The EmboTrap II Revascularization Device 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.

The EMBOTRAP III Revascularization Device 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 EmboTrap® II and EMBOTRAP™ III Revascularization Devices are composed of a retrievable, selfexpanding, Nitinol shaped section at the distal end of a tapered Nitinol shaft. They are designed to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke. The EmboTrap® II and EMBOTRAP™ III Revascularization Devices are supplied sterile and are intended for single-use only by physicians trained in neuro-interventional catheterization and the treatment of ischemic stroke.

AI/ML Overview

This is not an AI/ML device approval summary. The document describes a 510(k) premarket notification for a revascularization device (EmboTrap II and EMBOTRAP III) and focuses on demonstrating substantial equivalence to predicate devices, primarily through bench testing for compatibility with new microcatheters. There is no mention of an algorithm, AI, or machine learning model.

Therefore, I cannot extract the requested information regarding acceptance criteria and study proving an AI/ML device meets them, as the provided document does not pertain to such a device.

Summary

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October 13, 2021

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

Neuravi Ltd. Niall Fox Director of Regulatory Affairs Block 3, Ballybrit Business Park Galway H91 K5YD, Ireland

Re: K212908

Trade/Device Name: EmboTrap II Revascularization Device; EMBOTRAP III Revascularization Device Regulation Number: 21 CFR 870.1250

Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: September 10, 2021 Received: September 13, 2021

Dear Niall Fox:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Naira Muradyan, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K212908

Device Name EmboTrap II Revascularization Device EMBOTRAP III Revascularization Device

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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Prescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

K212908

l. SUBMITTER:

510(k) Owner: Neuravi Ltd.

Block 3, Ballybrit Business Park, Galway H91 K5YD, Ireland

Contact Person: Niall Fox

Director of Regulatory Affairs

Tel: +353-91-394123

E-mail: nfox5@its.jnj.com

Date Prepared: October 07, 2021

DEVICE II.

Trade Name of Device: EmboTrap II Revascularization Device

EMBOTRAP III Revascularization Device

Common Name of Device: Catheter, Thrombus Retriever

Classification Name: 21 CFR 870.1250 - Class II

Product Code: NRY

III. PREDICATE DEVICES

EmboTrap II Revascularization Device (K173452, May 9, 2018)

EMBOTRAP™ III Revascularization Device (K193063, July 14, 2020)

EMBOTRAP™ III Revascularization Device (K211338, July 30, 2021)

DEVICE DESCRIPTION IV.

V. INDICATIONS FOR USE

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COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE VI.

A summary of the technological characteristics of the EmboTrap® II and EMBOTRAP™ III devices in comparison to those of the predicate devices is presented below. The technological characteristics (e.g., principal device materials, design, dimensions) are unchanged in comparison to the predicate devices. The change in the subject submission is to add PROWLER SELECT PLUS and PROWLER EX Microcatheters to the device labelling as compatible with the EmboTrap II and EMBOTRAP III devices.

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	Predicate Devices Referenced in this Submission			Subject Device
Characteristics	EmboTrap II(5 x 21 mm and 5 x 33 mm)	EMBOTRAP III(5 x 22 mm and 5 x 37 mm)	EMBOTRAP III(6.5 x 45 mm)	EmboTrap II(5 x 21 mm and 5 x 33 mm)	EMBOTRAP III(5 x 22 mm and 5 x 37 mm)
Manufacturer	Neuravi Ltd.	Neuravi Ltd.	Neuravi Ltd.	Same as EmboTrap II	Same as EMBOTRAP III
510(k) Number	K173452	K193063	K211338	K212908	K212908
Classification	Class II (21CFR 870.1250)			Same as EmboTrap II	Same as EMBOTRAP III
Device Classification Name	Catheter, Thrombus Retriever			Same as EmboTrap II	Same as EMBOTRAP III
Classification Product Code		NRY		Same as EmboTrap II	Same as EMBOTRAP III
Indication for Use	The EmboTrap IIRevascularization Device isintended to restore bloodflow in the neurovasculatureby removing thrombus inpatients experiencingischemic stroke within 8hours of symptom onset.Patients who are ineligiblefor intravenous tissueplasminogen activator (IV t-PA) or who fail IV t-PAtherapy are candidates fortreatment.	The EMBOTRAP III Revascularization Device is intendedto restore blood flow in the neurovasculature byremoving thrombus in patients experiencing ischemicstroke within 8 hours of symptom onset. Patients whoare ineligible for intravenous tissue plasminogenactivator (IV t-PA) or who fail IV t-PA therapy arecandidates for treatment.		Same as EmboTrap II	Same as EMBOTRAP III
Target Population	Patients with symptoms of an ischemic stroke within 8 hours of symptom onset, whoare ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment			Same as EmboTrap II	Same as EMBOTRAP III
	Predicate Devices Referenced in this Submission			Subject Device
	EmboTrap II(5 x 21 mm and 5 x 33 mm)	EMBOTRAP III(5 x 22 mm and 5 x 37 mm)	EMBOTRAP III(6.5 x 45 mm)	EmboTrap II(5 x 21 mm and 5 x 33 mm)	EMBOTRAP III(5 x 22 mm and 5 x 37 mm,6.5 x 45 mm)
Characteristics
Microcatheter compatibilityas per applicableInstructions For Use	COMPATIBILITY:"Microcatheter: The Deviceshould be introducedthrough microcathetersindicated for the delivery oftherapeutic devices in theneurovasculature of a size"18" or larger, with aminimum internal diameterof 0.021" and an overalllength of not more than 155cm, e.g., Trevo 18, Merci18L, Headway 21, Cantata,Velocity 025, Marksman 27and Excelsior XT-27microcatheters.Performance of the Devicewith other microcathetersthat have not beenevaluated may be different."	COMPATIBILITY:"Microcatheter: The Device should be introducedthrough microcatheters indicated for the delivery oftherapeutic devices in the neurovasculature with aninternal diameter (ID) of 0.021" - 0.027" (0.53 mm -0.69 mm), e.g., Trevo 18, Headway 21, Velocity 025,Phenom 27 and Marksman 27 microcatheters.Performance of the Device with other microcathetersthat have not been evaluated may be different."	COMPATIBILITY:"Microcatheter: The Device should be introducedthrough microcatheters indicated for the delivery oftherapeutic devices in the neurovasculature with aninternal diameter (ID) of 0.021" - 0.027" (0.53 mm -0.69 mm), e.g., Trevo 18, Headway 21, Velocity 025,Phenom 27 and Marksman 27 microcatheters.Performance of the Device with other microcathetersthat have not been evaluated may be different."	SimilarDifferences do not raise newquestions of safety andeffectiveness, EMBOTRAPdevice has been tested forcompatibility with PROWLERSELECT PLUS and PROWLEREX Microcatheters:"Microcatheter: The Deviceshould be introducedthrough microcathetersindicated for the delivery oftherapeutic devices in theneurovasculature of a size"18" or larger, with aminimum internal diameterof 0.021" and an overalllength of not more than 155cm, e.g. PROWLER SELECTPLUS, PROWLER EX, Trevo18, Merci 18L, Headway 21,Cantata, Velocity 025Marksman 27 and ExcelsiorXT-27 microcatheters.Performance of the Devicewith other microcathetersthat have not beenevaluated may be different."	SimilarDifferences do not raise newquestions of safety andeffectiveness, EMBOTRAPdevice has been tested forcompatibility with PROWLERSELECT PLUS and PROWLER EXMicrocatheters:"Microcatheter: The Deviceshould be introduced throughmicrocatheters indicated forthe delivery of therapeuticdevices in theneurovasculature with aninternal diameter (ID) of0.021" - 0.027" (0.53 mm -0.69 mm), e.g., PROWLERSELECT PLUS, PROWLER EX,Trevo 18, Headway 21,Velocity 025, Phenom 27 andMarksman 27 microcatheters.Performance of the Devicewith other microcatheters thathave not been evaluated maybe different."
Design/TechnologicalPrinciples		Retrievable, self-expanding Nitinol shaped sectionNitinol guidewire like shaft		Same as EmboTrap II	Same as EMBOTRAP III
	Predicate Devices Referenced in this Submission			Subject Device	Subject Device
Characteristics	EmboTrap II(5 x 21 mm and 5 x 33mm)	EMBOTRAP III(5 x 22 mm and 5 x 37mm)	EMBOTRAP III(6.5 x 45 mm)	EmboTrap II(5 x 21 mm and 5 x 33mm)	EMBOTRAP III(5 x 22 mm and 5 x 37 mm6.5 x 45 mm)
Distal End (Retriever)Design	Bi-layer tubular design witha tapered distal end withtip	Bi-layer tubular designwith a tapered distal endwith tip	Bi-layer tubular designwith a tapered distal endwith tip	Same as EmboTrap II	Same as EMBOTRAP III
	Image: 5 x 21 mmImage: 5 x 33 mm	Image: 5 x 22 mmImage: 5 x 37 mm	Image: stent	Same as EmboTrap II	Same as EMBOTRAP III
Principal Device Materials
Shaped Section & ShaftWire	Nitinol	Nitinol	Nitinol	Same as EmboTrap II	Same as EMBOTRAP III
Distal Marker/Coil	Platinum/Tungsten Coil	Platinum/Tungsten Coil	Platinum/Tungsten Coil	Same as EmboTrap II	Same as EMBOTRAP III
Proximal Marker/Coil	Platinum/Tungsten Coil	Platinum/Tungsten Coil	Platinum/Tungsten Coil	Same as EmboTrap II	Same as EMBOTRAP III
Shaft Coating	HydrophobicPTFE Coating	HydrophobicPTFE Coating	HydrophobicPTFE Coating	Same as EmboTrap II	Same as EMBOTRAP III
Design Characteristics & Technology
Size(s) Offered(Retriever Diameter ×Length)	5×21 mm, 5×33 mm	5×22 mm, 5×37 mm	6.5x45 mm	Same as EmboTrap II	Same as EMBOTRAP III
Device Length	194 cm, 195 cm(Labeled Overall length)	194 cm, 195 cm(Labeled Overall length)	196 cm(Labeled Overall length)	Same as EmboTrap II	Same as EMBOTRAP III
Minimum Microcatheter ID	0.021"	0.021"-0.027"	0.021″-0.027″	Same as EmboTrap II	Same as EMBOTRAP III
Key Principles of Operation	The device is used in the neurovasculature to restore blood flow in patientsexperiencing ischemic stroke			Same as EmboTrap II	Same as EMBOTRAP III
No. of passes/device IFU	3 / Device & Vessel	3 / Device & Vessel	3 / Device & Vessel	Same as EmboTrap II	Same as EMBOTRAP III
Additional Characteristics
How suppled	Sterile/Single Use	Sterile/Single Use	Sterile/Single Use	Same as EmboTrap II	Same as EMBOTRAP III
Sterilization Method	Ethylene Oxide	Ethylene Oxide	Ethylene Oxide	Same as EmboTrap II	Same as EMBOTRAP III

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VII. PERFORMANCE DATA Biocompatibility Testing:

N/A - Changes do not impact biocompatibility.

Sterilization and Shelf Life:

N/A - Changes do not impact sterilization and established shelf-life of the product.

In Vitro (Bench) Testing:

Bench testing was conducted according to existing design controls and protocols / test methods previously reviewed by the FDA in relevant prior submissions. Description of each performance test used to support substantial equivalence determination is presented below.

Performance Testing
Test	Test Method Summary	Results
Simulated usetesting in a tortuousanatomical model	To provide evidence that the PROWLERmicrocatheters could safely and effectively deliverthe EMBOTRAP devices to the neurovasculature.	Test sample microcatheters successfullydelivered EMBOTRAP devices.
Particulate testing	To evaluate and compare the quantity and size ofparticles generated by the EMBOTRAP devicesduring simulated device delivery in a tortuousanatomical model with the PROWLER SELECT PLUSMicrocatheter versus particles generated by anapplicable reference cleared microcatheter.	Particle generation was comparable tothe cleared control microcatheterdevice.
Ease of use testing	To verify the compatibility of the EMBOTRAPdevice with the range of microcatheters includingPROWLER SELECT PLUS Microcatheter.	The EMBOTRAP device was successfullydelivered through PROWLER SELECTPLUS Microcatheter.
Short-length andfull-length re-sheathing forcetesting	To evaluate re-sheathing force (full and short-length) in the PROWLER SELECT PLUSMicrocatheter during simulated use in a full-lengthanatomical model simulating the tortuosity of theneurovascular system.	The EMBOTRAP device was re-sheathedsuccessfully into PROWLER SELECT PLUSMicrocatheter and no damage toPROWLER SELECT PLUS was observedduring or after testing.
Full-length deliveryforce duringsimulated usetesting	To evaluate full length delivery force in thePROWLER SELECT PLUS Microcatheter duringsimulated use in a full-length anatomical modelsimulating the tortuosity of the neurovascularsystem.	The delivery forces recorded areacceptable as EMBOTRAP device wassuccessfully delivered throughPROWLER SELECT PLUS Microcatheter,with no damage to the microcatheter orsubject devices observed during testing.

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Clinical Studies:

No clinical study was performed as there is no change to the indications for use or the fundamental scientific technology for the subject devices. Substantial equivalence of the subject devices has been established to the predicate devices through the results of bench testing.

CONCLUSIONS

Non-clinical studies demonstrate that the EmboTrap® II and EMBOTRAP™ III Revascularization Devices are substantially equivalent to the predicate devices.

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).