The WOLF Thrombectomy System, 6F is indicated for the nonsurgical removal and thrombi from arterial and venous blood vessels in the peripheral vasculature.

The device is intended for single use only.

Device Description

The WOLF Thrombectomy® System, 6F is comprised of two single lumen variable stiffness catheters (WOLF catheter & Devortex shaft) designed for use in removing clot from peripheral vasculature. The Devortex shaft is attached to the Devortex sleeve which when pulled, ingests the clot into the WOLF catheter. The WOLF Thrombectomy System, 6F is delivered through an access sheath that has an inner diameter of at least 0.087". Both the WOLF catheter and Devortex shaft have hydrophilic coating to facilitate tracking and reduce friction during ingestion of the clot. The Devortex shaft has one radiopaque marker band to indicate the tip of the catheter during tracking. The WOLF catheter has a distal radiopaque marker band toindicate its distal tip during tracking and pulling. The Devortex sleeve also has a radiopaque polymer cuff that allows for visualization of the weave movement during use.

AI/ML Overview

The provided text is a 510(k) premarket notification for the WOLF Thrombectomy® System, 6F. While it outlines the device's indications for use, technical characteristics, and performance data from bench studies and biocompatibility testing, it does not contain information about a study proving the device meets specific acceptance criteria related to its clinical performance or an AI/algorithm component.

The document focuses on demonstrating substantial equivalence to existing predicate devices based on:

Indications for Use: The WOLF Thrombectomy® System, 6F is indicated for the non-surgical removal of emboli and thrombi from arterial and venous blood vessels in the peripheral vasculature. This is identical or very similar to the predicate devices.
Technological Characteristics: Comparison tables show similarities in regulation, product code, FDA classification, common/classification name, intended use, and general design features. Differences, like the inclusion of reloads and the absence of funnels (due to the 6F device's target vessel size), are presented as not raising new safety or effectiveness concerns.
Performance Data (Non-Clinical): Bench studies were conducted to confirm the device performs as intended, covering durability, integrity, kink resistance, torsion/tensile strength, leak testing, simulated use, coating integrity, particulate testing, and corrosion resistance. Sterilization, transit, package integrity, and shelf-life testing were also performed.
Biocompatibility Testing: Extensive testing per ISO-10993-1 was conducted due to the addition of colorants and a manufacturing process change.
Animal Testing: The document states that previous pre-clinical studies for the primary and secondary predicate devices support the safety and performance of the subject device, and animal testing was not repeated for the subject device.

Therefore, I cannot provide the requested information about acceptance criteria for clinical performance, an AI/algorithm component, or studies demonstrating such, because this information is not present in the provided 510(k) summary.

The 510(k) clearance process primarily relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring new clinical trials to establish de novo safety and effectiveness or specific performance metrics against clinical acceptance criteria. Had there been an AI component or a need for a clinical study to establish new performance claims, the submission would likely include an entirely different section detailing that evidence.

Summary

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August 27, 2021

DeVoro Medical, Inc. % Roberta Hines Regulatory Consultant Northwest Clinical Research Group, Inc. 19836 NE 125th Place Woodinville, Washington 98077

Re: K210530

Trade/Device Name: WOLF Thrombectomy® System, 6F Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEW Dated: August 23, 2021 Received: August 24, 2021

Dear Roberta Hines:

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 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,

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) K210530

Device Name WOLF Thrombectomy System, 6F

Indications for Use (Describe)

The WOLF Thrombectomy System, 6F is indicated for the nonsurgical removal and thrombi from arterial and venous blood vessels in the peripheral vasculature.

The device is intended for single use only.

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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TRADITIONAL 510(k) SUMMARY

DeVoro Medical, Inc. WOLF Thrombectomy® System, 6F

Submitter
Name:Address:	DeVoro Medical, Inc.46724 Lakeview BlvdFremont, CA 94538, USA
Contact:	Roberta Hines, Requlatory Consultant
Telephone:	425-766-0308
Email:	rhines@nwcrg.com
Date Prepared:	August 26, 2021
Trade Name of Device:	WOLF Thrombectomy® System, 6F
Common or Usual Name:	Embolectomy Catheter
Classification Name:	Catheter, Embolectomy
Regulation Number:	21 CFR 870.5150
Product Code:	QEW
Primary Predicate Device	880 Medical, LLC WOLF Thrombectomy Device(K182835) (now owned by DeVoro Medical, Inc.)
Secondary Predicate Device	DeVoro Medical, Inc. WOLF Thrombectomy V System(K200101)

Device Description

Indication for Use

The WOLF Thrombectomy System®, 6F is indicated for the nonsurgical removal of emboli and thrombi from arterial and venous blood vessels in the peripheral vasculature.

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Summary of Technological Characteristics

Comparative Evaluation of the DeVoro Medical WOLF Thrombectomy System, 6F to the Primary and Secondary Predicate
Devices

Manufacturer /Device	Device Subject ofTraditional 510(k)	Primary Predicate	Secondary Predicate
Device andManufacturer	WOLF Thrombectomy®System, 6F DeVoroMedical, Inc.	WOLF Thrombectomy Device(6F)880 Medical, Inc. (Nowowned by DeVoro Medical,Inc.)	WOLF Thrombectomy VSystem (10F) DeVoroMedical, Inc.
510(k) Number andDescription	K210530	K182835	K200101
Regulation	21 CFR 870.5150	21 CFR 870.5150	21 CFR 870.5150
RegulationDescription	An embolectomy catheter isa balloon-tippedcatheter thatis used to removethromboemboli, i.e., bloodclots which have migrated inblood vessels from one site inthe vascular tree to another.	An embolectomy catheter is aballoon-tipped catheter that is usedto remove thromboemboli, i.e.,blood clots which have migrated inblood vessels from one site in thevascular tree to another.	An embolectomy catheter is aballoon-tipped catheter that isused to remove thromboemboli,i.e., blood clots which havemigrated in blood vessels fromone site in the vascular tree toanother.
Product Code	QEW	QEW	QEW
FDA Classification	Class II	Class II	Class II
Common Name	Embolectomy Catheter	Embolectomy Catheter	Embolectomy Catheter
Classification Name	Peripheral MechanicalThrombectomy WithAspiration	Peripheral MechanicalThrombectomy With Aspiration	Peripheral MechanicalThrombectomy WithAspiration
Intended Use	To remove thromboembolifrom the peripheralvasculature.	To remove thromboembolifrom the peripheralvasculature.	To remove thromboembolifrom the peripheralvasculature.
Indication for Use	The WOLF ThrombectomyDevice is indicated for thenonsurgical removal ofemboli and thrombi fromarterial and venous bloodvessels in the peripheralvasculature.	The WOLF ThrombectomyDevice is indicated for thenonsurgical removal of emboliand thrombi from arterial bloodvessels in the peripheralvasculature.	The WOLF ThrombectomyDevice is indicated for thenonsurgical removal ofemboli and thrombi fromarterial and venous bloodvesselsin the peripheralvasculature.
Design Features andDesign Intent	The WOLF ThrombectomySystem, 6F consists of aWOLF Catheter with a pre-loaded Devortex shaft whichhas a nitinol Devortex sleeveattached to the distal end ofthe Devortex shaft, two (2)Devortex shaft reloads withremovable hubs, two (2)grabbing tools and aguidewire loading tool. TheWOLF Catheter and Devortexshaft are both single lumencomposite catheters whichare intended to be loadedcoaxially with each other. TheDevortex sleeve is fabricatedfrom fine, nitinol wire formedinto a desirable shape andattached to the Devortexshaft.	The WOLF Thrombectomy Deviceis comprised of two coaxial singlelumen catheters (WOLF Inner &Outer) designed foruse inremoving clot from peripheralvascularvessels. The WOLFDevice is delivered with athirdcoaxial catheter, a Guide Catheteror Sheath.The Inner catheter is attachedto the nitinol weave structurewhich when pulled, ingests theclot into the Outer catheterwhich is pulled into the GuideCatheter upon its removal.	The WOLF ThrombectomyDevice is comprised of twocoaxial single lumen catheters(WOLF Inner & Outer) designedfor use in removing clot fromperipheral vascular vessels. TheWOLFDevice is delivered with athird coaxial catheter, a Sheath.The Inner catheter is attachedto the nitinol weave structurewhich when pulled, ingests theclot into the Outer catheterwhich is pulled into the sheathupon its removal. The Outercatheter has a braided funnelattached to its distal end. Thefunnel assists the weave inremoving larger volumes ofclot, seen in larger bloodvessels (>4mm diam). Three
	If further clot ingestion isrequired, the Devortex shaftis fully removed from theWOLF Catheter andadditional Devortex shafts(Reloads) are reloaded intothe distalend of the WOLFCatheter by the user, asneeded.A Devortex Reload Kit ispackaged separately. The Kitincludes three (3) WOLFDevortex Reloads placed into apackaging hoop on a hoopcard. The additional Reloadsenable further clot ingestion ifdesired.		size funnel devices are offered;4mm, 6mm and 8mm ODfunnels.
	Visualization: Radiopaquemarker bands on fluoroscopyEffective Length: 110cm,140cmDevortex Reload Kit: 140cm	Visualization: Radiopaquemarker bands on fluoroscopyEffective Length: 152cm	Visualization: Radiopaquemarker bands on fluoroscopyEffective Length: 110cm, 130cm
	Catheter Outer Diameter: 6FVessel Compatibility: vessels	Catheter Outer Diameter: 6FVessel Compatibility: vessels	Catheter Outer Diameter: 10F
TechnologicalCharacteristics	larger 1.8mm	larger 1.8mm	Vessel Compatibility: vesselsthat are larger than the funnelOD for the specific device (4, 6or 8mm)
	Materials:Devortex sleeve: nitinol wirestructure with urethanetungsten polymer and on itsend. No hydrophilic coatingon sleeve.	Materials:Weave: nitinol wire structurewith urethane tungstenpolymer and on its end &hydrophilic coating onweave.	Materials:Weave: nitinol wire structure &a urethane polymer on its end.No hydrophilic coating onweave.
	Devortex shaft: stainlesssteel, Technora, Pebaxpolymers, colorant,Tungsten polymer, TPU Inkhydrophilic coating,polytetrafluoroethylene(PTFE), UV adhesive /cyanoacrylate.	Inner Catheter: stainless steel,platinum iridium, Technora, UVepoxy, Pebax polymers, colorant,urethane polymers, Vestamidpolymer, hydrophilic coating,polytetrafluoroethylene (PTFE), UVadhesive & cyanoacrylate.	Inner Catheter: stainless steel,platinum iridium, HDPE, LDPEand Pebax polymers,polytetrafluoroethylene (PTFE),UV adhesive / cyanoacrylate.Outer Catheter: stainless steel,Pebax polymers, nylon polymer,hydrophilic coating, PTFE,platinum iridium.
	WOLF Catheter: stainlesssteel, Pebax polymers,nylon polymer, hydrophiliccoating, TPU Ink, PTFE,platinum iridium. Threeadded colorants: white(titanium dioxide), yellow(iron oxide) & black (ironoxide).	Outer Catheter: nitinol, stainlesssteel, Pebaxpolymers, urethanepolymers, nylon polymer,colorant, hydrophilic coating,PTFE, platinum iridium, solderflux.Hub Materials: Stainless steel, TPUInk solder, flux, UV epoxy, siliconepolycarbonate, cyanoacrylate	Hub Materials: Polycarbonate,silicone, UV adhesive /cyanoacrylate.Peelaway Sheath: PTFE, poly-lactic acid, UV adhesive /cyanoacrylate.
	Hub Materials:Polycarbonate, silicone, UVadhesive / Cyanoacrylate,Cyanoacrylate, polyolefinPeelaway Sheath: PTFE,	Peelaway Sheath: PTFE
	CyanoacrylatePerformance: equivalent topredicate devices	Performance: meets productspecifications for its intendeduse	Performance: meets productspecifications for its intendeduse

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Guidewire compatibility:0.014"	Guidewire compatibility: 0.014"	Guidewire compatibility: 0.035"
Sterilization Method: EO and nonpyrogenic	Sterilization Method: EO and nonpyrogenic	Sterilization Method: EO and nonpyrogenic

The technical features of the WOLF Thrombectomy® System, 6F and the primary predicate device, the WOLF Thrombectomy Device (6F), are the same or similar including design components and the mechanism of action. Both devices have the same materials and come in multiple sleeves (weaves) and usable lenqths, are quidewire and sheath compatible with saline and contrast, are provided sterile and have the same sterilization method. Both devices are radiopague, have similar packaging, and are biocompatible for human use. Several studies conducted on the primary and secondary predicate devices apply to the subject device based on the similarities between them, including stability over time, pre-clinical safety and performance, compatibility with saline and contrast and some functional and simulated use testing. Both the WOLF subject device and both predicate devices are delivered through the femoral artery and contain radiopaque markers for visualization under fluoroscopy. The subject device reloads within the package are the secondary predicate device. Funnels, which are a design feature of the secondary predicate, are intended to treat larger vessels 4mm and larger. Since the 6F device is intended to treat 1.8mm or larger vessels, funnels are not required.

Performance Data

Bench studies indicate that the DeVoro Medical WOLF Thrombectomy® System, 6F performs as intended. The following testing was repeated in conformance with design inputs, including performance standards for peripheral vascular embolectomy devices. Testing included dimensional and functional design verification/validation (durability and integrity, kink resistance, torsion and tensile strength, air and liquid leak testing, catheter tip durability, simulated use validation, coating integrity, particulate testing, and corrosion resistance). Sterilization validation for the subject device through the Product Adoption method. Transit and package integrity testing, shelf life testing were also repeated on the subject device and its packaging. Supporting data from the acute and chronic animal study for the secondary predicate device apply to the subject device basedon substantial equivalence between the devices; therefore, this repeat testing was not required.

Biocompatibility Testing

Biocompatibility for the WOLF Thrombectomy® System, 6F was repeated due to the addition of three colorants (white (titanium dioxide), yellow (iron oxide), and one new manufacturing process change replacing a soldering joint process with a laser welding process. The following tests were conducted per the ISO-10993-1 standard including:

Cytotoxicity - MEM Elution
Sensitization - Guinea Pig Maximization Test, 2 extracts
. Irritation or Intracutaneous Reactivity
. Material Mediated Pyrogenicity
. Acute Systemic toxicity
. Direct and indirect hemolysis
. Complement activation assay
. Heparinized Platelet and Leukocyte Count Assay, with comparison Article

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. Partial thromboplastin time
. Thrombogenicity – In Vitro Blood Loop test

In addition to the biocompatibility tests listed above, testing for extractables was conducted on the WOLF Thrombectomy System, 6F.

The tests concluded that there are no chemical, toxicological, or safety risks from the WOLF Thrombectomy® System, 6F components, manufacturing procedures and sterilization process and the device is considered biocompatible for its intended use as ISO 10993-1 category: externally communicating device, limited < 24 hour contact with circulating blood exposure.

Sterilization Validation

Sterilization validation testing verified with a high degree of assurance that Ethylene Oxide sterilization is effective in achieving sterility of the WOLF Thrombectomy® System, 6F at a sterility assurance level of 10-6.

Package Integrity After Aging and Distribution

Packaging was verified to protect the WOLF Thrombectomy® System, 6F adequately to ensure product function throughout the claimed shelf life and after exposure to the storage and distribution environment.

Animal Testing

Previous pre-clinical studies for the device's primary and secondary predicates support the safety and performance of the WOLF Thrombectomy® System, 6F. Pre-clinical testing was not repeated for the subject device.

Conclusions

Based on a comparison of the intended use/indications for use, technological characteristics, and the results from a series of non-clinical tests, the WOLF Thrombectomy® System, 6F has demonstrated substantial equivalence to the predicate device. The differences between the devices and its expanded Indication for Use do not raise new questions of safety or 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).