Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the mechanical design and function of a stentriever device, with no mention of AI or ML capabilities.

Therapeutic

Yes.
The device is intended to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke, which makes it a therapeutic device.

Diagnostic

No

The device is intended to treat ischemic stroke by removing thrombus, which is a therapeutic intervention, not a diagnostic one.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components like a nitinol braided mesh, stainless steel shaft, nitinol core wire, and a handle, indicating it is a hardware device.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
Device Function: The Tigertriever Revascularization Device is a therapeutic device used to physically remove a blood clot from a blood vessel within the body. It is an interventional device used during a medical procedure.
Intended Use: The intended use clearly states it's for "restor[ing] blood flow by removing thrombus from a large intracranial vessel." This is a treatment, not a diagnostic test.
Device Description: The description details a physical device (stentriever) designed for mechanical action within the body.
Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information.

Therefore, based on the provided information, the Tigertriever Revascularization Device is a medical device used for treatment, not an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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 (comma separated list FDA assigned to the subject device)

NRY

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 of ischemic stroke.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Fluoroscopy

Anatomical Site

large intracranial vessel (Neurovasculature)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Physicians trained in neurointerventional procedures 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)

Bench Tests:

Simulated use test: Simulated use testing of the Tigertriever Revascularization Device was performed in an anatomical model which simulated the tortuosity of the neurovasculature. Devices were delivered through the tortuous anatomical model to evaluate the effectiveness of the device at retrieval of firm and soft clots. Conclusion: 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: Damage was evaluated after delivery and withdrawal of the device beyond the recommended number of passes and resheathings recommended in the instructions for use. Conclusion: 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: The delivery, deployment and retrieval forces were measured during simulated use of the subject device. Conclusion: 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 was confirmed. Conclusion: 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: The minimum force to break the subject device was tested for the handle joint. Conclusion: The tensile strength of the device met acceptance criteria based on recognized standards (ISO 10555-1).
Particulate test: Particulate test was performed according to the light obscuration test method. Conclusion: The particulate generated by the subject device was similar to the particulate generated by the predicate device.

Biocompatibility Testing:

Cytotoxicity: Pass. Grade 0 reactivity observed 48 hours post exposure to test article extract. Conclusion: Non-cytotoxic.
Irritation (Intracutaneous Reactivity): Pass. Difference of overall mean score between test article and control was 0. Conclusion: Non-irritant.
Sensitization (Guinea Pig Maximization Test): Pass. Grade 0, no evidence of causing delayed dermal contact sensitization. Conclusion: Does not elicit sensitization response.
Hemocompatibility - Complement activation Assay: SC5b-9 concentration of the test article sample was statistically less than the positive control and was not statistically higher than the negative control. Conclusion: Pass.
Hemocompatibility - In Vitro Hemolysis: Both the test article in direct contact with blood and the test article extract were non-hemolytic. Conclusion: Non-hemolytic.
Pyrogenicity (Material Mediated Pyrogenicity): The total rise of rabbit temperatures during the 3-hour observation period was within acceptable USP limits. Conclusion: Non-pyrogenic.
ISO Systemic Toxicity Testing Study in Mice: No mortality or evidence of systemic toxicity from the extracts injected into mice. Conclusion: Non-toxic.

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.

K203592, K220808

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.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).

Summary

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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

1

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 337
Yokneam, 2069205 Israel |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------|
| | Phone: +972-72-250-3331
Facsimile: +972-72-250-3332 |
| Contact: | Orit Yaniv, Ph.D.
VP RA/QA
+972-72-250-3331
Orit@rapid-medical.com |
| Date Prepared: | April 12, 2023 |
| Device Trade Name: | Tigertriever 21 Revascularization Device, Tigertriever 17
Revascularization 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 mm

Expanded configuration 6 mm | Unexpanded configuration 0.5 mm

Expanded configuration 3 mm | Unexpanded configuration 0.5 mm

Expanded configuration 2.5 mm | Unexpanded configuration 1.5 mm

Expanded configuration 6 mm | Unexpanded configuration 0.5 mm

Expanded configuration 3 mm | Unexpanded configuration 0.5 mm

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 Tigertriever
Revascularization Device was performed
in an anatomical model which simulated
the tortuosity of the neurovasculature.
Devices were delivered through the
tortuous anatomical model to evaluate
the effectiveness of the device at
retrieval of firm and soft clots.	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.

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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 and
withdrawal of the device beyond the
recommended number of passes and
resheathings recommended in the
instructions for use. | 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 | The delivery, deployment and retrieval
forces were measured during simulated
use of the subject device. | 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 was confirmed. | 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 | The minimum force to break the subject
device was tested for the handle joint. | The tensile strength of the device
met acceptance criteria based on
recognized standards (ISO 10555-
1). |
| Particulate test | Particulate test was performed according
to the light obscuration test method. | The particulate generated by the
subject device was similar to the
particulate generated by the
predicate 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 observed
48 hours post exposure to test
article extract.	Non-cytotoxic
Irritation (Intracutaneous
Reactivity)	Pass. Difference of overall mean
score between test article and
control was 0.	Non-irritant
Sensitization
(Guinea Pig Maximization
Test)	Pass. 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
less than the positive control and
was not statistically higher than the	Pass

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	negative control.
Hemocompatibility -
In Vitro Hemolysis	Both the test article in direct
contact with blood and the test
article extract were non-
hemolytic.	Non-hemolytic
Pyrogenicity (Material
Mediated Pyrogenicity)	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	No mortality or evidence of
systemic toxicity from the
extracts 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.