(129 days)
No
The description focuses on the mechanical design and function of a stentriever device for clot removal, with no mention of AI or ML capabilities.
Yes
The device is intended to treat a medical condition (ischemic stroke) by removing thrombus, which directly addresses disease and aims to restore normal physiological function (blood flow).
No
This device is a therapeutic revascularization device (stentriever) used to remove blood clots in patients experiencing ischemic stroke. Its purpose is to restore blood flow, not to diagnose a condition.
No
The device description clearly outlines a physical, hardware-based medical device (stentriever) comprised of materials like nitinol, stainless steel, and a handle, intended for mechanical thrombus removal. It is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "restore blood flow by removing thrombus from a large intracranial vessel." This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a "stentriever" designed to physically interact with and remove a clot within a blood vessel. This is a medical device used for treatment.
- Lack of Diagnostic Elements: There is no mention of the device analyzing biological samples (blood, tissue, etc.) or providing information about a patient's health status based on such analysis.
- Performance Studies: The performance studies focus on the device's mechanical function, safety, and ability to remove clots in a model and animal setting. They do not involve diagnostic metrics like sensitivity, specificity, or AUC, which are typical for IVDs.
In summary, the Tigertriever Revascularization Device is a therapeutic medical device used for the treatment of ischemic stroke, not a diagnostic device.
N/A
Intended Use / 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.
Product codes
NRY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Neurovasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physicians trained in neuro-interventional catheterization and the treatment of ischemic stroke.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Data:
- Biocompatibility: Based on Comaneci Embolization Assist Device (DEN170064) due to shared manufacturing. Tests included Cytotoxicity, Irritation, Sensitization, Hemocompatibility, Pyrogenicity, Acute Systemic Toxicity, and in vivo thrombogenicity (for Tigertriever model). All tests showed acceptable results (non-cytotoxic, non-irritant, no sensitization, pass hemocompatibility, non-pyrogenic, non-toxic, and thrombogenicity comparable to predicate).
- Sterilization and Shelf life: Sterilized by 100% Ethylene Oxide, supports 2.5-year shelf life.
- Bench Tests:
- Simulated use test: Performed in an in vitro tortuous path anatomical model. The device effectively retrieved clot and restored flow.
- Radial force: Measured within 1.5mm and 2.5mm diameters, comparable to predicate device.
- Durability: No damage after delivery and withdrawal testing; established acceptable performance for 3 passes.
- Delivery, deployment and retrieval: Demonstrated acceptable performance in an in vitro tortuous path anatomical model.
- Torque strength: Withstood 5 rotations without damage.
- Dimensions test: Conformance to specifications, minor differences from predicate do not affect performance/safety/effectiveness.
- Tip flexibility: Met acceptance criteria.
- Kink resistance: Demonstrated acceptable performance under simulated anatomic tortuosity.
- Tensile test: Met acceptance criteria based on ISO 10555-1.
- Particulates: Particulate generation similar to predicate device.
- Austenite Finish (Af) Temperature: Met acceptance criteria.
- Coating integrity assessment: No damage to PTFE core wire coating observed after simulated use (performed with Comaneci device).
- Corrosion: No corrosion observed (performed with Comaneci device), met acceptance criteria based on ISO 10555-1.
Pre-Clinical Animal Testing Data:
- Study Type: Two pre-clinical studies (sub-acute and 30-day chronic time points) in a swine model.
- Sample Size: Not explicitly stated, but "animals were assessed" and "in each tested vessel three passes were performed."
- Key Results: Full reperfusion demonstrated in all procedures. No evidence of vessel damage (dissection, perforation, clot formation) related to device deployment. Histopathological assessment considered acceptable. Device demonstrated acceptable safety and clot retrieval performance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
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July 25, 2022
Image /page/0/Picture/1 description: The image contains 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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
2
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA)Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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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 Revascularization
Device (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 Revascularization
Device (TRPP7166)
(Predicate device) | Tigertriever 13 Revascularization Device
(TRPP7144)
(Subject device) |
| 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. | 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. |
| Anatomical Location | Neurovasculature | Neurovasculature |
| Technological Characteristics | | |
| Mode of operation | Manual expansion of the braided distal
portion into the clot using the handle
component | Manual expansion of the braided distal
portion into the clot using the handle
component |
| Design of distal
portion | Close end braided nitinol mesh,
manually expandable | Close end braided nitinol mesh, manually
expandable |
| Stent length (un-
expanded
configuration) | 23mm | 20.5mm |
| Stent size Distal OD
(unexpanded and
expanded
configuration) | Unexpanded configuration 0.5mm
Expanded configuration 3mm | Unexpanded configuration 0.5mm
Expanded configuration 2.5mm |
| Stent structure | Braided from eight (8) Niti DFT 0.075
mm wires with a tantalum core | Braided from eight (8) Niti DFT 0.05 mm
wires with a platinum core |
| Overall length | 228 cm
(shaft+cable+mesh+tip) | 208 cm
(shaft+cable+mesh+tip) |
| Compatibility | Microcatheter with an internal diameter
of 0.017 inches | Microcatheter with an internal diameter of
0.0165 inches |
| Materials | | |
| Stent (mesh) | Nitinol | Nitinol |
| Markers | 90% Platinum/ 10% Iridium | 90% Platinum/ 10% Iridium |
| Core wire (shaft) | Nitinol core wire and 304 Stainless Steel
shaft | Nitinol core wire and 304 Stainless Steel
shaft |
| Introducer sheath | PTFE | PTFE |
| Packaging | | |
| Sterilization Method | Ethylene oxide | Ethylene oxide |
| | Tigertriever 17 Revascularization
Device (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/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 Elution | ||
| Method | Grade 0 reactivity observed 48 hours post | |
| exposure to test article extract. | Non-cytotoxic | |
| Irritation – Intracutaeous | ||
| Reactivity in Rabbit | Difference of overall mean score between test | |
| article and control was 0. | Non-irritant | |
| Sensitization – Guinea Pig | ||
| Maximization Test | Grade 0, no evidence of causing delayed dermal | |
| contact sensitization. | Does not elicit | |
| sensitization response | ||
| Hemocompatibility – | ||
| Complement Activation Assay | SC5b-9 concentration of the test article sample | |
| was statistically lower than the activated NHS | ||
| control (p |