The SmartClaw™ Thrombectomy Catheter is a mechanical thrombectomy catheter designed to work with commercially available sheaths sized 8F or larger. The device consists of an inner catheter shaft, outer catheter shaft, heat set nitinol braid, and an actuation handle attached to the proximal ends of the shafts. There are two device configurations that differ only in length of the expandable nitinol braided basket. The two configurations are identified by the maximum diameter of the expanded basket (20 mm, 32 mm).
The SmartClaw™ Thrombectomy Catheter is introduced through a commercially available sheath sized 8F or larger and delivered to the targeted vessel location under fluoroscopy and standard endovascular techniques using a commercially available guidewire. After it is delivered to the targeted vessel location, the catheter's distal nitinol basket is expanded by moving the handle slider proximally. Fluoroscopic guidance is used to ensure the expanded basket achieves a 1:1 ratio with the vessel diameter. Subsequently, the SmartClaw™ Thrombectomy Catheter is retracted proximally to pull loosened clot towards the sheath. Then, the clot is removed from the patient via aspiration or another commercially available clot removal method as appropriate for procedure requirements. After the clot is removed, the catheter's distal nitinol basket is collapsed, and the SmartClaw™ Thrombectomy Catheter is withdrawn from the targeted vessel location through the sheath.

AI/ML Overview

The provided document is a 510(k) Premarket Notification from the FDA for a medical device called the "SmartClaw™ Thrombectomy Catheter." This type of document is a regulatory submission for a device that is substantially equivalent to a predicate device, meaning it's not a new groundbreaking technology, but rather a modification or similar version of an already cleared device.

Therefore, the document does not describe a study that would establish new acceptance criteria or prove device performance in a clinical setting in the way an AI/software device would. Instead, it relies on demonstrating substantial equivalence to a predicate device through non-clinical performance data (bench testing and packaging validation).

Here's an analysis based on the information provided, highlighting why it doesn't fit the requested format for an AI device study:

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

The document does not provide a table of acceptance criteria and reported clinical device performance in the way an AI study would (e.g., sensitivity, specificity, AUC). Instead, it discusses bench testing performance criteria.

Acceptance Criteria (from Bench Testing)	Reported Device Performance
Visual inspection	Conforms
Dimension requirements	Conforms
Mechanical integrity	Conforms
Fluid leakage	Conforms
Kink resistance	Conforms
Torsion	Conforms
Guidewire compatibility	Conforms (0.035 in guidewire)
Sheath compatibility	Conforms (8F or larger)
Packaging integrity (ISO 11607-1, -2)	Conforms

The general statement for all bench tests is "The results of these tests demonstrate the subject 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."

2. Sample sized used for the test set and the data provenance

The document only mentions "performance evaluations" and "testing" for bench tests. It doesn't specify sample sizes for these tests, nor does it refer to "test sets" in the context of clinical data. Data provenance (country of origin, retrospective/prospective) is not applicable or provided as this is a physical device submission based on non-clinical data.

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

This information is not applicable as there is no clinical "test set" or "ground truth" derived from expert review in the context of an AI algorithm's performance. The "ground truth" for the non-clinical tests would be the established engineering specifications and standards.

4. Adjudication method for the test set

Not applicable, as there is no clinical test set requiring expert adjudication.

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

Not applicable. This is a physical medical device (catheter) and not an AI/software device. Therefore, no MRMC study or AI assistance effect size is discussed.

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

Not applicable, as this is not an AI algorithm.

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

For the non-clinical bench testing, the "ground truth" would be the engineering specifications, design parameters, and relevant ISO standards (e.g., ISO 11607-1 and ISO 11607-2 for packaging).

8. The sample size for the training set

Not applicable, as this is not an AI algorithm.

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

Not applicable, as this is not an AI algorithm.

In summary:

This FDA 510(k) submission is for a physical medical device, not an AI software. The "study" referenced is a series of non-clinical bench tests and packaging validations, intended to demonstrate the device's physical integrity and functionality, and its substantial equivalence to a previously cleared predicate device. It does not involve patient data, clinical outcomes, or expert review for diagnostic accuracy, which would be typical for an AI/software device submission. The acceptance criteria are engineering and performance specifications, not clinical performance metrics like sensitivity or specificity.

Summary

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May 29, 2024

DeVoro Medical, Inc. Aaron Lynch Regulatory Affairs Specialist II 10700 Bren Rd W Minnetonka, Minnesota 55343

Re: K241207

Trade/Device Name: SmartClaw™ Thrombectomy Catheter, 20 mm (FD0660-01), SmartClaw™ Thrombectomy Catheter, 32 mm (FD0660-02) Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEW Dated: April 30, 2024 Received: April 30, 2024

Dear Aaron Lynch:

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 OS 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,

Digitally signed by Gregory Gregorv W. W. O'connell -S Date: 2024.05.29 15:54:50 O'connell -S

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) K241207

Device Name

SmartClaw™ Thrombectomy Catheter, 20 mm (FD0660-01); SmartClaw™ Thrombectomy Catheter, 32 mm (FD0660-02)

Indications for Use (Describe)

The SmartClaw Thrombectomy Catheter is indicated for the non-surgical removal of thrombi and emboli from the peripheral vasculature.

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 for K241207 Per 21 CFR §807.92

Sponsor	DeVoro Medical, Inc.10700 Bren Rd WMinnetonka, MN 55343-9679
Contact Name andInformation	Aaron LynchRegulatory Affairs Specialist IIOne Scimed PlaceMaple Grove, MN 55311-1566 Phone: (508) 521-4235Email: aaron.lynch@bsci.com
Date Prepared	May 24, 2024
Proprietary Name	SmartClaw™ Thrombectomy Catheter, 20 mm (FD0660-01),SmartClaw™ Thrombectomy Catheter, 32 mm (FD0660-02)
Common Name	Catheter, EmbolectomyPeripheral Mechanical Thrombectomy with Aspiration
Primary ProductCode	QEW
Classification	Class II, 21 CFR Part 870.5150
Predicate Device	WOLF Thrombectomy™ SmartClaw Catheter (K221391), cleared onNovember 10, 2022
Device Description	The SmartClaw™ Thrombectomy Catheter is a mechanicalthrombectomy catheter designed to work with commercially availablesheaths sized 8F or larger. The device consists of an inner cathetershaft, outer catheter shaft, heat set nitinol braid, and an actuationhandle attached to the proximal ends of the shafts. There are twodevice configurations that differ only in length of the expandable nitinolbraided basket. The two configurations are identified by the maximumdiameter of the expanded basket (20 mm, 32 mm).The SmartClaw™ Thrombectomy Catheter is introduced through acommercially available sheath sized 8F or larger and delivered to thetargeted vessel location under fluoroscopy and standard endovasculartechniques using a commercially available guidewire. After it isdelivered to the targeted vessel location, the catheter's distal nitinolbasket is expanded by moving the handle slider proximally.Fluoroscopic guidance is used to ensure the expanded basket achievesa 1:1 ratio with the vessel diameter. Subsequently, the SmartClaw™Thrombectomy Catheter is retracted proximally to pull loosened clottowards the sheath. Then, the clot is removed from the patient viaaspiration or another commercially available clot removal method asappropriate for procedure requirements. After the clot is removed, thecatheter's distal nitinol basket is collapsed, and the SmartClaw™Thrombectomy Catheter is withdrawn from the targeted vessel locationthrough the sheath.
Intended Use ofDevice	Removal of thromboemboli from the peripheral vasculature
Indications for Use	The SmartClaw™ Thrombectomy Catheter is indicated for the non-surgical removal of thrombi and emboli from the peripheral vasculature.
Device TechnologyCharacteristics andComparison toPredicate Device	The SmartClaw™ Thrombectomy Catheter incorporates substantiallyequivalent design, packaging, fundamental technology, and intendeduse as those featured in the predicate, the WOLF Thrombectomy™SmartClaw Catheter (K221391). The subject device's indications foruse are being modified to remove reference to the WOLFThrombectomy Aspiration Sheath, 14F (K210911), thereby allowing theSmartClaw™ Thrombectomy Catheter to be used with commerciallyavailable sheaths sized 8F or larger.

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Characteristic	Subject DeviceSmartClaw™ Thrombectomy Catheter	Predicate DeviceWOLF Thrombectomy™ SmartClawCatheter (K221391)
Intended Use	Removal of thromboemboli from theperipheral vasculature	Identical
Indications for Use	The SmartClaw™ Thrombectomy Catheteris indicated for the non-surgical removal ofthrombi and emboli from the peripheralvasculature.	The WOLF Thrombectomy™ SmartClawCatheter, in conjunction with the WOLFThrombectomy Aspiration Sheath, 14F, isindicated for:The non-surgical removal of thrombiand emboli from arterial and venousblood vessels in the peripheralvasculature.Injection, infusion, and/or aspiration ofcontrast media and other fluids into orfrom a blood vessel.
Device Class	Class II per 21 CFR 870.5150	Identical
Catheter Design	Outer catheter shaft, inner catheter shaft,heat set nitinol braid, and actuation handle	Identical
Effective Length	145 cm	115 cm
How provided	Sterile, single use	Identical
SheathCompatibility	Commercially available sheaths sized 8F orlarger	WOLF Thrombectomy Aspiration Sheath,14F (K210911)
GuidewireCompatibility	Compatible with 0.035 in (0.89 mm)guidewire	Identical

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Characteristic	Subject DeviceSmartClaw™ Thrombectomy Catheter	Predicate DeviceWOLF Thrombectomy™ SmartClawCatheter (K221391)
Operating Principle/Mechanism ofAction	The SmartClaw™ Thrombectomy Catheteris delivered through a commerciallyavailable sheath of appropriate size (≥ 8F)into or beyond the clot. The SmartClaw™Thrombectomy Catheter is expanded to thevessel diameter via actuation of the handleslider. The SmartClaw™ ThrombectomyCatheter is retracted proximally to pullloosened clot towards the sheath. Then, theclot is removed from the patient viaaspiration or another commercially availableclot removal method as appropriate forprocedure requirements.	The WOLF Thrombectomy™ SmartClawCatheter is delivered through the WOLFSheath past the clot location. The WOLFThrombectomy™ SmartClaw Catheter isexpanded to the vessel diameter viaactuation of the handle slider. The WOLFThrombectomy™ SmartClaw Catheter ispulled moving the thrombus towards theWOLF Sheath. The clot is removed via theWOLF Sheath and/or the WOLFThrombectomy System.
Visualization	Radiopaque marker band, basket visibleunder fluoroscopy	Identical

Non-clinicalPerformance Data	Determination of substantial equivalence is based on an assessmentof non-clinical performance data.
	Non-clinical performance data includes bench-top performanceevaluations and packaging validations.
	Bench Testing:Bench testing was performed to evaluate physical integrity,functionality and performance of the catheter. Performance criteriaincludes: visual inspection; dimension requirements; mechanicalintegrity; fluid leakage; kink resistance; torsion; and guidewire andsheath compatibility.
	Packaging Validation:The integrity of the packaging configuration was evaluated inaccordance with ISO 11607-1 and ISO 11607-2. Testing wasconducted on fully packaged units after ethylene oxide sterilization,climatic conditioning, and distribution challenge conditioning.
	The results of these tests demonstrate the subject device has beendesigned and tested to assure conformance to the requirements forits intended use. No new safety or performance issues were raisedduring the testing.
Clinical Testing	Clinical studies are not required to demonstrate substantialequivalence of the SmartClaw Thrombectomy Catheter.
Conclusion	Based on the indications for use, technological characteristics, andperformance testing, the SmartClaw Thrombectomy Catheter hasbeen shown to be appropriate for its intended use and is consideredsubstantially equivalent to the WOLF Thrombectomy SmartClawCatheter (K221391).

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).