The Trevo 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.

Device Description

The Modified Trevo ProVue Retriever 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 new radiopaque markers on the new truncated 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. The Modified Trevo ProVue Retriever is offered in two sizes.

AI/ML Overview

The provided text describes a 510(k) submission for a Modified Trevo ProVue Retriever, a medical device intended to remove thrombus in patients experiencing ischemic stroke. The submission focuses on demonstrating substantial equivalence to a predicate device (Concentric Trevo ProVue Retriever K122478) rather than an AI-powered diagnostic device. Therefore, many of the requested categories related to AI performance, ground truth, expert adjudication, and MRMC studies are not applicable or cannot be extracted from this document.

Here's the information that can be extracted or inferred from the provided text, with an explanation of why other requested information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
Dimensional Verification	Met	"Dimensional verification meets acceptance criteria."
Retriever Proximal Joint Tensile Strength	Met	"Retriever Proximal Joint Tensile Strength meets acceptance criteria."
Retriever Mid Joint Tensile Strength	Met	"Retriever Mid Joint Tensile Strength meets acceptance criteria."
Retriever Tip Tensile Strength	Met	"Retriever Tip Tensile Strength meets acceptance criteria."
Retriever Shaped Section Radial Force	Met	"Retriever Shaped Section Radial Force meets acceptance criteria."
Retriever/Vessel Interaction (Tip Flexibility)	Met	"Retriever/Vessel Interaction (Tip Flexibility) meets acceptance criteria."
Retriever Torque Tensile Durability	Met	"Retriever Torque Tensile Durability meets acceptance criteria."
Retriever Platinum Wire Joint Strength	Met	"Retriever Platinum Wire Joint Strength meets acceptance criteria."
Retriever Platinum Wire and Joint Durability	Met	"Retriever Platinum Wire and Joint Durability meets acceptance criteria."
Radiopacity	Assessed based on visual assessment of the device being used under fluoroscopy.	"Radiopacity meets acceptance criteria."
Retriever/Microcatheter Deliverability	Met	"Retriever/Microcatheter Deliverability meets acceptance criteria."
Proximal Curl Resistance	Met	"Proximal Curl Resistance meets acceptance criteria."
Simulated Use	Demonstrated successful performance in a silicone neurovascular model with simulated thrombus.	"Simulated Use meets acceptance criteria."
Biocompatibility (Cytotoxicity - ISO Elution Method)	Non-cytotoxic (Dilutions: Undiluted (3 - Moderate reactivity - noted as consistent with historical data), 50%, 25%, 12.5%, 6.25%, 3.13% - 0 reactivity)	Pass for all dilutions, with specific note on historical consistency for undiluted moderate reactivity.
Biocompatibility (ASTM Hemolysis)	Non-Hemolytic	Pass. Hemolytic index: 0.0% (direct contact) and 0.4% (extract)
Biocompatibility (Physicochemical Tests Plastics)	No heavy metals or leachables (Non-volatile residue: 2 mg, Residue on ignition: ≤ 2 mg, Heavy metal: < 1 ppm, Buffering capacity: < 1.0 mL)	Pass. Stated conclusion: "No heavy metals or leachables."

Explanation: The acceptance criteria are implicitly stated by the "Conclusion" column in the "Testing Summary" and "Biocompatibility" tables, which consistently reports that the device "meets acceptance criteria." The specific quantitative acceptance criteria are not explicitly detailed (e.g., what is the exact tensile strength required), but the summary confirms they were met.

2. Sample Size Used for the Test Set and the Data Provenance

Sample Size: The document does not specify the exact sample sizes (number of devices, number of tests, or number of simulated emboli) used for the various physical and simulated use tests.
Data Provenance:
- Simulated Use: The test used a "silicone neurovascular model cast from actual human neurovascular arteries," replicating tortuosity, diameter, and location of arteries. This indicates a benchtop, in vitro model.
- Other Tests: The other tests (dimensional, tensile strength, radial force, durability, radiopacity, deliverability, curl resistance) are laboratory benchtop tests performed on physical device samples.
- All testing was conducted by Concentric Medical, Inc. (the submitter), implying an internal, controlled testing environment.
- The tests are prospective in nature, as they were conducted specifically for this submission.
- The country of origin of the data is not explicitly stated but is implicitly the country where Concentric Medical, Inc. conducts its R&D and testing, likely the USA given the submission to the FDA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is Not Applicable to this submission. The Modified Trevo ProVue Retriever is a physical medical device, not an AI diagnostic algorithm. Ground truth for the performance characteristics of the device is established through physical and simulated benchtop testing, not through expert review of clinical data or images. The "Radiopacity" test mentions "visual assessment," which likely implies assessment by trained personnel (e.g., engineers, quality control specialists) using fluoroscopy, but no details on their qualifications or number are provided, as it's a standard engineering/device performance check.

4. Adjudication Method for the Test Set

This information is Not Applicable to this submission, as it pertains to expert consensus for clinical ground truth in AI studies. The tests conducted are objective physical and performance measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is Not Applicable. This is a submission for a physical medical device. There is no AI component or human-in-the-loop performance being evaluated in this K132641 summary.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is Not Applicable. This is a physical medical device, not a standalone algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established through objective, quantifiable physical and mechanical tests, and simulated use in a validated in vitro model. This implicitly serves as the "ground truth" for its functional characteristics.

Physical/Mechanical Properties: Measurements directly obtained during testing (e.g., force, dimensions, durability cycles) compared against predetermined specifications.
Simulated Use: The ability of the device to successfully retrieve simulated thrombus in a anatomically correct (cast from human arteries) silicone neurovascular model.
Biocompatibility: Laboratory test results (cytotoxicity, hemolysis, physicochemical properties) compared against ISO 10993-1 standards and internal specifications.

8. The Sample Size for the Training Set

This information is Not Applicable. The device is a physical medical device; there is no AI training set involved.

9. How the Ground Truth for the Training Set was Established

This information is Not Applicable. There is no "training set" for this physical medical device.

Summary

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5. 510(k) Summary

Trade Name:	Modified Trevo ProVue Retriever
Common Name:	Catheter, Thrombus Retriever
Classification Name:	Thrombus Retriever, 21CFR 870.1250 Class II
Product Code:	NRY
Submitter:	Concentric Medical, Inc.301 E. Evelyn AvenueMountain View, CA 94041Tel 510-413-2681Fax 510-413-2558Facility Registration #2954917
Contact:	Sarah MeyerSenior Regulatory Affairs Specialist
Date Prepared:	February 25, 2014
Predicate Device:	Concentric Trevo ProVue Retriever (K122478)

Device Description

Indications for Use

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Technological Characteristics and Product Feature Comparison

The Modified Trevo ProVue Retriever is substantially equivalent to the predicate device in terms of basic design, materials used, and function. A comparison of the subject device with predicate device is summarized in the below table.

Feature	Results
Indications for Use	Same
Device Description	Same except new truncated distal end with new distalradiopaque markers.
Target Population	Same
Accessory Devices Provided	Same
Materials	Same
Overall Length	Same except 3x20 size is longer.
Total Shaped Section Length	Shorter than predicate device.
Active Shaped SectionLength	Same
Distal Tip and Distal TaperLength	Not applicable to subject device, modified device distalend has been truncated.
Proximal Core Wire Diameter	Same except 3x20 size has a smaller diameter
Shaped Section Diameter	Same except 3x20 size has a smaller diameter
Packaging Materials andConfiguration	Same
Sterilization Method	Same
How Supplied	Same

Product Feature Comparison of Subject Device with Predicate Device

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 have demonstrated the Modified Trevo ProVue Retriever is substantially equivalent to the predicate device. Furthermore, the modifications did not result in any new failure modes nor were there any changes to existing failure modes.

Testing Summary

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The results of verification and validation testing conducted on the Modified Trevo ProVue Retriever demonstrate that it performs as designed, is suitable for its intended use and 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 specifiedmeasurement tool.	Dimensional verification meetsacceptance criteria.
2.	Retriever Proximal JointTensile Strength	Identified joint and cut sample fortest. Recorded peak tensile forceresults.	Retriever Proximal Joint TensileStrength meets acceptance criteria.
3.	Retriever Mid JointTensile Strength	Identified joint and cut sample fortest. Recorded peak tensile forceresults.	Retriever Mid Joint Tensile Strengthmeets acceptance criteria.
4.	Retriever Tip TensileStrength	Loaded sample. Recorded peaktensile force results.	Retriever Tip Tensile Strengthmeets acceptance criteria.
5.	Retriever ShapedSection Radial Force	Constrained shaped section ofretriever to specified diameter.Recorded radial force results.	Retriever Shaped Section RadialForce meets acceptance criteria.
6.	Retriever/VesselInteraction (TipFlexibility)	Loaded sample so that the distal tipwas flexed. Recorded peakcompression/flex force results.	Retriever/Vessel Interaction (TipFlexibility) meets acceptancecriteria.
7.	Retriever TorqueTensile Durability	Gripped device and applied rotationsto torque device. Pulled tensilecycles to a max load then last cycleto failure. Recorded results.	Retriever Torque Tensile Durabilitymeets acceptance criteria.
8.	Retriever Platinum WireJoint Strength	Identified joint and cut sample fortest. Recorded peak tensile force oneach individual platinum wire results.	Retriever Platinum Wire JointStrength meets acceptance criteria.
9.	Retriever Platinum Wireand Joint Durability	Wrapped and unwrapped the entirelength of the shaped section of theretriever (sheathed in insertion tool)around a pin and repeat. Performedvisual inspection and recordedresults. Performed deploy/reloadcycles into insertion tool. Performedvisual inspection and recordedresults.	Retriever Platinum Wire and JointDurability meets acceptance criteria.
10.	Radiopacity	Radiopacity was assessed based onvisual assessment of the devicebeing used under fluoroscopy.	Radiopacity meets acceptancecriteria.
11.	Retriever/MicrocatheterDeliverability	Measured the force to push thedevice through a tortuous model.	Retriever/MicrocatheterDeliverability meets acceptancecriteria.
12.	Proximal CurlResistance	Applied rotations to distal end of corewire with device constrained.Recorded the number of rotationsuntil a loop results or stop rotationsat specified number if no loopresults.	Proximal Curl Resistance meetsacceptance criteria.
13.	Simulated Use	Simulated use testing used a siliconeneurovascular model cast fromactual human neurovascular arteries.This bench testing model replicatesthe tortuosity, diameter and location	Simulated Use meets acceptancecriteria.
Test	Test Method Summary	Conclusions
	of the arteries in theneurovasculature including theinternal carotid artery (ICA) siphon.The model ends at the mid carotidarteries and proximal support isprovided by a guide catheter. Themodel incorporates a re-circulatingwater bath at 37°C pressurizedbetween 2 – 2.5 psi (100 – 126 mmHg) to simulate the human arterialcirculation. All testing follows theprocedural instructions outlined inthe Instructions for Use. Simulatedthrombus is used to assess thedevices ability to retrieve clot.

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Biocompatibility

The modified Trevo ProVue Retriever was assessed for impact to biocompatibility. Materials used in the modified Trevo ProVue Retriever are all the same materials used in the cleared Trevo ProVue Retriever (K122478). Furthermore, screening testing was performed successfully, providing further assurance that any design or process changes did not adversely affect the biocompatibility of the modified Trevo ProVue Retriever. Screening testing included cytotoxicity, hemolysis, and physicochemical testing, summarized below. Both the modified Trevo ProVue Retriever 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.

TestDescription	Result			Conclusion
CytotoxicityUsing theISO ElutionMethod	Dilution	Result Grade	Pass/Fail	Non-cytotoxic.
	Undiluted	3 – Moderatereactivity	*	The score of “3” is not attributed to thechanges made to the modified TrevoProVue Retriever since this result isconsistent with historical cytotoxicity datacollected on Retriever devices (such asK122478) with hydrophilic coating.
	50%	0 – No reactivity	Pass
	25%	0 – No reactivity	Pass
	12.5%	0 – No reactivity	Pass
	6.25%	0 – No reactivity	Pass
	3.13%	0 – No reactivity	Pass
ASTMHemolysis(combineddirectcontact andextract)	Pass.Hemolytic index: 0.0% (direct contact) and 0.4%(extract)			Non-Hemolytic
Physicoche-mical TestsPlastics	Pass.Non-volatile residue: 2 mgResidue on ignition: ≤ 2 mgHeavy metal: < 1 ppmBuffering capacity: < 1.0 mL				No heavy metals or leachables.

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Summary of Substantial Equivalence

The Modified Trevo ProVue Retriever 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 Modified Trevo ProVue Retriever demonstrate that the device performs as designed, is suitable for its intended use and is substantially equivalent to the legally marketed predicate device.

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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it, and three wavy lines extending from the top. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

January 13, 2014

Concentric Medical, Inc. c/o Ms. Sarah Meyer Senior Regulatory Affairs Specialist 301 E. Evelyn Ave. Mountain View, CA 94041

Re: K132641

Trade/Device Name: Modified Trevo ProVue Retriever Regulation Number: 21 CFR 870.1250 Regulation Name: Catheter, Thrombus Retriever Regulatory Class: Class II Product Code: NRY Dated: October 14, 2013 Received: October 15, 2013

Dear Ms. Meyer:

We have reviewed vour 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

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Page 2 - Ms. Sarah Meyer

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,

Joyce M. Whang -S

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

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Indications for Use

510(k) Number (if known): K132641

Device Name: Modified Trevo ProVue Retriever

Indications For Use:

X Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of Center for Devices and Radiological Health (CDRH)

Joyce M. Whang -S

Page 1 of 1

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).