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™ 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.

AI/ML Overview

The provided text describes the EMBOTRAP III Revascularization Device and demonstrates its substantial equivalence to a predicate device, the EmboTrap® II Revascularization Device (K173452). The acceptance criteria and the study that proves the device meets them are primarily based on non-clinical performance data (biocompatibility, sterilization, shelf life, in vitro/bench testing, and in vivo animal studies), as no clinical study was performed.

Therefore, a table of acceptance criteria and reported device performance as typically understood for an AI/software device studying human-in-the-loop or standalone performance, sample size for test/training sets, expert ground truth adjudication for these, MRMC studies, or specific "effect sizes" of AI assistance, are not applicable in this context. The document focuses on demonstrating physical and functional equivalence of a medical device (a mechanical thrombectomy device) to a legally marketed predicate.

Here's an interpretation of the requested information based on the provided document, adapting where necessary for a medical device rather than a software/AI product's performance study:

1. A table of acceptance criteria and the reported device performance

The document defines acceptance criteria through various tests (biocompatibility, bench, and animal studies) and concludes that "All required specifications were met." and "demonstrate substantial equivalence." for the subject device compared to the predicate. The "reported device performance" is framed as meeting these specifications and being comparable or equivalent to the predicate device.

Table: Acceptance Criteria and Device Performance (Summary derived from the document)

Test Category	Acceptance Criteria (Implicit)	Reported Device Performance
Biocompatibility	Meet requirements of ISO 10993-1 and FDA Biocompatibility Guidance; non-cytotoxic, non-sensitizing, non-irritant, non-toxic, non-pyrogenic, non-hemolytic, acceptable complement activation (C3a, SC5b-9 levels), thromboresistant.	All tests completed met pre-assigned acceptance criteria and applicable standards. The device was found to be non-cytotoxic, not a sensitizer, not an irritant, non-toxic, non-pyrogenic, non-hemolytic, with acceptable C3a/SC5b-9 levels, and thromboresistant (minimal to slight thrombus formation, comparable to control).
Sterilization & Shelf Life	Achieve a minimum SAL of 10-6; product and packaging remain functional and sterile for indicated shelf life.	Sterilization successfully validated (10-6 SAL). Shelf life of 3 years established; product and packaging remain functional and sterile.
In Vitro (Bench) Testing	Meet pre-determined product performance specification requirements; comparable to predicate device in: dimensions (within range for legally-marketed devices), radial force, outer cage recovery, durability, system tensile strength, marker push-out force, flexibility & kink resistance, coating integrity, torque durability, corrosion resistance, tip flexibility, re-sheathing force, deliverability force, radiopacity, clot retrieval & performance, physician usability, deployed shaped section kink resistance.	All required specifications were met. Device dimensions are comparable to predicate (except longest model length, which does not affect performance/safety/effectiveness). Performance (radial force, outer cage recovery, durability, tensile strength, kink resistance, coating integrity, torque durability, corrosion resistance, tip flexibility, re-sheathing force, deliverability force, clot retrieval, physician usability, deployed shaped section kink resistance) was comparable to the predicate device. Radiopacity was equivalent to or better than predicate.
In Vivo (Animal) Studies	Usability, effectiveness, and safety equivalent to predicate devices in swine model. Local and organ tissue response comparable.	Acute performance demonstrated equivalent usability and performance to the predicate device. Histological evaluation showed comparable local and organ tissue response after 3 and 28 days compared to predicate devices.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: The document doesn't provide specific numerical sample sizes (e.g., "N" units) for each bench test. Instead, it refers to "a range of device dimensions," "representative (worst-case) device model," or "worst-case subject device." For animal studies, it refers to "the swine model" implying multiple animals, but no specific number is given.
Data Provenance: Not explicitly stated as country of origin of the data. The studies are non-clinical (bench and animal lab tests). They appear to be prospective for the purpose of demonstrating equivalence, testing newly manufactured devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This concept is not directly applicable. For this type of medical device clearance, "ground truth" is established through physical and mechanical measurements, chemical analyses, and biological responses in laboratory or animal settings.
For the "Physician Usability Study," it states "The physician usability study demonstrated that the subject device met user needs." It doesn't specify the number of physicians or their qualifications, but these would be the "experts" assessing usability.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable for non-clinical testing. Adjudication methods like 2+1 or 3+1 are used for expert consensus on clinical data (e.g., image interpretation). Here, the "truth" is determined by measured physical properties or biological responses against predefined engineering or biological standards.

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

No MRMC or human-in-the-loop study was done. This device is a mechanical thrombectomy device, not an AI/software product intended to assist human readers (e.g., radiologists). The performance assessment focuses on its physical and biological attributes.

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

Not applicable. This is a physical medical device, not a standalone algorithm. Its "performance" is its ability to meet engineering specifications and biocompatibility.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance evaluation is established through:
- Defined Engineering Specifications: For bench tests like dimensions, radial force, durability, etc.
- Validated Biological/Chemical Standards: For biocompatibility tests (e.g., ISO 10993 series for cytotoxicity, sensitization, irritation, etc.).
- Histopathological Analysis: For animal studies assessing tissue response.
- Direct Observation/Measurement: For performance attributes like clot retrieval in simulated anatomy.

8. The sample size for the training set

Not applicable. This is a mechanical device, not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this device.

Summary

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

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

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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,

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)

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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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.

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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 RevascularizationDevice is intended to restore blood flow inthe neurovasculature by removingthrombus in patients experiencingischemic stroke within 8 hours of symptomonset. Patients who are ineligible forintravenous tissue plasminogen activator(IV t-PA) or who fail IV t-PA therapy arecandidates for treatment.	Same
Target Population	Patients with symptoms of an ischemicstroke within 8 hours of symptom onset,who are ineligible for intravenous tissueplasminogen activator (IV t-PA) or who failIV t-PA therapy are candidates fortreatment	Same
Design/TechnologicalPrinciples	Retrievable, self-expanding Nitinol shapedsectionNitinol guide-wire like shaft	Same
Principal Device Materials
Shaped Section	Nitinol	Same
Core Wire (Shaft)	Nitinol	Same
Body Markers	Gold	Platinum/IridiumResults of biocompatibility, bench andanimal testing demonstrate substantialequivalence.
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 testingdemonstrate 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 noevidence of causing cell lysis ortoxicity. The test article extractmet the requirements of the test.Based on the percentage viabilityvalues for the test article extractdilutions, the device is non-cytotoxic.	Device is non-cytotoxic per theCytotoxicity Studies conducted
ISO Guinea Pig MaximizationSensitization Test	Test article extracts showed noevidence of causing delayeddermal contact sensitization in theguinea pig.	Device is not considered asensitizer per the Guinea PigMaximization Test
ISO Intracutaneous Study inRabbits	The difference between the testextract overall mean score and thecorresponding control overallmean score was 1.0 or less.	Device is not an irritant wheninjected intracutaneously per theISO Intracutaneous Study inRabbits
ISO Systemic Toxicity Study inMice	There was no mortality or evidenceof systemic toxicity from theextracts injected into mice. Eachtest article extract met therequirements of the study.	Device is non-toxic per the ISOSystemic 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 risein temperature of ≥ 0.5°C aboveits baseline temperature and thetotal maximum temperature riseof all three animals was withinacceptable USP limits.The total rise of rabbittemperatures during the 3-hourobservation period was withinacceptable USP requirements. Thetest article met the requirementsfor the absence of pyrogens.	Device is non-pyrogenic per theMaterial Mediated Rabbit PyrogenStudy
ASTM Hemolysis	Both the test article in directcontact with blood and the testarticle extract were non-hemolytic.	Device is non-hemolytic per theASTM Hemolysis Test
Complement Activation AssayStudiesSC5b-9 Complement ActivationAssay Study	The C3a and SC5b-9concentrations of the test articlesamples were acceptable. All testmethod acceptance criteria weremet.	Levels of C3a and SC5b-9 wereacceptable.
In Vivo Thromboresistance Studyin Sheep - Jugular Vein, Acute(Thrombogenicity)	The implantation procedure wasroutine and there were nodifficulties encountered withinsertion or placement of the testdevice. There was no evidence ofbleeding or complications duringthe post-operative implant period.Minimal thrombus formation wasassociated with the control articleand minimal to slight thrombusformation was associated with thetest article.	Under the conditions of this study,both test and control articles wereconsidered 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 weremeasured using specifiedmeasurement tooling to verify thatthe required dimensionalspecifications were met for thesubject device models.	All required specifications were met.Device dimensions are comparable tothe predicate device models, with theexception of the longest model length,which is within the range ofdimensions for legally-marketedmechanical thrombectomy devices.The longer overall length of thesubject device does not affectperformance, safety or effectiveness.
Radial Force Testing	Radial force of the subject devicemodels was measured within a rangeof lumen diameters applicable to theintended vasculature to verify thatthe device performancespecifications have been met.	All required specifications were met.Radial force performance of thesubject device is comparable to that ofthe predicate device.
Outer Cage Recovery	Expansion characteristics of the self-expanding portion of arepresentative (worst-case) devicemodel were evaluated bymeasurement post-multiple loadingand deployment cycles.	All required specifications were met.Outer cage recovery performance iscomparable to that of the predicate.
Durability Testing	Damage was evaluated after deliveryand withdrawal of the subject devicemodels beyond the recommendednumber of passes and re-sheathingsrecommended in the instructions foruse.	All required specifications were met.Durability performance of the subjectdevice is comparable to that of thepredicate device.
Characteristic/Test	Method	Conclusions
Full Unit (System) TensileTesting	The system (full unit) tensile strengthof the proximal/distal sections of thedevice was evaluated post-simulateduse.	All required specifications were met.The system tensile strength of thesubject device is comparable to that ofthe predicate device.
Marker Push Out Force	Evaluated the force required todislodge riveted markers from arepresentative device model post-simulated use (all marker locationsand push-out directions wereassessed).	All required specifications were met.
Flexibility & KinkResistance	Kink resistance of the entire device(shaft and shaped section) wasevaluated using a representativeworst-case device model, which waswrapped around a series of mandrelsof decreasing radii until permanentdeformation was observed or untilthe smallest radius was used.	All required specifications were met.Kink resistance of the subject device iscomparable to that of the predicatedevice.
Coating Integrity	Coating integrity of the subjectdevice was evaluated on arepresentative (worst-case) devicemodel by examining the shaft coatingunder microscopy pre- and post-simulated use.	All required specifications were met.Coating integrity of the subject deviceis comparable to that of the predicatedevice.
Torque Durability(Strength)	The effects of torqueing the subjectdevice were evaluated using arepresentative (worst-case) devicemodel post-simulated use with thedevice positioned as follows (distalend constrained): (a) within themicrocatheter in a simulated vessel;and (b) with the shaped section ofthe device deployed in a simulatedvessel following retraction of themicrocatheter.	All required specifications were met.Torque durability of the subject deviceis comparable to that of the predicatedevice.
Corrosion Resistance	Representative (worst-case) devicemodels were subjected to corrosiontesting to determine resistance tocorrosion.	All required specifications were met.Corrosion resistance of the subjectdevice is comparable to that of thepredicate device.
Tip Flexibility	Tip flexibility was evaluated bymeasuring the deflection force of thedevice tip when advanced through amicrocatheter past its tip anddeflected against contact plates atpre-specified angles.	All required specifications were met.Tip flexibility of the subject device iscomparable to that of the predicatedevice.
Re-sheathing Force	A representative (worst-case) devicemodel was evaluated in a 0.021"microcatheter to determine the forcerequired to re-sheath the device.	All required specifications were met.Re-sheathing force is comparable tothose recorded for the predicatedevices.
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 andperformance(Simulated Use/Ease ofUse)	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-sheathingforce during simulateduse(in a clinically-representative, full-lengthanatomical 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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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.

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).