The device is indicated for mechanical de-clotting and controlled and selective infusion of physician specified fluids, including thrombolytics, in the peripheral vasculature.

Device Description

The ReVene Thrombectomy Catheter is a rotational venous thrombus extraction system for the treatment of vessels greater than 6mm diameter. The device is designed to be used in a medical catheter laboratory and allows for optional infusion of thrombolytic agents.

The device is compatible with a 10Fr introducer and includes a wire-braided cobalt chromium basket for thrombus disruption. A rotational thrombus-extractor, consisting of a helical coil housed inside a metal tube, is powered by an internal DC motor and batteries. The extractor runs the length of the catheter, and when activated, the coil rotates and is designed to macerate and transport thrombus from the basket to a collection container outside the body.

The main features of device are:

. The thrombus disruption cage
. The non-vessel contact thrombus extractor
. The handle

The ReVene Thrombectomy Catheter is packaged as a single unit and is sterilized using ethylene oxide. The device is provided sterile, non-pyrogenic and is for single-use only.

AI/ML Overview

This document is a 510(k) premarket notification for the "ReVene Thrombectomy Catheter" by Vetex Medical, Ltd. The information provided is for regulatory clearance based on substantial equivalence to a predicate device, not typically a study proving the device meets acceptance criteria of an AI/algorithm-based diagnostic device. The document describes various device performance tests for a mechanical thrombectomy catheter, an interventional medical device, not an AI or algorithm-based diagnostic tool.

Therefore, many of the requested criteria related to AI/algorithm development and validation (like sample size for training set, ground truth for training set, number of experts for ground truth, MRMC studies, standalone algorithm performance) are not applicable to this type of device submission.

However, I can extract the acceptance criteria and performance data for the mechanical thrombectomy catheter as described in the document, and highlight that this is not an AI/algorithm-based device study.

Here's a breakdown of the relevant information provided in the document:

1. A table of acceptance criteria and the reported device performance

The document states that "All tests met the pre-determined acceptance criteria" for various performance tests. It also specifies a primary performance endpoint for a clinical study.

Test/Performance Metric	Acceptance Criteria	Reported Device Performance
Bench Testing	(Implicit: Successful completion and meeting pre-determined pass/fail criteria for each test)	All tests met the pre-determined acceptance criteria.
Packaging and Labeling Inspection	(Implicit: Conformance to specifications)	Met acceptance criteria.
Pouch Peel Testing	(Implicit: Conformance to specifications)	Met acceptance criteria.
Bubble Leak Testing	(Implicit: Conformance to specifications)	Met acceptance criteria.
Radial Force Testing	(Implicit: Conformance to specifications)	Met acceptance criteria.
Conformity Assessment	(Implicit: Conformance to specifications)	Met acceptance criteria.
Catheter Integrity Testing (Tensile, Compression, Torque Resistance, Kink Resistance)	(Implicit: Conformance to specifications for each integrity aspect)	Met acceptance criteria.
Device Visual Dimensional Inspection	(Implicit: Conformance to specifications)	Met acceptance criteria.
Simulated Use Testing	(Implicit: Conformance to specifications)	Met acceptance criteria.
Post-use Inspection	(Implicit: Conformance to specifications)	Met acceptance criteria.
Corrosion Testing	(Implicit: Conformance to specifications)	Met acceptance criteria.
Radiopacity Testing	(Implicit: Conformance to specifications)	Met acceptance criteria.
Battery Life Testing	(Implicit: Conformance to specifications)	Met acceptance criteria.
Biocompatibility Evaluation	Compliance with ISO10993-1 and GLP (21 CFR Part 58)	ReVene Thrombectomy Catheter is biocompatible.
Shelf-life	12 months	Supported by aged testing.
Pre-Clinical Ovine Study	Device performs as intended for safety and performance.	Successfully evaluated; device will perform as intended.
Clinical Trial (Primary Performance Endpoint)	Achieving a Society of Interventional Radiology (SIR) Grade II Lysis (50-95% thrombus removal) or greater in the target vessel, with freedom from procedural related adverse events.	Met in 19/19 (100%) of subjects. No device-related adverse events. Device performed as intended.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size (Clinical Trial): 19 subjects were enrolled and treated.
Data Provenance: The document states it was a "multi-centre evaluation." While the country isn't explicitly stated for all centers, the submitter is Vetex Medical Ltd. from Galway, Ireland. The study was "prospective, non-randomized."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not an AI/algorithm-based diagnostic device where experts establish ground truth for images. The ground truth in the clinical study is based on direct observation of thrombus removal (SIR Grade Lysis) and adverse events by the treating clinicians/investigators. No specific number or qualification of experts for ground truth establishment is mentioned as it's not applicable in this context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication methods like 2+1 or 3+1 are typically for interpreting imaging data with multiple readers, which is not the primary focus here. For the clinical trial, the endpoint (SIR Grade II Lysis or greater and freedom from procedural adverse events) would have been assessed by the clinical investigators at each site, likely following pre-defined protocols. The document does not specify an adjudication method for this assessment.

5. 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, an MRMC comparative effectiveness study was not done. This is a thrombectomy catheter, not an AI assistance device for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a mechanical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the clinical study, the "ground truth" for efficacy was the Society of Interventional Radiology (SIR) Grade Lysis (a measurement of thrombus removal as assessed by imaging, presumably by the interventionalists) and freedom from procedural/device-related adverse events (outcomes data). For the animal study, it was also based on observed performance and safety.

8. The sample size for the training set

Not applicable. This is not an AI/algorithm device that requires a training set.

9. How the ground truth for the training set was established

Not applicable.

Summary

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December 22, 2020

Vetex Medical, Ltd. Mark Bruzzi CEO Business Innovation Center, NUI Galway Newcastle Road Galway, Ireland

Re: K201705

Trade/Device Name: ReVene Thrombectomy Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEW, KRA Dated: November 23, 2020 Received: November 24, 2020

Dear Mark Bruzzi:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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,

Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K201705

Device Name ReVene Thrombectomy Catheter

Indications for Use (Describe)

The device is indicated for mechanical de-clotting and controlled and selective infusion of physician specified fluids, including thrombolytics, in the peripheral vasculature.

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

Submitter:	Vetex Medical Ltd.,
	Business Innovation Centre,
	NUI, Galway, Newcastle Road,
	Galway, Ireland
Contact person:	Mark Bruzzi
	CEO
	Tel: +353 91 394795
Date Summary was prepared:	18 Dec 2020
Trade Name:	ReVene Thrombectomy Catheter
510(k) Number	K201705
Common/Usual Name:	Thrombectomy catheter
Classification Name:	Continuous Flush Catheter, (21 CFR 870.1210, product code KRA)
	Embolectomy Catheter, (21 CFR 870.5150, product code QEW)
Predicate device:	The Cleaner Rotational Thrombectomy System (K141617).
	This predicate device has not been subject to a design-related
	recall.
Reference devices:	No reference devices were used in this submission

Device Description

The main features of device are:

. The thrombus disruption cage
. The non-vessel contact thrombus extractor
. The handle

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The ReVene Thrombectomy Catheter is packaged as a single unit and is sterilized using ethylene oxide. The device is provided sterile, non-pyrogenic and is for single-use only.

Indications for Use

The ReVene Thrombectomy Catheter is indicated for mechanical de-clotting and controlled and selective infusion of physician specified fluids, including thrombolytics in the peripheral vasculature. The Indications for Use statement is identical to the predicate device.

Comparison of Technological Characteristics with the Predicate Device

The ReVene Thrombectomy Catheter is substantially equivalent to the Cleaner Rotational Thrombectomy System (K141617) in its intended use, principles of operation, design, materials, and sterile package configuration. The design differences have been evaluated through pre-clinical in vitro and in vivo testing.

Attribute	ReVene Thrombectomy Catheter	Cleaner Rotational Thrombectomy System (Cleaner XT and Cleaner 15)(K141617)
Intended Use	The device is intended for mechanical de-clotting and controlled and selective infusion of physician specified fluids, including thrombolytics, in the peripheral vasculature.	Same
Indications for use	The device is intended for mechanical de-clotting and controlled and selective infusion of physician specified fluids, including thrombolytics in the peripheral vasculature.	Substantially equivalent.Mechanical de-clotting of native vessel dialysis fistulae and synthetic dialysis access grafts.Mechanical de-clotting and controlled and selective infusion of physician specified fluids, including thrombolytics, in the peripheral vasculature.
Device Class	Class II	Same
Product Code	KRAQEW	KRA
Prescription Device	Yes	Same
Catheter Type	Mechanical Thrombectomy Catheter	Same

Table 1: Substantial Equivalence Comparison: ReVene versus Predicate Device

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Attribute	ReVene Thrombectomy Catheter	Cleaner Rotational ThrombectomySystem (Cleaner XT and Cleaner 15)(K141617)
Indicated Vessel Diameter	>6mm	Same
Sterilization Method	EtO	Same
Working Length	90cm	Substantially equivalent: 65cm, 135cm
Rotating wire	Yes	Same
Power source	Battery	Same
Voltage	9V	Same
Power activation	Switch located on handle	Same
Conditions of use	The device is used under fluoroscopyin a catheter lab	Same
Principle of operation	Mechanical clot disruption combinedwith extraction	Same
Access method	Access via introducer sheath	Same
Sheath compatibility	10F	Substantially equivalent: 7F
Radiopacity	Radiopaque marker band on distal end	Substantially equivalent. Radiopaque distal tip and sinusoidal wire.
Energy source Location	Battery & motor in device handle	Same

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Performance Testing

Vetex Medical Ltd. developed a design verification and validation bench testing program to evaluate the performance and safety of the ReVene Thrombectomy Catheter and testing included:

Packaging and labelling inspection
Pouch peel testing
Bubble leak testing
Radial force testing
Conformity assessment
. Catheter integrity testing:
- o Tensile testing
- o Compression testing
- O Torque resistance
- Kink resistance o
. & Device visual dimensional inspection
. Simulated Use testing
. Post-use inspection
. Corrosion testing
Radiopacity testing
Battery life testing

All tests met the pre-determined acceptance criteria. Aged testing has been performed to support a shelflife of 12 months for the ReVene Thrombectomy Catheter.

Biocompatibility Evaluation

A biological evaluation was performed to evaluate the biological risks associated with the ReVene Thrombectomy Catheter per FDA's Guidance Use of International Standard ISO10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process". Testing was performed in accordance with Good Laboratory Practices (GLP; 21 CFR Part 58) and results demonstrate the ReVene Thrombectomy Catheter is biocompatible for its intended use.

Pre-Clinical Ovine Study

The safety and performance of the ReVene Thrombectomy Catheter was successfully evaluated in an ovine model. The results demonstrate that the ReVene Thrombectomy Catheter will perform as intended.

Clinical Trial

The Venous Thrombus Extraction (VETEX) Clinical Study is an open label, prospective, non-randomized, multi-centre evaluation of the ReVene Thrombectomy Catheter for the treatment of acute iliofemoral deep vein thrombosis (DVT). A total of 19 subjects were enrolled and treated with the ReVene Thrombectomy Catheter. The Primary Performance Endpoint was met in 19/19 (100%) of subjects, with all subjects achieving a Society of Interventional Radiology (SIR) Grade II Lysis (50-95% thrombus removal) or greater in the target vessel, with freedom from procedural related adverse events. There were no

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device-related adverse events in any subject. The ReVene Thrombectomy Catheter performed as intended in all cases when used per the instructions for use. Note: Although this study evaluated the ReVene Thrombectomy Catheter in patients with DVT, the device is not indicated for treatment of DVT in the US.

Conclusion

Test results demonstrated that all acceptance criteria were met, and therefore, the device conforms to established product specifications and intended use. Based upon the technology, materials, intended use, non-clinical testing, and animal study results, it is concluded that the ReVene Thrombectomy Catheter is substantially equivalent to the predicate device. These results demonstrate that the ReVene Thrombectomy Catheter does not raise new questions of safety and effectiveness.

Regulation Number and Section

§ 870.5150 Embolectomy catheter.

(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).