(94 days)
No
The device description and performance studies focus on mechanical properties and physical interaction with the thrombus, with no mention of AI/ML for image analysis, decision support, or other functions.
Yes
The device is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke, which directly treats a medical condition.
No
The device is a medical instrument designed for therapeutic intervention (thrombus removal) and not for diagnosing a medical condition.
No
The device description clearly details physical components such as a core wire, shaped section, radiopaque wires, radiopaque markers, a torque device, and an insertion tool. It also mentions bench testing and animal studies, which are typical for hardware-based medical devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body.
- Device Function: The Trevo XP ProVue Retriever is a device designed to be inserted into the neurovasculature to physically remove a thrombus (blood clot). It is a therapeutic device used in vivo (within the body).
- Intended Use: The intended use clearly states it's for restoring blood flow by removing thrombus in patients experiencing ischemic stroke. This is a direct intervention within the body.
- Device Description: The description details a physical device with a core wire, shaped section, radiopaque markers, and a hydrophilic coating, all designed for mechanical interaction within the blood vessels.
- Input Imaging Modality: Fluoroscopic visualization is used to guide the device during the procedure, not to analyze a sample.
The device is a medical device, specifically a therapeutic device used for interventional procedures, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Trevo XP ProVue Retriever (4x30mm) is intended to restore blood flow in the neurovasculature by removing thrombus 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 Trevo XP ProVue Retriever (4x30mm) consists of a flexible, tapered core wire with a shaped section at the distal end. It is designed to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke. Radiopaque platinum wires in the shaped section and radiopaque markers on the distal end allow fluoroscopic visualization. Retriever dimensions are indicated on the product label. The Retriever has a hydrophilic coating to reduce friction during use. A torque device is provided with the Retriever to facilitate manipulation. The torque device is used to lock the core wire to the microcatheter during the procedure. Locking of the torque device to the wire allows the microcatheter and Retriever to be retracted as a system during clot retrieval. An insertion tool is provided to introduce the Retriever into a microcatheter. The proximal end of the device is compatible with the Abbott guide wire extension to facilitate removal or exchange of a catheter while maintaining the Retriever position in the vessel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Neurovasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Data – Bench
The results of verification and validation testing conducted on the Trevo XP ProVue Retriever (4x30mm) demonstrate that it performs as designed, and is suitable for its intended use. The verification and validation test results demonstrate that the Trevo XP ProVue Retriever (4x30mm) is substantially equivalent to the predicate device.
Tests performed include: Dimensional Verification, Retriever Mid Joint Tensile Strength, Retriever Tip Tensile Strength, Retriever Shaped Section Radial Force, Retriever / Vessel Interaction (Tip Flexibility), Retriever Torque Tensile Durability, Retriever Platinum Wire Joint Strength, Retriever Platinum Wire and Joint Durability, Radiopacity, Retriever / Microcatheter Deliverability, Particulate Evaluation, Coating Integrity Evaluation, Simulated Use.
All tests met acceptance criteria.
Performance Data - Animal
Animal Studies (acute and chronic) were conducted to demonstrate safety of the Trevo XP ProVue Retriever using a larger diameter device (6x30mm) than the subject device (4x30mm). A Trevo XP ProVue Retriever 6x30mm test article was developed for use in animal testing. The 6x30mm Trevo XP ProVue Retriever test article is comparable in design (i.e., same materials and similar tip design, cell size and distal truncation) and coating material to the Trevo XP ProVue Retriever 4x30mm design, except for the diameter (and associated radial force) which were increased to allow for a "worst case." The 6x30mm devices are worst case devices for assessing retriever/vessel interaction because they have a higher radial force part specification than the subject device. Animal studies were conducted in compliance with applicable requirements in the GLP regulation (21 CFR Part 58). The 6x30mm devices were deployed and animals were evaluated for evidence of arterial transmural dissection or perforation. The safety and usability results from the animal studies met acceptance criteria and suggest that the subject device is safe, usable and is equivalent to the predicate device.
Performance Data - Clinical
No clinical study was performed as there is no change to the indications for use or the fundamental scientific technology for the subject device. Substantial equivalence of the subject device has been established to the predicate device through the results of bench and animal testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of a human figure in profile, composed of three overlapping silhouettes. The silhouettes are arranged in a way that suggests movement or flow. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 12, 2015
Concentric Medical, Inc. Ms. Rhoda M. Santos Principal Regulatory Affairs Specialist 301 East Evelyn Avenue Mountain View, California 94041
Re: K150616
Trade/Device Name: Trevo XP ProVue Retriever (4x30mm) Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: May 8, 2015 Received: May 11, 2015
Dear Ms. Santos:
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 yours,
Carlos L. Pena -S 同公
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) K150616
Device Name Trevo XP ProVue Retriever (4x30mm)
Indications for Use (Describe)
The Trevo XP ProVue Retriever (4x30mm) is intended to restore blood flow in the neurovasculature by removing thrombus 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
| Trade Name: | Trevo XP ProVue Retriever (4x30mm) |
|---|---|
| Common Name: | Catheter, Thrombus Retriever |
| Classification Name: | Thrombus Retriever, 21CFR 870.1250 Class II |
| Product Code: | NRY |
| Submitter: | Concentric Medical, Inc. |
| 301 E. Evelyn Avenue | |
| Mountain View, CA 94041 | |
| Tel 510-413-2148 | |
| Fax 510-413-2558 | |
| Facility Registration #2954917 | |
| Contact: | Rhoda M. Santos |
| Principal Regulatory Affairs Specialist | |
| Date Prepared: | May 8, 2015 |
| Predicate Device: | Trevo XP ProVue Retriever (4x20mm) (K132641 |
Device Description
The Trevo XP ProVue Retriever (4x30mm) consists of a flexible, tapered core wire with a shaped section at the distal end. It is designed to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke. Radiopaque platinum wires in the shaped section and radiopaque markers on the distal end allow fluoroscopic visualization. Retriever dimensions are indicated on the product label. The Retriever has a hydrophilic coating to reduce friction during use. A torque device is provided with the Retriever to facilitate manipulation. The torque device is used to lock the core wire to the microcatheter during the procedure. Locking of the torque device to the wire allows the microcatheter and Retriever to be retracted as a system during clot retrieval. An insertion tool is provided to introduce the Retriever into a microcatheter. The proximal end of the device is compatible with the Abbott guide wire extension to facilitate removal or exchange of a catheter while maintaining the Retriever position in the vessel.
Indications for Use
The Trevo XP ProVue Retriever (4x30mm) is intended to restore blood flow in the neurovasculature by removing thrombus 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.
4
Technological Characteristics and Product Feature Comparison
The Trevo XP ProVue Retriever (4x30mm) is substantially equivalent to the primary predicate device in terms of basic design, materials used, and function. A comparison of the subject device with Primary Predicate Trevo XP ProVue Retriever (4x20mm) is summarized in the below table. Additionally, shaped section measurements are also compared to the reference predicate device [Solitaire FR Revascularization Device SFR2-4-40 (4x40mm) (K141491)].
| Feature | Primary Predicate
Cleared Trevo XP
ProVue Retriever
(4x20mm)
(K132641) | Subject Device
Trevo XP ProVue
Retriever (4x30mm) | Rationale for difference
(if applicable) |
|--------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
for Use | The Trevo XP ProVue
Retriever is intended to
restore blood flow in the
neurovasculature by
removing thrombus 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 |
| Feature | Primary Predicate
Cleared Trevo XP
ProVue Retriever
(4x20mm)
(K132641) | Subject Device
Trevo XP ProVue
Retriever (4x30mm) | Rationale for difference
(if applicable) |
| Device
Description | The Retriever consists of a
flexible, tapered core wire
with a shaped section at the
distal end. Platinum
markers at the distal end
allow fluoroscopic
visualization. In addition,
the shaped section is also
radiopaque. Retriever
dimensions are indicated on
product label.
The Retriever has a
hydrophilic coating to
reduce friction during use.
The Retriever has a shaft
marker to indicate
proximity of Retriever tip
relative to Microcatheter
tip. A torque device is
provided with the Retriever
to facilitate manipulation.
An insertion tool is
provided to introduce the
Retriever into a Trevo®
Microcatheter. | Same with the exception
that the subject Retriever is
introduced via an Excelsior
XT-27 Microcatheter
(whereas the predicate
device is introduced via a
Trevo® Microcatheter) | The Excelsior XT-27 and
Trevo Pro18 Microcatheters
are compatible with the
4x30mm device and will be
indicated as such in the
IFU.
Bench testing has
demonstrated that the
compatibility of Excelsior
XT-27 with the 4x30mm
device does not affect the
safety and effectiveness of
the device. |
| Target
Population | Patients with symptoms of
an ischemic stroke | Same | N/A |
| Anatomical
Sites | Neurovasculature | Same | N/A |
| Accessory
Devices
Provided
(not in direct
contact with
patient) | Insertion tool and torque
device provided in product
package | Same | N/A |
| Feature | Primary Predicate
Cleared Trevo XP
ProVue Retriever
(4x20mm)
(K132641) | Subject Device
Trevo XP ProVue
Retriever (4x30mm) | Rationale for difference
(if applicable) |
| Microcatheter
Compatibility | Trevo Pro 18 Microcatheter | Excelsior XT-27
Microcatheter and Trevo
Pro 18 Microcatheter | The Excelsior XT-27 and
Trevo Pro18 Microcatheters
are compatible with the
4x30mm device and will be
indicated as such in the
IFU.
Bench testing has
demonstrated that the
compatibility of Excelsior
XT-27 with the 4x30mm
device does not affect the
safety and effectiveness of
the device. |
| Materials | Core Wire Material: Nitinol
(nickel titanium alloy)
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 | Same | N/A |
| Dimensional
Drawing | Image: Dimensional Drawing of the 4x20mm Retriever | Image: Dimensional Drawing of the 4x30mm Retriever | Additional reference
(Length of the non-tapered
portion of shaped section
(F)) allows customers to
directly compare the length
of the 4x30mm retriever to
the labeling of competitive
stentrievers. |
| Overall
Length (A) | 180cm | Same | N/A |
| Total Shaped
Section
Length
(nominal) (B) | 32mm | 44mm | Shaped section has been
lengthened to meet user
preferences.
Bench and animal testing
has demonstrated that the
longer shaped section does
not affect the safety and
effectiveness of the device. |
| Feature | Primary Predicate
Cleared Trevo XP
ProVue Retriever
(4x20mm)
(K132641) | Subject Device
Trevo XP ProVue
Retriever (4x30mm) | Rationale for difference
(if applicable) |
| Active
Shaped
Section
Length
(nominal) (C) | 20mm | 30mm | Shaped section has been
lengthened to meet user
preferences.
Bench and animal testing
has demonstrated that the
longer shaped section does
not affect the safety and
effectiveness of the device. |
| Shaped
Section
Diameter
(nominal) (D) | 4mm | Same | N/A |
| Proximal
Core Wire
Diameter (E) | 0.0180in | Same | N/A |
| Length of the
non-tapered
portion of
shaped
section (F) | Not provided in labeling | 35mm | Additional reference
(Length of the non-tapered
portion of shaped section
(F)) allows customers to
directly compare the length
of the 4x30mm retriever to
the labeling of competitive
stentrievers. |
| Shaped
section | 4 rows and 4 rings of cells. | 4 rows and 7 rings of cells. | Shaped section has been
lengthened to meet user
preferences.
Bench and animal testing
has demonstrated that the
longer shaped section does
not affect the safety and
effectiveness of the device. |
| Hydrophilic
coating
length | Coating extends from the
proximal end of the core
wire up to the proximal
coil. | Coating extends from a
point 80cm distal to the
proximal end of the core
wire up to the proximal coil
to enable physician to hold
the device more securely. | The lubricious coating was
removed from the proximal
end of the core wire so the
physician can hold the
device more securely.
Bench testing has
demonstrated that the
change in coating length
does not affect the safety
and effectiveness of the
device. |
| Feature | Primary Predicate
Cleared Trevo XP
ProVue Retriever
(4x20mm)
(K132641) | Subject Device
Trevo XP ProVue
Retriever (4x30mm) | Rationale for difference
(if applicable) |
| Shaped
section distal
platinum coil
markers | Platinum markers attached
to 3 distal tips of the distal
end of the shaped section. | Same | N/A |
| Core wire
marker band
placement
and presence | Core wire marker bands at
59.53" from the proximal
end of the shaped section. | Core wire marker bands at
57.56" from the proximal
end of the shaped section.
Location moved (~5cm
more distal) to allow
compatibility with the XT-
27 Microcatheter. | The placement of the shaft
markers (Core wire marker
bands) was moved to allow
the Trevo XP ProVue
Retriever (4x30mm) to be
compatible with the
Excelsior XT-27
Microcatheter.
Bench testing has
demonstrated that the
difference in placement of
the core wire marker bands
does not affect the safety
and effectiveness of the
device. |
| | 6 marker bands are present
on the core wire. | 4 marker bands are present
on the core wire. | Difference in number of
shaft markers (core wire
marker bands) to make sizes
easily identifiable in
manufacturing.
Bench testing has
demonstrated that the
difference in number of
shaft markers (core wire
marker bands) does not
affect the safety and
effectiveness of the device. |
Product Feature Comparison of Subject Device with Primary Predicate Device Trevo XP ProVue Retriever (4x20mm) (K132641)
5
6
7
8
9
| Feature | Primary Predicate
Cleared Trevo XP
ProVue Retriever
(4x20mm)
(K132641) | Subject Device
Trevo XP ProVue
Retriever (4x30mm) | Rationale for difference
(if applicable) |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Radial Force | Radial Force at 1.5mm
diameter: 0.70 +0.15/-
0.20N | Radial Force at 1.5mm
diameter: 0.95 +0.15 /-
0.25N | The longer length of the
4x30mm device resulted in
a higher radial force
specification.
Bench and animal testing
has demonstrated that the
higher radial force
specification does not affect
the safety and effectiveness
of the device. No evidence
of vessel dissection or
perforation demonstrated in
animal testing using Trevo
XP ProVue retriever
(6x30mm, as worst case
size for 4x30mm). |
| | Radial Force at 3.0mm
diameter: $\u2264$ 0.5 N | Same | N/A |
| Packaging
Materials and
Configuratio
n | Polyethylene Hoop,
polycarbonate mounting
card, Tyvek/Film Pouch,
HDPE Tubing Clips,
Chipboard carton | Same | N/A |
| Sterilization
Method | 100% EtO | Same | N/A |
| How
Supplied | Sterile/Single Use | Same | N/A |
Risk Assessment
Risk assessment of the modifications has been conducted in accordance with EN ISO 14971:2012. Concentric Medical, Inc. has determined the modifications to the predicate device raise no new questions of safety or effectiveness. Results of verification and validation testing are appropriate for use in determining that the Trevo XP ProVue Retriever (4x30mm) is substantially equivalent to the predicate device.
The modifications did not result in the identification of any new failure modes nor were there any changes to existing failure modes, including no change to severity or occurrence; and, therefore, no change to overall residual risk.
10
Testing Summary
Performance Data – Bench
The results of verification and validation testing conducted on the Trevo XP ProVue Retriever (4x30mm) demonstrate that it performs as designed, and is suitable for its intended use. The verification and validation test results demonstrate that the Trevo XP ProVue Retriever (4x30mm) is substantially equivalent to the predicate device. Specifically, the following tests were performed on the subject device:
| Test | Test Method Summary | Conclusions |
|---|---|---|
| Dimensional | ||
| Verification | Verified dimensions using specified | |
| measurement tool. | Dimensional verification | |
| meets acceptance criteria. | ||
| Retriever Mid Joint | ||
| Tensile Strength | Identify joint and prepare sample for | |
| test. Use Instron tensile tester to | ||
| determine applied peak tensile force. | ||
| Record results. | Retriever Mid Joint | |
| Tensile Strength meets | ||
| acceptance criteria. | ||
| Retriever Tip | ||
| Tensile Strength | Load sample. Use Instron tensile tester | |
| to determine applied peak tensile | ||
| force. Record results. Repeat until | ||
| remaining distal cells with markers are | ||
| tested. Record results. | Retriever Tip Tensile | |
| Strength meets acceptance | ||
| criteria. | ||
| Retriever Shaped | ||
| Section Radial | ||
| Force | Constrain shaped section of retriever | |
| and release to specified diameter. Use | ||
| Instron tensile tester and Blockwise RF | ||
| iris fixture to determine applied force at | ||
| the specified diameter. Record results. | Retriever Shaped Section | |
| Radial Force meets | ||
| acceptance criteria. | ||
| Retriever / Vessel | ||
| Interaction (Tip | ||
| Flexibility) | Load sample so that the distal tip will | |
| be flexed. Use Instron tensile tester to | ||
| determine applied peak | ||
| compression/flex force. Record results. | Retriever/Vessel | |
| Interaction (Tip | ||
| Flexibility) meets | ||
| acceptance criteria. | ||
| Retriever Torque | ||
| Tensile Durability | Grip shape section and core wire. | |
| Apply two full rotations to core wire | ||
| grips to torque device. Instron pulls | ||
| five tensile cycles to 1.7lbs then sixth | ||
| cycle to failure. Record results. | Retriever Torque Tensile | |
| Durability meets | ||
| acceptance criteria. | ||
| Retriever Platinum | ||
| Wire Joint Strength | Identify joint and cut platinum wire, | |
| freeing it from the shaped section for | ||
| test. Use Instron tensile tester to | ||
| determine applied peak tensile force on | ||
| individual platinum wire. Record | ||
| results. | Retriever Platinum Wire | |
| Joint Strength meets | ||
| acceptance criteria. | ||
| Test | Test Method Summary | Conclusions |
| Retriever Platinum | ||
| Wire and Joint | ||
| Durability | Wrap and unwrap the entire length of | |
| the shaped section of the retriever | ||
| (sheathed in its insertion tool) around a | ||
| 2.0 mm pin. Repeat for a total of | ||
| 6 wrap-unwrap cycles. Perform visual | ||
| inspection and record results. Perform | ||
| 10 deploy/reload cycles into insertion | ||
| tool. Perform visual inspection and | ||
| record results. | Retriever Platinum Wire | |
| and Joint Durability meet | ||
| acceptance criteria. | ||
| Radiopacity | Radiopacity is assessed based on visual | |
| assessment of the device being used | ||
| under fluoroscopy per acceptance | ||
| criteria. | Same platinum weave | |
| wires (same diameter and | ||
| composition) and | ||
| configuration (weave | ||
| design) as the predicate | ||
| device (Trevo XP ProVue | ||
| 4x20), therefore previous | ||
| data remains valid. | ||
| Radiopacity meets | ||
| acceptance criteria. | ||
| Retriever / | ||
| Microcatheter | ||
| Deliverability | Measure the force to push the device | |
| through a tortuous model in a 37degC | ||
| water bath. Record maximum force | ||
| from the first 5 cm push. | Retriever/Microcatheter | |
| Deliverability meets | ||
| acceptance criteria. | ||
| Particulate | ||
| Evaluation | Measured total number of particulate | |
| and size of particulate generated during | ||
| the simulated delivery, deployment and | ||
| resheathing of the device. Particulate | ||
| counting was assessed for ≥10um, | ||
| ≥25µm, and ≥50µm size ranges | All samples meet | |
| acceptance criteria. | ||
| Coating Integrity | ||
| Evaluation | An assessment of coating lubricity and | |
| durability using a test model to evaluate | ||
| friction encountered from full | ||
| circumferential contact of the coated | ||
| core wire with pads. The hydrated core | ||
| wires (hydration simulates an aqueous | ||
| environment) are pulled through the | ||
| rubber pads using a calibrated tensile | ||
| machine so that the resistance can be | ||
| measured and recorded. | All samples meet | |
| acceptance criteria. | ||
| Test | Test Method Summary | Conclusions |
| Simulated Use | Simulated use testing uses a | |
| neurovascular model cast from actual | ||
| human neurovascular arteries. This | ||
| bench testing model replicates the | ||
| tortuosity, diameter and location of the | ||
| arteries in the neurovasculature. The | ||
| model incorporates a re-circulating | ||
| water bath at 37°C pressurized between | ||
| 2 – 2.5 psi (100 – 126mm Hg) to | ||
| simulate the human arterial circulation. | ||
| All testing follows the procedural | ||
| instructions outlined in the Instructions | ||
| for Use. | Simulated Use meets | |
| acceptance criteria. |
11
12
Performance Data - Animal
Animal Studies (acute and chronic) were conducted to demonstrate safety of the Trevo XP ProVue Retriever using a larger diameter device (6x30mm) than the subject device (4x30mm). A Trevo XP ProVue Retriever 6x30mm test article was developed for use in animal testing. The 6x30mm Trevo XP ProVue Retriever test article is comparable in design (i.e., same materials and similar tip design, cell size and distal truncation) and coating material to the Trevo XP ProVue Retriever 4x30mm design, except for the diameter (and associated radial force) which were increased to allow for a "worst case." The 6x30mm devices are worst case devices for assessing retriever/vessel interaction because they have a higher radial force part specification than the subject device. Animal studies were conducted in compliance with applicable requirements in the GLP regulation (21 CFR Part 58). The 6x30mm devices were deployed and animals were evaluated for evidence of arterial transmural dissection or perforation. The safety and usability results from the animal studies met acceptance criteria and suggest that the subject device is safe, usable and is equivalent to the predicate device.
Performance Data - Clinical
No clinical study was performed as there is no change to the indications for use or the fundamental scientific technology for the subject device. Substantial equivalence of the subject device has been established to the predicate device through the results of bench and animal testing.
13
Sterilization and Shelf life
The Trevo XP ProVue Retriever (4x30mm) is sterilized by 100% Ethylene Oxide using an identical method (including sterilization chamber) to the predicate device, Trevo ProVue Retriever (K132641) and to an earlier device iteration (Trevo ProVue Retriever). The materials of construction and packaging are identical to the predicate device. Therefore, the results from the Trevo ProVue sterilization are applicable to the subject device (Trevo XP ProVue Retriever 4x30mm) and no additional sterilization validation testing is required.
Ethylene oxide (EO) residual testing for the Trevo XP ProVue Retriever 4x30mm was adopted from the predicate device, Trevo ProVue Retriever (K132641) and an earlier device iteration (Trevo ProVue Retriever) as the materials and packaging are identical to the predicate device.
Aging studies for the Trevo XP ProVue Retriever (4x30mm) have established the product remains functional and maintains sterility through the proposed shelf life. Since the packaging materials and configuration are identical to the predicate device, aging studies previously conducted for packaging integrity remain valid and no new packaging testing is required for the Trevo XP ProVue Retriever (4x30mm).
Biocompatibility
The Trevo XP ProVue Retriever (4x30mm) was assessed for impact to biocompatibility. Materials used in the Trevo XP ProVue Retriever (4x30mm) are all the same materials used in the cleared Trevo ProVue Retriever (K132641). Both the Trevo XP ProVue Retriever (4x30mm) and the cleared Trevo ProVue Retriever meet biological safety requirements per ISO 10993-1 for externally communicating medical devices with circulating blood contact for less than 24 hours.
Summary of Substantial Equivalence
The Trevo XP ProVue Retriever (4x30mm) is substantially equivalent to the predicate device with regard to device design, materials, intended use, and patient population. The conclusions drawn from risk assessments and the verification and validation testing conducted using the Trevo XP ProVue Retriever (4x30mm) demonstrate that the device performs as designed, is suitable for its intended use and is substantially equivalent to the legally marketed predicate device.