WOLF Thrombectomy™ SmartClaw Catheter

K221391 · Devoro Medical, Inc. · QEW · Nov 10, 2022 · Cardiovascular

Device Facts

• Record ID: K221391
• Device Name: WOLF Thrombectomy™ SmartClaw Catheter
• Applicant: Devoro Medical, Inc.
• Product Code: QEW · Cardiovascular
• Decision Date: Nov 10, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The WOLF Thrombectomy SmartClaw Catheter, in conjunction with the WOLF Thrombectomy Aspiration Sheath, 14F, is indicated for: • the non-surgical removal of thrombi and emboli from arterial and venous blood vessels in the peripheral vasculature. • Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.

Device Story

The WOLF Thrombectomy SmartClaw Catheter is a mechanical thrombectomy device used in conjunction with the WOLF Thrombectomy Aspiration Sheath (14F). It consists of an inner and outer catheter shaft, a heat-set nitinol braided basket, and an actuation handle. Operated by a physician under fluoroscopic guidance, the device is delivered to the target vessel over a standard 0.035" guidewire. The operator moves the handle slider proximally to expand the nitinol basket within the vessel to engage the clot. The clot is then pulled proximally toward the aspiration sheath, where it is removed via aspiration. The device is intended for use in peripheral arterial and venous vasculature. It provides a mechanical means to clear obstructions, potentially restoring blood flow and improving patient outcomes in cases of thromboembolism.

Clinical Evidence

No human clinical data provided. Evidence consists of bench testing (simulated use, corrosion, torsion, trackability, dimensional verification, mechanical integrity, kink resistance, packaging validation), biocompatibility testing (cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, pyrogenicity, hemocompatibility, complement activation, PTT, platelet/leukocyte counts), and a GLP animal study to evaluate safety.

Technological Characteristics

Device comprises a braided nitinol basket on a polymer catheter shaft with an actuation handle. Radiopaque marker bands are included for fluoroscopic visualization. Compatible with 0.035" guidewires. Provided sterile, single-use. No software or electronic components.

Indications for Use

Indicated for non-surgical removal of thrombi and emboli from arterial and venous blood vessels in the peripheral vasculature, and for injection, infusion, or aspiration of contrast media/fluids in patients requiring peripheral thrombectomy.

Regulatory Classification

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.

Predicate Devices

• WOLF Thrombectomy System, 14F (K210911)

Reference Devices

• Fogarty Venous Thrombectomy Catheter

Submission Summary (Full Text)

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November 10, 2022

DeVoro Medical, Inc Vanessa Fowler Principal Regulatory Affairs Specialist One Scimed Place Maple Grove, MN 55311

Re: K221391

Trade/Device Name: WOLF Thrombectomy SmartClaw Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEW, KRA Dated: October 6, 2022 Received: October 6, 2022

Dear Vanessa Fowler:

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

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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 (OS) 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Image /page/1/Picture/5 description: This image shows a digital signature for Sara M. Royce -S, dated 2022.11.10 at 14:55:45 -05'00'. The signature is for Gregory O'Connell, Assistant Director. The text also mentions DHT2C: Division of Coronary and Peripheral Intervention Devices, OHT2: Office of Cardiovascular Devices, Office of Product Evaluation and Quality, and Center for Devices and Radiological Health.

Enclosure

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# Indications for Use

510(k) Number (if known) K221391

#### Device Name

WOLF Thrombectomy SmartClaw Catheter

### Indications for Use (Describe)

The WOLF Thrombectorny SmartClaw Catheter, in conjunction with the WOLF Thrombectomy Aspiration Sheath, 14F, is indicated for:

- · the non-surgical removal of thrombi and emboli from arterial and venous blood vessels in the peripheral vasculature.
- · Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size:16px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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| 510(k) Summary for K221391 |
|----------------------------|
| Per 21 CFR §807.92 |

| Sponsor | DeVoro Medical, Inc<br>46724 Lakeview Blvd.<br>Fremont, CA 94538<br>USA |
|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name and<br>Information | Vanessa Fowler<br>Principal Regulatory Affairs Specialist<br>One Scimed Place<br>Maple Grove, MN 55311-1566<br>Phone: [phone]<br>Fax: [phone]<br>e-mail: [e-mail] |
| Date Prepared | October 6, 2022 |
| Proprietary Name | WOLF Thrombectomy™ SmartClaw Catheter |
| Common Name | Catheter, Embolectomy<br>Peripheral Mechanical Thrombectomy with Aspiration |
| Primary Product Code | QEW |
| Subsequent Product<br>Code | KRA |
| Classification | Class II, 21 CFR Part 870.5150 |
| Predicate Device | WOLF Thrombectomy System, 14F (K210911), cleared October 19, 2021 |
| Reference Device | Fogarty Venous Thrombectomy Catheter, 510(k) unknown |
| Device Description | The WOLF Thrombectomy SmartClaw Catheter is a thrombectomy catheter<br>designed to work solely with the currently marketed WOLF Thrombectomy<br>Sheath (K210911). The device consists of an inner catheter shaft, outer<br>catheter shaft, heat set nitinol braid, and an actuation handle assembly<br>connected to the proximal ends of the shafts. There are two device<br>configurations that only differ in length of the expandable nitinol braided<br>basket. The two configurations are identified by the max diameter of the<br>expanded basket (20mm, 32mm).<br><br>The WOLF Thrombectomy SmartClaw Catheter is introduced through the<br>WOLF Sheath and delivered to the targeted vessel location under fluoroscopy<br>and standard endovascular techniques using a commercially available<br>guidewire. The distal nitinol basket is expanded by moving the handle slider<br>proximally and the clot may then be pulled proximally towards and aspirated<br>through the WOLF Sheath. |
| Intended Use of<br>Device | Removal of thromboemboli from the peripheral vasculature. |
| Indications for Use | The WOLF Thrombectomy SmartClaw Catheter, in conjunction with the<br>WOLF Thrombectomy Aspiration Sheath, 14F, is indicated for:<br>• the non-surgical removal of thrombi and emboli from arterial and venous<br>blood vessels in the peripheral vasculature.<br>• Injection, infusion, and/or aspiration of contrast media and other fluids into<br>or from a blood vessel. |

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Comparison of Device The WOLF Thrombectomy SmartClaw Catheter, as used with the WOLF Thrombectomy Aspiration Sheath 14F, incorporates substantially equivalent Characteristics design, packaging, fundamental technology, and intended use as those featured in the predicate, the WOLF Thrombectomy System, 14F.See table below for additional detail.

| Characteristics | Predicate Device -<br>WOLF Thrombectomy System 14F | Subject Device - WOLF Thrombectomy<br>SmartClaw Catheter |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| Intended Use | Removal of thromboemboli from the<br>peripheral vasculature. | |
| Indications for<br>Use | The WOLF Thrombectomy System,<br>14F is indicated for: | SAME |
| | • the non-surgical removal of thrombi<br>and emboli from arterial and venous<br>blood vessels in the peripheral<br>vasculature. | |
| | • Injection, infusion, and/or aspiration<br>of contrast media and other fluids into<br>or from a blood vessel. | SAME |
| Device Class | Class II per 21 CFR 870.5150 | |
| Materials | Nitinol weave structure attached to<br>polymer catheter. | Braided nitinol basket on polymer<br>catheter. |
| Operating<br>Principal | The inner catheter is attached to the<br>nitinol weave structure which<br>engages clot, and when pulled the<br>weave ingests the clot into the outer<br>catheter. | Nitinol basket is expanded and pulled to<br>remove thrombus.<br>Aspiration is applied via the WOLF sheath. |
| | Aspiration is applied via the WOLF<br>Sheath. | |
| Effective<br>Length | WOLF Catheter: 110 and 130 cm<br>configurations available.<br>WOLF Sheath: 75 or 95 cm<br>configurations available. | SmartClaw: 115 cm<br>SmartClaw is compatible with the 75 cm<br>WOLF sheath. |
| How provided | Sterile, single use | SAME |
| Guidewire<br>Compatibility | Compatible with 0.035" guidewire | SAME |
| Visualization | Radiopaque marker<br>bands visible<br>under fluoroscopy | Radiopaque marker band, basket visible<br>under fluoroscopy |

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| Performance Data | Bench, animal, and biocompatibility testing were performed to support a determination of substantial equivalence. The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the testing.<br><br>The following biocompatibility tests were completed on the WOLF Thrombectomy SmartClaw Catheter: | |
|------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | ● Cytotoxicity<br>● Sensitization<br>● Intracutaneous Reactivity<br>● Acute Systemic Toxicity<br>● Materials Mediated Pyrogenicity | ● Extract and Direct Contact Hemolysis<br>● Complement Activation<br>● Partial Thromboplastin Time<br>● In Vitro Hemocompatibility<br>● Platelet and Leukocyte Counts |
| | The following <i>in-vitro</i> performance tests were completed for the WOLF Thrombectomy SmartClaw Catheter. | |
| | ● Simulated Use<br>● Corrosion<br>● Torsion<br>● Trackability | ● Dimensional Verification<br>● Mechanical Integrity<br>● Kink Resistance<br>● Packaging Validation |
| | Additionally, a GLP animal study was performed to evaluate equivalent safety of the WOLF Thrombectomy SmartClaw Catheter. | |
| Conclusion | Based on the indications for use, technological characteristics, and safety and performance testing, the WOLF Thrombectomy SmartClaw Catheter has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the WOLF Thrombectomy System. 14F (K210911). | |