(253 days)
No
The summary describes a mechanical device for thrombus removal and does not mention any AI/ML components or image processing capabilities.
Yes
The device is described as "intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke," which is a direct treatment for a medical condition.
No
This device is described as a revascularization device intended to restore blood flow by removing thrombus, which indicates a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a physical device composed of a retrievable, self-expanding, Nitinol shaped section and a tapered Nitinol shaft, intended for physical removal of thrombus. It is not a software-only device.
No, 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 in patients experiencing ischemic stroke." This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device is a physical tool (a retrievable, self-expanding, Nitinol shaped section) designed to mechanically remove a clot from a blood vessel.
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such testing.
The EmboTrap III Revascularization Device is a medical device used for treatment, not for diagnosis based on in vitro testing.
N/A
Intended Use / Indications for Use
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
NRY
Device Description
The EmboTrap™ III Revascularization Device is composed of a retrievable, self-expanding, Nitinol shaped section at the distal end of a tapered Nitinol shaft. It is designed to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke. The EmboTrap™ III Revascularization Device is supplied sterile and is 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
Biocompatibility Testing: The biocompatibility evaluation for the Embotrap™ III Revascularization Device was conducted in accordance with International Standard ISO 10993-1 and FDA Biocompatibility Guidance. Tests included Cytotoxicity, ISO Guinea Pig Maximization Sensitization, ISO Intracutaneous Study in Rabbits, ISO Systemic Toxicity Study in Mice, USP Rabbit Pyrogen Study (Material Mediated), ASTM Hemolysis, Complement Activation Assay Studies (SC5b-9), and In Vivo Thromboresistance Study in Sheep - Jugular Vein, Acute (Thrombogenicity). All tests completed met pre-assigned acceptance criteria.
Sterilization and Shelf Life: The device is labeled as single-use, sterile, with a shelf life of 3 years. The sterilization process has been successfully validated to achieve a minimum SAL of 10-6. Shelf life studies confirm product and packaging functionality and sterility for 3 years.
In Vitro (Bench) Testing: Design verification and validation testing demonstrated that the EMBOTRAP™ III device performs as designed, fulfills all pre-determined product performance specification requirements, and is suitable for its intended use. Tests included System Dimensions, Radial Force Testing, Outer Cage Recovery, Durability Testing, Full Unit (System) Tensile Testing, Marker Push Out Force, Flexibility & Kink Resistance, Coating Integrity, Torque Durability (Strength), Corrosion Resistance, Tip Flexibility, Re-sheathing Force, Deliverability Force, Radiopacity, Clot retrieval and performance (Simulated Use/Ease of Use), Physician Usability Study, Delivery and re-sheathing force during simulated use (in a clinically-representative, full-length anatomical model), and Kink Resistance – Deployed Shaped Section. All tests met required specifications and demonstrated comparable performance to the predicate device.
In Vivo (Animal) Studies: Acute and chronic animal studies were performed in a swine model. Acute performance on Day 0 showed usability and performance equivalent to the predicate device. Histological evaluation at 3 and 28 days demonstrated comparable local and organ tissue response between the EmboTrap™ III device and predicate devices.
Clinical Studies: No clinical study was performed. Substantial equivalence was established through bench and animal testing.
Key Metrics
Not Found
Predicate Device(s)
EmboTrap® II Revascularization Device (K173452)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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July 14, 2020
Neuravi, Ltd. Niall Fox Associate Director of Regulatory Affairs Block 3, Ballybrit Business Park Galway H91 K5YD, Ireland
Re: K193063
Trade/Device Name: EMBOTRAP III Revascularization Device Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: June 12, 2020 Received: June 16, 2020
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,
Xiaolin Zheng, Ph.D., M.S. 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) K193063
Device Name EMBOTRAP III Revascularization Device
Indications for Use (Describe)
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) |
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3
510(k) Summary K193063
l. SUBMITTER:
510(k) Owner: Neuravi Ltd. Block 3, Ballybrit Business Park, Galway H91 K5YD, Ireland Contact Person: Niall Fox Associate Director Regulatory Affairs Tel.: +353-91-394123 E-mail: nfox5@its.jnj.com Date Prepared: July 10, 2020
ll. DEVICE
Trade Name of Device: EMBOTRAP™ III Revascularization Device Common Name of Device: Catheter, Thrombus Retriever Classification Name: 21 CFR 870.1250 - Class II Product Code: NRY
lll. PREDICATE DEVICE(S)
EmboTrap® II Revascularization Device (K173452)
DEVICE DESCRIPTION IV.
The EmboTrap™ III Revascularization Device is composed of a retrievable, self-expanding, Nitinol shaped section at the distal end of a tapered Nitinol shaft. It is designed to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke. The EmboTrap™ III Revascularization Device is supplied sterile and is intended for single-use only by physicians trained in neuro-interventional catheterization and the treatment of ischemic stroke.
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INDICATIONS FOR USE V.
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.
- COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE VI. A summary of the technological characteristics of the EmboTrap™ III device in comparison to those of the predicate device is presented below.
| Characteristics | EMBOTRAP® II
(Primary predicate) | EMBOTRAP™ III
(Subject device) |
|-----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Neuravi Ltd. | Same |
| 510(k) Number | K173452 | K193063 |
| Classification | Class II (21CFR 870.1250) | Same |
| Device Classification Name | Catheter, Thrombus Retriever | Same |
| Classification Product Code | NRY | Same |
| Indication for Use | 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 |
| 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 |
| Design/Technological
Principles | Retrievable, self-expanding Nitinol shaped
section
Nitinol guide-wire like shaft | Same |
| Principal Device Materials | | |
| Shaped Section | Nitinol | Same |
| Core Wire (Shaft) | Nitinol | Same |
| Body Markers | Gold | Platinum/Iridium
Results of biocompatibility, bench and
animal testing demonstrate substantial
equivalence. |
| Distal Marker/Coil | Platinum/Tungsten Coil | Same |
| Proximal Marker/Coil | Platinum/Tungsten Coil | Same |
| Design Characteristics & Technology | | |
| Size(s) Offered
(Retriever Diameter ×
Length) | 5×21 mm, 5×33 mm | 5×22 mm, 5×37 mm,
Results of bench and animal testing
demonstrate substantial equivalence. |
| Minimum Microcatheter ID | 0.021" | 0.021" |
| Additional Characteristics | | |
| Characteristics | EMBOTRAP® II
(Primary predicate) | EMBOTRAP™ III
(Subject device) |
| How suppled | Sterile/Single Use | Same |
| Sterilization Method | Ethylene Oxide | Same |
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VII. PERFORMANCE DATA
Biocompatibility Testing:
The biocompatibility evaluation for the Embotrap™ III Revascularization Device was conducted in accordance with International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process" as recognized by FDA (Recognition Number 2-156) and FDA Biocompatibility Guidance (Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", June 16, 2016).
Per ISO 10993-1, the EmboTrap™ III device is categorized as an external communicating device with limited exposure, i.e. whose contact with circulating blood is less than 24 hours.
| Test | Results | Conclusions |
|---|---|---|
| Cytotoxicity Study | The test article extract showed no | |
| evidence of causing cell lysis or | ||
| toxicity. The test article extract | ||
| met the requirements of the test. | ||
| Based on the percentage viability | ||
| values for the test article extract | ||
| dilutions, the device is non- | ||
| cytotoxic. | Device is non-cytotoxic per the | |
| Cytotoxicity Studies conducted | ||
| ISO Guinea Pig Maximization | ||
| Sensitization Test | Test article extracts showed no | |
| evidence of causing delayed | ||
| dermal contact sensitization in the | ||
| guinea pig. | Device is not considered a | |
| sensitizer per the Guinea Pig | ||
| Maximization Test | ||
| ISO Intracutaneous Study in | ||
| Rabbits | The difference between the test | |
| extract overall mean score and the | ||
| corresponding control overall | ||
| mean score was 1.0 or less. | Device is not an irritant when | |
| injected intracutaneously per the | ||
| ISO Intracutaneous Study in | ||
| Rabbits | ||
| ISO Systemic Toxicity Study in | ||
| Mice | There was no mortality or evidence | |
| of systemic toxicity from the | ||
| extracts injected into mice. Each | ||
| test article extract met the | ||
| requirements of the study. | Device is non-toxic per the ISO | |
| Systemic Toxicity Study in Mice |
The biocompatibility evaluation included the following tests:
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| Test | Results | Conclusions |
|---|---|---|
| USP Rabbit Pyrogen Study, | ||
| Material Mediated | No individual rabbit showed a rise | |
| in temperature of ≥ 0.5°C above | ||
| its baseline temperature and the | ||
| total maximum temperature rise | ||
| of all three animals was within | ||
| acceptable USP limits. |
The total rise of rabbit
temperatures during the 3-hour
observation period was within
acceptable USP requirements. The
test article met the requirements
for the absence of pyrogens. | Device is non-pyrogenic per the
Material Mediated Rabbit Pyrogen
Study |
| ASTM Hemolysis | Both the test article in direct
contact with blood and the test
article extract were non-hemolytic. | Device is non-hemolytic per the
ASTM Hemolysis Test |
| Complement Activation Assay
Studies
SC5b-9 Complement Activation
Assay Study | The C3a and SC5b-9
concentrations of the test article
samples were acceptable. All test
method acceptance criteria were
met. | Levels of C3a and SC5b-9 were
acceptable. |
| In Vivo Thromboresistance Study
in Sheep - Jugular Vein, Acute
(Thrombogenicity) | The implantation procedure was
routine and there were no
difficulties encountered with
insertion or placement of the test
device. There was no evidence of
bleeding or complications during
the post-operative implant period.
Minimal thrombus formation was
associated with the control article
and minimal to slight thrombus
formation was associated with the
test article. | Under the conditions of this study,
both test and control articles were
considered thromboresistant. |
All biocompatibility tests completed met the pre-assigned acceptance criteria as specified in the test protocol and in accordance with the requirements of the applicable standards.
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Sterilization and Shelf Life:
The EMBOTRAP™ III device is labeled as a single-use, sterile device, with a shelf life of 3 years. The sterilization process for the EMBOTRAP™ III device has been successfully validated and process monitoring controls are in place to assure that the device is EO-sterilized to achieve a minimum SAL of 10-6.
Shelf life studies have been conducted for the EMBOTRAP™ III device and establish that the product and packaging remain functional and sterile for the shelf life period of 3 years.
In Vitro (Bench) Testing:
The results of design verification and validation testing conducted on the EMBOTRAP™ III device models demonstrate that it performs as designed, fulfills all pre-determined product performance specification requirements, and is suitable for its intended use. The verification and validation test results demonstrate that EMBOTRAP™ III is substantially equivalent to the predicate device.
| Characteristic/Test | Method | Conclusions |
|---|---|---|
| System Dimensions | A range of device dimensions were | |
| measured using specified | ||
| measurement tooling to verify that | ||
| the required dimensional | ||
| specifications were met for the | ||
| subject device models. | All required specifications were met. |
Device dimensions are comparable to
the predicate device models, with the
exception of the longest model length,
which is within the range of
dimensions for legally-marketed
mechanical thrombectomy devices.
The longer overall length of the
subject device does not affect
performance, safety or effectiveness. |
| Radial Force Testing | Radial force of the subject device
models was measured within a range
of lumen diameters applicable to the
intended vasculature to verify that
the device performance
specifications have been met. | All required specifications were met.
Radial force performance of the
subject device is comparable to that of
the predicate device. |
| Outer Cage Recovery | Expansion characteristics of the self-
expanding portion of a
representative (worst-case) device
model were evaluated by
measurement post-multiple loading
and deployment cycles. | All required specifications were met.
Outer cage recovery performance is
comparable to that of the predicate. |
| Durability Testing | Damage was evaluated after delivery
and withdrawal of the subject device
models beyond the recommended
number of passes and re-sheathings
recommended in the instructions for
use. | All required specifications were met.
Durability performance of the subject
device is comparable to that of the
predicate device. |
| Characteristic/Test | Method | Conclusions |
| Full Unit (System) Tensile
Testing | The system (full unit) tensile strength
of the proximal/distal sections of the
device was evaluated post-simulated
use. | All required specifications were met.
The system tensile strength of the
subject device is comparable to that of
the predicate device. |
| Marker Push Out Force | Evaluated the force required to
dislodge riveted markers from a
representative device model post-
simulated use (all marker locations
and push-out directions were
assessed). | All required specifications were met. |
| Flexibility & Kink
Resistance | Kink resistance of the entire device
(shaft and shaped section) was
evaluated using a representative
worst-case device model, which was
wrapped around a series of mandrels
of decreasing radii until permanent
deformation was observed or until
the smallest radius was used. | All required specifications were met.
Kink resistance of the subject device is
comparable to that of the predicate
device. |
| Coating Integrity | Coating integrity of the subject
device was evaluated on a
representative (worst-case) device
model by examining the shaft coating
under microscopy pre- and post-
simulated use. | All required specifications were met.
Coating integrity of the subject device
is comparable to that of the predicate
device. |
| Torque Durability
(Strength) | The effects of torqueing the subject
device were evaluated using a
representative (worst-case) device
model post-simulated use with the
device positioned as follows (distal
end constrained): (a) within the
microcatheter in a simulated vessel;
and (b) with the shaped section of
the device deployed in a simulated
vessel following retraction of the
microcatheter. | All required specifications were met.
Torque durability of the subject device
is comparable to that of the predicate
device. |
| Corrosion Resistance | Representative (worst-case) device
models were subjected to corrosion
testing to determine resistance to
corrosion. | All required specifications were met.
Corrosion resistance of the subject
device is comparable to that of the
predicate device. |
| Tip Flexibility | Tip flexibility was evaluated by
measuring the deflection force of the
device tip when advanced through a
microcatheter past its tip and
deflected against contact plates at
pre-specified angles. | All required specifications were met.
Tip flexibility of the subject device is
comparable to that of the predicate
device. |
| Re-sheathing Force | A representative (worst-case) device
model was evaluated in a 0.021"
microcatheter to determine the force
required to re-sheath the device. | All required specifications were met.
Re-sheathing force is comparable to
those recorded for the predicate
devices. |
| Characteristic/Test | Method | Conclusions |
| Deliverability Force | A representative (worst-case) device model was evaluated in a tortuous track model to determine the force required to deliver the subject device in a 0.021" microcatheter. | All required specifications were met. |
| Radiopacity | The worst-case subject device (least number of radiopaque markers) was evaluated in a skull phantom model using fluoroscopy. | All required specifications were met.
Radiopacity of the subject device is equivalent to, or better than, that of the predicate devices tested. |
| Clot retrieval and
performance
(Simulated Use/Ease of
Use) | Device performance and ease of use attributes (including clot retrieval performance) were evaluated in simulated anatomy for the subject devices in relation to the key steps involved in the clinical procedure. | All required ease of use performance specifications were met.
The subject device effectively retrieved clot and restored flow in the test model.
Performance of the subject device (including loading, delivery, deployment and retrieval) was comparable to that of the predicate devices tested in an in vitro tortuous path anatomical model. |
| Physician Usability Study | Device performance and ease of use attributes were evaluated in simulated anatomy for the worst-case (largest) subject device model in relation to the key steps involved in the clinical procedure.
Performance was compared with the predicate device. | The physician usability study demonstrated that the subject device met user needs.
Device performance was comparable to that of the predicate device. |
| Delivery and re-sheathing
force during simulated
use
(in a clinically-
representative, full-length
anatomical model) | Delivery and re-sheathing forces were measured during simulated use of a representative (worst-case) device model device in a full-length anatomical model and compared with the forces measured for one or more predicate devices. | Delivery and re-sheathing performance of the subject device are comparable to that of the predicate device. |
| Kink Resistance –
Deployed Shaped Section | Kink resistance of the deployed shaped section of a representative (worst-case) device model was evaluated in a series of bend radii within a range of vessel lumen diameters. | Kink resistance of the deployed shaped section was comparable to that of the predicate device. |
Specifically, the following in vitro bench tests were performed on the subject device:
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9
10
In Vivo (Animal) Studies:
Acute and chronic animal studies have been performed to assess the usability, effectiveness and safety of the EmboTrap™ III device compared to the predicate devices in the swine model. Acute performance evaluated on Day 0 showed that the usability and performance of the EmboTrap™ III device was equivalent to that of the predicate device tested. Histological evaluation performed on treated vessels after 3 and 28 days demonstrated that the local and organ tissue response was comparable between the EmboTrap™ III device and the predicate devices tested.
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 device. Substantial equivalence of the subject device has been established to the predicate device through the results of bench and animal testing.
CONCLUSIONS
Non-clinical studies demonstrate that the EmboTrap™ III Revascularization Device is substantially equivalent to the predicate devices.