(181 days)
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.
The WOLF Thrombectomy SmartClaw Catheter is a thrombectomy catheter designed to work solely with the currently marketed WOLF Thrombectomy Sheath (K210911). The device consists of an inner catheter shaft, outer catheter shaft, heat set nitinol braid, and an actuation handle assembly connected to the proximal ends of the shafts. There are two device configurations that only differ in length of the expandable nitinol braided basket. The two configurations are identified by the max diameter of the expanded basket (20mm, 32mm).
The WOLF Thrombectomy SmartClaw Catheter is introduced through the WOLF Sheath and delivered to the targeted vessel location under fluoroscopy and standard endovascular techniques using a commercially available guidewire. The distal nitinol basket is expanded by moving the handle slider proximally and the clot may then be pulled proximally towards and aspirated through the WOLF Sheath.
The provided text is a 510(k) Summary for the WOLF Thrombectomy SmartClaw Catheter. It describes the device, its intended use, and a comparison to a predicate device. However, it does not contain specific acceptance criteria or a study that directly proves the device meets those criteria in a quantifiable manner (e.g., sensitivity, specificity, or improvement in human reader performance).
The "Performance Data" section lists various types of tests performed (biocompatibility, in-vitro performance, and an animal study) to support substantial equivalence. It states that "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" and "No new safety or performance issues were raised during the testing." However, detailed results, numerical acceptance criteria, or a description of how these tests prove the device meets specific acceptance criteria relevant to an AI/ML device's performance evaluation (which seem to be the focus of the request) are not provided.
Therefore, for the information requested, I can only provide what is available, which is very limited for an AI/ML context.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table of acceptance criteria and reported device performance in a quantitative manner that would be typical for an AI/ML device (e.g., sensitivity, specificity thresholds). It only broadly states that the device was tested to assure conformance to its intended use and raised no new safety or performance issues.
2. Sample size used for the test set and the data provenance
Not applicable. The document discusses bench testing, biocompatibility testing, and an animal study, not a clinical test set with human subject data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The document does not describe a process for establishing ground truth using experts for a test set, as would be relevant for an AI/ML device.
4. Adjudication method for the test set
Not applicable.
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. The WOLF Thrombectomy SmartClaw Catheter is a medical device for thrombectomy, not an AI/ML diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. For the performance data listed (bench, animal, biocompatibility), the "ground truth" would be the direct measurement of physical properties, biological responses, or clinical outcomes in the animal study, which are not detailed.
8. The sample size for the training set
Not applicable. This device is not an AI/ML product that undergoes training.
9. How the ground truth for the training set was established
Not applicable.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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) | |
|---|---|
| ☒ 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 K221391 |
|---|
| Per 21 CFR §807.92 |
| Sponsor | DeVoro Medical, Inc46724 Lakeview Blvd.Fremont, CA 94538USA |
|---|---|
| Contact Name andInformation | Vanessa FowlerPrincipal Regulatory Affairs SpecialistOne Scimed PlaceMaple Grove, MN 55311-1566Phone: 763-494-2537Fax: 763-494-2222e-mail: Vanessa.Fowler@bsci.com |
| Date Prepared | October 6, 2022 |
| Proprietary Name | WOLF Thrombectomy™ SmartClaw Catheter |
| Common Name | Catheter, EmbolectomyPeripheral Mechanical Thrombectomy with Aspiration |
| Primary Product Code | QEW |
| Subsequent ProductCode | 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 catheterdesigned to work solely with the currently marketed WOLF ThrombectomySheath (K210911). The device consists of an inner catheter shaft, outercatheter shaft, heat set nitinol braid, and an actuation handle assemblyconnected to the proximal ends of the shafts. There are two deviceconfigurations that only differ in length of the expandable nitinol braidedbasket. The two configurations are identified by the max diameter of theexpanded basket (20mm, 32mm).The WOLF Thrombectomy SmartClaw Catheter is introduced through theWOLF Sheath and delivered to the targeted vessel location under fluoroscopyand standard endovascular techniques using a commercially availableguidewire. The distal nitinol basket is expanded by moving the handle sliderproximally and the clot may then be pulled proximally towards and aspiratedthrough the WOLF Sheath. |
| Intended Use ofDevice | Removal of thromboemboli from the peripheral vasculature. |
| Indications for Use | The WOLF Thrombectomy SmartClaw Catheter, in conjunction with theWOLF Thrombectomy Aspiration Sheath, 14F, is indicated for:• the non-surgical removal of thrombi and emboli from arterial and venousblood vessels in the peripheral vasculature.• Injection, infusion, and/or aspiration of contrast media and other fluids intoor 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 -WOLF Thrombectomy System 14F | Subject Device - WOLF ThrombectomySmartClaw Catheter |
|---|---|---|
| Intended Use | Removal of thromboemboli from theperipheral vasculature. | |
| Indications forUse | The WOLF Thrombectomy System,14F is indicated for: | SAME |
| • the non-surgical removal of thrombiand emboli from arterial and venousblood vessels in the peripheralvasculature. | ||
| • Injection, infusion, and/or aspirationof contrast media and other fluids intoor from a blood vessel. | SAME | |
| Device Class | Class II per 21 CFR 870.5150 | |
| Materials | Nitinol weave structure attached topolymer catheter. | Braided nitinol basket on polymercatheter. |
| OperatingPrincipal | The inner catheter is attached to thenitinol weave structure whichengages clot, and when pulled theweave ingests the clot into the outercatheter. | Nitinol basket is expanded and pulled toremove thrombus.Aspiration is applied via the WOLF sheath. |
| Aspiration is applied via the WOLFSheath. | ||
| EffectiveLength | WOLF Catheter: 110 and 130 cmconfigurations available.WOLF Sheath: 75 or 95 cmconfigurations available. | SmartClaw: 115 cmSmartClaw is compatible with the 75 cmWOLF sheath. |
| How provided | Sterile, single use | SAME |
| GuidewireCompatibility | Compatible with 0.035" guidewire | SAME |
| Visualization | Radiopaque markerbands visibleunder fluoroscopy | Radiopaque marker band, basket visibleunder 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.The following biocompatibility tests were completed on the WOLF Thrombectomy SmartClaw Catheter: | |
|---|---|---|
| ● Cytotoxicity● Sensitization● Intracutaneous Reactivity● Acute Systemic Toxicity● Materials Mediated Pyrogenicity | ● Extract and Direct Contact Hemolysis● Complement Activation● Partial Thromboplastin Time● In Vitro Hemocompatibility● Platelet and Leukocyte Counts | |
| The following in-vitro performance tests were completed for the WOLF Thrombectomy SmartClaw Catheter. | ||
| ● Simulated Use● Corrosion● Torsion● Trackability | ● Dimensional Verification● Mechanical Integrity● Kink Resistance● 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). |
§ 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).