The pRESET LITE Thrombectomy Device is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion, and smaller core infarcts who have first received thrombolytic therapy. Endovascular therapy with the device should be started within 6 hours of symptom onset.
The pRESET LITE Thrombectomy Device is indicated 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 thrombolytic therapy or who fail thrombolytic therapy are candidates for treatment.

Device Description

The pRESET® LITE Thrombectomy Device is designed to restore blood flow in the neurovasculature by mechanical removal of thrombus in patients experiencing acute ischemic stroke due to large vessel occlusion with thrombus. The device is designed for use in large vessels of the neurovasculature such as the internal carotid artery (ICA) and the middle cerebral artery (MCA). The device is supplied sterile and intended for single use only.

AI/ML Overview

The provided document is a 510(k) summary for the phenox pRESET LITE Thrombectomy Device. It details the device's indications for use, comparison to a predicate device, and performance data to support substantial equivalence.

Based on the nature of this document (a 510(k) summary for a thrombectomy device), it does not describe a study involving an AI/Machine Learning device that requires a test set, ground truth experts, or MRMC studies. The performance data presented are for bench testing and biocompatibility, which are typical for physical medical devices, not AI software.

Therefore, many of the requested criteria such as "Sample sized used for the test set", "Number of experts used to establish the ground truth", "Adjudication method", "MRMC comparative effectiveness study", "Standalone performance", "Type of ground truth used", "Sample size for the training set", and "How the ground truth for the training set was established" are not applicable to this document's content.

The document explicitly states:

"No animal testing was required to support substantial equivalence."
"No clinical testing was required to support substantial equivalence."

This confirms that the assessment relies on non-clinical (bench) performance data and a comparison to a predicate device, rather than data from human or animal studies with clinical endpoints or AI performance metrics.

However, I can extract the acceptance criteria and reported device performance from the "Non-Clinical Performance Data - Bench" section.

Acceptance Criteria and Reported Device Performance (as extrapolated from Bench Testing)

The document primarily relies on engineering and material science-based acceptance criteria for a physical medical device. The "Conclusions" column in Table 5 serves as the reported device performance, indicating a "Pass" for each test, implying the acceptance criteria were met.

Table of Acceptance Criteria and the Reported Device Performance:

Test Name	Acceptance Criteria (Inferred from Description)	Reported Device Performance
Simulated Use	It shall be possible to safely and reliably prepare, deploy and retract the device in a nominal and worst-case 3D model as described in the instructions for use without damage to the device.	Pass
Simulated Clot Retrieval	It shall be possible to retrieve synthetic clots from a 3D neurovascular model as described in the instructions for use.	Pass
Kink Resistance	It shall be possible to deploy the device to the intended location without kinking of the device.	Pass
Dimensional Verification	Expanded outer diameter (OD), Retriever device length, Working length of retrieval device, Effective length of retrieval device, Diameter of heat shrink, Uncovered length, Marker position, System length shall meet specified dimensions.	Pass
Radial Force	The relative Chronic Outward Force (RCOF) in the labeled vessel diameters must meet acceptance criteria.	Pass
Austenitic Finish (Af) Transition Temperature	The Af transition temperature shall be appropriate for clinical use.	Pass
Radiopacity	Proximal and distal ends of the retrieval device must be radiopaque.	Pass
System Surface Finish	The external surface of the effective length of the device shall appear free from extraneous matter, process and surface defects.	Pass
Device Deployment	It shall be possible to safely and reliably deploy the device as described in the instructions for use without damage to the device.	Pass
Retraction into the Microcatheter	It shall be possible to advance a representative microcatheter over the deployed device, at the site of deployment, until it is fully contained within the inner lumen of the microcatheter without damage to the device.	Pass
Delivery and Re-sheathing Forces	The maximum delivery and re-sheathing forces measured during simulated use clinical conditions must meet acceptance criteria.	Pass
Re-Sheathing	It shall be possible to re-sheath the device, as described in the instructions for use, after it has been prepared, deployed and retracted as described in the instructions for use.	Pass
System Tensile Strength	The minimum tensile strength of the thrombectomy system is evaluated to the acceptance criteria.	Pass
Torque Strength	The system must not break after 3 full rotations of the insertion wire.	Pass
Ancillary Device Compatibility	The device shall be compatible with ancillary devices as listed in the Directions for Use (DFU).	Pass

Sample sized used for the test set and the data provenance: Not applicable. This document describes physical bench testing for a mechanical device, not a data-driven AI model.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical medical device's bench testing is typically established by engineering specifications and objective measurements, not expert consensus readouts.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This is for a mechanical thrombectomy device, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the performance data presented, the "ground truth" (or acceptance criteria) is based on engineering specifications, standardized test methods (e.g., ASTM, ISO), and performance expectations for a physical medical device in simulated environments.
The sample size for the training set: Not applicable. This is a physical device, not an AI model.
How the ground truth for the training set was established: Not applicable.

Summary

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October 21, 2023

Image /page/0/Picture/1 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

phenox Limited Rachel McDaid Senior Regulatory Affairs Specialist Kamrick Court, Ballybrit Business Park, Galway H91 XY38, Ireland

Re: K231539

Trade/Device Name: pRESET LITE Thrombectomy Device Regulation Number: 21 CFR 882.5600 Regulation Name: Neurovascular Mechanical Thrombectomy Device for Acute Ischemic Stroke Treatment Regulatory Class: Class II Product Code: POL, NRY Dated: September 22, 2023 Received: September 22, 2023

Dear Rachel McDaid:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 -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 Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K231539

Device Name pRESET LITE Thrombectomy Device

Indications for Use (Describe)

The pRESET LITE Thrombectomy Device is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion, and smaller core infarcts who have first received thrombolytic therapy. Endovascular therapy with the device should be started within 6 hours of symptom onset.
The pRESET LITE Thrombectomy Device is indicated to restore blood flow by removing thrombus from a large intracranial vessel in patients experienciscone within 8 hours of symptom onset. Patients who are ineligible for thrombolytic therapy or who fail thrombolytic therapy are candidates for treatment.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary (21 CFR 807.92)

K231539

I. SUBMITTER

phenox Limited,
Kamrick Court
Ballybrit Business Park,
Galway, Ireland,
H91 XY38.

Primary Correspondent Name:	Rachel McDaid
Title:	Regulatory Affairs Specialist
Phone:	+353 91 740 100
Email:	rachel.mcdaid@wallabyphenox.com
Secondary Correspondent Name:	Emily Dobosz
Title:	Senior Manager of Regulatory Affairs
Phone:	+353 91 740 100

Date Prepared: 20th October 2023

II. DEVICE

Email:

Device Trade Name: pRESET® LITE Thrombectomy Device Common or Usual Name: Neurovascular Mechanical Thrombectomy Device for Acute Ischemic Stroke Treatment; Catheter, Thrombus Retriever Classification: Class II device according to 21 CFR 882.5600; 21 CFR 870.1250 Product Code: POL, NRY Review Panel: Neurology

emily.dobosz@wallabyphenox.com

III. PREDICATE DEVICE Device Name: pRESET® Thrombectomy Device Manufacturer: phenox Limited 510(k) Number: K222848

IV. DEVICE DESCRIPTION

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Materials of Use: See table below for details of the materials used in the construction of the pRESET® LITE Thrombectomy Device.

Component	Material
Retrieval Structure	Nitinol
Push-Wire	Nitinol
Connector Shell	Nitinol
Marker coils	Platinum/Iridium
Shrink Tubing	PTFE
Introducer Sheath	HDPE

Table 1: Materials used in the construction of the pRESET® LITE Thrombectomy Device

V. INDICATIONS FOR USE

Comparison of Indications for Use for the pRESET ® LITE Thrombectomy Device and predicate device pRESET® Thrombectomy Device.

Parameter	Predicate Device (K222848)	Subject Device (K231539)
	pRESET® Thrombectomy Device	pRESET® LITE Thrombectomy Device
Indications for Use	1. The pRESET Thrombectomy Device isindicated for use to restore blood flow in theneurovasculature by removing thrombus forthe treatment of acute ischemic stroke toreduce disability in patients with a persistent,proximal anterior circulation, large vesselocclusion, and smaller core infarcts who havefirst received thrombolytic therapy.Endovascular therapy with the device shouldbe started within 6 hours of symptom onset.2. The pRESET Thrombectomy Device isindicated to restore blood flow by removingthrombus from a large intracranial vessel inpatients experiencing ischemic stroke within8 hours of symptom onset. Patients who areineligible for thrombolytic therapy or who failthrombolytic therapy are candidates fortreatment.	1. The pRESET LITE Thrombectomy Device isindicated for use to restore blood flow in theneurovasculature by removing thrombus forthe treatment of acute ischemic stroke toreduce disability in patients with a persistent,proximal anterior circulation, large vesselocclusion, and smaller core infarcts who havefirst received thrombolytic therapy.Endovascular therapy with the device shouldbe started within 6 hours of symptom onset.2. The pRESET LITE Thrombectomy Device isindicated to restore blood flow by removingthrombus from a large intracranial vessel inpatients experiencing ischemic stroke within 8hours of symptom onset. Patients who areineligible for thrombolytic therapy or who failthrombolytic therapy are candidates fortreatment.

Table 2: Indications for Use for the pRESET® LITE Thrombectomy Device and pRESET® Thrombectomy Device

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VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

Table 3. Comparison of technological characteristics of the pRESET® LITE Thrombectomy Device and pRESET® Thrombectomy Device

Parameter	Predicate Device	Subject Device
Trade Name	pRESET® Thrombectomy Device	pRESET® LITE Thrombectomy Device
510(k) Number	K222848	K231539
Product Classification	II	II
ClassificationRegulation	21 CFR 882.5600,21 CFR 870.1250	21 CFR 882.5600,21 CFR 870.1250
Product Code	POL, NRY	POL, NRY
Principle of Operation	The device is used in the neurovasculature to restore blood flow for treatment of acute ischemic stroke.	The device is used in the neurovasculature to restore blood flow for treatment of acute ischemic stroke.
Device Sizes	4x20mm5x40mm6x30mm	4x20mm3x20mm
Materials	Retrieval Structure- NitinolMarkers- Platinum/IridiumPush Wire- Stainless SteelShrink Tubing- PTFE	Retrieval Structure- NitinolMarkers- Platinum/IridiumPush Wire- NitinolShrink Tubing- PTFE
Use	Sterile, Single Use	Sterile, Single Use
Sterilization Method	Ethylene Oxide	Ethylene Oxide
Packaging	Stored within dispenser coil,Tyvek pouch, and shipping carton.	Stored within dispenser coil,Tyvek pouch, and shipping carton.

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VII. PERFORMANCE DATA

BIOCOMPATIBILITY

Biocompatibility testing was conducted based on International Organization for Standardization (ISO) 10993-1:2018: "Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process" and the US FDA guidance document "Use of International Standard ISO 10993, 'Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process" (2020). Results confirmed the pRESET® LITE Thrombectomy Device is biocompatible.

The biocompatibility evaluation of the pRESET® LITE Thrombectomy Device included relevant data sources related to component material history of safe biological use and testing, and where applicable, safe previous use in previously cleared product and testing. In addition, Table 4 below summarizes testing performed on the pRESET® LITE Thrombectomy Device.

Biological Effect	Test Name	Conclusions
Cytotoxicity	ISO MEM elution - L929 fibroblastcultures method	Non-cytotoxic
Hemocompatibility	Hemolysis (ASTM Method) directcontact	No hemolysis indicated
Hemocompatibility	Hemolysis (ASTM Method) indirectextract	No hemolysis indicated

Table 4. Biocompatibility Test Results for the pRESET® LITE Thrombectomy Device

STERILIZATION

The pRESET® LITE Thrombectomy Device is sterilized by Ethylene Oxide gas. The sterilization cycle has been validated to ensure a sterility assurance level (SAL) of 10° in accordance with the EN ISO 11135:2014 & A1:2019 and AAMI TIR28:2016.

SHELF LIFE

Aging studies have established the pRESET® LITE Thrombectomy Device packaging remains functional and maintains sterility for up to 3 years. Aging studies for packaging integrity, seal strength and device functionality were performed and met acceptance criteria.

NON-CLINICAL PERFORMANCE DATA

Non-clinical testing was completed to support the substantial equivalence determination to the predicate. The tests are summarized below.

Performance Testing - Bench

The following bench testing was performed to support substantial equivalence.

Table 5. Performance Test Results for the pRESET® LITE Thrombectomy Device

Test Name	Description	Conclusions
Simulated Use	It shall be possible to safely and reliably prepare, deploy andretract the device in a nominal and worst-case 3D model asdescribed in the instructions for use without damage to thedevice.	Pass
Simulated ClotRetrieval	It shall be possible to retrieve synthetic clots from a 3Dneurovascular model as described in the instructions for use.	Pass
Kink Resistance	It shall be possible to deploy the device to the intendedlocation without kinking of the device.	Pass
DimensionalVerification	Expanded outer diameter (OD)Retriever device lengthWorking length of retrieval deviceEffective length of retrieval deviceDiameter of heat shrinkUncovered lengthMarker positionSystem length	Pass
Radial Force	The relative Chronic Outward Force (RCOF) in the labeledvessel diameters must meet acceptance criteria.	Pass
Austenitic Finish (Af)TransitionTemperature	The Af transition temperature shall be appropriate for clinical use.	Pass
Radiopacity	Proximal and distal ends of the retrieval device must beradiopaque.	Pass
System Surface Finish	The external surface of the effective length of the device shallappear free from extraneous matter, process and surfacedefects.	Pass
Device Deployment	It shall be possible to safely and reliably deploy the device asdescribed in the instructions for use without damage to thedevice.	Pass
Retraction into theMicrocatheter	It shall be possible to advance a representative microcatheterover the deployed device, at the site of deployment, until it isfully contained within the inner lumen of the microcatheterwithout damage to the device.	Pass
Delivery and Re-sheathing Forces	The maximum delivery and re-sheathing forces measuredduring simulated use clinical conditions.	Pass
Re-Sheathing	It shall be possible to re-sheath the device, as described in theinstructions for use, after it has been prepared, deployed andretracted as described in the instructions for use.	Pass
System TensileStrength	The minimum tensile strength of the thrombectomy system isevaluated to the acceptance criteria.	Pass
Torque Strength	The system must not break after 3 full rotations of the insertionwire.	Pass
Ancillary DeviceCompatibility	The device shall be compatible with ancillary devices as listedin the Directions for Use (DFU).	Pass

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Performance Testing - Animal

No animal testing was required to support substantial equivalence.

Clinical Data

No clinical testing was required to support substantial equivalence.

VIII. CONCLUSIONS

phenox Limited has demonstrated that the pRESET® LITE Thrombectomy Device is substantially equivalent to the pRESET® Thrombectomy Device (K222848) based on the same intended use, similar technological characteristics, similar materials, and the same operating principle. The differences in technological characteristics do not raise new questions of safety or effectiveness. Substantial equivalence is also supported by bench testing.

Regulation Number and Section

§ 882.5600 Neurovascular mechanical thrombectomy device for acute ischemic stroke treatment.

(a)
Identification. A neurovascular mechanical thrombectomy device for acute ischemic stroke treatment is a prescription device used in the treatment of acute ischemic stroke to improve clinical outcomes. The device is delivered into the neurovasculature with an endovascular approach, mechanically removes thrombus from the body, and restores blood flow in the neurovasculature.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The patient contacting components of the device must be demonstrated to be biocompatible.
(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including:
(i) Mechanical testing to demonstrate the device can withstand anticipated tensile, torsional, and compressive forces.
(ii) Mechanical testing to evaluate the radial forces exerted by the device.
(iii) Non-clinical testing to verify the dimensions of the device.
(iv) Non-clinical testing must demonstrate the device can be delivered to the target location in the neurovasculature and retrieve simulated thrombus under simulated use conditions.
(v) Non-clinical testing must demonstrate the device is radiopaque and can be visualized.
(vi) Non-clinical testing must evaluate the coating integrity and particulates under simulated use conditions.
(vii) Animal testing must evaluate the safety of the device, including damage to the vessels or tissue under anticipated use conditions.
(3) Performance data must support the sterility and pyrogenicity of the patient contacting components of the device.
(4) Performance data must support the shelf-life of the device by demonstrating continued sterility, package integrity, and device functionality over the specified shelf-life.
(5) Clinical performance testing of the device must demonstrate the device performs as intended for use in the treatment of acute ischemic stroke and must capture any adverse events associated with the device and procedure.
(6) The labeling must include:
(i) Information on the specific patient population for which the device is intended for use in the treatment of acute ischemic stroke, including but not limited to, specifying time from symptom onset, vessels or location of the neurovasculature that can be accessed for treatment, and limitations on core infarct size.
(ii) Detailed instructions on proper device preparation and use for thrombus retrieval from the neurovasculature.
(iii) A summary of the clinical testing results, including a detailed summary of the device- and procedure-related complications and adverse events.
(iv) A shelf life.