(88 days)
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.
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.
This is an analysis of a 510(k) submission for the EMBOTRAP™ III Revascularization Device. The provided document does not describe acceptance criteria and a study proving device performance in the context of an AI/ML medical device. Instead, it details the substantial equivalence of a physical medical device (a thrombus retriever) to predicate devices through various non-clinical tests.
Therefore, I cannot extract the information requested as it pertains to AI/ML device acceptance criteria and studies (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, ground truth establishment for training set).
The document focuses on:
- Biocompatibility Testing: Demonstrating the device is non-cytotoxic, non-sensitizing, non-irritant, non-toxic, non-pyrogenic, non-hemolytic, has acceptable complement activation, and is thromboresistant.
- Sterilization and Shelf Life: Validating the EO sterilization process and a 3-year shelf life.
- In Vitro (Bench) Testing: Evaluating physical characteristics like dimensions, radial force, cage recovery, durability, 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, and physician usability.
- In Vivo (Animal) Studies: Assessing usability, effectiveness, and safety in a swine model, comparing it to predicate devices.
- Clinical Studies: Stating that no clinical study was performed because there was no change to the indications for use or fundamental scientific technology (this is typical for a 510(k) focused on substantial equivalence to existing devices).
Given the nature of the device (a thrombus retriever), the acceptance criteria and performance data are entirely focused on physical and biological characteristics, not AI/ML performance metrics.
In summary, the provided text does not contain any information relevant to the acceptance criteria or study design for an AI/ML medical device.
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July 30, 2021
Neuravi Ltd. Niall Fox Director of Regulatory Affairs Block 3, Ballybrit Business Park Galway H91 K5YD, Ireland
Re: K211338
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: April 30, 2021 Received: May 3, 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
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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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Naira Muradyan, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K211338
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) |
|---|
| ------------------------------------------------- |
| ☑ Recreational Use (Part 21 CFR 201.326 Subject) | □ Over-The-Counter Use (21 CFR 201.66 Subject) |
|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------ | ----------------------------------------------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
K211338
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: July 28th, 2021
DEVICE II.
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
PREDICATE DEVICES III.
EmboTrap® II Revascularization Device (K173452)
EMBOTRAP™ III Revascularisation Device (5 x 22 mm and 5 x 37 mm models via K193063)
Solitaire™ Platinum Revascularization Device (K160641)
IV. 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.
V. 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.
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 devices is presented below
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| Characteristics | Predicate Devices Referenced in this Submission | Proposed SE Device | ||
|---|---|---|---|---|
| EMBOTRAP III(5 x 22 mm and 5 x 37 mm) | EMBOTRAP II | Solitaire™ Platinum | EMBOTRAP III(6.5 x 45 mm) | |
| Manufacturer | Neuravi Ltd. | Neuravi Ltd. | Covidien/Medtronic | Same as EMBOTRAP II |
| 510(k) Number | K193063 | K173452 | K160641 | N/A |
| 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 bloodflow in the neurovasculature byremoving thrombus in patientsexperiencing ischemic stroke within8 hours of symptom onset. Patientswho are ineligible for intravenoustissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy arecandidates for treatment. | The EMBOTRAP II RevascularizationDevice is intended to restore bloodflow in the neurovasculature byremoving thrombus in patientsexperiencing ischemic stroke within8 hours of symptom onset. Patientswho are ineligible for intravenoustissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy arecandidates for treatment. | The Solitaire Platinum RevascularizationDevice is intended to restore blood flowby removing thrombus from a largeintracranial vessel in patientsexperiencing ischemic stroke within 8hours of symptom onset. Patients whoare ineligible for intravenous tissueplasminogen activator (IV t-PA) or whofail IV t-PA therapy are candidates fortreatment. | Same as EMBOTRAP models |
| Target Population | Patients with symptoms of an ischemic stroke within 8 hours of symptom onset, who are ineligible for intravenoustissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment | Same | ||
| Design/TechnologicalPrinciples | Retrievable, self-expanding Nitinol shaped sectionNitinol guide-wire like shaft | Same | ||
| Distal End (Retriever) Design | Bi-layer tubular design with a tapereddistal end with tipImage: [5 x 22 mm device]Image: [5 x 37 mm device] | Bi-layer tubular design with a tapereddistal end with tipImage: [device] | Same as EMBOTRAP II | |
| Principal Device Materials | ||||
| Shaped Section & Shaft Wire | Nitinol | Nitinol | Nitinol | Same as EMBOTRAP II |
| Distal Marker/Coil | Platinum/Tungsten Coil | Platinum/Tungsten Coil | Platinum/Iridium | Same as EMBOTRAP II |
| Proximal Marker/Coil | Platinum/Tungsten Coil | Platinum/Tungsten Coil | Platinum/Iridium | Same as EMBOTRAP II |
| Shaft Coating | HydrophobicPTFE Coating | HydrophobicPTFE Coating | Same as EMBOTRAP II | |
| Design Characteristics & Technology | ||||
| Size(s) Offered(Retriever Diameter ×Length) | 5×22mm, 5×37mm, | 5×21 mm, 5×33 mm | 6x40 mm | 6.5x45 mm |
| Device Length | 194 cm, 195 cm(Labeled Overall length) | 194 cm, 195 cm(Labeled Overall length) | 180 cm(Labeled Push Wire Length) | 196 cm(Labeled Overall length) |
| Minimum Microcatheter ID | 0.021"-0.027" | 0.021" | 0.027" (6 mm diameter size) | 0.021"-0.027" |
| Key Principles of Operation | The device is used in the neurovasculature to restore blood flow in patients experiencing ischemic stroke | Same |
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| No. of passes/device IFU | 3 / Device & Vessel | 3 / Device & Vessel | 3 / Device & Vessel | Same | ||||
|---|---|---|---|---|---|---|---|---|
| Additional Characteristics | ||||||||
| How supplied | Sterile/Single Use | Sterile/Single Use | Sterile/Single Use | Same | ||||
| Sterilization Method | Ethylene Oxide | Ethylene Oxide | 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 above itsbaseline temperature and the totalmaximum temperature rise of allthree 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.
Sterilization and Shelf Life:
The EMBOTRAP™ III device is labelled 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 demonstrate that it performs as designed, fulfils all pre-determined product performance
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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 devices.
| Characteristic/Test | Method | Conclusions |
|---|---|---|
| System Dimensions | A range of device dimensions were measured using specified measurement tools to verify that the required dimensional specifications were met for the subject device models. | All required specifications were met.Device dimensions are comparable to legally-marketed mechanical thrombectomy devices. The subject device includes a longer overall length and larger diameter. |
| 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. |
| 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 | All required specifications were met.Coating integrity of the subject device is comparable to that of the predicate |
| Torque Durability(Strength) | The effects of torquing 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. |
| Deliverability Force | A representative (worst-case) devicemodel was evaluated in a tortuoustrack model to determine the forcerequired to deliver the subject devicein a 0.021" microcatheter. | All required specifications were met. |
| Radiopacity | The worst-case subject device (leastnumber of radiopaque markers) wasevaluated in a skull phantom modelusing fluoroscopy. | All required specifications were met.Radiopacity of the subject device isequivalent to, or better than, that ofthe predicate devices tested. |
| Clot retrieval andperformance(Simulated Use/Ease ofUse) | Device performance and ease of useattributes (including clot retrievalperformance) were evaluated insimulated anatomy for the subjectdevices in relation to the key stepsinvolved in the clinical procedure. | All required ease of use performancespecifications were met.The subject device effectivelyretrieved clot and restored flow in thetest model.Performance of the subject device(including loading, delivery,deployment and retrieval) wascomparable to that of the predicatedevices tested in an in vitro tortuouspath anatomical model. |
| Physician Usability Study | Device performance and ease of useattributes were evaluated insimulated anatomy for the worst-case (largest) subject device model inrelation to the key steps involved inthe clinical procedure.Performance was compared with thepredicate device. | The physician usability studydemonstrated that the subject devicemet user needs.Device performance was comparableto that of the predicate device. |
| Delivery and re-sheathingforce during simulateduse(in a clinically-representative, full-lengthanatomical model) | Delivery and re-sheathing forceswere measured during simulated useof a representative (worst-case)device model device in a full-lengthanatomical model and comparedwith the forces measured for one ormore predicate devices. | Delivery and re-sheathingperformance of the subject device arecomparable to that of the predicatedevice. |
| Kink Resistance –Deployed Shaped Section | Kink resistance of the deployedshaped section of a representative(worst-case) device model wasevaluated in a series of bend radiiwithin a range of vessel lumendiameters. | Kink resistance of the deployedshaped section was comparable tothat of the predicate device. |
Specifically, the following in vitro bench tests were performed on the subject device:
simulated use.
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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 end 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.
§ 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).