(29 days)
Not Found
No
The device description focuses on mechanical components and manual operation under fluoroscopic guidance. There is no mention of AI/ML in the device description, intended use, or performance studies.
Yes
The device is designed for the non-surgical removal of thrombi and emboli from the peripheral vasculature, which is a therapeutic intervention aimed at treating medical conditions.
No
The SmartClaw™ Thrombectomy Catheter is described as a mechanical thrombectomy catheter indicated for the non-surgical removal of thrombi and emboli. Its function is to remove clot, not to diagnose a condition. Fluoroscopy is mentioned as guidance for the procedure, not as a diagnostic tool of the device itself.
No
The device description clearly details a physical medical device (catheter, shafts, braid, handle) used for mechanical thrombectomy, not a software-only application.
Based on the provided information, the SmartClaw™ Thrombectomy Catheter is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is the "non-surgical removal of thrombi and emboli from the peripheral vasculature." This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The description details a mechanical device designed to physically interact with and remove blood clots from blood vessels.
- Mechanism of Action: The device works by expanding a basket within the vessel to capture and remove clots. This is a physical intervention, not a test performed on a sample outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are typically used to perform tests on samples taken from a patient (e.g., blood tests, urine tests, genetic tests) to provide diagnostic or other information. The SmartClaw™ Thrombectomy Catheter is a therapeutic device used for a medical procedure.
N/A
Intended Use / Indications for Use
The SmartClaw™ Thrombectomy Catheter is indicated for the non-surgical removal of thrombi and emboli from the peripheral vasculature.
Product codes (comma separated list FDA assigned to the subject device)
QEW
Device Description
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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical performance data includes bench-top performance evaluations and packaging validations.
Bench Testing: Bench testing was performed to evaluate physical integrity, functionality and performance of the catheter. Performance criteria includes: visual inspection; dimension requirements; mechanical integrity; fluid leakage; kink resistance; torsion; and guidewire and sheath compatibility.
Packaging Validation: The integrity of the packaging configuration was evaluated in accordance with ISO 11607-1 and ISO 11607-2. Testing was conducted on fully packaged units after ethylene oxide sterilization, climatic conditioning, and distribution challenge conditioning.
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.
Clinical studies are not required to demonstrate substantial equivalence of the SmartClaw Thrombectomy Catheter.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
WOLF Thrombectomy™ SmartClaw Catheter (K221391)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on top and "ADMINISTRATION" below. The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products.
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).
1
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
2
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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3
510(k) Summary for K241207 Per 21 CFR §807.92
| Sponsor | DeVoro Medical, Inc.
10700 Bren Rd W
Minnetonka, MN 55343-9679 |
|-------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name and
Information | Aaron Lynch
Regulatory Affairs Specialist II
One Scimed Place
Maple Grove, MN 55311-1566 Phone: (508) 521-4235
Email: 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, Embolectomy
Peripheral Mechanical Thrombectomy with Aspiration |
| Primary Product
Code | QEW |
| Classification | Class II, 21 CFR Part 870.5150 |
| Predicate Device | WOLF Thrombectomy™ SmartClaw Catheter (K221391), cleared on
November 10, 2022 |
| Device Description | 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. |
| Intended Use of
Device | 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 Technology
Characteristics and
Comparison to
Predicate Device | The SmartClaw™ Thrombectomy Catheter incorporates substantially
equivalent design, packaging, fundamental technology, and intended
use as those featured in the predicate, the WOLF Thrombectomy™
SmartClaw Catheter (K221391). The subject device's indications for
use are being modified to remove reference to the WOLF
Thrombectomy Aspiration Sheath, 14F (K210911), thereby allowing the
SmartClaw™ Thrombectomy Catheter to be used with commercially
available sheaths sized 8F or larger. |
4
| Characteristic | Subject Device
SmartClaw™ Thrombectomy Catheter | Predicate Device
WOLF Thrombectomy™ SmartClaw
Catheter (K221391) |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Removal of thromboemboli from the
peripheral vasculature | Identical |
| Indications for Use | The SmartClaw™ Thrombectomy Catheter
is indicated for the non-surgical removal of
thrombi and emboli from the peripheral
vasculature. | 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 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 |
| Sheath
Compatibility | Commercially available sheaths sized 8F or
larger | WOLF Thrombectomy Aspiration Sheath,
14F (K210911) |
| Guidewire
Compatibility | Compatible with 0.035 in (0.89 mm)
guidewire | Identical |
5
| Characteristic | Subject Device
SmartClaw™ Thrombectomy Catheter | Predicate Device
WOLF Thrombectomy™ SmartClaw
Catheter (K221391) |
|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Operating Principle/
Mechanism of
Action | The SmartClaw™ Thrombectomy Catheter
is delivered through a commercially
available sheath of appropriate size (≥ 8F)
into or beyond the clot. The SmartClaw™
Thrombectomy Catheter is expanded to the
vessel diameter via actuation of the handle
slider. 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. | The WOLF Thrombectomy™ SmartClaw
Catheter is delivered through the WOLF
Sheath past the clot location. The WOLF
Thrombectomy™ SmartClaw Catheter is
expanded to the vessel diameter via
actuation of the handle slider. The WOLF
Thrombectomy™ SmartClaw Catheter is
pulled moving the thrombus towards the
WOLF Sheath. The clot is removed via the
WOLF Sheath and/or the WOLF
Thrombectomy System. |
| Visualization | Radiopaque marker band, basket visible
under fluoroscopy | Identical |
| Non-clinical
Performance Data | Determination of substantial equivalence is based on an assessment
of non-clinical performance data. |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Non-clinical performance data includes bench-top performance
evaluations and packaging validations. |
| | Bench Testing:
Bench testing was performed to evaluate physical integrity,
functionality and performance of the catheter. Performance criteria
includes: visual inspection; dimension requirements; mechanical
integrity; fluid leakage; kink resistance; torsion; and guidewire and
sheath compatibility. |
| | Packaging Validation:
The integrity of the packaging configuration was evaluated in
accordance with ISO 11607-1 and ISO 11607-2. Testing was
conducted on fully packaged units after ethylene oxide sterilization,
climatic conditioning, and distribution challenge conditioning. |
| | 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. |
| Clinical Testing | Clinical studies are not required to demonstrate substantial
equivalence of the SmartClaw Thrombectomy Catheter. |
| Conclusion | Based on the indications for use, technological characteristics, and
performance testing, the SmartClaw Thrombectomy Catheter has
been shown to be appropriate for its intended use and is considered
substantially equivalent to the WOLF Thrombectomy SmartClaw
Catheter (K221391). |