Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the mechanical properties and biological interactions of a physical medical device (a retriever for thrombus removal). There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.

Therapeutic

Yes
The Trevo XP ProVue Retriever is intended to restore blood flow by removing thrombus in patients experiencing ischemic stroke, which is a direct therapeutic action on the body.

Diagnostic

No
Explanation: The device is intended to restore blood flow by physically removing thrombus, which is a therapeutic intervention, not a diagnostic one.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a physical medical device (retriever) with specific dimensions, materials (platinum wires), and a hydrophilic coating. Performance studies include physical testing and animal studies, further indicating a hardware-based device.

IVD (In Vitro Diagnostic)

Based on the provided information, the Trevo XP ProVue Retriever (6x25 mm) is not an In Vitro Diagnostic (IVD) device.

Here's why:

Intended Use: The intended use is to "restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke." This is a therapeutic intervention performed in vivo (within the body).
Device Description: The description details a physical device designed to be inserted into blood vessels to mechanically remove a clot.
Mechanism of Action: The device works by physically interacting with the thrombus within the blood vessel.
Input Imaging Modality: Fluoroscopic visualization is used to guide the device during the procedure, not to analyze a sample outside the body.
Anatomical Site: The device is used within the "neurovasculature," which is inside the patient's body.

IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. The Trevo XP ProVue Retriever does not perform this function. It is a therapeutic medical device used to treat a condition directly within the patient's body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Trevo XP ProVue Retriever (6x25 mm) 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

NRY

Device Description

The Trevo XP ProVue Retriever (6x25mm) consists of a flexible, tapered core 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 and an insertion tool are provided with the Retriever. 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

Radiopacity was assessed based on visual assessment of the device being used under fluoroscopy.

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

Simulated Use: Simulated use testing used a silicone neurovascular model cast from actual human neurovascular arteries. This bench testing model replicates the tortuosity, diameter and location of the arteries in the neurovasculature including the internal carotid artery (ICA) siphon. The model ends at the mid carotid arteries and proximal support is provided by a guide catheter. The model incorporates a re-circulating water bath at 37 degree C pressurized between 2 – 2.5 psi (100 - 126 mm Hg) to simulate the human arterial circulation. All testing follows the procedural instructions outlined in the Instructions for Use. Simulated thrombus is used to assess the devices ability to retrieve clot. Conclusions: Simulated Use meets acceptance criteria.

Animal studies (acute and chronic): Animal studies consisting of an acute animal (swine) study and a chronic animal (swine) study were performed using devices representative of the Trevo XP ProVue Retriever (6x25mm) and were conducted in compliance with applicable requirements in the GLP regulation (21 CFR Part 58). In both the acute and the chronic animal studies: 12 test articles (4 per animal) were deployed 6 test article treatment runs were conducted successfully in both internal maxillary arteries (IMAs) of animals which resulted in the assessment of 6 arteries (2 per animal). Safety (vessel response) was assessed based on the presence or absence of arterial transmural dissection or perforation due to Stentriever use in the treated vessels. Device/vessel interaction is considered acceptable (pass) if there is no evidence of arterial transmural dissection or perforation due to Stentriever use in the treated vessels based on results of angiography and histopathology. Acute Animal Study Results: - Histopathology was consistent with arterial healing after routine catheterization commonly seen with guidewires / catheters. Angiography revealed No evidence of vessel dissection or perforation or thrombosis. Chronic Animal Study Results: -Histopathology was consistent with arterial healing after routine catheterization commonly seen with guidewires / catheters No evidence of vessel dissection or perforation Angiography revealed no evidence of vessel dissection or perforation at Day 0, and no angiographic evidence of stenosis, vessel irregularity, intimal flap or pseudoaneurysm was observed at treatment sites at Day 30. Conclusion: Animal studies meet acceptance criteria and are comparable to predicate device.

Key Metrics

Not Found

Predicate Device(s)

K132641

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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).

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of a stylized caduceus, which is a symbol of medicine and health. The caduceus is composed of three intertwined snakes and a staff.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 6, 2015

Concentric Medical, Inc. Mr. Bill Hyatt Regulatory Affairs Manager 301 East Evelyn Avenue Mountain View, California 94041

Re: K143077

Trade/Device Name: Trevo XP ProVue Retriever (6x25 mm) Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: March 3, 2015 Received: March 6, 2015

Dear Mr. Hyatt:

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

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K143077

Device Name Trevo XP ProVue Retriever (6x25 mm)

Indications for Use (Describe)

The Trevo XP ProVue Retriever (6x25 mm) 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)

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510(k) Summary

Trade Name:	Trevo XP ProVue Retriever (6x25 mm)
Common Name:	Catheter, Thrombus Retriever
Classification Name:	Percutaneous Catheter, 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:	Bill Hyatt
Manager, Regulatory Affairs
Date Prepared:	April 2, 2015
Predicate Device:	Trevo XP ProVue Retriever (4x20mm) (K132641)

Device Description

The Trevo XP ProVue Retriever (6x25mm) consists of a flexible, tapered core 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 and an insertion tool are provided with the Retriever. 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 (6x25mm) 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.

Technological Characteristics and Product Feature Comparison

The Trevo XP ProVue Retriever (6x25mm) 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.

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| Feature | Primary Predicate
Cleared Trevo XP ProVue Retriever (4x20mm) (K132641) | Subject Device
Trevo XP ProVue Retriever (6x25mm) | |
|-----------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 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 as K132641 | |
| 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 as K132641 with the
exception that the subject
Retriever is introduced via an
XT-27 Microcatheter (whereas
the predicate device is
introduced via a Trevo®
Microcatheter) | |
| Target Population | Patients with symptoms of an
ischemic stroke | Same as K132641 | |
| Anatomical Sites | Neurovasculature | Same as K132641 | |
| Feature | Primary Predicate
Cleared Trevo XP ProVue
Retriever (4x20mm)
(K132641) | Subject Device
Trevo XP ProVue Retriever
(6x25mm) | |
| Accessory Devices
Provided
(not in direct
contact with
patient) | Insertion tool and torque device
provided in product package | Same as K132641 | |
| Microcatheter
Compatibility | Trevo Pro 18 Microcatheter | Excelsior XT-27
Microcatheter | |
| 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 as K132641 | |
| Dimensional
Drawing | | E
D | |
| Overall Length
(A) | 180cm | 180cm | |
| Total Shaped
Section Length
(nominal) (B) | 32mm | 40mm | |
| Active Shaped
Section Length
(nominal) (C) | 20mm | 25mm | |
| Shaped Section
Diameter
(nominal) (D) | 4mm | 6mm | |
| Feature | Primary Predicate
Cleared Trevo XP ProVue
Retriever (4x20mm)
(K132641) | Subject Device
Trevo XP ProVue Retriever
(6x25mm) | |
| Proximal Core
Wire Diameter (E) | 0.0180in | Same as K132641 | |
| Length of the non-
tapered portion of
shaped section (F) | Not provided in labeling | 30mm | |
| Shaped section | 4 rows and 4 rings of cells. | 5 rows and 5 rings of cells. | |
| 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. | |
| Shaped section
distal platinum
coil markers | Platinum markers attached to 3
distal tips of the distal end of the
shaped section. | Platinum markers attached to 3
distal tips of the distal end of the
shaped section. | |
| Radiopaque
platinum wire
woven into shaped
section | Three platinum wires woven on
shaped section struts. | Four platinum wires woven on
shaped section struts. | |
| Core wire marker
band placement
and presence | Core wire marker bands at
59.53" from the proximal end of
the shaped section.

Product Feature Comparison of Subject Device with Primary Predicate Device Trevo XP ProVue Retriever (4x20mm) (K132641)

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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 (6x25mm) 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.

Testing Summarv

The results of verification and validation testing conducted on the Trevo XP ProVue Retriever (6x25mm) 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 (6x25mm) is substantially equivalent to the predicate device. Specifically, the following tests were performed on the proposed device:

	Test	Test Method Summary	Conclusions
1.	Dimensional
Verification	Verified dimensions using
specified measurement tool.	Dimensional
verification meets
acceptance criteria.
2.	Retriever Mid Joint
Tensile Strength	Identified joint and cut
sample for test. Recorded
peak tensile force results.	Retriever Mid Joint
Tensile Strength meets
acceptance criteria.
3.	Retriever Tip Tensile
Strength	Loaded sample. Recorded
peak tensile force results.	Retriever Tip Tensile
Strength meets
acceptance criteria.
4.	Retriever Shaped
Section Radial Force	Constrained and released
shaped section of retriever to
specified diameter. Recorded
radial force results.	Retriever Shaped
Section Radial Force
meets acceptance
criteria.
5.	Retriever/Vessel
Interaction (Tip
Flexibility)	Loaded sample so that the
distal tip was flexed.
Recorded peak
compression/flex force
results.	Retriever/Vessel
Interaction (Tip
Flexibility) meets
acceptance criteria.
6.	Retriever Torque
Tensile Durability	Gripped device and applied
rotations to torque device.
Pulled tensile cycles to a max
load then last cycle to failure.
Recorded results.	Retriever Torque
Tensile Durability
meets acceptance
criteria.

8

	Test	Test Method Summary	Conclusions
7.	Retriever Platinum
Wire Joint Strength	Identified joint and cut sample for test. Recorded peak tensile force results for each individual platinum wire.	Retriever Platinum Wire Joint Strength meets acceptance criteria.
8.	Retriever Platinum
Wire and Joint
Durability	Wrapped and unwrapped the entire length of the shaped section of the retriever (sheathed in insertion tool) around a pin and repeat.
Performed visual inspection and recorded results.
Performed deploy/reload cycles into insertion tool.
Performed visual inspection and recorded results.	Retriever Platinum Wire and Joint Durability meet acceptance criteria.
9.	Radiopacity	Radiopacity was assessed based on visual assessment of the device being used under fluoroscopy.	Radiopacity meets acceptance criteria.
10.	Retriever /
Microcatheter
Deliverability	Measured the force to push the device through a tortuous model.	Retriever/Microcatheter Deliverability meets acceptance criteria.
11.	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 $≥10µm$ , $≥25µm$ , and $≥50µm$ size ranges	All samples meet acceptance criteria.

9

	Test	Test Method Summary	Conclusions
12.	Coating Integrity
Evaluation	A visual assessment of the
coating integrity of the
subject device was performed
before (baseline) and after
tracking through a tortuous
path fixture representative of
clinical conditions (simulated
use). The visual assessment
evaluation included a
comparison of the visual
assessment using higher
magnification and a dye to
assess the adhesion of the
coating. Proximal and distal
coating edges were evaluated
to determine if the coating
was intact. The entire
coating length of the device
was evaluated for defects
(visible voids or scratches).	Neither the Baseline
test articles nor the
Post-tracking test
articles exhibited any
delamination at coating
edges (either proximal
or distal). The Baseline
test articles did not
exhibit any coating
defects (voids or
scratches). The Post
tracking devices
exhibited minimal
defects along the 75cm
coating length. When
considered in
conjunction with
coating lubricity and
durability results and
the particulate
generation results, the
coating functions as
intended and has
exhibited appropriate
integrity (via visual
assessment) post
simulated use.

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	Test	Test Method Summary	Conclusions
13.	Simulated Use	Simulated use testing used a
silicone neurovascular model
cast from actual human
neurovascular arteries. This
bench testing model
replicates the tortuosity,
diameter and location of the
arteries in the
neurovasculature including
the internal carotid artery
(ICA) siphon. The model
ends at the mid carotid
arteries and proximal support
is provided by a guide
catheter. The model
incorporates a re-circulating
water bath at 37°C
pressurized between 2 – 2.5
psi (100 - 126 mm Hg) to
simulate the human arterial
circulation. All testing
follows the procedural
instructions outlined in the
Instructions for Use.
Simulated thrombus is used
to assess the devices ability to
retrieve clot	Simulated Use meets
acceptance criteria.
	Test	Test Method Summary	Conclusions
14.	Animal studies (acute
and chronic)	Animal studies consisting of
an acute animal (swine) study
and a chronic animal (swine)
study were performed using
devices representative of the
Trevo XP ProVue Retriever
(6x25mm) and were
conducted in compliance with
applicable requirements in
the GLP regulation (21 CFR
Part 58).
In both the acute and the
chronic animal studies:	Acute Animal Study
Results: -
Histopathology was
consistent with arterial
healing after routine
catheterization
commonly seen with
guidewires / catheters.
Angiography revealed
No evidence of vessel
dissection or
perforation or
thrombosis.
		12 test articles (4 per animal) were deployed 6 test article treatment runs were conducted successfully in both internal maxillary arteries (IMAs) of animals which resulted in the assessment of 6 arteries (2 per animal). Safety (vessel response) was assessed based on the presence or absence of arterial transmural dissection or perforation due to Stentriever use in the treated vessels.
Device/vessel interaction is considered acceptable (pass) if there is no evidence of arterial transmural dissection or perforation due to Stentriever use in the treated vessels based on results of angiography and histopathology.	Chronic Animal Study
Results: -
Histopathology was
consistent with arterial
healing after routine
catheterization
commonly seen with
guidewires / catheters
No evidence of vessel
dissection or
perforation
Angiography revealed
no evidence of vessel
dissection or
perforation at Day 0,
and no angiographic
evidence of stenosis,
vessel irregularity,
intimal flap or
pseudoaneurysm was
observed at treatment
sites at Day 30
Conclusion: Animal
studies meet
acceptance criteria and
are comparable to
predicate device

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Biocompatibility

The Trevo XP ProVue Retriever (6x25mm) was assessed for impact to biocompatibility. Materials used in the Trevo XP ProVue Retriever (6x25mm) are all the same materials used in the cleared Trevo ProVue Retriever (K132641). Both the Trevo XP ProVue Retriever (6x25mm) 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 (6x25mm) 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 (6x25mm) demonstrate that the device performs as designed, is suitable for its intended use and is substantially equivalent to the legally marketed predicate device.