(184 days)
Not Found
No
The device description and performance studies focus on mechanical aspects of clot removal and do not mention any AI/ML components or algorithms.
Yes
The device is indicated for the "nonsurgical removal and thrombi from arterial and venous blood vessels in the peripheral vasculature," which directly addresses a medical condition or health problem.
No
The device is described as a system for the nonsurgical removal of blood clots from blood vessels, which is a therapeutic function, not a diagnostic one.
No
The device description clearly outlines physical components (catheters, shaft, sleeve, marker bands) and mentions bench studies involving physical testing (durability, integrity, kink resistance, etc.), indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is the "nonsurgical removal and thrombi from arterial and venous blood vessels in the peripheral vasculature." This describes a therapeutic procedure performed directly on the patient's body to remove a physical obstruction (thrombi).
- Device Description: The device is a mechanical system (catheters, shaft, sleeve) designed to physically interact with and remove blood clots from within blood vessels.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used to diagnose, monitor, or screen for diseases or conditions.
This device is a therapeutic medical device used for a procedure within the body, not a diagnostic test performed on a sample outside the body.
N/A
Intended Use / Indications for Use
The WOLF Thrombectomy System, 6F is indicated for the nonsurgical removal and thrombi from arterial and venous blood vessels in the peripheral vasculature.
Product codes
QEW
Device Description
The WOLF Thrombectomy® System, 6F is comprised of two single lumen variable stiffness catheters (WOLF catheter & Devortex shaft) designed for use in removing clot from peripheral vasculature. The Devortex shaft is attached to the Devortex sleeve which when pulled, ingests the clot into the WOLF catheter. The WOLF Thrombectomy System, 6F is delivered through an access sheath that has an inner diameter of at least 0.087". Both the WOLF catheter and Devortex shaft have hydrophilic coating to facilitate tracking and reduce friction during ingestion of the clot. The Devortex shaft has one radiopaque marker band to indicate the tip of the catheter during tracking. The WOLF catheter has a distal radiopaque marker band toindicate its distal tip during tracking and pulling. The Devortex sleeve also has a radiopaque polymer cuff that allows for visualization of the weave movement during use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscopy
Anatomical Site
peripheral vasculature, arterial and venous blood vessels
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)
Bench studies indicate that the DeVoro Medical WOLF Thrombectomy® System, 6F performs as intended. The following testing was repeated in conformance with design inputs, including performance standards for peripheral vascular embolectomy devices. Testing included dimensional and functional design verification/validation (durability and integrity, kink resistance, torsion and tensile strength, air and liquid leak testing, catheter tip durability, simulated use validation, coating integrity, particulate testing, and corrosion resistance). Sterilization validation for the subject device through the Product Adoption method. Transit and package integrity testing, shelf life testing were also repeated on the subject device and its packaging. Supporting data from the acute and chronic animal study for the secondary predicate device apply to the subject device basedon substantial equivalence between the devices; therefore, this repeat testing was not required.
Biocompatibility for the WOLF Thrombectomy® System, 6F was repeated due to the addition of three colorants (white (titanium dioxide), yellow (iron oxide), and one new manufacturing process change replacing a soldering joint process with a laser welding process. The conducted tests concluded that there are no chemical, toxicological, or safety risks from the WOLF Thrombectomy® System, 6F components, manufacturing procedures and sterilization process and the device is considered biocompatible for its intended use as ISO 10993-1 category: externally communicating device, limited
§ 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 & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" in blue as well. The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products.
August 27, 2021
DeVoro Medical, Inc. % Roberta Hines Regulatory Consultant Northwest Clinical Research Group, Inc. 19836 NE 125th Place Woodinville, Washington 98077
Re: K210530
Trade/Device Name: WOLF Thrombectomy® System, 6F Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEW Dated: August 23, 2021 Received: August 24, 2021
Dear Roberta Hines:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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 (QS) 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,
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) K210530
Device Name WOLF Thrombectomy System, 6F
Indications for Use (Describe)
The WOLF Thrombectomy System, 6F is indicated for the nonsurgical removal and thrombi from arterial and venous blood vessels in the peripheral vasculature.
The device is intended for single use only.
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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3
TRADITIONAL 510(k) SUMMARY
DeVoro Medical, Inc. WOLF Thrombectomy® System, 6F
| Submitter | ||
|---|---|---|
| Name: | ||
| Address: | DeVoro Medical, Inc. | |
| 46724 Lakeview Blvd | ||
| Fremont, CA 94538, USA | ||
| Contact: | Roberta Hines, Requlatory Consultant | |
| Telephone: | 425-766-0308 | |
| Email: | rhines@nwcrg.com | |
| Date Prepared: | August 26, 2021 | |
| Trade Name of Device: | WOLF Thrombectomy® System, 6F | |
| Common or Usual Name: | Embolectomy Catheter | |
| Classification Name: | Catheter, Embolectomy | |
| Regulation Number: | 21 CFR 870.5150 | |
| Product Code: | QEW | |
| Primary Predicate Device | 880 Medical, LLC WOLF Thrombectomy Device | |
| (K182835) (now owned by DeVoro Medical, Inc.) | ||
| Secondary Predicate Device | DeVoro Medical, Inc. WOLF Thrombectomy V System | |
| (K200101) |
Device Description
The WOLF Thrombectomy® System, 6F is comprised of two single lumen variable stiffness catheters (WOLF catheter & Devortex shaft) designed for use in removing clot from peripheral vasculature. The Devortex shaft is attached to the Devortex sleeve which when pulled, ingests the clot into the WOLF catheter. The WOLF Thrombectomy System, 6F is delivered through an access sheath that has an inner diameter of at least 0.087". Both the WOLF catheter and Devortex shaft have hydrophilic coating to facilitate tracking and reduce friction during ingestion of the clot. The Devortex shaft has one radiopaque marker band to indicate the tip of the catheter during tracking. The WOLF catheter has a distal radiopaque marker band toindicate its distal tip during tracking and pulling. The Devortex sleeve also has a radiopaque polymer cuff that allows for visualization of the weave movement during use.
Indication for Use
The WOLF Thrombectomy System®, 6F is indicated for the nonsurgical removal of emboli and thrombi from arterial and venous blood vessels in the peripheral vasculature.
4
Summary of Technological Characteristics
Comparative Evaluation of the DeVoro Medical WOLF Thrombectomy System, 6F to the Primary and Secondary Predicate
Devices
| Manufacturer /
Device | Device Subject of
Traditional 510(k) | Primary Predicate | Secondary Predicate |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device and
Manufacturer | WOLF Thrombectomy®
System, 6F DeVoro
Medical, Inc. | WOLF Thrombectomy Device
(6F)880 Medical, Inc. (Now
owned by DeVoro Medical,
Inc.) | WOLF Thrombectomy V
System (10F) DeVoro
Medical, Inc. |
| 510(k) Number and
Description | K210530 | K182835 | K200101 |
| Regulation | 21 CFR 870.5150 | 21 CFR 870.5150 | 21 CFR 870.5150 |
| Regulation
Description | An embolectomy catheter is
a balloon-tippedcatheter 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. | 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. | 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. |
| Product Code | QEW | QEW | QEW |
| FDA Classification | Class II | Class II | Class II |
| Common Name | Embolectomy Catheter | Embolectomy Catheter | Embolectomy Catheter |
| Classification Name | Peripheral Mechanical
Thrombectomy With
Aspiration | Peripheral Mechanical
Thrombectomy With Aspiration | Peripheral Mechanical
Thrombectomy With
Aspiration |
| Intended Use | To remove thromboemboli
from the peripheral
vasculature. | To remove thromboemboli
from the peripheral
vasculature. | To remove thromboemboli
from the peripheral
vasculature. |
| Indication for Use | The WOLF Thrombectomy
Device is indicated for the
nonsurgical removal of
emboli and thrombi from
arterial and venous blood
vessels in the peripheral
vasculature. | The WOLF Thrombectomy
Device is indicated for the
nonsurgical removal of emboli
and thrombi from arterial blood
vessels in the peripheral
vasculature. | The WOLF Thrombectomy
Device is indicated for the
nonsurgical removal of
emboli and thrombi from
arterial and venous blood
vesselsin the peripheral
vasculature. |
| Design Features and
Design Intent | The WOLF Thrombectomy
System, 6F consists of a
WOLF Catheter with a pre-
loaded Devortex shaft which
has a nitinol Devortex sleeve
attached to the distal end of
the Devortex shaft, two (2)
Devortex shaft reloads with
removable hubs, two (2)
grabbing tools and a
guidewire loading tool. The
WOLF Catheter and Devortex
shaft are both single lumen
composite catheters which
are intended to be loaded
coaxially with each other. The
Devortex sleeve is fabricated
from fine, nitinol wire formed
into a desirable shape and
attached to the Devortex
shaft. | The WOLF Thrombectomy Device
is comprised of two coaxial single
lumen catheters (WOLF Inner &
Outer) designed foruse in
removing clot from peripheral
vascularvessels. The WOLF
Device is delivered with athird
coaxial catheter, a Guide Catheter
or Sheath.
The Inner catheter is attached
to the nitinol weave structure
which when pulled, ingests the
clot into the Outer catheter
which is pulled into the Guide
Catheter upon its removal. | The WOLF Thrombectomy
Device is comprised of two
coaxial single lumen catheters
(WOLF Inner & Outer) designed
for use in removing clot from
peripheral vascular vessels. The
WOLFDevice is delivered with a
third coaxial catheter, a Sheath.
The Inner catheter is attached
to the nitinol weave structure
which when pulled, ingests the
clot into the Outer catheter
which is pulled into the sheath
upon its removal. The Outer
catheter has a braided funnel
attached to its distal end. The
funnel assists the weave in
removing larger volumes of
clot, seen in larger blood
vessels (>4mm diam). Three |
| | If further clot ingestion is
required, the Devortex shaft
is fully removed from the
WOLF Catheter and
additional Devortex shafts
(Reloads) are reloaded into
the distalend of the WOLF
Catheter by the user, as
needed.
A Devortex Reload Kit is
packaged separately. The Kit
includes three (3) WOLF
Devortex Reloads placed into a
packaging hoop on a hoop
card. The additional Reloads
enable further clot ingestion if
desired. | | size funnel devices are offered;
4mm, 6mm and 8mm OD
funnels. |
| | Visualization: Radiopaque
marker bands on fluoroscopy
Effective Length: 110cm,
140cm
Devortex Reload Kit: 140cm | Visualization: Radiopaque
marker bands on fluoroscopy
Effective Length: 152cm | Visualization: Radiopaque
marker bands on fluoroscopy
Effective Length: 110cm, 130cm |
| | Catheter Outer Diameter: 6F
Vessel Compatibility: vessels | Catheter Outer Diameter: 6F
Vessel Compatibility: vessels | Catheter Outer Diameter: 10F |
| Technological
Characteristics | larger 1.8mm | larger 1.8mm | Vessel Compatibility: vessels
that are larger than the funnel
OD for the specific device (4, 6
or 8mm) |
| | Materials:
Devortex sleeve: nitinol wire
structure with urethane
tungsten polymer and on its
end. No hydrophilic coating
on sleeve. | Materials:
Weave: nitinol wire structure
with urethane tungsten
polymer and on its end &
hydrophilic coating on
weave. | Materials:
Weave: nitinol wire structure &
a urethane polymer on its end.
No hydrophilic coating on
weave. |
| | Devortex shaft: stainless
steel, Technora, Pebax
polymers, colorant,
Tungsten polymer, TPU Ink
hydrophilic coating,
polytetrafluoroethylene
(PTFE), UV adhesive /
cyanoacrylate. | Inner Catheter: stainless steel,
platinum iridium, Technora, UV
epoxy, Pebax polymers, colorant,
urethane polymers, Vestamid
polymer, hydrophilic coating,
polytetrafluoroethylene (PTFE), UV
adhesive & cyanoacrylate. | Inner Catheter: stainless steel,
platinum iridium, HDPE, LDPE
and Pebax polymers,
polytetrafluoroethylene (PTFE),
UV adhesive / cyanoacrylate.
Outer Catheter: stainless steel,
Pebax polymers, nylon polymer,
hydrophilic coating, PTFE,
platinum iridium. |
| | WOLF Catheter: stainless
steel, Pebax polymers,
nylon polymer, hydrophilic
coating, TPU Ink, PTFE,
platinum iridium. Three
added colorants: white
(titanium dioxide), yellow
(iron oxide) & black (iron
oxide). | Outer Catheter: nitinol, stainless
steel, Pebaxpolymers, urethane
polymers, nylon polymer,
colorant, hydrophilic coating,
PTFE, platinum iridium, solder
flux.
Hub Materials: Stainless steel, TPU
Ink solder, flux, UV epoxy, silicone
polycarbonate, cyanoacrylate | Hub Materials: Polycarbonate,
silicone, UV adhesive /
cyanoacrylate.
Peelaway Sheath: PTFE, poly-
lactic acid, UV adhesive /
cyanoacrylate. |
| | Hub Materials:
Polycarbonate, silicone, UV
adhesive / Cyanoacrylate,
Cyanoacrylate, polyolefin
Peelaway Sheath: PTFE, | Peelaway Sheath: PTFE | |
| | Cyanoacrylate
Performance: equivalent to
predicate devices | Performance: meets product
specifications for its intended
use | Performance: meets product
specifications for its intended
use |
5
6
| Guidewire compatibility:
| 0.014" | Guidewire compatibility: 0.014" | Guidewire compatibility: 0.035" |
|---|---|---|
| Sterilization Method: EO and nonpyrogenic | Sterilization Method: EO and nonpyrogenic | Sterilization Method: EO and nonpyrogenic |
The technical features of the WOLF Thrombectomy® System, 6F and the primary predicate device, the WOLF Thrombectomy Device (6F), are the same or similar including design components and the mechanism of action. Both devices have the same materials and come in multiple sleeves (weaves) and usable lenqths, are quidewire and sheath compatible with saline and contrast, are provided sterile and have the same sterilization method. Both devices are radiopague, have similar packaging, and are biocompatible for human use. Several studies conducted on the primary and secondary predicate devices apply to the subject device based on the similarities between them, including stability over time, pre-clinical safety and performance, compatibility with saline and contrast and some functional and simulated use testing. Both the WOLF subject device and both predicate devices are delivered through the femoral artery and contain radiopaque markers for visualization under fluoroscopy. The subject device reloads within the package are the secondary predicate device. Funnels, which are a design feature of the secondary predicate, are intended to treat larger vessels 4mm and larger. Since the 6F device is intended to treat 1.8mm or larger vessels, funnels are not required.
Performance Data
Bench studies indicate that the DeVoro Medical WOLF Thrombectomy® System, 6F performs as intended. The following testing was repeated in conformance with design inputs, including performance standards for peripheral vascular embolectomy devices. Testing included dimensional and functional design verification/validation (durability and integrity, kink resistance, torsion and tensile strength, air and liquid leak testing, catheter tip durability, simulated use validation, coating integrity, particulate testing, and corrosion resistance). Sterilization validation for the subject device through the Product Adoption method. Transit and package integrity testing, shelf life testing were also repeated on the subject device and its packaging. Supporting data from the acute and chronic animal study for the secondary predicate device apply to the subject device basedon substantial equivalence between the devices; therefore, this repeat testing was not required.
Biocompatibility Testing
Biocompatibility for the WOLF Thrombectomy® System, 6F was repeated due to the addition of three colorants (white (titanium dioxide), yellow (iron oxide), and one new manufacturing process change replacing a soldering joint process with a laser welding process. The following tests were conducted per the ISO-10993-1 standard including:
- Cytotoxicity - MEM Elution
- Sensitization - Guinea Pig Maximization Test, 2 extracts
- . Irritation or Intracutaneous Reactivity
- . Material Mediated Pyrogenicity
- . Acute Systemic toxicity
- . Direct and indirect hemolysis
- . Complement activation assay
- . Heparinized Platelet and Leukocyte Count Assay, with comparison Article
7
- . Partial thromboplastin time
- . Thrombogenicity – In Vitro Blood Loop test
In addition to the biocompatibility tests listed above, testing for extractables was conducted on the WOLF Thrombectomy System, 6F.
The tests concluded that there are no chemical, toxicological, or safety risks from the WOLF Thrombectomy® System, 6F components, manufacturing procedures and sterilization process and the device is considered biocompatible for its intended use as ISO 10993-1 category: externally communicating device, limited