(129 days)
The Tigertriever Revascularization Device is intended to restore blood flow by removing thrombus from a large intracranial vessel 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 Tigertriever 13 device is a stentriever that is comprised of an adjustable nitinol braided mesh, stainless steel shaft, nitinol core wire and a handle. The shaft connects the mesh and the handle by the core wire that runs inside the shaft from the distal end of the slider activation element in the handle. The mesh is expanded when the physician pulls the slider, since the wires of the mesh are completely radiopaque, the physician sees the mesh under fluoroscopy and controls it until it conforms to the vessel diameter. The design of the wire mesh is optimized to penetrate the clot and encapsulate it during retrieval. The Tigertriever 13 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.
The provided document does not describe acceptance criteria for an AI/ML device or a study proving that an AI/ML device meets acceptance criteria. Instead, it is a 510(k) summary for a medical device called the "Tigertriever 13 Revascularization Device," which is a stentriever used to remove thrombus in ischemic stroke patients. This type of device is a physical medical instrument, not an AI/ML software.
The document discusses non-clinical performance data, including biocompatibility, sterilization, shelf life, and various bench tests for the Tigertriever 13 Revascularization Device. It also mentions pre-clinical animal testing.
Therefore, I cannot provide the requested information about acceptance criteria and studies for an AI/ML device based on the given input.
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July 25, 2022
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Rapid Medical Ltd. % Janice Hogan Partner Hogan Lovells US LLP 1735 Market Street, 23rd Floor Philadelphia, Pennsylvania 19103
Re: K220808
Trade/Device Name: Tigertriever 13 Revascularization Device Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: June 21, 2022 Received: June 21, 2022
Dear Janice Hogan:
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
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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 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 (OS) 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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below
510(k) Number (if known) K220808
Device Name
Tigertriever 13 Revascularization Device
Indications for Use (Describe)
The Tigertriever Revascularization Device is intended to restore blood flow by removing thrombus from a large intracranial vessel 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) 図 Prescription Use (Part 21 CFR 801 Subpart D)
□ Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image contains the logo for Rapid Medical. The logo consists of a stylized green symbol on the left, resembling three curved lines converging. To the right of the symbol, the words "Rapid Medical" are written in bold, black font. The logo appears to be for a medical company.
510(k) Summarv
K220808
Submission Sponsor
Rapid Medical Ltd. Carmel Building, P.O. Box 337 Yokneam, 2069205 Israel Company Phone No.: +972-72-250-3331
Contacts:
Dr. Orit Yaniv, VP of QA/RA Email: orit@rapid-medical.com
Ronen Eckhouse, CEO Email: ronen@rapid-medical.com
Date Prepared
July 15, 2022
Device Identification
Trade/Proprietary Name: Tigertriever 13 Revascularization Device Common/Usual Name: Catheter, Thrombus Retriever Classification Name: Percutaneous catheter Regulation Number: 21 CFR 870.1250 Product Code: NRY Device Class: II Classification Panel: Neurology
Legally Marketed Predicate Device(s)
Tigertriever and Tigertriever 17 Revascularization Device (K203592)
Indications for Use Statement
The Tigertriever Revascularization Device is intended to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA), or who fail IV t-PA therapy, are candidates for treatment.
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Image /page/4/Picture/1 description: The image contains the logo for Rapid Medical. The logo consists of a stylized green symbol on the left, resembling three curved lines converging. To the right of the symbol is the text "Rapid Medical" in a bold, sans-serif font. The text is black, providing a strong contrast against the white background.
Device Description
The Tigertriever 13 device is a stentriever that is comprised of an adjustable nitinol braided mesh, stainless steel shaft, nitinol core wire and a handle. The shaft connects the mesh and the handle by the core wire that runs inside the shaft from the distal end of the slider activation element in the handle. The mesh is expanded when the physician pulls the slider, since the wires of the mesh are completely radiopaque, the physician sees the mesh under fluoroscopy and controls it until it conforms to the vessel diameter. The design of the wire mesh is optimized to penetrate the clot and encapsulate it during retrieval. The Tigertriever 13 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.
Comparison of Technological Characteristics with the Predicate Device
The Tigertriever 13 Revascularization Device is substantially equivalent to the Tigertriever 17 Revascularization Device (model: TRPP7166) previously cleared as part of K203592. The two devices have the same indications for use and principles of operation, and similar technological characteristics. There are minor differences in dimensions between the two device models; however, they provide physicians with a slightly broader range of lengths and diameters to accommodate the range of large vessel occlusion (LVO) dimensions. This difference in dimensions does not raise new questions of safety or effectiveness. A summary of the technological characteristics of the Tigertriever 13 Revascularization Device in comparison to those of the predicate device is presented in the table below.
| Tigertriever 17 RevascularizationDevice (TRPP7166)(Predicate device) | Tigertriever 13 Revascularization Device(TRPP7144)(Subject device) | |
|---|---|---|
| 510(k) Number | K203592 | K220808 |
| Regulation No. | 21 CFR 870.1250 | 21 CFR 870.1250 |
| Regulation Name | Percutaneous catheter | Percutaneous catheter |
| Classification | Class II | Class II |
| Product Code | NRY | NRY |
| Tigertriever 17 RevascularizationDevice (TRPP7166)(Predicate device) | Tigertriever 13 Revascularization Device(TRPP7144)(Subject device) | |
| Indications for Use | The Tigertriever 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. | The Tigertriever Revascularization Device isintended to restore blood flow by removingthrombus from a large intracranial vessel inpatients experiencing ischemic stroke within8 hours of symptom onset. Patients who areineligible for intravenous tissue plasminogenactivator (IV t-PA), or who fail IV t-PAtherapy, are candidates for treatment. |
| Anatomical Location | Neurovasculature | Neurovasculature |
| Technological Characteristics | ||
| Mode of operation | Manual expansion of the braided distalportion into the clot using the handlecomponent | Manual expansion of the braided distalportion into the clot using the handlecomponent |
| Design of distalportion | Close end braided nitinol mesh,manually expandable | Close end braided nitinol mesh, manuallyexpandable |
| Stent length (un-expandedconfiguration) | 23mm | 20.5mm |
| Stent size Distal OD(unexpanded andexpandedconfiguration) | Unexpanded configuration 0.5mmExpanded configuration 3mm | Unexpanded configuration 0.5mmExpanded configuration 2.5mm |
| Stent structure | Braided from eight (8) Niti DFT 0.075mm wires with a tantalum core | Braided from eight (8) Niti DFT 0.05 mmwires with a platinum core |
| Overall length | 228 cm(shaft+cable+mesh+tip) | 208 cm(shaft+cable+mesh+tip) |
| Compatibility | Microcatheter with an internal diameterof 0.017 inches | Microcatheter with an internal diameter of0.0165 inches |
| Materials | ||
| Stent (mesh) | Nitinol | Nitinol |
| Markers | 90% Platinum/ 10% Iridium | 90% Platinum/ 10% Iridium |
| Core wire (shaft) | Nitinol core wire and 304 Stainless Steelshaft | Nitinol core wire and 304 Stainless Steelshaft |
| Introducer sheath | PTFE | PTFE |
| Packaging | ||
| Sterilization Method | Ethylene oxide | Ethylene oxide |
| Tigertriever 17 RevascularizationDevice (TRPP7166)(Predicate device) | Tigertriever 13 Revascularization Device(TRPP7144)(Subject device) | |
| Single Use | Yes | Yes |
| Packaging | Placed into a Dispenser hoop, blister,Tyvek pouch, and Carton box | Placed into a Dispenser hoop, Tyvek pouch,and Carton box |
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Image /page/5/Picture/1 description: The image shows the logo for Rapid Medical. The logo consists of a green abstract symbol on the left and the words "Rapid Medical" in bold, dark gray font on the right. The abstract symbol appears to be three curved lines that converge to a point.
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Image /page/6/Picture/1 description: The image shows the logo for Rapid Medical. The logo consists of a stylized green symbol on the left, resembling three curved lines. To the right of the symbol is the text "Rapid Medical" in a bold, sans-serif font. The text is black.
Non-Clinical Performance Data
As part of demonstrating safety and effectiveness of the device and in showing substantial equivalence to the predicate device, Rapid Medical Ltd. completed a number of non-clinical performance tests. The device meets all the requirements of overall design, sterilization, and biocompatibility. Testing results confirm that the design output meets the design specification for the device.
Biocompatibility
Biocompatibility of the Tigertriever 13 was based on the biocompatibility testing data for the Comaneci Embolization Assist Device (DEN170064). The two devices share the same manufacturing process and same manufacturing environment. In addition, the two devices are intended to be used in the same anatomical locations and are identical in terms of frequency and duration of exposure. Biocompatibility testing was completed for Comaneci device and consisted of the following tests: Cytotoxicity, Irritation (Intracutaeous Reactivity), Sensitization, Hemocompatibility, Pyrogenicity, Acute Systemic and Toxicity Testing. In addition, in vivo thrombogenicity was performed for the Tigertriever model. Results of the biocompatibility testing indicate that Tigertriever 13 Revascularization Device is biocompatible and is substantially equivalent for its intended use.
| Biological Endpoint | Test Results | Conclusion |
|---|---|---|
| Cytotoxicity – ISO ElutionMethod | Grade 0 reactivity observed 48 hours postexposure to test article extract. | Non-cytotoxic |
| Irritation – IntracutaeousReactivity in Rabbit | Difference of overall mean score between testarticle and control was 0. | Non-irritant |
| Sensitization – Guinea PigMaximization Test | Grade 0, no evidence of causing delayed dermalcontact sensitization. | Does not elicitsensitization response |
| Hemocompatibility –Complement Activation Assay | SC5b-9 concentration of the test article samplewas statistically lower than the activated NHScontrol (p<0.05), and was not statistically higherthan the negative control. | Pass |
| Hemocompatibility – In VitroHemolysis | Test article = 0.0% hemolysis. | Non-Hemolytic |
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Image /page/7/Picture/1 description: The image contains the logo for Rapid Medical. The logo features a green abstract symbol on the left, resembling three curved lines. To the right of the symbol, the words "Rapid Medical" are written in a bold, sans-serif font.
| Biological Endpoint | Test Results | Conclusion |
|---|---|---|
| Pyrogenicity – MaterialMediated Pyrogenicity inRabbit | The total rise of rabbit temperatures during the3-hour observation period was within acceptableUSP limits. | Non-pyrogenic |
| Systemic Toxicity –SystemicToxicity Study in Mice | No mortality or evidence of systemic toxicityfrom the extracts injected into mice. | Non-toxic |
| Thrombogenicity – Acute Pre-Clinical Evaluation of theSafety of Tigertriever device ina Swine ModelThrombogenicity | Test device did not show higherthrombogenicity rate compared to the predicatedevice. | Pass |
Sterilization and Shelf life
The device and its accessories are sterilized by 100% Ethylene Oxide. The previously conducted shelf-life testing for the Tigertriever Revascularization Device supports a 2.5-year shelf life for the Tigertriever 13 Revascularization Device.
Bench Tests
The device passed all performance bench testing in accordance with internal requirements, national standards and international standards as shown in the table below. Results of the performance bench testing indicate that Tigertriever 13 Revascularization device meets established performance requirements and is substantially equivalent for its intended use.
| Performance Bench Testing | |||
|---|---|---|---|
| Test | Test Method Summary | Conclusions | |
| Simulated use test | Simulated use testing of the Tigertriever 13Revascularization Device was performed inan anatomical model which simulated thetortuosity of the neurovasculature. Deviceswere delivered through the tortuousanatomical model to evaluate theeffectiveness of the device at retrieval offirm and soft clots. | The device was tested for handling andclot retrieval in an in vitro tortuouspath anatomical model, which hasbeen used in the evaluation of thepredicate device. The subject deviceeffectively retrieved clot and restoredflow in the test model. | |
| Radial force | The radial force of the subject device wasmeasured within a range of diameters from1.5mm and 2.5mm, and compared with theradial forces measured for the predicatedevices. | The radial force of the subject devicewhen tested in applicable lumen sizesis comparable to the predicatedevice. | |
| Durability | Damage was evaluated after delivery andwithdrawal of the device beyond therecommended number of passes and | Devices tested demonstrated nodamage after delivery andwithdrawal testing. Durabilityestablished acceptable performance | |
| Performance Bench Testing | |||
| Test | Test Method Summary | Conclusions | |
| resheathings recommended in theinstructions for use. | for 3 passes, which is at leastequivalent to the number of passesspecified in the predicate labeling (2passes per device). | ||
| Delivery, deploymentand retrieval | The delivery, deployment and retrievalforces were measured during simulated useof the subject device. | The device was tested for delivery,deployment, and retrieval in an invitro tortuous path anatomical model,which has been used in theevaluation of the predicate device.The subject device demonstratedacceptable performance with respectto delivery, deployment and retrieval. | |
| Torque strength | Devices were tracked through amicrocatheter in a tortuous path anatomicalmodel and evaluated for damage following anumber of rotations with the distal endconstrained. | The device demonstrated the abilityto withstand 5 rotations withoutdamage. Like the predicate device,rotational maneuvers are notexpected under the intendedconditions of clinical use. Therefore,the results demonstrate acceptabletorque strength. | |
| Dimensions test | Dimensional conformance to specificationswas confirmed. | The subject device dimensions arewithin the range of existing predicatedevice dimensions. The minordifferences in dimensions do notaffect performance, safety oreffectiveness. | |
| Tip flexibility | Tip Flexibility testing was performed tomeasure the force required to deflectTigertriever 13 tips to 90 degrees. | The subject device met acceptancecriteria. | |
| Kink resistance | Kink evaluation was performed for the distalsection and for the proximal section of thedevice, in simulated bends representativeof the intended clinical anatomy. | Kink resistance was evaluated underconditions simulating anatomictortuosity and demonstratedacceptable performance. | |
| Tensile test | The minimum force to break the subjectdevice was tested for all joints. | The tensile strength of the device metacceptance criteria based onrecognized standards (ISO 10555-1). | |
| Particulates | Particulate test was performed according tothe light obscuration test method. Simulateduse testing of the subject device wasperformed in an anatomical model. Deviceswere flushed and the fluid was evaluated forparticle sizes of ≥10, ≥25 and ≥50 µm. | The particulate generated by thesubject device was similar to theparticulate generated by the predicatedevice. | |
| Austenite Finish (Af)Temperature | The Active Af temperature was determinedfrom a graph of displacement as a functionof temperature (Bend and Free Recovery perASTM F2082) | The Af temperature of the device metacceptance criteria. | |
| Performance Bench Testing | |||
| Test | Test Method Summary | Conclusions | |
| Coating integrityassessment | The test was performed with the Comaneci device, as the design of the two devices is the same in terms of the core wire mechanism. Damage to the PTFE core wire coating was evaluated following simulated use. | Results demonstrated no damage to the coating following simulated use. | |
| Corrosion | The test was performed with the Comaneci device and not with the subject device. The device was immersed in saline for 5 hours at room temperature, boiled in distilled water for 30 min, and maintained in 37°C for 48 hours. After the above treatment, device is tested for corrosion. | No corrosion was observed, which meets the acceptance criteria based on recognized standards (ISO 10555-1). |
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Image /page/8/Picture/1 description: The image shows the logo for Rapid Medical. The logo consists of a green abstract symbol on the left and the words "Rapid Medical" in bold, dark gray font on the right. The symbol appears to be three curved lines that converge to a point.
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Image /page/9/Picture/1 description: The image contains the logo for Rapid Medical. The logo consists of a stylized green symbol on the left, resembling three curved lines converging. To the right of the symbol, the words "Rapid Medical" are written in a bold, sans-serif font, with "Rapid" and "Medical" on the same line.
Pre-Clinical Animal Testing Data
The safety of the Tigertriever 13 was assessed in two pre-clinical studies at sub-acute and 30-day (chronic) time points. After procedures, animals were assessed in vivo until their scheduled subchronic or chronic timepoints. In each tested vessel three passes were performed, one pass with clot and two passes without clots. The simulation included clots of variable hardness and consistency. Treated vessel diameters ranged from 1.1-3.2mm; this range complies with the target clinical indication of the large intracranial vessel occlusion, which includes vessels size of 1.5 mm and larger. Full reperfusion was demonstrated in all procedures, and there was no evidence of vessel damage (i.e., dissection, perforation, clot formation) related to device deployment. Histopathological assessment of treated vessels was considered acceptable. Tigertriever 13 preclinical studies thus demonstrate that the device has acceptable safety and clot retrieval performance.
Conclusion
The Tigertriever 13 Revascularization Device has the same indications for use and principles of operation, and similar technological characteristics as the predicate device. The differences in technological characteristics between the subject and predicate devices do not raise different questions regarding the safety and effectiveness. Non-clinical performance testing as discussed above demonstrates similar performance and safety characteristics between the Tigertriever 13 Revascularization Device and the predicate device, thus supporting the conclusion that the Tigertriever 13 Revascularization Device is substantially equivalent to the predicate device.
§ 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).