordance with AAMI/ANSI/ISO 10993-1: 2009, Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process. There have been no changes to the finished device or the manufacturing processes in support of this submission. Therefore, no additional biocompatibility is required. Biocompatibility testing completed for the reference Solitaire™ FR Revascularization Device includes:
| Test
Category | Test
Description | Method | Acceptance Criteria | Conclusion |
|-------------------------------|-----------------------------------------------------|--------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| Cytotoxicity | L929 MTT
Cytotoxicity | ISO 10993-5 | Viability is ≥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 In-vitro Mouse
Lymphoma
Assay | | Test article is
considered non-
mutagenic | |
| | In-vivo Mouse
Micronucleus
Assay | | Test article is
considered non-
mutagenic | |
8
9
Performance Data – Bench:
Performance testing conducted to support this Solitaire™ 2 Revascularization Device submission includes particulate testing under simulated use conditions. Performance Bench testing completed for this submission and previously conducted for the reference device, the currently cleared Solitaire™ 2 Revascularization device, includes:
| Test Description | Method | Acceptance
Criteria | Conclusion |
|----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| Delivery Force | Peak delivery force was
measured through a
representative tortuous
anatomical model. | Stent must be below
delivery force
specification. | Acceptance criteria met |
| Re-sheathing
Force | Retrieval force was
measured through a
representative tortuous
anatomical model. | Stent must be below
re-sheathing force
specification. | Acceptance criteria met |
| Total System
Length | Total system length was
measured from the
proximal tip of the push-
wire to the distal-most tip
of the finger marker coils. | System length must
meet product
specification. | Acceptance criteria met |
| Fluorosafe
Marker Length | The total length
of the fluorosafe
marker was measured. | Fluorosafe marker
length must meet
product
specification. | Acceptance criteria met |
| 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
Instructions for Use
(IFU). | Device must reliably
deploy and resheath
up to four times. | Acceptance criteria met |
| Body Marker
Tensile | Body Marker tensile
strength testing is
performed to verify the
strength of the laser weld
of the Platinum/Iridium
markercoil to the Nitinol
distal finger of the device. | Body marker should
be greater than or
equal to existing
tensile strength
specification. | Acceptance criteria met |
| Body Marker
Radiopacity | Verification analysis of
body markers. | The radiopaque
body markers must
be visible using
standard catheter
laboratory
equipment | Acceptance criteria met |
| Test Description | Method | Acceptance
Criteria | Conclusion |
| Proximal Marker
to Distal Marker | The length of the laser cut
and electro-polished
stents are measured 100%
in process. | Length of stent must
meet all inspection
criteria | Acceptance criteria met |
| Torque Response | Samples were evaluated
to determine the number
of turns required to
produce 1 rotation of the
distal tip of the device. | Device turns must
be less than or equal
to torque response
criteria | Acceptance criteria met |
| Torque Strength | Samples were evaluated
to determine the number
of turns required to
break the device in a
representative tortuous
model. | Device turns must
be greater than
torque strength
criteria | Acceptance criteria met |
| System Tensile | Samples were evaluated
to determine the tensile
strength of the full
system. | Devices must be
greater than or equal
to the system tensile
criteria | Acceptance criteria met |
| Af Temperature | In-process 100% tracking
of heat set parameters
used to set final Af | Temperature should
be less than or equal
to existing Af
temperature
specification. | Acceptance criteria met |
| Radial Force | The radial force was
measured 100% in-
process. | Stent must be within
existing radial force
specification. | Acceptance criteria met |
| Kink Resistance | Kink resistance testing
verified the device
flexibility across various
levels of tortuosity. | Device must be able
to maintain vessel
wall apposition at a
minimum radius
bend. | Acceptance criteria met |
| Clot Removal in
a Simulated
Neurovascular
Model | Both hard and soft clot
retrieval success was
evaluated in an in vitro
tortuous anatomical
model. | Overall success rate
of the device
(usability and
effectiveness) must
be equal to or better
than the predicate*
device. | Acceptance criteria met |
| Test Description | Method | Acceptance Criteria | Conclusion |
| Particulate Under Simulated Use Conditions | Device was evaluated for particulate generation under simulated use in a representative tortuous anatomical model per USP | Device was evaluated for particulate generation under simulated use in a representative tortuous anatomical model per USP | Acceptance criteria met |
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*Predicate for K113455, Merci® Retrievers
Performance Data - Animal:
No additional animal performance testing was conducted to support this Solitaire™ 2 Revascularization Device submission. Performance Animal testing previously conducted to support clearance of the reference device, the Solitaire™ 2 Revascularization device, includes:
- An acute and 30 day animal study was performed that assessed safety . effectiveness, and usability of the Solitaire™ 2 device as compared to the predicate* device. Safety was evaluated for tissue damage, hemorrhage, and thrombi using angiographic images and histopathological evaluation.
- Histological findings of the Solitaire™ 2 device 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.
- 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 deplov 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 device is safe, usable and is equivalent to the predicate* device.
*Predicate for K113455, Merci® Retrievers
Performance Testing - Clinical:
Study Design
SWIFT PRIME (Solitaire™ FR or Solitaire™ 2 With the Intention For Thrombectomy as Primary Endovascular Treatment for Acute Ischemic Stroke) is a global, multicenter, two-arm, prospective, randomized, open, blinded endpoint (PROBE) clinical Investigation Device Exemption (IDE) study comparing neurological disability outcomes (defined by mRS) in Acute Ischemic Stroke (AIS) patients who are treated with either IV t-PA alone or IV t-PA in combination with Solitaire™ FR or Solitaire™ 2 mechanical thrombectomy intervention. Subjects receiving IV t-PA within 4.5 hours of symptom onset were randomized 1:1 to mechanical thrombectomy with Solitaire within 6 hours of onset, or to continuation with IV t-PA alone. Within this group, the Analysis cohort was
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defined as those subjects who were administered IV t-PA within 3 hours of symptom onset.
Sample Size
A total of 196 subjects were randomized into the SWIFT PRIME Study (98 in each group). The SWIFT PRIME study allowed IV t-PA use beyond 3 hours, although IV t-PA is not approved in the United States beyond 3 hours. Patients treated with IV t-PA beyond 3 hours did not factor strongly in the evaluation of the Solitaire 2 revascularization device and have been excluded from the analyses. The resulting Analysis Cohort consists of 161 subjects (84 in the IV t-PA plus Solitaire™ group and 77 with IV t-PA only). Additionally, 17 subjects in the IV t-PA plus Solitaire™ group were excluded from the primary and secondary efficacy endpoint analyses. These 17 subjects either received carotid stenting and/or angioplasty or were treated in a manner inconsistent with the Solitaire Instructions for Use. Therefore, the primary and secondary efficacy endpoint analyses cohort consists of 144 subjects.
Statistical Analysis
Standard summary statistics were calculated for all study variables and subject data were analyzed according to the group to which they were randomized. For continuous variables, statistics included means, standard deviations, medians and ranges. Categorical variables were summarized in frequency distributions.
For the primary efficacy endpoint, statistical significance was declared using bounds predefined in the group sequential analysis plan, which accounts for multiplicity due to interim analyses. Elsewhere, one-sided statistical tests having p-values less than 0.025 were deemed significant while two-sided tests having p-values less than 0.05 were deemed significant.
For adverse event reporting, the primary analysis is based on subject counts, not event counts. Both subject counts and event counts are presented in tabular summaries of results.
Study Endpoints
The primary effectiveness endpoint of the study is 90-day global disability assessed via the blinded evaluation of modified Rankin Scale (mRS). Secondary clinical efficacy endpoints of the study are:
- Death due to any cause at 90 days.
- Functional independence as defined by mRS score 100 cc of tissue) on presentation
- Baseline non-contrast CT or DWI MRI evidence of a moderate/large core o defined as extensive early ischemic changes of Alberta Stroke Program Early CT score (ASPECTS) less than 6. Patients enrolled under RAPID were excluded based on the following:
- a) MRI- or CT-assessed core infarct lesion greater than 50 cc; or
- b) Severe hypoperfusion lesion (10 sec or more Tmax lesion larger than 100 cc; or
- c) Ischemic penumbra 1 flow in the intracranial internal carotid artery, M1
segment of the MCA, or carotid terminus confirmed by CT or MR angiography that is accessible to the
Solitaire™ FR Device. | 28 |
| MRI- or CT-assessed core infarct lesion greater than 50 cc; severe hypoperfusion lesion (Tmax>10secs
lesion greater than 100 cc); and/or Ischemic penumbra 100 cc of tissue) on presentation. | 6 |
| NIHSS 1 | 2 |
| Baseline non-contrast CT or DWI MRI evidence of a moderate/large core defined as extensive early
ischemic changes of Alberta Stroke Program Early CT score (ASPECTS) 80 years old | 1 |
| Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency. | 1 |
| Contraindication to IV t-PA as per local national guidelines. | 1 |
| History of stroke in the past 3 months. | 1 |
| Arterial tortuosity, calcification, pre-existing stent, and/or stenosis which would prevent the device
from reaching the target vessel and/or preclude safe recovery of the device. | 2 |
| Subject is unable to be treated within 6 hours of onset of stroke symptoms and within 1.5 hours (90
minutes) from qualifying imaging to groin puncture. | 2 |
| CT or MRI evidence of a basilar artery (BA) occlusion or posterior cerebral artery (PCA) occlusion. | 1 |
| No certified rater available to assess ASPECTS prior to study enrollment | 1 |
| Total | 77* |
| * Column does not sum to 77 due to some subjects having more than 1 screen failure reason | |
- Baseline non-contrast CT or DWI MRI evidence of a moderate/large core o defined as extensive early ischemic changes of Alberta Stroke Program Early CT score (ASPECTS) less than 6. Patients enrolled under RAPID were excluded based on the following:
Primary Safety and Efficacy Outcomes
The proportion of patients functionally independent (mRS 0-2) at the 90-day visit was higher in the IV t-PA plus Solitaire™ device group.
| Primary Effectiveness Endpoint (Analysis Cohort) | |||
|---|---|---|---|
| mRS Score at 90 days | IV t-PA Only* | IV t-PA + Solitaire | p-value |
| 0.0007 | |||
| 0 | 7.9% (6/76) | 16.4% (11/67) | |
| 1 | 11.8% (9/76) | 31.3% (21/67) | |
| 2 | 17.1% (13/76) | 14.9% (10/67) | |
| 3 | 18.4% (14/76) | 11.9% (8/67) | |
| 4 | 18.4% (14/76) | 13.4% (9/67) | |
| 5/6 | 26.3% (20/76) | 11.9% (8/67) | |
| Missing data at 90-day was imputed using LOCF (except baseline data not used) | |||
| *One subject from the IV t-PA only group withdrew consent 27 hours post | |||
| randomization. No 90 day mRS Score was available for this subject. |
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Image /page/16/Figure/2 description: This image is a bar chart comparing the outcomes of two different treatments: Solitaire + IV tPA and IV tPA. For Solitaire + IV tPA (N=67), the outcomes are distributed as follows: 16, 31, 15, 12, 13, and 12. For IV tPA (N=76*), the outcomes are distributed as follows: 8, 12, 17, 18, 18, and 26. The chart visually represents the distribution of outcomes for each treatment group.
Patients (%)
- One subject from the IV t-PA only group withdrew consent 27 hours post randomization. No 90 day mRS Score was available for this subject.
Modified Rankin Shift at 90 days (Analysis Cohort)
| Primary Safety Endpoints (Analysis Cohort) | |||
|---|---|---|---|
| Safety Endpoint | IV t-PA Only | IV t-PA + Solitaire | Odds Ratio |
| Primary Safety Variables | |||
| Any serious adverse event* | 33.8% (26/77) | 31.0% (26/84) | 0.88 (0.45-1.70) |
| Symptomatic ICH at 27 hours** | 3.9% (3/77) | 0.0% (0/84) | NA |
| NA denotes not applicable | |||
| *Per Clinical Events Committee adjudication | |||
| **Per Core Laboratory assessed data |
| Safety Endpoints, RAPID Imaging Requirement Subgroup
| (Analysis Cohort) | ||||
|---|---|---|---|---|
| Safety Endpoint | IV t-PA Only | IV t-PA + Solitaire | Odds Ratio | |
| All Serious Adverse Events* | 43.3% (13/30) | 42.9% (12/28) | 0.98 | |
| (0.35-2.77) | ||||
| Symptomatic ICH at 27 hours** | 0.0% (0/30) | 0.0% (0/28) | NA | |
| NA denotes not applicable | ||||
| *Per Clinical Events Committee adjudication | ||||
| **Per Core Laboratory assessed data | ||||
| Patients enrolled under RAPID were excluded based on the following: | ||||
| a) MRI- or CT-assessed core infarct lesion greater than 50 cc; or | ||||
| b) Severe hypoperfusion lesion (10 sec or more Tmax lesion larger than 100 cc; or |
c) Ischemic penumbra