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. Two versions of the device are available. The standard version Tigertriever (TRPP7155) has a net length of 32mm (unexpanded form) and it is delivered through a microcatheter with an internal diameter of 0.021 inches. The shorter version Tigertriever 17 (TRPP7166) has a net length of 23 mm (unexpanded form) and it is delivered through a microcatheter with an internal diameter of 0.017 inches. The Tigertriever is provided with a 3.5 Fr peelable loading sheath.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

The Tigertriever Revascularization Device's performance was evaluated against specific criteria established through a clinical trial (the TIGER study), with a performance goal derived from several other successful stroke device trials.

Table 1: Acceptance Criteria and Reported Device Performance

Endpoint	Acceptance Criteria (Performance Goal from Predicate Devices)	Reported Device Performance (TIGER Study)
Primary Effectiveness Endpoint:	Revascularization rate (mTICI ≥ 2b) of 60% or greater.	73% (108/148 patients)
Successful revascularization (mTICI ≥ 2b) after ≤ 3 passes of Tigertriever device		Lower Bound of 95% CI: 66.3%
Primary Safety Endpoint:	Composite of all-cause mortality at 90 days and/or symptomatic intracranial hemorrhage (sICH) within 24 hours (18-36 hours) of procedure of 30% or less.	17.7% (26/147 patients)
Composite of all-cause mortality at 90 days and/or sICH within 24 hours post-procedure		Upper Bound of 95% CI: 24.8%

Note: The document explicitly states that "the TIGER study was successfully met all pre-defined success criteria." The reported performance for both primary endpoints falls within the predefined acceptable ranges/thresholds.

Study Details for Device Performance

The clinical study conducted to demonstrate the device meets the acceptance criteria is the TIGER (Treatment with Intent to Generate Endovascular Reperfusion) clinical trial.

Sample Size used for the test set and the data provenance:
- Test Set Sample Size: 148 patients in the modified Intent-to-Treat (mITT) Cohort.
- Data Provenance: Not explicitly stated, but it is a multi-center clinical trial. Given the nature of medical device trials and FDA submissions, it would be considered prospective data collection. The document does not specify the country of origin of the data, but the sponsor is Rapid Medical Ltd. (Israel).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Ground Truth for Effectiveness (revascularization): The revascularization (mTICI scores) were adjudicated by a Core Laboratory. The number and specific qualifications of the experts within this Core Laboratory are not provided in this document.
- Ground Truth for Safety (sICH): The symptomatic intracranial hemorrhage (sICH) events were adjudicated by the Clinical Events Committee (CEC). The number and specific qualifications of the experts within this CEC are not provided in this document.
Adjudication method for the test set:
- Effectiveness (mTICI): Adjudicated by a Core Laboratory (specific method like 2+1 not detailed).
- Safety (sICH): Adjudicated by a Clinical Events Committee (CEC) (specific method like 2+1 not detailed).
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This document describes a clinical trial for a physical medical device (thrombus retriever), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study involving AI assistance for human readers was not performed or relevant in this context.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This device is a manual thrombus retriever, requiring direct human intervention and skill in its operation. There is no "algorithm only" performance component to be evaluated in a standalone manner.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Clinical Outcomes Data:
  - Revascularization (mTICI score): Based on angiographic imaging, adjudicated by a Core Laboratory (implies expert consensus).
  - Clinical Outcome (mRS ≤ 2 at 90 days): Direct patient outcome survey/assessment.
  - Safety (Mortality, sICH): Patient outcome data and clinical assessment, with sICH adjudicated by a Clinical Events Committee (implies expert consensus based on imaging and clinical presentation).
The sample size for the training set:
- As this is a physical medical device used for treatment and not an AI/machine learning algorithm, there is no concept of a "training set" in the typical sense. The "training" for the device's design and preclinical development would come from engineering principles, in vitro testing, and animal studies, rather than a data-driven training set.
How the ground truth for the training set was established:
- Not applicable as there is no "training set" in the context of an AI algorithm. The device's efficacy and safety were established through a combination of engineering design, non-clinical bench testing, pre-clinical animal testing, and finally, a human clinical trial.

Summary

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March 23, 2021

Rapid Medical Ltd. % Janice Hogan Partner Hogan Lovells US LLP 1735 Market Street, 23rd Floor Philadelphia, Pennsylvania 19103

Re: K203592

Trade/Device Name: Tigertriever and Tigertriever 17 Revascularization Device Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: February 19, 2021 Received: February 19, 2021

Dear Janice Hogan:

We have reviewed vour 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/cfpmp/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 mediation-emitting products, including information about labeling regulations, please see Device (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, Neurointerventiona1 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) K203592

Device Name

Tigertriever and Tigertriever 17 Revascularization Device

Indications for Use (Describe)

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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510(K) SUMMARY Tigertriever Revascularization Device K203592

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

March 23, 2021

Device Identification

Trade/Proprietary Name: Tigertriever and Tigertriever 17 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)

Solitaire 2 Revascularization Device (K141491)

Indication for Use Statement

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Device Description

Comparison of Technological Characteristics with the Predicate Device

The Tigertriever and the Solitaire 2 predicate have the same indications for use, similar technological characteristics and principle of operations. Both stentrievers share similar design and similar construction materials. Both devices are used to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke. Both stentrievers are delivered to the target vessel by means of a microcatheter and expanded once deployed from the microcatheter. The expansion of the subject device is controlled by the physician, while the predicate mesh is self-expanded to a fixed diameter upon deployment. However, this difference does not raise new questions of safety or effectiveness. A detailed comparison between the Tigertriever and the predicate device is provided in the table below.

	Tigertriever RevascularizationDevice	Solitaire 2 Revascularization Device(Predicate Device)
510(k) Number	K203592	K141491
Regulation	21 CFR 870.1250	21 CFR 870.1250
Product Code	NRY	NRY
	Tigertriever RevascularizationDevice	Solitaire 2 Revascularization Device(Predicate Device)
Indications forUse	The Tigertriever RevascularizationDevice is intended to restore bloodflow by removing thrombus from alarge intracranial vessel in patientsexperiencing ischemic strokewithin 8 hours of symptom onset.Patients who are ineligible forintravenous tissue plasminogenactivator (IV t-PA), or who fail IVt-PA therapy, are candidates fortreatment.	The Solitaire 2 RevascularizationDevice is intended to restore bloodflow by removing thrombus from alarge intracranial vessel in patientsexperiencing ischemic stroke within 8hours of symptom onset. Patients whoare ineligible for intravenous tissueplasminogen activator (IV t-PA) orwho fail IV t-PA therapy arecandidates for treatment.
AnatomicalLocation	Neurovasculature	Neurovasculature
SterilizationMethod	Ethylene oxide	Ethylene oxide
Single Use	Yes	Yes
Packaging	Placed into a Dispenser hoop,blister, Tyvek pouch, and Cartonbox	Placed into a Dispenser hoop, Tyvekpouch, and Carton box
Distal OD(expandedconfiguration)	3mm Tigertriever 176mm Tigertriever	4mm6mm
Stent length(unexpandedconfiguration)	23mm Tigertriever 1732mm Tigertriever	31mm
Overall length	200 cm	184 cm
Design of distalportion	Close end braided nitinol mesh,manually expandable	Open end laser cut stent, self-expanded
Mode ofoperation	Manual expansion of the braideddistal portion into the clot using thehandle component	Self-expansion of the distal stentportion into the clot followingretraction of the delivery catheter
Materials
Stent	Nitinol	Nitinol
Markers	90% Platinum/ 10% Iridium	90% Platinum/ 10% Iridium
	Tigertriever Revascularization Device	Solitaire 2 Revascularization Device (Predicate Device)
Core wire (shaft)	Nitinol core wire and stainless steel shaft	Nitinol wire
Push wire shrink tubing	PTFE	PTFE
Introducer Sheath	PTFE/Grilamid	PTFE

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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 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 (Intracutaneous Reactivity), Sensitization, Hemocompatibility, Pyrogenicity, Acute Systemic and Toxicity Testing. In addition, in vivo thrombogenicity was performed for the Tigertriever. Results of the biocompatibility testing indicate that Tigertriever revascularization device is biocompatible and is substantially equivalent for its intended use.

Biological Endpoint	Test Results	Conclusion
Cytotoxicity - ISOElution Method	Grade 0 reactivity observed 48 hourspost exposure to test article extract.	Non-cytotoxic
Irritation -Intracutaneous Reactivityin Rabbit	Difference of overall mean scorebetween test article and control was 0.	Non-irritant
Sensitization - GuineaPig Maximization Test	Grade 0, no evidence of causingdelayed dermal contact sensitization.	Does not elicitsensitizationresponse

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Biological Endpoint	Test Results	Conclusion
Hemocompatibility -Complement activationAssay	SC5b-9 concentration of the test articlesample was statistically lower than theactivated NHS control (p<0.05), andwas not statistically higher than thenegative control.	Pass
Hemocompatibility – InVitro Hemolysis	Test article = 0.0% hemolysis.	Non-Hemolytic
Pyrogenicity - MaterialMediated Pyrogenicity inRabbit	The total rise of rabbit temperaturesduring the 3-hour observationperiod was within acceptable USPlimits.	Non-pyrogenic
Systemic Toxicity -Systemic Toxicity Studyin Mice	No mortality or evidence of systemictoxicity from the extracts injectedinto mice.	Non-toxic
Thrombogenicity - AcutePre-Clinical Evaluationof the Safety ofTigertriever device in aSwine ModelThrombogenicity	Test device did not show higherthrombogenicity rate compared to thepredicate device.	Pass

Sterilization and Shelf Life

The device is sterilized by 100% Ethylene Oxide.

The shelf life testing for Tigertriever revascularization device has been conducted (T = 2.5 years) with test results confirmed that all acceptance criteria were met.

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 to support substantial equivalence of the device.

Performance Bench Testing
Test	Test Method Summary	Conclusions
Simulated use test	Simulated use testing of theTigertriever RevascularizationDevice was performed in an	The device was tested forhandling and clot retrieval inan in vitro tortuous path
Performance Bench Testing
Test	Test Method Summary	Conclusions
anatomical model which simulatedthe tortuosity of theneurovasculature. Devices weredelivered through the tortuousanatomical model to evaluate theeffectiveness of the device atretrieval of firm and soft clots.	anatomical model, which hasbeen used in the evaluation ofother similar devices. Thesubject device effectivelyretrieved clot and restored flowin the test model.
Radial force	The radial force of the subject devicewas measured within a range oflumen diameters applicable to theintended vasculature and comparedwith the radial forces measured forthe predicate devices.	The radial force of the subjectdevice when tested inapplicable lumen sizes iscomparable to the predicatedevice.
Durability	Damage was evaluated after deliveryand withdrawal of the device beyondthe recommended number of passesand resheathings recommended inthe instructions for use.	Devices tested demonstratedno damage after delivery andwithdrawal testing. Durabilityestablished acceptableperformance for 3 passes,which is at least equivalent tothe number of passes specifiedin the predicate labeling (2passes per device).
Delivery,deployment andretrieval	The delivery, deployment andretrieval forces were measuredduring simulated use of the subjectdevice.	The device was tested fordelivery, deployment, andretrieval in an in vitro tortuouspath anatomical model, whichhas been used in the evaluationof other similar devices. Thesubject device demonstratedacceptable performance withrespect to delivery,deployment and retrieval.
Torque strength	Devices were tracked through amicrocatheter in a tortuous pathanatomical model and evaluated fordamage following a number ofrotations with the distal endconstrained	The device demonstrated theability to withstand 5 rotationswithout damage. Like thepredicate device, rotationalmaneuvers are not expectedunder the intended conditions
Performance Bench Testing
Test	Test Method Summary	Conclusions
		of clinical use. Therefore, the
		results demonstrate acceptable
		torque strength.
Dimensions test	Dimensional inspection wastested per engineering drawings.	The subject device dimensionsare within the range of existingpredicate dimensions for thisdevice type. The minordifferences in dimensions donot affect performance, safetyor effectiveness.
Tip flexibility	Tip Flexibility was performed tomeasure the force required to deflectTigertriever tips to 90 degrees at7mm test lengths.	The subject device metacceptance criteria based oncomparable device used in thesame anatomy anddemonstrated similar tipflexibility.
Kink resistance	Tigertriever with ancillarymicrocatheter was looped aroundpost of calibrated kink measurementjig (0.25" diameter) about 50mmfrom the distal end of themicrocatheter.	Kink resistance was evaluatedunder conditions simulatinganatomic tortuosity,comparable to predicates, anddemonstrated acceptableperformance.
Tensile test	The minimum force to break theTigertriever was tested for all joints.	The tensile strength of thedevice met acceptance criteriabased on recognized standards(ISO 10555-1).
Particulates	Particulate test was performedaccording to the light obscurationtest method. Simulated use testing ofthe subject and predicate devices wasperformed in an anatomical model.Devices were flushed and the fluidwas evaluated for particle sizes of≥10, ≥25 and ≥50 $ μ $ m.	The particulate generated bythe subject device was similarto the particulate generated bythe predicate device.
Austenite Finish (Af)Temperature	The Active Af temperature wasdetermined from a graph ofdisplacement as a function of	The Af temperature of thedevice met acceptance criteria.
Performance Bench Testing
Test	Test Method Summary	Conclusions
Coating integrityassessment	temperature (Bend and FreeRecovery per ASTM F2082).	Results demonstrated nodamage to the coatingfollowing simulated use.
	The test was performed with the
	Comaneci device and not with the
	subject device (the design of the two
	device is the same in terms of the
	core wire mechanism). Damage to
	the PTFE core wire coating was
	evaluated following simulated use.
	Corrosion

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Pre-Clinical Animal Testing Data

The safety of the Tigertriever was demonstrated in a controlled animal study in domestic swine comparing the Tigertriever device and the predicate device. The results of the study showed substantial equivalence between the subject device and the predicate device.

The study included four animals; two animals were used for the acute stage (3 days period) and two animals were used for the chronic stage (30 days period). The study included two procedures: the first procedure was performed on day zero (3 or 30 days before the animal was sacrificed), and the second procedure was performed on the sacrifice day (day 30).

The first procedure included simulation (both for test device and predicate device) at two sites in the femoral artery, each simulation included three passes, first pass with clot removal, and two additional passes without clot (total three device delivery and retrieval simulations at each site of the femoral artery). No damage was observed by angiography during procedure in the subject device and the predicate device treated sites, no safety related abnormalities were observed by the veterinarian and no abnormal gross findings were recorded for external surface, orifices, cavities, or muscles and tissues downstream of the femoral arteries. In addition, the histology evaluations of the arterial tested sites revealed a comparable range of observations for the subject and predicate devices.

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The second procedure was performed on the study termination day before the animal was sacrificed. To evaluate the thrombogenicity of the subject and predicate device, the tested unit was inserted to the renal artery in one side of the kidney and deployed for 10 minutes, then an additional two passes were performed, resulting in a total of 30 minutes for each device. Thrombogenicity scores revealed comparable values for the subject and predicate devices; kidney microscopic and histology evaluations revealed comparable range of observations for the subject and predicate devices.

In conclusion, the animal study showed that thrombectomy using the Tigertriever was safe without evidence of vessel injuries or abnormal thrombogenicity. Clinical, angiographic, pathologic, and histologic data supported a similar safety profile between the Tigertriever and the Solitaire predicate.

Clinical Study

The TIGER (Treatment with Intent to Generate Endovascular Reperfusion) clinical trial assessed the efficacy and safety of the Tigertriever Revascularization Device against a performance goal derived from the TREVO 2, SWIFT, MR CLEAN, ESCAPE, REVASCAT and SWIFT PRIME clinical trials. Key inclusion criteria were: patients with a large-vessel occlusion who could be treated within 8 hours of stroke symptom onset; age 18-85; 8_NIHSS_29; angiographic confirmation of an occlusion of an ICA, MCA, M1 or M2, vertebral or basilar arteries, and IV t-PA, if used, was initiated within 3 hrs of stroke onset. Key exclusion criteria were: angiographically evident excessive arterial tortuosity, stenosis, or any occlusion, in a proximal vessel that required treatment or would prevent access to the site of occlusion.

One hundred and sixty (160) patients signed informed consent, treated with the Tigertriever device and included in the study. Of these. 148 patients met all inclusion and exclusion criteria as requested by FDA for the modified Intent-to-Treat (mITT) Cohort. Among the 12 patients excluded to meet the FDA defined mITT criteria, 1 had excessive arterial tortuosity, 2 had prior recent stroke in the past 3 months, 1 had a 100% occluded vessel which required stenting, 2 did not meet the criteria around laboratory ranges, 1 was given IV t-PA initiated >3 hours from symptom onset, 1 was treated with mRS 3, 2 missing pregnancy test, 1 was treated with the device over 8 hours from symptom onset, and 1 was treated with an aspiration device prior to the Tigertriever. Per FDA's request, within this mITT cohort, use of rescue therapy at any point in the procedure was imputed as a failure for the revascularization and clinical outcome endpoints. The table below summarizes the effectiveness and safety outcomes of this cohort.

The Primary Effectiveness Endpoint was successful revascularization defined as an mTICI score of at least 2b in the target vessel, following three or less passes of the Tigertriever device, using Core Laboratory adjudicated data. The Primary Safety Endpoint defined as the composite

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of all-cause mortality at 90 days and/or symptomatic intracranial hemorrhage (sICH) within 24 (18-36) hours of the study procedure. The Primary Safety Endpoint was adjudicated by the Clinical Events Committee (CEC).

TIGER Study ResultsEffectiveness and Safety Results for use of only Tigertriever
Endpoint	mITT (N=148)
Successful revascularization rate after Tigertrievertreatment1 -Patients with mTICI ≥2b, n (%)	108/148 (73%)
Lower Bound of 95% CI	66.3%
Secondary Effectiveness Endpoints
Successful revascularization rate after first pass withTigertriever - patients with mTICI ≥ 2bn (%)	mITT (N=148)81 (54.7%)
Good Clinical Outcome:mRS ≤2 at 90 days2n, (%)	N= 14881/148 (54.7%)
Patient Reported Outcomes: EQ5D at 90 days3	N= 107
Mean (SD)	73.5 (21.8)
Median	80
25th to 75th	62.5,90
Patient Reported Outcomes: ALDS at 90 days3	N= 109
Mean (SD)	11.1 (4.5)
Median	13.0
25th to 75th	8,15
Primary Composite Safety Endpoint
Endpoint	mITT (N=147)4
Mortality at 90 Days and/or sICH at 24 Hours postprocedure4	26 (17.7%)
Upper Bound of 95% CI	24.8%
Mortality at 90 Days4	26 (17.7%)
sICH at 24 Hours post procedure5	3 (2.0%)
Secondary Safety Endpoints
Endpoint	mITT (N=147)6
Total Asymptomatic ICH at 24 Hours (%), n (%)	47 (31.9%)
HI-1	18 (12.2%)
HI-2	12 (8.8%)
PH-1	0
PH-2	2 (1.4%)
SAH	11 (7.5%)
SAH and HI-2	2 (1.4%)
SAH and PH-2	1 (0.7%)
Neurological Deterioration at 24 Hours, n (%)	13 (8.8%)
Embolization to New Territory at End of Procedure, n(%)	4 (2.7%)

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1 Use of rescue therapy at any point in the procedure was imputed as a failure to achieve the endpoint.
There were 12 cases imputed as failure.
2 Five patients had missing 90 days mRS and were imputed as a failure to achieve the endpoint.
3 Sample sizes vary due to missing data at 90 days.
4 Reduced sample size due to one patient who withdrew consent prior to the 90 d follow up visit.
5 All 3 subjects with sICH at 24 hours post-procedure died.
6 Reduced sample size due to missing 24 hour CT or final angiogram.

Definitions:

mRS:	modified Rankin Score.
EQ5D:	EuroQol Five Dimensions.
ALDS:	Academic Medical Center Linear Disability Score.
SICH:	symptomatic Intracranial Hemorrhage, any parenchymal hematoma type 2, remote intracerebral hemorrhage, subarachnoid hemorrhage, or intraventricular hemorrhage that is the predominant cause of ≥4 points NIHSS deterioration at 24 hours.
HI:	Hemorrhagic Infarction.
PH:	Parenchymal Hematoma.
SAH:	Subarachnoid Hemorrhage.

TIGER Summary of Serious Adverse Events (SAEs)

One hundred and sixty-five (165) SAE occurred within all the study population, all patients enrolled and treated with Tigertriever. The table below summarizes the frequency of the SAEs classified by System Organ.

System Organ Class (SOC)	All(165 Events)
Blood and lymphatic system disorders	3 (1.8%)
Cardiac disorders	22 (13.3%)
Gastrointestinal disorders	6 (3.6%)
General disorders and administration site conditions	2 (1.2%)
Infections and infestations	11 (6.7%)
Injury, poisoning and procedural complications	12 (7.3%)
Injury, poisoning and procedural complications Vascular disorders	1 (0.6%)
Investigations	3 (1.8%)
Metabolism and nutrition disorders	3 (1.8%)
Musculoskeletal and connective tissue disorders Psychiatric disorders	1 (0.6%)
Nervous system disorders	40 (24.2%)
Nervous system disorders Injury, poisoning and procedural complications	1 (0.6%)
Nervous system disorders Nervous system disorders	1 (0.6%)
Nervous system disorders Surgical and medical procedures	1 (0.6%)
Psychiatric disorders	1 (0.6%)
Renal and urinary disorders	4 (2.4%)
Reproductive system and breast disorders	1 (0.6%)

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System Organ Class (SOC)	All(165 Events)
Respiratory, thoracic and mediastinal disorders	25 (15.2%)
Skin and subcutaneous tissue disorders	1 (0.6%)
Surgical and medical procedures	2 (1.2%)
Vascular disorders	24 (14.5%)

To conclude, the TIGER study was successfully met all pre-defined success criteria. Based on the results of this clinical study, the Tigertriever device, when used for the revascularization in ischemic stroke due to LVOs, has reperfusion rates and a safety profile similar to alternative devices. Therefore, the clinical data support the substantial equivalence.

Statement of Substantial Equivalence

The Tigertriever device has the same intended use and indications for use, and similar technological characteristics compared to the Solitaire 2 predicate device. The differences in technological characteristics between the Tigertriever and the predicate device were evaluated in bench, animal and clinical testing as discussed above and do not raise different questions regarding the safety and effectiveness and demonstrate similar performance and safety characteristics between the Tigertriever and predicate device. Therefore, the results from these tests support the conclusion that the Tigertriever device is substantially equivalent to the predicate device.

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).