Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a mechanical device (retrievable stent-like device) for removing blood clots and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.

Therapeutic

Yes
The device is described as "intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke," which directly addresses and treats a medical condition.

Diagnostic

No

This device is a revascularization device designed to remove thrombus and restore blood flow, which is a therapeutic function, not a diagnostic one.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is composed of a retrievable, self-expanding, Nitinol shaped section at the distal end of a tapered Nitinol shaft, which are physical hardware components.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to "restore blood flow in the neurovasculature by removing thrombus." This is a therapeutic intervention performed directly on the patient's body.
Device Description: The device is a physical, retrievable, self-expanding device designed to mechanically remove a thrombus.
Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with such specimens for diagnostic purposes.

The EmboTrap II and EMBOTRAP III Revascularization Devices are medical devices used for a therapeutic procedure (thrombus removal) within the patient's neurovasculature.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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) 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.

Product codes (comma separated list FDA assigned to the subject device)

NRY

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.

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

physicians trained in neuro-interventional catheterization and the treatment of ischemic stroke.

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)

Study Type: In Vitro (Bench) Testing

Tests and Results:

Simulated use testing in a tortuous anatomical model: Test sample microcatheters successfully delivered EMBOTRAP devices.
Particulate testing: Particle generation was comparable to the cleared control microcatheter device.
Ease of use testing: The EMBOTRAP device was successfully delivered through PROWLER SELECT PLUS Microcatheter.
Short-length and full-length re-sheathing force testing: The EMBOTRAP device was re-sheathed successfully into PROWLER SELECT PLUS Microcatheter and no damage to PROWLER SELECT PLUS was observed during or after testing.
Full-length delivery force during simulated use testing: The delivery forces recorded are acceptable as EMBOTRAP device was successfully delivered through PROWLER SELECT PLUS Microcatheter, with no damage to the microcatheter or subject devices observed during testing.

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

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.

K173452, K193063, K211338

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.

Not Found

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

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

0

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

1

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

2

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)
-------------------------------------------------

☑ 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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3

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.

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.

4

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 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.		Same as EmboTrap II	Same as EMBOTRAP III
Target Population	Patients with symptoms of an ischemic stroke within 8 hours of symptom onset, who
are 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 compatibility
as per applicable
Instructions For Use	COMPATIBILITY:

"Microcatheter: The Device
should be introduced
through microcatheters
indicated for the delivery of
therapeutic devices in the
neurovasculature of a size
"18" or larger, with a
minimum internal diameter
of 0.021" and an overall
length of not more than 155
cm, e.g., Trevo 18, Merci
18L, Headway 21, Cantata,
Velocity 025, Marksman 27
and Excelsior XT-27
microcatheters.
Performance of the Device
with other microcatheters
that have not been
evaluated may be different." | COMPATIBILITY:

"Microcatheter: The Device should be introduced
through microcatheters indicated for the delivery of
therapeutic devices in the neurovasculature with an
internal 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 microcatheters
that have not been evaluated may be different." | COMPATIBILITY:

"Microcatheter: The Device should be introduced
through microcatheters indicated for the delivery of
therapeutic devices in the neurovasculature with an
internal 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 microcatheters
that have not been evaluated may be different." | Similar

Differences do not raise new
questions of safety and
effectiveness, EMBOTRAP
device has been tested for
compatibility with PROWLER
SELECT PLUS and PROWLER
EX Microcatheters:

"Microcatheter: The Device
should be introduced
through microcatheters
indicated for the delivery of
therapeutic devices in the
neurovasculature of a size
"18" or larger, with a
minimum internal diameter
of 0.021" and an overall
length of not more than 155
cm, e.g. PROWLER SELECT
PLUS, PROWLER EX, Trevo
18, Merci 18L, Headway 21,
Cantata, Velocity 025
Marksman 27 and Excelsior
XT-27 microcatheters.
Performance of the Device
with other microcatheters
that have not been
evaluated may be different." | Similar

Differences do not raise new
questions of safety and
effectiveness, EMBOTRAP
device has been tested for
compatibility with PROWLER
SELECT PLUS and PROWLER EX
Microcatheters:

6

7

8

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 use
testing in a tortuous
anatomical model	To provide evidence that the PROWLER
microcatheters could safely and effectively deliver
the EMBOTRAP devices to the neurovasculature.	Test sample microcatheters successfully
delivered EMBOTRAP devices.
Particulate testing	To evaluate and compare the quantity and size of
particles generated by the EMBOTRAP devices
during simulated device delivery in a tortuous
anatomical model with the PROWLER SELECT PLUS
Microcatheter versus particles generated by an
applicable reference cleared microcatheter.	Particle generation was comparable to
the cleared control microcatheter
device.
Ease of use testing	To verify the compatibility of the EMBOTRAP
device with the range of microcatheters including
PROWLER SELECT PLUS Microcatheter.	The EMBOTRAP device was successfully
delivered through PROWLER SELECT
PLUS Microcatheter.
Short-length and
full-length re-
sheathing force
testing	To evaluate re-sheathing force (full and short-
length) in the PROWLER SELECT PLUS
Microcatheter during simulated use in a full-length
anatomical model simulating the tortuosity of the
neurovascular system.	The EMBOTRAP device was re-sheathed
successfully into PROWLER SELECT PLUS
Microcatheter and no damage to
PROWLER SELECT PLUS was observed
during or after testing.
Full-length delivery
force during
simulated use
testing	To evaluate full length delivery force in the
PROWLER SELECT PLUS Microcatheter during
simulated use in a full-length anatomical model
simulating the tortuosity of the neurovascular
system.	The delivery forces recorded are
acceptable as EMBOTRAP device was
successfully delivered through
PROWLER SELECT PLUS Microcatheter,
with no damage to the microcatheter or
subject devices observed during testing.

9

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.