(59 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 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 mesh to 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 Revascularization Device is supplied sterile and is intended for single-use only by physicians trained in neurointerventional procedures and the treatment of ischemic stroke.
This document is a 510(k) summary for the Tigertriever 21, 17, and 13 Revascularization Devices. It largely references predicate devices and non-clinical testing for substantial equivalence, rather than a de novo clinical study with specific acceptance criteria.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission based on substantial equivalence to predicate devices and non-clinical testing, explicit numerical acceptance criteria and a single overall "device performance" metric are not presented in the same way they would be in a de novo clinical trial. Instead, the "acceptance criteria" are implied by successful completion of each test method as summarized in the tables below. The reported performance is that the device "met acceptance criteria" or "demonstrated acceptable performance."
| Test Category | Test Name | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Bench Tests | Simulated use test | Effective clot retrieval and restoration of flow in an in vitro tortuous path anatomical model. | The device was tested for handling and clot retrieval in an in vitro tortuous path anatomical model, which has been used in the evaluation of the predicate device. The subject device effectively retrieved clot and restored flow in the test model. |
| Durability | No damage after delivery and withdrawal beyond recommended passes. Durability established acceptable performance for 3 passes. | Devices tested demonstrated no damage after delivery and withdrawal testing. Durability established acceptable performance for 3 passes, which is at least equivalent to the number of passes specified in the predicate labeling (2 passes per device). | |
| Delivery, deployment, and retrieval forces | Acceptable performance in delivery, deployment, and retrieval in an in vitro tortuous path anatomical model. | The device was tested for delivery, deployment, and retrieval in an in vitro tortuous path anatomical model, which has been used in the evaluation of the predicate device. The subject device demonstrated acceptable performance with respect to delivery, deployment and retrieval. | |
| Dimensions test | Dimensional conformance to specifications. | The subject device dimensions are within the range of existing predicate device dimensions. The minor differences in dimensions do not affect performance, safety or effectiveness. | |
| Tensile test | Tensile strength meets ISO 10555-1 standards. | The tensile strength of the device met acceptance criteria based on recognized standards (ISO 10555-1). | |
| Particulate test | Particulate generation similar to predicate device. | The particulate generated by the subject device was similar to the particulate generated by the predicate device. | |
| Biocompatibility Testing | Cytotoxicity | Non-cytotoxic (Grade 0 reactivity). | Pass. Grade 0 reactivity observed 48 hours post exposure to test article extract. Non-cytotoxic. |
| Irritation (Intracutaneous Reactivity) | Non-irritant (difference of overall mean score between test and control was 0). | Pass. Difference of overall mean score between test article and control was 0. Non-irritant. | |
| Sensitization (Guinea Pig Maximization Test) | Does not elicit sensitization response (Grade 0). | Pass. Grade 0, no evidence of causing delayed dermal contact sensitization. Does not elicit sensitization response. | |
| Hemocompatibility - Complement activation Assay | SC5b-9 concentration statistically less than positive control and not statistically higher than negative control. | Pass. SC5b-9 concentration of the test article sample was statistically less than the positive control and was not statistically higher than the negative control. | |
| Hemocompatibility - In Vitro Hemolysis | Non-hemolytic. | Both the test article in direct contact with blood and the test article extract were non-hemolytic. Non-hemolytic. | |
| Pyrogenicity (Material Mediated Pyrogenicity) | Non-pyrogenic (total rise of rabbit temperatures within acceptable USP limits). | The total rise of rabbit temperatures during the 3-hour observation period was within acceptable USP limits. Non-pyrogenic. | |
| ISO Systemic Toxicity Testing Study in Mice | Non-toxic (no mortality or evidence of systemic toxicity). | No mortality or evidence of systemic toxicity from the extracts injected into mice. Non-toxic. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify a numerical sample size (e.g., number of devices, number of clots, number of anatomical models) for the bench tests. It refers to "devices" being tested. For biocompatibility, it refers to "a representative Tigertriever device."
- Data Provenance: The data is based on non-clinical (bench and in vitro) testing conducted by the manufacturer, Rapid Medical Ltd. The country of origin for the testing is not explicitly stated, but the manufacturer is based in Yokneam, Israel. The data is prospective in the sense that these tests were performed for this submission to demonstrate substantial equivalence.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- This information is not provided as the submission relies on non-clinical (bench) testing, not on human expert evaluation of images or clinical outcomes that would typically require ground truth establishment by experts.
- The simulated use test involved an "anatomical model," and the interpretation of its "effectiveness" would have been by the testers, not external experts establishing ground truth in the context of diagnostic performance.
4. Adjudication Method for the Test Set
- Again, this is not applicable as there was no clinical test set requiring expert adjudication. The tests described are engineering and chemical performance tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. The document explicitly states: "A clinical study was not deemed necessary to evaluate the modifications to the Tigertriever Revascularization Device." Therefore, no effect size of human readers improving with AI vs. without AI assistance can be reported.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- No, this entire submission is for a physical medical device (stentriever), not an AI algorithm. Therefore, "standalone" algorithm performance is not relevant.
7. The Type of Ground Truth Used
- For the bench tests, the "ground truth" is established by the physical and chemical properties of the device meeting predetermined engineering specifications and international standards (e.g., ISO 10555-1 for tensile strength, USP limits for pyrogenicity). For the simulated use, the "ground truth" is the observed successful performance (clot retrieval, flow restoration) in the in vitro model.
- For biocompatibility tests, the ground truth is based on recognized biological endpoints and standard testing methodologies (e.g., Grade 0 reactivity for cytotoxicity/sensitization, specific SC5b-9 concentrations, non-hemolytic results, acceptable temperature rise for pyrogenicity).
8. The Sample Size for the Training Set
- This is not applicable. The device is a physical stentriever, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- This is not applicable for the same reason as point 8.
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April 17, 2023
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
Rapid Medical Ltd. Orit Yaniv, Ph.D. VP RA/QA Carmel Building, P.O. Box 337 Yokneam, 2069205 Israel
Re: K230429
Trade/Device Name: Tigertriever 21 Revascularization Device, Tigertriever 17 Revascularization Device, Tigertriever 13 Revascularization Device Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: March 20, 2023 Received: March 20, 2023
Dear Orit Yaniv:
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
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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 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 -S
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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K230429
Device Name
Tigertriever 21 Revascularization Device, Tigertriever 17 Revascularization Device, Tigettriever 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)
| ☑ 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/0 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 of varying shades of green, arranged in a way that suggests movement or flow.
510(k) Summary
K230429
| Manufacturer/Sponsor: | Rapid Medical Ltd.Carmel Building, P.O. Box 337Yokneam, 2069205 Israel |
|---|---|
| Phone: +972-72-250-3331Facsimile: +972-72-250-3332 | |
| Contact: | Orit Yaniv, Ph.D.VP RA/QA+972-72-250-3331Orit@rapid-medical.com |
| Date Prepared: | April 12, 2023 |
| Device Trade Name: | Tigertriever 21 Revascularization Device, Tigertriever 17Revascularization Device, Tigertriever 13 Revascularization Device |
| Common/Usual Name: | Catheter, Thrombus Retriever |
| Classification: | 21 CFR 870.1250, Percutaneous Catheter |
| Class: | II |
| Product Code: | NRY |
| Predicate Devices: | Tigertriever and Tigertriever 17 Revascularization Device (K203592)Tigertriever 13 Revascularization Device (K220808) |
Indications for Use:
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.
Device Description:
The Tigertriever 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 mesh to 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 Revascularization Device is supplied sterile and is intended for single-use only by physicians trained in neurointerventional procedures and the treatment
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Image /page/4/Picture/0 description: The image shows the logo for Rapid Medical. The logo consists of a green abstract symbol on the left, followed by the words "Rapid Medical" in bold, dark gray font. The abstract symbol appears to be three curved lines that converge to a point on the right.
of ischemic stroke.
Comparison of Technological Characteristics with the Predicate Devices:
The Tigertriever 21, Tigertriever 17, Tigertriever 13 Revascularization Devices subject to this submission are substantially equivalent to the predicate devices, Tigertriever and Tigertriever 17 Revascularization Device (K203592) and Tigertriever 13 Revascularization Device (K220808), based on the same indications for use, device design, materials, manufacturing, packaging and sterilization methods, and similar technological characteristics. A comparison of the subject device with the predicate devices is summarized in Table 1 below.
| Predicate devices | Subject devices | |||||
|---|---|---|---|---|---|---|
| Device Name | Tigertriever TRPP7155 | Tigertriever 17 TRPP7166 | Tigertriever 13 TRPP7144 | Tigertriever 21 TRPP7155 | Tigertriever 17 TRPP7166 | Tigertriever 13 TRPP7144 |
| 510(k) Number | K203592 | K220808 | K230429 | |||
| Regulation No. | 21 CFR 870.1250 | Same | ||||
| Regulation Name | Percutaneous Catheter | Same | ||||
| Classification | Class II | Same | ||||
| Product Code | NRY | Same | ||||
| Indications for Use | 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. | Same | ||||
| Anatomical Location | Neurovasculature | Same | ||||
| Technological Characteristics | ||||||
| Mode of Operation | Manual expansion of the braided distal portion into the clot using the handle component | Same | ||||
| Design of Distal Portion | Close end braided nitinol mesh, manually expandable | Same | ||||
| Stent Length (un-expanded configuration) | 32 mm | 23 mm | 20.5 mm | 32 mm | 23 mm | 20.5 mm |
| Stent Size Distal OD (Unexpanded and Expanded Configuration) | Unexpanded configuration 1.5 mmExpanded configuration 6 mm | Unexpanded configuration 0.5 mmExpanded configuration 3 mm | Unexpanded configuration 0.5 mmExpanded configuration 2.5 mm | Unexpanded configuration 1.5 mmExpanded configuration 6 mm | Unexpanded configuration 0.5 mmExpanded configuration 3 mm | Unexpanded configuration 0.5 mmExpanded configuration 2.5 mm |
| Stent Structure | Braided fromtwelve (12)Niti DFT0.075 mmwires with atantalum core | Braided fromeight (8) NitiDFT 0.075 mmwires with atantalum core | Braided fromeight (8) NitiDFT 0.05 mmwires with aplatinum core | Braided fromtwelve (12) NitiDFT 0.075 mmwires with atantalum core | Braided fromeight (8) NitiDFT 0.075 mmwires with atantalum core | Braided fromeight (8) NitiDFT 0.05 mmwires with aplatinumcore |
| Overall Length(shaft+cable+mesh+tip) | 212 cm | 208 cm | 228 cm | 218 cm | 218 cm | 228 cm |
| FluorosafeMarkers on Shaft | No | Yes | ||||
| Compatibility | Microcatheterwith an internaldiameter of0.021 inches | Microcatheterwith an internaldiameter of0.017 inches | Microcatheterwith an internaldiameter of0.0165 inches | Microcatheterwith an internaldiameter of0.021 inches | Microcatheterwith an internaldiameter of0.0165 inches | Microcatheterwith an internaldiameter of0.0165 inches |
| Materials | ||||||
| Stent (mesh) | Nitinol | Same | ||||
| Markers | 90% Platinum/ 10% Iridium | Same | ||||
| Core wire (shaft) | Nitinol core wire and 304 Stainless Steel shaft | Same | ||||
| Introducer sheath | PTFE | Same | ||||
| Packaging | ||||||
| SterilizationMethod | Ethylene oxide | Same | ||||
| Single Use | Yes | Same | ||||
| Packaging | Placed into a Dispenser hoop, blister, Tyvek pouch,and Carton box | Same |
Table 1: Substantial Equivalence - Predicate Comparison
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Image /page/5/Picture/0 description: The image shows the logo for Rapid Medical. The logo consists of a green abstract symbol on the left, followed by the words "Rapid Medical" in a bold, dark gray font. The symbol appears to be three curved lines that converge to a point on the right.
The differences between the subject and predicate devices do not raise new questions of safety and effectiveness and are evaluated through the nonclinical testing referenced below.
Nonclinical Performance Testing:
Bench Tests:
Table2: Bench testing
| Performance Bench Testing | ||
|---|---|---|
| Test | Test Method Summary | Conclusions |
| Simulated use test | Simulated use testing of the TigertrieverRevascularization Device was performedin an anatomical model which simulatedthe tortuosity of the neurovasculature.Devices were delivered through thetortuous anatomical model to evaluatethe effectiveness of the device atretrieval of firm and soft clots. | The device was tested forhandling and clot retrieval in an in vitro tortuous path anatomicalmodel, which has been used in theevaluation of the predicate device.The subject device effectivelyretrieved clot and restored flow inthe test model. |
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Image /page/6/Picture/0 description: The image shows the logo for Rapid Medical. The logo consists of a green graphic on the left and the words "Rapid Medical" in bold, dark gray font on the right. The graphic is made up of three curved lines that converge to a point on the right.
| Durability | Damage was evaluated after delivery andwithdrawal of the device beyond therecommended number of passes andresheathings recommended in theinstructions for use. | Devices tested demonstrated nodamage after delivery andwithdrawal testing. Durabilityestablished acceptableperformance for 3 passes, whichis at least equivalent to thenumber of passes specified in thepredicate labeling (2 passes perdevice). |
|---|---|---|
| Delivery, deploymentand retrieval | The delivery, deployment and retrievalforces were measured during simulateduse of the subject device. | The device was tested fordelivery, deployment, andretrieval in an in vitro tortuouspath anatomical model, which hasbeen used in the evaluation of thepredicate device. The subjectdevice demonstrated acceptableperformance with respect todelivery, deployment andretrieval. |
| Dimensions test | Dimensional conformance tospecifications was confirmed. | The subject device dimensions arewithin the range of existingpredicate device dimensions. Theminor differences in dimensionsdo not affect performance, safetyor effectiveness. |
| Tensile test | The minimum force to break the subjectdevice was tested for the handle joint. | The tensile strength of the devicemet acceptance criteria based onrecognized standards (ISO 10555-1). |
| Particulate test | Particulate test was performed accordingto the light obscuration test method. | The particulate generated by thesubject device was similar to theparticulate generated by thepredicate device. |
Biocompatibility Testing:
Biocompatibility tests were repeated with a representative Tigertriever device that contains the new fluorosafe markers and shares the same overall design and materials as the three subject device models and represents the worst case in terms of biocompatibility.
All biocompatibility tests met the acceptance criteria.
Table3: Biocompatibility testing results and methodology
| Biological Endpoint | Test Results | Conclusion |
|---|---|---|
| Cytotoxicity | Pass. Grade 0 reactivity observed48 hours post exposure to testarticle extract. | Non-cytotoxic |
| Irritation (IntracutaneousReactivity) | Pass. Difference of overall meanscore between test article andcontrol was 0. | Non-irritant |
| Sensitization(Guinea Pig MaximizationTest) | Pass. Grade 0, no evidence ofcausing delayed dermal contactsensitization. | Does not elicit sensitization response |
| Hemocompatibility -Complement activation Assay | SC5b-9 concentration of the testarticle sample was statisticallyless than the positive control andwas not statistically higher than the | Pass |
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Image /page/7/Picture/0 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 black on the right. The abstract symbol appears to be three curved lines that converge.
| negative control. | ||
|---|---|---|
| Hemocompatibility -In Vitro Hemolysis | Both the test article in directcontact with blood and the testarticle extract were non-hemolytic. | Non-hemolytic |
| Pyrogenicity (MaterialMediated Pyrogenicity) | The total rise of rabbittemperatures during the 3-hourobservation period was withinacceptable USP limits. | Non-pyrogenic |
| ISO Systemic ToxicityTesting Study in Mice | No mortality or evidence ofsystemic toxicity from theextracts injected into mice. | Non-toxic |
Sterilization and Shelf Life:
The modifications to the Tigertriever Revascularization Device do not impact sterilization and established shelf-life of the product.
Clinical Testing:
A clinical study was not deemed necessary to evaluate the modifications to the Tigertriever Revascularization Device. Substantial equivalence of the subject devices has been established to the predicate devices through the results of nonclinical testing.
Conclusion:
The subject Tigertriever Revascularization Device has the same intended use, indications for use, principles of operation, and similar technological characteristics as the predicate devices. The technological differences of the subject Tigertriever Revascularization Device do not raise any new questions of safety or effectiveness. Performance data demonstrate that the subject Tigertriever 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).