EmboTrap II Revascularization Device, EMBOTRAP III Revascularization Device

K212908 · Neuravi, Ltd. · NRY · Oct 13, 2021 · Cardiovascular

Device Facts

• Record ID: K212908
• Device Name: EmboTrap II Revascularization Device, EMBOTRAP III Revascularization Device
• Applicant: Neuravi, Ltd.
• Product Code: NRY · Cardiovascular
• Decision Date: Oct 13, 2021
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Retrievable, self-expanding Nitinol thrombus retriever; distal end features bi-layer tubular design; tapered shaft; used in neurovasculature to restore blood flow in ischemic stroke patients. Operated by physicians trained in neuro-interventional catheterization; delivered via microcatheter. Device captures thrombus; enables removal from neurovasculature. Benefits include restoration of blood flow. Subject submission adds compatibility with PROWLER SELECT PLUS and PROWLER EX microcatheters.

Clinical Evidence

No clinical data provided. Substantial equivalence established via bench testing only, including simulated use in tortuous anatomical models, particulate testing, and re-sheathing force evaluation.

Technological Characteristics

Materials: Nitinol (shaped section/shaft), Platinum/Tungsten (markers/coils), PTFE (shaft coating). Design: Self-expanding, bi-layer tubular retriever. Sterilization: Ethylene Oxide. Connectivity: None. Software: None.

Indications for Use

Indicated for patients experiencing ischemic stroke within 8 hours of symptom onset who are ineligible for or failed IV t-PA therapy.

Regulatory Classification

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.

Predicate Devices

• EmboTrap II Revascularization Device (K173452)
• EMBOTRAP III Revascularization Device (K193063)
• EMBOTRAP III Revascularization Device (K211338)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

| <span style="font-family: Arial, sans-serif; font-size: 10pt;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|----------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|
|----------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|

> 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: [phone]

E-mail: [e-mail]

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.

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.

#### V. INDICATIONS FOR USE

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 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.

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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<br>(5 x 21 mm and 5 x 33 mm) | EMBOTRAP III<br>(5 x 22 mm and 5 x 37 mm) | EMBOTRAP III<br>(6.5 x 45 mm) | EmboTrap II<br>(5 x 21 mm and 5 x 33 mm) | EMBOTRAP III<br>(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 II<br>Revascularization Device is<br>intended to restore blood<br>flow in the neurovasculature<br>by removing thrombus in<br>patients experiencing<br>ischemic stroke within 8<br>hours of symptom onset.<br>Patients who are ineligible<br>for intravenous tissue<br>plasminogen activator (IV t-<br>PA) or who fail IV t-PA<br>therapy are candidates for<br>treatment. | The EMBOTRAP III Revascularization Device is intended<br>to restore blood flow in the neurovasculature by<br>removing thrombus in patients experiencing ischemic<br>stroke within 8 hours of symptom onset. Patients who<br>are ineligible for intravenous tissue plasminogen<br>activator (IV t-PA) or who fail IV t-PA therapy are<br>candidates 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, who<br>are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-<br>PA therapy are candidates for treatment | | | Same as EmboTrap II | Same as EMBOTRAP III |
| | Predicate Devices Referenced in this Submission | | | Subject Device | |
| | EmboTrap II<br>(5 x 21 mm and 5 x 33 mm) | EMBOTRAP III<br>(5 x 22 mm and 5 x 37 mm) | EMBOTRAP III<br>(6.5 x 45 mm) | EmboTrap II<br>(5 x 21 mm and 5 x 33 mm) | EMBOTRAP III<br>(5 x 22 mm and 5 x 37 mm,<br>6.5 x 45 mm) |
| Characteristics | | | | | |
| Microcatheter compatibility<br>as per applicable<br>Instructions For Use | COMPATIBILITY:<br><br>"Microcatheter: The Device<br>should be introduced<br>through microcatheters<br>indicated for the delivery of<br>therapeutic devices in the<br>neurovasculature of a size<br>"18" or larger, with a<br>minimum internal diameter<br>of 0.021" and an overall<br>length of not more than 155<br>cm, e.g., Trevo 18, Merci<br>18L, Headway 21, Cantata,<br>Velocity 025, Marksman 27<br>and Excelsior XT-27<br>microcatheters.<br>Performance of the Device<br>with other microcatheters<br>that have not been<br>evaluated may be different." | COMPATIBILITY:<br><br>"Microcatheter: The Device should be introduced<br>through microcatheters indicated for the delivery of<br>therapeutic devices in the neurovasculature with an<br>internal diameter (ID) of 0.021" - 0.027" (0.53 mm -<br>0.69 mm), e.g., Trevo 18, Headway 21, Velocity 025,<br>Phenom 27 and Marksman 27 microcatheters.<br>Performance of the Device with other microcatheters<br>that have not been evaluated may be different." | COMPATIBILITY:<br><br>"Microcatheter: The Device should be introduced<br>through microcatheters indicated for the delivery of<br>therapeutic devices in the neurovasculature with an<br>internal diameter (ID) of 0.021" - 0.027" (0.53 mm -<br>0.69 mm), e.g., Trevo 18, Headway 21, Velocity 025,<br>Phenom 27 and Marksman 27 microcatheters.<br>Performance of the Device with other microcatheters<br>that have not been evaluated may be different." | Similar<br><br>Differences do not raise new<br>questions of safety and<br>effectiveness, EMBOTRAP<br>device has been tested for<br>compatibility with PROWLER<br>SELECT PLUS and PROWLER<br>EX Microcatheters:<br><br>"Microcatheter: The Device<br>should be introduced<br>through microcatheters<br>indicated for the delivery of<br>therapeutic devices in the<br>neurovasculature of a size<br>"18" or larger, with a<br>minimum internal diameter<br>of 0.021" and an overall<br>length of not more than 155<br>cm, e.g. PROWLER SELECT<br>PLUS, PROWLER EX, Trevo<br>18, Merci 18L, Headway 21,<br>Cantata, Velocity 025<br>Marksman 27 and Excelsior<br>XT-27 microcatheters.<br>Performance of the Device<br>with other microcatheters<br>that have not been<br>evaluated may be different." | Similar<br><br>Differences do not raise new<br>questions of safety and<br>effectiveness, EMBOTRAP<br>device has been tested for<br>compatibility with PROWLER<br>SELECT PLUS and PROWLER EX<br>Microcatheters:<br><br>"Microcatheter: The Device<br>should be introduced through<br>microcatheters indicated for<br>the delivery of therapeutic<br>devices in the<br>neurovasculature with an<br>internal diameter (ID) of<br>0.021" - 0.027" (0.53 mm -<br>0.69 mm), e.g., PROWLER<br>SELECT PLUS, PROWLER EX,<br>Trevo 18, Headway 21,<br>Velocity 025, Phenom 27 and<br>Marksman 27 microcatheters.<br>Performance of the Device<br>with other microcatheters that<br>have not been evaluated may<br>be different." |
| Design/Technological<br>Principles | | Retrievable, self-expanding Nitinol shaped section<br>Nitinol guidewire like shaft | | Same as EmboTrap II | Same as EMBOTRAP III |
| | Predicate Devices Referenced in this Submission | | | Subject Device | Subject Device |
| Characteristics | EmboTrap II<br>(5 x 21 mm and 5 x 33<br>mm) | EMBOTRAP III<br>(5 x 22 mm and 5 x 37<br>mm) | EMBOTRAP III<br>(6.5 x 45 mm) | EmboTrap II<br>(5 x 21 mm and 5 x 33<br>mm) | EMBOTRAP III<br>(5 x 22 mm and 5 x 37 mm<br>6.5 x 45 mm) |
| Distal End (Retriever)<br>Design | Bi-layer tubular design with<br>a tapered distal end with<br>tip | Bi-layer tubular design<br>with a tapered distal end<br>with tip | Bi-layer tubular design<br>with a tapered distal end<br>with tip | Same as EmboTrap II | Same as EMBOTRAP III |
| | Image: 5 x 21 mm<br>Image: 5 x 33 mm | Image: 5 x 22 mm<br>Image: 5 x 37 mm | Image: stent | Same as EmboTrap II | Same as EMBOTRAP III |
| Principal Device Materials | | | | | |
| Shaped Section & Shaft<br>Wire | 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 | Hydrophobic<br>PTFE Coating | Hydrophobic<br>PTFE Coating…