(181 days)
No
The device description focuses on mechanical components and operation, and there are no mentions of AI, ML, or related concepts in the provided text.
Yes
The device is indicated for the non-surgical removal of thrombi and emboli from arterial and venous blood vessels, which directly treats a medical condition.
No
The device is designed for the non-surgical removal of thrombi and emboli, and for the injection/infusion/aspiration of fluids, which are therapeutic and procedural functions, not diagnostic ones.
No
The device description clearly outlines physical components such as an inner catheter shaft, outer catheter shaft, heat set nitinol braid, and an actuation handle assembly. The performance studies also include bench, animal, and biocompatibility testing, which are typical for physical medical devices, not software-only devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Function: The WOLF Thrombectomy SmartClaw Catheter is a surgical device used to physically remove thrombi and emboli from blood vessels within the body. It is an interventional device, not a device that analyzes samples outside the body.
- Intended Use: The intended use clearly describes a procedure performed directly on the patient's vasculature.
- Device Description: The description details a mechanical device with a catheter, nitinol basket, and handle for physical manipulation within the body.
- Testing: The performance studies focus on mechanical properties, biocompatibility, and animal studies, which are typical for interventional devices, not IVDs.
Therefore, the WOLF Thrombectomy SmartClaw Catheter is an interventional medical device, not an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes
QEW, KRA
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscopy
Anatomical Site
peripheral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Fogarty Venous Thrombectomy Catheter, 510(k) unknown
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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
2
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, Inc
46724 Lakeview Blvd.
Fremont, CA 94538
USA |
|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name and
Information | Vanessa Fowler
Principal Regulatory Affairs Specialist
One Scimed Place
Maple Grove, MN 55311-1566
Phone: 763-494-2537
Fax: 763-494-2222
e-mail: Vanessa.Fowler@bsci.com |
| Date Prepared | October 6, 2022 |
| Proprietary Name | WOLF Thrombectomy™ SmartClaw Catheter |
| Common Name | Catheter, Embolectomy
Peripheral Mechanical Thrombectomy with Aspiration |
| Primary Product Code | QEW |
| Subsequent Product
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
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. |
| Intended Use of
Device | Removal of thromboemboli from the peripheral vasculature. |
| 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. |
4
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 Thrombectomy
SmartClaw Catheter |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| Intended Use | Removal of thromboemboli from the
peripheral vasculature. | |
| Indications for
Use | The WOLF Thrombectomy System,
14F is indicated for: | SAME |
| | • 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. | SAME |
| Device Class | Class II per 21 CFR 870.5150 | |
| Materials | Nitinol weave structure attached to
polymer catheter. | Braided nitinol basket on polymer
catheter. |
| Operating
Principal | The inner catheter is attached to the
nitinol weave structure which
engages clot, and when pulled the
weave ingests the clot into the outer
catheter. | Nitinol basket is expanded and pulled to
remove thrombus.
Aspiration is applied via the WOLF sheath. |
| | Aspiration is applied via the WOLF
Sheath. | |
| Effective
Length | WOLF Catheter: 110 and 130 cm
configurations available.
WOLF Sheath: 75 or 95 cm
configurations available. | SmartClaw: 115 cm
SmartClaw is compatible with the 75 cm
WOLF sheath. |
| How provided | Sterile, single use | SAME |
| Guidewire
Compatibility | Compatible with 0.035" guidewire | SAME |
| Visualization | Radiopaque marker
bands visible
under fluoroscopy | Radiopaque marker band, basket visible
under fluoroscopy |
5
| 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). | |