(75 days)
No
The summary describes a mechanical revascularization device and does not mention any software, image processing, or AI/ML capabilities.
Yes
The device is intended to restore blood flow by removing thrombus in patients experiencing ischemic stroke, which directly treats a medical condition.
No
The device is described as a revascularization device intended to restore blood flow by removing thrombus, which is a therapeutic function rather than a diagnostic one.
No
The device description clearly indicates it is a physical device ("Solitaire™ Platinum Revascularization Devices are designed to restore blood flow..."). The performance studies also describe bench testing on physical properties like force and durability.
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, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The Solitaire™ Platinum Revascularization Device is a physical device designed to be inserted into the body to mechanically remove a thrombus (blood clot) from a blood vessel. It directly interacts with the patient's anatomy.
- Intended Use: The intended use is to restore blood flow by removing a thrombus, which is a therapeutic intervention, not a diagnostic test performed on a specimen outside the body.
The description clearly indicates this is an interventional device used within the patient's circulatory system.
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 subject 4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization Devices are 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
large intracranial vessel, neurovasculature, 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
The following performance testing was performed to support the subject 4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization Devices: Delivery Force Testing Re-Sheathing Force Testing Multiple Re-Sheathing Durability Body Marker Tensile Body Marker Radiopacity (in-process) Proximal Marker Band to Distal Marker Band (in-process) Af Temperature (in-process) Radial Force (in-process).
The following performance testing was leveraged from the predicate device: Total System Length Kink Resistance Distal Finger Marker Coil and Push-wire Tensile Clot Retrieval and Device Recovery Durability Torque Response Torque Strength Radiopacity (Fluoroscopic Visualization Distal Finger Marker Coil) Fluorosafe Marker Location.
Biocompatibility Particulate testing was performed.
Non-clinical bench testing confirmed that the portfolio expansion of the subject 4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization Devices do not introduce new risks or increase existing risks.
Conclusion: The subject 4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization Devices (K161879) are substantially equivalent to the predicate Solitaire™ Platinum Revascularization Device (K153071) based on non-clinical bench testing, similarities in design, principles of operation, and indications for use.
Sterilization and Shelf Life: The subject 4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization Devices are sterilized using the identical validated, Ethylene Oxide (EO) sterilization cycle as the predicate Solitaire™ Platinum Revascularization Device. The materials of construction, design, manufacturing process, sterilization load configuration and packaging process for this portfolio expansion of the subject 4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization Devices are equivalent to the predicate Solitaire™ Platinum Revascularization Device. The packaging of the subject 4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization Devices remains functional and maintain sterility for up to two (2) years. Therefore, no additional sterilization or shelf life validation testing is required for the subject 4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization Devices.
Biocompatibility: The subject 4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization Devices do not introduce any new materials into the finished device or the manufacturing process. The material of construction for the subject 4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization Devices are identical to the predicate Solitaire™ Platinum Revascularization Device. Biocompatibility was leveraged from the predicate Solitaire™ Platinum Revascularization Device in support of the subject 4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization Devices. Tests include: Cytotoxicity (L929 MTT Cytotoxicity, ISO 10993-5), Sensitization (Guinea Pig Maximization Sensitization, ISO 10993-10), Irritation (Intracutaneous Irritation Test, ISO 10993-10), Acute Systemic Toxicity (Acute Systemic Injection Test, Materials Mediated Rabbit Pyrogen, ISO 10993-11), Hemo-compatibility (Hemolysis, Partial Thromboplastin Time, Platelet and Leukocyte Count, Complement Activation C3a and SC5b-9 Assay, Thrombosis, ISO 10993-4), Genotoxicity (Bacterial Mutagenicity Test, In-vitro Mouse Lymphoma Assay, In-vivo Mouse Micronucleus Assay, ISO 10993-3). All tests met acceptance criteria and concluded substantial equivalence to the predicate device.
Bench Testing:
- Delivery Force: Peak delivery force was measured through a representative tortuous anatomical model. Stent must be below delivery force specification. Met acceptance criteria.
- Re-sheathing Force: Retrieval force was measured through a representative tortuous anatomical model. Stent must be below re-sheathing force specification. 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 Instructions for Use (IFU). The subject 4-20-05 and 6-24-06 devices must reliably deploy and resheath up to four (4) times. Met acceptance criteria, showed no irregularities, breaks, kinks, body marker migration, glue separations, or other observed defects.
- 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. Met acceptance criteria.
- Body Marker Radiopacity: Verification analysis of body markers. The radiopaque body markers must be visible using standard catheter laboratory equipment. Met acceptance criteria.
- 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. Met acceptance criteria.
- Af Temperature: In-process 100% tracking of heat set parameters used to set final Af. Temperature should be less than or equal to existing A f temperature specification. Met acceptance criteria.
- Radial Force: The radial force was measured 100% in-process. Stent must be within existing radial force specification. Met acceptance criteria.
Animal Performance Data: Not performed as the device does not change the indications for use or the fundamental scientific technology of the predicate device.
Clinical Performance Testing: No additional clinical study was performed as the device does not change the indications for use or the fundamental scientific technology of the predicate device and is substantially equivalent.
Key Metrics
Not Found
Predicate Device(s)
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 21, 2016
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Mr. Ryan Kenney Product Specialist, Regulatory Affairs 9775 Toledo Way Irvine, California 92618
Re: K161879
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: August 19, 2016 Received: August 22, 2016
Dear Mr. Kenney:
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/Resourcesfor You/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.
Michael J.Hoffmann -A
for Carlos L. Peña, Ph.D., M.S. 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) K161879
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
K161879 510(k) Summary
| 510(k) Owner: | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
9775 Toledo Way
Irvine, CA 92618
Establishment Registration No. 2029214 |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Ryan Kenney
Product Specialist, Regulatory Affairs
Telephone: (949) 297-5489
E-mail: ryan.j.kenney@medtronic.com |
| Date Summary
| Prepared: | September 08, 2016 |
|---|---|
| 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™ Platinum Revascularization Device |
| 510(k)#: K153071 | |
| Performance Data: | The following performance testing was performed to support the |
| subject 4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization | |
| Devices: | |
| Delivery Force Testing Re-Sheathing Force Testing Multiple Re-Sheathing Durability Body Marker Tensile Body Marker Radiopacity (in-process) Proximal Marker Band to Distal Marker Band (in-process) Af Temperature (in-process) Radial Force (in-process) The following performance testing was leveraged from the predicate | |
| device: Total System Length Kink Resistance Distal Finger Marker Coil and Push-wire Tensile Clot Retrieval and Device Recovery Durability Torque Response Torque Strength Radiopacity (Fluoroscopic Visualization Distal Finger Marker Coil) Fluorosafe Marker Location | |
| Biocompatibility Particulate | |
| The materials of construction, design, and packaging process for this | |
| portfolio expansion of the subject 4-20-05 and 6-24-06 SolitaireTM | |
| Platinum Revascularization Devices (K161879) are equivalent to the | |
| predicate SolitaireTM Platinum Revascularization Device (K153071). | |
| In addition, the manufacturing process of the subject 4-20-05 and 6- | |
| 24-06 SolitaireTM Platinum Revascularization Devices (K161879) is | |
| equivalent to the predicate SolitaireTM Platinum Revascularization | |
| Device (K153071). Therefore; no additional biocompatibility, | |
| sterilization, packaging, or shelf life validations are required. | |
| Non-clinical bench testing confirmed that the portfolio expansion of | |
| the subject 4-20-05 and 6-24-06 SolitaireTM Platinum | |
| Revascularization Devices do not introduce new risks or increase | |
| existing risks. | |
| Conclusion: | The subject 4-20-05 and 6-24-06 SolitaireTM Platinum |
| Revascularization Devices (K161879) are substantially equivalent to | |
| the predicate SolitaireTM Platinum Revascularization Device | |
| (K153071) based on non-clinical bench testing, similarities in | |
| design, principles of operation, and indications for use. |
4
Device Description:
The subject 4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization Devices are 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.
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 following table provides a comparative of the technological characteristics associated with the portfolio expansion of the subject 4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization Devices (K161879) and the predicate Solitaire™ Platinum Revascularization Device (K153071).
5
| | Predicate Device | Subject Devices | Rationale for Difference
(if applicable) |
|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Solitaire™ Platinum
Revascularization
Device
(K153071) | 4-20-05 and 6-24-06
Solitaire™ Platinum
Revascularization
Devices
(K161879) | |
| 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 as K153071. | N/A. |
| Method of
Supply | Stored within
dispenser coil, Tyvek
pouch, and shipping
carton. | Same as K153071. | N/A. |
| Sterilization
Method | Ethylene Oxide | Same as K153071. | N/A. |
| Device Size(s) | 4-20-10
4-40-10
6-20-10 | 4-20-05
6-24-06 | The subject devices share
identical technological
characteristics to the
predicate device. Non-
clinical bench testing has
demonstrated that the
devices do not raise
questions about the safety
and effectiveness. |
| Materials | | | |
| | Predicate Device
Solitaire™ Platinum
Revascularization
Device
(K153071) | Subject Devices
4-20-05 and 6-24-06
Solitaire™ Platinum
Revascularization
Devices
(K161879) | Rationale for Difference
(if applicable) |
| Solitaire™
Platinum Non-
Detachable EP | Nitinol | Same as K153071. | N/A |
| Push-wire | Nitinol | Same as K153071. | N/A |
| Proximal Coil | 90% Platinum/
10% Iridium | Same as K153071. | N/A |
| Body Marker | N/A | 90% Platinum/
10% Iridium. | Same material as the Body
Finger Marker Coil. |
| Body Finger
Marker Coil | 90% Platinum/
10% Iridium | N/A | Not a design feature of the
subject devices. |
| Distal Finger
Marker Coil | 90% Platinum/
10% Iridium | Same as K153071. | N/A |
| Push-wire
Shrink Tubing | PTFE | Same as K153071. | N/A |
| Dymax Glue | Dymax 1128A-M-T | Same as K153071. | N/A |
| Guidewire Clip | UV Curing Adhesive | Same as K153071. | N/A |
| Dispenser Coil | HDPE, ID Coated
with Hydro-Sil 2000 | Same as K153071. | N/A |
| Stent
Introducer
Sheath | PTFE/Grilamid | Same as K153071. | N/A |
6
Sterilization and Shelf Life:
The subject 4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization Devices are sterilized using the identical validated, Ethylene Oxide (EO) sterilization cycle as the predicate Solitaire™ Platinum Revascularization Device. The materials of construction, design, manufacturing process, sterilization load configuration and packaging process for this portfolio expansion of the subject 4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization Devices are equivalent to the predicate Solitaire™ Platinum Revascularization Device. The packaging of the subject 4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization Devices remains functional and maintain sterility for up to two (2) years. Therefore, no additional sterilization or shelf life validation testing is required for the subject 4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization Devices.
Biocompatibility:
The subject 4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization Devices do not introduce any new materials into the finished device or the manufacturing process. The material of construction for the subject 4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization Devices are identical to the predicate Solitaire™ Platinum
7
Revascularization Device. Biocompatibility was leveraged from the predicate Solitaire™ Platinum Revascularization Device in support of the subject 4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization Devices. A summary of the biocompatibility testing leveraged for the subject 4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization Devices is summarized in the table below.
| Test
Category | Test
Description | Method | Acceptance
Criteria | Conclusion |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Cytotoxicity | L929 MTT
Cytotoxicity | ISO 10993-5 | Viability is ≥70%. | The subject 4-20-05
and 6-24-06 devices
met the acceptance
criteria for ISO
10993-5 and are
substantially
equivalent to the
predicate device. |
| Sensitization | Guinea Pig
Maximization
Sensitization | ISO 10993-10 | Test article does not
elicit a sensitization
response. | The subject 4-20-05
and 6-24-06 devices
met the acceptance
criteria for ISO
10993-10 and are
substantially
equivalent to the
predicate device. |
| 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 | |
| | | | | |
| 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. | The subject 4-20-05 and 6-24-
06 devices met the acceptance
criteria for delivery force and
are substantially equivalent to
the predicate device. | |
| Re-sheathing
Force | Retrieval force was
measured through a
representative tortuous
anatomical model. | Stent must be
below re-sheathing
force specification. | The subject 4-20-05 and 6-24-
06 devices met the acceptance
criteria for re-sheathing force
and are substantially
equivalent to the predicate
device. | |
| 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). | The subject 4-20-
05 and 6-24-06
devices must
reliably deploy and
resheath up to four
(4) times. | The subject 4-20-05 and 6-24-
06 devices showed no
irregularities, breaks, kinks,
body marker migration, glue
separations, or other observed
defects after all deployment
and resheathing attempts.
The subject 4-20-05 and 6-24-
06 devices met the acceptance
criteria for multiple re-
sheathing durability and are
substantially equivalent to the
predicate device. | |
| 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. | The subject 4-20-05 and 6-24-
06 devices met acceptance
criteria for body marker
tensile and are substantially
equivalent to the predicate
device. | |
| Test Description | Method | Acceptance
Criteria | Conclusion | |
| Body Marker
Radiopacity | Verification analysis of
body markers. | The radiopaque
body markers must
be visible using
standard catheter
laboratory
equipment | The subject 4-20-05 and 6-24-
06 devices met acceptance
criteria for body marker
radiopacity and are
substantially equivalent to the
predicate device. | |
| 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 | The subject 4-20-05 and 6-24-
06 devices met acceptance
criteria for proximal marker to
distal marker and are
substantially equivalent to the
predicate device. | |
| A f Temperature | In-process 100%
tracking of heat set
parameters used to set
final Af | Temperature
should be less than
or equal to existing
A f temperature
specification. | The subject 4-20-05 and 6-24-
06 Solitaire™ Platinum
Revascularization Devices
met acceptance criteria for Af
and are substantially
equivalent to the predicate
device. | |
| Radial Force | The radial force was
measured 100% in-
process. | Stent must be
within existing
radial force
specification. | Radial force was measured
100% in-process.
The subject 4-20-05 and 6-24-
06 devices met acceptance
criteria for radial force and
are substantially equivalent to
the predicate device. | |
8
9
Performance Data – Bench:
A summary of the bench testing performed for the subject 4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization Devices is summarized in the table below.
10
Performance Data – Animal:
The subject 4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization Devices do not change the indications for use or the fundamental scientific technology of the predicate Solitaire™ Platinum Revascularization Device. Therefore, no additional non-clinical animal testing was performed for the subject 4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization Devices.
Performance Testing - Clinical:
The subject 4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization Devices do not change the indications for use or the fundamental scientific technology of the predicate device. The subject 4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization Devices are substantially equivalent to the predicate Solitaire™ Platinum Revascularization Device and do not raise new questions of the safety and effectiveness of the subject 4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization Devices. Therefore, no additional clinical study was performed.